Supreme Court

Waxman attacks FDA preemption rule

Tracy Staton — Thu, 18 Sep 2008 10:48:33 -0400

The legal argument over preemption is already heating up again. You know the idea, that FDA approval shields drugmakers from state-court liability suits. The Supreme Court is set to rule on the idea in November, and each side is hinting at its strategies. The Vermont musician who sued Wyeth over its antinausea drug Phenergan, Diana Levine, filed one brief. Wyeth filed another that is perhaps more telling: It's narrowing the preemption argument.

At least in this case. Wyeth says that this isn't a failure-to-warn case, so ideas about FDA preemption in those cases don't apply. Rather, Levine's case has been based "on the theory that the FDA had the pertinent information but reached the wrong conclusion, and that the jury should set the FDA right. In this situation, state tort law is undoubtedly preempted." So it's all about the FDA, not Wyeth.

That's not how we read Levine's brief filed this summer, which argues that the issue is whether a drugmaker "may be held liable under state law for inadequately warning." But the standard disclaimer--that we're not lawyers--applies.

Meanwhile, the FDA may be attempting an end run on preemption--but Rep. Henry Waxman wants to stop it. In a letter sent yesterday, the chairman of the House oversight committee attacked a rule change that would preempt people from suing drug companies over risks disclosed on a drug's label. And this, Waxman said, "At a time in which FDA's own Science Board warns that 'American lives are at risk' due to chronic underfunding of the agency." The FDA hasn't replied to Waxman yet, but whatever the agency says, this argument is far from over.

- read Rep. Waxman's letter to the FDA
- read the Wall Street Journal Health Blog item

Judge reverses Paxil preemption ruling

Tracy Staton — Mon, 21 Jul 2008 11:05:30 -0400

Pre-emption fans took one on the chin last week when a federal judge changed his mind. U.S. District Court Judge David Hamilton reversed a previous opinion that dismissed a Paxil suicide case, saying that FDA approval would shield drugmakers from state-court claims. In his new opinion, Hamilton wrote that he had "failed to appreciate the significance of the fact that the ongoing ability, authority, and responsibility to strengthen a label still rests squarely with the drug manufacturer."

That Paxil case--brought by a woman whose brother, a priest, shot himself 22 days after starting the drug--will be reopened. But like so many other state-court claims brought by patients, it could be rendered moot this fall when the Supreme Court hears a case widely considered to be an opportunity for the justices to confirm pre-emption.

- see the post at Pharmalot

Dems plan anti-preemption bill for devices

Tracy Staton — Thu, 05 Jun 2008 20:20:06 -0400

What the Supreme Court gives, Congress may take away. Democrats are planning to introduce legislation that would specify that FDA regulation doesn't shield device makers from state liability suits.

You'll recall that in February, the Supremes ruled that patients can't sue in state courts over FDA-approved medical devices. The high court said that the 1976 Medical Devices Amendment preempted patients' rights to sue in state court.

The justices are set to hear a preemption case involving drugs--a Wyeth drug, to be exact--this fall. And the debate over whether FDA approval should protect manufacturers from lawsuits is really heating up as that date approaches.

- read the Pharmalot post
- check out the Congress Daily story

Did Merck settle too soon?

Tracy Staton — Fri, 30 May 2008 10:22:10 -0400

Yesterday, we reported that two appeals courts--in Texas and New Jersey--overturned multimillion-dollar verdicts against Merck in Vioxx cases. The Jersey court's reasoning: A state product liability law was pre-empted by federal law.

Wait a minute: Isn't pre-emption that big legal debate the Supreme Court intends to rule on later this year? The one that says FDA approval, being federal, should shield drugmakers from state liability? Yes and yes. If the Supremes decide pre-emption is the way to go, patients will find it difficult to sue drugmakers at all, and the companies will have a stronger position in settlement negotiations.

So, the Wall Street Journal Health Blog asks, did Merck jump the gun when it offered the big $4.85 billion settlement last year? At the time, it seemed like a good deal for the company. But in light of the overturned verdicts, and the possibililty of pre-emption, it seems Merck might have been able to get off even more lightly if it had waited a bit longer.

- read the post at the Health Blog

Preemption debate heats up

Tue, 13 May 2008 06:59:58 -0400

That little legal argument known as preemption is back in the news. You know the one: That FDA approval, being federal, supersedes any state-court lawsuits over blessed drugs and devices. Pushed by the Bush Administration, it's set for a Supreme test this fall when the U.S.'s highest court hears a case in which Wyeth claims it shouldn't be liable for claims about an FDA-approved med.

The latest? Supreme Court justices have had to recuse themselves from various cases lately because of their pharma-stock holdings. Yesterday, it was Samuel Alito bowing out because of Bristol-Myers stock. (Four of the nine justices had to sit out of that case, which involved a laundry list of big U.S. companies.) Two months ago, it was Chief Justice John Roberts sitting out a case involving Pfizer. Given the fact that ratifying preemption as a legal defense wouldn't simply help Wyeth, but all drugmakers, will the two men recuse themselves from that case, too? Inquiring minds want to know.

Meanwhile, Congress is dipping into the preemption fray with a hearing on the concept tomorrow. The House Committee on Oversight and Government Reform--Rep. Henry Waxman's group--is calling a bunch of preemption opponents to testify. On the roster: Actor Dennis Quaid, who's suing Baxter over a heparin overdose given to his infant twins.

- see the item at Pharmalot
- check out the hearing announcement

SPOTLIGHT: High Court won't hear "Zoloft defense"

Tue, 15 Apr 2008 06:59:52 -0400

The U.S. Supreme Court has refused to hear an appeal in the infamous "Zoloft defense" case of a teen sentenced to 30 years for killing his grandparents with a shotgun. The case attracted nationwide attention when the child's lawyers blamed his violent behavior on the antidepressant Zoloft. Report

SPOTLIGHT: New bill would change law on device suits

Tue, 18 Mar 2008 07:59:52 -0400

Last month, the U.S. Supreme Court voted that patients can't sue device makers over products approved by the FDA. Now, a Congressman has introduced a bill that would change the law to make those lawsuits possible. Report

Bush: FDA's word shields against lawsuits

Wed, 05 Dec 2007 06:59:58 -0500

Preempt away. That's what the Bush Administration told the Supreme Court yesterday, supporting Medtronic's contention that its FDA-approved products shouldn't be subject to liability claims in state court. By throwing its weight behind Medtronic, of course, the administration is really supporting a sweeping change to patients' rights that could affect hundreds of outstanding lawsuits.

As we reported yesterday, the Supreme Court is hearing two cases that deal with the public's right to sue drug and device makers over FDA-approved products. Industry types, plus tort-reform activists, would like the court to say the agency's approval preempts state law. In other words, if the FDA says a product is safe, then patients potentially damaged by drugs or devices have no right to argue in state court.

"Even serious problems are exempt from state tort liabilities," Deputy U.S. Solicitor General Edwin Kneedler told the court. In fact, Kneedler said, companies are shielded from lawsuits even if they continue to sell a product that's mislabeled. Several justices, though, seemed to question whether manufacturers should be shielded after they've discovered safety problems with their own products, but before the FDA takes action. A decision is expected by July.

- see the the report at CNN Money
- read this item from the Wall Street Journal's Health Blog

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Supreme Court to hear Pfizer liability case

Wed, 26 Sep 2007 06:59:58 -0400

Do states have any business policing drugs? We're about to find out. The Supreme Court has agreed to hear Pfizer's appeal in a product liability suit originally brought in a Michigan court, but thrown out because of a state law limiting lawsuits over FDA-approved drugs. The suit concerns Rezulin, a Warner-Lambert drug pulled from the market for liver side effects just as Pfizer bought that company.

That court waved off the Michigan law's sole exception--that it's OK to sue in state court when a drug maker misrepresents info presented to the FDA--by saying that federal law pre-empted it. The U.S. Circuit Court disagreed and reinstated the suit.

Now, the Supremes will have their say--and legal experts say they might be inclined to agree with Pfizer, which wants product liability cases to be restricted to federal courts. The top court has also agreed to hear a case whose central issue is whether federal approval of a medical device--in this case made by Medtronic--shields it from liability claims under state law.

- read this article in the Houston Chronicle

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