According to an opinion piece that was recently published in the New England Journal of Medicine, doctors are calling for a close to a legal loophole that lets generic drug makers off the hook for drug injuries that patients suffer. This loophole was created when the Supreme Court ruled that generic drug makers don’t have to change their warning labels to include information that their brand name counterparts don’t include.
The doctors that wrote this piece (Drs. Aaron S. Kesselheim, Jerry Avorn and Jeremy A. Greene) were specifically worried about how this loophole can hurt patients taking generic drugs. While the FDA seems to believe that the Supreme Court’s upheld rules regarding drug labelling were not meant to stop the drug makers from making new warnings on the labels, that issue is clearly allowing the drug companies to downplay side effects with immunity from prosecution. Judge Clarence Thomas stated that it was congress’ job to do something about that. What this generally means is that when it comes to liability issues for the harmful drugs, drug makers blame the Supreme Court for its immunity while judges that rule to dismiss the generic drug lawsuits blame congress. In the end, it is clearly the patient that suffers.
Two of the most common drug manufacturers to be let off on this legal loophole are Teva and Pliva, both of which manufacture the generic version of Reglan. Reglan is an acid reflux drug that causes patients to develop tardive dyskinesia and other neurological conditions. The Supreme Court’s ruling has allowed judges to dismiss lawsuits alleging liability of generic manufacturers of Reglan. Some attorneys have changed their lawsuit to focus on the brand name manufacturers of the drug, Wyeth based on Wyeth providing the warnings for Reglan. Two courts have allowed these lawsuits to proceed while to date at least 5 courts have rejected this theory of liability. It will be quite a while before the courts definitively rule on this new theory of liability and it may take another opinion of the U.S. Supreme Court to resolove this issue.