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Pelvic Mesh Plaintiffs Say Cases Can Be Heard In Philly
Feb 18, 2015 | Law360
By Matt Fair
...In a brief filed in September, J&J sought to have some 118 cases against the company, filed by plaintiffs in 31 different states, booted from Philadelphia on grounds that the claims did not have any clear link to Pennsylvania. "While plaintiffs have alleged that Ethicon and J&J 'regularly conduct substantial business in Philadelphia County... -
Pelvic Mesh Lawsuits: J&J Drops Claim That Women Were Asked to Lie For Payouts
Feb 18, 2015 | Mass Device
By Brian Johnson
Johnson & Johnson (NYSE:JNJ) has withdrawn its motion to have a federal judge overseeing thousands of pelvic mesh lawsuits to force the plaintiffs to prove they have a valid claim. Attorneys for JNJ and its Ethicon subsidiary were granted a motion to withdraw the discovery bid by U.S. District Judge Joseph Goodwin on Feb. 11... -
Bard Avaulta Mesh Injury Cases Heading to Settlement
Feb 18, 2015 | The Legal Examiner
By Shezad Malik
...There are currently more than 75,000 product liability, and personal injury lawsuits filed in the federal court system involving transvaginal mesh or bladder sling products made by Bard, American Medical Systems (AMS), Ethicon, Boston Scientific, Coloplast Corp., Cook Medical and Neomedic... -
Boston Scientific's J&J Settlement Cheers Investors
Feb 18, 2015 | Minneapolis Star Tribune
By Joe Carlson
One down, two to go. Boston Scientific Corp., the global medical devicemaker that employs 5,000 people in the Twin Cities, pleased investors Tuesday by settling a potentially $7 billion lawsuit with its longtime adversary Johnson & Johnson for the relative bargain price of $600 million. -
Boston Scientific Hands Over $600m To Settle Breach-Of-Contract Guidant Suit With J&J
Feb 18, 2015 | Fierce Medical Devices
By Emily Wasserman
Boston Scientific ($BSX) is forking over $600 million to settle its ongoing breach-of-contract lawsuit with Johnson & Johnson ($JNJ) over a failed bidding war for devicemaker Guidant, laying its decade-old courtroom saga to rest. The Marlborough, MA-based company will pay far less than the $7.2 billion originally requested by J&J... -
Study Brings Spotlight Back on Quality-of-Life Hernia Outcomes
Feb 18, 2015 | General Surgery News
By Victoria Stern
...The meshes of choice were macroporous polyester mesh (Parietex Anatomical, Covidien), used in 65% of cases, and macroporous polypropylene mesh (Physiomesh, Ethicon), used in 31% of cases. Mean patient age was 56.4 years and mean body mass index was 26.1±3.7 kg/m2...
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Pelvic Mesh Plaintiffs Say Cases Can Be Heard In Philly
Feb 18, 2015 | Law360
By Matt Fair
A Pennsylvania state judge has been asked to find that claims against Johnson & Johnson and Boston Scientific Corp. over alleged injuries from pelvic mesh products should be subject to jurisdiction in the Philadelphia County Court of Common Pleas.
Judge Arnold New was urged in a brief Feb. 11 to find that decisions by both J&J and BSC to officially register to do business in Pennsylvania were enough to allow claims leveled against the companies by out-of-state plaintiffs to proceed as part of a mass tort program in Philadelphia.
“Johnson & Johnson has registered itself to conduct business in Pennsylvania, according to the Pennsylvania Department of State,” the plaintiffs said in their filing. “BSC has also registered itself to conduct business in Pennsylvania. As these defendants have voluntarily come to Pennsylvania to conduct business, they have subjected themselves to the jurisdiction of Pennsylvania’s courts.”
The brief comes in response to arguments by the companies that plaintiffs from outside of Pennsylvania could not pursue claims in Philadelphia because neither J&J nor BSC had any legitimate ties to the state.
In a brief filed in September, J&J sought to have some 118 cases against the company, filed by plaintiffs in 31 different states, booted from Philadelphia on grounds that the claims did not have any clear link to Pennsylvania.
"While plaintiffs have alleged that Ethicon and J&J 'regularly conduct substantial business in Philadelphia County, Pennsylvania,' the non-Pennsylvania plaintiffs have not alleged that their injuries arose in Pennsylvania or that their injuries arose out of any activity conducted by Ethicon and J&J in this Commonwealth," J&J said in its motion.
J&J also argued that it is the plaintiffs who bear the burden of supporting their claims for jurisdiction in Pennsylvania after the defendants have challenged it. The company also invoked the U.S. Supreme Court's landmark January 2014 ruling Daimler AG v. Barbara Bauman, in which the justices concluded that DaimlerChrysler could not be sued in California for injuries allegedly caused by the conduct of an Argentine firm that took place entirely outside the U.S.
But in their Feb. 11 brief, the plaintiffs pointed to a Delaware federal judge’s ruling in January finding that a defendant was subject to general jurisdiction in the state by virtue of its decision to register to conduct business there.
“The court found the defendant’s consent to jurisdiction was not vitiated by the U.S. Supreme Court’s decision in Daimler AG v. Bauman because Daimler did not address a situation where the defendant affirmatively consented to jurisdiction,” the brief said.
Nearly 700 suits have been filed as part of the mass tort program in Philadelphia, according to court records.
Attorneys for J&J and BSC did not immediately return messages seeking comment Wednesday.
The plaintiffs are represented by Thomas Kline, Lee Balefsky and Michelle Tiger of Kline & Specter PC.
J&J is represented by Andrew Reeve, Kenneth Murphy, and Melissa Graff of Drinker Biddle & Reath LLP.
BSC is represented by Joseph Blum of Shook Hardy & Bacon LLP.
The case is In Re: Pelvic Mesh Litigation, case number 140200829, in the Philadelphia County Court of Common Pleas. -
Pelvic Mesh Lawsuits: J&J Drops Claim That Women Were Asked to Lie For Payouts
Feb 18, 2015 | Mass Device
By Brian Johnson
Johnson & Johnson (NYSE:JNJ) has withdrawn its motion to have a federal judge overseeing thousands of pelvic mesh lawsuits to force the plaintiffs to prove they have a valid claim.
Attorneys for JNJ and its Ethicon subsidiary were granted a motion to withdraw the discovery bid by U.S. District Judge Joseph Goodwin on Feb. 11, according to a report in Law360. Attorneys for the New Brunswick, N.J.-based medical products conglomerate did not provide a reason as to why they withdrew their motion, the news source reported.
"The plaintiffs' leadership is pleased that Ethicon has decided to withdraw its motion," Bryan Aylstock of Aylstock Witkin Kreis & Overholtz PLLC said in a statement to Law 360 on Tuesday. "Moreover, the plaintiffs' leadership has always stood ready to work with Ethicon to investigate and put an end to any wrongful conduct, and the parties have pledged to work together to investigate and attempt to put an end to any wrongful solicitation of clients."
On January 15th, attorneys for JNJ claimed in legal filings that plaintiffs have engaged in a campaign of telephone solicitation aimed at generating more cases
"Women across the nation are receiving unsolicited phone calls from strangers who are seeking – or, more disturbingly, already know – their very personal medical information. These individuals, who on some occasions may call as often as 50 times a month, try to entice each woman into filing a lawsuit, oftentimes disregarding whether she has an injury or even had a mesh implant at all. In an apparent effort to legitimize their message or engender the woman's trust, some callers have gone so far as to say that they are associated with the FDA or with Johnson & Johnson," the company wrote in a court filing.
"What is happening here is wrong. And the fallout includes a compromised judicial system, exploitation of women and their federally (HIPPA) protected private health information, and undermined doctor-patient relationships," Johnson & Johnson argued, according to the filing.
At the time of the claim, the company asked Goodwin, who's overseeing the multi-district litigation that covers 10s of thousands of product liability lawsuits, to force plaintiffs to prove that they have a legitimate claim. And it wanted Goodwin to force the plaintiffs' lawyers to testify under oath and in front of the judge "to determine who may be profiting from the unethical and illegal direct solicitation of women and whether further investigation of others is warranted," according to the filing.
"With the court's help, the parties can take steps to identify claims that should be dismissed because the plaintiff cannot demonstrate she ever had an injury or even had an Ethicon pelvic mesh device implanted at all. These steps also should help to curtail the tactics that have violated women's rights, put women at risk, and jeopardized the integrity of the judicial process," J&J wrote. "It is important that women bringing non-fraudulent claims have an opportunity to have their claims presented in court. At the same time, production of basic information supporting the claims is required to weed out fraudulent or unmeritorious suits."
The company provided a transcript of a cold call allegedly received by someone looking to file false cases:
Caller: Ma'am, yeah, we are the – yeah, because we have the criteria here to receive this medical compensation for the bladder sling surgery and for the mesh implant surgery, and I know you never have done this surgery before, but still as a good human being what I can do, I can provide information about the bladder sling surgery and you just have to share this information only two times on the call, I send to my counselor and then after to my attorney, that's it, ma'am, apart from that you doesn't have to do anything to receive your compensation. Okay?
Female Recipient of Call [FRC]: But I've never had a bladder sling or mesh surgery.
Caller: I know, [FRC] you never had done this surgery, but if you are interested to receive 30 up to 40 thousand dollars, you just have to tell my compensation officer that I had a bladder sling surgery and after that I had a complication.
[FRC]: I know, but –
Caller: So I will tell my –-
[FRC]: That would be lying though.
Caller: I do understand, but you have to tell a lie if you want to get the 30 up to 40 thousand dollars –
[FRC]: No.
Caller: No one will give you 30, 40 thousand dollars like that. You have to tell a lie for that.
[FRC]: Right, but that's illegal.
Caller: Can you do this?
[FRC]: No, I will not do that.
Caller: Can you?
[FRC]: That is ridiculous, that is illegal.
Caller: Okay, [FRC] bye bye.
[FRC]: So you are – I mean this is fraud.
Caller: Hello?
[FRC]: Yes.
Caller: What happened, miss, you don't want to lie for the 30 to 40 thousand dollars?
[FRC]: No, I don't want to lie. I mean I have morals. This is fraud, this is illegal, so...
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Bard Avaulta Mesh Injury Cases Heading to Settlement
Feb 18, 2015 | The Legal Examiner
By Shezad Malik
Finally the monster transvaginal mesh litigation is heading for a global settlement. U.S. District Judge, John Goodwin, who presiding over all federal vaginal mesh lawsuits has appointed a Special Master to forge settlement talks between C.R. Bard and women who allege the mesh and bladder sling company’s products left them with painful and serious injuries.
75,000 Women Cannot Be Wrong
There are currently more than 75,000 product liability, and personal injury lawsuits filed in the federal court system involving transvaginal mesh or bladder sling products made by Bard, American Medical Systems (AMS), Ethicon, Boston Scientific, Coloplast Corp., Cook Medical and Neomedic.
Seven different MDLs (multidistrict litigations) have been organized against the various manufacturers, and are all centralized before U.S. District Judge Joseph Goodwin in the Southern District of West Virginia for discovery and pretrial proceedings.
The Bard Avaulta MDL was the first to be centralized in the Southern District of West Virginia in October 2010. Several “bellwether” trials have resulted in multi-million dollar damage awards for plaintiffs. But their has been slow progress to resolve large numbers of vaginal mesh claims by most of the manufacturers.
Only AMS has settled the majority of claims involving their products, agreeing to pay about $1.6 billion to resolve more than 20,000 claims.
Special Master Appointed to Push Bard Settlements
In a February 12 , court order, Judge Goodwin appointed Ellen Reisman to serve as a Special Master in the Bard litigation, to work with the manufacturer and plaintiffs’ lawyers to help jump start serious settlement talks.
Reisman served as the national settlement counsel for AMS, and according to Judge Goodwin, Reisman is the most qualified person to promote settlement between Bard and injured women.
Trans Vaginal Mesh Claims Continues to Grow
According to the latest data released by the U.S. Judicial Panel on Multidistrict Litigation (JPML) on February 17, there are over 10,348 Bard Avaulta mesh lawsuits, 23,523 Ethicon vaginal mesh lawsuits, 19,159 American Medical Systems (AMS) mesh lawsuits, 15,278 Boston Scientific mesh lawsuits, 1,830 Coloplast vaginal mesh lawsuits, 289 Cook Medical vaginal mesh lawsuits and 83 Neomedic vaginal mesh lawsuits.
Plaintiffs Allegations
According to the complaints, injured women suffered pain and severe complications from vaginal mesh implanted for treatment of pelvic organ prolapse (POP) and stress urinary incontinence.
The mesh and bladder slings caused infections, erosion of the mesh through the vagina and other severe injuries.
What is TransVaginal Mesh?
Vaginal mesh, or pelvic mesh, is a plastic surgical device that is implanted into the vaginal area to prevent pelvic organ prolapse (POP), which can occur in women after childbirth or abdominal surgery.
Pelvic organ prolapse causes the womb or uterus to slide into the vagina, and can lead to the bladder and bowels shifting onto the vagina, causing pain, discomfort, and urinary incontinence.
FDA Warning No Benefit
According to a FDA warning in July 2011, there is no evidence that vaginal mesh bladder sling surgery provides any greater clinical benefit than non-mesh surgeries.
The FDA stated that the agency has received thousands of reports of complications after the bladder sling mesh has been implanted, and also warn of an increased risk of organs being punctured during the surgery to implant the devices.
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Boston Scientific's J&J Settlement Cheers Investors
Feb 18, 2015 | Minneapolis Star Tribune
By Joe Carlson
One down, two to go.
Boston Scientific Corp., the global medical devicemaker that employs 5,000 people in the Twin Cities, pleased investors Tuesday by settling a potentially $7 billion lawsuit with its longtime adversary Johnson & Johnson for the relative bargain price of $600 million. The news sent Boston Scientific’s stock to one of its largest single-day gains in a decade.
Two clouds of litigation still hang over the company. One involves claims from about 20,000 women who say they were injured by a Boston Scientific pelvic mesh product, and the other centers on a demand for more than $1 billion in back taxes from the Internal Revenue Service dating back to 2001.
Stock analysts have voiced concern that the company’s mounting legal problems are depressing its stock price. That concern seemed borne out Wednesday, as Boston Scientific’s stock climbed 12.4 percent to close at $16.68 on the news of the J&J settlement.
Investors are now watching the company’s other cases for signs of resolution. But if walking a legal high-wire bothers company executives, they don’t show it. The company has already set aside $972 million to cover litigation costs, and has pooled another large sum related to the IRS dispute.
“For a company of our size, with more than $7 billion in sales and very profitable, that is a very manageable number,” Chief Financial Officer Dan Brennan said in an interview earlier this month, when asked about the legal reserves.
On Tuesday, Boston Scientific announced it would pay its courtroom nemesis Johnson & Johnson a pretax settlement of $600 million to resolve a decade-old contract dispute. The first $300 million will come within 10 days of the agreement, and the rest will follow within 60 days. Boston Scientific is not admitting wrongdoing as part of the settlement.
The case stemmed from a binding agreement J&J had in 2006 to buy heart-device maker Guidant, which was based in Indianapolis with major operations in the Twin Cities. J&J lawyers argued that Guidant broke the contract when it shared confidential company data that allowed Boston Scientific to put in a better offer and buy Guidant for $27 billion. J&J claimed the tactic cost it $4 billion in revenue, plus another $3 billion in interest.
Tuesday’s settlement was only latest milestone in a long-running legal rivalry with J&J. In 2010, Boston Scientific paid $1.7 billion to settle three lawsuits over patents with J&J, just six months after Boston Scientific agreed to pay $716 million to settle a dozen other patent cases with J&J. All the settlements involve disputes over patents on stents, tiny metal tubes that prop open clogged blood vessels.
This week, Boston Scientific revealed that it had been considering a lawsuit against J&J over the rights to a different stent technology. But on Tuesday, it announced that as part of the settlement, it would agree to not to bring infringement cases related to flexible stents and related products sold by Johnson & Johnson.
“To me, this is just another piece of [Boston Scientific CEO Michael Mahoney’s] strategy to get rid of distractions, get rid of overhangs on earnings, and moving the business forward,” said Eric Simso, a Twin Cities medical device consultant and a former vice president at Boston Scientific.
Whether that spirit will translate into the company’s other lawsuits remains to be seen.
The IRS tax disputes are long-range issues that are tougher to predict, but the company right now is fighting the vaginal-mesh claims. It has won two in Massachusetts and lost two in Texas. More than 20,000 women now say the company’s netlike implant to treat pelvic organ prolapse and urinary incontinence left them injured because of bad product design. Several major devicemakers face thousands lawsuits of their own over the same types of devices.
Analysts with Leerink Partners in Massachusetts predict Boston Scientific will settle the cases en masse for just over $1 billion, which was “manageable” considering the company’s free cash flow of well over $1 billion.
“Ultimately, we think the mesh litigation will largely be resolved by the end of 2016,” the analysts wrote.
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Boston Scientific Hands Over $600m To Settle Breach-Of-Contract Guidant Suit With J&J
Feb 18, 2015 | Fierce Medical Devices
By Emily Wasserman
Boston Scientific ($BSX) is forking over $600 million to settle its ongoing breach-of-contract lawsuit with Johnson & Johnson ($JNJ) over a failed bidding war for devicemaker Guidant, laying its decade-old courtroom saga to rest.
The Marlborough, MA-based company will pay far less than the $7.2 billion originally requested by J&J, and will not have to acknowledge any liability by Guidant. Boston Scientific also agreed not to bring any patent infringement claims over J&J's S.M.A.R.T., S.M.A.R.T. Control and S.M.A.R.T. Flex stent products in the future. The company will use $587 million in cash at the end of Q4 2014 and future cash flows to finance its $600 million charge.
"We feel this settlement is in the best interests of the company and its shareholders," Tim Pratt, executive vice president and chief administrative officer, general counsel and secretary for Boston Scientific, said in a statement. "We are pleased to end this longstanding litigation between Guidant and Johnson & Johnson, and to continue focusing on delivering innovative products and solutions to physicians and patients."
Boston Scientific and J&J's beef dates back to 2004, when J&J struck a deal to purchase Guidant and later agreed to shell out $21.5 billion for the company. J&J said it would sell a portion of Guidant's business to Abbott Laboratories ($ABT) to clear the acquisition of antitrust hurdles, and wagered a "no-solicitation" clause that prevented Guidant from seeking a better offer.
But before the merger closed, Boston Scientific swooped in with a $25 billion offer and said it would sell assets to Abbott to ease through the deal. J&J and Boston Scientific had a heated bidding war, with Boston Scientific emerging the winner and shelling out $27 billion for Guidant. J&J walked away with a $705 million termination fee.
In September 2006, J&J sued Guidant, Abbott and Boston Scientific for breach of contract, claiming that Guidant told Abbott about the asset deal, leaving the door open for Boston Scientific to make a better offer. Abbott was subsequently dismissed from the case.
The settlement could allow Boston Scientific to wipe its slate clean and recoup from fallout over its Guidant purchase--a deal Forbes deemed "arguably the second-worst ever." In 2012, the Massachusetts device giant took a $3.4 billion goodwill impairment write-off tied to the acquisition and faced slumping revenues from outstanding debt. Boston Scientific also inherited a crop of pending product liability lawsuits through the deal and paid out more than $30 million in October 2013 to settle the last federal claims over two recalled defibrillators.
Even though the company still faces a raft of product liability suits over vaginal mesh products, its settlement with J&J takes its "largest potential burden" off the table, Leerink analyst Danielle Antalffy said in a note to investors. Armed with more cash, Boston Scientific could take a more aggressive stance toward M&A, focusing on smaller bolt-on acquisitions and next-generation technologies.
The company is trading up 10% upon news of the settlement.
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Study Brings Spotlight Back on Quality-of-Life Hernia Outcomes
Feb 18, 2015 | General Surgery News
By Victoria Stern
Experts continue to explore and debate the best method for repairing an inguinal hernia. To date, dozens of studies evaluating laparoscopic techniques have shown consistently compelling outcomes for total extraperitoneal (TEP) inguinal hernia repair, which highlight low rates of recurrence and complications (Surg Endosc 2011;25:2773-2843).
“Now that surgeons have completed the learning curve in laparoscopic inguinal hernia repair, it is time to reassess the most important outcome of repair: quality of life,” said lead study author Michael Ujiki, MD, a general surgeon in the Section of Minimally Invasive Surgery, Department of Surgery, NorthShore University HealthSystem, Evanston, Ill.
In the current study, Dr. Ujiki and his colleagues assessed quality-of-life outcomes in the first year after patients underwent TEP (Surg Endosc 2014 Dec 6. [Epub ahead of print]).
Four surgeons at NorthShore University HealthSystem performed more than 1,000 TEP inguinal hernia repairs between June 2009 and February 2014. The analysis included 301 patients with 388 hernias evaluated preoperatively (43.8% of patients), and at three weeks (56%), six months (20%) and one year (40%) postoperatively using the Short Form-36 Health Survey Version 2 (SF-36v2), which ranges from 0 (worst health) to 100 (best health) and the Carolinas Comfort Scale, developed explicitly to evaluate quality of life after hernia repair.
The meshes of choice were macroporous polyester mesh (Parietex Anatomical, Covidien), used in 65% of cases, and macroporous polypropylene mesh (Physiomesh, Ethicon), used in 31% of cases. Mean patient age was 56.4 years and mean body mass index was 26.1±3.7 kg/m2.
Of the 301 patients, 23% (69) encountered early complications, including urinary retention (8%), seroma (8.3%) and hematoma (4.3%), but only 2.1% of patients (6) had recurrences. Patients, on average, returned to their normal activities and to work 5.5 days (±4.4) and 5.6 days (±3.9) after surgery, respectively. Physical functioning also improved before surgery and six months after surgery (84.0±22.4 to 92.8±14.7; P=0.05).
One year after surgery, TEP patients generally reported significant improvements in physical health, social functioning and pain. Although, on average, patients had worse pain at three weeks (67.4±23.3; P=0.005), they got progressively better at six months (82.9±16.1; P=0.14) and one year after surgery (88.0±23.3; P=0.49). At one year, 13% of patients reported worse pain compared with baseline using the SF-36v2 scale, but when the authors switched to the hernia-specific Carolinas Comfort Scale, the number dropped to less than 2%. Using this surgery-specific scale, the authors found that after one year, 91% of patients reported no sensation of mesh, 95% described no limitations in movement and 92% had no pain, whereas only 0.4% of patients reported severe pain or limited mobility.
Patients also reported better emotional well-being and social functioning one year after surgery, although the improvement was only statistically significant for social functioning (92.9 at baseline vs. 87.4 at one year; P=0.02). Scores for general health and energy and fatigue, however, were not significantly different throughout the year compared with baseline reports.
Dr. Ujiki concluded that overall TEP inguinal hernia repair is associated with low recurrence and morbidity as well as improvements in several quality-of-life parameters.
“We were happy to see that less than 2% of patients reported any bothersome groin symptoms at a year,” Dr. Ujiki said.
Commenting on the study, Guy Voeller, MD, professor of surgery at the University of Tennessee Health Science Center, in Memphis, who was not involved in the research, said, “What this study does is continue to show that TEP is a good operation. When TEP is done properly by expert surgeons, patients do well.”
To this end, Dr. Ujiki noted that the four surgeons in the study had ample experience in TEP, which could help explain the good outcomes. “TEP certainly has a long learning curve, so this study helps show that we must teach the next generation this technique so that it becomes standard,” Dr. Ujiki said.
Although the study results did not surprise Drs. Ujiki or Voeller, Dr. Voeller noted that these kinds of studies evaluating quality of life after hernia repair will become increasingly relevant in the emerging health care landscape.
“With the rollout of Obamacare, it’s getting more and more important to show that a surgical procedure has value in terms of quality and cost,” Dr. Voeller said. “Evaluating cost wasn’t so important a decade ago but, in the near future, it will be. Surgeons will need to show that a costly technology or more expensive procedure gives true value to the patient for the cost.”
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