preemption

Broader implications of Wyeth v. Levine rulings

Christe Bruderlin-Nelson — Wed, 05 Nov 2008 10:04:06 -0500

The way things go in the courts might have more of an affect on how investors view pharma down the line than anything else.

Take the case of the woman suing Wyeth over her arm amputation. When clinicians injected Wyeth's blockbuster anti-nausea medication, Phenergan, into her arm, she developed gangrene, which is a known side effect. She sued and won, but Wyeth appealed, and the case went to the Supreme Court.

The method of administration, an "IV push" has the rare side effect of irreversible gangrene if the drug enters an artery rather than the intended vein, which is what happened to the woman who lost her arm.

The woman is set to gain $6.7 million--a paltry sum for a lost arm and not much of a hit for Wyeth financially, but the drugmaker wants the ruling overturned nonetheless. Why? Because it opens the doors for state-level lawsuits over side effects for every drug on the market.

It also calls into question who will hold the ultimate responsibility for drug labeling: drug companies or the FDA. Either way, pharma investors would be smart to keep their eyes on what is happening in the courts when looking at individual companies, but also for potential sweeping decisions. Patients, it seems, will have to do due diligence when it comes to pharma labeling for now--but that's no small task for patients suffering from nausea in the hospital.

- read the full story at NPR.com
- find more about investment implications at the Motley Fool

Justices focus on FDA in preemption case

Tracy Staton — Tue, 04 Nov 2008 10:42:27 -0500

Did the FDA know enough? Was Wyeth vigilant enough? Those questions seem to be at the heart of the Supreme Court's deliberation over that much-publicized Supreme Court case Wyeth v. Levine. As you know, the Justices heard arguments yesterday in the case, which pits the drugmaker against Vermonter Diana Levine, who lost her arm after an IV "push" of the antinausea treatment Phenergan.

The case has drawn so much attention because it could shift legal doctrine. Businesses that comply with federal rules, the idea goes, shouldn't be subject to state lawsuits from consumers. Specifically to Wyeth, the FDA's approval of Phenergan and its labeling would "pre-empt" lawsuits from patients.

But the Justices seemed wary of granting such a broad legal shield. Justice Anthony Kennedy specifically said he didn't agree that FDA approval should prevent juries from questioning the agency's decisions. And Justice David Souter said Wyeth could have raised safety concerns about Phenergan "at any time," but didn't. Justice Samuel Alito seemed to agree, suggesting that Phenergan's FDA-approved label was inadequate. Justice Antonin Scalia, however, said that juries shouldn't be able to overrule the risk-benefit analysis FDA has already made.

Of course, guessing what the Justices might do is a cottage industry in itself, and we're not lawyers. But the analyses we've checked out suggest that the Court might look to balance consumer and business concerns. By zeroing in on what the FDA knew and what Wyeth did, the Justices hinted that, had the drugmaker kept the agency apprised of all safety info--and the agency properly analyzed and acted on that data--then patients shouldn't be able to sue. But we've included a link to the transcript so you can gauge the mood for yourselves.

- read the Boston Globe story
- see the article in the Wall Street Journal
- check out the WSJ Law Blog's take
- get the transcript at Pharmalot

Supremes sing on preemption today

Tracy Staton — Mon, 03 Nov 2008 10:26:28 -0500

By now, most pharma-watchers are familiar with the story of Diana Levine, the Vermont musician who lost her arm to the Wyeth drug Phenergan. And we all know that the U.S. Supreme Court is set to hear arguments over Levine's victory in a state-court suit based on the drugmaker's "failure to warn" patients and healthcare providers of Phenergan's potential dangers.

Now, the day has come: The Supremes will quiz Wyeth's and Levine's lawyers today as they gather the legal data they need to decide the case. Drugmakers aren't the only companies watching the High Court carefully, either. Companies of all stripes see this case as a precedent-setter for state torts. So do lawmakers who oppose the idea that a federal agency's approval could pre-empt a consumer's right to sue.

If a Washington Post editorial offers any insight into reasoned opinions on this case, it will be Congress that will need to act to withdraw that right. Lawmakers know tort lawsuits are common, and yet they haven't written a law that would shield companies like Wyeth from those suits. "[T]he justices should respect that determination," the Post writes.

Then again, plenty of observers have tried to read the tea leaves on this case, and they've issued opinions that are all over the map. So we invite you to do your own prognostications. Everything you need to know is in one SCOTUS primer on the case. Take it under advisement... and stay tuned for the post-arguments analysis.

- see the Post editorial
- read the SCOTUS primer

Memos show FDAers fought preemption

Tracy Staton — Thu, 30 Oct 2008 10:39:35 -0400

Is Rep. Henry Waxman looking to preempt preemption? Just as the U.S. Supreme Court prepares to hear the big pharma preemption case--Wyeth v. Levine--next week, the Congressman released internal memos that show FDA officials fighting the Bush Administration's move to make the agency's stand on drugs legally unassailable.

As you know, FDA brass and the Bush Administration have been advancing a new doctrine: that agency approval ought to shield drugmakers from legal challenges in state court. But longtime agency officials opposed that view in the memos Waxman released. They said that it's wrong to assume FDA-approved drug labels are always up-to-date, reliable, and based on a drugmaker's full disclosure of safety risks.

"[M]uch of the argument for why we are proposing to invoke preemption seems to be based on a false assumption that the FDA approved labeling is fully accurate and up-to-date in a real time basis," wrote John Jenkins, a top official in the drug approval section, according to the Wall Street Journal. And Jane Axelrad, FDA's associate director of CDER at the time, wrote that, "we usually find ourselves dealing with situations where sponsors want to minimize the risk information." According to Axelrad, preemption wouldn't be "consistent with the agency's role in protecting the public health."

The memos appear to be fuel for a Congressional bid to reverse Bush's anti-lawsuit policy, which has extended not only to the FDA and drugmakers, but through other regulatory agencies as well. So no matter what the Supremes decide on the Wyeth v. Levine case, the preemption argument won't be over.

- read the WSJ story

NJ Supremes to hear Vioxx preemption claims

Tracy Staton — Tue, 14 Oct 2008 09:53:47 -0400

In an ironic juxtaposition, confirmation of Vioxx's long-term risks comes just as the New Jersey Supreme Court agrees to consider whether FDA's approval of the Merck painkiller supersedes any state-court liability for the drugmaker. In an appeal of an earlier appeals court ruling, Merck had argued that jurors in the original trial shouldn't have second-guessed the FDA's approval. The agency had blessed labeling that didn't point out any heart attack risks, so no argument allowed.

NJ's highest court said it would take up the issue--which, as you know, falls under the legal theory that federal agency decisions "preempt" state liability. No hearing date was set, however, perhaps because the U.S. Supreme Court is looking at the theory itself. On Nov. 3, the court will hear the much-debated Wyeth v. Levine case, in which a Vermont patient sued the drugmaker over Phenergan, an IV nausea treatment. Wyeth claims that because the FDA approved Phenergan's labeling, it had no further responsibility for warning patients or providers that IV administration might cause limb loss.

What of the Vioxx risk confirmation? Research was released showing that Vioxx doubled the risk of heart attack, stroke, and death for at least a year after people stopped taking the drug. The long-term data comes from the study that prompted Merck to pull Vioxx off the market. Published online today in the Lancet, the data appears to show that the risks began soon after patients started Vioxx. The findings appear to vindicate some doctors, who have argued that Vioxx increased cardiovascular risks early and that the risks continued after therapy stopped. Merck maintains that the risks didn't arise until people took Vioxx for about 18 months.

- read the story in the Star-Ledger
- check out the court news at Pharmalot
- get more on the study from AFP

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

States: Say no to pre-emption

Tracy Staton — Fri, 15 Aug 2008 09:22:34 -0400

Forty-seven states are weighing in on the legal battle over pre-emption--and predictably enough, they're against it. The pre-emption doctrine would, of course, enshrine FDA approval as the be-all and end-all of drug safety. If the agency has blessed a drug for sale, then drugmakers are covered; nobody could sue drugmakers for damages in state court. Or so the reasoning goes.

The states aren't convinced. They're asking the U.S. Supreme Court to uphold a Vermont ruling in Wyeth v. Levine, the case of a professional musician whose arm had to be amputated after she was injected with one of the drugmaker's products. The musician was awarded $6.8 million in damages, and Vermont's high court wasn't convinced by Wyeth's argument that FDA approval should shield it from liability.

Now, the U.S. Supremes are set to hear the case in November, and various parties are lining up on either side of the case. The federal government supports pre-emption. Trial lawyers are fighting it. It will be closely watched: If the Court blesses pre-emption, drug suits across the country could be tossed.

As you know, the Court sided with device makers on pre-emption this spring, but devices are governed by different law, so there's no guarantee that it will do the same in the Wyeth case. Plus, Congress quickly started working to revamp the device law to protect the people's right to sue.

- read the story in the Boston Globe

Judge strikes down Biogen preemption case

Maureen Martino — Thu, 07 Aug 2008 14:01:22 -0400

Biogen and Elan--along with proponents of preemption--were dealt a setback today as a federal judge declined to transfer a case from Massachusetts to a federal court in Iowa. The lawsuit stems from the death of a patient who contracted PML after taking Tysabri; the drug was pulled from the market 11 days later. The patient's wife sued the drugmakers in Massachusetts, where Biogen is based. But drugmakers are waiting for the Supreme Court to rule on the issue of preemption, which asserts that the FDA's approval of a drug shields companies from lawsuits. They're expected to hear a precedent-setting case--Wyeth v. Levine--this fall. Biogen and Elan argued that the Massachusetts case should be moved to federal court because the fundamental question is whether the FDA's word protects drugmakers.

However, Judge Douglas Woodcock ruled against the developers, saying that preemption is not part of the law at this time and as such, the suit should stay in state court where it was filed. "The Defendants are essentially proposing that I exercise federal jurisdiction given the unsettled nature of the law in this area. I decline their offer," he said in his opinion. "Present posture of case law does not justify removal from state court to this [federal] court.

- here's the Wall Street Journal article
- check out the Pharmalot post for more

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

Reps introduce anti-preemption bill

Tracy Staton — Fri, 27 Jun 2008 10:18:03 -0400

They said they would, and now they have: two Democratic Congressmen have introduced a bill that explicit allows consumers to sue medical device makers under state law. You'll recall that in February the U.S. Supreme Court ruled that patients injured by defective devices can't sue because the FDA's approval preempts state law. The ruling angered some congressional reps, who said that lawsuits play an important role in keeping companies honest and protecting patients. So, they've put together the Medical Device Safety Act in the House; a companion Senate bill is set for introduction by Sen. Ted Kennedy and Sen. Patrick Leahy.

This bill doesn't affect drugmakers; pharma companies, unlike device makers, aren't covered by a statute that implies preemption. But the Supreme Court is expected to rule in a pharma preemption case this fall. We'll have to wait and see what that ruling is--and whether Congress might step up to reverse it, too.

- read the Pharmalot item

ALSO: Medtronic announced that William A. Hawkins, the company's chief executive, has been named to the additional position of chairman, effective August 21. Report

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

Quaid: Preemption unfair to patients

Thu, 15 May 2008 06:59:54 -0400

Dennis Quaid added some star power--and colorful language--to a dry legal debate yesterday. Testifying before Congress, Quaid backed people's right to sue drugmakers, saying that FDA approval shouldn't automatically negate patient lawsuits. "If preemption of lawsuits is allowed to prevail, it will make all of us--the public--uninformed and uncompensated lab rats," he said.

You'll recall that Quaid and his wife sued Baxter after their twin infants were given an enormous overdose of heparin. The lawsuit alleges Baxter knew other babies had died as a result of improper labeling of the drug, had started making heparin with new labels, but failed to recall the older vials mistakenly given to the Quaid twins. Among Baxter's defenses is the FDA's approval of its product.

The Bush administration has been pushing preemption, saying that approval by FDA, a federal agency, should supersede any state-level claims. This fall the Supreme Court will consider the idea when it hears a case pitting a patient against Wyeth. A Congressional committee met yesterday to hear testimony about preemption; presumably, Congress could circumvent a Supreme Court ruling in favor of it by enacting a law specifically allowing the lawsuits.

- read the Los Angeles Times story
- see the article in the Wall Street Journal

ALSO: Currently the sole supplier of heparin for the U.S. market, APP Pharmaceuticals is increasing its prices because of tightening Chinese stocks of the drug's raw ingredient. Several suppliers there have been shut down in the wake of an investigation of contaminated lots of the drug. Report

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

If J&J misled FDA, can patients sue?

Mon, 07 Apr 2008 06:59:57 -0400

Drug companies appear to be close to gaining a long-coveted prize: A shield against patient lawsuits. The Bush administration has been arguing in favor of it, saying that only the FDA has the expertise to regulate pharma. And the Supreme Court will rule during its next term on a case that could make FDA approval pre-empt any liability claims.

In the meantime, Johnson & Johnson is using the argument in a case over the Ortho Evra birth control patch. Company documents show that J&J knew the patch delivered more estrogen to patients than low-dose birth-control pills did--knew this even before the FDA approved the product in 2001. A 1999 trial showed the patch delivering 30 to 38 micrograms into the bloodstream daily. But the company marketed the product as delivering 20 micrograms daily. High doses of estrogen are known to raise the risk for blood clots that can cause heart attack and stroke. Families and patients have sued, alleging a variety of health problems, including death, ensued after women began using the patch--and that the company either hid or altered data to mislead the FDA and patients.

The FDA didn't warn women of the product's dangers until 2005, after receiving reports of at least 50 deaths associated with the drug. As one FDA official admitted during the Zyprexa trial last month, the agency doesn't always ask for strong warnings even on risky drugs because companies typically oppose them. "We at the FDA know what we can and cannot obtain," the official said, according to the New York Times. Plus, the fiddling J&J did with the estrogen numbers--a "correction factor"--was only disclosed once in its 435-page approval app for the patch.

Nevertheless, patients shouldn't be allowed to sue, the company's lawyers say, because the agency approved the product and its label: "FDA is responsible for making those decisions." We'll see how that defense fares.

- read the NYT story
- see the item at PharmaGossip

Related Articles:
FDA issues warning for Ortho Evra patch. Report
Patch delivers killer doses. Report
Bush: FDA's word shields against lawsuits. Report
Supremes to mull block on drug suits. Report

Supremes vote 4-4 in pre-emption suit

Tue, 04 Mar 2008 06:59:54 -0500

The Supreme Court came and saw and voted but left no clarity on pre-emption behind. Because Chief Justice John Roberts sat out the case, the vote ended in a 4-4 tie, automatically affirming the lower court's ruling and allowing a liability suit against Pfizer to go forward. In that suit, 27 diabetes patients allege that they suffered liver damage while taking Rezulin, a Warner-Lambert drug withdrawn three years after its 1997 approval at the FDA's request. Pfizer inherited the dispute when it bought Warner-Lambert.

Apparently, Roberts owns between $15,000 and $50,000 in Pfizer stock, so he had to recuse himself. But as a result of his doing so, the Court has left a critical issue open--whether a drugmaker's lying to regulators opens them up to liability despite legal reasoning that FDA approval, being federal, shields companies from state lawsuits. In Michigan, it's illegal to sue a drugmaker over an FDA-approved product unless the company withheld or misrepresented data during the approval process. A definitive ruling would have addressed that provision of the law. Of course, we won't get real closure on pre-emption for months, until the court hears a broader drug-related case.

- read the coverage in The New York Times
- check out the Associated Press story

Related Articles:
Supremes leaning toward pre-emption? Report
Bush: FDA's word shields against lawsuits. Report
Supremes to mull block on drug suits. Report

Supremes leaning toward pre-emption?

Tue, 26 Feb 2008 06:59:56 -0500

Yesterday court-watchers got another sneak peek at which way the Supreme Court might lean when they hear the big drug liability case next term. In hearing arguments over Michigan's law that shields pharma from liability suits unless they commit fraud to get their drug approved, Justices Stephen Breyer and Anthony Kennedy "expressed broad skepticism" about liability suits against drug makers, Forbes reports. Breyer said--and this is key--that the suits second-guess the FDA's decision to approve the drug. An expert agency is better qualified to make decisions about a drug's safety than is a jury of 12 randomly selected citizens, Breyer said.

Of course, that sentiment is just what drugmakers would like to see borne out when the Court takes on the case of Wyeth v. Levine in October. In that case, the court is being asked to determine whether FDA approval pre-empts personal injury lawsuits. Last week, the Supremes decided that for medical devices, a specific type of rigorous FDA approval does shield manufacturers from liability suits.

If the wind were ever blowing in drugmakers' favor on this issue, it's now. Before the Bush administration, the FDA argued that lawsuits gave patients additional protection, the New York Times notes. Now, the administration says lawsuits conflict with the agency's ability to do its job. So, apparently, believes Justice Samuel Alito, who asked yesterday whether a state lawsuit should be allowed to proceed even though it might "very seriously interfere with what the FDA is doing."

Ironically, part of the government's argument in this case is that the FDA competently oversees the drug and device markets. An assessment that, after recent expert critique and importation snafus, is certainly open to question.

- read the Forbes article
- check out the NYT article

Related Articles:
Supreme Court shields device makers. Report
Bush: FDA's word shields against lawsuits. Report
Supremes to mull block on drug suits. Report