Generic Drug Labeling and Personal Injury Claims

Newborns and young children often suffer catastrophic personal injury due to defective drugs. In many of these cases, drug companies were aware of dangerous and potentially lethal side effects, yet failed to clearly disclose such risks on their labels. When this happens, California law permits victims to recover damages for the manufacturer’s “failure to warn.”

Novartis Faces Lawsuit From Family of Autistic Twins

The California Supreme Court recently considered whether this “failure to warn” rule is limited to a manufacturer’s own brand-name drug, or whether it extends to chemically identical generic drugs containing the same labeling information.

The plaintiffs in this personal injury case are minor fraternal twins. Their father brought suit on their behalf in California state court. During childbirth, the mother’s doctor prescribed terbutaline sulfate. This is a drug intended to treat asthma, but it is also prescribed “off label” to help stop or slow preterm labor, a common occurrence with multiple births.

Terbutaline sulfate is the generic equivalent of a branded drug called Brethine, which was originally manufactured and distributed by Novartis. Novartis actually stopped selling Brethine in 2001, several years before the children in this case were born. However, by law the generic manufacturer had to ensure its label and warnings were identical to that of the original branded drug.

Apparently, the label did not warn doctors and patients that using the drug carried a substantial risk of neurological damage to unborn children. Because that is what allegedly happened in this case. The father said his children “were diagnosed with developmental delays at three years of age and autism by the time they turned five.” He sued Novartis, maintaining its failure to properly warn of potential side effects when labeling the original branded drug, led to his children’s injuries.

The California Supreme Court was asked to review whether or not the father had stated a viable personal injury claim against Novartis. In a December 21 opinion, a majority of the Court said he did. Although Novartis did not manufacture the generic drug prescribed to the children’s mother, it was nevertheless legally responsible for its warning label. The generic manufacturer is only responsible for making sure its label “is identical to that of the brand-name drug,” the Court noted. It was therefore foreseeable that any negligence by Novartis in preparing its label would carry over to the generic drug’s label.

Furthermore, the Supreme Court said “public policy” concerns supported holding brand-name drug manufacturers liable for negligent generic labels. The Court rejected Novartis’ self-serving claims that imposing such liability would “stifle innovation” or raise generic drug costs. Ultimately, the Court said the “brand-name drug manufacturer is in the best position to discover and cure deficiencies in its warning label,” and therefore it was reasonable to hold it negligent when it failed to do so.

Speak With a Pasadena Personal Injury Lawyer Today

The Supreme Court’s decision is welcome news for patients who have been seriously injured due to improperly labeled or mis-prescribed medications. If you have been injured due to any kind of third-party negligence, it is important to work with a qualified Pasadena personal injury lawyer who can review your case and help you hold the negligent parties responsible. Call the offices of Strassburg, Gilmore, & Wei, Attorneys at Law, today at (626) 683-9933 if you are need of assistance and would like to schedule a consultation.

Leave a Reply