This week marks the typical end of the yearly session for the United States Supreme Court. Per tradition, it is during this week that the Court officially releases their rulings in the most controversial cases that were heard over the last eight to ten months. Yesterday, the court did just that in a case related to liability for defects in generic drugs in Mutual Pharmaceutical Co. v. Bartlett. This is a case that we have discussed before as having important implications for many different Chicago residents and medical patients.
Unfortunately, though not wholly unexpected, the court’s opinion runs counter to the best interests of those harmed by dangerous drugs. The full online text version of the opinion can be found online here.
This legal matter affects the public regulation of the drug industry, in particular the tort liability of generic drug manufacturers following design defect claims.
Both state and federal governments are involved in regulating the drug industry, fighting to ensure that only safe products make it to the market. Under federal law, the U.S. Food and Drug Administration (FDA) has a process regard design and labeling standards that must be met to ensure consumers are aware of the risks posed by each product. Under federal law generic drug manufacturers are similarly required to have consistent labeling with the brand name products that they are mimicking. The law also requires that the generic drug itself be chemically the same as the brand name drugs they are copying.
The issue in this most recent case, are whether federal rules regarding avoidance of liability after meeting FDA standards “preempts’ state laws which allow liability for such defects by generic harm. In other words, the case decided whether a patient harmed by a generic drug with a design defect could sue and win damages under state law even though they did not have a cause of action under federal law.
In yesterday’s opinion the court sided with the pharmaceutical company and determined that the patient harmed by the dangerous drug could not sue under state law (she had been awarded $21 million in damages by the state court).
Justice Alito wrote the opinion for the divided court. The 5-4 majority agreed that because federal law required the generic drug manufacturer not to change the product and because injuries of this nature lead to “strict liability” then allowing the generic drug manufacturer to be held accountable made it impossible for it comply with both state and federal law. The Court rejected the notion put forward by lower courts that the manufacturer could either stop selling in the state or pay for damages as part of the cost of doing business there.
Four justices disagreed with the assessment and took issue with the fact that this ruling ignores the roles of the state to regulate itself. One of the dissents from Justice Sotomayor explained that the ruling “has left a seriously injured customer without any remedy despite Congress’ explicit efforts to preserve state common-law liability.”
Regardless of the changes in the legal landscape as a result of this case, please be sure to speak with an attorney for tailored guidance following any injury related to medical errors or dangerous drugs.
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