The verdict was notable, especially given that U.S. Federal Judge Joseph R. Goodwin had ruled out punitive damages in the case, as well as the fact that the jury was not allowed to hear about tens of thousands of other pelvic mesh lawsuits currently pending in U.S. courts, that Johnson & Johnson’s pelvic mesh was found in a previous case to be defectively designed, that the FDA is considering a proposal to reclassify pelvic mesh as a high-risk device, and that the device was released without gaining FDA approval for safety in the first place.
The trial also dredged up some of J&J’s dirty secrets surrounding the development and marketing of the mesh. Despite the fact that the company spent over $200 million in one year on outreach and education to doctors about pelvic mesh, internal corporate documents indicate that scientists within J&J had their doubts about the product. As these newly-surfaced documents show, many of J&J’s scientists thought the mesh was too stiff, too clumsy to implant, and fraught with potential problems. [Note: Read the full coverage at Mesh News Desk [link], where I compiled my observations and analysis from the courtroom in partnership with the We Are Mesh Survivors Coalition. [link].
J&J is just one of companies that produce pelvic mesh implants, and two days ago, an even larger settlement was reached against another manufacturer. On Monday, jurors in Dallas awarded a record-breaking $73.5 million to a woman injured by a pelvic mesh device manufactured and marketed by Boston Scientific, including about $23 million in compensatory damages and $50 million in punitive damages.
As in J&J’s trial, evidence of faulty studies and questionable ethics arose, including cancelling a study of pelvic mesh when the data was not going Boston Scientific’s way. An expert for the plaintiff also alleged that the company’s call center personnel were not well-trained and did not pass on complaints submitted by customers, effectively making post-market surveillance, a requirement under FDA guidelines, impossible.
In a span of four days, two healthcare giants that have stood defiant in the face of tens of thousands of lawsuits from mesh-injured women received multi-million dollar wake up calls. Trials are only just beginning, but already the house of cards is toppling down.
Pelvic mesh manufacturers should settle while they still can and salvage whatever confidence in their medical devices still remains. Further, these devices should be removed from the market until we understand more about whom they affect and how doctors can safely implant or explant them. Until then, this unregulated experiment will continue to seriously injure a generation of women – more than one hundred thousand mothers, sisters, wives, and daughters have been hurt, with more implanted with mesh every day. As the industry leader, Johnson & Johnson and its CEO Alex Gorsky have the power to end this disaster and set an example for the rest of the industry.
How long will we have to wait for Johnson & Johnson and the pelvic mesh industry to stop hurting these women?