In re Propulsid Products Liability Litigation Lawsuit

In re Propulsid Products Liability Litigation

• Product: Propulsid (cisapride), a prokinetic gastrointestinal drug

• Manufacturer: Janssen Pharmaceuticals (Johnson & Johnson)

• Court: United States District Court for the Eastern District of Louisiana

• Judge: Eldon E. Fallon

• Docket: MDL No. 1355

• Outcome: settlement (2004)

• MDL status: terminated

The product

Cisapride, sold in the United States as Propulsid (and as Prepulsid in many other markets), was a prescription gastroprokinetic. Discovered by Janssen Pharmaceuticals — the pharmaceutical division of Johnson & Johnson — in 1980, the drug increased motility in the upper gastrointestinal tract. It acted as a selective agonist at serotonin 5-HT4 receptors, which in turn stimulated the release of acetylcholine in the enteric nervous system, speeding gastric emptying and intestinal transit. It was prescribed for gastroesophageal reflux disease and, in certain patients, for delayed gastric emptying associated with diabetes.

The alleged harm

The drug carried a cardiac risk. Cisapride can prolong the QT interval — a measure of electrical recovery in the heart — through its effect on the hERG potassium channel, and a prolonged QT interval can trigger serious ventricular arrhythmias, some of which are fatal. Because the drug is cleared mainly by the hepatic enzyme CYP3A4, co-administration with other medicines that slow its metabolism could raise exposure and, with it, the cardiac risk. Reported deaths included infants and children. After the FDA issued a warning letter to physicians, Johnson & Johnson voluntarily removed Propulsid from the U.S. market on July 14, 2000; other countries followed with withdrawals or restrictions on its approved uses. Cisapride remains available in some jurisdictions for veterinary use.

The litigation

More than 300 deaths and about sixteen thousand injuries were alleged in connection with the drug. Claims by patients, surviving family members, and others were brought in federal and state courts, and the federal cases were centralized in the United States District Court for the Eastern District of Louisiana as In re Propulsid Products Liability Litigation, MDL No. 1355, before Judge Eldon E. Fallon.

The disputes in the MDL turned on the relationship between cisapride and the cardiac events alleged by the plaintiffs, on the adequacy of the warnings on the label, and on the role of drug interactions in the reported cases.

Resolution

In February 2004, Johnson & Johnson agreed to settle the U.S. Propulsid litigation, and a structured resolution program then ran for years, during which individual claims were processed and resolved. The program ended only much later than the agreement itself: on January 3, 2013, the court docket recorded that "This matter has now been concluded." The MDL is recorded as terminated.

The Propulsid case is frequently cited for the unusually long tail of its settlement program — the docket marked the matter concluded nearly a decade after the settlement agreement was reached in 2004 — and as an early example of a mass-tort resolution designed to handle a very large population of alleged injuries without trial-by-trial litigation.