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Ethicon Media Monitoring 10/21/16
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Judge Defends Jury But Carves $2M From Mesh Verdict
Oct 20, 2016 | Law 360
By Brandon Lowrey
A Georgia federal judge on Thursday halved a $4 million punitive damages verdict against a Johnson & Johnson unit in a defective pelvish mesh lawsuit, but waxed philosophical about J&J attorneys' attempts to undermine a diligent jury's verdict. -
FDA Covers for Device Makers, Keeps Injuries Under Wraps
Oct 20, 2016 | Mesh Medical Device Newsdesk
The system is supposed to be transparent. Medical device makers are required to alert the U.S. Food and Drug Administration (FDA) when their products injure consumers or malfunction. -
Reduce stigma of symptoms
Oct 20, 2016 | Journal Sentinal
By Sherrie Palm
The article, “Cashing in on overactive bladder market” generates dialogue, pointing fingers regarding the right and wrong of pharmaceutical companies vs. health care ethics.
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Judge Defends Jury But Carves $2M From Mesh Verdict
Oct 20, 2016 | Law 360
By Brandon Lowrey
Law360, Los Angeles (October 20, 2016, 6:55 PM EDT) -- A Georgia federal judge on Thursday halved a $4 million punitive damages verdict against a Johnson & Johnson unit in a defective pelvish mesh lawsuit, but waxed philosophical about J&J attorneys' attempts to undermine a diligent jury's verdict.
Chief U.S. District Judge Clay D. Land applied a statutory, $2 million damages cap to the jury's punitive award but rejected Mentor Worldwide LLC's bid to overturn the entire verdict in a 46-page order. He said that his perspective is informed by the experience of trying 12 jury trials in a 10-month period — "a perspective that brings focus to the difference between a jury's job and a judge's job."
Jurors based their decision on ample evidence and reached it through deliberations, ultimately offering the court a verdict based on their collective wisdom, he wrote, so the company's attorneys' post-trial efforts to "mine" the trial transcript and parse language weren't persuasive.
"After the jury is dismissed thinking that justice has been done, losing lawyers — well trained in dissecting every comma and spinning every word — mine the written transcript to weave a different story, one that suits their purposes but is often very different than what was actually experienced by that factfinding jury," Land said.
The judge upheld a $400,000 compensatory damages verdict, bringing the total awarded to Florida resident Tessa Taylor to $2.4 million. Taylor alleged she had been implanted in 2004 with the prescription medical device known as the ObTape sling to treat her incontinence. But over the next seven years, the defective implant caused her serious pain and recurring infections, she claimed.
Her doctor then diagnosed her again with stress urinary incontinence and recommended that her ObTape be removed and replaced with another sling in 2011, according to court documents.
Taylor filed suit in 2012 as a tagalong to more than 800 cases against Mentor consolidated in multidistrict litigation.
One day before the ObTape suits were consolidated, the company settled 111 of them at once last January, agreeing to establish a trust to manage and distribute funds agreed upon in 2014.
On Nov. 12, Mentor reached an undisclosed deal with Beryl Cole and Roger Gupton, whose complaint regarding the ObTape sling was among six designated as bellwethers by Judge Land in 2015 and was slated for a two-week jury trial starting Nov. 30.
Cole, who received the ObTape device in 2004, claimed in 2011 that she suffered infections, abscesses and scarring, requiring multiple surgeries.
Mentor had settled another proposed bellwether case in July 2013 shortly before trial.
Mentor scored a favorable verdict in June 2013 in a previous bellwether case when a jury found that plaintiff Irene Morey hadn't shown that the device maker was negligent.
In the Taylor case, however, jurors sided with the plaintiff.
Mentor argued in a post-trial motion that it was entitled to a new trial or judgment, saying the jury's decision was against the greater weight of the evidence and that alleged evidentiary errors and rule violations prejudiced it.
Judge Land said that he felt the curative instructions provided to jurors solved the problem presented by testimony that shouldn't have been offered, and disagreed with the company's claims that the court erred in admitting other evidence. Aside from the statutory cap on punitive damages, he said the verdict should be left alone.
"The law has long recognized that only the jury can do this factfinding and that mischief can be created when judges are lulled into believing that due to their superior training and experience, they can actually second-guess that uniquely juror task of factfinding," the judge wrote. "Thus, we learn early in law school that these jury verdicts are entitled to great deference. But it is tempting to forget what we learned long ago and to inject ourselves into the factfinding inquiry, particularly when we may disagree with the facts found."
Taylor is represented by Edward Blizzard, Katherine Cornell and Holly W. Gibson of Blizzard & Nabers LLP.
Mentor is represented by John Q. Lewis of Tucker Ellis LLP.
The case is Taylor v. Mentor Worldwide LLC, case number 4-12-cv-00176, in the U.S. District Court for the Middle District of Georgia.
The MDL is In Re: Mentor Corp. Obtape Transobturator Sling Products Liability Litigation, case number 4:08-md-02004, in the same venue.
--Additional reporting by Emily Field. Editing by Kely Duncan.http://www.law360.com/articles/853947/judge-defends-jury-but-carves-2m-from-mesh-verdict
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FDA Covers for Device Makers, Keeps Injuries Under Wraps
Oct 20, 2016 | Mesh Medical Device Newsdesk
The system is supposed to be transparent. Medical device makers are required to alert the U.S. Food and Drug Administration (FDA) when their products injure consumers or malfunction.
The FDA then theoretically alerts doctors who alert consumers. In rare cases, such as pelvic mesh, the FDA will actually issue a public health notification.
That is not happening, according to an investigation by theMinneapolis Star Tribune. Its analysis, based on data from the FDA, shows the agency has created programs that allow manufacturers to keep injury reports out of view of the public.
One example is Baxter International.
The Illinois-based company put 75,000 malfunctions of its Colleague drug pump into a report, kept out of the eyes of the public while a brief summary was issued. When the Star Tribune challenged the decision, the FDA revealed the actual number of injuries.
Medical device manufacturer Medtronic, maker of the Infuse bone graft, was given permission to summarize adverse event reports numbering more than 1,000 malfunction and potentially product-related injuries related to Infuse in a three- sentence summary about six years after they were due.
This was allowed even though Medtronic had been warned four times previously for not reporting problems.
Medtronic said the failure to report was unintentional.
The Star Tribune filed a Freedom of Information Act request with the FDA, which took more than one year to fulfill. It showed more than 40 patients out of 100 who had the Infuse placed in the neck had trouble swallowing. The company had these reports back in October 2007. Nine months later, after receiving adverse reports from others sources, the FDA warned that Infuse can cause swelling near the airways.
LifeScan, a Johnson & Johnson company finally reported 186,000 potential malfunctions in its diabetic blood meters in 2006. The reports went back two years and had not previously been reported to the FDA.
The program is called the retrospective summary reporting program and it was created because so many companies fail to issue their reports in the required 30-day deadline. The newspaper reports there is no description of the program on the FDA’s website, so the public would not know of its existence. There is no punishment for failing to report in a timely manner.
The FDA has allowed injury or adverse event summaries, from as far back as 2005, to be entered into the program. At least 2 companies have issued more than 130,000 overdue adverse event reports. To date that number is now more than 300,000, after the Star Tribune investigation.
r. David Challoner, who led an Institute of Medicine team that studied adverse-event reporting problems in 2011, told the Star Tribune he had never heard of retrospective summary reporting.
“That’s a loophole you’ve identified,” Challoner said. “It should not happen. The fact that [overdue adverse event reports] can be reported in summary, without details, is inappropriate and, at least in my understanding of the basic congressional intent of reporting, outside the boundaries.”
While the FDA declined an interview request, a spokesperson by e-mail said that the medical community already understand the issues well and additional documentation would just waste resources.
Often the devices mentioned in the summaries are controversial. For example Baxter Colleague pump has been recalled. Vaginal mesh implant reports are submitted late. There are in excess of 100,000 defective product cases filed against seven makers of these products.
Madris Tomes, who used to work with the FDA and now runs the website Device Events told the paper “Physicians might change their minds if they knew how many problems there really were.”
Rules for posting a quarterly summary of adverse events, called Alternative Summary Reporting, is designed for companies that acquire another and find unreported issues. A full report must be obtained through a Freedom of Information Act request which can take up to a year to fulfill.
Minnesota’s U.S. senators expressed criticism of the secret program earlier this week, reports theStar Tribune.
Sen. Amy Klobuchar says the retrospective summary reports “stands in the way” of keeping the public informed. “All patients deserve to know the risks and side effects of a medical procedure and a medical device.”
Sen. Al Franken says he’s been pushing to revamp the medical device reporting system.
http://www.meshmedicaldevicenewsdesk.com/fda-covers-device-makers-keeps-injuries-wraps/
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Oct 20, 2016 | Journal Sentinal
By Sherrie Palm
The article, “Cashing in on overactive bladder market” generates dialogue, pointing fingers regarding the right and wrong of pharmaceutical companies vs. health care ethics.
What is overlooked is the impact of stigmatizing conditions such as pelvic organ prolapse (POP) and overactive bladder (OAB) to patient quality of life.
If health care and big pharma would effectively join hands to focus on the destigmatization of conditions such as POP and OAB, the patient populace would not care how much money they made or their financial relationships.
Fifty percent of the female population suffers in silence with POP symptoms they don’t recognize or understand, including OAB. What will it take to break the silence and stigma of embarrassing symptoms and generate awareness and open dialogue regarding these common health conditions?
Pelvic organ prolapse is a highly prevalent women’s health issue that deserves greater visibility and public discourse. Ditto for OAB in both males and females. Highly stigmatized pelvic organ prolapse has been on medical record for nearly 4,000 years, yet remains shrouded in silence.
Stigmatizing POP symptoms, including incontinence, significantly diminishes public discussion, reduces awareness and impacts health status and patient quality of life, including that of intimate partners and families.
Clinicians and big pharma who comfortably speak out loud about POP and OAB and fund efforts to reduce stigma send a strong message that patient needs are their first priority, not who makes how much money. It’s time for health care, big pharma and media to recognize the most significant pivot point.
Sherrie Palm
Founder/Executive Director
Association for Pelvic Organ Prolapse Support
http://www.jsonline.com/story/opinion/readers/2016/10/20/letters-friday-oct/92488556/
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