The Supreme Court has given a major injury to the American consumer with its decision in Mutual Pharmaceutical Co., Inc. v. Bartlett. Deciding that federal law preempts defect design claims for generic drug manufacturers, the Justices have again displayed their allegiance to American and Big Pharma corporations.
For those unaware of the circumstances surrounding the Bartlett decision, a legal war has been waging over whether generic drug manufacturers can be held responsible for injuries caused by the use of their product. Until Bartlett, it had been held that generic drug manufacturers were granted indemnity against civil action resulting from the use of their drugs as the warning labels and the composition of their products are required to be the same as the brand-name version of the drug.
“The majority opinion in Bartlett turns one hundred years of American jurisprudence on its ear: a manufacturer brings a product to market and creates a risk for consumers; that risk must be shared by the consumers and the manufacturer which profits from the distribution of that risk. The Alito majority gave the generic drug manufacturers a permanent ‘get-out-of-jail-free’ card,” commented Tim O’Brien, an attorney with the Levin, Papantonio law firm, who practices in the areas of pharmaceutical and bad drug litigation.
In 2011, the Supreme Court decided the case of Pliva, Inc. v. Mensing. In Pliva, the Supreme Court determined that federal law protects generic drug manufacturers from facing lawsuits over injuries patients suffered as a result of being misinformed due to the label on the drug. At that time, the Court held that because the generic drug manufacturer is required to distribute the same warning label as the brand name manufacturer, it cannot be held responsible for failing to warn patients of the risks associated with its product.
Here, Karen Bartlett, the plaintiff in the original suit, and the respondent to Mutual’s petition, was issued a prescription of Clinoril, the name-brand version of sundilac – a nonsteroidal anti-inflammatory drug (NSAID). The pharmacist engaged in the common practice of exchanging the name-brand drug for the generic equivalent and provided Ms. Bartlett with sundilac. Ms. Bartlett suffered from toxic epidermal necrolysis; the condition disfigured Ms. Bartlett, leaving her disabled and nearly blind. When Ms. Bartlett took the drug, it did not carry a warning on its label for toxic epidermal necrolysis. Initially, the lower courts decided with Ms. Bartlett, that her pain, suffering and the wrong of of Mutual justified the jury’s award of $21 million. Unfortunately, the Supreme Court has now reversed those decisions.
“Generic pharmaceutical companies can legally steal other companies’ medicines, make billions selling them as their own, and patients who lose anything from their livers, their eyesight, and even their lives, as a result of unreasonably dangerous drugs, have no rights or remedies against these agents of their injuries,” Mr. O’Brien added.
By deciding that generic drug manufacturers are protected from litigation from defective drug designs, the Supreme Court is effectively erasing these companies of all liability. Ripple effects of the decision will be felt across many areas of law, though none will feel it more acutely than the injured.
Hundreds of drugs, Pradaxa, Byetta & Januvia, Granuflo, and Tylenol, etc., and products are currently being investigated across the nation for potential hazards they pose to the health of patients and consumers. With the Supreme Court’s decision today to side with corporations instead of consumers, the fate of thousands of injured individuals became much bleaker.
In the wake of the Supreme Court’s decision in Mutual Pharmaceutical Co., Inc. v. Bartlett, the FDA has proposed a new rule to allow generic drug companies to petition to change the label on their drugs ahead of name-brand manufacturers.
The proposed rule would allow the generic manufacturers to respond to new information found through subsequent, after-production studies. These studies often find that, after a drug has been released into the market, the associated risks and potential complications are more severe or widespread than initially anticipated. Studies finding the increased or more widespread risk do not immediately translate to protecting consumers and patients.
Generic drug manufacturers are required to distribute their version of a drug using the same label as the name brand manufacturer. This requirement can cause significant delays to updating labels, if they ever come at all, and the time between them is more time for patients and consumers to be injured.
The insult added to this injury is that the requirement that the generic manufacturer rely on the brand-name’s label, which can cause the delay discussed above, also insulates the generic manufacturer from liability for the injuries caused by their drugs. This was confirmed by the Supreme Court in the Mensing case.
If the proposed amendment is implemented, generic manufacturers would have greater control and autonomy in petitioning the FDA to let them update their labels in light of new information. Relieving the dependence generic manufacturers have on brand-name manufacturers in this way could help provide an avenue for relief for those injured in the future who, as the law stands now, have little hope for recovery.
Joshua is a writer and researcher with Ring of Fire.