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St. Jude Aortic Connector
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Judge Allows Valve Case Against St. Jude To Proceed

Jan 7, 2004 | AP

A judge's ruling will allow a class-action lawsuit over a defective heart valve to proceed against St. Jude Medical Inc., even though federal regulators approved the device.

U.S. District Judge John Tunheim on Monday also reduced the number of potential plaintiffs in the lengthy lawsuit against the Little Canada-based medical device company.

The case involves St. Jude's Silzone heart valve, which was surgically implanted in about 36,000 people worldwide after receiving Food and Drug Administration approval in 1998. However, clinical trials done after the FDA approval determined that the Silzone valves were prone to leak.

In 2000, St. Jude voluntarily recalled all the Silzone valves that had not been implanted and told hospitals and doctors to quit using the product. The company also contacted patients with implanted Silzone valves and established a fund to pay for uninsured medical costs associated with any leaks. About 10,500 of the Silzone valves were implanted in U.S. patients.

Tunheim dismissed one class of patients seeking standing to sue St. Jude over the Silzone but also certified a class of patients from 13 states and the District of Columbia who received the valve.

Officials from St. Jude declined to comment on the ruling.

Nearly 40 federal cases have been consolidated in U.S. District Court in Minneapolis. Other cases nationwide were settled or dismissed. A similar class-action lawsuit is pending in Ontario, Canada.

Thomas Gunderson, an analyst at Piper Jaffray in Minneapolis, said St. Jude has $200 million in reserves to cover expenses from the Silzone.

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