The US Supreme Court has ruled that generic drug companies cannot be sued due to adverse reactions to their products. The decision (with five votes to four against) was made on Monday after a patient living in the state of New Hampshire filed a $21 million settlement with Mutual pharmaceutical Co, a Sun pharmaceutical industries Ltd group, arguing that the drug was unsafe due to its chemical formulation. The court rejected the request, with the reasoning! nor that state laws cannot go against federal laws, and in this case the prescribed drugs had been approved by the Food and Drug Administration. The reaction of consumer associations was not long in coming. Michael Carole, director of the Public citizen's health research group, recalling that in the USA the 80% of prescriptions concerns precisely equivalent medicines, declared: «The Court's decision constitutes a disincentive to monitor safety for generic drug manufacturers and to implement surveillance systems to identify adverse effects that may endanger the health of patients". The patient had been taking a generic drug manufactured by Mutual to treat shoulder pain, but three weeks into therapy she had suffered a rare hypersensitivity reaction: her skin had peeled off over two-thirds of her body surface area, l! leaving her disfigured and almost blind. But the manufacturer, supported by the federal administration, had argued that it had not introduced changes to a drug already approved by the FDA and had put it on the market with the same warnings in terms of safety that had been formulated for the original drug. And this was the reasoning accepted by the Supreme Court.
June 26, 2013 – DoctorNews33
