FDAnews Device Daily Bulletin

GUIDANT HEART DEVICE LITIGATION CONSOLIDATED IN MINNESOTA FEDERAL COURT

Nov. 9, 2005
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Cardiac devicemaker Guidant has provided new details of the product liability litigation it faces over flaws in its implantable cardioverter defibrillators (ICDs) and pacemakers.

In a recent SEC filing, Guidant reported that roughly 45 product liability class action lawsuits and 50 individual lawsuits have been filed in various state and federal jurisdictions.

The majority of product liability cases are pending in federal court, Guidant said in the SEC report. "The complaints in these product liability lawsuits generally allege strict liability, negligence, warranty and other common law and/or statutory claims," Guidant said. "The majority of claimants alleges no physical injury, but is suing for medical monitoring and anxiety. The complaints generally seek class certification, monetary damages and injunctive relief."

Meanwhile, the Judicial Panel on Multidistrict Litigation (MDL) ruled recently that all federal lawsuits involving Guidant would be consolidated in the Minnesota federal district. Minnesota was selected since many of the Guidant facilities involved in the development and manufacturing of the heart devices are located there, MDL said.

Guidant's legal woes follow the firm's decision last summer to recall or issue warnings on roughly 88,000 ICDs and nearly 200,000 pacemakers after problems were reported in the devices.

In other legal news, Guidant reported the SEC also has begun a formal inquiry into issues related to product disclosures and trading in Guidant stock. The firm said it is cooperating with the inquiry.