American Home Products has told drug analysts that it should have littleto fear from class action suits and individual suits filed by users of Redux (dexfenfluramine) and Pondamin (fenfluramine) because it had no duty to warn patients of side effects it knew nothing about. The law does not impose a duty to warn about any unknown and unintended risk, said AHP general counsel Louis Hoynes.
Prior to the Mayo Clinic report linking the fenfluramine/phentermine combination to heart problems (Marketletter September 22), AHP had received 11 adverse drug reaction reports out of 6 million users of the products, which Mr Hoynes noted were very scattered and very isolated. AHP also said that the Mayo Clinic study did not show the drugs caused heart damage but only that a statistical link may exist. At present, there are 21 class action suits and over 50 individual suits filed against the company, Mr Hoynes said, adding that only eight allege the existence of actual valvular damage.
Fen-Phen Combo Neither Promoted, Nor FDA-Approved The company noted that most of the claims are from dieters who took the fen-phen combinations, which was neither approved by the US Food and Drug Administration nnor promoted by AHP. Some analysts feel the company's legal exposure is probably limited. Even if AHP is found guilty, Mariola Haggar of Deutsche Morgan Grenfell feels its penalty is unlikely to go much beyond the $2.8 billion settlement it reached for patients who claimed damages from using Dalkon Shield contraceptives.
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