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Just two months after the U.S. Supreme Court decided patients can sue drugmakers over injuries from medicines approved by the government, long-stalled lawsuits against GlaxoSmithKline Plc and Bristol-Myers Squibb Co. are again moving toward trials.
The March 4 decision in a case on Wyeth’s nausea treatment Phenergan broke a logjam of cases in state and federal courts. Federal regulatory approval of a medicine and information about side effects does not shield drugmakers from claims that patients and doctors were not adequately warned, the high court ruled. The decision already affected more than 250 lawsuits involving at least 10 companies that were in limbo before the ruling.
Glaxo this month settled two cases on claims its antidepressant Paxil can make patients suicidal, after judges set trials citing the Wyeth decision. A Barr Pharmaceuticals hyperactivity-drug case is to be tried in August in federal court in Tallahassee, Florida. And a group of Bristol-Myers lawsuits over the blood-thinner Plavix may now proceed to trial in federal court in Trenton, New Jersey.
The court, on a 6-3 vote, said U.S. Food and Drug Administration approval of a drug does not necessarily preempt lawsuits under state law.
“Had the Supreme Court decided in favor of preemption, it would have sent a strong signal that pharmaceutical failure-to- warn cases were not a profitable place to be” for plaintiffs’ lawyers, said Professor Howard Erichson of Fordham Law School in New York.
The court upheld a $6.8 million Vermont jury award to Diana Levine. Levine got two Phenergan injections in 2002 to treat nausea associated with a migraine headache.
The second injection used a method in which the needle puts the medicine into a vein. The drug entered an artery, leading to gangrene and amputation of much of Levine’s right arm.
She sued Wyeth, claiming the company should have warned doctors not to use the direct-injection method.
“The drug is corrosive and causes irreversible gangrene if it enters a patient’s artery,” according to the Supreme Court.
Wyeth, based in Madison, New Jersey, lost its argument that the Vermont suit was preempted because the FDA had approved its warnings.
“It has remained a central premise of federal drug regulation that the manufacturer bears responsibility for the content of its label at all times,” Justice John Paul Stevens wrote for the majority.
“Congress did not intend FDA oversight to be the exclusive means of ensuring drug safety and effectiveness,” Stevens wrote. The FDA has “limited resources” and lawsuits “uncover unknown drug hazards and provide incentives for drug manufacturers to disclose safety risks promptly.”
“Every failure-to-warn case against a drug company has been affected by Wyeth,” Michael Miller, a plaintiffs’ attorney in Alexandria, Virginia, said of the high-court ruling.
Plavix, a blood-thinner designed to prevent clots, was marketed as safer than aspirin, according to patients who claim companies withheld information about its risks.
U.S. District Judge in February 2008 put 27 Plavix suits combined before her on hold pending the Wyeth decision. She reinstated them April 2, citing the ruling.
GlaxoSmithKline was to go to trial May 4 in Philadelphia on claims by the family of Thomas Turek, who killed himself on his 47th birthday in 2003, eight days after he started taking Paxil.
The antidepressant made him agitated and paranoid, and the company understated its side effects, his family said.
The judge refused to throw out the case, citing the Wyeth decision. Glaxo settled April 24 on confidential terms.
The court’s decision on the Turek case will be extended to about 25 other Paxil suits in Philadelphia, the patients’ lawyer Bijan Esfandiari said. The first trial will be July 20.
Glaxo, also settled a Paxil case set for trial May 4 in Cheyenne, Wyoming, after the court rejected the preemption argument because of the Wyeth decision. The family of Jack Van Dyke sued in 2005, claiming Paxil was responsible for his suicide. Settlement terms were not disclosed.
In Tallahassee, a suit against Barr Laboratories over a generic form of the hyperactivity drug Adderall was stalled for months waiting for the Wyeth decision, said Peter Kaufman, the lawyer for the mother of Kristina Flatt, 21, who died in 2005 of sudden cardiac arrhythmia.
Five days after the ruling, the U.S. District Judge set a trial for Aug. 3.
The family claims Flatt received a toxic dose of amphetamines and Barr failed to warn of the risks of taking the drug along with an over-the-counter decongestant.
Barr has since renewed its request for preemption, arguing the Wyeth decision did not apply to generic-drug manufacturers.
Barr tried without success to block a suit in federal court in Oklahoma City over a generic form of Reglan, a treatment for acid reflux. Plaintiff Susan Schrock claims the drug left her with the neurological disorder tardive dyskinesia.
U.S. District Judge Vicki Mills-LaGrange rejected Barr’s motion March 11, citing Wyeth. A trial is set for May 2010.
The high court’s decision also gave new life to cases previously dismissed.
A Texas appeals court in state court in Houston April 14 revived a suit brought against Wyeth by a woman who said her breast cancer was caused by the menopause medicine Prempro.
Three days after ruling in Wyeth, the Supreme Court sent two suits over antidepressants back to the federal appeals court in Philadelphia, which had rejected them on preemption grounds. The cases, both on alleged failure to warn of the risk of suicide, include one against Glaxo over Paxil and one against New York-based Pfizer Inc. over Zoloft.
Drugmakers have not given up on preemption in every case. The Supreme Court left an opening for the argument that state- court suits are barred if the FDA rejected a stronger warning or if there is evidence the FDA would have rejected the warning.
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The decision described “sparse correspondence” between Wyeth and the FDA about the Phenergan label. Federal preemption may be found for drugs where “the FDA had thought very hard on the issue for many years,” Herrmann said.
The ruling does not apply to Paxil cases, Glaxo argued in a March court filing in Indianapolis. The FDA “has repeatedly decided what information should and should not be included in Paxil’s warnings about the risk of suicidality,” the company said, seeking reversal of a no-preemption finding in a suit over a priest’s suicide. The other side disagreed, and the judge refused to reconsider.
Lawyers for AstraZeneca Plc asked a judge April 22 at a hearing in Orlando, Florida, to find that almost 6,000 cases over its antipsychotic drug Seroquel were preempted by FDA approval of the label.
Seroquel, the target of suits because of its links to diabetes, is not covered by the Wyeth ruling because the FDA mandated that drugmakers add a classwide warning for all atypical antipsychotic drugs.
The Supreme Court ruling “significantly limited preemption.” It is now only a viable argument “if the FDA specifically rejects a stronger warning” than the current one. “There’s no evidence that AstraZeneca proffered a stronger warning that the FDA rejected.”
The lawsuits include Turek v. GlaxoSmithKline, 2006-3595, Court of Common Pleas, Philadelphia County, Pennsylvania; Van Dyke v. GlaxoSmithKline, 05-cv-153, U.S. District Court, District of Wyoming (Cheyenne); Schrock v. Wyeth, 5:08-cv-00453, U.S. District Court, Western District of Oklahoma (Oklahoma City); Munroe v. Barr Pharmaceuticals, 07-395, U.S. District Court, Northern District of Florida (Tallahassee); Tucker v. SmithKline Beecham Corp., 1:04-cv-01748, U.S. District Court, Southern District of Indiana (Indianapolis); and In re Seroquel Products Litigation, 06-MD-01769, U.S. District Court, Middle District of Florida (Orlando).
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