A Medical Device Daily

Two Manhattan law firms – Weitz & Luxenberg and Seeger Weiss – drew first blood in what is likely to be a flood of lawsuits against Guidant (Indianapolis) in regard to its recent recall of 50,000 implantable cardioverter defibrillators (ICDs) and failure to alert customers to the danger of one of those devices for nearly three years after it was aware of the problem (Medical Device Daily, June 21, 2005).

The two firms said they jointly filed a class-action lawsuit on behalf of patients implanted with malfunctioning ICDs manufactured by the embattled cardiovascular device maker.

The lawsuit said that while Guidant informed the FDA of the malfunction in its August 2003 annual report, “it has been asserted that the company made no move to alert doctors or heart patients of the malfunction until after it was told that the New York Times was preparing an article on May 23 about the faulty devices.”

In other legal news, a U.S. District Court jury in Wilmington, Delaware, found that Boston Scientific’s (Natick, Massachusetts) Taxus drug-eluting stent and its Libert and Express bare metal stents infringe Cordis’ (Miami Lakes, Florida) Palmaz patent for balloon-expandable stents, and that the bare-metal Libert stent also infringes another Cordis patent – the Gray patent – which relates to flexible balloon expandable stents and expires in 2016.

A new jury is scheduled to convene in August for a trial to determine the amount of damages owed to Cordis, a Johnson & Johnson (J&J; New Brunswick, New Jersey) subsidiary, and whether the infringement was willful.

If the jury finds willful infringement, U.S. District Court Judge Sue Robinson can as much as triple the damages judgment.

Earlier in the trial, Robinson dismissed “without prejudice” Cordis’ claims that Boston Sci’s drug-eluting version of the Libert stent infringes both the Palmaz and Gray patents, indicating the court had no jurisdiction to hear the claims now because that stent is not currently marketed in the U.S.

“We are confident that the finding of infringement of the Gray patent by the bare-metal Libert stent will also apply to the drug-eluting version of Liberte, and Cordis will strongly assert its patent claim against it if and when the product is launched,” said Nick Valeriani, worldwide chairman, cardiovascular devices and diagnostics, for Cordis.

“Today’s findings of infringement against the Taxus, Libert and Express stents – together with previous findings of infringement by Boston Scientific’s NIR stent – reinforces the strength of Cordis’ deep patent estate on balloon expandable stents,” he added.

Boston Scientific noted that J&J is not seeking injunctive relief against the Taxus Express, Express or Express Biliary products. The company also said that while it is “disappointed” in the jury’s decision, “significant post-verdict motions and hearings, as well as an appeal of the decision” are likely to come.

Analysts have said monetary damages could surpass $1 billion if Boston Scientific lost on appeal, but the appeals process could take several years.

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