A leading drug company may be poised to win a landmark legal victory next fall. If the drug manufacturer, Wyeth, prevails in a case soon to be argued before the U.S. Supreme Court (Wyeth v. Levine),1 drug companies could effectively be immunized against state-level tort litigation if their products that have been approved by the Food and Drug Administration (FDA) are later found to be defective.
A medical-device company won such a victory in April. In Riegel v. Medtronic,2 the Supreme Court determined that a product-liability lawsuit against Medtronic in a state court was preempted because the device had received FDA approval. Preemption is a legal doctrine based on the supremacy clause of the U.S. Constitution, which states that when federal and state laws are at odds, federal law takes precedence. Its application to state tort litigation is a radical extension of its original meaning.
Medtronic won its case because the 1976 law that grants the FDA authority to regulate medical devices contains a clause asserting that state requirements with regard to medical devices are preempted by federal requirements. Although the preemption clause is silent on common-law tort actions, the Supreme Court (with Justice Antonin Scalia writing for the Court) interpreted the preemption clause broadly to include such actions.
Unlike the law governing medical devices, the Food, Drug, and Cosmetic Act, which provides the statutory framework for the regulation of drugs by the FDA, contains no such preemption clause. Thus, in Wyeth v. Levine — which concerns a patient who lost her arm after an injection of Wyeth’s antiemetic drug Phenergan — the Court will decide whether preemption of state tort litigation is implied by the law, even though it is not explicitly stated.
Previous administrations and the FDA considered tort litigation to be an important part of an overall regulatory framework for drugs and devices; product-liability litigation by consumers was believed to complement the FDA’s regulatory actions and enhance patient safety. Margaret Jane Porter, former chief counsel of the FDA, wrote, “FDA product approval and state tort liability usually operate independently, each providing a significant, yet distinct, layer of consumer protection.”3 Persons who are harmed have the right to seek legal redress. Preemption would erase that right.
Real conservatives note that the courts are an avenue for personal redress for injury. what is it called when a company has immunity provided by a government agency-something ism, I believe.
Current Republicans also complain of tort law and insurance, but have not made any case at all using court statistics to prove the point of awards versus malpractice insurance rates.
Usually just insurance rates are quoted, which is real. But I have yet to see reasonably open books by insurance companies to make the case, and a list of judgements on which they based their predictions of higher payouts/rate ratios.
Wouldn’t it be simpler if insurance companies supply the data, since I assume they have had to access such data?
If they did not demand policy and regulation changes, perhaps they might have an easier time of it. If you demand regulatory action and favors, is it reasonable to open the books some for a check on the claims?