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Transvaginal Mesh: Transient Notions of Consumer Safety

Joseph DiNardo, Esq. | Founder & CEO

Since 2008, thousands of plaintiffs have filed lawsuits against manufacturers and sellers of defective pelvic mesh products, commonly referred to as transvaginal mesh (“TVM”). Plaintiffs include women who received TVM implants to treat Pelvic Organ Prolapse (“POP”) or Stress Urinary Incontinence (“SUI”), common conditions involving the weakening of the vaginal walls after childbirth. TVM is a surgical mesh typically made from polypropylene, a plastic material surgically implanted into or attached to the vaginal wall. TVM related complications include mesh contraction and mesh erosion causing severe pain, vaginal scarring, infection, urinary problems, inability to have sex, and perforations of the bowel, all of which will likely require one or more revision surgeries. Plaintiffs also include men asserting injury claims sustained during sexual relations, as well as derivative claims for loss of consortium.

 

Two individual state actions involving TVM claims have resulted in large verdicts. In July 2012, a jury in Bakersfield, California found TVM manufacturer C.R. Bard liable for $3.6 million for damages caused to Christine Scott and her husband by Bard’s Avaulta Plus implant. The physician who surgically implanted the mesh was held responsible for the remaining $1.9 million awarded. In February 2013, a New Jersey jury awarded Linda and Jeff Gross $3.35 million in compensatory damages and $7.76 million in punitive damages for injuries Linda sustained as a result of Ethicon’s Prolift device. Gross endured 18 separate surgeries due to severe complications from the device, including mesh erosion, scar tissue formation and organ damage.

 

In addition to individual state court cases, there are currently five related MDLs consolidated before U.S. District Judge Joseph Goodwin in the Southern District of West Virginia.1 that are summarized in the table below:

 

In the MDLs, plaintiffs seek compensatory and punitive damages based upon theories of strict liability for product defects, failure to warn, and breach of express and implied warranty. Plaintiffs in the American Medical Systems Ethicon Inc., and Coloplast actions have also asserted claims based upon defendants’ negligence, gross negligence, constructive fraud, violation of consumer protection laws, and negligent infliction of emotional distress. In addition, plaintiffs in the Ethicon action have alleged common law fraud based on the sale of the Prolift mesh product without FDA clearance.

 

The substance of these allegations is that defendants underreported and withheld information about the propensity of the products to fail and cause injury and complications, and that defendants intentionally misled the FDA, the medical community, and patients in this regard. Further, plaintiffs allege that the defendants failed to establish effective procedures for removal of the products.

 

Plaintiffs cite multiple FDA statements as evidence that defendants were fully aware of the dangers inherent in their TVM products, yet kept marketing the products and allowing their usage due to their immense profitability. Indeed, during the manufacture and sale of TVM products over a number of years, the FDA issued multiple statements regarding serious complications. In 2008, the FDA issued a notification involving 1,000 reports of complications with TVM products.2 In 2011, the FDA issued a safety communication regarding TVM.3 In 2012, the FDA issued an order to manufacturers mandating additional studies of the product.4 In each period, pelvic mesh production and marketing continued unabated while such safety concerns went unaddressed.

 

Plaintiffs highlight Ethicon’s Prolift mesh product as a particularly egregious example of the manufacturers’ emphasis of profits over safety. Plaintiffs allege that Prolift was marketed and distributed for over two years without the necessary clearance under Section 501(k) of the Medical Device Amendment. To support their claims for punitive damages, plaintiffs have focused on such conduct and the on marketing and promotional materials defendants employed, including their direct consumer marketing techniques, to assert such gross negligence and willful and wanton conduct warranting the award of such damages.

 

On August 16, 2013 the first of four bellwether trials5, all in the Bard MDL, resulted in another favorable result for plaintiffs. In Cisson v. C.R. Bard, Inc., a case involving Bard’s Avaulta mesh product, a jury awarded plaintiffs $250,000 in compensatory damages and $1.75 million in punitive damages. Of significance is that Cisson was a defense selected case involving a plaintiff with significant unrelated medical issues and co-morbidities. Despite such challenges to medical causation and damages, the jury found in favor of plaintiffs’ allegations of defective product and failure to warn and awarded punitive damages. C.R. Bard has indicated it will appeal.

 

While Judge Goodwin has set a daunting schedule, allowing just 12 days for each bellwether trial to be completed, it is anticipated that it will take a significant amount of time before the bellwether Bard trials are concluded and before the non-bellwether Bard cases are remanded back to their respective transferor courts. Moreover, pretrial proceedings for the other MDLs are currently forecasted to last into 2014. The Coloplast pretrial proceedings have been underway for ten months thus far, while the other MDLs have been in pretrial proceedings since at least February 2012.

 

Given the number and complexity of TVM claims, the time it will take for all MDLs to progress through discovery, trial and possible appeals, and well-funded war chests of the defendants and their counsel, it is clear that plaintiff firms handling TVM litigation will require significant resources.

 

Since 2010, over 300,000 women have had pelvic mesh implants.6 Accordingly, as more victims become aware of the potential for relief, more cases will get traction in the emerging pelvic mesh litigation. The start of the bellwether trials does not preclude attorneys and law firms from taking on additional transvaginal mesh cases, and additional financing would enable attorneys and law firms to take on even more cases.

 

Transvaginal mesh litigation is likely to yield plaintiff-favorable outcomes. Plaintiffs’ evidence includes material data safety sheets for polypropylene, evidence of the defendants’ lack of testing and inspecting, pre- and post-regulatory developments, product complaints and adverse event reports, and marketing and promotional materials. Moreover, plaintiffs may present evidence of defendants’ financial motives as relevant to punitive damages, such as their financial information and conditions, and evidence of their corporate cultures. This evidence is relevant to all plaintiffs’ cases, and the strength of this evidence should become clearer after the bellwether trials conclude.

 

1 In re Avaulta Pelvic Support Sys. Prods. Liab. Litig., MDL 2187, (S.D. W. Va. certified Oct. 12, 2010); In re Am. Med. Sys., Inc., Pelvic Repair Sys. Prods. Liab. Litig., MDL 2325 (S.D. W. Va. certified Feb. 7, 2012); In re Boston Sci. Corp., Pelvic Repair Sys. Prods. Liab. Litig., MDL 2326(S.D. W. Va. certified Feb 7, 2012); In re Ethicon, Inc., Pelvic Repair Sys. Prods. Liab. Litig., MDL 2327 (S.D. W. Va. certified Feb. 7, 2012); In re Coloplast Corp., Pelvic Support Sys. Prods. Liab. Litig., MDL 2387 (S.D. W. Va. certified Aug. 6, 2012).

2 U.S. Food & Drug Admin., FDA Public Health Notification: Serious Complications Associated With Transvaginal Placement of Surgical Mesh in Repair of Pelvic Organ Prolapse and Stress Urinary Incontinence (Oct. 20, 2008), www.fda.gov/MedicalDevices/Safety/AlertsandNotices/PublicHealthNotifications/UCM061976.htm.

3 U.S. Food & Drug Admin., FDA Safety Communication: UPDATE on Serious Complications Associated With Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse (July 13, 2011), www.fda.gov/MedicalDevices/Safety/AlertsandNotices/UCM262435.htm.

4 U.S. Food & Drug Admin., Urogynecologic Surgical Mesh Implants (Jan. 4, 2012), www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/UroGynSurgicalMesh/ default.htm. The FDA may require a manufacturer to conduct postmarket surveillance of a class II or III device for a period of up to 36 months. 21 U.S.C. §360L (2012).

5 Cisson, et al. v. C. R. Bard, Inc. 2:11-cv-00195 (July 8, 2013); Queen, et al. v. C. R. Bard, Inc. 2:11-cv-00012 (July 29, 2013); Rizzo, et al. v. C. R. Bard, Inc. 2:10-cv-01224 (Aug. 19, 2013); Jones v. C. R. Bard, Inc. 2:11-cv-00114 (Sept. 9, 2013).

6 Alex Nussbaum & David Voreacos, J&J, C.R. Bard Must Study Safety of Vaginal Mesh, FDA says, Bloomberg News (Jan. 5, 2012), www.bloomberg.com/news/2012-01-04/fda-orders-safety-studies-for-vaginalimplants-made-by-j-j-and-c-r-bard.html.

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