Ethicon Media Monitoring 12/11/2018

Client Attorney Privileged/Attorney Work Product/At Request of Counsel

Online Sources

1. Why Johnson & Johnson Is a Litigation Magnet

   Dec 10, 2018 | Bloomberg

   By Joe Nocera
   
   
   I asked a corporate lawyer not long ago which company tends to be involved in the most litigation. He didn’t hesitate: Johnson & Johnson.
2. FDA to revisit transvaginal mesh issues at February meeting

   Dec 10, 2018 | MedTech Dive

   By Susan Kelly
   
   
   FDA formally announced it will convene an advisory panel meeting on Feb. 12 to review surgical mesh devices for transvaginal pelvic organ prolapse repair.

Client Attorney Privileged/Attorney Work Product/At Request of Counsel

Online Sources

1. Why Johnson & Johnson Is a Litigation Magnet

   Dec 10, 2018 | Bloomberg

   By Joe Nocera

   I asked a corporate lawyer not long ago which company tends to be involved in the most litigation. He didn’t hesitate: Johnson & Johnson. A quick look at last year’s annual report would seem to confirm this: Its “legal proceedings” section runs close to 10,000 words. The number of suits climbs into the mid-five digits.

   For most companies, lawsuits are just another cost of doing business. What makes J&J unique is that its businesses—consumer health products, pharmaceuticals, and medical devices—tend to be litigation magnets. The company trades suits with everyone from rival companies to powerful government agencies to classes of consumers. Product Liability

   According to its 2017 annual report, Johnson & Johnson is facing 53,000 suits against its pelvic mesh, 13,700 against its schizophrenia drug Risperdal, and 6,600 against its most famous product, talcum powder. The latter have gotten the most attention, and justly so: In July, for instance, 22 women who claimed J&J’s product caused their ovarian cancer were awarded an eye-popping $4.6 billion. The company has appealed those judgments; it’s also won several recent cases, arguing there’s no science to back the alleged cancer link.

   Intellectual Property

   Patent lawsuits are baked into the model of the pharmaceutical business, so it’s no surprise that the J&J legal department is constantly either suing to keep a generic product off the market or defending against a generic company trying to invalidate one of its patents. For instance, J&J has at least six ongoing lawsuits to protect its patent for Zytiga, a cancer drug. It settled litigation over Complera, an HIV drug, in November of last year. And it’s fighting a lawsuit brought by the University of Texas system alleging that sutures made by Ethicon, a J&J company, infringe two of its patents.

   Government Inquiries

   J&J lists all sorts of these in its annual report: “alleged price fixing,” “nondisclosure of alleged health risks,” whistleblower complaints, and so on. But one category stands out: the lawsuits being brought by cities, counties, and about two dozen states against J&J and other opioid manufacturers seeking compensation for the damage the drugs have done in their communities. State attorneys general are describing these cases as similar to the ones brought 20 years ago against Big Tobacco. They’re hoping for a similar multibillion-dollar result.

   How Much Does All This Cost? 

   A lot. J&J spent $1.3 billion on legal expenses last year, which is, on average, what it’s been spending since at least 2012. I tried to get a company spokesman to tell me how many lawyers it had on staff, but he wouldn’t bite. “Our in-house legal teams do much more than litigate,” he said. 

   https://www.bloomberg.com/news/articles/2018-12-10/why-johnson-amp-johnson-is-a-litigation-magnet
   

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2. FDA to revisit transvaginal mesh issues at February meeting

   Dec 10, 2018 | MedTech Dive

   By Susan Kelly

   Dive Brief:

   FDA formally announced it will convene an advisory panel meeting on Feb. 12 to review surgical mesh devices for transvaginal pelvic organ prolapse repair. The meeting is part of an effort to identify concerns about the devices and strengthen regulatory oversight to protect patients, the agency said.

   Earlier versions of surgical mesh products were removed from the market after a history of adverse events, including malfunctions, injury and death. But FDA said it wants to enable those who need the devices to benefit from them.

   The committee will discuss and make recommendations regarding the safety and effectiveness of surgical mesh placed transvaginally in the anterior vaginal compartment to treat pelvic organ prolapse. The public, including patients, has an opportunity to comment and may submit input through Feb. 11 to the electronic filing system at https://www.regulations.gov.Dive Insight:

   Only three transvaginal mesh products remain on the market, and FDA will consider additional regulatory actions based on feedback from the advisory committee meeting. The agency has said that improving the safety net for women's health is a top priority in its broader plan to boost postmarket surveillance of medical devices.

   FDA Commissioner Scott Gottlieb first announced the agency would hold a meeting on safety and effectiveness of surgical mesh intended for transvaginal pelvic organ prolapse repair in a statement Nov. 20. But the agency has now laid out further details.

   "The advisory committee meeting will seek expert opinion regarding the available evidence of the benefits and risks of mesh for transvaginal POP repair and provide an opportunity for the FDA to hear directly from the public, including patients, about their experiences, and consider additional regulatory actions," Gottlieb said in November.

   FDA in 2011 issued a safety communication identifying concerns about use of surgical mesh for transvaginal repair of pelvic organ prolapse. After an advisory panel meeting was conducted, the agency ordered 34 manufacturers to conduct postmarket surveillance studies, resulting in most of the companies choosing to stop marketing the products.

   Pelvic mesh products by Johnson & Johnson and Boston Scientific cost those companies millions of dollars in legal claims and are now off the market.

   FDA said there are four studies ongoing for five devices. In 2016, the agency reclassified surgical mesh for transvaginal repair of pelvic organ prolapse into Class III, which requires premarket regulatory approval (PMA).

   PMA applications were mandated by July 2018. That led to all manufacturers ending marketing of surgical mesh for transvaginal repair of posterior compartment prolapse. The three surgical mesh products that remain on the market currently are for transvaginal repair of anterior compartment prolapse. FDA is reviewing their PMA applications.

   At the Feb. 12 meeting, the advisory committee will be asked to provide scientific and clinical input on assessing the effectiveness, safety, risks and benefits of mesh placed transvaginally in the anterior vaginal compartment and to identify the appropriate patient population and physician training needed for these devices.​

   https://www.medtechdive.com/news/fda-to-revisit-transvaginal-mesh-issues-at-february-meeting/543963/
   

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