Reference no: EM131613206

Janie Dorsett, a resident of Maryland, and Betsy Crandall a resident of Missouri, suffered from a gastrointestinal disorder, and gastroesophageal reflux disorder (reflux), respectively.

Each of them was prescribed Somavrol, a drug manufactured by Acme Pharmaceutical Corp. (ACME) which was approved in 1997 by the U.S. Food and Drug Administration (FDA) as a short-term treatment (two to eight weeks) to relieve symptoms of acute and recurrent gastrointestinal distress-related ailments. Shortly thereafter, ACME received a patent on the drug.

The active ingredient in Somavrol is celiomide, which is available in both branded and generic forms. According to Maryland's drug substitution law, beginning around 2009, Ms. Dorsett's pharmacist filled her prescriptions with generic celiomide which was manufactured by Defendants Idgi, Inc. (IDGI), Avi Pharmaceuticals USA, Inc. (AVI), and XYZ Laboratories (XYZ). Ms. Dorsett took celiomide, as prescribed, for four years.

Ms. Dorsett's long-term use of celiomide caused her to develop turboencabulesia, a severe and irreversible neurological disorder, characterized by awkward involuntary facial, hand and foot movements, as well as a general sense of anxiety.

Around the same time as Ms. Dorsett, Ms. Crandall's pharmacist filled her prescriptions with generic celiomide in accordance with Missouri's drug substitution statute. The generic celiomide Ms. Crandall ingested was manufactured by Defendant XYZ. Like Ms. Dorsett, Ms. Crandall took celiomide, as prescribed, for approximately four years. She too developed turboencabulesia as a result of her long-term use of celiomide.

Although Somavrol/celiomide was approved only for short-term use, many doctors have prescribed the drug for longer periods because gastrointestinal disorders such as those suffered by the Plaintiffs are most often chronic conditions. IDGI's, AVI's and XYZ's own data show that over 80% of patients have been using Somavrol long-term-with one study even indicating that as many as 34% of patients taking celiomide for longer than one year.

Consequently, both Plaintiffs have sued the manufacturers of the celiomide they had ingested. They claim that the defendants provided inadequate warnings regarding the risk of turboencabulesia from long-term celiomide use and that the absence of adequate warnings of that risk caused their injuries.

The generic drug manufacturers have countered that federal law specifically prohibits a generic drug manufacturer from "unilaterally changing its approved labeling" and that, therefore, federal law preempts the state law failure-to-warn claims being made by Plaintiffs.

Both Plaintiffs lost in federal court at the trial level and on appeal to their respective circuit courts, and have now appealed in a consolidated case before the U.S. Supreme Court. You are a U.S. Supreme Court Justice and must decide this case. Draft your decision declaring which side wins and why. You must cover at least THREE of the following areas of law in your decision:

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