MJ True Jersey
by Margaret Cronin Fisk and Jef Feeley / Bloomberg News
Sunday May 03, 2009, 3:00 PM
Long-stalled suits against drugmakers are again moving toward trial just two months after the U.S. Supreme Court decided patients can sue them over injuries from government-approved medicines.
A decision involving a Wyeth nausea treatment broke a logjam of cases in state and federal courts. The Supreme Court ruling affected more than 250 lawsuits involving at least 10 companies that were in limbo.
The Supreme Court decision may cost the industry “billions of dollars,” said attorney Mark Herrmann at Jones Day in Chicago, who defends companies in similar suits. “There’s no way to quantify it, but the number has as many zeroes in it as attacked Pearl Harbor.”
A group of Bristol-Myers lawsuits over the blood-thinner Plavix may now proceed to trial in federal court in Trenton. A Barr Pharmaceuticals hyperactivity-drug case is to be tried in August in federal court in Tallahassee, Fla.
Glaxo just settled two cases on allegations its antidepressant Paxil can make patients suicidal, after judges set trials citing the Wyeth decision.
Federal regulatory approval of a medicine and information about side effects doesn’t shield drugmakers from allegations that patients and doctors weren’t adequately warned, the high court ruled on March 4.
The court, in a 6-3 vote, said U.S. Food and Drug Administration approval of a drug doesn’t necessarily pre-empt lawsuits under state law.
“Had the Supreme Court decided in favor of pre-emption, it would have sent a strong signal that pharmaceutical failure-to-warn cases were not a profitable place to be” for plaintiffs’ lawyers, said Howard Erichson, a professor at Fordham Law School in New York.
The court upheld a $6.8 million Vermont jury award to Diana Levine, a former bass guitarist who specialized in children’s music. Levine got two Phenergan injections in 2002 to treat nausea associated with a migraine headache.
The second injection involved 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, saying 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, 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.”
Since the decision, judges have set trial dates, removed holds, reversed dismissals and sent cases back to lower courts for further review. Defendants have withdrawn motions seeking dismissal on preemption grounds.
“Every failure-to-warn case against a drug company has been affected” by the Wyeth ruling, said Michael Miller, a plaintiffs’ attorney in Alexandria, Va.
Miller represents ex-users of Plavix in suits against Bristol-Myers of New York, which has operations in Mercer County, and Sanofi Aventis of Paris.
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.
“The judge overseeing the Plavix cases specifically put them on hold while she waited to see what the Supremes would do,” Miller said.
U.S. District Judge Freda Wolfson in Trenton in February 2008 put 27 Plavix suits combined before her on hold pending the Wyeth decision. She reinstated them April 2, citing the ruling.
The reinstatement affects more than the cases before Wolfson, said Mark Burton, a San Francisco attorney who also represents Plavix patients.
“Now that it’s lifted, we have thousands of clients” ready to sue, Burton said.
Brian Henry, a Bristol-Myers spokesman, declined to comment.
TWO BIG CASES
Three days after ruling on 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 over Zoloft. Pfizer has a strong presence in New Jersey, employing about 1,600 people at operations in Peapack-Gladstone, Bridgewater and Morris Plains.
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 the case April 24 on confidential terms.
Sarah Alspach, a Glaxo spokeswoman, confirmed the settlement and declined to comment further.
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, based in London, also settled a Paxil case set for trial Monday in Cheyenne, Wyo., after the court rejected the pre-emption argument because of the Wyeth decision. The family of Jack Van Dyke sued in 2005, claiming Paxil was responsible for his suicide. Settlement terms weren’t 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, U.S. District Judge Robert Hinkle set a trial for Aug. 3.
The family says 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, said Kaufman, of Levin Papantonio Thomas Mitchell Echsner & Proctor in Pensacola, Fla.
Barr has since renewed its request for pre-emption, arguing the Wyeth decision didn’t 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.