Pharmacy Error Injury Lawyer Blog
Maryland personal injury plaintiffs can bring failure-to-warn claims if a manufacturer fails to adequately warn consumers of a product’s risks. In one recent case against drug manufacturer GlaxoSmithKline, a patient alleged that the manufacturer failed to warn consumers of its association with suicide for certain patients.
The Facts of the Case
A doctor prescribed a patient Paxil, manufactured by GlaxoSmithKline (GSK) to treat the patient’s depression and anxiety. However, his prescription was filled with the generic version of Paxil, paroxetine. A few days later, the patient committed suicide and paroxetine was found in his system. The patient’s wife sued GSK, alleging that the manufacturer negligently failed to warn patients that paroxetine was associated with suicides in patients older than 24, and that her husband (who was 57) died as a result.
Generic drug manufacturers are required to use a label approved by the brand-name manufacturer and approved by the U.S. Food and Drug Administration (FDA), and only the brand-name manufacturer can obtain FDA approval to change the label. In this case, the brand-name manufacturer of Paxil, GSK, created the its label, and the generic drug manufacturers were required to use the same label. Labels for paroxetine warned that it was associated with suicide in patients under 24, but did not warn about an association with suicide in older patients.
The case went to trial and the jury awarded the wife $3 million. GSK appealed, arguing that it should not be held liable for the husband’s death. A federal court of appeals agreed, reversing the jury’s award. The appeals court found that the FDA prevented GSK from adding a warning about the relationship between paroxetine and suicides in adults. GSK asked the FDA for permission to add the warning four times since 2007, but each time the FDA said it could not. Because the FDA told GSK not to add a paroxetine-specific suicide risk warning, GSK could not be held liable, and the case was dismissed.
Alleging a Failure to Warn
A pharmaceutical company may be held liable for failing to warn consumers of the product’s risks. A company must warn consumers of the risks involved in using a product, unless the dangers are obvious or a matter of common knowledge. Courts will take into consideration the knowledge and expertise of the consumers are reasonably expected to use the product. Warnings and instructions on the product’s use must be clear, direct, and easy to understand.
Contact a Personal Injury Lawyer
If you or a loved one has been injured and you believe a drug manufacturer or another individual or entity is at fault, contact a personal injury lawyer as soon as possible. At Lebowitz & Mzhen, LLC, our attorneys have nearly two decades of experience representing victims of Maryland prescription errors, car accidents, and other negligent conduct throughout the Maryland and Washington, D.C. area. Our compassionate attorneys take pride in advocating for the rights of victims. Contact us at 1-800-654-1949 or 410-654-3600 or fill out our online form for a free consultation.
More Blog Posts:
Pharmacy Errors on the Rise, According to One Industry Source, Pharmacy Error Injury Lawyer Blog, August 27, 2018.
Medication Alert: Blood-Pressure Medication Recall, Pharmacy Error Injury Lawyer Blog, September 3, 2018.