The Supreme Court's rulings in June covered many topics, with media attention surrounding those pertaining to gay marriage and voting rights. However, another ruling that did not receive attention is equally as important and will affect all Americans. The Court ruled that manufacturers of generic drugs are immune from liability suits if accused of fraud, mislabeling, side effects or accidental death. The original lawsuit began in 2004 when Karen Bartlett sued Mutual Pharma in New Hampshire state court after she experienced "toxic epidermal necrolysis," a severe skin condition that causes peeling akin to a third degree burn. Ms. Bartlett suffered permanent disfiguring injuries from the generic anti-inflammatory drug Sulindac manufactured by Mutual. The drug information did not contain a warning that this skin condition may occur and the lower court ruled in favor of Ms. Bartlett awarding her $21 million. The FDA then forced both Mutual, the generic manufacturer of the drug, and Merck & Co., the original drug manufacturer, to include the dangerous side effect on the warning labels.
Now, the Supreme Court overruled the lower court's ruling in favor of Ms. Bartlett, holding that all generic drugs and their manufacturers are immune from liability for any negative reaction a patient may suffer from taking the medication. This holding protects 80% of all drugs prescribed in the United States. The ruling makes the FDA's conclusion about a drug's safety the ultimate authority. If a drug is approved for use by the FDA, a victim who takes a generic drug and suffers an adverse reaction has no recourse against the manufacturer, even when the side effect was not stated in the warning label. In 2011, the Supreme Court made a similar ruling stating that the original inventors and manufacturers of brand-name drugs are the only entity that can be sued for mislabeling, fraud, or adverse reactions. So if a victim is unfortunate enough to take the generic version and suffer the same adverse reaction as someone who took the brand name, he will have no recourse and no way to obtain damages to make up for the injuries suffered. The ruling gives generic drug manufacturers freedom to bypass safety regulations since they will suffer no penalties by doing so and they need not fear any multi-million dollar judgments. Even before this far-reaching judicial decision was decided, drugs were responsible for the most preventable and accidental deaths in the United States.
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