In the past few years, more and more litigation has ensued concerning pharmaceutical drugs and the potential hazards associated with those medications. In a typical situation, a consumer has been prescribed a certain medication and after taking the recommended dosage (by the prescribing physician), the consumer develops some side effect that was omitted from the warning. As a result, the consumer brings suit against the drug’s manufacturer alleging a cause of action predicated on negligence. The consumer must show that the potential Defendant had a drug that it put into the stream of commerce, that there was a negligent design due to the manufacturer’s omission of a meaningful warning, that had the consumer been made aware of the warning he or she would have avoided the product, and that the consumer has been harmed as a result.
With the growing cost of prescriptions, generic drug manufacturers have stepped up to offer alternatives to the high price of name brand drugs. Name brand drugs carry a cachet associated with their usage due to the rigorous testing and studies their drugs go through in order to get approval from the Food and Drug Administration (FDA). After this testing is complete, and the beneficial effects of the drugs are substantiated, the drugs are allowed to be placed on the market for direct buy or prescription. Generic drug manufacturers can circumvent the costly testing process by showing the FDA that they have drugs that are the bio-equivalent of the already approved name brand drug. In addition to showing bio-equivalence (meaning that the substance of the pills are identical), the generic drug manufacturer must agree to have the same label information- including the same warnings.
Consumers, when presented with the option of choosing the costly name brand drug and the generic, cheap, bio-equivalent drug, often choose the latter. This is where litigation has ensued. In the 2011 decision of Pliva v. Mensing, the Supreme Court heard arguments concerning a diabetes medication intended to speed up the process of moving food through the digestive system. Two individuals, who had taken the generic drug, brought suit claiming that they developed dyskinesia (a neurological disorder). After suing the drug manufacturer, the Court held that suits against manufacturers of generic drugs are preempted by federal law. Put another way- because the generic drug manufacturers complied with the FDA in putting the same labels and warnings as their name brand counterparts, they cannot be sued for failing to put additional information on a label as “sameness” needs to remain. Essentially, individuals who take name brand drugs may sue, but if that individual takes the generic version of the drug- his or her suit may be impossible to pursue.
In a recent development out of the Northern District of Illinois, a federal judge has denied a name brand drug manufacturer’s motion to dismiss a suit brought against them due to the injuries sustained by a patient who took the generic version of their drug. The manufacture has asked for the 7th Circuit Court of Appeals to immediately weigh in on this case of first impression. The effect of the decision could brace drug companies for a battle in the Supreme Court in the next few years.
Defective medication cases can be quite difficult to understand. If you believe you have a medical malpractice case or a products liability case, our office can help you. To schedule a free consultation with lawyer Daniel Cappetta, call our office today at (508) 969-9505 or fill out or contact form available on the right side of this page.