March 4, 2008 New York Times

Court Allows Suit Against Drug Maker

A 4-to-4 vote on Monday left the Supreme Court unable to decide a pharmaceutical pre-emption case 連邦法が州法に勝つこと that was argued a week ago.

The tie vote, with Chief Justice John G. Roberts Jr. not participating, will permit a lawsuit to proceed against the Warner-Lambert Company, the maker of a diabetes drug, Rezulin. The plaintiffs are 27 diabetes patients from Michigan who suffered liver damage while taking the drug. Rezulin was approved by the Food and Drug Administration in 1997 and withdrawn from the market three years later at the agency's request.

A tie vote at the Supreme Court automatically affirms the lower court's judgment. In this case, the federal appeals court in New York had rejected the company's argument that the reasoning of a seven-year-old Supreme Court precedent barred individual damage suits that are based on the claim that a drug manufacturer obtained F.D.A. approval through fraud. Affirmance by a tie vote resolves only the particular dispute, without setting a precedent for other cases.

According to his financial disclosure form, Chief Justice Roberts owns $5,001 to $50,000 in stock in Pfizer Inc., Warner-Lambert's corporate parent. When there is a tie vote, the court issues a one-sentence order that does not identify the positions of the justices who voted.

This case, Warner-Lambert Co. v. Kent, presented a narrow slice of the broad pre-emption issue that the court will take up in its next term. In that new case, Wyeth v. Levine, the question is whether the Food and Drug Administration's approval of a drug's label precludes individual damage suits based on the claim that the label failed to include sufficient information or adequate warnings.

In essence, if the answer is yes, most individual lawsuits for damages caused by approved drugs would be pre-empted. Last month, in Riegel v. Medtronic Inc., the court interpreted a federal law, the Medical Device Amendments, as barring most individual lawsuits against manufacturers of approved medical devices.

The Warner-Lambert case, by contrast, specifically questioned the status of lawsuits alleging that F.D.A. approval was obtained by withholding or misrepresenting crucial information - in other words, by fraud. A 2001 Supreme Court decision, Buckman v. Plaintiffs' Legal Committee, barred general claims of fraud.


Facts of the Case

The Federal Food, Drug, and Cosmetic Act (FDCA) and the Medical Device Amendments of 1976 (MDA) regulate medical devices. Under the MDA, Class III devices "present a potential unreasonable risk of illness or injury" and thus require the Food and Drug Administration's (FDA) strictest regulation. In 1985, after a previously failed attempt, the AcroMed Corporation sought approval for its orthopedic bone screw device, a Class III device, for use in spinal surgery with the assistance of Buckman Company, a regulatory consultant to medical device manufacturers. The FDA also denied the second application. On the third attempt, instead of trying to show the bone screw device was "substantially equivalent" to similar devices already on the market and thus as safe and effective, AcroMed and Buckman split the device into its component parts, renamed them, and altered the intended use of the parts. Thus, the FDA approved the component devices for long bone surgery. Subsequently, the Judicial Panel on Multidistrict Litigation has directed over 2,300 civil actions related to these medical devices to the Federal District Court. Many actions claim, under state tort law, that AcroMed and Buckman made fraudulent representations to the FDA as to the intended use of the bone screws and that, as a result, the devices were improperly given market clearance, which injured the plaintiffs. The District Court dismissed the fraud claims as pre-empted by the MDA. The Court of Appeals reversed.


Does the Federal Food, Drug, and Cosmetic Act, as amended by the Medical Device Amendments of 1976, pre-empt civil actions related to the alleged fraudulent approval of orthopedic bone screw devices?


Yes. In an opinion delivered by Chief Justice William H. Rehnquist, the Court held that the plaintiffs' state-law fraud-on-the-FDA claims conflicted with, and were therefore pre-empted by, the FDCA, as amended by the MDA. "The conflict," wrote Chief Justice Rehnquist for the Court, "stems from the fact that the federal statutory scheme amply empowers the FDA to punish and deter fraud against the Agency, and that this authority is used by the Agency to achieve a somewhat delicate balance of statutory objectives. The balance sought by the Agency can be skewed 歪曲される by allowing fraud-on-the-FDA claims under state tort law." Chief Justice Rehnquist concluded that the "FDA...has at its disposal a variety of enforcement options that allow it to make a measured response to suspected fraud upon the Agency." Justices John Paul Stevens and Clarence Thomas concurred.

But the lawsuit by the Rezulin patients was brought under the specific provisions of a Michigan law that, while prohibiting product liability suits against makers of approved drugs, specifically permits claims that the manufacturer withheld or misrepresented information that was important to the approval process. The question was whether the existence of the state law placed the lawsuit on a different footing for the purpose of pre-emption analysis.

The Bush administration, which has embraced a broad theory of federal pre-emption of individual tort suits, entered the case on the manufacturer's behalf. It argued that "permitting lay juries to second-guess" the adequacy of a drug application would interfere with the agency's "exercise of its expert judgment."

2008/3/3 Forbes

Preemption Pullback

After delivering medical-device manufacturers an unqualified victory against tort lawyers last month, the U.S. Supreme Court pulled back when it came to lawsuits over Warner-Lambert's anti-diabetes drug Rezulin.

2000年、3月21日、米国食品医薬品局(FDA: Food and Drug Administration)が2型糖尿病の処方薬として流通していたトログリタゾン(商品名リズリン、Rezulin)のリコールを製造社のWarner-Lambertに指示。それまでに同薬によると思われる死亡が63件に達していた。

2004年5月27日、カリフォルニアの12人の陪審員は「Warner-Lambert社に、経口血糖降下薬・Rezulin(日本での商品名はノスカール)を服用中におきたManuel Cervantes氏とLupe Contreras氏の死とLeonard Clinkenbeard氏の肝障害の責任はない」と満場一致で判断しました。

In a 4-4 tie, the court refused to overturn a decision by a New York federal appeals court allowing Rezulin cases to proceed under a law that requires plaintiffs to first prove the company misled the Food and Drug Administration. Chief Justice John Roberts abstained because of stock investments in Warner-Lambert.

The Supreme Court's non-decision, entered without comment, halts what some thought was gathering momentum in favor of so-called "preemption," a legal concept that bars traditional tort-law 不法行為法 suits over drugs and devices that have been approved by the FDA.

The court applied this doctrine to medical devices last month in a case called Medtronic v. Riegel, involving an FDA-approved balloon catheter that popped after the physician inflated it past its recommended pressure. But in that case federal law specifically precluded such lawsuits; with the Rezulin suits, Warner-Lambert could only argue that public policy favored allowing the FDA to do its job without conflicting verdicts from juries applying state tort law.

Medtronic v. Riegel,

After suffering serious injury when a balloon catheter burst while he was undergoing an angioplasty procedure, Charles Riegel and his wife sued the catheter's manufacturer, Medtronic, Inc. Medtronic moved to dismiss the lawsuit, arguing that the Food, Drug, and Cosmetic Act expressly preempts state-law damages actions brought by patients who have been injured by medical devices that received premarket approval from the Food and Drug Administration. The court agreed and dismissed the case.

Public Citizen represented the Riegels on appeal and represents them now before the U.S. Supreme Court. The Supreme Court heard oral argument on December 4, 2007. The question before the Court is whether the express preemption provision of the Medical Device Amendments to the Food, Drug, and Cosmetic Act preempts state-law claims seeking damages for injuries caused by medical devices that received premarket approval from the FDA.

"A lot of people were thinking about busting out the champagne after Riegel, but this is going to be a long process," said James Beck, a lawyer of counsel with Dechert LLC who co-authors the Drug and Device Law Blog.

The court's unwillingness to offer blanket protection against tort suits might bode poorly for another closely watched case scheduled to be argued this fall, Wyeth v. Levine. In that case, Wyeth is trying to overturn a $6.8 million Vermont ruling on behalf of a woman who lost part of her arm after being injected with the anti-nausea drug Phenargan. The drug had at least three warnings against injecting the drug into an artery, but the plaintiffs argued the FDA-approved label didn't go far enough.

The Rezulin litigation has a confused history. Plaintiffs sued after the drug was found to cause liver damage and Warner-Lambert removed it from the market in 2000. Michigan, where the drug company is based, passed a law prohibiting traditional tort suits over FDA-approved drugs unless the plaintiffs can show the company misled the agency during the approval process.

Subsequent to that, the Supreme Court appeared to ban such "fraud-on-the-FDA suits," saying the states had no business second-guessing federal decisions. A federal appeals court in Michigan used the decision to throw out some Rezulin cases, but then the New York appeals court came to the opposite conclusion over another collection of suits.

The 4-4 tie probably reflects the court's unwillingness to eliminate any possibility of traditional tort suits over FDA-approved drugs, Beck said. If it had eliminated the fraud-on-the-FDA exception in the Michigan law, "this is a case where there would be no possibility of a claim, and I think the court had trouble with that," he said.

But the 4-4 split leaves the law unsettled. Plaintiff lawyers will likely jockey to get their cases into the Second Circuit, based in New York, and avoid the Sixth Circuit, based in Michigan, Beck said. Meanwhile drug companies will reassess their chances of winning the long-sought protection in Wyeth v. Levine.


2nd UPDATE: Supreme Court Splits In Warner-Lambert Drug Suit

The U.S. Supreme Court Monday deadlocked in a Michigan lawsuit against Pfizer Inc.'s Warner-Lambert unit, an outcome that allows a product liability case over Rezulin to proceed.

The high court heard oral arguments in the appeal just last week where the justices appeared sharply-divided on whether earlier Supreme Court precedent restricts state product liability lawsuits alleging fraud in the Food and Drug Administration drug-review process.

The court was split 4-4, it announced in a brief order. The court does not disclose how each justice voted when it deadlocks. Chief Justice John Roberts Jr. was recused from the case, presumably because he owns about $15,000 in Pfizer stock, according to his most recent financial disclosure.

The outcome provides no new legal precedent, but it is a blow for Warner- Lambert because a lower-court ruling that revived the lawsuit now stands.

Pfizer, which acquired Warner-Lambert in 2000, has already announced a fourth- quarter charge against earnings in 2003 to cover all the costs associated with Rezulin litigation.

The case was over injuries from Rezulin, a diabetes drug that was removed from the market in 2000 after less than four years on the market. The lawsuit is proceeding under a unique Michigan state drug products liability law that favors pharmaceutical companies by generally barring lawsuits over drugs approved for sale by the FDA. But the law has an exemption that allows injured patients to sue if they allege a drug company committed fraud during the FDA drug-review process.

The issue of federal preemption of state lawsuits over drugs is one the Supreme Court is scheduled to hear in a separate case next fall when it takes up Wyeth's challenge to a $6.8 million judgment awarded to a Vermont woman over complications from an anti-nausea drug.

The Michigan claims were thrown out by a federal trial judge in 2005 prior to the Second Circuit ruling that revived the claims on appeal.

The case is Warner-Lambert Co. v. Kent, 06-1498.

A group of Michigan residents who were injured after taking Warner-Lambert’s Rezulin diabetes drug sued the company in Michigan state court. The plaintiffs invoked a Michigan tort reform statue immunizing drug makers’ liability for FDA-approved products unless the drug makers made misrepresentations to the agency. The federal district court that eventually heard the case dismissed it, ruling that the Michigan “fraud on the FDA” cause of action was preempted by a federal law that empowered the FDA itself to punish misrepresentations. The appeals court reversed, reasoning that the Michigan law did not provide retribution 懲罰 for misrepresentations themselves, but merely created a window for consumers to bring product liability claims where the product reached the market solely through the manufacturer’s chicanery.ごまかし