By Dan C. Bolton, Of Counsel, Keller, Fishback & Jackson LLP
In recent months, Endo Pharmaceuticals made several announcements concerning global settlements in the transvaginal mesh litigation against American Medical Systems (AMS) pending before Judge Goodwin in federal district court in West Virginia (MDL 2325). Based on the numbers of women participating, the AMS settlement averages about $40,000 for each woman who had an AMS pelvic mesh device for pelvic organ prolapse (POP) or stress urinary incontinence (SUI), though some women will receive more than that, while others will receive less.
In evaluating the settlement value of TVM cases, it is important to take a look at the trial results to date. Recent jury verdicts since an earlier article continue to demonstrate the strength of these cases. The seven-figure jury verdicts are impressive and in stark contrast to the small average settlements offered by AMS—a company that has yet to face a jury:
- $3.6 million jury verdict in July 2012 against C.R. Bard (Avaulta Plus/POP) in California state court (the implanting physician was held responsible for another $1.9 million in damages). This verdict was affirmed by the California Court of Appeal on November 19, 2014. No punitive damages were awarded by the jury.
- $11.1 million jury verdict in February 2013 against Ethicon (Prolift/POP) including $7.76 million in punitive damages in New Jersey state court. The jury found that defendants failed to adequately warn of the risks of TVM.
- $2 million jury verdict in August 2013 against C.R. Bard (Avaulta Plus/POP) in the first case tried last year before Judge Goodwin in federal court in West Virginia, including $1.75 million in punitive damages. The jury found that the mesh was defective and contained inadequate warnings. Soon after, Bard settled a second case before trial.
- $1.2 million jury verdict in April 2014 against Ethicon (TVT-O/SUI) in Texas state court (Dallas). The jury found that the mesh was defectively designed. No punitive damages were awarded.
- $73 million jury verdict in September 2014 in Texas state court (Dallas) against Boston Scientific (Obtryx/SUI). The verdict included $23 million in compensatory damages and $50 million in punitive damages. The court reduced the verdict to $34 million after trial because of Texas law limiting punitive damages.
- $3.27 million jury verdict in September 2014 in West Virginia federal court against Ethicon (Gynecare TVT-O/SUI). The jury found the mesh was defective and the warnings inadequate. The court did not permit the punitive damage claim to go to the jury.
- $26.7 million jury verdict in November 2014 in Florida federal court (Miami) against Boston Scientific (Pinnacle/POP) in a four plaintiff case tried before Judge Goodwin. The jury found the mesh was defective, the warnings were inadequate and the risks outweighed the benefits of the device. No punitive damages were awarded.
- $18.5 million jury verdict in November 2014 in West Virginia federal court against Boston Scientific (Obtryx/SUI) in a four plaintiff case. The jury found that the manufacturer acted with “gross negligence” and awarded $4 million in punitive damages.
The pelvic mesh manufacturers have prevailed in just three cases—one where Ethicon obtained a directed verdict in its favor before the case went to a jury and two others against Boston Scientific tried in its home jurisdiction in Boston.
Juries understand these cases and recognize the harm caused by defective mesh used for pelvic organ prolapse and stress urinary incontinence.
The verdicts make that loud and clear–eight cases, fourteen plaintiffs, over $100 million in compensatory and punitive damages. While the jury system is inherently unpredictable and any trial is risky, these results underscore the strength of transvaginal mesh cases. The results are nothing short of extraordinary.
It is important to remember that pelvic mesh devices were never approved for safety and efficacy by the FDA. Rather, the mesh manufacturers relied upon the 510(k) process to quickly get devices marketed in the United States. The 510(k) process determines only whether a new device is “substantially equivalent” to a legally marketed “predicate” device. As I discussed in another article, the 510(k) process is fundamentally flawed. Transvaginal mesh devices were marketed based on claims of substantial equivalence to predicate mesh devices that were never reviewed for safety and effectiveness.
Hopefully, the basis for this disparity between large jury verdicts and small AMS settlement amounts will be explained for the thousands of women who had an AMS device implanted. The purpose of “bellwether” trials is to give the parties a chance to evaluate the strengths and weaknesses of the cases. While settlements, which resolve a case before trial and therefore involve less risk, cannot be expected to match jury verdicts, they should bear some reasonable relationship to results at trial. Based on the jury verdicts so far, that reasonable relationship appears obscure. If your knowledge of this litigation was limited to the AMS settlement, you might conclude that the injuries caused by pelvic mesh were minimal. Jurors, who have sat through these cases and heard the evidence, have quite a different view.
Dan C. Bolton is Of Counsel in the Los Angeles office of Keller, Fishback & Jackson LLP. The firm represents plaintiffs nationwide in pharmaceutical and medical device cases, including transvaginal and hernia mesh litigation. Mr. Bolton oversees the pharmaceutical and medical device practice.