Drug manufacturer GlaxoSmithKline won a significant ruling this week in the Third Circuit of the United States Court of Appeals in Colaccio vs. Apotex.SmithKline, the manufacturer of the anti-depressants Paxil and Zoloft, defended two separate state tort claims that the manufacturer failed to warn of the risk of suicide from taking the drug.Plaintiffs product liability suits failed.
In a split decision, the Third Circuit ruled that federal regulatory law pre-empted state tort law claims in cases against manufacturers of anti-depressants for failure to warn of the risk of suicide.
Anti-depressants are drugs known as selective serotonin re-upate inhibitors (SSRIs).The drugs block the re-absorption of serotonin into the brain.Serotonin is a natural body chemical that regulates mood, sleep and appetite.By blocking the re-absorption the brain cells get an extra dose of a feel-good chemical.Some experts believe that the increase in serotonin causes a drop in the natural chemical dopamine. Dopamine regulates cognition and behavior.
In 1991 the Food and Drug Administration (FDA) Advisory Panel showed that there was no causal link between anti-depressants and suicide or violent behavior.However, in 2003 a subsequent FDA panel issued a Public Health Advisory for Paxil, Zoloft and other SSRIs urging health care providers to be on the lookout for worsening of depression and the onset of suicidal behavior in the beginning stages of drug therapy or if dosage amounts change.Although none of the drug trials showed an increase in suicide, the FDA has asked drug manufacturers to issue stronger labels. However, given the lack of scientific data, strong warnings are not required.
From documents obtained through discovery in the civil jury trials, SmithKline was aware that a small number of people could become agitated or violent while on the drugs.Despite this knowledge, no warning was placed on the label.Experts believe that the drug may cause a side effect known as akathisia.Akathisia causes overwhelming mental and physical restlessness.Some medical experts believe this causes patients to be sufficiently energized to harm themselves or others.
In the recent two cases on appeal before the Third Circuit, one district court held that the plaintiff’s product liability claims were pre-empted by federal regulatory FDA rulings.Another district court ruled the opposite, federal law did not pre-empt a state tort suit.In the majority opinion, the Third Circuit held that the FDA was a regulatory agency specifically mandated to scientifically assess the nature of drugs and the warning required.The court held that state tort law could not pre-empt federal law, and therefore the state suits on the failure to warn could not go forward.
The dissenting opinion argued that in many ways the FDA is an imperfect agency as it receives much of its data from the drug manufacturers.Discovery in state tort lawsuits provides a different way for third parties to raise questions about new and existing drugs.The dissent argued that policing drug companies is helped through tort suits, which act as a companion investigative tool for the FDA.
However compelling the dissent argument, as it stands, where drug manufacturers are not required to place a warning label on drugs, plaintiffs have no ground for suit on the issue of failure to warn.
Antidepressants account for $14 billion a year of wholesale drug revenues in the United States.When the best-selling and most profitable drug poses a risk of suicide, drug manufacturers have a strong incentive to quash warning claims.Often there exists a clash between the manufacturers marketing tactics and the well-being of the consumer.Regulatory agencies must be above the tactics of drug companies.The pharmaceutical industry is regulated because drugs can cause serious harm and drug companies, with their financial conflict of interest, cannot be relied upon to serve the public interest.
At this point in the legal field, however, for consumers of anti-depressants drugs it is “buyer beware.”
If you have a product liability claim against a drug manufacturer, contact Robert N. Katz for a free private consultation.