LAW & REGULATION
IllustrationImages.com/Corbis/Greg Hargreaves
FDA SAFETY NET The US Supreme Court has just removed one of the pharmaceutical industry’s main defences to product liability claims, write Angus Rodger, Gavin Coull and Gary Farmer.
which Ms Levine was given the drug (IV-pushadministration) increased the risk.
Drug warning labels in the US are regulated by
the Food and Drug Administration (FDA). Its job is to ensure that drugs are safe for
Wyeth argued that Ms Levine’s state law claims
public distribution by approving the warning labels
were pre-empted by federal law. According to Wyeth,
before any drug is put on the market, and by
it could not be sued under state law because the
overseeing any proposed changes to the labels over
FDA had approved Phenergan’s warning label, and
Wyeth could not unilaterally change the label.
In recent years, pharmaceutical companies have
Changing its warning labels to satisfy state law
been trying to use the FDA’s role as a shield to
would, in Wyeth’s view, have frustrated Congress’s
product liability lawsuits brought against them in state
purpose in establishing the FDA as the authority
courts. Their argument was: “Drug safety questions are on drug regulation across the US. a matter for the federal government (in the form of
The court disagreed, holding that it was not
the FDA) to decide – it is nothing to do with state
Congress’ intent to pre-empt state law tort claims
courts and state tort laws.” The companies have used
when it established the FDA. The court noted that,
this defence, known as “federal pre-emption”, with
on the contrary, “the FDA traditionally regarded
some success. In the past, several cases were thrown
state law as a complementary form of drug regula-
out of state courts long before trial, so saving
tion.” The court concluded that Wyeth could have
considerable defence costs. But some state courts
strengthened its label while complying with both
rejected the defence and allowed claims against the
state and federal law, and that Ms Levine’s claims did
not obstruct Congress’s intent for the FDA. Wyeth
The validity of the defence was brought before
could not simply hide behind the FDA’s regulatory
the US Supreme Court recently in Wyeth v Levine
approval of its existing labels to absolve it from
129 S.Ct. 1187 (2009). In a blow to the industry,
state-level products liability claims for failure to warn.
the court roundly rejected the pharmaceutical
The Wyeth case is important for all insurers and
reinsurers who provide product liability coverage forpharmaceutical companies. Federal pre-emption has,
WYETH DECISION
in recent years, been one of the main ways in which
The Wyeth case began when the claimant, Diana
pharmaceutical companies have been able to knock
Levine, went to her local clinic for treatment for a
out claims without trials: it has helped to keep
migraine. She was given an injection of the anti-
defence costs down and has probably acted as a
nausea drug Phenergan, manufactured by Wyeth.
strong deterrent to other claimants. The removal
The drug caused gangrene and she had to have her
of this defence will increase the prospect of cases
forearm amputated, resulting in the loss of her career
reaching trial. As a result, it is sure to increase
substantially insurers’ exposure to defence costs,
Ms Levine sued Wyeth in state court in common
law negligence and strict liability, claiming thatWyeth’s warnings for Phenergan were inadequate.
Angus Rodger and Gavin Coull are partners in the
The warning label stated that the drug could cause
London office and Gary Farmer is an associate in the
gangrene, but it did not warn that the method by
Washington DC office of Steptoe & Johnson
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Effective January 1, 2013 2013 EMPIRE PLAN FLEXIBLE FORMULARY Administered by UnitedHealthcare The following is a list of the most commonly prescribed generic and brand-name drugs included on the 2013 Empire Plan Flexible Formulary. This is not a complete list of all prescription drugs on the flexible formulary or covered under The Empire Plan. This list and excluded medication