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St. Jude Medical Lawsuit Will Soon Face Critical Juncture

Plaintiffs move to cooperate in class-action case

Aug 5, 2002 | The Business Journal (Minneapolis/St. Paul) A battle to turn 37 individual product liability lawsuits filed in federal court against Little Canada-based St. Jude Medical Inc. into a class-action suit will head to court this fall. It will be a crucial step for the 2-year-old case, which likely won't conclude for another year.

U.S. District Court Judge John Tunheim in Minneapolis will hear arguments Sept. 10 to consider making the individual claims a class-action suit that would include about 11,000 patients who were implanted with St. Jude's Silzone mechanical heart valves. It would also roll up the 89 cases pending in various state courts.

If the case is certified as class action, then it affects not just those people who came forward and filed lawsuits, but every person who has a Silzone valve implanted, said a lawyer, who represents some of the plaintiffs in the case.

"St. Jude is a company that has definitely had an excellent reputation and a serious problem with a product it manufactured. I think it's a significant and serious issue for them," the lawyer said.

Some of the cases involve patients who were not injured but fear that they might be at risk and want St. Jude to pay for follow-up monitoring. Neither side has estimated how much this ongoing monitoring would cost.

St. Jude voluntarily recalled the valves in January 2000 after a company-administered study showed the Silzone coating caused a postoperative complication known as paravalvular leak in about 2 percent of patients vs. a less than 1 percent rate of leakage with a non-Silzone-coated valve. Silzone is a silver coating applied to St. Jude's mechanical heart valves as a way to reduce infections. The suits allege that the leakage forced some patients to undergo further surgery to repair or replace the valve.

St. Jude spokesman Peter Gove declined to be interviewed about the lawsuits. In an e-mailed statement to The Business Journal, he said the company "is vigorously defending against the Silzone claims brought against it."

St. Jude "acted promptly and voluntarily" to recall Silzone heart valve products when it found out there was a problem, he said.

Gove said while it is impossible to predict the outcome of these cases, St. Jude believes that it has adequate product-liability insurance to cover any costs associated with them.

In 2000, St. Jude wrote off $26 million to cover the cost of pulling the Silzone-coated valves from the market.

It remains unknown as to what caused the small, but statistically significant, increase in paravalvular leaks in the patients who had been involved in the study by St. Jude, said Gove. Such leaks are known complications for all heart-valve patients. The normal monitoring that these patients receive should detect any paravalvular leaks; therefore the monitoring sought by the class-action plaintiffs is not medically necessary, he said.

St. Jude continues to stress the importance of the normal diligent monitoring recommended for all patients with mechanical heart valves (regardless of type or manufacturer), and it continues to recommend that clinicians emphasize to patients the importance of keeping scheduled appointments and of reporting all changes in symptoms, Gove said.

The company has established a Medical Expense Reimbursement Program (MERP), Gove said. This program reimburses any out-of-pocket expenses not otherwise covered by the patients' insurance that are medically necessary and associated with the treatment and detection of paravalvular leak. St. Jude Medical also maintains a Silzone hotline for patients or physicians who may have questions about these products, he said.

Unlike when your car gets recalled, and you just have to stop in a garage and have a leaky radiator or some other part replaced, recalling heart valves involves major surgery. "Obviously you prefer not to expose someone to further surgery if there's no need at the moment," said Steven Angstreich, an attorney from Cherry Hill, N.J., who is representing the plaintiffs in the federal lawsuits along with Rudd.

A lawyer who represents Lester Grovatt, a South Jersey, N.J., man who was implanted with a St. Jude valve that had the Silzone coating.

"He had numerous problems and then learned to his dismay that it was a Silzone valve that was being recalled," Grovatt's lawyer said. "He was very upset by it ... and he's very troubled by the fact that he has to live with what he fears to be a defective product in him."

The Silzone case is small by comparison to many class-action suits, said Jodine Mayberry, managing editor of Medical Devices Litigation Reporter out of Wayne, Penn., which follows product-liability litigation. There are some cases with 500 or 600 plaintiffs active right now, Mayberry said. And the Silzone case doesn't come close to measuring up to the asbestos or breast implant cases that involved thousands of plaintiffs and multiple defendants for years, she said.

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