In mesh litigation, how a casual corporate decision ruined one woman’s life

March 30, 2016

(Reuters) – In 2005, as Johnson & Johnson was preparing to roll out Prolift, a new medical device designed to treat a urogynecological condition that affects millions of women, a French physician sent an urgent email to the J&J product director in the United States. Clinical evidence in Europe, the doctor’s email said, showed that Prolift mesh occasionally eroded through the walls of the vagina in women implanted with the device. Prolift also had a tendency to retract, according to the French physician, who said both of those complications could interfere with a patient’s ability to have sex. The doctor proposed adding cautionary language to the information J&J planned to provide to doctors in the U.S., warning them about potential complications of implanting Prolift in sexually active women, especially those who’d had hysterectomies.

The French doctor worked for J&J and had helped develop Prolift. His suggestion was reviewed by a number of corporate officials in the U.S. Ultimately, J&J didn’t add the cautionary disclosures he proposed – but not because the company engaged in some kind of sophisticated cost-benefit analysis and decided potential profits outweighed liability risk.

J&J’s decision, if you can call it that, seems to have been motivated by inertia. Prolift information packets had already been written, approved and delivered to the printer. According to sworn testimony from J&J witnesses, the company didn’t want to go to the trouble of revising and reprinting the materials it planned to send doctors. In principle, J&J officials didn’t object to adding a warning about Prolift complications. They just didn’t want to delay the device’s roll-out. They figured they could add the warning later, in a subsequent version of the information packet.

The company didn’t end up revising the Prolift warnings until 2008, which was way too late to help a South Dakota nurse named Linda Gross. Gross was 41 years old in 2006, when she was diagnosed with pelvic organ prolapse, a condition in which the muscles of the pelvic floor cannot support internal organs. (In Gross’s case, after a hysterectomy, her small intestine collapsed into her uterine cavity.) She and her doctor talked for about 15 or 20 minutes about her options, and Gross checked J&J’s website for patient information. They concurred that Prolift was the best treatment for her. Gross was implanted with Prolift in June 2006.

Her reaction to the mesh was “catastrophic,” to use her surgeon’s word. When Gross went to trial against J&J in New Jersey Superior Court in 2013, she and a bevy of doctors testified about the years of chronic pain, disabling medical complications and additional surgery Gross endured after her Prolift implant. Gross is under treatment for anxiety and depression. She can no longer have sexual intercourse with her husband.

Gross said she would not have chosen Prolift if she had known all of risks the product posed for sexually active women who had had hysterectomies. The doctor who implanted her mesh testified that he relied on J&J to provide him with a complete disclosure of the potential complications in the information packet the company sent to doctors. He said he recommended Prolift to Gross based on that information – and would not have recommended it if J&J had included the additional warning suggested by the French doctor.

Linda Gross’s fate, in other words, was sealed because J&J happened to have already sent doctors’ information packets to the printer when the French doctor sent his cautionary 2005 email.

The New Jersey Appellate Division made that point twice Tuesday in its opinion affirming an $11 million verdict – $3.35 million in compensatory damages and $7.76 million in punitive – for Gross. The three-judge panel said J&J cannot shift blame onto Gross’s doctor for failing to tell her about possible complications because the company, in a rush to get the product to market, sent doctors information packets that didn’t disclose all of the potential problems the company knew Prolift could cause. The three-judge panel also said Gross was entitled to punitive damages because of J&J’s failure to warn doctors and patients. The panel of judges paraphrased testimony from a J&J witness: “The document was already at the printers and the company wanted to get the product to market as soon as possible.”

The 68-page opinion from Judges Clarkson Fisher, Marianne Espinosa and Garry Rothstadt is a deeply depressing account of the extraordinary consequences of seemingly ordinary corporate decision-making. The appellate ruling does not suggest a cover-up or conspiracy at J&J, just a series of ill-considered choices, culminating in the 2005 decision to disregard a warning from Prolift’s developer about adverse clinical results because materials were already at the printer. The opinion portrays the French doctor’s cautionary email as a matter of corporate routine at J&J, like other reports in 2004 and 2005 of clinical problems with Prolift.

J&J stopped selling Prolift in 2012, though it still sells other mesh products to treat prolapsed and urinary incontinence. Unlike pelvic mesh manufacturers Boston Scientific and C.R. Bard, the company has not reached a billion-dollar settlement with thousands of mesh plaintiffs. (It did reportedly agree in January to a $120 million deal to resolve claims by as many as 3,000 women.) J&J and other mesh makers contend they followed Food and Drug Administration regulations and sold safe products that have helped hundreds of thousands of women.

Retrospect is easy, of course. From the perspective of 2016, with J&J accused of harming tens of thousands of mesh implant patients and facing hundreds of millions of dollars (if not more) in exposure to personal injury claims, it seems crazy that no one at the company stood up and said J&J should wait a few weeks and eat a few bucks in printers’ fees to put out more robust information about Prolift. But it also seems crazy that no one at GM called on the company to investigate ignition-switch defects even as the company reached confidential settlements with crash victims.

Even if they don’t stop to think of the consumers who will be affected by their decisions, people who work at big companies that make dangerous products by now ought to know enough to consider how their actions will look to judges and juries. Maybe then, they will remember the ripples of ordinary corporate business.

(Reporting by Alison Frankel)

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