In a ruling that should shock any person who is now taking a generic drug, or who has taken generics in the past, the U.S. Supreme Court held last month that generic drug companies cannot be sued under state law over the companies failing to provide adequate label warnings about potential side effects. By a 5-4 vote, the Justices gave a huge victory to Teva Pharmaceutical Industries Mylan Inc.’s UDL Laboratories and Actavis Inc. by overturning four U.S. appeals court rulings that allowed the lawsuits. The ruling also is seen as a stinging defeat, not only for persons damaged by generic drugs, but also for American taxpayers who now will have to pick up the massive remedial costs relating to the damages done by the manufacturers of these drugs.
Victims of wrongdoing by the generic manufacturers, many of whom have disabling injuries, may well have had the judicial system shut down for them. Hopefully, that won’t be the case. It’s most difficult to understand how the five Justices in the majority reached their decision. To say it defies logic is a gross understatement. I have to wonder if they really realize what great harm they have done to the American people.
The companies argued that federal law barred such lawsuits because the drug had been approved by the U.S. Food and Drug Administration. Under federal law, the Court said generic drugs were required to have the same labels as their brand name equivalents. Justice Clarence Thomas wrote the Court’s majority opinion, saying federal drug regulations applicable to generic drug manufacturers directly conflicted with and thus pre-empted state lawsuits. The Justices reversed several U.S. appeals court rulings that the lawsuits against the companies could go forward. Generic drugs account for more than 70% of all prescriptions filled in the United States.
Justices Sonia Sotomayor, Ruth Bader Ginsburg, Stephen Breyer and Elena Kagan dissented. The impact of this decision, which goes against the position taken by the federal government, including the FDA, will be discussed in more detail in the August issue. If this decision doesn’t wake up the public, I am afraid nothing will.
Source: Insurance Journal
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