Tag Archives: preemption

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WLF Web Seminar Program Spotlights Physician Payment Sunshine Act

PodiumPic1Washington Legal Foundation hosted a Web Seminar program yesterday, Physician Payments in the “Sunshine”: Implications of CMS Regulations for Businesses and the Future of American Health Care.

Speakers James Stansel and Meenakshi Datta of Sidley Austin LLP delved into the complicated and often vague data collection and reporting mandates required under the Physician Payment Sunshine Act and the regulations promulgated to implement it. They paid particular attention to how the mandates will impact research and development of new drugs, biologics, and medical devices, processes where physicians play an integral role.

The program is available as an on-demand file by clicking on the title above.

Click here for the slides our speakers utilized.

During the program, it was mentioned that WLF would be filing comments with CMS on the First Amendment problems with the Sunshine Act rules failing to exempt the sharing of medical textbooks and chapters of textbooks with doctors and teaching hospitals.  Those comments can be downloaded here.

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“Natural,” “Honey,” and Lots of Fruit Products: Three Wins for Food Labeling Suit Defendants

ArizonaTea_3Cross-posted at WLF’s Forbes.com contributor page

With class action lawyers still buzzing around food makers like angry gnats in summer, targets of these labeling and marketing suits welcome any instance where a federal judge gets the fly-swatter out and slaps down a case or two. Or three, as we’re about to describe.

Evidence, Why do We Need Evidence?: Ries v. AriZona Beverages. We’ve been a bit hard on the U.S. District Court for the Northern District of California (aka “The Food Court”). We’ve even been critical of Judge Seeborg’s ruling in Ries late last year. His latest ruling in this “high fructose corn syrup (HFCS) and citric acid are not ’100% natural’” class action, however, hits the spot just like cold ice tea. The defendants moved for summary judgment based on the fact that Ries had not provided evidence that HFCS and citric acid are artificial. Judge Seeborg had granted Ries discovery last September and urged her to find such evidence.

As the judge wrote in his March 28 ruling, “Plaintiffs have not introduced any evidence showing that HFCS or citric acid are artificial.” The plaintiffs urged Judge Seeborg to “take judicial notice” of the fact that federal patents have been issued for the process of producing HFCS, which they claimed proved it was not natural. The judge saw this as “an extension of their rhetoric,” and that “In the face of a motion for summary judgment, rhetoric is no substitute for evidence.” Separately the judge also found that there was not a “scintilla of evidence” to support damages in the case, and that due to the attorneys’ failure “to prosecute this action adequately,” the class action should be decertified due to inadequate representation. Continue reading →

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Ninth Circuit Advances the Ball on Preemption for Medical Devices

laserThe plaintiffs’ bar has long sought to impose duties under state law on doctors and manufacturers anytime there is an off-label use of a medical device.  In Riegel v. Medtronic, the Supreme Court held that states may provide a damages remedy for any claims that “parallel” federal requirements, so long as such an award does not interfere with the federal regulatory scheme.

In a case that will be of keen interest to the medical device industry, the Ninth Circuit recently ruled that such common law claims for off-label use against the manufacturer of a pre-market approved (PMA) medical device are impliedly preempted.

In Perez v. Nidek Corp., a putative class action plaintiff filed suit on behalf of patients who received LASIK surgery for farsightedness between 1996 and 2006.  Plaintiffs sued a group of eye surgeons and Nidek Co. Ltd., the manufacturer of a PMA surgical laser, for allegedly failing to inform patients that the laser used to perform their surgery was not specifically approved to treat far-sightedness.  (Nidek had provided the surgeons with replacement chips, which would modify the lasers to treat farsightedness).

Dismissing the suit, the 9th Circuit panel held that the plaintiffs’ common law fraud claims invaded the authority of the FDA and thus were impliedly preempted by federal law governing medical devices.  Specifically, the appeals court found that the state law claims were in conflict with the Medical Device Amendments (MDA) to the Food Drug and Cosmetics Act.  Relying on the Supreme Court’s holding in Riegel, the court rejected plaintiffs’ efforts to impose a duty on physicians and manufacturers to inform patients of any off-label use as little more than an attempt “to write in a new provision to the FDCA.”

The full opinion is available here.

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Another Grocery Basket Full of Lawsuit Claims for The Food Court

Heading to The Food Court?

Heading to The Food Court?

Cross-posted at WLF’s Forbes.com contributor page

Gum, crackers, granola, fruit punch, cheese, nuts and nut mixes, lemonade, stuffing mix, gelatin, easy bake mac-and-cheese.

A good day’s shopping for most, but for some, such as California resident Susan Ivie, this basket full of goods represents a lawsuit in the making. Ms. Ivie purchased these products, produced by Kraft Foods, Cadbury, and Back to Nature, over a four-year period. Upon discovering that those companies had, in her opinion, duped her into making those purchases through false or misleading statements, Ms. Ivie contacted some lawyers, and volunteered to be the lead plaintiff in a class action lawsuit.

Well, we’re not sure if Ivie v. Kraft Foods Global et. al actually came about that way, but a recent decision in the suit provides us another opportunity to opine about the proliferation of food labeling lawsuits and the preferred venue for these claims: The Food Court (aka the U.S. District Court for the Northern District of California). To learn more about this litigation trend and why the Northern District is so popular, read a recent story from The Recorder, coincidentally called “Welcome to Food Court“, or read our numerous past posts which use that moniker.

State-level enforcement of federal labeling rules. Ivie pleads her case under, among other laws, California’s “Sherman Laws.” Those laws explicitly adopt all federal food labeling laws and regulations. This tactic allows plaintiffs, and federal judges, to do what federal law explicitly reserves to the FDA — interpret and enforce food labeling rules. Defendants, such as Kraft, Cadbury, and Back to Nature, have tried to get such claims dismissed by arguing the “primary jurisdiction doctrine” and federal preemption. In Ivie, Judge Ronald Whyte went through Ms. Ivie’s shopping cart, item by item, and examined the defendants’ arguments. Continue reading →

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Update: Published Dissent, New WLF Paper Criticize Alabama Supreme Court’s Weeks v. Wyeth Ruling

Alabama Supreme Court

Alabama Supreme Court

In mid-January, we discussed a troubling decision from the Alabama Supreme Court, Weeks v. Wyeth.  In Weeks, 8 of the Court’s 9 justices agreed that a plaintiff allegedly harmed by a generic drug can sue the manufacturer of the branded drug on which the generic is based. The opinion noted a dissent by Justice Murdock would be forthcoming.

That dissent came out on February 4. In 45 well-reasoned pages, Justice Murdock illuminates how far the Weeks majority strayed from, as he put it, “bedrock principles of tort law,” and how dramatically out of line the decision is with an overwhelming majority of analogous state and federal court decisions.

The opinion begins by expressing an overarching principle that courts must consider when assessing legal controversies that affect commerce and industry. It’s a statement that WLF should etch into the front of our headquarters:

The law must protect the fruits of enterprise and create a climate in which trade and business innovation can flourish. Concomitantly, the law must justly allocate risks that are a function of that free trade and innovation.”

One fundamental principle of tort law which advances this allocation of risks is that businesses should only be responsible for injuries caused by their own products. There must be some relationship between plaintiff and defendant which gives rise to a duty of care to which businesses must conform. Continue reading →

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DOJ/FDA Brief in SCOTUS Generic Drug Preemption Case Hands Plaintiffs New Liability Theories

DOJ

Cross-posted at WLF’s Forbes.com contributor page

During the last four years, the Food and Drug Administration has been a faithful ally of the plaintiffs’ bar, routinely opposing any suggestion that federal approval of a prescription drug preempts a state-law tort claim against the drug’s manufacturer.  That’s why it came as surprise to some when last week the United States filed an amicus curiae brief urging the Supreme Court to rule in Mutual Pharmaceutical Co. v. Bartlett that federal law preempts design-defect claims against the manufacturer of a generic drug.  The plaintiffs’ bar need not worry, however; the amicus brief set out a detailed roadmap that explained to plaintiffs how they can avoid preemption findings in all future cases.  The roadmap was wholly gratuitous; it raised issues not presented by Bartlett, and its only apparent purpose was to help lawyers filing tort suits to draft complaints that could withstand preemption claims.

Plaintiffs already have a clear path for suing brand-name drug companies; the Supreme Court held in 2009’s Wyeth v. Levine that failure-to-warn claims against brand-name companies were not preempted, even though the warning language on product labeling has in all cases been explicitly approved by FDA.  But tort suits against generic drug companies have been more difficult to maintain.  Over the objections of FDA and the Solicitor General, the Supreme Court held in 2011’s PLIVA, Inc. v. Mensing that failure-to-warn claims against generic drug companies are preempted by federal law, primarily because generic companies have no authority to make unilateral changes to their product labels even if they come to believe that stronger safety warnings are warranted. Continue reading →

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Stengel v. Medtronic: The 9th Circuit Switches Sides on Medical Device Preemption

ReedGuest Commentary

by Matthew A. Reed, Sedgwick LLP

Mr. Reed is an associate in the firm’s Los Angeles office and author of a November 2012 WLF Legal Backgrounder, What’s The Implication? Courts And The Scope Of Implied Medical Device Preemption

Overview

The expansive view of Buckman implied preemption lost an important ally last week.  In Stengel v. Medtronic Inc., — F.3d —, 2013 WL 106144 (9th Cir. Jan. 10, 2013), the en banc Ninth Circuit held, contrary to a previous ruling by its 3-judge panel, that Buckman v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001), did not impliedly preempt a state-law failure-to-warn claim predicated on alleged regulatory violations.  The legal grounding for the court’s preemption analysis in reaching that conclusion is difficult to discern.  The overarching message, however, is not: Buckman is now construed quite narrowly in the Ninth Circuit.

Background

In Stengel, plaintiffs brought four state tort law claims involving Medtronic’s Class III, premarket-approved pain pump, alleging it had caused Richard Stengel’s paralysis.  Medtronic moved to dismiss those claims as expressly preempted by the Medical Device Amendments (“MDA”) to the Food, Drug and Cosmetic Act (“FDCA”).  While that motion was pending, the Stengels sought to amend their complaint by alleging that each cause of action was triggered by Medtronic’s failure to report injury information to the FDA, as required by FDA regulations.  The district court granted Medtronic’s motion under Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), because the original claims asserted violations of state tort law with no allegation that Medtronic violated FDA regulations, and thus the state claims were different from or additional to FDCA requirements.  Conversely, it denied the Stengels’ motion to amend as a matter of law, because the new claims alleging regulatory violations were impliedly preempted under Buckman. Continue reading →

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The Food Court Stays Open: Preemption Defense in Food Labeling Class Action Rejected

Cruz-Alvarez_FStorch_TGuest Commentary

by Frank Cruz-Alvarez and Talia M. Zucker, Shook, Hardy & Bacon L.L.P.

On November 9, 2012, the United States District Court for the Northern District of California, dubbed “The Food Court” by this blog, struck again – and this time, not in favor of food manufacturers.  In Khasin v. The Hershey Company, the federal district court rejected preemption of a nutrient content claims-based class action.

In this putative class action, Plaintiff contends that The Hershey Company made unlawful nutrient content claims on the label of its food products.  In moving to dismiss the class action, Hershey made several arguments, including preemption, addressed below.

First, Hershey maintained that a private right of action to enforce labeling requirements was barred by the Food, Drug, and Cosmetic Act (“FDCA”).  Finding this argument inapposite, the court observed that Plaintiff was not suing to enforce the federal statute, but rather his action was founded on parallel state laws that prescribed labeling requirements similar, if not identical, to the FDCA’s requirements.  And, in cases of this kind, courts have refused to find that preemption precludes the private, state-based causes of action because “the state duties in such a case ‘parallel,’ rather than add to, federal requirement.” (citation omitted).  In reaching this conclusion, the court found Hershey’s application of Pom Wonderful LLC v. Coca-Cola Co. irrelevant because Plaintiff did not bring a cause of action based on the federal FDCA, but rather state law, unlike the plaintiff in Pom. Continue reading →

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Judges Help Lawyers Circumvent SCOTUS Generic Drug Preemption Ruling

Guest Commentary

by Kelly Day Savage, Sedgwick LLP*

Many commentators (including this one) correctly predicted that savvy plaintiffs and sympathetic courts would create exceptions to the Supreme Court’s decision in PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011)– that state-law tort claims against manufacturers of generic drugs based on insufficient product warnings are preempted by federal law–to permit plaintiffs to recover damages in otherwise barred actions.

In Whitener v. PLIVA, Inc., No. 10-1552, 2012 WL 3948797, at *4 (E.D. La. Sept. 10, 2012), the Federal District Court for the Eastern District of Louisiana created yet another legal loophole by permitting “a state-law tort claim based on alleged promotion of metoclopramide [the generic version of Reglan] for off-label purposes in violation of federal law” to escape preemption on defendants’ motion to dismiss. Continue reading →

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American Trucking Ass’n v. Los Angeles: Preemption at Issue in SCOTUS Appeal

Guest Commentary

Hon. James H. Burnley IV, Venable LLP*

On March 26, the U.S. Supreme Court invited the Solicitor General of the United States to weigh in on whether the Court should review the U.S. Court of Appeals for the Ninth Circuit’s decision in American Trucking Associations, Inc. v. City of Los Angeles, California, et al. (No. 11-798).  This case and recent development should be of interest to any business that relies upon federal preemption.  They should find disturbing the Ninth Circuit’s insistence on neutering the effect of preemption through narrow construction of statutory text and broad construction of exceptions that cannot be found in text and have no place in the preemption analysis.  In effect, the Ninth Circuit has again ignored the express written determination of Congress and substituted its judgment to favor a limited number of special interest groups. 

This case began as a result of the Ports of Los Angeles and Long Beach adopting Concession Plans that impose mandates on trucks and operators doing business at the ports as part of the Ports’ Clean Trucks Program.  Purportedly aimed at improving the surrounding environment, the initiative contained mandates wholly unrelated to the environment, such as a mandate to use only employee drivers – thus banning owner-operators.  Other provisions that directly regulated motor carriers included:  1) submitting an off-street parking plan with parking locations for all permitted trucks; 2) ensuring maintenance according to manufacturer’s specifications; 3) posting placards on permitted trucks with number for the public to call with concerns about emissions, safety, and compliance; and 4) demonstrating to the Port’s satisfaction that the concessionaire is financially capable. Continue reading →