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In a 5-4 vote, the US Supreme Court struck down a lower court’s ruling and award for the victim of a pharmaceutical drug’s adverse reaction. According to the victim and the state courts, the drug caused a flesh-eating side effect that left the patient permanently disfigured over most of her body. The adverse reaction was hidden by the drug maker and later forced to be included on all warning labels. But the highest court in the land ruled that the victim had no legal grounds to sue the corporation because its drugs are exempt from lawsuits.
The U.S. Supreme Court, in a busy day of opinion releases, protected generic drug manufacturers from lawsuits while rejecting a Vermont law that was designed to make generics more widely prescribed.
Now, nine years after the tragedy began, the US Supreme Court overturned the state court’s verdict and award. Justices cited the fact that all generic drugs and their manufacturers, some 80% of all drugs consumed in the United States, are exempt from liability for side effects, mislabeling or virtually any other negative reactions caused by their drugs. In short, the Court ruled that the FDA has ultimate authority over pharmaceuticals in the US. And if the FDA says a drug is safe, that takes precedent over actual facts, real victims and any and all adverse reactions.
The Court’s ruling a week ago on behalf of generic drug makers is actually a continuation of a ruling made by the same Court in 2011. At that time, the Justices ruled that the original inventors and manufacturers of pharmaceutical drugs, also known as ‘name brand’ drugs, are the only ones that can be sued for mislabeling, fraud or adverse drug reactions and side effects. If the generic versions of the drugs are made from the exact same formula and labeled with the exact same warnings as their brand name counterparts, the generics and their manufacturers were not liable.
The Court ruled, “Because it is impossible for Mutual and other similarly situated manufacturers to comply with both state and federal law, New Hampshire's warning-based design-defect cause of action is pre-empted with respect to FDA-approved drugs sold in interstate commerce."
One industry critic was quoted by Reuters after the verdict. "Today's court decision provides a disincentive for generic makers of drugs to monitor safety of their products and to make sure that they have a surveillance system in place to detect adverse events that pose a threat to patients," Michael Carome, director of Public Citizen's Health Research Group told the news outlet
In other words, if the FDA says something is safe, it doesn’t matter if that decision is wrong or the result of lies, fraud or deception on the part of the world’s pharmaceutical companies. And there’s no way to sue the FDA for being wrong and costing millions of unsuspecting Americans their lives. That result leaves 240 million Americans unprotected from an industry responsible for more preventable deaths in the US than any other cause.
The court ruled Monday that generic drug makers could not be sued by patients over defective drug design because they're required by federal law to copy their brand-name counterparts.
Originally posted by halfmask
reply to post by ColCurious
Who is Murica?
At that time, the Justices ruled that the original inventors and manufacturers of pharmaceutical drugs, also known as ‘name brand’ drugs, are the only ones that can be sued for mislabeling, fraud or adverse drug reactions and side effects