A recent article in the Orlando Sentinel regarding the U.S. Supreme Court and the pharmaceutical industry reports that the high court’s decision is “shielding the makers of generic drugs from most lawsuits filed by injured patients.” Based on Thursday’s ruling by the Supreme Court, generic drug companies can no longer be sued for failing to provide adequate warnings about the potential side effects of their products.
It is well known that companies manufacturing brand-name drugs are required by federal law to label drugs with warnings, as well as to update those warnings when problems occur. Although, following a 5 to 4 ruling by the U.S. Supreme court, these same brand-name companies can be held liable for patient injuries caused by insufficient warnings, while the same legal duty does not apply to companies manufacturing generic versions of brand-name medications.
Approximately 75 percent of the prescriptions written in the U.S. are for low-cost, generic drugs. Federal law requires that these copy-cat drugs carry the same warning labels as their brand-name counterparts. However, under federal law, if the brand-name product displays inadequate warnings, then the generic cannot be held responsible if its label also fails to display insufficient warnings. Conversely, state law holds both the generic drug company and the brand-name drug company responsible. Ultimately, the high court ruled that federal law trumps state law.
Justice Clarence Thomas concluded that warning labels are the responsibility of both the makers of the brand-name drug therapy, as well as the U.S. Food and Drug Administration. Justice Thomas went on to explain that because generic drugs are simply the copy-cat version of brand-name product, they should not be held liable for patient injuries caused by insufficient warnings.
Generic drugs are essentially incomplete copies of patented drugs, and based on the ruling by the Supreme Court, these incomplete drugs are being offered better protection than the originals. Patients who are injured as a result of using generic drugs still deserve an avenue for recourse. The Supreme Court’s ruling effectively stripped many injured patients of their legal right to sue.
Source: Orlando Sentinel, “Drug industry tallies 2 high-court victories,” June 24, 2011.