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ULTAMET Past Trial Coverage

Openings Coverage

Trial Proceedings Coverage

Verdict Coverage

Jury Awards $500 Million to Plaintiffs in Johnson & Johnson Hip Case
Mar 17, 2016 | Wall Street Journal
By Lisa Beilfuss

A federal jury in Dallas on Thursday awarded $500 million to five people who said they had suffered physical problems after receiving a certain type of hip implant manufactured by a subsidiary of Johnson & Johnson, a decision the company intends to appeal.
Johnson & Johnson hit with $500 mln verdict in trial over hip implants
Mar 17, 2016 | Reuters
By Jessica Dye

Johnson & Johnson and its DePuy unit were ordered by a Texas federal jury on Thursday to pay a total of about $500 million to five plaintiffs who said they were injured by Pinnacle metal-on-metal hip implants.
J&J Ordered to Pay $502 Million Over Pinnacle Hip Failures
Mar 17, 2016 | Bloomberg
By Tom Korosec and Jef Feely

Johnson & Johnson was ordered to pay $502 million to a group of patients who accused the company of hiding flaws in its Pinnacle artificial hips that caused the devices to prematurely fail and left them facing surgeries and pain, in J&J’s first loss over the products.
$500M Verdict in Hip Implant Case
Mar 17, 2016 | National Law Journal
By Amanda Bronstad

Johnson & Johnson and its subsidiary were hit with a $500 million verdict on Thursday after a federal jury in Texas found gross negligence and fraud in connection with the defective design of a hip implant.
Johnson & Johnson (JNJ) Stock Declines, Ordered to Pay $502 Million in Hip Implant Suit
Mar 17, 2016 | TheStreet
By Rachel Graf

Johnson & Johnson (JNJ - Get Report) stock is retreating 0.59% to $106.78 in late-afternoon trading on Thursday after the pharmaceutical company and its DePuy unit were ordered to pay $502 million to five plaintiffs who claimed they were injured by hip implants.
Johnson & Johnson must pay $502 million settlement over hip devices
Mar 17, 2016 | Modern Healthcare
By Lisa Schencker

A federal jury decided Thursday that Johnson & Johnson must pay five Texans $502 million for injuries caused by defective hip replacement devices. The outcome could affect how similar cases filed by another 7,000 plaintiffs are resolved.
J&J slapped with $500M verdict in metal-on-metal hip implant cases
Mar 17, 2016 | Fierce Medical Devices
By Emily Wasserman

Johnson & Johnson ($JNJ) is facing a dark chapter in its legal saga over its Pinnacle devices. A federal jury ordered the company to fork over $500 million to 5 plaintiffs who claimed injuries from J&J's metal-on-metal hip implants.
DePuy Must Pay $498M for Hip Implant Injuries
Sep 17, 2016 | Courthouse News Service
By David Lee

A federal jury in Dallas ruled Thursday that DePuy Orthopaedics should pay five Texas a total $498 million for severe medical complications they suffered as a result of the company's defective metal-on-metal hip implants.
Jury slaps Johnson & Johnson with $500m verdict in Pinnacle hip bellwether
Mar 17, 2016 | Mass Device
By Brad Perriello

A Texas federal jury today slapped Johnson & Johnson (NYSE:JNJ) subsidiary DePuy Orthopaedics with a $500 million judgment in favor of a quintet of plaintiffs who said the metal-on-metal Pinnacle hip implant caused their injuries.
Jury Awards $497M In 5-Case Pinnacle Hip Bellwether Trial
Mar 17, 2016 | Lexis Legal News

A Texas federal jury on March 17 returned a $497 million verdict in a five-case Pinnacle hip multidistrict litigation bellwether trial, according to plaintiff attorney W. Mark Lanier of the Lanier Firm in Houston (Margaret Aoki v. Johnson & Johnson Services, Inc., et al., No. 13-1071, Jacqueline Christopher v. Johnson & Johnson Services, Inc., et al., No. 14-194, Donald Greer v. Johnson & Johnson Services, Inc., et al., No. 12-1672, Susan Klusmann v. Johnson & Johnson Services, Inc., et al., No. 11-2800, and Robert Peterson v. Johnson & Johnson Services, Inc., et al., No. 11-1941, N.D. Texas, Dallas Div.).
Dallas jury awards $502 million to five hip implant victims
Mar 17, 2016 | Texas Law Book
By Mark Curriden

A federal jury in Dallas ruled Thursday that severe medical problems suffered by five Texans were the result of defective metal-on-metal hip implants manufactured by DePuy Orthopaedics Inc., a subsidiary of Johnson & Johnson.
J&J Hit With $498M Verdict In 2nd Pinnacle Bellwether Trial
Mar 17, 2016 | Law360
By Sindhu Sundar

Johnson & Johnson was hit with an eye-popping $497.6 million verdict Thursday in the second bellwether trial in the multidistrict litigation over allegedly defective Pinnacle hip prosthetics manufactured by its DePuy Orthopaedics Inc. unit, a major win for the plaintiffs in the litigation who had this time put forth the consolidated claims of five patients alleging problems from the devices.
BREAKING - Jury Awards Just Under $500 Million Total to Plaintiffs in 5 Separate Cases at Conclusion of Pinnacle Hip Implant Consolidated MDL Trial HarrisMartin
Mar 17, 2016 | HarrisMartin

A Texas federal jury has awarded just under $500 million total to five separate plaintiffs at the conclusion of a consolidated trial involving allegedly defective Pinnacle Hip Implants manufactured by DePuy Orthopaedics and Johnson & Johnson, HarrisMartin Publishing is reporting.
J&J Ordered To Pay $502 Million In Hip Suit
Mar 17, 2016 | Grey Sheet

A jury in Dallas, Texas ordered Johnson & Johnson to pay $502 million to a group of patients who say they were injured when Pinnacle artificial hips made by the company’s DePuy Orthopaedics Inc.business unit failed prematurely.
Injury Awards In $497M Pinnacle Bellwether Trial Ranged From $47M to $14M
Mar 18, 2016 | Lexis Legal News

Personal injury damages awarded March 17 by a Texas federal jury to five plaintiffs in a Pinnacle Ultamet hip multidistrict litigation bellwether trial range from $47.51 million to $14.25 million, according to the 30-page verdict sheet
Pharmalot, Pharmalittle: Johnson & Johnson to pay $498M over hip implant injuries
Mar 18, 2016 | STAT News
By Ed Silverman

Johnson & Johnson was ordered by a Texas federal jury to pay $498 million to five plaintiffs who claimed they were injured by Pinnacle metal-on-metal hip implants made by the company’s DePuy unit, Reuters writes. This was the second federal trial involving the Pinnacle device. In that first case, which occurred in 2014, J&J was cleared of liability. The health care giant intends to appeal the verdict.
US court asks Johnson & Johnson to pay $500 million in hip implants case
Sep 19, 2016 | International Business Times
By Bismah Malik

A U.S. federal court has asked Johnson & Johnson (J&J) to pay $500 million to five patients, who alleged they suffered from injuries after using the brand's Pinnacle metal-on-metal hip implants.
In Hip Implant Suits, Two Bellwethers, Two Outcomes---And a $500M Question
Sep 21, 2016 | AM Law Litigation Daily
By Jenna Greene

Bellwether trials can be funny things. The word dates back to the 13th century, when shepherds would hang a bell around the neck of the lead sheep, a castrated male called a wether.

Post-Verdict Coverage

J&J Ultamet Verdict Is Too Much Green
Apr 12, 2016 | Law360
By Michael A. Walsh

On St. Patrick’s Day 2016 a pot of gold was dispensed in Dallas federal court as the jury saw green, awarding almost $500 million to five plaintiffs in a consolidated trial against DePuy Orthopaedics Inc. and Johnson & Johnson over the Ultamet hip implant. The post-trial motions are pouring in and there is plenty for the trial court to reconsider and correct in reducing the verdict. And, when some of the post-trial motions are denied, there will be plenty for the Fifth Circuit to pore over, including consolidating five plaintiffs for a single trial, presentation of prejudicial and irrelevant evidence and preemption for 510k devices.
Metal-on-Metal Hip Replacement Devices Implanted after 2006 have a High Revision Rate
May 6, 2016 | Reuters
By Marilynn Larkin

Certain metal-on-metal (MoM) hip replacement devices implanted after 2006 have an “unacceptably high” revision rate, due mainly to manufacturing problems, according to a new study.
J&J Seeks To Pause Hip Implant Trials After $498M Verdict
May 26, 2016 | Law360
By Emily Field

Johnson & Johnson has asked a Texas federal judge to put upcoming bellwether trials on ice in the multidistrict litigation over allegedly defective Pinnacle hip prosthetics manufactured by its DePuy Orthopaedics Inc. unit, as it intends to appeal a whopping $497.6 million verdict.
Judge Won't Stay J&J Hip Implant Trials After $498M Verdict
Jun 13, 2016 | Law360
By Emily Field

The Texas federal judge overseeing multidistrict litigation over allegedly defective Pinnacle hip prosthetics made by Johnson & Johnson’s DePuy Orthopaedics Inc. unit on Friday picked seven bellwether cases for trial, after J&J asked to stay cases pending its appeal of an eye-popping $497.6 million verdict.
J&J Tells 5th Circ. Hip Implant MDL Is Flawed
Jun 23, 2016 | Law360
By Emily Field

Johnson & Johnson’s DePuy Orthopaedics Inc. unit told the Fifth Circuit Thursday that the Texas federal court overseeing multidistrict litigation over allegedly defective Pinnacle hip prosthetics has been abusing the bellwether process and asked for a halt to a trial scheduled for early fall.
J&J asks 5th Circuit to delay next Pinnacle hip bellwether trial
Jun 24, 2016 | Reuters
By Jessica Dye

Johnson & Johnson and its DePuy Orthopaedics unit have asked a federal appeals court to halt an upcoming bellwether trial over their Pinnacle metal-on-metal hip implants until their challenges to a previous $502 million verdict are resolved.
Johnson & Johnson wants Pinnacle bellwethers stayed after $500m loss
Jun 24, 2016 | Mass Device
By Brad Perriello

A Johnson & Johnson (NYSE:JNJ) subsidiary wants a federal appeals court to hit the pause button in the multi-district litigation over its Pinnacle metal-on-metal hip implant to give it enough time to appeal a $500 million jury verdict.
Hello Fifth Circuit: The Pinnacle Hip Implant MDL Finally Introduces Itself to the Appellate Court
Jun 29, 2016 | Drug & Device Law Blog
By John Sullivan

We suggested in our most recent post on the Pinnacle Hip Implant MDL that, the sooner the Fifth Circuit weighs in on the evidentiary and procedural concerns being raised by the defense, the better. The defense is trying for sooner.
J&J, DePuy Can't Put Texas Hip Implant MDL On Hold
Jul 5, 2016 | Law360
By Kat Greene

Johnson & Johnson’s DePuy Orthopaedics Inc. can’t stay upcoming bellwether trials in multidistrict litigation over allegedly defective hip replacements while it appeals the trial process, in part because it had the chance to raise issues earlier and didn’t, a Texas federal judge ruled Tuesday.
U.S. judge cuts $500 million verdict over J&J hip implants
Jul 6, 2016 | Reuters
By Jessica Dye

A U.S. judge has slashed a $500 million verdict against Johnson & Johnson and its DePuy unit over allegedly defective metal-on-metal Pinnacle hip implants to approximately $151 million.
Award In J&J Hip Implant Bellwether Trial Slashed To $150M
Jul 6, 2016 | Law360
By Emily Field

A Texas federal judge cut a $497.6 million verdict from the second bellwether trial in the multidistrict litigation over allegedly defective Pinnacle hip prosthetics manufactured by Johnson & Johnson’s DePuy Orthopaedics Inc. unit to about $150 million on Tuesday, according to an attorney representing patients alleging injuries.
J&J Asks 5th Circ. To Hurry Hip MDL Appeal
Jul 13, 2016 | Law360
By Cara Salvatore

A Johnson & Johnson unit facing more than 8,000 lawsuits over its hip prosthetics pressed a Texas federal appeals court on Tuesday to accelerate an appeal after a trial loss, saying the completed bellwether trials in the multidistrict litigation have revealed that the federal judge in charge is willing to condone wildly off-base legal arguments.
Johnson & Johnson’s DePuy wants expedited appeal of $151m Pinnacle hip loss
Jul 14, 2016 | MassDevice
By Brad Perriello

Johnson & Johnson (NYSE:JNJ) subsidiary DePuy Orthopaedics asked a federal appeals court this week to expedite the appeal of its $151 million loss in a product liability lawsuit brought over its Pinnacle metal-on-metal hip implant.

Openings Coverage

Trial Proceedings Coverage

Verdict Coverage

Jury Awards $500 Million to Plaintiffs in Johnson & Johnson Hip Case

Mar 17, 2016 | Wall Street Journal

By Lisa Beilfuss

A federal jury in Dallas on Thursday awarded $500 million to five people who said they had suffered physical problems after receiving a certain type of hip implant manufactured by a subsidiary of Johnson & Johnson, a decision the company intends to appeal.
Five Texas residents who received a type of metal-on-metal hip implant made by DePuy Orthopaedics Inc. suffered “a variety of debilitating physical problems,” according to attorneys associated with the plaintiffs.
All five alleged the devices had unreasonably high failure rates, resulting in severe pain and inflammation, bone erosion and tissue loss, among other problems, according to the lawyers.
Johnson & Johnson said its defense counsel expects “grounds for appeal are strong” and that the $360 million in punitive damages will be reduced to around $10 million.
Mindy Tinsley, a spokeswoman for J&J, said “DePuy acted appropriately and responsibly in the design and testing” of the product, which she said “is backed by a strong record of safety and effectiveness.”
Ms. Tinsley said DePuy will immediately begin filing post-trial appellate motions.
The jury decision is the latest blow to Johnson & Johnson’s Pinnacle hip replacements. DePuy has seen a raft of suits alleging defective hip joints, and the J&J unit at one point stopped selling them.
Thursday’s verdict has to do with one part of the product, its cup system, over which the company in 2014 won a favorable court ruling.

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Johnson & Johnson hit with $500 mln verdict in trial over hip implants

Mar 17, 2016 | Reuters

By Jessica Dye

Johnson & Johnson and its DePuy unit were ordered by a Texas federal jury on Thursday to pay a total of about $500 million to five plaintiffs who said they were injured by Pinnacle metal-on-metal hip implants.
Following a two-month trial, jurors found that the Pinnacle hips were defectively designed, and that the companies failed to warn the public about their risks. Jurors awarded about $130 million in total compensatory damages and about $360 million in punitive damages, according to the plaintiffs' lead trial lawyer, Mark Lanier.
"There are thousands of these cases, and J&J needs to get responsible," Lanier said following the verdict, which came in the second federal trial involving the Pinnacle device.
J&J was cleared of liability in the first trial ended in 2014.
A J&J spokeswoman said the company plans to appeal the verdict.
All five plaintiffs are Texas residents who were implanted with metal-on-metal Pinnacle hip devices. They said design flaws caused the devices to fail more frequently and quickly than expected, leading to injuries including tissue death, bone erosion and high levels of metal in their blood. (Reporting by Jessica Dye, Editing by G Crosse, Alexia Garamfalvi and Richard Chang)

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J&J Ordered to Pay $502 Million Over Pinnacle Hip Failures

Mar 17, 2016 | Bloomberg

By Tom Korosec and Jef Feely

Johnson & Johnson was ordered to pay $502 million to a group of patients who accused the company of hiding flaws in its Pinnacle artificial hips that caused the devices to prematurely fail and left them facing surgeries and pain, in J&J’s first loss over the products.
A federal-court jury in Dallas concluded Thursday that artificial hips sold by J&J’s DePuy unit under the Pinnacle brand name were defective and company officials knew about the flaws but failed to warn patients and doctors of the risks. They awarded $142 million in actual damages and $360 million in punitive damages to a group of five patients whose hips broke down and had to be surgically removed.
“The defendants have tried six different arguments against people with failed implants,” said Mark Lanier, a lawyer for those who sued. “One worked, that the surgeon put it in wrong. The other five haven’t worked and won’t, because it is a defective product.”
In an earlier trial, J&J won, using the first argument in a trial with a single plaintiff. Lanier was the attorney for the patient with the implant.
“The grounds for appeal are strong and the punitive damages will be reduced to around $10 million subject to the Texas statutory cap,” John Beisner, a lawyer for the company, said by e-mail.
Company Statement
Mindy Tinsley, a DePuy spokeswoman, said the company “acted appropriately and responsibly in the design and testing” of the devices. “The product is backed by a strong record of safety and effectiveness in reducing pain and restoring mobility for patients,” she said in an e-mailed statement.
The verdict comes in the second trial of about 8,000 lawsuits filed against J&J and DePuy over the metal-on-metal version of the Pinnacle hips. J&J stopped selling the devices in 2013 after the U.S. Food and Drug Administration toughened artificial-hip regulations. J&J won the first Pinnacle case heard by a jury in 2014.
The devices weren’t covered by New Brunswick, New Jersey-based J&J’s $2.5 billion settlement of claims over another line of artificial hips known as ASRs. J&J recalled 93,000 of those implants worldwide in August 2010, saying 12 percent failed within five years.
Cases Gathered
The Pinnacle cases have been consolidated before U.S. District Judge Ed Kinkeade in Dallas for pretrial information exchanges and test trials. Kinkeade agreed to combine five cases selected by plaintiffs’ lawyers in the most recent trial. About 170,000 DePuy hips were implanted after the devices went on the market in the U.S. in 2000, according to court filings.
Margaret Aoki, Jay Christopher, Donald Greer, Richard Klusmann and Robert Peterson all got Pinnacle Ultamet metal-on-metal hips that failed and had to be surgically removed. Greer, 79, is a plastic surgeon from Chicago, and Klusmann, 68, is a former chief executive of a hospital, according to court filings.
The group said their DePuy hips leached cobalt and chromium material into their bloodstreams, leading to the hips’ failures and surgical removal. They claimed J&J officials knew their metal-on-metal design would cause such injuries but pushed ahead to rack up billions in sales.
Lanier told jurors in closing arguments that DePuy officials launched an aggressive campaign to market the metal-on-metal hips in the U.S. and across the world. The effort included paying kickbacks and bribes overseas, paying U.S. doctors millions to tout the devices and misleading doctors and consumers about the safety of the hips, the lawyer said.
‘Seedy Story’
“It’s a seedy story of deception, payoffs and hidden truths,” Lanier said. DePuy hip patients “are walking time bombs,” he said.
Richard Sarver, DePuy’s lead lawyer, countered that the metal-on-metal design was not defective and each of the five plaintiffs’ had an individual reason the device failed.
“The defect doesn’t exist and didn’t cause” the hips to fail, Sarver said in his closing arguments. “The devices may not be perfect, but they are not defective.”
Lanier unfairly attempted to paint J&J as a rogue company when it came to selling artificial hips, Sarver said.
“This is not a bad company,” he told the panel. “This company is a good company.”
The case is In re: DePuy Orthopaedics Inc. Pinnacle Hip Implant Products Liability Litigation, 11-md-02244, U.S. District Court, Northern District of Texas (Dallas).

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$500M Verdict in Hip Implant Case

Mar 17, 2016 | National Law Journal

By Amanda Bronstad

Johnson & Johnson and its subsidiary were hit with a $500 million verdict on Thursday after a federal jury in Texas found gross negligence and fraud in connection with the defective design of a hip implant.
The award against Johnson & Johnson and subsidiary DePuy Orthopaedics Inc., which includes $360 million in punitive damages, comes in the second bellwether trial in the multidistrict litigation over its Pinnacle hip implants, which plaintiffs claim caused pain and additional surgeries. A federal jury in 2014 had rendered a defense verdict in the first bellwether trial.
But in this case, which involved five plaintiffs, the jury found DePuy and Johnson & Johnson liable for gross negligence and fraud. It also found that DePuy had failed to warn of a hip implant it had defectively designed and that Johnson & Johnson aided and abetted DePuy’s actions. The total award was $502 million to five plaintiffs and three of their spouses.
“We’re just really stoked,” said lead plaintiffs counsel W. Mark Lanier of The Lanier Law Firm in Houston. “The jury just said money doesn’t get you out of problems. You’ve got to be responsible.”
DePuy immediately vowed to file posttrial motions and appeal the award.
“DePuy acted appropriately and responsibly in the design and testing of Ultamet metal-on-metal, and the product is backed by a strong record of safety and effectiveness in reducing pain and restoring mobility for patients suffering from chronic hip pain,” said DePuy spokeswoman Mindy Tinsley, referring to the Ultamet metal liner used in the Pinnacle devices implanted in all five plaintiffs. DePuy discontinued the liner in 2013.
John Beisner, leader of the mass torts, insurance and consumer litigation group at New York’s Skadden, Arps, Slate, Meagher & Flom, who represented Johnson & Johnson and DePuy, called the verdict a “pyrrhic victory” given that there are “strong” grounds for appeal and that, with damages caps under Texas law, the award could be reduced to around $10 million.
Beisner also had harsh words for Lanier. “The lead plaintiff lawyer in this case, Mr. Lanier, has a history of pushing the evidentiary envelope at trial to score substantial verdicts, only to have those trial court victories reversed on appeal.”
U.S. District Judge Ed Kinkeade of the Northern District of Texas, who is overseeing 8,000 lawsuits filed over injuries associated with the Pinnacle, a metal-on-metal hip implant, consolidated the cases of five plaintiffs for the trial, which began on Jan. 11.
In the first bellwether trial, Lanier said the jury found the doctor at fault and a replacement hip implant the plaintiff had received—which he planned to argue was safer than the Pinnacle—failed three weeks before trial. None of that happened in this case, he said.

“That’s the most fun case I’ve tried in a long time,” he said.

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Johnson & Johnson (JNJ) Stock Declines, Ordered to Pay $502 Million in Hip Implant Suit

Mar 17, 2016 | TheStreet

By Rachel Graf

Johnson & Johnson (JNJ - Get Report) stock is retreating 0.59% to $106.78 in late-afternoon trading on Thursday after the pharmaceutical company and its DePuy unit were ordered to pay $502 million to five plaintiffs who claimed they were injured by hip implants.
The patients alleged that Johnson & Johnson covered up flaws in its Pinnacle artificial hips that caused the implants to fail prematurely, Bloomberg reports.
A federal-court jury in Dallas found that the hips were defectively designed, and the company did not warn the public about the risks.
Johnson & Johnson "acted appropriately and responsibly in the design and testing" of the devices, a spokesperson told Bloomberg. "The product is backed by a strong record of safety and effectiveness in reducing pain and restoring mobility for patients."
The company plans to appeal, Reuters notes.
Separately, TheStreet Ratings team rates the stock as a "buy" with a ratings score of A-.
Johnson & Johnson's strengths include its solid stock price performance, increase in net income, largely solid financial position with reasonable debt levels by most measures, reasonable valuation levels and expanding profit margins.
You can view the full analysis from the report here: JNJ
TheStreet Ratings objectively rated this stock according to its "risk-adjusted" total return prospect over a 12-month investment horizon. Not based on the news in any given day, the rating may differ from Jim Cramer's view or that of this article's author.

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Johnson & Johnson must pay $502 million settlement over hip devices

Mar 17, 2016 | Modern Healthcare

By Lisa Schencker

A federal jury decided Thursday that Johnson & Johnson must pay five Texans $502 million for injuries caused by defective hip replacement devices. The outcome could affect how similar cases filed by another 7,000 plaintiffs are resolved.
The lawsuits allege that Pinnacle Ultamet metal-on-metal hip replacements, made by Johnson & Johnson's DePuy Orthopaedics, spread metal debris into their bloodstreams, causing major injuries that sometimes required further surgery, according to the law firm that represented the Texans, Simmons Hanly Conroy.
The device was designed to relieve pain and provide a smooth range of motion for people with damaged or diseased hip joints.
The five cases decided Thursday were consolidated and chosen to go to trial as so-called “bellwether” cases meant to help test the waters and guide possible future settlements.
DePuy said it will appeal the verdict in a statement Thursday. The company has denied that the devices are defective.
“DePuy acted appropriately and responsibly in the design and testing of ULTAMET Metal-on-Metal, and the product is backed by a strong record of safety and effectiveness in reducing pain and restoring mobility for patients suffering from chronic hip pain,” DePuy spokeswoman Mindy Tinsley said in the statement.
DePuy was victorious in a 2014 federal trial over the same device.
The decision Thursday came after 37 days of testimony in a federal district court in Texas.
The jury found that the devices were defective, that the company didn't adequately warn doctors about the product's dangers, and that the injuries were a result of gross negligence and fraud by DePuy and Johnson & Johnson.
The devices have not been recalled. In 2013, Johnson & Johnson announced it would pay $2.5 billion to settle thousands of lawsuits over a different line of failed metal-on-metal hip implants.

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J&J slapped with $500M verdict in metal-on-metal hip implant cases

Mar 17, 2016 | Fierce Medical Devices

By Emily Wasserman

Johnson & Johnson ($JNJ) is facing a dark chapter in its legal saga over its Pinnacle devices. A federal jury ordered the company to fork over $500 million to 5 plaintiffs who claimed injuries from J&J's metal-on-metal hip implants.
After a two-month trial, jurors in the U.S. District Court for the Northern District of Texas in Dallas found that Pinnacle hip implants made by J&J's DePuy unit were defectively designed and that the company did not warn the public about the product's risks, Reuters reports. J&J/DePuy still faces more than 8,000 cases in federal court regarding the devices.
J&J will begin filing motions to appeal "immediately," DePuy spokeswoman Mindy Tinsley told FierceMedicalDevices in an email.
"We have no greater responsibility than to the patients who use our products, and our goal is to create medical innovations that help people live more active and comfortable lives," Tinsley said. "DePuy acted appropriately and responsibly in the design and testing of Ultamet Metal-on-Metal, and the product is backed by a strong record of safety and effectiveness in reducing pain and restoring mobility for patients suffering from chronic hip pain."
The latest verdict marks a low point for J&J, which has dealt with a legal storm over its hip implants. In 2014, the company scored a victory after a Texas jury ruled against a woman who claimed that Pinnacle devices made by DePuy caused her undue pain and suffering. The jury also denied the plaintiff's request for more than $1.5 million in damages.
But J&J is still dealing with the fallout over safety issues tied to hip implants. In 2010, the company said that it would shell out $2.5 billion to settle thousands of claims over its all-metal ASR hip implants. Last year, J&J said that it would hand over as much as $420 million to resolve claims over recalled hip implants, adding to its previous settlement.
At the end of the day, J&J will likely pay more than $4 billion to resolve all its implant cases, Carl Tobias, a product-liability law professor at Virginia's University of Richmond, said last year.

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DePuy Must Pay $498M for Hip Implant Injuries

Sep 17, 2016 | Courthouse News Service

By David Lee

A federal jury in Dallas ruled Thursday that DePuy Orthopaedics should pay five Texas a total $498 million for severe medical complications they suffered as a result of the company's defective metal-on-metal hip implants.
A subsidiary of Johnson & Johnson, DePuy is facing several thousand such lawsuits over its discontinued Pinnacle hip implants.
The cases have since been consolidated under multidistrict litigation in Dallas Federal Court under U.S. District Judge Ed Kinkeade.
The jury awarded over $130 million in compensatory damages and over $360 million in punitive damages, according to plaintiffs' attorney W. Mark Lanier, of Houston.
"There are thousands of these cases, and Johnson & Johnson needs to get responsible," Lanier said after the verdict.
During the two-month trial, the five plaintiffs claimed the implants were defectively designed and led to high levels of metal debris due to quicker than expected wear and tear.
DePuy said it plans to appeal the verdict.
In October 2014, the first Pinnacle case to go to trial ended when a Dallas federal jury cleared DePuy of liability and ordered the plaintiff take nothing.Depuy said at the time that it "expects additional cases to be tried" and that it "remains committed to the long-term and vigorous defense" of the cases.

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Jury slaps Johnson & Johnson with $500m verdict in Pinnacle hip bellwether

Mar 17, 2016 | Mass Device

By Brad Perriello

A Texas federal jury today slapped Johnson & Johnson (NYSE:JNJ) subsidiary DePuy Orthopaedics with a $500 million judgment in favor of a quintet of plaintiffs who said the metal-on-metal Pinnacle hip implant caused their injuries.
After a 2-month trial, jurors found that the Pinnacle hips were defectively designed and that DePuy failed to warn patients about the risks. Jurors awarded about $130 million in total compensatory damages and about $360 million in punitive damages, said plaintiffs’ lead trial lawyer Mark Lanier.
“There are thousands of these cases, and J&J needs to get responsible,” Lanier said.
The 1st bellwether trial in the Pinnacle multi-district litigation went J&J’s way in October 2014, when the jury acquitted DePuy. Last month, the company won another legal victory with the dismissal of a False Claims Act lawsuit brought by a pair of British surgeons over its since-discontinued Pinnacle metal-on-metal hip implant.
A J&J spokeswoman said today that the company plans to appeal the most recent verdict.

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Jury Awards $497M In 5-Case Pinnacle Hip Bellwether Trial

Mar 17, 2016 | Lexis Legal News

A Texas federal jury on March 17 returned a $497 million verdict in a five-case Pinnacle hip multidistrict litigation bellwether trial, according to plaintiff attorney W. Mark Lanier of the Lanier Firm in Houston (Margaret Aoki v. Johnson & Johnson Services, Inc., et al., No. 13-1071, Jacqueline Christopher v. Johnson & Johnson Services, Inc., et al., No. 14-194, Donald Greer v. Johnson & Johnson Services, Inc., et al., No. 12-1672, Susan Klusmann v. Johnson & Johnson Services, Inc., et al., No. 11-2800, and Robert Peterson v. Johnson & Johnson Services, Inc., et al., No. 11-1941, N.D. Texas, Dallas Div.).
Lanier told Mealey Publications that the jury in the U.S. District Court for the Northern District of Texas awarded the plaintiffs $137 million in compensatory damages and $360 million in punitive damages. He said the jury assessed $240 million in punitives to co-defendant Johnson & Johnson and $120 million to DePuy Orthopaedics Inc.
The jury had been in deliberations since March 10 and returned its verdict shortly before noon March 17.
Lanier told Mealey Publications that the facts in the case are “so egregious that it’s a pity that Johnson & Johnson hasn’t been responsive and resolved these cases. They need to find a resolution.”
DePuy: Acted Appropriately
In a press statement, DePuy spokesperson Mindy Tinsley said the defendants will immediately file post-trial appellate motions. “DePuy acted appropriately and responsibly in the design and testing of Ultamet Metal-on-Metal, and the product is backed by a strong record of safety and effectiveness in reducing pain and restoring mobility for patients suffering from chronic hip pain.”
The jury began deliberations March 10 after 37 days of testimony. The trial began Jan. 8.
Margaret Aoki, Jay Christopher, Donald Greer, Richard Klusmann and Robert Peterson were each implanted with a Pinnacle Acetabular Cup System hip using the Ultamet metal-on-metal configuration. The plaintiffs or their survivors sued the defendants, and their cases were transferred into the Pinnacle hip MDL in the Northern District of Texas, where they were selected as bellwether cases.
Metal Wear, Injury Alleged
The plaintiffs allege that the metal-on-metal configuration of the Pinnacle hip resulted unreasonable high early failure rates, metallosis, biologic toxicity, tissue death, bone erosion, pseudotumors, severe inflammation, severe pain and other related diseases. They also allege that they required revision surgery.
The plaintiffs also allege that the defendants improperly offered financial benefits to physicians to induce them to use the Pinnacle hip, including Dr. Eric Heinrich, a surgeon for Klusmann and Peterson.
The plaintiffs assert claims of design and manufacturing defect, negligent undertaking, tortious interference, breach of the patient/physician fiduciary relationship and exemplary damages.
JMOL, Mistrial Denied
On March 10, Judge Ed Kinkeade denied a defense motion for summary judgment as a matter of law on the affirmative defense of limitations; preemption of design defect claims; fear of risk of cancer or other systemic harm; failure to warn; misrepresentation or omission; and exemplary damages. The judge also denied a defense motion for a mistrial based on improper cross-examination of defense witnesses and improper references to cancer.
The first Pinnacle bellwether trial ended with a defense verdict on Oct. 23.
As of March 15, the Judicial Panel on Multidistrict Litigation reports that there are more than 8,217 Pinnacle hip cases in the MDL, down from 8,329.
Counsel
The plaintiffs in the ongoing trial are represented by Lanier; Richard J. Arsenault of Neblett, Beard & Arsenault in Alexandria, La.; Larry P. Boyd and Wayne Fisher of Fisher, Boyd, Johnson & Huguenard in Houston; and Jane Conroy of Simmons Hanly Conroy of New York.
The defendants are represented by Michael V. Powell and Seth M. Roberts of Locke Lord in Dallas and Stephen J. Harburg, John H. Beisner, Jessica Davidson Miller and Geoffrey M. Wyatt of Skadden, Arps, Slate, Meagher & Flom in New York.

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Dallas jury awards $502 million to five hip implant victims

Mar 17, 2016 | Texas Law Book

By Mark Curriden

A federal jury in Dallas ruled Thursday that severe medical problems suffered by five Texans were the result of defective metal-on-metal hip implants manufactured by DePuy Orthopaedics Inc., a subsidiary of Johnson & Johnson.
The jury heard 37 days of testimony from the plaintiffs, company officials and expert witnesses for both sides.
After more than five days of deliberations, the jury awarded the five plaintiffs $502 million — $360 million of it in punitive damages.
The plaintiffs argued that DePuy’s hip implant device design was defective and that the company knew it was defective but failed to give adequate warnings to the public. They also claimed that Johnson & Johnson, the parent company, committed fraud by helping to misrepresent the dangers of the product to users.
Testimony by plaintiffs’ witnesses during the trial revealed that the devices had unreasonably high failure rates resulting in severe pain and inflammation, bone erosion, tissue loss and other problems.
“Today’s verdict is the result of years of hard work by my clients and every member of their legal teams, and almost three months of trial before one of the hardest-working juries I’ve seen during my years in the courtroom,” said Mark Lanier, a lawyer representing the plaintiffs.
"Now that DePuy and Johnson & Johnson have been found liable, we’re looking forward to trying another set of plaintiffs’ cases, hopefully this fall,” he said.
The Pinnacle metal-on-metal system was manufactured from 2002 to 2012 before DePuy pulled the metal liners off the market in 2013. Although the Pinnacle devices have never been recalled, DePuy recalled other metal-on-metal hip implants that were sold under the ASR brand name to roughly 35,000 patients.
The case was tried before U.S. District Judge Ed Kinkeade in Dallas

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J&J Hit With $498M Verdict In 2nd Pinnacle Bellwether Trial

Mar 17, 2016 | Law360

By Sindhu Sundar

Johnson & Johnson was hit with an eye-popping $497.6 million verdict Thursday in the second bellwether trial in the multidistrict litigation over allegedly defective Pinnacle hip prosthetics manufactured by its DePuy Orthopaedics Inc. unit, a major win for the plaintiffs in the litigation who had this time put forth the consolidated claims of five patients alleging problems from the devices.
After a two-month trial and days of deliberations, a Dallas jury found in favor of all five plaintiffs in the trial, delivering a verdict that included $360 million in punitive damages, lead plaintiffs' attorney Mark Lanier of the Lanier Law Firm confirmed to Law360 Thursday.
The jury found for the plaintiffs on their failure-to-warn and design defect claims, holding both J&J and DePuy liable, he said. About $240 million of the punitive damages were assessed directly against J&J while DePuy is on the hook for the other $120 million. The $140 million in compensatory damages will be divided among the plaintiffs based on the extent of their individual injuries, Lanier said.
"The jury was very careful and deliberate in the way they went about working through the evidence, and it took a week to come to the conclusion," Lanier told Law360. "I'm not surprised by the outcome."
The defendants will appeal the verdict, according to DePuy spokeswoman Mindy Tinsley. The products at issue included the Pinnacle Acetabular Cup System, a metal hip implant product with a cobalt-chromium liner that the company brands the "Ultamet" liner.
“We have no greater responsibility than to the patients who use our products, and our goal is to create medical innovations that help people live more active and comfortable lives,” Tinsley said. “DePuy acted appropriately and responsibly in the design and testing of ULTAMET Metal-on-Metal, and the product is backed by a strong record of safety and effectiveness in reducing pain and restoring mobility for patients suffering from chronic hip pain.”
The trial had involved the consolidated claims of plaintiffs Margaret Aoki, Jay Christopher, Donald Greer, Richard Klusmann and Robert Peterson, who all underwent hip arthroplasty, where a hip joint is replaced with a prosthetic. In their case, the prosthetics were DePuy Pinnacle metal-on-metal devices, which they alleged cause serious health problems including inflammation of surrounding tissues, bone erosion and metallosis, a toxic condition allegedly caused when the device’s components grind against each other and shed metal debris into the bloodstream.
U.S. District Judge Ed Kinkeade, who is presiding over the trial and the MDL, had ruled on Jan. 8 that the five cases had enough issues in common that they should be consolidated for trial. In particular, all five plaintiffs here underwent similar implantation surgeries, their doctors received similar warnings, and the patients all alleged similar injuries, according to his ruling.
Aoki, who had filed her suit in March 2013, was implanted with a DePuy Pinnacle metal-on-metal device in 2010. She contended that after DePuy's other hip implant product, the DePuy ASR Hip System, was recalled in 2010, J&J doubled down on marketing the metal-on-metal device as a replacement.
She claimed that the ASR recall spurred J&J into "damage control" mode, where it assured surgeons that the metal-on-metal device was safe but knew it posed the risk of complications including metallosis. She claimed in particular that more than 1,300 adverse event complaints had been made to the U.S. Food and Drug Administration about the devices — among the roughly 150,000 such devices sold — and that J&J knew that patients implanted with those devices wound up with unsafe levels of cobalt and chromium in their bloodstream.
The first bellwether trial in the MDL ended in a significant verdict for J&J, in which a federal jury in October 2014 unanimously cleared DePuy Orthopedics of similar accusations.
The jury had found in favor of Johnson & Johnson on all counts, rejecting plaintiff Kathy Herlihy-Paoli's claims of negligence, defective design, failure to warn and violations of the Montana Consumer Protection Act after an eight-week trial in Dallas. The product at issue in the trial was the Ultamet metal-on-metal articulation.
The MDL was consolidated in May 2011, when the U.S. Judicial Panel on Multidistrict Litigation centralized three actions and identified 54 potential tag-along actions. There are now more than 8,000 cases in the MDL, all involving Pinnacle devices that contain sockets with metal, ceramic or polyethylene lining, according to court documents.
The plaintiffs are represented by W. Mark Lanier of The Lanier Law Firm, Larry Boyd, Wayne Fisher and Justin Presnal of Fisher Boyd Johnson & Huguenard LLP, Richard J. Arsenault of Neblett Beard & Arsenault and Jayne Conroy of Simmons Hanly Conroy.
Johnson & Johnson and DePuy are represented by Michael V. Powell and Seth M. Roberts of Locke Lord LLP and John H. Beisner, Stephen J. Harburg, Jessica Davidson Miller and Geoffrey M. Wyatt of Skadden Arps Slate Meagher & Flom LLP.
The five cases consolidated for trial are Aoki v. Johnson & Johnson Services et al., case number 3:13-cv-01071; Christopher et al v. Johnson & Johnson Services Inc. et al., case number 3:14-cv-01994; Greer v. DePuy Orthopaedics Inc. et al., case number 3:12-cv-1672; Klusmann et al v. DePuy Orthopaedics Inc. et al., case number 3:11-cv-02800; and Peterson et al v. Johnson & Johnson Services Inc. et al, case number 3:11-cv-01941, all in the U.S. District Court for the Northern District of Texas.
The MDL is In re: DePuy Orthopaedics Inc. Pinnacle Hip Implant Products Liability Litigation, case number 3:11-md-02244, in the U.S. District Court for the Northern District of Texas.

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BREAKING - Jury Awards Just Under $500 Million Total to Plaintiffs in 5 Separate Cases at Conclusion of Pinnacle Hip Implant Consolidated MDL Trial HarrisMartin

Mar 17, 2016 | HarrisMartin

A Texas federal jury has awarded just under $500 million total to five separate plaintiffs at the conclusion of a consolidated trial involving allegedly defective Pinnacle Hip Implants manufactured by DePuy Orthopaedics and Johnson & Johnson, HarrisMartin Publishing is reporting.
The U.S. District Court for the Northern District of Texas jury reached the verdict on March 17 after hearing 37 days of testimony, sources said. The jury received the case late in the afternoon on March 10 and deliberated for four more days before reaching the verdict.
The MDL Court had consolidated the five cases for trial after determining that the plaintiffs were all from Texas and were all implanted with the DePuy Pinnacle Metal-on-Metal device. MDL Judge Ed Kinkeade presided over the trial, which began with jury selection on Jan. 8. Opening arguments were heard Jan. 11.
According to recent court filings, defendants DePuy Orthopaedics Inc., DePuy Synthes Inc., Johnson & Johnson, Johnson & Johnson Services Inc., and Johnson & Johnson International were all involved with the case at the time of the verdict.
Aoki
Plaintiff Margaret E. Aoki contended in her March 2013 lawsuit that she was implanted with a Pinnacle device with an Ultamet liner in Sept. 2010. After the left total hip arthroplasty procedure, Aoki said the device corroded and released toxic cobalt-chromium metal debris into her tissue surrounding the device.
As a result of the corrosion, Aoki said she began experiencing pain and difficulty with her implant. According to the plaintiff, the hip began malfunctioning and, in July 2012 during an incidence when her hip “stuck,” she fell and broke her arm.
Aoki underwent revision surgery in Feb. 2013 to remove the allegedly defective Pinnacle device.
Christopher
Jay and Jacqueline Christopher alleged in their complaint, filed in June 2014, that Jay Christopher underwent a right total hip arthroplasty procedure, which included the implantation of a Pinnacle Device with an Ultamet liner.
Since he was implanted with the device, Christopher said he has experienced pain and difficulty with his hip; a subsequent MARS scan showed fluid collection in his hip.
Christopher underwent revision surgery in Dec. 2013. At the time, his surgeon’s report stated that “metal-on-metal reaction was encountered with fluid and synovial hypertrophy, and the fluid in the hip was yellowish-greenish fluid.”
Greer
Filed in May 2012, Donald Greer’s lawsuit contended that he underwent a hip replacement in 2004, at which time the Pinnacle Device was implanted into his right hip.
A revision surgery was performed eight years later after the device failed, according to the complaint.
Greer alleged in the lawsuit that as a result of the defective hip implant, he has experienced degenerative pain, soreness and walking difficulty.
Klusmann
Richard and Susan Klusmann filed their complaint in Oct. 2011, maintaining that the defendants were liable for injuries sustained by Richard Klusmann, who was implanted with the Pinnacle Device with Ultamet liner in his left hip in Dec. 2004. Klusmann underwent a right total hip arthroplasty nearly one year later for his right hip, into which the Pinnacle Device with an Ultamet liner was also implanted.
In June 2011, Klusmann’s blood was tested and showed “dangerously elevated levels of cobalt and chromium,” the complaint said. A subsequent MRI also showed a “fluid-filled cyst and fluid around his left hip,” the plaintiffs said.
Richard Klusmann underwent a revision surgery on his left hip in Aug. 2011 and on his right hip in Nov. 2011.
"To this day,” the complaint alleged, “Plaintiffs continue to experience harm and damage.”
Peterson
According to Robert and Karen Peterson’s Aug. 2011 lawsuit, Robert (Pete) Peterson underwent a left total hip arthroplasty procedure in Jan. 2005. Peterson, a former U.S. Navy SEAL was implanted with the Pinnacle Device with an Ultamet liner, the complaint said.
However, Peterson began experiencing difficulty with his device in Dec. 2010 and was required to undergo a revision surgery in April 2011.
“All of the injuries and complications suffered by Plaintiff were caused by the defective design, warnings, construction and unreasonably dangerous character of the Pinnacle Device that was implanted in him,” the lawsuit said.
Testifying on behalf of the plaintiffs were Minette E. Drumwright, Ph.D.; Pamela Plouhar, Ph.D.; Albert Burstein, Ph.D.; Dr. Richard Kearns; Dr. Bernard Morrey; Dr. Thomas Schmalzried, M.D.; Dr. Matthew C. Morrey; and Dr. Nicholas A. Athanasou.
Testifying on behalf of the defendants were Brian D. Hass, M.D.; Scott Nelson, M.D.; Patricia A. Campbell, Ph.D.; Cato T. Laurencin, M.D., Ph.D.; Donald Belsito, M.D.; Edward W. Boyer, M.D., Ph.D.; Aaron B. Waxman, Ph.D.; Timothy A. Ulatowski, M.S.; Roger Emerson, M.D.; William L. Griffin, M.D. (via video deposition); Thomas K. Fehring, M.D. (via video deposition); and Roger Emerson, M.D.
The defendants were represented by trial by Michael V. Powell and Seth M. Roberts of Locke Lord LLP in Dallas; Richard E. Sarver of Barrasso, Usdin, Kupperman, Freeman & Sarver in New Orleans; and Steven W. Quattlebaum of Quattlebaum, Grooms & Tull PLLC in Little Rock, Ark.
The plaintiffs were represented by trial by W. Mark Lanier of the Lanier Law Firm in Houston; Wayne Fisher of Fisher, Boyd, Johnson & Huguenard LLP in Houston; Jayne Conroy of Simmons Hanly Conroy in New York; Richard Arsenault of Neblett Beard & Arsenault in Alexandria, La.; and Ernest H. Cannon of Stephenville, Texas.
Iin re: DePuy Orthopaedics Inc. Pinnacle Hip Implant Product Liability Litigation, MDL No. 2244; Aoki, No. 13-01071; Christopher, No. 14-01994; Greer, No. 12-01672; Klusmann, No. 11-02800; Peterson, No. 11-01941 (N.D. Texas).
Documents are Available Call (800) 496-4319 or Search www.harrismartin.com Aoki Complaint Ref# HIP-1603-03 Christopher Complaint Ref# HIP-1603-04 Greer Complaint Ref# HIP-1603-05 Klusmann Complaint Ref# HIP-1603-06 Peterson Complaint Ref# HIP-1603-07

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J&J Ordered To Pay $502 Million In Hip Suit

Mar 17, 2016 | Grey Sheet

A jury in Dallas, Texas ordered Johnson & Johnson to pay $502 million to a group of patients who say they were injured when Pinnacle artificial hips made by the company’s DePuy Orthopaedics Inc.business unit failed prematurely.
The verdict in the bellwether case, which combined claims filed by five patients whose Pinnacle hips broke down and needed to be surgically removed and replaced, orders J&J to pay $142 million in actual damages and $360 million in putative damages. The patients alleged the company knew about the risks posed by the hips, but failed to adequately warn patients and physicians.
This is the second Pinnacle hip case to go to trial and the first DePuy has lost. The company won a 2014 suit involving a single patient by arguing that the surgeon had implanted the hip incorrectly. Around 7,000 lawsuits have been filed against DePuy over the metal-on-metal version of Pinnacle hips. The company stopped selling the hips in 2013 after FDA proposed new PMA requirements. Pinnacle and other metal-and-metal hips reached the market via 510(k) clearance. The agency finalized the PMA requirement earlier this year. (See "PMAs Are The New Reality For Metal-On-Metal Hips" — "The Gray Sheet," Feb. 17, 2016.)
Significant evidence shows that metal-on-metal hips have a notably higher revision rate than hips with porcelain or ceramic components. In addition, some research suggests the hips may leach toxic metal ions into the blood. (See "Metal-On-Metal Hips Get Failing Grade In New Registry Analysis" — "The Gray Sheet," Mar. 19, 2012.)
DePuy, which maintains its conduct around the hips was appropriate, plans to appeal the verdict. “The product is backed by a strong record of safety and effectiveness in reducing pain and restoring mobility for patients,” company spokeswoman Mindy Tinsley said in an email.
However, plaintiffs’ counsel Jayne Conroy, shareholder, Simmons Hanly Conroy, said the award was well-deserved.
"This a significant and well-earned victory for the plaintiffs, who have suffered major injuries caused by these dangerous devices," she said. Conroy alleges physicians received kickbacks for using and recommending the hips.

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Injury Awards In $497M Pinnacle Bellwether Trial Ranged From $47M to $14M

Mar 18, 2016 | Lexis Legal News

Personal injury damages awarded March 17 by a Texas federal jury to five plaintiffs in a Pinnacle Ultamet hip multidistrict litigation bellwether trial range from $47.51 million to $14.25 million, according to the 30-page verdict sheet (Margaret Aoki v. Johnson & Johnson Services, Inc., et al., No. 13-1071, Jacqueline Christopher v. Johnson & Johnson Services, Inc., et al., No. 14-194, Donald Greer v. Johnson & Johnson Services, Inc., et al., No. 12-1672, Susan Klusmann v. Johnson & Johnson Services, Inc., et al., No. 11-2800, and Robert Peterson v. Johnson & Johnson Services, Inc., et al., No. 11-1941, N.D. Texas, Dallas Div.).
The jury in the U.S. District Court for the Northern District of Texas awarded the plaintiffs and three spouses a total of $497 million in compensatory and punitive damages against defendants Johnson & Johnson and DePuy Orthopaedics Inc.
The jury found that the Pinnacle Ultamet hip was defectively designed and was the producing cause of injuries to plaintiffs Richard Klusmann, Jay Christopher, Donald Greer, Margaret Aoki and Pete Peterson. It also found that defective warnings about the hip were the cause of injuries to the plaintiffs.
Parent Company Culpability
The jury also found that Johnson & Johnson was engaged in the business of selling the Pinnacle Ultamet hip and participated in the device’s design. However, the jury found that Johnson & Johnson actually knew in the case of Aoki that the hip’s defect resulted in injury.
The panel said Johnson & Johnson negligently undertook a duty to provide services to subsidiary DePuy Orthopaedics that proximately caused injuries to all five plaintiffs.
Finally, the jury found that Johnson & Johnson knowingly gave substantial assistance or encouragement to the tortious conduct of DePuy and that the parent company’s actions were a substantial factor in injuring all five plaintiffs.
Personal Injury Awards
The jury awarded Klusmann personal injury damages totaling $47.51 million. The award was for past and future physical pain and mental anguish, disfigurement, physical impairment and medical care expenses.
The largest amounts for Klusmann were for past and future physical pain and mental anguish.
Klusmann’s wife, Susan, was awarded $2.48 million for loss of past and future household services and consortium. Each of the four findings was for $621,405.
No Disfigurement Award
Christopher was awarded a total of $14.25 million for past and future pain and mental anguish, physical impairment and medical care expenses. The jury awarded no damages for past and future disfigurement.
Christopher’s wife, Jacqueline, was awarded $746,980 for loss of household services and consortium.
Greer was awarded $30 million for past and future pain and mental anguish, physical impairment and medical care expenses. The jury made no award for past or future disfigurement.
AokI was awarded $15 million for past and future pain and mental anguish, physical impairment and medical care expenses. The jury made no award for past or future disfigurement.
$30M To 1 Plaintiff
Peterson was awarded $30.44 million for past and future pain and mental anguish, physical impairment and medical care expenses. The jury made no award for past or future disfigurement.
Peterson’s wife, Karen, was awarded $1.59 million for past and future loss of household services and consortium.
On the issue of punitive damages, the jury found clear and convincing evidence that gross negligence and fraud by DePuy and Johnson & Johnson resulted in harm to the plaintiffs. DePuy was assessed $120 million and Johnson & Johnson $240 million.
Defense Bribery Win
Richard Klusmann and Aoki each asserted a claim of commercial bribery against DePuy for knowingly offering a benefit to the implanting surgeon Dr. Eric Heinrich to influence the doctor’s conduct towards both plaintiffs. The jury found no such conduct by either defendant.
Finally, the jury was asked when Klusmann and Greer knew or should have known that they were injured by the Pinnacle Ultamet implant. The jury found that Klusmann knew as of Nov. 14, 2011, and Greer as of Feb. 14, 2012.
The jury began deliberations on March 10 after 37 days of testimony and the verdict was returned shortly before noon March 17.
During deliberations, the jury told Judge Ed Kinkeade it wanted to see timelines for metal, polyethylene and ceramic hip implants and the curriculum vitae of Pamela Plouhar, Ph.D., a DePuy executive who was called as a witness by the plaintiffs.
Plaintiffs: Evidence Most Helpful
One of the plaintiff attorneys, W. Mark Lanier of the Lanier Firm in Houston told Mealey Publications on March 17 that the facts in the case are “so egregious that it’s a pity that Johnson & Johnson hasn’t been responsive and resolved these cases. They need to find a resolution.”
Another plaintiff attorney, Jayne Conroy of Simmons Hanly Conroy of New York said she is “thrilled” with the compensatory verdicts because the evidence in the trial was “extraordinary.” She said the trial included expert testimony that metal-on-metal hips were not an innovation “but a resurrection of a failed project.”
Conroy also said the defendants opened to the door to allow testimony about their deferred prosecution agreement and a Foreign Corrupt Practice Act violation.
$10M Texas Punitives Cap?
One of the defendants’ attorneys, John H. Beisner of Skadden, Arps, Slate, Meagher & Flom in New York told Mealey Publications on March 18, “We expect this to be a temporary victory for plaintiffs’ counsel, like other of his trial wins, as not only will the punitive damages be reduced under Texas law to around $10 million, but the whole verdict has a good chance of being reversed based on the strong grounds for appeal.”
In a March 17 press statement, DePuy spokesperson Mindy Tinsley said “DePuy acted appropriately and responsibly in the design and testing of Ultamet Metal-on-Metal, and the product is backed by a strong record of safety and effectiveness in reducing pain and restoring mobility for patients suffering from chronic hip pain.”
Aoki, Christopher, Greer, Klusmann and Peterson were each implanted with a Pinnacle Acetabular Cup System hip using the Ultamet metal-on-metal configuration. They sued the defendants, and their cases were transferred into the Pinnacle hip MDL in the Northern District of Texas where they were selected for the second bellwether trial.
Metal Wear, Injury Alleged
The plaintiffs allege that the metal-on-metal configuration of the Pinnacle hip resulted unreasonable high early failure rates, metallosis, biologic toxicity, tissue death, bone erosion, pseudotumors, severe inflammation, severe pain and other related diseases. They also allege that they required revision surgery.
On March 10, Judge Kinkeade denied a defense motion for summary judgment as a matter of law on the affirmative defense of limitations; preemption of design defect claims; fear of risk of cancer or other systemic harm; failure to warn; misrepresentation or omission; and exemplary damages. The judge also denied a defense motion for a mistrial based on improper cross-examination of defense witnesses and improper references to cancer.
The first Pinnacle bellwether trial ended with a defense verdict on Oct. 23.
As of March 15, the Judicial Panel on Multidistrict Litigation reports that there are more than 8,217 Pinnacle hip cases in the MDL, down from 8,329.
Counsel
The plaintiffs in the second bellwether trial are represented by Lanier; Richard J. Arsenault of Neblett, Beard & Arsenault in Alexandria, La.; Larry P. Boyd and Wayne Fisher of Fisher, Boyd, Johnson & Huguenard in Houston; and Conroy.

The defendants are represented by Michael V. Powell and Seth M. Roberts of Locke Lord in Dallas and Stephen J. Harburg, Jessica Davidson Miller, Geoffrey M. Wyatt and Beisner of Skadden, Arps, Slate, Meagher & Flom in New York.

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Pharmalot, Pharmalittle: Johnson & Johnson to pay $498M over hip implant injuries

Mar 18, 2016 | STAT News

By Ed Silverman

Johnson & Johnson was ordered by a Texas federal jury to pay $498 million to five plaintiffs who claimed they were injured by Pinnacle metal-on-metal hip implants made by the company’s DePuy unit, Reuters writes. This was the second federal trial involving the Pinnacle device. In that first case, which occurred in 2014, J&J was cleared of liability. The health care giant intends to appeal the verdict.

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US court asks Johnson & Johnson to pay $500 million in hip implants case

Sep 19, 2016 | International Business Times

By Bismah Malik

A U.S. federal court has asked Johnson & Johnson (J&J) to pay $500 million to five patients, who alleged they suffered from injuries after using the brand's Pinnacle metal-on-metal hip implants.
The jury after a two-month trial declared the hip implants were defectively designed and J&J has failed to warn the public about their risks, the Reuters reported.
The jury has asked the J&J to pay $140 million in total compensatory damages and about $360 million in punitive damages to the five patients, Mark Lanier, lead trial counsel for the patients told the news agency.
The patients, who received the hip implants said the design flaws caused the devices to fall more frequently and quickly than expected, leading to tissue injuries, bone erosion and high concentration of metal in their blood.
They said Johnson & Johnson had described its metal-on-metal hip implants as durable and safe, despite being aware of its risks. The brand has also been accused of aggressively promoting these hip implants for use among younger patients.
The company stopped selling its hip implant devices in 2013 and paid $2.5 billion to settle more than 7,000 lawsuits.
J&J was earlier cleared by a US federal court trial in 2014 involving its hip implants devices.
In February 2016, a U.S. jury reportedly asked the American brand to pay $72 million to a 62-year old woman's family, after she died of cancer due to prolonged use of the company's talcum powder.
"There are thousands of these cases, and J&J needs to get responsible," Lanier added.
J&J's lawyer, John Beisner said the punitive damages could be reduced to $10 million.

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In Hip Implant Suits, Two Bellwethers, Two Outcomes---And a $500M Question

Sep 21, 2016 | AM Law Litigation Daily

By Jenna Greene

Bellwether trials can be funny things.
The word dates back to the 13th century, when shepherds would hang a bell around the neck of the lead sheep, a castrated male called a wether.
So maybe it shouldn’t be a big surprise that bellwether outcomes can sometimes be about as reliable as a bunch of sheep following one with a bell, who doesn’t know where he’s going either.
Case in point: a $500 million verdict delivered by a Texas federal jury last week. The jury found for five victims of allegedly faulty hip implants made by Johnson & Johnson’s DePuy Orthopaedics Inc.
The verdict comes 17 months after the first hip implant bellwether trial, when another jury in the same Dallas court before the same federal judge, Ed Kinkeade, found DuPuy was not liable.
Who got it right?
It’s an $800 billion question, considering there are more than 8,000 hip implant lawsuits pending. (Even if you factor in Texas’s cap on punitive damages, we’re still talking $240 billion based on the hefty compensatory award.)
On the other hand, if the first bellwether is a more reliable gauge, the claims are worth nothing.
Such a spread does little to pave the way for a global settlement. If anything, it has the opposite effect.
“It’s hard to fathom that the defense will accept such an out-sized verdict as indicative of anything relevant to settling these cases,” wrote Cozen O’Conner partner John Sullivan (who is not involved in the case) in the Drug and Device Law blog. “Additionally, the verdict itself, simply by its amount, calls the trial into question. How could a half-billion dollar verdict provide meaningful information to value the plaintiffs’ inventory of cases?”
DePuy in a statement said it “will immediately begin filing post-trial appellate motions.” And defense counsel John Beisner, a partner at Skadden, Arps, Slate, Meagher & Flom, said in a statement, “We expect this to be a temporary verdict for plaintiffs’ counsel, like some of his other trial wins, as not only will the punitive damages be reduced under Texas law to around $10 million, but the whole verdict has a good chance of being reversed based on the strong grounds for appeal.”
On the plaintiffs side, W. Mark Lanier of the Lanier Law Firm said he hoped the mega-verdict would lead to a global settlement to compensate all plaintiffs. But if not, he said, “I could try 10 of these a year. It would be a like an annuity--a nice retirement.”
So how does Lanier square striking out in one bellwether and hitting a home run in another?
In essence, he said that the first trial failed because it wasn’t a good case (never mind that the plaintiffs lawyers picked it).
In that trial, the defense argued that the doctor put the hip implant in at such an extreme angle that any implant would have failed. It wasn’t the fault of the metal-on-metal Pinnacle Ultamet device.
Lanier said the plaintiffs were prepared to counter that a hip implant with poly liner would have been a safer alternative than the metal one. Indeed, when plaintiff Kathleen Herlihy-Paoli’s left hip was re-done, a poly liner was used.
Except three weeks before trial, the poly liner inside her broke. So much for the safer alternative argument. After a seven week trial and two days of deliberations, the jury found for DePuy.
In the most recent trial, Lanier said the plaintiffs team, which also included Ernest Cannon & Associates; Richard Arsenault of Neblett, Beard & Arsenault; Jayne Conroy of Simmons Hanly Conroy and dozens of others, picked cases where there was “no question” about how the implant was put in.
The plaintiffs also got a boost when the judge shorty before trial ruled that the five bellwether cases would be heard together, overruling the objections of defense counsel, who argued that doing so would be unfair.
“Faced with a mammoth trial involving a mountain of evidence regarding the plaintiffs’ individual causation issues, medical histories, physician decisions and other factors… there is a substantial risk that the jury would quickly lose track of the differences among plaintiffs and render verdicts that conflate different plaintiffs’ claims and evidence,” wrote Beisner and Michael Powell of Locke Lord for DePuy.
Kinkeade was not persuaded. He ruled that the defense would not be prejudiced, and that “the actions in this MDL share factual questions as to whether the Pinnacle Device was defectively designed and/or manufactured, and whether defendants failed to provide adequate warnings concerning the device.”
Over the course of the trial, which began on Jan. 11, defense counsel filed multiple mistrial motions.
For example, they complained that the judge wrongly allowed the jury to learn that more than 8,000 suits have been filed over the Pinnacle hip implant. They also objected that evidence about the recall of a different hip implant, the ASR, was introduced. And they complained that the judge allowed references to Johnson & Johnson and DePuy’s 2011 settlement stemming from alleged violations of the Foreign Corrupt Practices Act. (Lanier said the company opened the door to this by talking about its all-American, small-town values.)
The defense complained in one mistrial motion that court has “allowed plaintiffs counsel to inject his own argumentative takes on the evidence, often without foundation, with the clear intent of provoking the jury to decide this case based on emotion and prejudice, rather than the facts.”
Indeed, it seems this was not one of those lawsuits that’s like a vigorous tennis match where everyone has gin-and-tonics together afterwards and congratulates each other on a game well-played.
Beisner (who declined comment for this article) told Lit Daily sibling publication The National Law Journal shortly after the verdict that Lanier “has a history of pushing the evidentiary envelope at trial to score substantial verdicts, only to have those trial court victories reversed on appeal.”
Lanier in turn told Lit Daily that the “behavior of the corporation through its lawyers at trial was reprehensible.”
Such acrimony is unfortunate, since these two are nowhere near done with each other. Because this bellwether verdict is about as useful as a stray sheep.

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Post-Verdict Coverage

J&J Ultamet Verdict Is Too Much Green

Apr 12, 2016 | Law360

By Michael A. Walsh

On St. Patrick’s Day 2016 a pot of gold was dispensed in Dallas federal court as the jury saw green, awarding almost $500 million to five plaintiffs in a consolidated trial against DePuy Orthopaedics Inc. and Johnson & Johnson over the Ultamet hip implant. The post-trial motions are pouring in and there is plenty for the trial court to reconsider and correct in reducing the verdict. And, when some of the post-trial motions are denied, there will be plenty for the Fifth Circuit to pore over, including consolidating five plaintiffs for a single trial, presentation of prejudicial and irrelevant evidence and preemption for 510k devices. There is some good news for the defendants, however. Importantly, the jury found against the plaintiff on the commercial bribery claim. Had the jury favored the plaintiffs on that claim, it would have provided an exception to the cap on punitive damages. Without that exception, Texas’ significant caps on punitive damages will likely result in a significant reduction in the jury award.

Foul Ball Results in Homerun for Plaintiffs

To use a baseball analogy, in the J&J Ultamet Hip Implant medical products liability mass tort litigation, plaintiffs get 8,000 swings at the plate and J&J needs to throw 8,000 unhittable strikes. This scenario is all the more difficult with multiple batters swinging at each pitch. Litigation of this magnitude places a great burden on the judge presiding over the multidistrict litigation to be fair in calling balls and strikes and not allow runners to reach base or score on foul balls. While the work of an MDL judge in litigation such as this is daunting, the overall objectives are simple enough: coordinate discovery, resolve common issues and dispose of cases through settlement, trial or remand for trial. Parties hope that a trial before the MDL judge who has overseen all of the pretrial proceedings will produce a balanced result that can serve as an important bellwether to help them resolve or dispose of all claims. When a verdict appears heavily one sided, however, or where unbalanced evidentiary rulings produce a result that clouds the pathway to resolution, such a trial may cause more harm than good.

Both Sides now Face Obstacles

The Dallas St. Patty’s Day pot of gold verdict will cause issues on both sides — unquestionably larger problems for the defense — but nonetheless a colossal problem for both sides. First, a huge verdict like this one makes it a virtual certainty that the docket of cases will continue to grow. Second, for plaintiffs the bar is now very high with expectations of massive recoveries. While a reduction in the verdict by the trial or appellate court will help, the plaintiffs’ lawyers will still need to talk their clients down out of the stratosphere if they expect to resolve these cases any time soon. For J&J and DePuy the problem is complex because, irrespective of the merits or lack thereof of the litigation or any individual case, the mere existence of a major litigation involving close to ten thousand plaintiffs threatens business, and the pressure to settle increases. While any sizeable verdict places pressure on a defendant to settle, a verdict of this magnitude makes a global settlement unattainable any time soon leaving the parties few options but to aggressively prosecute more cases.

Medical products liability cases, such as the Ultamet hip replacement cases, have three components: the company, the product and the plaintiff specific issues. The effort and expense of trying these cases differs for the plaintiffs and defendants. On the defense side, the plaintiff specific issues and the product portions of the cases have become commodity work. In every city in the U.S. you can find a cadre of skilled defense counsel well versed on how to defend these claims. Defending the company and dispelling the myth of greedy and evil pharma remains an elusive quest. While there are good and competent counsel on both sides throughout the country, the number favor the defense and multiple simultaneous trials would present a much higher hurdle for the plaintiffs.

The companies will take a sober look at the evidence that plaintiffs employed to persuade the Dallas jury to grant such a large award and parse the testimony to determine why the jury did not buy their narrative, i.e., that they are responsible and compliant medical device manufacturers. If a sober assessment concludes that these are defensible cases, a more aggressive approach, requesting remand and multiple simultaneous trials may provide leverage. If the defendants conclude that the plaintiffs’ counsel cheated, the judge botched the trial, there were banana peels on the floor at defense counsel table and the sun was in their eyes the whole time, they will need a different strategy. In that case, the companies should focus on the individual claims to identify those that could counter the March 17, 2016, verdict and strive to keep all the claims on the field in the MDL ballpark as they negotiate some way out of this massive litigation.

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Metal-on-Metal Hip Replacement Devices Implanted after 2006 have a High Revision Rate

May 6, 2016 | Reuters

By Marilynn Larkin

Certain metal-on-metal (MoM) hip replacement devices implanted after 2006 have an “unacceptably high” revision rate, due mainly to manufacturing problems, according to a new study.

To determine risk factors for revision in patients implanted with the commonly used DePuy Pinnacle MoM hip prostheses, the researchers identified all patients at the Stockton-based hospital who were implanted with a 36 mm MoM Pinnacle hip in conjunction with an S-ROM or Corail uncemented stem. They then identified only patients with components that had been implanted by either of the two senior authors of the study, Dr. Raj Logishetty or Dr. Antoni Viral Francis Nargol.

Implantations were performed from 2003-2009 and patients were monitored yearly. From 2007-2011, as awareness of the risk of adverse reactions to metal debris (ARMD) from MoMs increased, the hospital offered patients who developed symptoms blood metal ion testing and as-needed ultrasound scanning. From 2011 onward, given the widespread problems reported with MoMs, the hospital recalled all Pinnacle MoM patients for examination.

A total of 489 MoM Pinnacle hips had been implanted into 243 women and 191 men. Of these, 352 patients attended the MoM recall clinics and 64 died during the study period (mean
followup, about 7.5 years). For the purposes of survival analyses, those who did not attend the recall clinics were assumed to have well-functioning prostheses.

A total of 71 hips were revised — an “unacceptably high” rate, according to the authors. All but one were carried out for ARMD, with one revision for a loose cup. Prosthetic survival rate for the cohort as a whole was 83.6% at nine years.

In 53 revisions (75%), “copious amounts” of fluid were found, and in 32 (45%), it was noted to be under pressure or had fistulated through the capsule. No abnormal fluid was identified at revision in only one case.
The researchers noted obvious damage to the abductor musculature in 38 cases. They documented a moderate-to-severe aseptic lymphocyte-dominated vasculitis-associated lesion on examination of retrieved tissues in 36 cases (51%). In 13 cases (19%), they found metallosis with no identified lymphocytic infiltration.

The majority of explanted devices showed signs of taper junction failure. A significant number of devices were found to be manufactured out of their specifications — a finding that was confirmed by an analysis of a wider data set from the Northern Retrieval Registry.

Risk factors for revision were bilateral MoM prostheses, smaller Pinnacle liners, and implantation in 2006 or later. Women were found to be at greater risk of early device failure. However, shell sizes and bearing diameters confounded the analyses, and liner size and/or earlier year of liner manufacture were determined to be greater threats to prosthetic survival than gender. The authors suggest that this analysis be repeated with input from an additional registry.

Dr. Langton, who is involved in litigation related to the Pinnacle device, told Reuters Health by email, “We have essentially shown that one of the major health care/orthopedic product manufacturers sold a product to surgeons and health care systems on the basis (that it was a) technologically advanced precision-engineered device, and it wasn’t precision-engineered.”

He added, “the product was produced in the same factories as (DePuy’s) other failed product, the ASR, which was . . . marketed on the same premise.”

Mindy Tinsley, senior director, Communications and Public Affairs at DePuy Synthes Franchise, refuted the study findings. “We stand behind the strong record of safety and effectiveness of the (Pinnacle) ULTAMET Metal-on-Metal,” she told Reuters Health by email.

She added that “there are no manufacturing problems” with the device and noted that DePuy “questions the validity of the . . . paper given significant flaws in how it was conducted.” According to Tinsley, “measurements taken following an accepted international standard at the DePuy UK manufacturing facility” showed the device liners “were manufactured within specification.”

Dr. Mark W. Hungerford, director of Joint Replacement and Reconstruction at Mercy Medical Center in Baltimore, told Reuters Health by phone, “One study does not make or break anything in science. There have been issues in the field about MoM and early failure rates or not. That’s a serious issue being looked at by a lot of people. This is one more study showing a problem, but it’s not a definitive one.”

With respect to patients, “the obligation is no different than for any orthopedic device,” said Dr. Hungerford, who has not used the Pinnacle device. “All can fail, all need to be monitored for failure on a regular basis, and if problems arise, they need to be dealt with.”

The authors reported no funding. Dr. Langton, Dr. Nargol, and coauthors Dr. Thomas Joyce and Dr. Nick Cooke are retained experts for plaintiffs in ongoing MoM litigation. Dr. Langton and Dr. Nargol have worked with the U.S. Department of Justice in litigation involving DePuy.

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J&J Seeks To Pause Hip Implant Trials After $498M Verdict

May 26, 2016 | Law360

By Emily Field

Johnson & Johnson has asked a Texas federal judge to put upcoming bellwether trials on ice in the multidistrict litigation over allegedly defective Pinnacle hip prosthetics manufactured by its DePuy Orthopaedics Inc. unit, as it intends to appeal a whopping $497.6 million verdict.

J&J and DePuy said in a May 24 motion that, depending on how the judge rules on their post-trial motions, they intend to appeal to the Fifth Circuit a number of issues that will have a broad effect on how the rest of the cases are tried. They contend that they were prejudiced by critical pieces of evidence introduced at the second bellwether trial that consolidated the claims of five plaintiffs.

That evidence includes “references to Saddam Hussein’s ‘henchmen,’ unsupported speculation that plaintiffs might develop cancer as a result of their Pinnacle implants,” as well as lawyers and expert witness who have testified on behalf on a number of companies with no connection to the litigation, the company said.

“We believe there are significant and likely recurring legal issues coming out of the trial that should be resolved by the federal appellate court before any new trials are scheduled.” John Beisner of Skadden Arps Slate Meagher & Flom LLP, an attorney for J&J, said in a statement. “Otherwise, the MDL proceeding will be at risk of becoming a costly exercise in inefficiency for all involved.”

The court has indicated that the next bellwether trial will start in September and will likely involve California plaintiffs, according to the motion.

Following a two-month trial and days of deliberations, a Dallas jury on March 17 found in favor of all five plaintiffs in the trial, delivering a verdict that included $360 million in punitive damages. At the time, Beisner said that the punitive damages are expected to be reduced to $10 million based on the statutory cap in Texas.

The jury had found for the plaintiffs on their failure-to-warn and design defect claims, holding both J&J and DePuy liable. About $240 million of the punitive damages were assessed directly against J&J while DePuy is on the hook for the other $120 million. The $140 million in compensatory damages will be divided among the plaintiffs based on the extent of their individual injuries.

The trial had involved the consolidated claims of plaintiffs Margaret Aoki, Jay Christopher, Donald Greer, Richard Klusmann and Robert Peterson, who all underwent hip arthroplasty, where a hip joint is replaced with a prosthetic.

In their case, the prosthetics were DePuy Pinnacle metal-on-metal devices, which they alleged cause serious health problems including inflammation of surrounding tissues, bone erosion and metallosis, a toxic condition allegedly caused when the device’s components grind against each other and shed metal debris into the bloodstream.

J&J and DePuy also argued in the motion that those cases present legal issues that will likely appear again in the future, including whether the plaintiffs’ theory that all metal-on-metal hip implant devices are inherently defective is preempted by federal law.

“This is a futile attempt at delay that should be dead on arrival,” Mark Lanier of the Lanier Law Firm told Law360 on Thursday. “There are 8,500 people needing justice and Depuy/Johnson & Johnson is afraid to go to trial.”

U.S. District Judge Ed Kinkeade, who is presiding over the trial and the MDL, had ruled on Jan. 8 that the five cases had enough issues in common that they would be consolidated for trial. In particular, all five plaintiffs here underwent similar implantation surgeries, their doctors received similar warnings, and the patients all alleged similar injuries, according to his ruling.

The first bellwether trial in the MDL ended in a significant verdict for J&J, in which a federal jury in October 2014 unanimously cleared DePuy Orthopedics of similar accusations.

The jury had found in favor of Johnson & Johnson on all counts, rejecting plaintiff Kathy Herlihy-Paoli's claims of negligence, defective design, failure to warn and violations of the Montana Consumer Protection Act after an eight-week trial in Dallas. The product at issue in the trial was the Ultamet metal-on-metal articulation.

The MDL was consolidated in May 2011, when the U.S. Judicial Panel on Multidistrict Litigation centralized three actions and identified 54 potential tag-along actions. There are now more than 8,000 cases in the MDL, all involving Pinnacle devices that contain sockets with metal, ceramic or polyethylene lining, according to court documents.

The plaintiffs are represented by W. Mark Lanier of The Lanier Law Firm, Larry Boyd, Wayne Fisher and Justin Presnal of Fisher Boyd Johnson & Huguenard LLP, Richard J. Arsenault ofNeblett Beard & Arsenault and Jayne Conroy of Simmons Hanly Conroy.

Johnson & Johnson and DePuy are represented by Michael V. Powell and Seth M. Roberts ofLocke Lord LLP and John H. Beisner, Stephen J. Harburg, Jessica Davidson Miller and Geoffrey M. Wyatt of Skadden Arps Slate Meagher & Flom LLP.

The five cases consolidated for trial are Aoki v. Johnson & Johnson Services et al., case number 3:13-cv-01071; Christopher et al v. Johnson & Johnson Services Inc. et al., case number 3:14-cv-01994; Greer v. DePuy Orthopaedics Inc. et al., case number 3:12-cv-1672; Klusmann et al v. DePuy Orthopaedics Inc. et al., case number 3:11-cv-02800; and Peterson et al v. Johnson & Johnson Services Inc. et al, case number 3:11-cv-01941, all in the U.S. District Court for the Northern District of Texas.

The MDL is In re: DePuy Orthopaedics Inc. Pinnacle Hip Implant Products Liability Litigation, case number 3:11-md-02244, in the U.S. District Court for the Northern District of Texas.

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Judge Won't Stay J&J Hip Implant Trials After $498M Verdict

Jun 13, 2016 | Law360

By Emily Field

The Texas federal judge overseeing multidistrict litigation over allegedly defective Pinnacle hip prosthetics made by Johnson & Johnson’s DePuy Orthopaedics Inc. unit on Friday picked seven bellwether cases for trial, after J&J asked to stay cases pending its appeal of an eye-popping $497.6 million verdict.

U.S. District Judge Ed Kinkeade in a short order selected the cases to be prepared for trial starting Sept. 6, saying that the rest of the cases in the MDL are on hold until after the trials. J&J and DePuy had asked the judge to hit pause on the upcoming bellwether trials in late May, as they intend to appeal to the Fifth Circuit a number of issues they contend will have a wide effect on how the rest of the cases are tried.

"We moved to stay further trials in the MDL proceeding until the numerous issues raised by the previous trial are resolved by the federal appellate court,” John Beisner of Skadden Arps Slate Meagher & Flom LLP, counsel for J&J, said in a statement. “We are concerned that the court's decision to move ahead with further trials without appellate review of those issues will undermine the efficiency and fairness of the MDL proceeding."

Mark Lanier of the Lanier Law Firm told Law360 on Monday that the judge’s selection is “a great way” to continue helping the parties evaluate cases.

“We have five [verdicts] on Texas cases, one on a Wyoming case, and now we will have six from California,” Lanier said. “If DePuy continues to assert that the judge will need to try all 8,500 cases, at some point, the number in each group may need to increase.”

J&J and DePuy had argued in a May 24 motion that they were prejudiced by critical pieces of evidence introduced at the second bellwether trial that consolidated the claims of five plaintiffs.

That evidence includes “references to Saddam Hussein’s ‘henchmen,’ unsupported speculation that plaintiffs might develop cancer as a result of their Pinnacle implants,” as well as lawyers and expert witness who have testified on behalf of a number of companies with no connection to the litigation, the company said.

Following a two-month trial and days of deliberations, a Dallas jury on March 17 found in favor of all five plaintiffs in the trial, delivering a verdict that included $360 million in punitive damages. At the time, Beisner said that the punitive damages are expected to be reduced to $10 million based on the statutory cap in Texas.

The jury had found for the plaintiffs on their failure-to-warn and design defect claims, holding both J&J and DePuy liable. About $240 million of the punitive damages were assessed directly against J&J while DePuy is on the hook for the other $120 million. The $140 million in compensatory damages will be divided among the plaintiffs based on the extent of their individual injuries.

The trial had involved the consolidated claims of plaintiffs Margaret Aoki, Jay Christopher, Donald Greer, Richard Klusmann and Robert Peterson, who all underwent hip arthroplasty, where a hip joint is replaced with a prosthetic.

In their case, the prosthetics were DePuy Pinnacle metal-on-metal devices, which they alleged cause serious health problems including inflammation of surrounding tissues, bone erosion and metallosis, a toxic condition allegedly caused when the device’s components grind against each other and shed metal debris into the bloodstream.

The first bellwether trial in the MDL ended in a significant verdict for J&J, in which a federal jury in October 2014 unanimously cleared DePuy Orthopedics of similar accusations.

The jury had found in favor of Johnson & Johnson on all counts, rejecting plaintiff Kathy Herlihy-Paoli's claims of negligence, defective design, failure to warn and violations of the Montana Consumer Protection Act after an eight-week trial in Dallas. The product at issue in the trial was the Ultamet metal-on-metal articulation.

The MDL was consolidated in May 2011, when the U.S. Judicial Panel on Multidistrict Litigation centralized three actions and identified 54 potential tag-along actions. There are now more than 8,000 cases in the MDL, all involving Pinnacle devices that contain sockets with metal, ceramic or polyethylene lining, according to court documents.

The plaintiffs are represented by W. Mark Lanier of The Lanier Law Firm, Larry Boyd, Wayne Fisher and Justin Presnal of Fisher Boyd Johnson & Huguenard LLP, Richard J. Arsenault ofNeblett Beard & Arsenault and Jayne Conroy of Simmons Hanly Conroy.

Johnson & Johnson and DePuy are represented by Michael V. Powell and Seth M. Roberts ofLocke Lord LLP and John H. Beisner, Stephen J. Harburg, Jessica Davidson Miller and Geoffrey M. Wyatt of Skadden Arps Slate Meagher & Flom LLP.

The cases selected for trial are Marvin Andrews v. DePuy Orthopaedics Inc et al., case number 3:15-cv-03484, Kathleen Davis v. DePuy Orthopaedics Inc et al., case number 3:15-cv-01767, Sandra Llamas v. DePuy Orthopaedics Inc et al., case number 3:13-cv-03804, Rosa Metzler v. DePuy Orthopaedics Inc et al., 3:12-cv-02066, Judith Rodriguez v. DePuy Orthopaedics Inc et al., 3:13-cv-3938, Lisa Standerfer v. DePuy Orthopaedics Inc et al., case number 3:14-cv-01730 and Michael Weiser v. DePuy Orthopaedics Inc et al. 3:13-cv-03631, all in the U.S. District Court for the Northern District of Texas.

The MDL is In re: DePuy Orthopaedics Inc. Pinnacle Hip Implant Products Liability Litigation, case number 3:11-md-02244, in the U.S. District Court for the Northern District of Texas.

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J&J Tells 5th Circ. Hip Implant MDL Is Flawed

Jun 23, 2016 | Law360

By Emily Field

Johnson & Johnson’s DePuy Orthopaedics Inc. unit told the Fifth Circuit Thursday that the Texas federal court overseeing multidistrict litigation over allegedly defective Pinnacle hip prosthetics has been abusing the bellwether process and asked for a halt to a trial scheduled for early fall.

In a petition for a writ of mandamus, J&J and DePuy told the panel that marching ahead with another trial now would corrupt the bellwether process as a number of rulings in the last trial — which resulted in a nearly $500 million verdict for five plaintiffs — have vast implications for the rest of the cases in the MDL. J&J wants its appeal heard first.

“We are concerned that the trial court's decision to move ahead with additional trials before those issues are resolved by the appellate court will undermine the efficiency and fairness of the MDL proceeding.” John Beisner of Skadden said in a statement.

Although J&J had asked U.S. District Judge Ed Kinkeade, who is overseeing the litigation, to put those cases on ice, pending their appeal to the Fifth Circuit, the judge earlier this month picked out seven cases to be prepared for trial starting on Sept. 6.

“Given the confidence plaintiffs' counsel expressed in the March verdict, we would expect them to welcome prompt appellate review," Beisner said.

Over the past two years, there have been two bellwether trials — the first of which J&J won — but the court hasn’t entered final judgment on either, J&J said, which would allow for the verdict to be appealed. Nor has it ruled on the company's post-trial motions, the company said.

That has created significant settlement pressure before J&J can obtain sufficient information about the pool of claims, the company said.

“The course chosen by the MDL court can neither yield representative verdicts nor aid the parties in achieving a fair or efficient resolution of the mass litigation,” J&J said in the petition. “As such, the MDL court’s bellwether process is so flawed that it constitutes a clear abuse of discretion.”

In the petition, J&J argued that the court allowed the plaintiffs in the last trial to put forth “irrelevant and highly inflammatory” evidence, such as assertions that subsidiaries not party to the litigation had made payments to “Saddam’s henchmen.”

J&J also said that the jury was allowed to see an email from an expert, who didn’t testify, who speculated that a patient was driven to kill himself over the failure of his hip implant. The email was dated after the plaintiffs' surgeries, the company noted in a separate filing.

However, plaintiffs’ lawyer Mark Lanier said the letter was written by a doctor to the president of DePuy before the case was filed, and at the time had been paid by the company. The doctor was listed as an expert in the case years later so he could testify about other matters, and the letter came in because DePuy's president denied failing to properly follow up on complaints made by its doctors, Lanier wrote in an email.

“I am appalled at J&J’s flagrant disregard for the record and substantive misrepresentations made to the court in this ill-timed filing,” Lanier said. “Since J&J know we would file a full response pointing out the many errors, we conclude that this was more a trial maneuver seeking to intimidate the trial judge.”

After a two-month trial and days of deliberations, a Dallas jury on March 17 found in favor of all five plaintiffs in the trial, delivering a verdict that included $360 million in punitive damages. At the time, Beisner said the punitive damages are expected to be reduced to $10 million based on the statutory cap in Texas.

The trial had involved the consolidated claims of plaintiffs Margaret Aoki, Jay Christopher, Donald Greer, Richard Klusmann and Robert Peterson, who all underwent hip arthroplasty, where a hip joint is replaced with a prosthetic.

In their case, the prosthetics were DePuy Pinnacle metal-on-metal devices, which they alleged cause serious health problems including inflammation of surrounding tissues, bone erosion and metallosis, a toxic condition allegedly caused when the device’s components grind against each other and shed metal debris into the bloodstream.

The first bellwether trial in the MDL ended in a significant verdict for J&J, in which a federal jury in October 2014 unanimously cleared DePuy Orthopedics of similar accusations.

The jury had found in favor of Johnson & Johnson on all counts, rejecting plaintiff Kathy Herlihy-Paoli's claims of negligence, defective design, failure to warn and violations of the Montana Consumer Protection Act after an eight-week trial in Dallas. The product at issue in the trial was the Ultamet metal-on-metal articulation.

The MDL was consolidated in May 2011, when the U.S. Judicial Panel on Multidistrict Litigation centralized three actions and identified 54 potential tag-along actions. There are now more than 8,000 cases in the MDL, all involving Pinnacle devices that contain sockets with metal, ceramic or polyethylene lining, according to court documents.

The plaintiffs are represented by W. Mark Lanier of The Lanier Law Firm, Larry Boyd, Wayne Fisher and Justin Presnal of Fisher Boyd Johnson & Huguenard LLP, Richard J. Arsenault ofNeblett Beard & Arsenault and Jayne Conroy of Simmons Hanly Conroy.

Johnson & Johnson and DePuy are represented by Michael V. Powell and Seth M. Roberts ofLocke Lord LLP and John H. Beisner, Stephen J. Harburg, Jessica Davidson Miller and Geoffrey M. Wyatt of Skadden Arps Slate Meagher & Flom LLP.

The MDL is In re: DePuy Orthopaedics Inc. Pinnacle Hip Implant Products Liability Litigation, case number 3:11-md-02244, in the U.S. District Court for the Northern District of Texas.

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J&J asks 5th Circuit to delay next Pinnacle hip bellwether trial

Jun 24, 2016 | Reuters

By Jessica Dye

Johnson & Johnson and its DePuy Orthopaedics unit have asked a federal appeals court to halt an upcoming bellwether trial over their Pinnacle metal-on-metal hip implants until their challenges to a previous $502 million verdict are resolved.
In a petition for a writ of mandamus filed Thursday in the 5th U.S. Circuit Court of Appeals, J&J said the Texas judge overseeing multidistrict litigation for Pinnacle hips had "abused the bellwether process" by scheduling a trial involving as many as seven different plaintiffs to start Sept. 6. Allowing that to go forward would be costly, counterproductive and potentially prejudicial, the company argued.
To read the full story on Westlaw Practitioner Insights, click here: bit.ly/28VryCU

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Johnson & Johnson wants Pinnacle bellwethers stayed after $500m loss

Jun 24, 2016 | Mass Device

By Brad Perriello

A Johnson & Johnson (NYSE:JNJ) subsidiary wants a federal appeals court to hit the pause button in the multi-district litigation over its Pinnacle metal-on-metal hip implant to give it enough time to appeal a $500 million jury verdict.
In March, a Texas federal jury slapped DePuy Orthopaedics with a $500 million judgment in favor of a quintet of plaintiffs who blamed the Pinnacle implant for their injuries. After a 2-month trial, jurors found that the Ultamet metal-on-metal version of the Pinnacle hips were defectively designed and that DePuy failed to warn patients about the risks, awarding $130 million in total compensatory damages and $360 million in punitive damages. DePuy won the 1st bellwether trial in the MDL, in October 2014.
In a petition for a writ of mandamus filed yesterday with the U.S. Court of Appeals for the 5th Circuit, DePuy argued that the next bellwether involving 7 plaintiffs slated for trial Sept. 6 should be delayed. Courts can grant mandamus to compel or prevent other bodies from performing their required duties.
“Mandamus relief is needed because pressing forward with another trial now – before this court has had an opportunity to review several critical legal and evidentiary rulings in the last trial that have broad implications for the remaining cases in the MDL proceeding – would corrupt the bellwether process,” DePuy told the appeals court, alleging that Judge Ed Kinkeade of the U.S. District Court for Northern Texas abused the bellwether process.
“The petitioners won the 1st bellwether trial against a single plaintiff almost 2 years ago; yet, the MDL court has not entered judgment in that case. Over petitioners’ objection, and without calling for briefing from the parties on the issue, the MDL court then consolidated five plaintiffs’ cases for trial shortly before the 2nd bellwether trial was set to begin in January 2016. At trial, the MDL court rejected defendants’ dispositive motions wholesale, allowing plaintiffs to proceed with novel and far-flung theories, unsupported in law, that will likely recur in most if not all cases in the MDL proceeding – including that parent companies can be held liable for the acts of their subsidiaries on an ‘aiding and abetting’ theory and that a design defect can be proven not by singling out a specific flaw in a specific device but instead by arguing that an entire line of products should not have been sold by any of a range of manufacturers,” the company argued.
“The MDL court also allowed (again over petitioners’ objections) the injection of all manner of irrelevant and highly inflammatory evidence – including, for example, plaintiffs’ counsel’s gratuitous assertions that nonparty subsidiaries of J&J had made payments to ‘Saddam’s henchmen;’ hearsay assertions from a book about supposedly improper scientific articles planted in the literature by ‘Big Tobacco’ and other ‘industr[ies];’ allegations that the Pinnacle Ultamet poses a risk of cancer, even though no plaintiff alleged such an injury and no science supports it; references to an employee’s unproven allegations of racist treatment at DePuy; and a suggestion that the failure of a metal-on-metal implant in another, nonparty individual led him to commit suicide. Not surprisingly, the jury, awash in this flood of prejudicial evidence, returned a verdict in excess of $500 million – including $360 million in exemplary damages,” DePuy wrote in the brief.
DePuy wants a stay of future trials until the 5th Circuit has a chance to review the issues raised in the mandamus petition.
“Because the MDL court has indicated that it will consolidate the new bellwether cases for a multi-plaintiff trial and because it is likely to issue the same rulings on a slew of issues that petitioners intend to appeal, the order raises the prospect that petitioners could soon be facing twelve adverse verdicts, totaling potentially $1 billion and causing significant reputational harm, all before this court has ever had a chance to review any judgment in these proceedings,” the company wrote.

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Hello Fifth Circuit: The Pinnacle Hip Implant MDL Finally Introduces Itself to the Appellate Court

Jun 29, 2016 | Drug & Device Law Blog

By John Sullivan

We suggested in our most recent post on the Pinnacle Hip Implant MDL that, the sooner the Fifth Circuit weighs in on the evidentiary and procedural concerns being raised by the defense, the better. The defense is trying for sooner.
On Thursday, the defense filed in the Fifth Circuit a Petition for a Writ of Mandamus to the MDL court. This isn’t a petition asking the Fifth Circuit to review the evidentiary and procedural rulings that the defense has been raising since the second bellwether trial was scheduled. It couldn’t do that. But the petition does ask the Fifth Circuit to order the MDL court to do the things that are necessary to allow the Fifth Circuit to conduct that review. And it asks that, in the meantime, the Fifth Circuit stop the bellwether process:
Petitioners seek a writ from this Court directing the district court to: (1) vacate its Order on Bellwether Trials, dated June 10, 2016, which scheduled a trial for September 6, 2016 (Exhibit A); (2) rule promptly on petitioners’ pending post-trial motions in the last bellwether trial; and (3) enter judgment in those cases so that an appeal may follow, see Fed. R. Civ. P. 58(b).
Petition at 1.
It seems that a significant amount of paperwork has been piling up on the MDL court’s desk. The MDL court hasn’t entered final judgment on the first bellwether trial, even though that verdict will soon be two years old. The MDL court has also not ruled on the post-trial motions from, or entered judgment on, the second bellwether trial, the one that raised so many procedural and evidentiary concerns and resulted in a half-billion dollar verdict.
The defense did not mince words on why it filed its petition, arguing that the MDL court’s procedural and evidentiary rulings have destroyed the representative nature of the bellwether process, placing the litigation in an unhelpful place from which settlement pressure is applied while little to no information on the true value of plaintiffs’ claims is learned:
First, the bellwether process has been sapped of its putative benefits. Bellwether cases are supposed to be representative cases that aid the parties in efficiently resolving large-scale litigation. Instead, the MDL court has destroyed the representative character of the cases by making legal and evidentiary rulings that would not be followed by other courts. Second, by failing to enter final orders in the bellwether trials that have been litigated to verdict, the MDL court has deprived petitioners of a viable means of exercising their right to appeal to this Court. Third, the combined effect of this course of proceeding is to create significant settlement pressure before sufficient information about the claims pool can be obtained.
Petition at 14-15.
The defense also used the petition as an opportunity to flag for the Fifth Circuit the key MDL court rulings from the second bellwether trial that, as the defense put it, “would not be followed by other courts”:
[T]he MDL court entered a host of erroneous and prejudicial rulings in the last trial – from its decision to consolidate five disparate cases for trial without meaningful analysis, to its resolution of a range of legal issues in dispositive motions, to its evidentiary rulings allowing plaintiffs to inject inflammatory issues into trial.
This includes permitting plaintiffs’ counsel to:
Ask a 30(b)(6) witness whether “bribes” were made by nonparty subsidiaries of J&J to “the henchmen of Saddam Hussein” and public officials in Iraq, Poland, and Romania. (See, e.g., 1/29/16 Trial Tr. 68:25-69:5, 77:8-13, 99:15-18 (attached as Ex. K).)
Introduce speculative evidence that plaintiffs face a risk of cancer as a result of having once had metal-on-metal hip implants,14 which led one plaintiff to testify later in the trial that after hearing the testimony, she was now worried about dying of cancer. (1/26/16 Trial Tr. 86:20-25 (attached as Ex. M); 1/27/16 Trial Tr. 234:10-14 (attached as Ex. N).)
Read into the record portions of a book maligning “industry” to the jury as though it were evidence, including pages of hearsay statements about supposedly improper scientific articles planted in the literature by “Big Tobacco” and other industries, and then insinuate that petitioners’ attorneys had similarly “maneuvered” science “to influence juries in litigation.” (2/25/16 Trial Tr. 124:1-18, 126:10, 126:12, 127:3-9, 127:18-128:9, 132:10-133:5.)
Introduce into the record emails from an African-American individual who was formerly employed by DePuy, containing, inter alia, unproven allegations of “nepotism, favoritism, and racism” on the part of other DePuy employees. (1/13/16 Trial Tr. 95:7-100:23 (attached as Ex. O).)
Refer to “thousands” of other Pinnacle lawsuits and tell the jury that the Pinnacle Ultamet has been a “tragic failure[],” as evidenced by the fact that “[t]here have been thousands of cases” filed against defendants, in addition to the five at issue in the second bellwether trial. (1/11/16 Trial Tr. 31:15-17 (attached as Ex. P).) These references were also a centerpiece of plaintiffs’ counsel’s closing argument, during which counsel told the jury that “[t]housands of people suffered.” (3/10/16 Trial Tr. 54:12; id. 54:14-15 (“[T]housands of them, are – they’re walking time bombs.”).)
Introduce evidence about 45,000 lawsuits that have been filed by women against a different J&J subsidiary with regard to transvaginal mesh products, presumably to prejudice the predominantly female jury against J&J. (1/15/16 Trial Tr. 221:16-24 (attached as Ex. Q).)
Show the jury an email by a plaintiffs’ expert who did not testify in which he speculated that a patient in whom he implanted a metal-on-metal hip implant “just committed suicide because he was so depressed and thought he would never resolve the issue. Shot himself.” (1/19/16 Trial Tr. 78:9-13 (attached as Ex. R).)
Petition at 19-21.
That is some list. We wonder whether it will have any influence on the Fifth Circuit. It’ll have to. Writs of mandamus to trial courts are extraordinarily rare.
In any event, at least for now, the defense is finally before the Fifth Circuit. We’ll continue to follow this one.

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J&J, DePuy Can't Put Texas Hip Implant MDL On Hold

Jul 5, 2016 | Law360

By Kat Greene

Johnson & Johnson’s DePuy Orthopaedics Inc. can’t stay upcoming bellwether trials in multidistrict litigation over allegedly defective hip replacements while it appeals the trial process, in part because it had the chance to raise issues earlier and didn’t, a Texas federal judge ruled Tuesday.

U.S. District Judge Ed Kinkeade shot down J&J and DePuy’s bid to put all further bellwether trials in the MDL on hold, finding that not only would the next trial — the third bellwether in the dispute over whether Pinnacle hip prosthetics were defective — cover different issues because the plaintiffs were from California rather than Texas or Montana as in the first two trials, but also that J&J had been repeatedly warned about some of the issues it’s now trying to raise in trial court motions and an appeal to the Fifth Circuit, according to the order.

J&J and DePuy had agreed on the bellwether process the court is now following and can’t grind the MDL to a halt now just because it lost one of the trials, Judge Kinkeade said. The next trial is slated for early September.

“Only after losing the second bellwether trial did defendants object to the process,” Judge Kinkeade wrote in the order denying the stay. “There are more than 8,000 pending cases in this MDL; the court cannot grant a stay every time plaintiffs win a trial.”

The judge noted that the companies had agreed in January 2013 not to raise a venue objection to any of the cases being tried in Texas’ Northern District, one of the issues J&J and DePuy are now raising after having lost the second trial, according to the order.

J&J and DePuy had argued in a May 24 motion that they were prejudiced by critical pieces of evidence introduced at the second bellwether trial that consolidated the claims of five plaintiffs.

That evidence includes “references to Saddam Hussein’s ‘henchmen,’ unsupported speculation that plaintiffs might develop cancer as a result of their Pinnacle implants,” as well as lawyers and expert witnesses who have testified on behalf of a number of companies with no connection to the litigation, the company said.

But Judge Kinkeade said in Tuesday’s order that he had “repeatedly warned” the companies that if they raised evidence at trial of good character, product safety or success of their products abroad, the plaintiffs would be allowed to introduce contrary evidence. It was up to the defendants to decide “whether to open those doors” in the California plaintiffs’ trial, the judge said.

After a two-month trial and days of deliberations, a Dallas jury on March 17 found in favor of all five plaintiffs in the trial, delivering a verdict that included $360 million in punitive damages. At the time, Beisner said the punitive damages are expected to be reduced to $10 million based on the statutory cap in Texas.

The trial had involved the consolidated claims of plaintiffs Margaret Aoki, Jay Christopher, Donald Greer, Richard Klusmann and Robert Peterson, who all underwent hip arthroplasty, where a hip joint is replaced with a prosthetic.

In their case, the prosthetics were DePuy Pinnacle metal-on-metal devices, which they alleged cause serious health problems including inflammation of surrounding tissues, bone erosion and metallosis, a toxic condition allegedly caused when the device’s components grind against each other and shed metal debris into the bloodstream.

The first bellwether trial in the MDL ended in a significant verdict for J&J, in which a federal jury in October 2014 unanimously cleared DePuy Orthopedics of similar accusations.

The jury had found in favor of Johnson & Johnson on all counts, rejecting plaintiff Kathy Herlihy-Paoli's claims of negligence, defective design, failure to warn and violations of the Montana Consumer Protection Act after an eight-week trial in Dallas. The product at issue in the trial was the Ultamet metal-on-metal articulation.

The MDL was consolidated in May 2011, when the U.S. Judicial Panel on Multidistrict Litigation centralized three actions and identified 54 potential tag-along actions. There are now more than 8,000 cases in the MDL, all involving Pinnacle devices that contain sockets with metal, ceramic or polyethylene lining, according to court documents.

The judge had ignored the stay bid in June when he selected a handful of cases for trial in a short order that J&J and DePuy said at the time would undermine the efficiency and fairness of the MDL proceedings, court records show.

The companies then went to the Fifth Circuit on June 23 asking for a writ of mandamus to halt the upcoming trial. Judge Kinkeade hadn’t entered final judgment in either case at the time, putting significant settlement pressure on the company before it could get more information about the pool of claims, the companies said.

Judge Kinkeade entered final judgment on the second trial Tuesday.

But he also said in the order refusing to stay the upcoming trial that pausing the claims would be unfair to everyone involved. The average plaintiff in the case is 68 years old this year, he said.

"Judge Kinkeade continues to work a very difficult MDL in spite of the defendants' constant harassment, threats, intimidating muscle flexing, and efforts of the defendants to cloak themselves in Article III robes and claim control of the court," said W. Mark Lanier of The Lanier Law Firm, who represents the plaintiffs.

Representatives for the parties didn’t immediately respond to requests for comment late Tuesday.

The plaintiffs are represented by W. Mark Lanier of The Lanier Law Firm, Larry Boyd, Wayne Fisher and Justin Presnal of Fisher Boyd Johnson & Huguenard LLP, Richard J. Arsenault ofNeblett Beard & Arsenault, and Jayne Conroy of Simmons Hanly Conroy.

DePuy and Johnson & Johnson are represented by Michael V. Powell and Seth M. Roberts ofLocke Lord LLP and Stephen J. Harburg, John H. Beisner, Jessica Davidson Miller and Geoffrey M. Wyatt of Skadden Arps Slate Meagher & Flom LLP.

The MDL is In re: DePuy Orthopaedics Inc. Pinnacle Hip Implant Products Liability Litigation, case number 3:11-md-02244, in the U.S. District Court for the Northern District of Texas.

--Additional reporting by Emily Field. Editing by Philip Shea.

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U.S. judge cuts $500 million verdict over J&J hip implants

Jul 6, 2016 | Reuters

By Jessica Dye

A U.S. judge has slashed a $500 million verdict against Johnson & Johnson and its DePuy unit over allegedly defective metal-on-metal Pinnacle hip implants to approximately $151 million.
On Tuesday, U.S. District Judge Ed Kinkeade in the Northern District of Texas said he was compelled to reduce the verdict under a Texas state law limiting punitive damages according to a specific formula.
In March, the five plaintiffs and three of their spouses had been collectively awarded roughly $360 million in punitive damages, along with $140 million in compensatory damages, following a two-month trial.
Kinkeade also denied J&J's bid to set aside the verdicts and order a new trial. The company had argued jurors were biased by hearing irrelevant and unfair evidence during trial. Plaintiffs' lawyers had claimed the company was seeking an improper "do-over" after its trial strategy backfired.
Mark Lanier and Richard Arsenault, lead lawyers for the Pinnacle plaintiffs, said they disagreed with Texas' cap on punitive damages but were pleased J&J's bid for a new trial had been rejected.
A lawyer for J&J, John Beisner, said that the company is "confident that the trial verdict will be reversed on appeal."
J&J and DePuy are facing roughly 8,400 lawsuits over the devices, which plaintiffs say contain design flaws that cause them to fail. The lawsuits claim friction between the devices' metal components can shed ions into the bloodstream, leading to injuries such as tissue death, bone erosion and high levels of metal in their blood.
J&J and DePuy have denied any wrongdoing in connection with developing and marketing the devices. DePuy stopped selling the metal-on-metal version of Pinnacle hips in 2013. That year, it paid $2.5 billion to settle more than 7,000 lawsuits over another metal-on-metal hip device, the ASR, which was recalled in 2010.
The $500 million verdict in March was the second in a trial involving Pinnacle hip devices. J&J was cleared of liability in the first trial, which involved a single plaintiff and ended in 2014. A third trial involving multiple plaintiffs is scheduled for September.

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Award In J&J Hip Implant Bellwether Trial Slashed To $150M

Jul 6, 2016 | Law360

By Emily Field

A Texas federal judge cut a $497.6 million verdict from the second bellwether trial in the multidistrict litigation over allegedly defective Pinnacle hip prosthetics manufactured by Johnson & Johnson’s DePuy Orthopaedics Inc. unit to about $150 million on Tuesday, according to an attorney representing patients alleging injuries.
U.S. District Judge Ed Kinkeade slashed the verdict according to the caps on punitive damages under Texas law, lead plaintiffs' attorney Mark Lanier of The Lanier Law Firmtold Law360 on Wednesday. A Dallas jury on March 17 found in favor of all five plaintiffs in the trial, returning a verdict that had included $360 million in punitive damages.

“While we believe that the Texas law is unconstitutional, we are not surprised that the judge used it to reduce the judgment,” Lanier said.

The trial had involved the consolidated claims of Margaret Aoki, Jay Christopher, Donald Greer, Richard Klusmann and Robert Peterson, who all underwent hip arthroplasty, where a hip joint is replaced with a prosthetic.

In their case, the prosthetics were DePuy Pinnacle metal-on-metal devices, which they alleged cause serious health problems including inflammation of surrounding tissues, bone erosion and metallosis, a toxic condition caused when the device’s components grind against each other and shed metal debris into the bloodstream.

“The court’s reduction of the punitive damages to $10 million, per Texas law, significantly reduces the damages awarded at trial," John Beisner of Skadden Arps Slate Meagher & Flom LLP said in a statement. "With the court’s issuance of final orders, entering judgment and reducing the punitive damages, we will now proceed with the appellate process. We remain confident that the trial verdict will be reversed on appeal.”

The verdict was slashed on the same day Judge Kinkeade shot down J&J and DePuy’s bid to put all further bellwether trials in the MDL on hold while they appeal the trial process, in part because the company had the chance to raise issues earlier and didn’t.

The judge found that not only would the next trial — the third bellwether in the dispute over whether Pinnacle hip prosthetics were defective, set for early September — cover different issues because the plaintiffs were from California rather than Texas or Montana, as in the first two trials, but that J&J had been repeatedly warned about some of the issues it’s now trying to raise in trial court motions and an appeal to the Fifth Circuit.

J&J and DePuy had agreed on the bellwether process the court is now following and can’t grind the MDL to a halt now just because it lost one of the trials, Judge Kinkeade said.

“Only after losing the second bellwether trial did defendants object to the process,” Judge Kinkeade said. “There are more than 8,000 pending cases in this MDL; the court cannot grant a stay every time plaintiffs win a trial.”

The judge noted that the companies had agreed in January 2013 not to raise a venue objection to any of the cases being tried in Texas’ Northern District, one of the issues J&J and DePuy are now raising after losing the second trial.

J&J and DePuy had argued in a May 24 motion that they were prejudiced by crucial pieces of evidence introduced at the second bellwether trial.

That evidence includes “references to Saddam Hussein’s ‘henchmen,’ unsupported speculation that plaintiffs might develop cancer as a result of their Pinnacle implants,” as well as lawyers and expert witnesses who have testified on behalf of a number of companies with no connection to the litigation, the company said.

But Judge Kinkeade said Tuesday that he had repeatedly warned the companies that if they raised evidence at trial of good character, product safety or success of their products abroad, the plaintiffs would be allowed to introduce contrary evidence. It was up to the defendants to decide “whether to open those doors” in the California plaintiffs’ trial, the judge said.

The first bellwether trial in the MDL ended in October 2014 in a verdict for J&J when a jury cleared DePuy Orthopedics of similar accusations.

The jury found in favor of J&J on all counts, rejecting plaintiff Kathy Herlihy-Paoli's claims of negligence, defective design, failure to warn and violations of the Montana Consumer Protection Act. The product at issue in the trial was the Ultamet metal-on-metal articulation.

The MDL was consolidated in May 2011, when the U.S. Judicial Panel on Multidistrict Litigation centralized three actions and identified 54 potential tagalong actions. There are now more than 8,000 cases in the MDL, all involving Pinnacle devices that contain sockets with metal, ceramic or polyethylene lining, according to court documents.

The judge had ignored the stay bid in June when he selected a handful of cases for trial in a short order that J&J and DePuy said at the time would undermine the efficiency and fairness of the MDL proceedings, court records show.

The companies then went to the Fifth Circuit on June 23 asking for a writ of mandamus to halt the upcoming trial. Judge Kinkeade hadn’t entered final judgment in either case at the time, putting significant settlement pressure on the company before it could get more information about the pool of claims, the companies said.

When Judge Kinkeade entered final judgment on the second trial Tuesday, he said that pausing the claims would be unfair to everyone involved. The average plaintiff in the case is 68 years old this year, he said.

The patients are represented by W. Mark Lanier of The Lanier Law Firm, Larry Boyd, Wayne Fisher and Justin Presnal of Fisher Boyd Johnson & Huguenard LLP, Richard J. Arsenault ofNeblett Beard & Arsenault, and Jayne Conroy of Simmons Hanly Conroy.

DePuy and Johnson & Johnson are represented by Michael V. Powell and Seth M. Roberts ofLocke Lord LLP and Stephen J. Harburg, John H. Beisner, Jessica Davidson Miller and Geoffrey M. Wyatt of Skadden Arps Slate Meagher & Flom LLP.

The MDL is In re: DePuy Orthopaedics Inc. Pinnacle Hip Implant Products Liability Litigation, case number 3:11-md-02244, in the U.S. District Court for the Northern District of Texas.

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J&J Asks 5th Circ. To Hurry Hip MDL Appeal

Jul 13, 2016 | Law360

By Cara Salvatore

A Johnson & Johnson unit facing more than 8,000 lawsuits over its hip prosthetics pressed a Texas federal appeals court on Tuesday to accelerate an appeal after a trial loss, saying the completed bellwether trials in the multidistrict litigation have revealed that the federal judge in charge is willing to condone wildly off-base legal arguments.

J&J's DePuy Orthopaedics Inc. asked the Fifth Circuit for an expedited appeal of the most recent trial as it eyes the next bellwether, set for September. A jury awarded $498 million in March — an amount that was later slashed by two-thirds — to Margaret Aoki, Jay Christopher, Donald Greer, Richard Klusmann and Robert Peterson.

Each had undergone a hip arthroplasty, trading a real hip joint for a prosthetic. But the five plaintiffs said their Pinnacle Ultamet metal-on-metal joints caused serious health problems, including inflammation of nearby tissue, erosion of bone and metallosis, the shedding of tiny bits of metal into the bloodstream when metal parts grind against each other.

J&J accused U.S. District Judge Ed Kinkeade of allowing a virtual free-for-all in that trial and distorting the course of the bellwether process.

“After the first trial ... the 'bellwether' process lost its information-generating purpose,” J&J said. “The MDL court allowed plaintiffs to proceed with novel and far-flung theories, unsupported in law, that will likely recur in most if not all cases in the MDL proceeding.”

“The disposition of the appeal will have broad implications for additional bellwether trials in this litigation, including an upcoming seven-plaintiff trial that the district court has slated to begin in September 2016,” it said.

In J&J's eyes, the potentially recurring problems include the claim that parent companies might be to blame for aiding and abetting their subsidiaries and the claim that a design defect can be shown not through an individual device's single issue but by "arguing that an entire line of products should not have been sold by any of a range of manufacturers."

"We remain concerned that starting a new trial before issues from the last one are resolved compromises the efficiency and fairness of the entire MDL proceeding," J&J attorney John Beisner of Skadden Arps Slate Meagher & Flom LLP said on Wednesday.

This month, Judge Kinkeade reduced the original verdict of $497.6 million to about $150 million, citing Texas law's cap on punitive damages, lead plaintiffs' attorney Mark Lanier of The Lanier Law Firm told Law360 at the time. The March 17 verdict had included $360 million in punitives, but according to Beisner, they were reduced to $10 million.

Judge Kinkeade has refused to put further bellwethers on hold during J&J's promised appeal, in part because the company had the chance to raise issues earlier and didn’t. The third bellwether, set for early September, will cover slightly different issues, the judge has said. Pausing the claims would be unfair to everyone involved, he said, noting that the average plaintiff in the case is now 68 years old.

“Only after losing the second bellwether trial did defendants object to the process,” Judge Kinkeade has said. “There are more than 8,000 pending cases in this MDL; the court cannot grant a stay every time plaintiffs win a trial.”

The first bellwether ended in a verdict for J&J in October 2014. The jury rejected Kathy Herlihy-Paoli's claims of negligence, defective design, failure to warn and violations of the Montana Consumer Protection Act.

The U.S. Judicial Panel on Multidistrict Litigation had consolidated three actions and identified 54 potential tagalong actions in 2011. The thousands of MDL cases all involve Pinnacle devices that contain sockets with metal, ceramic or polyethylene lining, according to court documents.

The patients are represented by W. Mark Lanier of The Lanier Law Firm; Larry Boyd, Wayne Fisher and Justin Presnal of Fisher Boyd Johnson & Huguenard LLP; Richard Arsenault ofNeblett Beard & Arsenault; and Jayne Conroy of Simmons Hanly Conroy.

DePuy and Johnson & Johnson are represented by Michael Powell and Seth Roberts of Locke Lord LLP and Stephen Harburg, John Beisner, Jessica Davidson Miller and Geoffrey Wyatt of Skadden Arps Slate Meagher & Flom LLP.

The MDL is In re: DePuy Orthopaedics Inc. Pinnacle Hip Implant Products Liability Litigation, case number 3:11-md-02244, in the U.S. District Court for the Northern District of Texas.

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Johnson & Johnson’s DePuy wants expedited appeal of $151m Pinnacle hip loss

Jul 14, 2016 | MassDevice

By Brad Perriello

Johnson & Johnson (NYSE:JNJ) subsidiary DePuy Orthopaedics asked a federal appeals court this week to expedite the appeal of its $151 million loss in a product liability lawsuit brought over its Pinnacle metal-on-metal hip implant.
In March, a Texas federal jury slapped DePuy Orthopaedics with a $500 million judgment in favor of a quintet of plaintiffs who blamed the Pinnacle implant for their injuries. After a 2-month trial, jurors found that the Ultamet metal-on-metal version of the Pinnacle hips were defectively designed and that DePuy failed to warn patients about the risks, awarding $130 million in total compensatory damages and $360 million in punitive damages. DePuy won the 1st bellwether trial in the MDL, in October 2014. The judge in the case last week slashed the award to roughly $151 million.
J&J’s bid for a stay was denied by Judge Ed Kinkeade of the U.S. District Court for Northern Texas, but the appeals court has yet to decide on a similar request. Johnson & Johnson also wants to delay a 3rd bellwether trial slated to commence in September.
In a July 12 filing with the U.S. Court of Appeals for the 5th Circuit, the company asked that court to speed its review of the appeal and asked that the 5 cases be consolidated into a single appeal.
“First, expedited appeal should be granted because the disposition of the appeal will have broad implications for additional bellwether trials in this litigation, including an upcoming 7-plaintiff trial that the district court has slated to begin in September 2016. The [multi-district litigation] court denied defendants’ request for a stay pending appeal, citing the need to continue trying cases without delay (even though the MDL court allowed more than a year to pass between the defense verdict in the 1st bellwether trial and the start of the 2nd trial). The MDL court’s desire to try as many cases as quickly as possible underscores the importance of swift appellate review to minimize the extent to which the errors in these cases are repeated in future trials,” J&J wrote. “Second, the court should consolidate its review of defendants’ appeals in the 5 cases tried together by the trial court. While each of the cases presents individualized legal and factual issues, and they should have therefore been tried separately, a number of legal errors affected all 5 cases, making it more efficient to address the appeals together.”
In overturning the $500 million award in the 2nd bellwether, Kinkeade said he was compelled to reduce the verdict under a Texas state law limiting punitive damages according to a specific formula. Kinkeade also ruled that DePuy can’t delay the 3rd bellwether in the Pinnacle MDL; the company had asked the judge to give it enough time to appeal a $500 million jury verdict in the 2nd bellwether. DePuy wanted Kinkeade to pause the 3rd bellwether while the the U.S. Court of Appeals for the 5th Circuit considers its petition for a writ of mandamus.

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