Results matching “pre-emption”

Ted Frank has already briefly discussed this important decision, and I thought it might be useful to elaborate a bit here. I want to summarize the facts, the holding, the dissent, and the implications of the decision as I see them.

1. The underlying facts and the legal issue on appeal

-In 1978, the FDA approved a nonsteroidal antiinflammatory pain reliever (NSAID) called "sulindac" under the brand name Clinoril. When Clinoril's patent expired, the FDA approved several generic versions of sulindac, including one manufactured by Mutual Pharmaceutical.

-In a very small number of patients, NSAIDs--including sulindac (Clinoril®, etc), ibuprofen (Advil®, etc.), naproxen (Aleve®), and Cox2-inhibitors (Celebrex®, etc)--have the rare serious side effect of causing hypersensitivity skin reactions characterized by necrosis of the skin and the mucous membranes: toxic epidermal necrolysis (Lyell's Syndrome) in more or less severe form. This rare, life-threatening skin condition consists of the top layer of skin (the epidermis) detaching from lower layers of the skin (the dermis) all over the body.

-In December 2004, New Hampshire resident Karen Bartlett was prescribed Clinoril for shoulder pain. Her pharmacist dispensed a generic equivalent manufactured by Mutual Pharmaceutical. Ms. Bartlett soon developed an acute case of toxic epidermal necrolysis. The results were horrific. Sixty to sixty-five percent of the surface of her body was burned off or turned into an open wound. She spent months in a medically induced coma, underwent 12 eye surgeries, and was tube-fed for a year. She is now severely disfigured, has a number of physical disabilities, and is nearly blind.

-Bartlett sued Mutual Pharmaceutical for compensation for her injuries, on the grounds that the sulindac it manufactured was defective and unreasonably dangerous. Bartlett complained about two things: the warning on the defendant's sulindac (what I call "informational defect" in my book on Products Liability, and the chemical composition of its drug ("design defect").

-At the time respondent was prescribed sulindac, the drug's label did not specifically refer to toxic epidermal necrolysis, but did warn that the drug could cause "severe skin reactions" and "[f]atalities." However, Stevens-Johnson Syndrome (a lesser form of Lyell's Syndrome) and Lyell's Syndrome (aka toxic epidermal necrolysis) were listed as potential adverse reactions on the drug's package insert. In 2005, after Bartlett was already a victim, the FDA recommended changes tothe labeling of all NSAIDs, including sulindacs, to more explicitly warn against toxic epidermal necrolysis.

-the federal District Court that heard the case dismissed Bartlett's failure-to-warn (informational defect) claim because her doctor, to whom the duty to warn is owed where prescription drugs are concerned, had admitted "that he had not read the box label or insert." [In other words, a more thorough warning on the label would have made no difference.] But he let the design defect claim go to the jury, and after a 2-week trial, it granted over $21 million in damages to Ms. Bartlett. The First Circuit Court of Appeals affirmed, and Mutual appealed the design defect liability to the Supreme Court.

-The Supreme Court, in PLIVA, Inc. v. Mensing (2011), had previously held that state failure-to-warn (informational defect) liability of generic manufacturers are pre-empted by federal law: to wit, by the Food, Drug and Cosmetic Act (FDCA)'s prohibition of any changes to generic drug labels as compared with the branded drug label. But Bartlett argued that her design defect claim was not covered by the logic of Pliva, since generic manufacturers could escape liability for producing a defective drug by simply choosing "not to make the drug at all." This was the issue before the court: does the logic of Pliva apply to design defect claims?

2. The Court's holding

-A bare majority of the court held that the logic of Pliva does indeed extend to design defect claims. In this case, however, redesign of the drug was not possible for two reasons. First, the FDCA requires a generic drug
to have the same active ingredients, route of administration, dosage form and strength as the brand-name drug on which it is based. Second, because of sulindac's simple composition, the drug is in any case chemically incapable of being redesigned.

-The label is part of the design of a drug, but as Pliva held, "[f]ederal drug regulations, as interpreted by the FDA, prevented the Manufacturers from independently changing their generic drugs' safety labels."

-Of course, no law actually forced Mutual to manufacture any sulindac at all. It could have complied with federal and state laws by closing up shop. But this was also the case for the manufacturer in Pliva, and the Court there was unimpressed with the argument that federal law did not preempt state law because a manufacturer could comply with both by ceasing to manufacture. Thus, the logic of Pliva compels that it be extended to design defect cases.

-Justice Breyer, in dissent, found the FDA's work on this issue to be insufficiently studied, and therefore decided to accept the claim that Mutual could have satisfied both federal and state law by going out of business. He would not have accepted the claim had he approved of the FDA's work.

-Justice Sotomayor, also in dissent, claimed that Pliva only addressed failure-to-warn (informational defect) claims, not design defect claims. According to her, "nothing in Mensing, nor any other precedent, dictates finding ... pre-emption here." How so? Because Mutual could have made its product with the same warning and the same composition as the branded drug, as required by law, and then "compensate consumerswho were injured by an unreasonably dangerous drug." Thus Mutual was not forced to violate either state or federal law.

3. Analysis

-Justice Sotomayor's dissent is clearly specious, and the majority was correct to gently chide her for in actuality saying that Bartlett should recover because she was grievously injured. Sympathy for an injured party is not sufficient for tort liability, President Obama's exhortations to the contrary notwithstanding. Indeed, Justice Sotomayor's dissent makes a mockery of Pliva, for there too the generic manufacturer could have published the required warning and then paid liability damages. The only competent way to read Sotomayor's dissent is as a repudiation of Pliva, without the honesty of saying so. It is embarrassing that Justice Ginsburg joined this lawless opinion, and it is, I suppose, perversely comforting that Justices Breyer and Kagan repudiated it by insisting, pragmatically, that they would evaluate each FDA action according to their own second-guessing of its thoroughness, following the logic of Pliva or not depending on their sovereign discretion.

-It is clear now that only manufacturing defect (i.e., the generic drug was not made correctly, was diluted or contaminated, etc) is available to those suing the manufacturers of generics. Perversely, this gives more rights to plaintiffs suing brand-name manufacturers than to those suing off-patent producers. The former remain liable for manufacturing, informational and design defects, while the latter are only liable for manufacturing issues. Clearly, this is a weird equilibrium, as it reduces the brand-name manufacturer's profits relative to the generic maker's. The former of course bears all development and testing costs, while the latter "free-rides". At the margin, this may encourage drug makers to select generic manufacturing instead of R and D. Sooner or later, I think, either Pliva and Bartlett will have to be repudiated, or (much more likely) the logic of their protection will have to be extended to informational and design defect cases against the makers of brand-name drugs, repudiating cases such as Wyeth v. Levine.

Johnson & Johnson (through a wholly-owned subsidiary) manufactures Benecol Regular and Benecol Light Spreads. J&J has had to defend against multiple suits, including one by a Thomas Young, who filed a consumer fraud class action against alleging that Benecol's labeling was false and misleading In particular, the complaint focused on Benecol's claims, on its packaging, that Benecol was: (1) "Proven to Reduce Cholesterol"; and contained (2) "NO TRANS FAT."

In fact, Benecol does contain a tiny amount of partially hydrogenated oil (aka trans fat): an amount that FDA called "insignificant." As for the "Proven to Reduce Cholesterol" claim, Young asserted that it must be false too, because Benecol is allegedly rendered so unhealthy by virtue of containing "dangerous, non-nutritious, unhealthy partially hydrogenated oil" that the cholesterol claim is misleading. So Young sued, invoking New York and New Jersey consumer laws.

In April 2012, the federal district court granted Johnson & Johnson's motion to dismiss the complaint, ruling inter alia that Young's claims were expressly preempted by the Federal Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. § 301 et seq., which (since the adoption of the Nutrition Labeling and Education Act (NLEA) in 1990) expressly preempts any state law "requirement" regarding food labeling "that is not identical to the requirement[s]" imposed by federal law. FDA regulations "require that trans fat levels less than 0.5 grams per serving 'shall be expressed as zero.'" Thus, even if the trans fat claims were misleading under New York and New Jersey statutes, these laws could not be enforced. Young disagreed and appealed to the Third Circuit, arguing that his state consumer protection claims were not preempted because they were "not inconsistent" with FDA regulations. The alert reader has doubtless noted, however, that the statutory test is not whether state requirements are "consistent" with FDA requirements;, but whether they are "identical." Thus did the Third Circuit today affirm that NLEA pre-empts state consumer laws as regards food product labeling.

Another victory for common labeling standards for goods marketed nationally, and for amicus Washington Legal Foundation, which filed a persuasive brief for the winning side!

Podcast with Ilya Shapiro: Arizona v. U.S. - PointOfLaw Forum

Jarrett Dieterle
Legal Intern, Manhattan Institute's Center for Legal Policy

In the wake of the oral arguments in Arizona v. United States earlier this year, Ilya Shapiro, senior fellow in constitutional studies at the Cato Institute and editor-in-chief of the Cato Supreme Court Review, discussed his views on the case as part of our podcast series. We have invited Shapiro to participate in another podcast now that the case has been decided, this time to gauge his reaction to the decision.

In the podcast, Shapiro analyzes the provisions in the Arizona bill that were being contested and notes that both sides are likely to claim victory in the wake of the decision:

At the end of the day, both sides obviously are going to be spinning this in their favor. Arizona is going to say most of our law is already in place and this most controversial one - the so-called "your papers, please" thing that was demagogued - it's legal, it's constitutional. On the other hand the Administration is going to say we prevailed on three of the four, this is clearly a slap in the face to Arizona and all these other states that are taking the law into their own hands. But it's really a mixed message. [Pre-emption analysis] is very technical ... you have to really look at the technical statutory language of the state law and the federal law.

In summarizing his reaction to the decision, Shapiro emphasized the importance of federal engagement on the issue of immigration:

The broader point here is simply that ... real immigration reform has to come from Congress and from the lawmaking capacity of the federal government. Immigration is a national issue and requires a national solution. States are not capable, practically or legally, in dealing with it.

Yesterday, we featured another post-decision podcast on Arizona v. United States with Adam Freedman, a contributor at Ricochet.com and author of the forthcoming book The Naked Constitution. As the Supreme Court completes its term this Thursday, stay tuned for upcoming analysis and podcasts regarding the Court's decision on the constitutionality of ObamaCare.

FBI Stings: Combatting Terrorism or Creating It? - PointOfLaw Forum

In the fall of 2008, James Cromitie - a 45 year old Wal-Mart employee who had converted to Islam in prison on drug charges - met "Maqsood" at a Newburgh, New York mosque. Cromitie told his new friend that he felt sure he was "gonna run into something real big." Maqsood was just the person to help in this regard. As the Washington Post recently reported, and unbeknownst to Cromitie, "Maqsood" was actually Shahed Hussain, a native of Pakistan who had fled to the U.S. when he was arrested for murder in 1994. Hussain got a job as a translator for the DMV, and became an informant when he was arrested on fraud charges for helping applicants cheat on tests. By the fall of 2008, he was working for the FBI, hunting supposed "lone wolf" terrorists in the suburbs of New York. He visited the Newburgh mosque 12 times before he met Cromitie. Hussain told Cromitie that he was part of a Pakistani terrorist group, and when Cromitie told Hussain he'd "like to get a synagogue," Hussain was happy to help, even suggesting, when it appeared that Cromitie had lost interest, that Cromitie could make $250,000. Ultimately, Hussain put together a plot that resulted in the arrests of Cromitie and 3 others for planting fake bombs outside 2 synagogues.

At trial, U.S. District Judge Colleen McMahon expressed concern with the FBI's tactics. "I believe beyond a shadow of a doubt," she said, "that there would have been no crime here except the government instigated it, planned it and brought it to fruition." However, she said, "[t]hat does not mean that there was no crime." She sentenced the 4 men to 25 years in prison.

If you've followed the news for the past decade, Cromitie's case may seem familiar -- "sting" operations involving FBI informants have resulted in arrests in supposed plots to bomb the U.S. Capitol, the Washington, D.C. metro, the Sears Tower and the Portland, Oregon Christmas tree, among others. These cases are part of the government's so-called "pre-emption" strategy against terrorism, in which government agents attempt to identify individuals who might commit an act of terrorism had they the means and opportunity, and to provide those means an opportunity, in order to "neutralize such threats before they come to fruition." This strategy has become so prevalent that the FBI's stable of informants has reportedly grown by a factor of 10 since 1975. In its 2008 budget, the FBI requested more than $12 million for software to track and manage all of its informants.

Government authorities often make deals with participants in crime in order to get information necessary to prove criminal cases. But when it recruits criminals and manufactures crimes, the government enters a whole new Orwellian landscape. There may be room for on honest debate over whether it is necessary to jail individuals for their thought and beliefs in order to combat terrorism. But the tactics that landed James Cromitie -- and dozens of others -- in prison have that result, without the debate.

Around the web, April 19 - PointOfLaw Forum

  • Alien Tort Statute: Citing lack of causation, judge dismisses case tying Mideast terror to oil sales [Russell Jackson]
  • A history of federal intervention in executive pay [Bachelder, NYLJ/Harvard Corporate Governance Blog via Bainbridge]
  • McKool law firm of Dallas does well on patent-suit contingency work [WSJ Law Blog]
  • St. Clair County, Ill., nearby sibling of Madison, attracting many asbestos cases [Hartley, more]
  • Bill moving through Connecticut legislature would limit use of criminal background checks on workers [Daniel Schwartz]
  • The kind of pre-emption products liability plaintiffs adore [Beck et al]

In one of the most cogent, readily understandable explanations of the importance of federal pre-emption, Jeff Rosen and Jay Lefkowitz write in the Washington Post today a column taking President Obama to task for kowtowing to the trial lawyers. Good stuff.

Carter Wood yesterday mentioned a congressional hearing slanted in favor of those who want to change pre-emption laws governing medical devices. Hans von Spakovsky at Heritage now has a good paper on the subject. Bottom line:
"The chaos and confusion caused by subjecting manufacturers of medical devices to the varying and conflicting rules generated by individual verdicts rendered by nonmedical experts would severely damage America's health system." Good stuff.

Around the web, May 21 - PointOfLaw Forum

  • President Obama issues policy memo on preemption, tilts toward allowing more scope for state-law litigation [UPI]
  • Syracuse prof Mark Obbie discontinuing his blog on legal journalism, though a successor might choose to resume it [LawBeat, Ambrogi]
  • Widest filament dept.: "The most conservative law faculties" [Bainbridge]
  • Fine print from Washington pushes bigger government: "If state cuts too deep, it loses stimulus funds" [San Francisco Chronicle]
  • Are state auto dealership tenure laws vulnerable to a Dormant Commerce Clause challenge? [Magliocca, ConcurOp]
  • Dueling headlines: did chemical-company defendants win or lose a big Modesto groundwater contamination case? [Cal Biz Lit]

More liveblogging of DRI conference - PointOfLaw Forum

Bruce Nye at Cal Biz Lit concludes his liveblogging of a Defense Research Institute West Coast conference by summarizing several more sessions, including one on the sophisticated user defense, and another in which Dean Erwin Chemerinsky discussed pre-emption at the Supreme Court; Nye concludes with some thoughts about the distinctiveness of California product liability and toxics law. Earlier here.

Around the web, April 7 - PointOfLaw Forum

"Plaintiff's bar pushes Capitol Hill agenda" - PointOfLaw Forum

Besides their highly visible campaigns against pre-emption and consumer arbitration, they're hoping to obtain more favorable tax treatment of lawsuit settlements, destroy the confidentiality of many settlements, and open up med-mal suits by uniformed personnel against military doctors, for starters. [Legal Times]

Judge Solomon Olivier Jr. of the The United States District Court in Cleveland has just ruled that some claims against drug manufacturers are still pre-empted by FDA approval, despite the Supreme Court decision in Wyeth v. Levine.

Longs v Wyeth concerns Redux, one-half of the diet-drug cocktail known as fen-phen. Plaintiff sued for design defect, alleging that Redux was so dangerous a drug that it never should have been approved by the Food and Drug Administration. In February 2008 Judge Olivier dismissed the case on the ground that the FDA had approved Redux. The plaintiff moved for reconsideration of this decision in light of Levine.

Judge Olivier has just upheld his ruling. He distinguished Wyeth v Levine as being concerned with post-FDA-approval events. The claim against Redux was about pre-approval facts, all known to the FDA when it made its ruling that the drug was worthwhile.

New Republic: "Pre-emption games" - PointOfLaw Forum

Yale lawprof Peter Schuck declines to join in the isn't-it-wonderful media chorus about Wyeth v. Levine:

...Juries have great virtues in many kinds of cases, but making these medical cost-benefit tradeoffs is not one of them. They sit in only one case, and the plaintiff's lawyer makes sure that the severely injured, extremely sympathetic plaintiff whom they see is not representative of the much larger group of those who reap the drug's benefits when it is properly administered. The trial lawyers intentionally seek jurors who know nothing about the subject at hand. The jury's verdict is completely opaque and unexplained. It is accountable to no one. And juries in different states make different decisions on the same drug--hardly a recipe for the uniformity and predictability to which manufacturers should be entitled.

A jury's flaws are inherent in its design. In contrast, the FDA's flaws--and they are many--can at least be remedied by Congress, to which it is highly accountable.

Empowering institutionally limited lay juries to make life-and-death decisions about drugs is a foolish way to make public policy, especially when the real culprit is not the manufacturer but the malpracticing clinician. ...

Read the whole thing here.

What follows is my two cents' worth on the Wyeth v Levine case, already discussed on this blog.

First, it is important always to understand that appellate courts are bound by the procedural posture of a case. This case rose out of a plaintiff's jury verdict in a "failure to warn" suit. Now, I fully agree that there was indeed ample warning in this case. But the Vermont jury decided to the contrary, and appeals are not "do-overs" of trials. To prevail on appeal the defendant must claim that the case should never have gotten to the jury (because, the defendant Wyeth claimed, the warning's content had been pre-empted by the FDA-approved label and therefore the plaintiff's theory should not have been submitted to the jury). If there is no pre-emption, the adequacy of Wyeth's warning is for state courts, not the federal court, to decide. Therefore, and with respect, I take serious issue with that part of Justice Alito's dissent that emphasizes that the warning was adequate. That can only be obiter dictum. The Supreme Court's sole task was to determine whether there had been federal pre-emption. Discussing the content of Wyeth's warning is relevant to the absurdity of Vermont products liability law, not to the pre-emption question.

As regards pre-emption, I expected a 5-4 decision (I wasn't sure in which direction), with Justice Breyer favoring pre-emption based on his prior pragmatic approach to interstate commerce and federal regulation, and of course I was wrong on that count. I also expected Thomas to concede that the Geier v Honda case was good law, and this he did not do, enabling him to dissent on grounds of federalism. Last but not least, I found the majority's distinguishing of Geier to be almost pathetically weak and most unpersuasive.

I think the Wyeth case severely weakens the effect of Geier, possibly generally (if the court is to be principled, which I doubt, given its pre-emption history) and certainly as regards pharmaceutical litigation. Ultimately, the effect of the decision may be confined to FDA matters, because of the lack of a pre-emption clause in the statute. That clause should not make a difference, conceptually, given the logic of the Geier case, as both the dissent and Justice Thomas's concurrence maintain, but these four Justices did not prevail on this point.

Express pre-emption, all concede, occurs in "a case in which state law penalizes what federal law requires." But the Geier case (disallowing a state lawsuit based on design defect for failure to equip a Honda with an air bag, when federal regulations had required a certain percentage of Hondas to be so equipped, and Honda had complied with that regulation) saw pre-emption in "a case in which state law penalizes what federal law explicitly allows." That was precisely the case in Wyeth -- the warning deemed defective was explicitly allowed (if not mandated) by the FDA. But Geier is no more -- at least as regards the FDA.

Meanwhile, Justice Thomas's insistence on federal principles is, I think, welcome. He clearly (alone among Justices) would explicitly overrule Geier, thereby possibly forcing the hand of the federal government to expressly pre-empt state product liabiilty law if it wishes to trump state sovereignty. Thomas's concurrence is coherent, unlike Justice Stevens,' in my opinion. As for Justice Breyer's opaque concurrence, the most that can be said for it in my opinion is that it follows his increasingly explicit pragmatism -- it is unprincipled, but pragmatism disdains principles.

Supreme Court pre-emption jurisprudence has been even less satisfying, intellectually, than Supreme Court punitive damages jurisprudence. Wyeth is the latest in a back-and-forth that now brings us back to the pre-Geier days when, essentially, pre-emption was minimized. It remains to be seen whether the Court will in the future restrict Wyeth to the drug field, as I suspect, in which case an express pre-emption cause in the Food, Drug and Cosmetic Act would at last be welcome.

Around the web, February 23 - PointOfLaw Forum

  • "How a Few Radical Employment Law Changes Will Create Lots of Work for Attorneys" [NLJ]
  • Discussion of what to do with teetery banks often totally misses issue of their holding companies [Tyler Cowen, MargRev] "Regulators to Banks: We Want You To Lend, But..." [Bank Lawyer's Blog] TARP "a lousy program", says CEO of one of the Midwest's largest banks [same]
  • Stimulus bill massively expands health-privacy law, with state-AG enforcement and damage awards for patients whose privacy is impaired: lots more HIPAA liability and litigation coming up [Health Law News][HIPAA Blog]
  • More stimulus woe: "Sweeping New Whistleblower Law May Cover All Employers Who Receive Stimulus Funds" [Morrison & Foerster, PDF, JD Supra]
  • "Our view: Latest efforts to roll back Maryland's malpractice reforms are misguided" [Baltimore Sun editorial]
  • ABA views on medical device pre-emption good for prosperity of litigators, not so hot as national policy [Hillyer, D.C. Examiner]

Around the web, February 20 - PointOfLaw Forum

Around the web, February 13 - PointOfLaw Forum

  • Parol evidence rule usually seen as helping defense side in employment litigation, but not always [Workplace Prof Blog]
  • "Businesses' Data Collection: What Legal Risks Exist and Who Can Sue If Breaches Occur?" (WLF, PDF)
  • "It's hard for women lawyers to hear, but it's true": male lawyers tend to do better in mock jury experiments [Anne Reed, Deliberations]
  • Upcoming Feb. 24 webcast: Liability of Professionals in the Financial Crisis [Securities Docket]
  • NYU School of Law magazine: Roderick Hills and Catherine Sharkey on pre-emption [via Mass Tort Lit]
  • Push for broad tort reform package in South Carolina [S.C. Civil Justice Coalition]

The U.S. Supreme Court today ruled in Altria Group v. Good that a group of Maine smokers who puffed "light" cigarettes can sue Philip Morris under the state's law governing deceptive advertising. The court's 5-4 opinion is available here.

The general take so far is that the ruling is a bit of a surprise, and some theorize that it could represent the court distancing itself from federal pre-emption in other cases such as Wyeth v. Levine, regarding FDA labeling of pharmaceuticals. At least that's the contention in the WSJ Washington Wire account, "High Court to Smokers: Preemption, Shmeemption; Bring Your State Suits."

Altria issued a statement calling the "light" cases still manageable:

"While we had hoped for a dismissal based upon federal preemption, it is important to note that the Supreme Court made no finding of liability. We continue to view these cases as manageable, and the company will assert many of the strong defenses used successfully in the past to defend against this very type of case," said Murray Garnick, Altria Client Services senior vice president and associate general counsel, speaking on behalf of Philip Morris USA.

The Court said that the plaintiffs "still must prove that [the companies'] use of 'lights' and 'lowered tar' descriptors in fact violated the state deceptive practices statute."

More...

UPDATE: I should have noted the amicus brief submitted by my employers, the National Association of Manufacturers. The LegalNewsline story on today's ruling mentions it.

AEI's Roger Bate on Wyeth v. Levine - PointOfLaw Forum

Another voice on pre-emption: "abuse of the system by trial lawyers is driving safe drugs from the market and patients from mainstream medicine. The Supreme Court -- and eventually Congress -- must take a stand against these tort abuses for the sake of public health."

"Off-label" drug use and pre-emption - PointOfLaw Forum

Despite perennial hints from some quarters that off-label use of prescription drugs or medical devices is somehow subterranean or illicit, it's in fact a perfectly recognized and appropriate thing for doctors to do across much of medical practice, and there's no reason why off-label use should ordinarily deprive drugmakers of an otherwise available preemption defense, argue Beck & Herrmann.

P.S. In a second post, they discuss the current vogue for entrepreneurial qui tam lawsuits demanding vast sums to compensate for moneys states laid out for off-label uses of drugs -- and never mind that the uses may in fact have been medically beneficial to patients.

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