Day two in the latest pelvic mesh trial in Dallas brought evidence from the plaintiff’s attorneys that Johnson & Johnson and Ethicon executives identified red flags during the development of the Prosima pelvic mesh, yet chose to put the product on the market anyway. It was later withdrawn after problems continued and the FDA called for safety testing.
Readers are cautioned and advised that the plaintiff’s lawyers get to present the plaintiff’s side first; then the defense gets to present its case. Defense attorneys made many objections to the release of the internal Ethicon emails below, which were entered into evidence in this case.
Dr. Peggy Pence
Dr. Peggy Pence was the first witness for the plaintiff’s case. Through her testimony, we learned that Dr. Pence has a Ph.D in toxicology from Indiana University. She has worked directly with FDA on behalf of several drug and medical device companies, including Eli Lilly, where she worked in regulatory affairs. She also worked in product development for Serono Laboratories. She designed and oversaw clinical trials, working with the cancer drug Interferon and other drugs and devices. Through further questioning from attorney Tim Goss, Dr. Pence explained to the jury that safety is first and foremost in all her work. She has a Regulatory Affairs Certified rating of 4, the highest given. She also teaches Masters degree students – at California State – the design of studies and clinical trials.
Instructions for Use – IFU Testimony
Dr. Pence is expert in the IFU – Instructions for Use. These are directions a medical device maker posts on its products. They are a critically important element in a defective medical device action. Central to the plaintiff’s defective product claim and failure to warn claims in this case is whether or not the IFU for Prosima mesh was adequate. According to Dr. Pence, it was not.
Standard of Care
Dr. Pence testified that J&J and Ethicon violated the standard of care in marketing and post marketing the Prosima device. “Yes, the company violated the standard of care,” she testified, over several objections from the defense counsel table.
510(k) Clearance not FDA Approval
Dr. Pence further testified to the 510(k) clearance process which J&J used to bring Prosima to market. She explained that this route does not demonstrate FDA approval or a finding that a given product is safe and effective. It is only a clearance (emphasis ours) for marketing.
PMA (premarket approval) by contrast, requires that FDA make independent findings of safety, which requires a detailed review and inspection. No such testing was ever done on Prosima mesh, Dr. Pence testified.
Key Opinion Leaders
Key opinion leaders – KOLs – are important to J&J and Ethicon, according to Dr. Pence’ further testimony. The company uses KOLs – nomenclature invented by J&J marketers – not only as targets for their products; KOL’s can also help promote the products to other health professionals. Key opinion leaders are typically surgeons or others at the top of their field, and they are recognized by their peers as such. One such KOL working for Ethicon was Dr. Vincent Lucente, whom the company paid to use and promote its mesh. Dr. Lucente’s opinion, represented by internal Ethicon emails entered in the trial, appeared to be that he did not think Prosima would be effective for the highest grades of 3 or 4 POP (pelvic organ prolapse) – “based on his personal experience of seeing failures with this technique,” – according to one email, which was objected to by defense attorneys, as “heresay,” among other objections. The plaintiff in this case was implanted with Prosima despite suffering grade 3 POP. For that higher level of injury, the Prosima should not have been used, according to Dr. Pence’s testimony in interpreting Ethicon’s own guidelines revealed in company emails entered into the trial record. Mr. Goss then asked Dr. Pence what grade of POP the plaintiff suffered; her answer was 3.
Prosima vs. Sutures
One very large issue in regard to any sort of plastic mesh is that it competes with the nearly 60-year method of suturing for the treatment of pelvic organ prolapse (POP). The plastic mesh needs to be at least as effective and at least as safe as the old suturing, also known in layman’s terms as the “Burch method,” which was the gold standard for POP surgery for some 60 years before women’s pelvic mesh came along. Ethicon Medical Affairs Director Dr. Martin Weisberg stated in an email in 2005, which was entered into the trial record on this day: “Why would anyone spend any money on a device and take what they consider a risk of using graft when they could get the same results for free with native tissue?”
Study fails to show Prosima worthwhile
Ethicon’s own documents revealed that Prosima showed no greater success rate than sutures for treating POP. Meanwhile, when the plastic fails or causes a woman problems, there is little question but that it is more difficult to remove or revise than is the traditional suturing method.
Prosima Launch delayed
Ethicon launch of the Prosima was delayed twice due to the company’s studies failing to show its safety and efficacy. An important study known as Carey-Slack failed to give the company strong assurance that the product was safe and effective. At six months, 78 (82%) of women returned for physical examination; 80 (84%) returned at twelve months.
Dr. Pence testified that, assuming the 15 women not examined at the 12-month juncture were objective failures, then the failure rate would be 28.4%. Defense objected to this analysis as speculative, because even though history tends to show those unhappy with a product in a trial tend not to return for followups, nobody could say for certain exactly why the women failed to return for the followup visits.
If Prosima not Superior to Colporrhapy. . .
The plaintiff’s attorneys placed a large sign in the courtroom before the jury, titled in big letters: “Weisberg Principle: If Prosima not superior to Colporrhapy, DO NOT pursue because no benefit to patient.”
One Ethicon email from Judith Gauld (Ethicon’s clinical director in Scotland) to Director David Robinson (Ethicon Medical Director Worldwide) 12 April, 2008 (Plaintiff’s exhibit 663) read: “[W]ould consider a success if failure rate had upper 95% CI of less than 20% at 12 months. We have already failed that. . . I am concerned that this looks like a good bit of spin going on, and due to his commercial interest, this is not going to come over as objective as perhaps it should.”
Prosima a Reckless Product – email
One email from a J. Meek to David Robinson reported that one KOL called Prosima reckless: “When he went through his presentation with me, he was quite scathing of Prosima being a reckless product.”
Attorney Tim Goss walked Dr. Pence through the Oct. 20, 2008 FDA report of 1,000 adverse event events reported to the agency. She pointed out that the Congressional record and other sources readily concede that perhaps 1 in 100 adverse events is reported. (The total number of mesh cases filed in federal and state courts incidentally approaches 100,000.) Worth noting here is that these are not solely Prosima reports but ALL adverse event reports from ALL mesh products, which come from several different makers.
Objections to Prosima
Aaron Kirkemo, Ethicon’s associate medical director worldwide, emailed Harel Gadot, David Robinson and others after conferring with KOLs: “. . . You will find a fairly recurring theme that objections to Prosima came up in virtually every venue regardless of what topic. . . A second recurring theme was that it did not make sense to use mesh in people with lesser degrees of prolapse given the outcomes.”
The less harsh problems of POP (1-2 stage) were the only ones generalists should operate on, according to Ethicon’s own documents, while Prosima was marketed to generalists, people with less experience in POP surgery, those who didn’t have as much skill and knowledge as others more qualified to operate on the more severe stage 3-4 POP cases.
Prosima’s Questionable Data
Prosima feedback from Ethicon’s Andrew Meek to Johnathan Meek Feb. 9, 2009 further showed Ethicon’s awareness of Prosima problems prior to the product’s being launched: “Met with KOLs: “The feelings are very negative towards Prosima. . . The target appears to be skilled generalists. At a time when scrutiny against mesh is at an all time high, why would we want to put a product with questionable data in this group’s hands?” Meek also quoted Ethicon’s own KOLs telling him “over and over” that launching Prosima was a “Big mistake” and “Don’t do it” and “Give me VSD and keep Prosima.”
No Benefit that Justifies the Risk
Further questioning from Mr. Goss over the objections of defense lead to this conclusion from Dr. Pence: “There is no benefit to this product that justifies the risk.”
Mr. Goss reminded the court again and again that all this was occurring before Prosima was launched, that all these red flags were out before Ethicon put it on the market..
Piet Hinoul, Ethicon Medical Affairs Director
Piet Hinoul wrote in internal email: “It is also clear to me that this Prosima is not the “mesh for dummies” [generalists] as I thought when I first saw its description. . . It requires the skill of a pelvic floor surgeon.”
Despite Hinoul’s own and other Ethicon executives’ cautions, Hinoul pushed to launch Prosima in April 2009, writing: “Prosima, with the evidence backing it up, is our perfect timely weapon against both Pinnacle [a competitor’s mesh], that will be hitting the UK soon, and Elevate [another competitor’s mesh], which I expect to be starting their aggressive sales techniques soon. . . As both the products are ready to start hitting Europe and Pinnacle is already starting to give us a headache, let’s not delay (in launching Prosima).
Mr. Goss asked Dr. Pence if she thought that push to launch Prosima was contrary to the standard of care and to Ethicon’s own credo. She answered in the affirmative, over the continued objections of defense lawyers for Ethicon.