In an important new decision favoring consumers, the Pennsylvania Supreme Court has ruled that pharmaceutical companies can be held responsible for negligently designing and selling a dangerous drug that is too harmful to be taken by anyone.
The case involved the prescription diet drug Redux, a poisonous medicine made by Wyeth containing dexfenfluramine that causes lung and heart disease. The lawsuit was brought on behalf of Ruth Lance, who took Redux and later died of pulmonary hypertension, Case. No 17 EAP 2011.
In September 1997, Wyeth and the FDA yanked Redux from the market in the United States. In the aftermath, consumers filed thousands of lawsuits asserting that the drugs caused injuries and deaths.
Before the landmark decision, drug makers were immune from responsibility if the Food and Drug Administration approved their drug. Pharmaceutical makers could be held liable only in rare cases if their drug had impurities or if there were deficient warnings.
The lawsuit charges that Wyeth knew, or should have known, that the drug was so unreasonably dangerous and defective in design that it should never have been on the market. The lower courts had dismissed the case because the claim didn’t involve impurities or deficient warnings, before the Pennsylvania high court revived the case.
“[T]he public interest requires the holding of companies which make and sell drugs and medicine for use in the human body to a high degree of responsibility for any failure to exercise vigilance commensurate with the harm which would be likely to result …” the state supreme court said.
“[P]rimary responsibility for drug safety rests with the manufacturer, which has superior access to information about [its] drugs,” the court added. “Under Pennsylvania law, pharmaceutical companies violate their duty of care if they introduce a drug into the marketplace … with actual or constructive knowledge that the drug is too harmful to be used by anyone.”
Pharma Company Excuses
Importantly, the Pennsylvania court said that FDA approval does not give drug companies immunity. The court drew an “inference is that Wyeth failed to share relevant information with the federal agency.” The court added that the FDA has limited resources to monitor the thousands of drugs in the marketplace.
The drug companies argue that they need legal immunity because of the enormous cost of bringing a new drug to the market. But the court had no sympathy, saying the drug makers benefit from the federal patent system, which gives them exclusive profits from a patented drug for up to 20 years.
Wyeth also asserted that it was not responsible because a doctor is the actual person prescribing the drug. But the court pointed out the Wyeth did not convey the real dangers to doctors, and circumvented doctors with direct-to-consumer advertising about its drugs.
Ruth Lance died in 2004 and her mother has been pursuing the lawsuit since 2006. Now, finally, the case will get its day in court.
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