Drug companies have argued they should be protected from state product-liability claims, as long as they meet federal safety standards, which are less strict than some state standards. Patient advocates and consumer rights groups applauded the Supreme Court two years ago when it ruled the FDA’s federal requirements for updating warning labels did not pre-empt state-level lawsuits against brand-name drug-makers.
Recent Supreme Court arguments follow lawsuits filed by two individuals who developed a neurological disorder after taking the generic-version of Reglan for four years to treat their heartburn and acid reflux. At issue now is whether generic drug-makers should be held to the same standard as brand-name drug-makers.
Justice Sonia Sotomayor argued no individual would take a generic drug if they were unable to sue the drug-maker for an unsafe product. On the other hand, Justice Samuel Alito said requiring generic drug-makers to update warning labels and face the same accountability as brand-name drug makers may drive up the costs in manufacturing generic drugs, which defeats the purpose behind low-cost drugs. Even after debates ceased, there was no clear indication of which way the Justices were leaning.
Read the news report about Supreme Court debates on generic drug safety.
Read other coverage about medication safety:
– Bar Code Medication Administration Can Yield Both Positive and Negative Results
– 8 Ways for Surgery Centers to Reduce Look-Alike/Sound-Alike Drug Errors
– E-Prescribing System Helps Johns Hopkins Reduce Medication Errors