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Ethicon Media Monitoring 9/14/2017
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Judge Probes Ethicon's Pa. Connections in Pelvic Mesh Mass Tort
Sep 14, 2017 | The Legal Intelligencer
By Max Mitchell
The judge overseeing pelvic mesh mass tort litigation said the New Jersey-based defendant may have had a "strong" relationship with a Pennsylvania mesh-manufacturer, but he questioned whether that relationship would be enough to allow the Keystone State to retain jurisdiction over 90 pelvic mesh cases involving out-of-state plaintiffs. -
Um, Doctors Really Need to Start Taking Women's Sexual Problems Seriously
Sep 14, 2017 | Glamour
By Suzannah Weiss
Hundreds of women in Australia recently pressed charges against Johnson & Johnson over pelvic mesh implants that made sex painful for them. In an email exchange debating how to talk to patients about these potential effects, a gynecologist associated with the company wrote that "sodomy could be a good alternative"—suggesting that women who experience pain during vaginal sex can just have anal sex instead. -
New Physiomesh Lawsuits Claim Ethicon Knew of Hernia Mesh Problems, Did Nothing
Sep 13, 2017 | RX Injury Help
By Laurie Villanueva
The litigation surrounding Ethicon, Inc.’s allegedly defective Phyisomesh hernia products continues to grow. -
Irish Manufacturer of TVM Mesh Announces Settlement Pool worth $775 Million
Sep 13, 2017 | Lawyers and Settlements
By Gordon Gibb
A decision last month by a Dublin-based manufacturer of transvaginal mesh to wind up all known US claims associated with transvaginal mesh complications flew under the radar, but is nonetheless worth three-quarters of a billion dollars.
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Judge Probes Ethicon's Pa. Connections in Pelvic Mesh Mass Tort
Sep 14, 2017 | The Legal Intelligencer
By Max Mitchell
The judge overseeing pelvic mesh mass tort litigation said the New Jersey-based defendant may have had a "strong" relationship with a Pennsylvania mesh-manufacturer, but he questioned whether that relationship would be enough to allow the Keystone State to retain jurisdiction over 90 pelvic mesh cases involving out-of-state plaintiffs.
Philadelphia Court of Common Pleas Judge Arnold New heard arguments Wednesday over whether the U.S. Supreme Court decision in Bristol-Myers Squibb v. Superior Court of California meant 90 out-of-state plaintiffs suing New Jersey-based medical device company Ethicon will have their cases tossed from the mass tort program, leaving just 30 pelvic mesh cases pending in Philadelphia.
The Bristol-Myers Squibb decision, which has been characterized as a game-changing decision by some, made clear that out-of-state plaintiffs can't sue companies where the defendants aren't considered to be "at home," or haven't conducted business directly linked to the claimed injury.
That ruling hinged on the relationship between drugmaker Bristol-Myers Squibb and McKesson Corp., a California drug distributor. The plaintiffs had argued that, because McKesson distributed Plavix, the drug at issue in the case, California had jurisdiction over hundreds of Plavix-related claims. However, the justices determined the relationship between McKesson and Bristol-Myers Squibb was not adequate to establish jurisdiction in the Golden State.
Since that ruling came out in June, numerous defendants have pointed toBristol-Myers and asked courts to toss out-of-state plaintiffs from mass tort programs in state courts across the country.
In the pelvic mesh program, plaintiffs have pointed to the fact that Secant, a Pennsylvania-based company, manufactured the plastic mesh materials used in the mesh implants as the basis for their argument that jurisdiction is proper in Pennsylvania even though the main defendant, Johnson & Johnson subsidiary Ethicon, is based in New Jersey.
Early in the nearly 90-minute hearing Wednesday, New asked Drinker Biddle & Reath attorney Alicia Hickok to discuss Ethicon's relationship with Secant in comparison to Bristol-Myers Squibb's relationship with McKesson.
"Your honor, it's a different relationship," Hickok said.
"I agree," New cut in. "It's a stronger relationship."
However, Hickok said the relationship needs to go directly to the causes of action each plaintiff has alleged in their lawsuit.
In the case of the pelvic mesh plaintiffs, those causes of action are defective design and failure to warn, but Hickok noted that those decisions and related regulatory submissions were all conducted by Ethicon executives in New Jersey.
"These were not responsibilities as to people who were in Pennsylvania," Hickok said. Using a roll of mesh manufactured in Pennsylvania "is not enough to say the cause of action arises out of it."
Hickok also noted that Secant was previously dismissed as a defendant in the pelvic mesh litigation, but New seemed dismissive of that argument, noting the prior ruling regarding Secant hinged on issues arising out of the Biomaterials Access Assurance Act.
"That's an entirely different definition than would be applicable to what's before us today, which is jurisdiction," New said.
New initially ruled in 2015 that Philadelphia should have jurisdiction over the pelvic mesh mass tort, but agreed to reconsider the issue in the wake of Bristol-Myers.
Kline & Specter attorney Charles "Chip" Becker, arguing for the plaintiffs, contended the ruling did not change the plaintiffs' argument on jurisdiction, and should not change the reasoning behind New's 2015 decision.
"They placed themselves in the jurisdiction of Pennsylvania courts," Becker said.
http://www.thelegalintelligencer.com/id=1202797941482/Judge-Probes-Ethicons-Pa-Connections-in-Pelvic-Mesh-Mass-Tort?mcode=1202617075166&curindex=0
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Um, Doctors Really Need to Start Taking Women's Sexual Problems Seriously
Sep 14, 2017 | Glamour
By Suzannah Weiss
Hundreds of women in Australia recently pressed charges against Johnson & Johnson over pelvic mesh implants that made sex painful for them. In an email exchange debating how to talk to patients about these potential effects, a gynecologist associated with the company wrote that "sodomy could be a good alternative"—suggesting that women who experience pain during vaginal sex can just have anal sex instead.
Several of the plaintiffs told The Guardian their doctors had given them similar advice. Such an approach "suggests that a woman is nothing more than a receptacle to satisfy men and that 'any hole will do,'" one of them said. "I'm appalled that anyone, particularly a woman’s treating medical practitioner, would be so thoughtless and arrogant as to suggest that anal sex is an adequate solution to sexual dysfunction." Unfortunately, though, many medical professionals do take such attitudes, including here in the U.S.
"For the first two years that I dealt with pain during intercourse, my ob/gyn doctor told me to drink wine and take some Advil before sex," Tara Langdale-Schmidt, 33, who has a pelvic pain condition called vulvodynia, remembers. "He literally told me this every appointment, which I went about six times a year due to the pain."
Nicole*, 32, also has vulvodynia. "I now have a gynecologist that thinks I need to speak to a psychiatrist about my fear of getting pregnant," she says. "The gynecologist thinks it's irrational. Frankly, it's not. I'm always in pain."
When Elizabeth*, 28, began experiencing swelling and pain after sex, her doctor told her to use lube—which ended up making it worse. She had to figure out on her own that she probably has a spermicide allergy, since the problem went away when she stopped using it. "I didn't feel like my concerns of being in pain, discomfort, or how this was affecting my relationship were being taken seriously," she says. "I knew something was wrong, and it seemed like it was easier for the doctor to make me feel like I had to learn how to cope with this 'new reality' rather than looking for solutions."
"[I] had a baby, and post-birth, I was in agonizing, tender, sharp pain, and I was told 'eh it happens! Just wait it out!'" Cameron McCosh, 32, remembers. "Last week, I went to a naturopathic doctor, and I left the office crying because I was grateful for someone just hearing me and proposing some first steps in changing things. A doctor who was totally cool with me being a sexual human being and also a mother. A doctor who's like 'hey, that's not OK. let's do something.' I don't think women are allowed to be anything aside from sluts or prude mothers."
Things like this don't seem to be happening to men at such extreme levels–the evidence suggests medical professionals are specifically devaluing women's sexual health and pleasure. "I have heard stories about patients' physicians telling them to 'relax,' 'just have a glass of wine,' to yes—'just have anal sex if your vagina hurts you,'" says Michael Ingber, MD, Board-Certified in Urology and Female Pelvic Medicine & Reconstructive Surgery at the Center for Specialized Women's Health. "There has been so much research dedicated to male sexual health and very little to female sexual health. Even at our national meetings, 90-plus percent of the sexual health part of our conferences is about male erections, male libido, penile complaints, etc. The reality is that female sexual dysfunction is more common."
Ingber views the fact that we didn't get an FDA-approved medication for low female libido, flibanserin, until 2015 as evidence of this. "Many in our field feel there has been a bias toward male sexual dysfunction at the FDA level," he says. "Even to get flibanserin approved it was extremely difficult, whereas Viagra was much easier and had just as severe (if not more severe) adverse events associated with it."
The problem is not just with doctors but also with the entire healthcare system. Insurance companies are far less likely to cover medications that treat women's sexual issues than ones for men's, explains Ronald D. Blatt, MD, Chief Surgeon and Medical Director of the Manhattan Center for Vaginal Surgery and the Manhattan Centers for Women's Health. "There is a double standard doctors see for women with sexual problems," he says. "For instance, payment for prescription medications to help a woman with a low libido are often declined for a large number of reasons, and insurers often exclude other sexual health services that women need."
This discrepancy dates back to a longstanding stereotype that women aren't really sexual beings. "Many in our society feel the traditional role of the woman is to please the man," says Ingber. It's incredible that this idea persists, but somehow, it does.
After multiple doctors shrugged off her sexual issues, Langdale-Schmidt has learned that it's worth shopping around until you find someone who takes them seriously. "If a doctor dismisses you or your pain, go to 10 more to find an answer," she says. "Don't stop. As much as we want to rely on doctors, we are in charge of our own health."
https://www.glamour.com/story/doctors-need-to-take-womens-sexual-problems-seriously
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New Physiomesh Lawsuits Claim Ethicon Knew of Hernia Mesh Problems, Did Nothing
Sep 13, 2017 | RX Injury Help
By Laurie Villanueva
Laurie Villanueva is an attorney with Bernstein Liebhard LLP
The litigation surrounding Ethicon, Inc.’s allegedly defective Phyisomesh hernia products continues to grow.
According to court records, new Physiomesh lawsuits were filed just last week in the U.S. District Court, Southern District of New York, on behalf of three plaintiffs who suffered hernia recurrence and other complications, allegedly due to the falure of an Ethicon device. (Case No. 1:17-cv-06667, 1:17-cv-06681, 1:17-cv-06682).What is Physiomesh?
Ethicon’s Physiomesh hernia patches are constructed from non-absorbable polypropylene (plastic) filaments that are woven into fabric and laminated with an absorbable film coating. The company claims that this unique, multilayer design helps the hernia mesh incorporate into the body and reduces inflammation.
Ethicon obtained regulatory clearance for its first Physiomesh products in 2010, via the U.S. Food & Drug Administration’s (FDA) 510(K) program, which allows a medical device to come to market without human clinical trials, as long as a manufacturer can demonstrate that it is “substantially equivalent” to another product previously approved by the agency.
Ethicon announced it was withdrawing Physiomesh Flexible Composite Mesh from the worldwide market in May 2016, after unpublished data from two European hernia registries suggested that the product was associated with higher average recurrence and revision rates compared to other meshes used in laparoscopic ventral hernia repair.
“Based on the currently available data, Ethicon believes the higher rates to be a multifactorial issue (including possible product characteristics, operative and patient factors), but has not been able to fully characterize these factors,” the company said in an Urgent Field Safety Notice issued on May 25, 2016.
Ethicon has indicated it will not be returning Physiomesh Flexible Composite Mesh to the products. Physiomesh Lawsuit Allegations
According to the New York lawsuits, all three plaintiffs experienced severe abdominal pain and hernia recurrence after receiving Physiomesh during laparoscopic ventral hernia repair. During the plaintiff’s respective revision surgeries, the hernia mesh was found to have lost its integrity and pieces of the mesh had broken off and adhered to their bowels.
The complaints cite Ethicon’s decision to withdraw Physiomesh from the market in May 2016, noting that the company “never notified patients of potentially unacceptably high rates of complication and failure.”
The lawsuits also dispute claims that the polypropylene material used in Physiomesh is inert, and assert that “substantial body of scientific evidence shows that this mesh material is biologically incompatible with human tissue and promotes and immune response in a large subset of the population receiving Defendants’ Products.”
The complaints also claim that Ethicon was aware of the problems associated with Physiomesh, but did not act on this information.
Earlier this year, the U.S. Judicial Panel on Multidistrict Litigation (JPML) centralized all federally-filed Physiomesh lawsuits in the U.S. District Court, Northern District of Georgia. The proceeding got underway last month, when it convened an Initial Conference on August 1st. Court records indicate that more than 100 Physiomesh lawsuits are now pending in the Northern District of Georgia.
https://www.rxinjuryhelp.com/news/2017/09/13/new-physiomesh-lawsuits-claim-ethicon-knew-of-hernia-mesh-problems-did-nothing/
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Irish Manufacturer of TVM Mesh Announces Settlement Pool worth $775 Million
Sep 13, 2017 | Lawyers and Settlements
By Gordon Gibb
Dublin, IRELAND A decision last month by a Dublin-based manufacturer of transvaginal mesh to wind up all known US claims associated with transvaginal mesh complications flew under the radar, but is nonetheless worth three-quarters of a billion dollars.
Endo International PLC announced in early August that it will set aside a massive $775 million fund to end “virtually all known” US claims over problematic mesh devices. The number of women having filed a mesh lawsuit against Endo and its subsidiary, Astora Women’s Health – formerly known as AMS Women’s Health – totals about 22,000 in the US.
“We believe it is a very important milestone for Endo to have reached agreements to resolve virtually all known US mesh product liability claims,” Endo CEO Paul Campanelli said in a statement. “While it remains possible that additional claims will be filed, we believe today’s announcement will assist most mesh claimants to move forward with their lives and will permit Endo to move forward with an even greater focus on executing against our core strategic priorities.”
Transvaginal mesh has proven to be a scourge for countless women requiring treatment for conditions common in middle-aged women who have borne children. Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI) occur when internal organs begin to sag, and droop. Historically, surgeons at one time fashioned slings derived from a patient’s own tissue to shore things up and give women relief from the symptoms of POP and SUI. However, the invasive surgery required resulted in substantial blood loss, risk of infection and long periods of convalescence.
The advent of transvaginal mesh, rolled into a tube and deployed laparoscopically, was originally viewed as a vast improvement over more traditional forms of invasive surgery. However, in recent years there have been scores of adverse event reports asserting transvaginal mesh has shifted, or become intertwined with internal organs. There have been numerous reports of mesh protruding through, and into the vagina, causing pain and suffering for both the woman and her partner.
2014 turned out to be a watershed year for both Endo in particular and the mesh industry overall. That was the year when the US Food and Drug Administration (FDA) announced the issuance of two proposed orders that would result in the re-classification of transvaginal mesh as high-risk, and would require manufacturers to obtain premarket approvals from the federal regulator.The next day, Endo announced the establishment of a fund worth $830 million to settle “a substantial majority” of transvaginal mesh complication lawsuits associated with its AMS line.
Five months after that, Endo announced it had reached settlements resolving “a substantial majority” of transvaginal mesh lawsuits in the AMS litigation file.
Combined with the 2014 settlement, this most recent announcement of a US $775 million fund equates to a US $1.6 billion hit overall for the Dublin-based manufacturer.
In March of last year, Endo announced it was winding down Astora Women’s Health.
Under terms of the most recent agreements, Endo will begin issuing installment payments in Q4 of 2017 and expects those payments to continue for two years, until the end of 2019.https://www.lawyersandsettlements.com/articles/transvaginal-mesh-tvt-sling/interview-transvaginal-mesh-lawsuit-4-22571.html
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