The lawsuit itself, Mutual Pharmaceutical Co., Inc. v. Bartlett, centered on the fact that the label for the anti-inflammatory did not carry a warning regarding the potential rare side effect of developing Stevens-Johnson syndrome (SJS), which is precisely what happened to the plaintiff in the case. It also accused the maker of producing a dangerous product. The plaintiff’s reaction was so severe, that she developed toxic epidermal necrolysis, spent 10 weeks in the hospital, suffered two incidents of septic shock, suffered burns to 60% of her body, endured a medically induced coma, and required 12 separate eye surgeries.
At the time the plaintiff took the medication, the label did not have a warning regarding the risk of SJS, although the package insert did. Following the ordeal, the FDA recommended that all drugs within this class (non-steroidal anti-inflammatory or NSAID) carry a warning regarding toxic epidermal necrolysis.
The plaintiff in the case sued the drug manufacter, claiming that the drug was defectively designed. A lower court awared her $21 million in damages, including amounts for pain and suffering, loss of enjoyment of life, and past and future medical expenses. The drugmaker appealed, alleging that federal law preempts lawsuits for the defective design of drugs against generic drugmakers; the argument being that the original manufacturer designed and sought approval from the FDA for the chemical makeup of the drug. There were also allegations regarding the label, which the drugmaker challenged on the same grounds.
In a 5-4 decision, the Court ruled in favor of the drug company, finding:
“Once a drug is approved, a manufacturer is prohibited from making any major changes to the qualitative or quantitative formulation of the drug product, including active ingredients, or in the specifications provided in the approved application. Generic manufacturers are also prohibited from making any unilateral changes to a drug’s label.”
Needless to say, this is an incredibly upsetting blow to plaintiffs’ rights in products liability cases. It effectively states that manufacturers of dangerous products cannot be held liable for any of the damages that their drugs cause, even if the risk of those adverse affects are well known. The plaintiff likely cannot sue the original manufacturer of the drug, because she did not buy their product, and she cannot sue the FDA for approving the drug because of sovereign immunity. It remains unclear what the take home lesson from this is for plaintiffs: only buy brand name drugs, just in case something happens? Federal law can potentially be amended to allow for these types of suits, but that remedy seems unlikely.
If you or a loved one has suffered injury or death as a result of a defective consumer product, you should contact an experienced products liability attorney as soon as possible in order to discuss your claim. You may be entitled to damages for your medical bills, pain & suffering, lost wages, or other relief. The dedicated personal injury attorneys at Lebowitz & Mzhen have many years of experience representing the rights of people in the Washington, DC area who have suffered injuries due to defective or dangerous products. Call us today in order to schedule a free and confidential consultation. You can contact us by calling (800) 654-1949 or through our website.
More Blog Posts:
The Reality of Cruise Line Lawsuits, Washington DC Injury Lawyer Blog, published June 28, 2013
Jeeps Recalled for Potential Fuel Tank Rupture Risks, Washington DC Injury Lawyer Blog, published June 21, 2013