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Ethicon 28/1
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J&J to Pay $120 Million in Its First Big Mesh Settlement
Jan 27, 2016 | Bloomberg
By Jef Feeley
Johnson & Johnson has made its first serious move to settle thousands of lawsuits filed by women who fault the company’s vaginal-mesh inserts for their injuries, according to people familiar with the matter. -
J&J reportedly settles first transvaginal mesh suits
Jan 27, 2016 | Reuters
By Jessica Dye
Johnson & Johnson's Ethicon Inc unit has reportedly reached a $120 million deal to resolve as many as 3,000 lawsuits alleging that its transvaginal mesh products are defective, marking the first time the manufacturer has agreed to a group settlement in the litigation. -
Johnson & Johnson to pay $120m in 1st mesh settlement
Jan 27, 2016 | Mass Device
By Fink Densford
Johnson & Johnson (NYSE:JNJ) is making the 1st move in settling thousands of lawsuits from women who claim the company’s vaginal-mesh inserts caused organ damage and serious pain, paying $120 million to settle the 1st 2,000 to 3,000 suits, according to Bloomberg. -
Johnson & Johnson Offers First Transvaginal Mesh Settlement $120 Million
Jan 28, 2016 | Mesh Medical Device ENws Desk
By Jane Akre
Bloomberg News reports Johnson & Johnson has agreed to pay $120 million to settle thousands of injury lawsuits filed by women implanted with the company’s transvaginal mesh. -
Judge boots Boston Scientific counterfeit mesh case to the FDA
Jan 27, 2016 | Mass Device
By Brad Perriello
A federal judge yesterday booted a purported class-action racketeering lawsuit filed against Boston Scientific (NYSE:BSX), accusing the medical device maker of illegally smuggling counterfeit resin made in China to make pelvic mesh. -
Judge Goodwin Defers Counterfeit Mesh Allegations Against Boston Scientific to the FDA
Jan 27, 2016 | Mesh Medical Device News Desk
By Jane Akre
Judge Joseph Goodwin who is overseeing thousands of pelvic mesh injury cases in his West Virginia court has decided to let the U.S. Food and Drug Administration (FDA) handle the latest hot potato – counterfeit mesh from China.
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J&J to Pay $120 Million in Its First Big Mesh Settlement
Jan 27, 2016 | Bloomberg
By Jef Feeley
Johnson & Johnson has made its first serious move to settle thousands of lawsuits filed by women who fault the company’s vaginal-mesh inserts for their injuries, according to people familiar with the matter.
The medical-device maker agreed to pay more than $120 million to resolve 2,000 to 3,000 suits alleging women suffered organ damage and were left in constant pain by mesh surgical inserts that eroded in their bodies, according to three people who asked not to be named because they weren’t authorized to speak publicly about the settlement.
The company faces another 42,400 such cases, according to a regulatory filing. It’s unclear what J&J’s exposure will be after those suits are resolved through verdicts, settlements or dismissals because average payouts will vary based on the strength of cases.
“From time to time we have appropriately agreed to resolve some cases,” Ernie Knewitz, a J&J spokesman, said in an e-mailed statement. “We will not discuss the terms, nor discuss our ongoing litigation strategy."
The settlements mark the first time J&J and its Ethicon unit have agreed to resolve a significant number of mesh cases. The company, which has settled only a handful of cases so far, has set aside an undisclosed reserve for those and other product-liability claims, according to its October filing with the Securities and Exchange Commission. J&J has said it doesn’t consider the financial risk from the mesh cases to be material. Total Expenses
The New Brunswick, New Jersey-based company reported $141 million in total litigation expenses in 2015, down from $1.2 billion in 2014 legal costs and $2.2 billion in 2013, according to its filings.
Clayton Clark, a Houston-based lawyer who represents the settling women, declined to comment on the accord. The company has said it acted appropriately and responsibly in the development and marketing of the device.
J&J faces the most cases in the sprawling vaginal-mesh litigation, which began in 2011 and has encompassed at least 100,000 suits against more than a half-dozen device makers. Companies including Boston Scientific Corp. and C.R. Bard Inc. have settled some cases while setting aside more than $1 billion to deal with claims over inserts, which bolster sagging organs and treat incontinence.
Women complain that Ethicon’s inserts shrink once implanted, causing organ damage and constant pain. J&J agreed in June 2012 to pull some lines off the market.Join Talks
J&J has so far refused to join talks between plaintiffs’ lawyers and other insert makers seeking a global resolution of sprawling litigation, said Carl Tobias, who teaches product-liability law at the University of Richmond in Virginia.
“J&J still has a ton of cases to deal with, but this settlement may encourage other lawyers to consider taking their offer,” Tobias said.
The U.S. Food and Drug Administration in 2012 ordered J&J, Boston Scientific, Bard and other mesh makers to study rates of organ damage and complications linked to the implants after the companies faced a wave of lawsuits. The FDA this month tightened regulations governing inserts after finding they should be classified as higher-risk products when used to bolster sagging organs.
Juries in Texas, New Jersey, and California have found J&J and Ethicon liable for injuries tied to the inserts. A Philadelphia jury last month ordered the device maker to pay $12.5 million to a woman who said Ethicon’s Prolift mesh harmed her bladder. The company has won several trials, including a 2014 case brought in West Virginia over mesh used to treat incontinence.Federal Judge
U.S. District Judge Joseph Goodwin in Charleston, West Virginia, was tapped in 2012 to oversee mesh cases in federal courts across the country. He’s been pushing manufacturers to consider settling, Tobias said.
Marlborough, Massachusetts-based Boston Scientific faces 30,000 mesh suits, the company said in a November filing. In April, the device maker said it agreed to pay $119 million to resolve almost 3,000 cases in its first substantial settlement.
Bard said in an October SEC filing that it faced 12,850 mesh suits after settling about 6,400 cases. The company agreed in August to pay more than $200 million to resolve at least 3,000 cases, people familiar with the accord said at the time.
The case is In Re Ethicon Inc. Pelvic Repair System Products Liability Litigation, 12-MDL-2327, U.S. District Court, Southern District of West Virginia (Charleston).
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J&J reportedly settles first transvaginal mesh suits
Jan 27, 2016 | Reuters
By Jessica Dye
Johnson & Johnson's Ethicon Inc unit has reportedly reached a $120 million deal to resolve as many as 3,000 lawsuits alleging that its transvaginal mesh products are defective, marking the first time the manufacturer has agreed to a group settlement in the litigation.
The deal will cover between 2,000 and 3,000 plaintiffs suing over Ethicon's mesh products who are represented by Clayton Clark of Clark Love Hutson, Bloomberg reported Wednesday, citing three people who declined to be named because they were not authorized to publicly discuss the settlement.
To read the full story on WestlawNext Practitioner Insights, click here: bit.ly/1PTZWZk
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Johnson & Johnson to pay $120m in 1st mesh settlement
Jan 27, 2016 | Mass Device
By Fink Densford
Johnson & Johnson (NYSE:JNJ) is making the 1st move in settling thousands of lawsuits from women who claim the company’s vaginal-mesh inserts caused organ damage and serious pain, paying $120 million to settle the 1st 2,000 to 3,000 suits, according to Bloomberg.
The company still faces over 40,000 suits related to vaginal meshes, and its unsure how much the company will owe for each case, as average payouts will vary.
“From time to time we have appropriately agreed to resolve some cases. We will not discuss the terms, nor discuss our ongoing litigation strategy,” J&J spokesperson Ernie Knewitz toldBloomberg in an emailed statement.
The settlement is the 1st for J&J and its Ethicon unit, though the company has reportedly set aside an undisclosed reserve for those claims.
J & J faces the most cases of all the medical device companies being charged in the over 100,000 suits, which includes Boston Scientific (NYSE:BSX) and C.R. Bard (NYSE:BCR).
Earlier this month, A federal appeals court upheld a $2 million loss for Bard in a product liability lawsuit brought over its Avaulta pelvic mesh.
A jury awarded plaintiff Donna Cisson $250,000 in compensatory damages and $1.75 million in punitive damages back in August 2013, in 1 of the 1st of thousands of federal lawsuits to go to trial over pelvic mesh implants. The devices are designed to treat female urinary incontinence and pelvic organ prolapse.
Earlier in January the FDA, prompted by a significant increase in complaints about a type of surgical mesh used to treat pelvic organ prolapse in women, put the product under its most stringent level of review.
The federal safety watchdog said it re-classified the mesh from Class II to Class III and will require makers to go through its pre-market approval process for transvaginal POP procedures. The moves do not apply to mesh used in other indications, including stress urinary incontinence and abdominal POP repair, the FDA said.
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Johnson & Johnson Offers First Transvaginal Mesh Settlement $120 Million
Jan 28, 2016 | Mesh Medical Device ENws Desk
By Jane Akre
Bloomberg News (here) reports Johnson & Johnson has agreed to pay $120 million to settle thousands of injury lawsuits filed by women implanted with the company’s transvaginal mesh.
The offer resolves anywhere from 2,000 to 3,000 lawsuits. The number represents $40,000 to $60,000 per case before legal fees and outstanding debt is settled.
This is the first time J&J has offered to resolve its product liability cases regarding mesh.
J&J and its Ethicon division is currently facing more product liability lawsuits than any other mesh maker, in excess of 40,000 actions. According to its fourth quarter SEC filing the company does not consider the financial risk from pelvic mesh to be material.
Earnie Knewitz, spokesman J&J
“From time to time we have appropriately agreed to resolve some cases,” Ernie Knewitz, a J&J spokesman, said in an e-mailed statement. “We will not discuss the terms, nor discuss our ongoing litigation strategy.”
J&J says it has spent $141 million in costs of defending itself against a handful of pelvic mesh cases. The company spent $2.2 billion in 2013 and $1.2 billion in 2014 in legal costs.
J&J’s Prolene Mesh
The J&J Fourth Quarter report says, “The number of pending product liability lawsuits continues to increase, and the Company continues to receive information with respect to potential costs and the anticipated number of cases.”
Besides 30,665 cases filed in multidistrict litigation in Charleston, WV (here) , a number of personal injury cases have been filed in Australia, Belgium, Canada, England, Israel, Italy, the Netherlands, Scotland and Venezuela seeking damages.
While other mesh manufacturers such as American Medical Systems and C.R. Bard have agreed to settle its outstanding product liability actions regarding pelvic mesh, J&J has not done so to date until the eve of a jury trial or, in one case, just as the case was about to go to the jury.
Any settlement requires at least 90 percent of qualified recipients agree to the terms of settlement.
J&J recently announced it was restructuring its medical device division and dismissing 3,000 employees after disappointing sales figures. #
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Judge boots Boston Scientific counterfeit mesh case to the FDA
Jan 27, 2016 | Mass Device
By Brad Perriello
A federal judge yesterday booted a purported class-action racketeering lawsuit filed against Boston Scientific (NYSE:BSX), accusing the medical device maker of illegally smuggling counterfeit resin made in China to make pelvic mesh.
The lawsuit was filed Jan. 12 in the U.S. District Court for Southern West Virginia, the venue for multi-district litigation against a clutch of companies over their respective mesh products for treating female urinary incontinence and pelvic organ prolapse.
Plaintiff Teresa Stevens alleged that Marlborough, Mass.-based Boston Scientific conspired with subsidiaries in Belgium and Ireland to use the counterfeit resin to make the Advantage mesh used in all of its pelvic mesh products after its original supplier allegedly refused to continue providing the product because it’s not supposed to be implanted in humans.
Judge Joseph Goodwin ruled yesterday that the FDA has jurisdiction over the case, as “many of the factual allegations contained in the complaint and supporting documents are based on alleged violations of statutes and regulations over which the FDA exercises its expertise and impressive administrative dominance.”
“The FDA is in the best position to determine whether Boston Scientific’s mesh device is in compliance with the FDA’s own statutes, regulations, and directives – particularly because the FDA was the very agency that cleared Boston Scientific’s mesh device in the first place,” Goodwin wrote.
The judge also stayed the case until Stevens gets a determination from the federal safety watchdog, retaining jurisdiction over the charges leveled under the Racketeer Influenced & Corrupt Organizations Act and West Virginia statutes, according to court documents.
The complaint charges Boston Scientific and co-defendants EMAI, Luxilon and Proxy with racketeering, mail fraud, wire fraud, intentional and negligent misrepresentation, unfair and deceptive acts and practices, fraud and unjust enrichment. Stevens asked Judge Joseph Goodwin for a jury trial, temporary and permanent injunctions barring the manufacture and sale of products using the allegedly fake Marlex, a warning to the public about it, punitive and consequential damages, legal costs, pre- and post-judgment interest and a temporary restraining order.
Goodwin declined to grant the temporary restraining order, ruling that Stevens’ counsel never told Boston Scientific’s attorneys that a motion for the TRO was planned, as strictly required by federal law, according to the documents. Goodwin reserved judgment on Stevens’ motion seeking a preliminary injunction.
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Judge Goodwin Defers Counterfeit Mesh Allegations Against Boston Scientific to the FDA
Jan 27, 2016 | Mesh Medical Device News Desk
By Jane Akre
Judge Joseph Goodwin who is overseeing thousands of pelvic mesh injury cases in his West Virginia court has decided to let the U.S. Food and Drug Administration (FDA) handle the latest hot potato – counterfeit mesh from China.
Citing the doctrine of primary jurisdiction, the federal judge, in a January 26 Memorandum Opinion and Order, said the FDA is the administrative agency with the most knowledge over whether the mesh manufactured by Boston Scientific comes from counterfeit, adulterated polypropylene resin smuggled in from China and not the Marlex polypropylene the manufacturer is approved to use.
“The FDA is in the best position to determine whether Boston Scientific’s mesh device is in compliance with the FDA’s own statutes, regulations, and directives – particularly because the FDA was the very agency that cleared Boston Scientific’s mesh device in the first place.” ~ Judge Joseph Goodwin
The plaintiff complaint, Teresa L. Stevens v. Boston Scientific 2:16-cv-00265, accuses the company of racketeering and asked the court to restrain Boston Scientific from marketing, selling or importing its mesh devices containing the alleged counterfeit polypropylene resin.
That request was stayed until Judge Goodwin hears an updated status report from the FDA and plaintiffs’ lawyers no later than May 1, 2016.
BACKGROUND STORY
Boston Scientific says each year approximately 55,000 women are implanted with its pelvic mesh, Marlex HGX-030-1. This is mesh that the FDA approved for use in the Boston Scientific pelvic meshes it manufactures. Technically, if the company uses any other polypropylene to make its Marlex mesh, that product would not be approved for sale by the FDA.
Marlex is made from polypropylene resin in pellet form by a joint venture between the Chevron Corporation and Phillips Sumika Polypropylene Company of LaPorte, Texas.
According to the Stevens complaint, by 2011, Boston Scientific (BSX) began running out of Marlex supplies because Phillips decided to discontinue selling it to the company. BSX then allegedly resorted to smuggling counterfeit Marlex pellets out of China into Belgium and ultimately the U.S. between June 2011 to the fall of 2012. The plaintiff alleges women were implanted with a counterfeit, adulterated product that was not approved by the FDA under Boston Scientific’s 510(k) application.
The Houston-based Mostyn law firm filed Stevens v. Boston Scientific January 12 making claims under the Racketeer Influenced and Corrupt Organizations Act or RICO, used to prosecute organized crime. The actions employed by BSX were also a violation of West Virginia’s Consumer Credit and Protection Act, it said and Boston Scientific “acted like a drug dealer” to hide overseas shipments from regulators in both China and the U.S. See the Stevens RICO-Complaint January 2016.
Judge Goodwin’s court will retain jurisdiction over the case until there is an FDA determination to the specific allegations.
DOCTRINE OF PRIMARY JURISDICTION
In 1907, the U.S. Supreme Court decided the courts should promote proper relationships with administrative agencies charged with particular regulatory duties. In that case, a shipper claimed a carrier’s rate was unreasonable and sued the carrier in state court. The US Supreme Court decided the Interstate Commerce Commission alone was competent to determine whether the rate was reasonable.
In other words, agency expertise is needed to resolve the issue before a court can allocate jurisdiction. The court can stay the proceedings and look to the FDA for a determination, it may request an amicus curiae brief from the FDA (friends of the court) or it may certify questions to the agency.
FDA AND THE INDUSTRY IT REGULATES
The plaintiffs say the court will not benefit from agency expertise. Judge Goodwin disagreed, citing confidence with the federal agency.
The FDA tightened some control over medical devices with the enactment of the Medical Device Amendments of 1976 (MDA) but the bulk of medical devices are approved under 510(k) with an exchange of paperwork and the naming of a “predicate” device already on the market.
Judge Goodwin states the FDA can require medical device companies to conduct post-approval marketing, such as what its done with the mesh makers. The agency can adopt a method of tracking a device within the marketplace, he writes, however, while that has been discussed, the FDA still has no way to track a troubling medical device. If an automobile has a problem, its VIN number can be traced. Not so with medical devices.
The FDA can have a device recalled, but it rarely does. Generally that is left up to the manufacturer to enact a voluntary recall or a quiet withdrawal from the market, as has occurred with Johnson & Johnson and C.R. Bard.
Judge Goodwin says private individuals may initiate an administrative proceeding to petition the FDA commissioner to take administrative action.
Mesh News Desk has reported on what happened to Bruce Rosenberg when he tried to do just that. Calling a member of the FDA’s medical device division, he wanted to show them a videotape made by Johnson & Johnson that showed the company knew its Prolene hernia mesh was too stiff for use in humans. In the video, a consultant/doctor is shown hitting a hardened piece of plasticized mesh against a table. The video was made to promote a softer mesh.
When Rosenberg, who heads the nonprofit Meshoma Foundation, called the agency, a device regulator, David Krause, whose job it was to authorize 510(k) clearances for medical devices including pelvic mesh, called the head of regulatory affairs for Ethicon, Peter Cecchini. Cecchini replied in an internal Ethicon October 20 email, “According to David K., it seems that Bruce Rosenberg claims to have a DVD that speaks to a mesh that falls apart after 1 year implantation. David would like the details of this and has requested a copy of the DVD. He did state that if this is true the product should be removed from the market and the 510(k) removed.”
Krause calls consumer groups headed by Rosenberg and patient advocate, Lana Keeton “serious, irrational and nasty.”
Mesh News Desk has also obtained notes from a meeting between industry and the FDA prior to an expert panel meeting in September 2011 that clearly show industry schooling the agency about mesh.
Additionally, the FDA has no mechanism by which to review medical devices on the market that named a “predicate” device that’s been found to be defective as was the case with the ProteGen mesh, which was removed from the market.
The Mostyn firm is hoping to turn the Stevens case into a class action and to try and stop the sale of transvaginal mesh implants made by Boston Scientific. #
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