It’s not often the US Supreme Court gets to issue a ruling on labels, but the case of Wyeth-v-Levine (06-1249) provided just that opportunity.  The case revolved around whether Federal approval of a drug label gave protection to pharmaceutical manufacturers and retailers for adverse health effects and whether victims could sue under local State laws.  The ruling demonstrates that drug labels which warn of the effects of a drug do not protect the manufacturer or supplier from being sued for adverse side-effects.

In brief, drug warning labels telling you of potential side effects can still be bad for your health, and for pharma companies, bad for their wealth!

Drug label warnings, dosage and side-effect notifications are a very ripe area for litigation, and certainly a highly profitable one, though victims and pharmaceutical companies appear to be the also-rans in the financial stakes; as usual when matters come to a court, it is the lawyers who are set to clean up.  Tort lawyers are the most financially rewarded of the entire legal profession, and highly profitable pharmaceutical companies with deep pockets provide very tempting targets for hungry lawyers.

In the Wyeth-v-Levine case, there were three notable dissenters from the verdict – Justices Alito and Scalia being joined by Chief Justice Roberts who noted, quite accurately, that the case turned “a common law tort case into a frontal assault on the FDA’s regulatory regime for drug labeling”.

Before proponents for tort reform start citing this case as a reason why such lawsuits should be restrained, we should take a look at the underlying case which gave rise to the matter coming before the US Supreme Court.

Diana Levine was a musician who attended a health clinic in Montpelier, VT in 2000, complaining of severe migraine headaches with nausea.  She received an injection of Phenargen without success, and returned the next day where she received a further injection.  Unfortunately, the injection was made into an artery and caused gangrene, resulting in Ms Levine’s arm needing to be amputated.  The drug warning label, approved by the FDA, clearly indicated that injection of the drug into an artery could cause gangrene (but did not state that the particular type of injection she received, known as a “push injection” would result in this risk).

Ms Levine sued the health clinic and successfully won damages of $700,000 against the clinic augmented as a consequence of the loss of her career as a musician.

Madame Levine then sued Wyeth, the drug-manufacturer for failure to note the risk associated with the “push injection” and a jury awarded her $6,774,000.  Wyeth appealed the decision to the VT Supreme Court which ruled they had a duty to comply with a Vermont common law responsibility not to use a risky method of injection, i.e. push injection.  The FDA approved labeling did not protect Wyeth and this exposed the pharma company to tens of thousands of potential claims representing potentially billions of dollars in costs and reparations.

The US Supreme Court verdict upholds Ms Levine’s multi-million dollar damages, but of broader concern is that not only is the duty owed for clear labeling and avoidance of risk demanded by VT’s own laws shown to be permanent, but that of the 46 other States who listed their interest in the case.  Even when following federal labeling legislation and guidelines, even to the extent of gaining federal approval, manufacturers and suppliers are not protected from damaging actions or effects which result from the use of their products.

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