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Ethicon Media Monitoring 9/5/2018
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J&J Loses Pa. Rehearing Bid Over Out-Of-State Mesh Cases
Sep 4, 2018 | Law 360
By Matt Fair
A Pennsylvania appeals court has denied a Johnson & Johnson unit's bid for en banc rehearing, following a decision that the company's business ties in the state allowed Philadelphia County to serve as venue for claims from an Indiana woman who won $13 million for injuries sustained from a mesh implant. -
Federal Judge Cuts $35 Million Pelvic Mesh Jury Award By $15 Million
Sep 4, 2018 | Top Class Actions
By Brigette Honaker
A federal judge recently reduced a $35 million pelvic mesh jury award which was awarded to a woman who allegedly experienced injury as a side effect of her implanted pelvic mesh. -
Dunoon mum’s victory in battle over funding for mesh removal treatment
Sep 2, 2018 | The Sunday Post
By Marion Scott
A mum who fought for years to have a full mesh implant removal has won her battle for funding for the final part of her treatment. -
Netflix’s ‘The Bleeding Edge’ Mirrors Hip Implants Fiasco in India
Sep 4, 2018 | The Quint
By Sameeksha Khare
“Let's continue to improve lives by unleashing innovation.” That’s how a new Netflix documentary ‘The Bleeding Edge’, on the medical device industry in the United States, starts.
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J&J Loses Pa. Rehearing Bid Over Out-Of-State Mesh Cases
Sep 4, 2018 | Law 360
By Matt Fair
A Pennsylvania appeals court has denied a Johnson & Johnson unit's bid for en banc rehearing, following a decision that the company's business ties in the state allowed Philadelphia County to serve as venue for claims from an Indiana woman who won $13 million for injuries sustained from a mesh implant.
Ethicon Inc., which is headquartered in New Jersey along with parent company J&J, sought reconsideration from the full Superior Court bench following a three-judge panel's decision in June saying plaintiffs in a cluster of mesh-related cases brought by out-of-state plaintiffs could move forward in Philadelphia County thanks to Ethicon's relationship with a Pennsylvania-based company in the manufacture of its mesh implants.
The Superior Court, however, rejected the petition without comment on Aug. 29.
The appeal presented the first opportunity for a Pennsylvania appeals court to weigh in on a recent U.S. Supreme Court decision — Bristol-Myers Squibb Co. v. Superior Court of California — limiting the ability of state courts to hear claims from out-of-state residents.
In that decision, handed down in June 2017, the justices ruled that Bristol-Myers Squibb did not have sufficient business contacts in California to confer courts there with jurisdiction over some 600 lawsuits brought by out-of-state plaintiffs over injuries allegedly caused by the blood thinner Plavix.
Since the decision was handed down, Ethicon has attempted to use it to boot a group of mesh-related cases from non-Pennsylvanians out of the Philadelphia County Court of Common Pleas, where they are pending as part of a mass tort program.
Ethicon's efforts included using the decision to challenge a nearly $13 million verdict won by Indiana resident Patricia Hammons in December 2015, the first trial the company faced in Philadelphia County over its allegedly defective mesh products.
The verdict stemmed from claims that a mesh implant Hammons received to correct sagging of her internal organs became embedded in her bladder, leaving her in chronic pain and unable to have sex.
Ethicon argued on appeal that it did not have sufficient business ties to Pennsylvania for the case to pass jurisdictional muster under the Bristol-Myers Squibb ruling, but the Superior Court pointed to the company's reliance on Philadelphia-area Secant Medical Inc. to manufacture its mesh products.
"This evidence establishes an affiliation between Pennsylvania and Hammons' cause of action against Ethicon for defective design of the ... device," the Superior Court said in its decision in June.
In addition to challenging the verdict in the Hammons case, Ethicon also used the Bristol-Myers Squibb decision to petition the supervising judge of the pelvic mesh mass tort to revisit his 2015 ruling saying the Philadelphia County did had jurisdiction over claims from out-of-state plaintiffs.
Much like the conclusion reached by the Superior Court in June, the supervising judge in Philadelphia County ruled in December that Ethicon's work with Secant meant out-of-state plaintiffs can bring mesh claims in Pennsylvania.
That decision is also on appeal to the Superior Court.
Shanin Specter, an attorney with Kline & Specter PC representing Hammons, said he is pleased with last week's order, but hinted that he expects Ethicon to appeal the case to the Pennsylvania Supreme Court.
"We are heartened by the Superior Court's rapid disposition of this petition. We've got another step to go before getting Ms. Hammons compensated, which we hope occurs soon," Specter said.
A representative for Ethicon did not immediately return a request for comment on Tuesday.
Ethicon is represented by D. Alicia Hickok, William Carr, Kenneth Murphy and Molly Flynn of Drinker Biddle & Reath LLP, Julie Callsen of Tucker Ellis LLP, Tarek Ismail of Goldman Ismail Tomaselli Brennan & Baum LLP, Stephen Brody of O'Melveny & Myers LLP and Susan Robinson.
Hammons is represented by Charles "Chip" Becker, Shanin Specter, Michelle Tiger, Lee ,Balefsky, Kila Fickes and Ruxandra Laidacker of Kline & Specter PC, and Adam Slater of Mazie Slater Katz & Freeman LLC.
The case is Patricia Hammons v. Ethicon Inc. et al., case numbers 1522 EDA 2016 and 1526 EDA 2016, before the Pennsylvania Superior Court.https://www.law360.com/articles/1079434/j-j-loses-pa-rehearing-bid-over-out-of-state-mesh-cases
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Federal Judge Cuts $35 Million Pelvic Mesh Jury Award By $15 Million
Sep 4, 2018 | Top Class Actions
By Brigette Honaker
A federal judge recently reduced a $35 million pelvic mesh jury award which was awarded to a woman who allegedly experienced injury as a side effect of her implanted pelvic mesh.
In March, plaintiff Barbara K. was granted a $35 million pelvic mesh jury award as compensation for her injuries related to a Johnson & Johnson pelvic mesh product. On Aug.t 8, U.S. District Judge Phillip P. Simon reduced the $35 million pelvic mesh jury award by $15 million, finding that the awarded punitive damages were excessive, according to Law360.
The original pelvic mesh jury award consisted of $10 million in compensatory damages and $25 million in punitive damages. In response to this jury award, Johnson & Johnson motioned for a judgment as a matter of law and a new trial. However, Judge Simon began his ruling by denying both of these motions, stating that the court had seen “sufficient evidence for a reasonable jury to find in favor of [Barbara].”
Judge Simon also denied Johnson & Johnson’s request to reduce compensatory damages, finding that the $10 million award “was neither monstrously excessive nor the product of passion or prejudice.” Under this reasoning, he allowed the compensatory damages portion of the pelvic mesh jury award to stay intact.
“The jury’s punitive damage award, however, is another story,” Judge Simon wrote. “I find the punitive damages award excessive and unreasonable under controlling law.”
In his ruling, Judge Simon found that $25 in punitive damages was excessive and proposed a more “reasonable” punitive damages award of $10 million. Barbara now has the choice to accept the $15 million reduction of her pelvic mesh jury award or face another trial.
“[Barbara] now faces a choice: she can either accept a reduced punitive damage award (and thus be awarded $20 million dollars in total compared to the original $35 million awarded by the jury) or I will order a new trial on the issue of punitive damages,” Judge Simon stated in his ruling.
Barbara originally filed that lawsuit in 2012, alleging that she suffered from vaginal pain, pelvic pain, pain during intercourse, bladder spasms, and bowel issues due to her implantation with an allegedly defective pelvic mesh.
Barbara was implanted with the Johnson & Johnson Prolift mesh in 2009 to treat her pelvic organ prolapse. Pelvic organ prolapse occurs when one or more pelvic organs drop to a lower position than is normal. After experiencing problems with the Prolift mesh, she underwent a second surgery to have as much of the mesh removed as possible.
“There was evidence that once the mesh is implanted it becomes very difficult, if not impossible, to have it all removed; it grows into the tissue, hardens and causes substantial pain,” Judge Simon noted in his ruling.
In her lawsuit and subsequent trial, Barbara claimed that Johnson & Johnson failed to adequately test their Prolift mesh product, resulting in the injuries of her and countless other individuals.
The Transvaginal Mesh Lawsuit is Case No. 2:17-cv-00114 in the United States District Court for the Northern District of Indiana.
https://topclassactions.com/lawsuit-settlements/lawsuit-news/854966-federal-judge-cuts-35-million-pelvic-mesh-jury-award-by-15-million/
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Dunoon mum’s victory in battle over funding for mesh removal treatment
Sep 2, 2018 | The Sunday Post
By Marion Scott
A mum who fought for years to have a full mesh implant removal has won her battle for funding for the final part of her treatment.
Nancy Honeyball, 49, from Dunoon, was left crippled following a mesh implant for bladder problems – but was told a full removal was not possible.
But she then discovered a surgeon in London, Sohier Elneil, who was prepared to carry out the procedure.
“After fighting for almost two years, NHS Highlands agreed to fund treatment in London,” she said.
Nancy had her surgery in December, but was left with a couple of pieces of mesh still embedded in her groin.
She said: “The particular implant I was given is extremely hard to remove in its entirety.”
Nancy said NHS Highlands initially told her this finally surgery would have be considered as a new case. But after The Sunday Post contacted NHS Highland, health chiefs said they would fund her final surgery.
Their spokesman said: “We can confirm that the ongoing treatment for Mrs Honeyball will be funded by NHS Highland and will not be treated as a new case.
“We have also apologised to Mrs Honeyball for the fact that this has not been communicated to her sooner.”
Nancy said: “I can’t thank The Sunday Post enough for ending this nightmare. I’ve been in tears of relief.”
https://www.sundaypost.com/fp/dunoon-mums-victory-in-battle-over-funding-for-mesh-removal-treatment/
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Netflix’s ‘The Bleeding Edge’ Mirrors Hip Implants Fiasco in India
Sep 4, 2018 | The Quint
By Sameeksha Khare
“Let's continue to improve lives by unleashing innovation.” That’s how a new Netflix documentary ‘The Bleeding Edge’, on the medical device industry in the United States, starts. At a conference for industry manufacturers, a presenter can be seen giving a pep talk to leading companies to “unleash” medical innovation in this age of technological advancement.
And unleash innovation, they did. Unbridled, unethical and unregulated. That’s what the terrifying documentary reveals, as it goes into the dark underbelly of the $400 billion industry through stories of victims of faulty medical devices. These are not the stories of just a rare case here and an isolated case there. These are hundreds of thousands of patients who have suffered because of this ‘unleashed innovation’.
While the documentary focuses on what is happening in the US, the story isn’t any different, only worse, in India and across the globe.The Johnson & Johnson’s faulty hip implants fiasco that affected 4,700 patients and even took lives in India is a fitting example of the phenomenon that the film exposes.
These faulty devices were also implanted in patients in Australia, US, UK, Canada and Brazil.
Similarly, the 1 hr 40 minute-long documentary gives the example of birth control devices, hip implants, vaginal mesh, robotic surgery and breast implants gone woefully wrong.Intestines falling out of bodies, paranoia, neurological disorders, unbearable pain, bleeding and even deaths – this is how the devices have wreaked havoc in patients’ lives.The Fault in Medical Devices
Essure, a birth control device by Bayer, was implanted in thousands of women for over a decade. In several cases, the device not just failed to achieve its objective, but also introduced severe complications in women’s bodies like heavy continuous bleeding and pain. Patients who spoke in the film recount how it handicapped them physically, mentally or socially.
A mother of four lost her job and her husband because of ill health triggered by the device, and had to eventually put her kids in a foster home. Another woman lost all hopes of ever having sexual intimacy with her partner again.
What’s more scary is that doctors didn’t know how to remove the device. The manual told them how to shoot it up the uterus, but nothing on how to take it out. This resulted in the implant either getting stuck, or broken pieces of the metal strewn in women’s uteri as attempts were made to remove the device.
The faulty J&J metal-on-metal hip implants led to chemicals seeping into the patients’ bloodstreams causing complications. The film shows this as well. The chemicals gave birth to psychological symptoms and neurological disorders.
Another major culprit was robotic surgery. Some women who underwent hysterectomy through robotic surgeries, which weren’t performed correctly, had their intestines falling out of their bodies.What Fed the Monster?
Other than the testimonies of affected patients, doctors afflicted by the effects of some devices, scientists aware of the abhorrent impact and authorities concerned for patient safety have all come forward.
So, how did this snowball into a problem of catastrophic levels? Why were medical devices whose safety and efficacy were unknown put in people’s bodies? Why was there such disregard for human lives?Lack of regulations, loopholes in law, the nexus between hospitals and manufacturers and people in power protecting the interests of companies rather than patients are to be blamed, shows the film.
The US Food and Drug Administration’s (FDA) regulations for medical devices are not stringent. There are two ways a device can be approved by the FDA – either under the premarket approval (PMA) or the 510(k) process. The former is more strict than the latter, but is still not as robust as the process for drug approval.
The latter, a huge loophole, is also one under which majority of devices are approved. It says that a device doesn’t even need to undergo the process of approval if it can be established that it is similar to a product already in the market.The situation in India is even more gruesome. For imported devices, they have to be FDA approved or adhere to European standards. And for Indian devices, there is no concrete law.
Only recently, they’ve introduced some rules under the Indian Certification of Medical Devices Scheme (ICMED), but they’re not compulsory. And there’s no liability on the manufacturer. In addition, whatever little regulation is there, it is only for 23 devices. So, hundreds of unapproved devices plague the market.
What about the faulty devices brought to light in the film? The J&J hip implants have already been globally recalled.
The FDA, even after seeing the cases of several women who suffered because of Essure, refused to take it off the market saying that the “benefits outweigh the risks”. This is after European countries banned the product. Later, in July this year, Bayer announced it would stop selling Essure at the end of 2018. Not because they accepted the product may be faulty, but because of “business reasons”.Attacking the film, the company said women in the US are not inclined to buy it because of “inaccurate and misleading publicity about the device”.
While the recall of the device comes as a success, the public, lawmakers and medical community need to push for change in industry regulations for lasting effect.
https://fit.thequint.com/health-news/netflix-the-bleeding-edge-review
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