(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.
In August, when Johnson & Johnson disclosed its deal to resolve criminal allegations that it falsely marketed the potent schizophrenic drug Risperdal, I said that if ever a board was ripe for a big, fat shareholder derivative suit, it was J&J’s. The Risperdal settlement was the company’s third criminal plea in a little more than a year, on top of a Justice Department and Food and Drug Administration investigation of its over-the-counter children’s drugs, state attorneys general subpoenas, whistleblower suits, and product recalls. The 111-page consolidated complaint that Bernstein Litowitz Berger & Grossmann and Robbins Geller Rudman & Dowd filed against J&J’s board members last December offered more red flags than a training school for toreadors.
In the next day or two, W. Mark Lanier of the Lanier Law Firm will file a letter with Dallas federal judge Ed Kinkeade outlining the reasons why he should lead what Lanier believes will become a huge mass tort: the multidistrict litigation over DePuy’s Pinnacle hip replacements. More than 300 personal injury suits accusing the Johnson & Johnson unit of failing to warn patients about design defects in the best-selling product have been filed in federal courts around the country and consolidated before Judge Kinkeade. Lanier made a preemptive play to take charge of the MDL, proposing that he and a handful of other well-known mass tort veterans head up a broadly inclusive plaintiffs steering committee. But instead, in an August 10 order, Judge Kinkeade threw open the leadership contest with a call for plaintiffs firms to respond to a long list of questions about their experience in big cases.