May 1

FDA-US Justice Dept. Withdraw Amicus Brief in Colacicco v. Apotex Inc,

Following the Supreme Court decision in Wyeth v Levine, denying Wyeth’s argument that FDA approval preempts state product liability suits, the US Justice Department withdrew its Amicus brief on behalf of Apotex (in Colacicco v. Apotex Inc, et al, (below).

Apotex, the manufacturer of a generic form of the SSRI antidepressant, Paxil, claimed immunity from product liability by claiming the company was absolved from its failure to add warnings about the drug’s hazards above those required by the FDA.

As expected, the Wyeth v Levine case quite simply reasserts consumer protection rights, overturning lower court judgments that relied on FDA preemption arguments.

“Every failure-to-warn case against a drug company has been affected by Wyeth,” Michael Miller, a plaintiffs’ attorney who represents ex-users of Plavix in suits against Bristol-Myers of New York and Sanofi Aventis SA of Paris, said of the high-court ruling.


U.S. Department of Justice
Civil Division, Appellate Staff
950 Pennsylvania Ave., N.W., Rm: 7250
DNL:SSwingle Washington, D.C. 20530 Tel: (202) 353-2689
Fax: (202) 514-8151

April 28, 2009
Ms. Marcia M. Waldron, Clerk
United States Court of Appeals for the Third Circuit
21400 U.S. Courthouse
601 Market Street
Philadelphia, PA 19106-1790

Re: Joseph C. Colacicco v. Apotex Inc., No. 06-3107 (3d Cir.)

Dear Ms. Waldron:

The United States has previously participated in the above-captioned case as amicus
curiae in support of defendants-appellees. This Court entered judgment for defendants-appellees
on Apr. 8, 2008. The plaintiffs filed a petition for certiorari, which the Supreme Court granted
on Mar. 17, 2009. The Supreme Court vacated the judgment of this Court, and remanded the
case for further consideration in light of Wyeth v. Levine, 555 U.S. ___ (2009).

The purpose of this letter is to notify the Court that the United States does not take a
position on whether plaintiffs-appellants’ claims in this case are preempted. The Food and Drug
Administration has not yet conducted the sort of reexamination of various preemption issues
following the Supreme Court’s decision in Wyeth that would be necessary to inform a position of
the United States in this case. Accordingly, the United States hereby withdraws the amicus brief
previously filed in this Court.

Thank you very much for your attention to this matter.

Very truly yours,

Sharon Swingle

Case: 06-3107 Document: 00319577893

cc: Harris Pogust
Derek Braslow
Pogust & Braslow
161 Washington Street, Suite 1520
Conshohocken, PA 19428
xxx cut long list of attorneys involved xxxxx

Wyeth Supreme Court Loss Breaks Drug Lawsuit Logjam
By Margaret Cronin Fisk and Jef Feele

April 30 (Bloomberg) — 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 doesn’t shield drugmakers from claims that patients and doctors weren’t 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 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.”

The court, on a 6-3 vote, said U.S. Food and Drug Administration approval of a drug doesn’t necessarily preempt lawsuits under state law.

Plaintiffs’ Victory

“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, 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 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.

Company Duty

“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 Wyeth,” Michael Miller, a plaintiffs’ attorney in Alexandria, Virginia, said of the high-court ruling.

Miller represents ex-users of Plavix in suits against Bristol-Myers of New York and Sanofi Aventis SA of Paris.

Plavix Claims

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.

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.

Side Effects

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.

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 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 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.

Tallahassee Trial

Five days after the ruling, U.S. District Judge Robert Hinkle 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, said Kaufman, of Levin Papantonio Thomas Mitchell Echsner & Proctor PA in Pensacola, Florida.

Barr has since renewed its request for preemption, 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.

U.S. District Judge Vicki Mills-LaGrange rejected Barr’s motion March 11, citing Wyeth. A trial is set for May 2010.

Barr Spokeswoman

Carol Cox, a Barr Laboratories spokeswoman, didn’t return a call or e-mail seeking comment on the Supreme Court ruling on product-liability cases against the company.

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 haven’t 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,” said Herrmann, the corporate defense lawyer.

Little Contact

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 doesn’t 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 London-based 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, isn’t covered by the Wyeth ruling because the FDA mandated that drugmakers add a classwide warning for all atypical antipsychotic drugs, Steven Weisburd, a company attorney, told U.S. District Judge Anne Conway.

Seroquel Argument

In reply, Robert Cowan, a Houston-based lawyer representing former Seroquel users, told the judge the fact Seroquel was part of such a warning doesn’t mean it falls into a “loophole” under the Wyeth decision.

The Supreme Court ruling “significantly limited preemption,” Cowan said. It’s now only a viable argument “if the FDA specifically rejects a stronger warning” than the current one, he said. “There’s no evidence that AstraZeneca proffered a stronger warning that the FDA rejected.”

Glaxo’s American depositary receipts, each representing two ordinary shares, fell 9 cents to $30.76 in New York Stock Exchange composite trading. They have declined 17 percent this year. Wyeth dropped 20 cents to $42.40 and Bristol-Myers rose 5 cents to $19.20.

AstraZeneca fell 58 pence, or 2.4 percent, to 2,385 pence in London trading. The stock has lost 15 percent this year.

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).

To contact the reporters on this story: Margaret Cronin Fisk in Southfield, Michigan, at; Jef Feeley in Wilmington, Delaware, at

Last Updated: April 30, 2009 16:34 EDT

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