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Legislative & Administrative Response to Supreme Court Generic Drug Decision

Late last month the U.S. Supreme Court returned a decision in a hotly followed case known as Mutual Pharmaceutical v. Bartlett. The case was important for all medical patients, as it related to the potential liability of generic drug manufacturers following defect claims. In short, it interpreted federal statute to decide if those manufacturers could be sued when defects caused harm to patients who took the drug.

The main issue was whether state law regarding potential liability were “preempted’ by federal statutes which seemed to give immunity to the manufacturers. In a ruling that we discussed a few weeks ago, the court sided with the drug maker and against the medical patient.

The Court was closely divided, but a 5-4 majority stated that the generic drug company could not comply with both the state and federal law at the same time, and so the federal law must trump. A dissent argued otherwise, noting that the drug company did not have to sell its products in the state where liability was allowed. Therefore, they actually were able to abide by both laws, but simply had to decide on their own which states to sell their products and which ones not to sell them.

In any event, the majority’s ruling stands, which seems to act as a significant roadblock to all those harmed by potential design or labeling defects built into generic drugs. It is a dangerous situation, because it means that patients may be severely hurt, or killed, without any legal recourse options at all. It also acts as a barrier preventing any incentive for the generic drug company from doing anything to improve labeling or other safety features.

Fixing the Problem
Recently, the American Association for Justice (AAJ) sent out a mailer discussing possible next steps that patient safety advocates can pursue in response to the court decision. Essentially, those of us who care about dangerous generic drugs and medical errors must work through the legislative and administrative channels to change rules and/or the federal law to better protect patients.

We are already seeing some progress. The AAJ letter notes that the U.S. Food and Drug Administration (FDA) is set to issue new rules that will allow generic drug makers to edit safety labels from those used on the original product. This change comes following the urging of various members of Congress–and the lobbying efforts of the AAJ.

Those members wrote to the FDA and explained that “changes are critically important to ensure that the public is adequately informed of the risks and benefits of prescription drugs, and that consumers who are injured by generic drugs have the same legal rights as those who are injured by the brand-name versions of the same drugs.”

Dangerous Drugs
Most patients are understandably confused about when they can or cannot seek legal accountability after being hurt by a dangerous drug. As a result of various court rulings, laws, and administrative rules, there is no easy answer. At the end of the day, it is prudent always to speak with an experienced injury attorney, share your experience, and receive tailored feedback to determine what the best step is in your particular case.

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