Drug Manufacturer Johnson & Johnson Held Liable

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Written by George

Wednesday, 27 May 2009 17:00

From 1993 to 1998, pharmaceutical manufacturer Johnson & Johnson made over $1 billion in sales from Propulsid, a prescription heartburn medication, even as the company knew hundreds of patients were dying from lethal side effects.

By early 1995, the Food and Drug Administration (FDA) had received reports of 18 patients who had developed serious heart problems after taking the medication. Within 18 months, the number had risen to 57. Children were at particular risk, and federal regulators told the company it would not approve the drug for pediatric sales.

It is despicable for a drug company to market pills they knew caused harm Documents from lawsuits on behalf of injured patients against Johnson & Johnson showed that the company did not conduct studies recommended by federal regulators and never published other studies that might have warned physicians of possible risks associated with the drug. Moreover, while Johnson & Johnson agreed not to market Propulsid directly for children because of their increased risk of side effects, the company did push so-called educational efforts advocating the drug’s use in pediatric patients. The educational efforts had the effect of sidestepping the agreement not to market for children. Documents would show that Johnson & Johnson knew that 90 percent of the company’s cherry-flavored liquid Propulsid went to children, even though the company claimed it was aimed at geriatric patients.

By 1998, reports of side effects in children were so numerous that Johnson & Johnson executives debated limiting Propulsid’s pediatric use. The company banned sales for premature infants in some European countries, but senior executives overruled a ban in the United States. Later that year, the FDA proposed major changes to Propulsid’s warning label. The agency, however, did not have the power to order Johnson & Johnson to change the label, and so relied on them to voluntarily agree. The company’s internal analysis estimated the changes would cost over $250 million a year in lost sales, and so rejected almost all of them. Over the next three years, over 100 infants were injured and at least 24 died.

In all, at least 300 people died and as many as 16,000 were injured by Propulsid. The civil justice system played a major role in bringing the facts of Johnson & Johnson’s deceptive practices to light. In 2004, Johnson & Johnson agreed to pay $90 million in restitution to injured patients and the families of those who were killed. Propulsid has now been discontinued in the United States.

^{Sources: Gardiner Harris and Eric Koli, “Lucrative Drug, Danger Signals and the F.D.A.,” New York Times, June 10, 2005; MDL-1355 Propulsid Product Liability Litigation – website created by presiding judge as repository for documents related to the Propulsid case - http://propulsid.laed.uscourts.gov/Default.htm; Moore TJ, Weiss SR, Kaplan S, Blaisdell CJ, Reported Adverse Drug Events in Infants and Children under 2 Years of Age, PEDIATRICS 2002 Nov; 110(5):e53), available at http://pediatrics.aappublications.org/cgi/reprint/.}

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