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Supreme Court to Clarify Generic Drug Maker's Duty to Warn of Danger

Imagine that as you go about your ordinary life, you begin to notice that parts of your body suddenly and involuntarily twitch. Your fear grows over time as you without warning grimace, blink repeatedly, smack your lips or stick out your tongue. Your limbs may repetitively and without purpose move; your hands play an invisible piano keyboard out of your control.

You have developed the neuromuscular disorder tardive dyskinesia, known as TD. TD almost always occurs after a patient has had a long-term exposure to a medication, usually a neuroleptic to treat psychosis or for a calming effect.

The Nightmare Begins

Turn to the true story of Minnesotan Gladys Mensing who has diabetic gastroparesis, an incurable condition. With gastroparesis, your stomach muscles do not contract to stimulate digestion, causing weight loss, nausea, vomiting and weight loss. In a severe case, food stuck in the stomach can grow dangerous bacteria or harden into a potentially fatal mass.

Mensing's doctor prescribed Reglan or its generic equivalent metoclopramide over a long period of time to ease Mensing's painful stomach symptoms. At all times she took generic brands of the medication. When she developed uncontrollable lip-smacking and tongue-thrusting movements, her physician discontinued the drug. Mensing was diagnosed with TD from the long-term use of metoclopramide.

The Lawsuit

Mensing sued Wyeth, the manufacturer of the brand-name drug Reglan, and several manufacturers of its generic equivalent, in the U.S. District Court in Minnesota for her development of TD from the drug. She alleged that the companies' warnings of the potential movement-disorder dangers of metoclopramide were inadequate or false, in particular in relation to the enhanced risk for diabetic patients, in violation of state law.

The District Court dismissed the state-law claims against generic manufacturers Actavis and Pliva based on the constitutional rule of federal pre-emption, meaning if a federal law conflicts with a corresponding state law, the federal law "trumps" the state law.

Complicated federal law regulates in detail generic medication warning labels, requiring that they be the same as the equivalent brand-name labels. In this case the generic manufacturers' warning labels had to match those of Wyeth, the name-brand manufacturer. Having met the pre-empting federal standard of matching the brand-name warning label, the court said that the generic manufacturers were not required to comply with state law that would require enhanced warning labeling.

The Appeal

Plaintiff appealed the dismissal from the lawsuit of the generic manufacturers to the U.S. Court of Appeals for the 8th Circuit, which reversed, holding that federal law did not pre-empt the state law claims alleging failure to adequately warn of the dangers of ingesting metoclopramide over a long period of time.

The Court of Appeals said that although the generic manufacturers were restricted under federal law from amending their warning labels on their own because they were required to match the brand-name labels, there were other ways in which they could have tried to warn of enhanced dangers. For example, they could have asked the federal Food and Drug Administration to send a letter to physicians. The generic manufacturers could even just have stopped selling the drug if they believed it was more dangerous than the approved label stated.

The Appeals Court also noted that if Congress had meant for federal law to pre-empt state law on drug safety, it could have expressly done so as it did for medical devices. In addition, the generic makers could simply have stopped selling the drug if they felt warnings were inadequate and that they could not amend the labeling.

Accordingly, the Court of Appeals reinstated the claims against the generic manufacturers.

The Highest Court Will Decide

The generic manufacturers brought their case to our highest court. Oral argument before the U.S. Supreme Court was held on March 30, 2011. The pharmaceutical manufacturers and the personal injury lawyers await the Supreme Court's decision. If the Court decides that because of pre-emption all a generic manufacturer needs to do is exactly match the brand-name label as required under federal law, generic manufacturers will save a lot of money and time they would have used fighting state lawsuits.

On the other hand, if the Supreme Court decides there is no federal pre-emption, the legal rights of those harmed by inadequate labeling generic drugs will be expanded to include related state-law claims.

If you or a loved one is injured by a prescribed medication, be sure to discuss the situation with an experienced personal injury attorney right away.