Wyeth v. Levine Archives - Shopfloor

Attacking Preemption, the Opposite of Health Care Reform

By | Briefly Legal, Health Care | No Comments

A Forbes column by noted Chicago law professor Richard Epstein, writing about H.R. 1346 and S. 540, the Medical Device Safety Act, “A Sickly Medical Device Safety Act.” Epstein analyzes both Wyeth v. Levine and Riegel v. Medtronic as basically malpractice cases that were exploited and turned into cash-seeking legislation against the drug and medical device industries, respectively.

Judges constantly state that product liability law is supposed to make manufacturers bear the full costs of their product defects. But they have crafted bizarre, upside-down rules that make drug companies and device makers bear the full costs of the mistakes of downstream actors whose actions take place outside of their control. Fix state tort law, and you can forget about federal preemption. But with loopy tort law a fixture at the state level, Congress has to act. It should let the MDSA die. And it should restore parity by offering the same statutory protection to drug manufacturers that it now supplies to device manufacturers.

Elsewhere in the world of preemption, the Heritage Foundation has posted the video of its panel discussion last week, “Hurting or Helping Consumers? Destroying Federal Preemption One Industry at a Time.

The Medical Device Litigation Act, a Hearing

By | Briefly Legal, Health Care, Regulations | One Comment

Balanced story in today’s Cleveland Plain Dealer on a House committee hearing scheduled this afternoon on H.R. 1346, the Medical Device Safety Act. This is the bill that would end what’s called “preemption,” the federal liability protection for FDA-approved medical devices, opening the gates wide for product liability suits in state courts.

The bill comes in response to the Supreme Court’s ruling in Riegel v. Medtronic, and has long been a priority of the trial lawyers at the American Association for Justice.

The Plain Dealer’s headline represents the pro-lawsuit arguments, “Patients injured by faulty medical devices want laws to hold manufacturers accountable,” and the story leads with the claims of the injured party. Still, the Plain Dealer provides space for manufacturers and others to comment on innovation-stifling effects of the legislation.

“This bill does not in any way improve patient safety,” said Steris spokesman Stephen Norton. “It will, however, restrict patient access to essential medical technologies, produce a chilling effect on medical innovation, create more lawsuits, and ultimately result in higher health-care costs for all Americans.”

And from Medtronic spokesman Rob Clark:

“When you regulate through litigation, which is the recipe the Medical Device Safety Act is aimed at, it places decisions in the hands of a 12-person jury that’s only looking at one particular patient, and one particular situation and not evaluating the safety and efficacy and risk benefit of that device for everyone,” Clark said.

Washington Post columnist Michael Kinsley, who is testifying at today’s House Energy and Commerce subcommittee hearing, made that important point last year when commenting on the high-profile preemption case, Wyeth v. Levine.

The flaws of litigation as a method of making important government decisions are well rehearsed. It is ungodly expensive: The lawyers typically cost more than even the most worthy plaintiff ever gets. It is arbitrary: The same issues get litigated again and again, usually with a different result each time. Most people who suffer never sue and get nothing. While the FDA has scientists, the courts have jurors, for whom ignorance of the subject at hand is not merely the norm but a virtual requirement. And because trials occur only when a risk has gone wrong, they inevitably overemphasize the risk and undervalue the benefit.

The Subcommitte on Health holding the hearing is chaired by Rep. Frank Pallone (D-NJ), sponsor of the bill, so the agenda is clear enough. We trust that agenda allows space for the argument that undermining preemption will create a chaotic, expensive and capricious regulatory system ruled not by medical experts and the disinterested FDA but by juries in the 50 different states. And that’s a regulatory regime that does not serve the public.

For more on the hearing, see our post at Point of Law.com, “Medical Device Safety Act hearing, the PR angle.” It’s an interesting witness list.

Wyeth v. Levine: Michael Kinsley on the Flaws of Litigation

By | Briefly Legal, Health Care | No Comments

In today’s Washinton Post, prominent liberal columnist Michael Kinsely makes a pointed critique of the Supreme Court’s decision in Wyeth v. Levine and upbraids Congress for its flawed handling of federal drug regulation. From “Drug Regulators in the Jury Box“:

The flaws of litigation as a method of making important government decisions are well rehearsed. It is ungodly expensive: The lawyers typically cost more than even the most worthy plaintiff ever gets. It is arbitrary: The same issues get litigated again and again, usually with a different result each time. Most people who suffer never sue and get nothing. While the FDA has scientists, the courts have jurors, for whom ignorance of the subject at hand is not merely the norm but a virtual requirement. And because trials occur only when a risk has gone wrong, they inevitably overemphasize the risk and undervalue the benefit. Why did Levine return to the hospital for a second time the same day? After long spasms of retching and vomiting, she was desperate for a treatment like Phenergan.

What happened to Diana Levine is a tragedy and a scandal. But what did Wyeth do wrong? Is there any way the company could have stayed out of trouble? It’s unlikely. Phenergan has been legal for half a century. (If you Google the word “Phenergan,” the results include pages containing an ad for Phenergan online.) So if you can’t get them for the product itself, you nail them for a “failure to warn.” The basic fiction at the heart of the whole system of regulation by lawsuits is that people read and act on warning labels. But the FDA approved Wyeth’s original warning label and every change since. “Not good enough,” said a Vermont jury, and, incredibly, a majority of the Supreme Court agreed.

To fill in the one gap in Kinsley’s analysis, it’s worth noting that the medical clinic that improperly administered the anti-nausea drug reached a settlement with Ms. Levine. But it wasn’t enough for her and her lawyers, who turned a clear malpractice case into a multi-million-dollar lawsuit against the manufacturer of a very useful and proven drug.

Ruling in Wyeth v. Levine Hardly a Victory for Consumers

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Happened upon this San Francisco Chronicle story report on the U.S. Supreme Court’s ruling in Wyeth v. Levine, the most prominent preemption and business case of the year. Although it’s a week old, the story’s worth taking a look at: “Ruling says patients can sue drugmakers.”

(03-04) 17:08 PST WASHINGTON — In a resounding victory for consumers over the pharmaceutical industry, the Supreme Court ruled Wednesday that patients harmed by medication can sue the drugmaker for neglecting to list known dangers on the label even if federal regulators haven’t required them to do so.

No! That’s not a fact. That’s a statement of editorial opinion about a matter of policy. We’d argue that the court’s ruling was in reality a resounding defeat for consumers because it will discourage innovation and the development of new prescription drugs that can save the lives of those very same consumers.

As L. Gordon Crovitz writes about Wyeth v. Levine in his Wall Street Journal column, “The Supreme Court and the Tyranny of Lawyers“:

The Food and Drug Administration had required Wyeth to distribute carefully worded warnings with its antinausea drug. The FDA told Wyeth to warn that “under no circumstances should Phenergan Injection be given by intra-arterial injection.” The warning label also included, in uppercase letters: INADVERTENT INTRA-ARTERIAL INJECTION CAN RESULT IN GANGRENE OF THE AFFECTED EXTREMITY. Tragically, a physician’s assistant in Vermont ignored the clear warnings and injected the drug into the arm of Diana Levine, who then developed gangrene and lost the arm. She sued the hospital, successfully. But she also sued Wyeth.

The legal issue was whether the medical experts at the FDA had pre-empted state lawsuits by mandating clear warnings. A majority of justices said that such implied pre-emption could not block lawsuits. The case would have been different if Congress had specifically pre-empted state drug lawsuits. The simple lesson businesspeople took was that the drug maker could not have done anything to avoid being sued. This logic leads to every drug (and ladder, hammer and toaster) having to carry 50 different warnings, one for each state, updated by local juries from time to time.

More broadly, this case is Exhibit A for how our legalistic culture puts a drag on the innovation, transparency and risk-taking that our new era champions. The result will be higher hurdles for funding to start health companies. There will be less research and development for new drugs, at a time when genome and other path-breaking information should be breaking important new ground, curing people, and helping drive the economy. Prices for drugs will rise to cover future jury verdicts. Defensive medicine already accounts for 30% of doctor bills, an amount equal to the cost of covering the 50 million Americans without health insurance.

This system, worsened now by the court’s ruling, does not serve consumers. Or anybody…except litigants and their lawyers who happen to win individual lawsuits.

Wyeth v. Levine, the Consequences for Innovation

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The Wall Street Journal comments on “drug labeling by jury verdict” in an editorial, “Pre-empting Drug Innovation“:

Juries are presented with tragic plaintiffs who were injured, not the unknown patients who are helped, by a product. Hence, they tend to focus on risks more than overall benefits. By contrast, federal regulators are tasked to take the long view and factor in the interests of all potential users of a drug. Just as importantly, “the FDA conveys its warning with one voice,” writes Justice Alito, “rather than whipsawing the medical community with 50 (or more) potentially conflicting ones.”

A consequence of this ruling is an almost-certain spike in product-liability suits aimed at drug companies. Merck’s Vioxx litigation has already cost the company $4 billion, and Eli Lilly has paid out more than $1 billion to settle suits related to the antipsychotic drug Zyprexa. A legal standard that said the FDA, not a state tort jury, is responsible for regulating warning labels would have given both drug companies a stronger position in these lawsuits.

Yesterday’s ruling will expose drug companies to a kind of double innovation jeopardy. They typically spend $1 billion on research and development to bring a drug to market, with an 11% success rate on average. But they endure that burden on the understanding that FDA approval will give them a period to sell that drug with patent protection and that FDA approval provides some protection from lawsuits. Now they will have to contemplate paying up front — and paying later, even if the tragic mistake in applying the drug is someone else’s. Wyeth is a dream come true for the plaintiffs bar.

Ten years from now, when somebody dies because no drug was available to treat his illness, well, who will know? But that’s a result that can be anticipated thanks to a legal system that punishes innovation.

Wyeth v. Levine: Implied Preemption Cases are Fact Intensive

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Victor Schwartz, general counsel for the American Tort Reform Association (who has also represented the NAM on occasion), issued a statement in reaction to the Supreme Court’s ruling in Wyeth v. Levine. From ATRA:

Personal injury lawyers will applaud today’s Supreme Court decision, but we caution against any over-reading of the Court’s ruling. As the Court’s decision makes clear, implied preemption cases are fact-intensive, turning on what information the agency considered in a specific instance.

The Supreme Court’s decision focuses more attention on the flipside of the federal preemption coin. Several states have already determined, through courts or legislatures, that due deference should be given to the FDA in assessing the validity of a medicine’s warnings, particularly when there has been no wrongdoing by the defendant. The unfortunate truth is that all medicines come with risks. States should pick up the baton left for them today and join these other states in yielding to FDA scientists when, after years of earnest study, the FDA stamps a drug as safe and effective when accompanied by warnings explaining a medicine’s known risks.


Wyeth v. Levine, Tragic Facts, a Bad Ruling

By | Briefly Legal, Health Care | One Comment

The Supreme Court today released its 6-3 opinion in Wyeth v. Levine, holding that a Vermont woman could sue in state court for harm caused by the improper injection of Phenergan anti-nausea drug, despite the FDA’s approval of the labeling of the drug. (Opinion here.)

Justice Alito, writing the dissent, says it well: “This case illustrates that tragic facts make bad law. The Court holds that a state tort jury, rather than the Food and Drug Administration (FDA), is ultimately responsible for regulating warning labels for prescription drugs.”

Andrew Grossman of the Heritage Foundation has an excellent post at Point of Law hitting the salient points, including the PR elements of the case:

Story after story (see, e.g., here and here) focused on Diana Levine, a musician who lost her arm to gangrene after being administered Phenergan, Wyeth’s drug, via IV-Push injection. But in that simple summary, so many facts are lost:

  • The drug’s label did warn about the risk of gangrene due to “intra-arterial injection”–exactly what happened to Levine.
  • The physician’s assistant who injected the case used a disfavored, though not contraindicated (i.e., banned) method of injecting the drug.
  • Twice the maximum labeled dose was injected.
  • The physician’s assistant continued to inject the drug despite Levine’s complaints of pain.
  • IV-push, the method of administration at issue in the case, is a particularly quick-acting and effective way to administer the drug, though it does carry with it some (labeled) risks, such as gangrene.

In short, then, this really wasn’t about “failure to warn”–because the warnings were there–but failure to outright ban a method of administration that already carries heavy warnings but that the FDA, balancing all the interests at stake, determined should still remain available.

So now individual trial juries in the separate states will, in effect, establish the nation’s regulatory regime for the administration of prescription drugs. The public will certainly not be served by the uncertainty, capricious awards and costs that result. Trial lawyers certainly will be served, as one can gather from the American Association for Justice’s release on the decision.


Wyeth v. Levine

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Catching up …(earlier posts here):

In this key pre-emption case, Wyeth v. Levine, arguing for Wyeth was the former solicitor general, Seth P. Waxman of Wilmer Hale, and representing the Justice Department as amicus was Deputy Solicitor General Edwin S. Kneedler. (DOJ’s amicus brief is here.) Representing Diana Levine was David C. Frederick of David C. Frederick, Kellogg, Huber, Hansen, Todd, Evans & Figel. News coverage:

  • U.S. Supreme Court, transcript of the oral arguments.
  • Legal Times, “High Court Appears Torn Over Drug Labeling Case
  • FoxNews, “Supreme Court Hears Arguments on Drug Labeling in Case of Woman
  • ABA Journal, “Court Ruling in Drug Labeling Pre-Emption Case Expected to be Narrow
  • The American Lawyer, “Wyeth v. Levine: An Actual Toss-up?
  • Washington Post, “High Court Case Looms Large for Drugmakers
  • New York Times, “Justices Weigh Effect of F.D.A. Approval of Drug Labels on Suits in State Courts
  • Adam Liptak of the New York Times did a nice job providing legal context and framing the issues:

    Several justices appeared open to the idea that pre-emption could follow from the F.D.A.’s approval of a drug label – but only if drug companies remained subject to lawsuits if they failed to disclose new information about potential risks. There was much discussion of what information should be considered new.


    Other justices seemed prepared to allow pre-emption – but only if the drug agency had considered the particular risk before approving the label.


    Given the justices’ interest in those refinements, the court seemed unlikely to rule broadly on the larger issues in the case: whether the agency and other federal regulators set minimum safety standards that states are free to augment or whether they make judgments about the optimal balance between risks and benefits that states must follow.

    Ted Frank of the American Enterprise Institute also summarized the issues well in August in the D.C. Examiner, “As even Clinton appointee Justice Stephen Breyer pointed out in a February 8-1 Supreme Court decision about medical devices, if we are to have meaningful safety regulation, those standards should be determined by federal regulators, not by untrained juries who hear only the sad stories of side effects in hindsight without considering the larger policy issues.”

    Wyeth v. Levine, Preemption and Federal Standards

    By | Briefly Legal, Health Care | No Comments

    On Monday morning, the U.S. Supreme Court hears oral arguments in Wyeth v. Levine, a major case dealing with pre-emption, that is, whether federal rules governing such products as medical devices or prescription drugs take precedent over state regulation. Generally speaking, businesses support the principle of pre-emption because a national regulatory regime — one that includes a single safety standard — provides for consistent legal treatment and predictability in costs.

    Trial lawyers and self-proclaimed consumer activists dislike pre-emption because, they contend, state enforcement can encourage safer products and injured parties should not lose access to the state courts. Preemption also limits the number of venues where the trial lawyers can cash in on outrageous jury verdicts, it reduces the opportunity to play “Jackpot Justice.”

    (The Wyeth case actually deals with drug labeling. The NAM’s Legal Beagle summary of the case is here; and earlier Shopfloor.org posts here.)

    Anyway, a review of the news coverage previewing Monday’s oral arguments. Now, we haven’t read the articles yet in order to test a thesis: Just in time for Tuesday’s election, the articles will feature references to a “pro-business Supreme Court,” framed in the context of court appointments by the next President. So here goes…

    Nope! (He said, cheerfully acknowledging error.) The stories all play the issue straight, not trying to fit the issue into a predetermined line about Obama v. McCain’s court appointments needed to fix the one-sided, anti-consumer Supreme Court.

    Included in several is a very silly comment from a Fordham law professor , Ben Zipursky, commenting on the effect of a ruling in of Wyeth: “That effectively would cut off virtually all pharmaceutical liability for prescription drugs.”

    The coverage does acknowledge a legitimate political angle, though, that is, Congressional Democrats have supported legislation to allow state lawsuits. Rep. Henry Waxman’s House Oversight Committee last week released a “report” on FDA career staffers objecting to the agency’s support for pre-emption. Because apparently some people believe mid-level agency staffers should have determine regulatory policy, no matter the results of an election.

    Walter Olson has a post at Point of Law on pre-emption, with many links, including to several examining the Waxman document.

    Jackpot Justice, Undermining Good Health and Good Sense

    By | Briefly Legal | No Comments

    In today’s DC Examiner, Ted Frank of the American Enterprise Institute reports the story of a man who gambled, started taking a drug to control his Parkinson’s, continued gambling, stopped taking the drug, still gambled and eventually, four years on, gambled compulsively on the Internet and lost lots of money. He then sued the drug manufacturer.

    A jury awarded Gary Charbonneau $204,000 to reimburse him for his gambling losses, $175,000 for “pain and suffering” and $7.8 million in punitive damages. The manufacturer had failed to provide enough warnings about side effects, or so they concluded.

    All drugs from aspirin on up have side effects; doctors prescribe them because the benefits outweigh the costs. There can always be “more” warnings, and can always be accusations that the additional warnings weren’t sufficient.

    After all, if the doctor knew the patient was going to have a side effect, she would not have prescribed the drug, so the warning must not have been good enough. The manufacturer can solve the problem only by taking every drug off the market, making everyone worse off.

    Thus, the Food and Drug Administration says that courts should not permit such “failure-to-warn” lawsuits. Lawsuits can destroy the effectiveness of warning labels.

    The trial bar wants to undermine the federal regime of drug regulation, preferring to sue in state courts where juries are more liable to make outrageous awards like those cashed in by Mr. Charbonneau. This “preemption issue” of federally regulated labeling was addressed by the U.S. Supreme Court in the Riegel v. Medtronic decision about medical devices, which limited tort claims in state courts when the manufacturer met federal labeling standards.  In the fall the court will consider Wyeth v. Levine, concerning the regulation of drugs (in this case, an anti-nausea drug treatment). In the meantime, preemption is coming under attack in Congress. (For example, this medical device legislation, H.R.6381.)

    As Frank concludes: “As even Clinton appointee Justice Stephen Breyer pointed out in a February 8-1 Supreme Court decision about medical devices, if we are to have meaningful safety regulation, those standards should be determined by federal regulators, not by untrained juries who hear only the sad stories of side effects in hindsight without considering the larger policy issues. ”