Boston Scientific to Pay $73 Million: What's Next for TVM Suits?

Boston Scientific Corp. was hit with a $73.4 million verdict earlier this month after a jury found that the company’s Obtryx transvaginal sling was defective and caused serious injuries. The decision, made by a Texas state jury, marks a dramatic change in Boston Scientific’s luck after juries found in the company’s favor in two previous transvaginal mesh rulings. It remains too early to be seen, however, which way the transvaginal mesh litigation will go: seven different companies now face a total of more than 65,800 cases that have been consolidated into seven multidistrict litigations being heard in West Virginia, as well as an additional number of lawsuits filed in state courts. Along with Boston Scientific, these companies are:

• C. R. Bard, Inc.
• American Medical Systems, Inc.
• Ethicon, Inc.
• Coloplast Corp.
• Cook Medical, Inc.
• Neomedic

The verdict against Boston Scientific comes after a two-week trial. Plaintiff Martha Salazar was awarded around $23 million in compensatory damages, as well as $50 million in punitive damages. Salazar initially sought help for a minor urine leakage and, according to her claims, ended up needing four major surgeries to treat organ damage and intense pain. Her suit claimed a design defect in the mesh was to blame.

While Boston Scientific continues to deny its pelvic mesh is responsible – the company won two previous bellwether trials and was cleared of liability in both cases – mesh manufacturers have been held increasingly accountable for mesh-related injuries. Within the last year, Endo International agreed to pay $830 million to settle thousands of mesh lawsuits, both Johnson & Johnson (Ethicon) and C. R. Bard have lost jury trials over their mesh devices, and the FDA has issued proposals to reclassify transvaginal mesh products as high-risk, which means they would require rigorous testing before being sold.

These are all good steps in the fight to protect patients, but those two bellwether trials won by Boston Scientific are also indicators of how complicated these cases can be. Plaintiffs’ attorneys are tasked with showing, by a preponderance of the evidence, that the mesh was the cause of the patient’s injuries and not just circumstantial. Since, by definition, women implanted with mesh products have ongoing medical problems in the affected areas, manufacturers have been quick to point out that doubt may always remain over the specific cause of the complications.

Clearly, for the jurors in Texas, there was little doubt as to what caused Salazar’s injuries. In addition to finding that Boston Scientific’s Obtryx mesh was defectively designed, the jury ruled that the company failed to properly warn patients about the products’ risks even though they knew about them – effectively constituting gross negligence. As part of the trial, Salazar’s lawyers presented an e-mail from 2000 sent by Alex Robbins, an executive at Boston scientific who had seen a company study raising concerns about the mesh, advising salespeople not to hand out the report to doctors. This is very important: suspicions that manufacturers knew about, or at least suspected, defects within the mesh products have been validated.

This could have ramifications for remaining lawsuits. The FDA’s new push to change the way it approves and monitors mesh products, coupled with more high-profile victories for plaintiffs, may make manufacturers more willing to discuss settlements. Endo, for example, originally budgeted $520 million to cover known, pending and future claims, but raised that to more than $830 million after the number of plaintiffs in the multidistrict litigation rose above 16,000 and the dates of its first bellwether trials approached. C. R. Bard has also shown at least a willingness to settle: the second of four bellwether trials was settled for an undisclosed sum on the day it was due to start after the first bellwether trial ended in a $2 million verdict against the company. While still strong, and definitely still fighting, mesh manufacturers are rattled, and have clearly begun looking seriously at all their financial options, including settlements.

The ruling against Boston Scientific is one case among thousands, but it’s another important milestone on the road to seeing transvaginal mesh patients properly compensated for the suffering they’re experienced.