Tag Archives: FDA

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Update: Court Throws Out Class Action Claiming Yogurt Wasn’t “Yogurt”

activia-vanillaSeveral past Legal Pulse posts have discussed food labeling class action suits against yogurt makers, including this one on a case against Clover-Stornetta Farms for its allegedly misleading use of the term “evaporated cane sugar.” That suit is currently pending in the Food Court Northern District of California.

Another yogurt-related class action suit, this one claiming that the use of milk protein concentrate (MPC) rendered Activa yogurt misbranded, recently reached a welcome end in the Southern District of New York (Conroy v. The Dannon Company, Inc.).

Conroy alleged injury under a number of state common law theories as well as provisions of New York General Business Law. None of those theories or laws are referenced beyond the opinion’s first page; instead, Judge Vincent Briccetti devoted his analysis entirely to whether MPC is an allowable “other optional ingredient” under Food and Drug Administration (FDA) standards for “yogurt.” If it wasn’t, Conroy’s claims would no doubt have proceeded.

Had one started reading in the middle of the opinion, one would fairly think the complaining entity was FDA, not a random yogurt consumer. Judge Briccetti found that FDA’s views on yogurt were that MPC was permitted as an “other optional ingredient.” FDA’s views, Judge Briccetti wrote, were contained in “a FDA-issued memorandum from the Milk Safety Branch to all Regional Food and Drug Directors.” The document memorialized an answer given by an FDA employee at a Regional Milk Seminar to a question specifically on MPC.

A memo restating the answer to a question at an obscure seminar in 2004 circulated among regional FDA directors — not exactly our idea of good federal rulemaking practice, but enough, it seems to get a class action suit dismissed. That is what Judge Briccetti ultimately did do: grant Dannon’s motion to dismiss as well as its request that the plaintiff be prohibited from amending her complaint.

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Update: Judge in “All Natural” Food Labeling Class Action Won’t Wait for FDA Action

all naturalIn our ongoing discussion of and commentary on class actions alleging consumer fraud in food labeling,  we’ve assessed numerous cases where use of “natural” or “all natural” allegedly rendered the labeling false or misleading (our latest here and here). These crusading lawyers have rushed into the void left by the Food and Drug Administration (FDA), which has refused to issue a formal definition of “natural” for use on food labels.

Defendants in such cases have routinely argued that FDA policy statements on the meaning of natural should preempt state law-based consumer protection claims, or that courts should defer to the federal agency under the prudential “primary jurisdiction” doctrine. The preemption arguments have been unsuccessful, but some judges have put class action suits on hold and urged FDA action. Such action has not been forthcoming.

Judge Hamilton of the Northern District of California addressed these issues on May 10 in Janney v. General Mills.  The suit involves General Mills’s Nature Valley® line of products and claims that certain sweeteners in those products are not “natural.” The defendants sought dismissal based on the primary jurisdiction doctrine. They pointed to a November 2012 Northern District ruling, Astiana v. Hain Celestial,  that dismissed claims against the use of “natural” on cosmetics packaging based on FDA’s primary jurisdiction.

Though Judge Hamilton called the question “a close one,” she said General Mills’s motion must be denied “at least at this stage of the litigation.” She acknowledged the cosmetics case precedent, but reasoned that because FDA has “signaled its relative lack of interest” in defining natural, the Janney case was different from the Astiana case because FDA had “issued no guidance.” Because “any referral to the FDA would likely prove futile,” Judge Hamilton declined to stay or dismiss Janney’s suit.

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Food Class Action Suit Invokes WLF-FDA Correspondence to Prove Website Is “Labeling”

OrganicVanilla-Bean-300x300Cross-posted at WLF’s contributor page at Forbes.com

Perusing yet another class action complaint filed in the Northern District of California, Gitson v. Clover-Stornetta Farms, we were positively amused to find that on page 19, the plaintiffs’ lawyers cite a letter from the Food and Drug Administration (FDA) to WLF for the proposition that under federal law, a company’s website is definitively considered “labeling.” FDA’s letter was in response to WLF’s April 2001 petition urging the agency to establish a formal policy on the nature of information on websites like that of Clover-Stornetta Farms.

While it’s flattering that WLF’s public interest work has such enduring relevance and utility, we can’t let the plaintiffs’ invocation of FDA’s letter pass without refutation.

Clover-Stornetta Farms’s alleged transgression was to misleadingly refer to the sweetener used in some of its yogurt products as “evaporated cane juice.” Misleading or false labeling under federal law, incorporated into the California laws under which Gitson is suing, renders the product “misbranded.” And according to the complaint, because the yogurt label referred to the company’s website (which did little more than helpfully reprint the ingredient label), the website constituted labeling which equally misbranded the product. Continue reading →

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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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Federal Government Abandons Defense of Graphically Unconstitutional FDA Tobacco Warnings

nosmokingAfter obtaining extension after extension from the U.S. Supreme Court (something our Rich Samp criticized here a few weeks ago), the time had come this week for the federal government to “fish or cut bait,” as it were, on whether it would urge reversal in one case involving the FDA’s graphic tobacco warnings, and oppose certiorari in another case.

As reported by several news outlets this morning, the Department of Justice announced that it would not seek Supreme Court review of the U.S. Court of Appeals for the D.C. Circuit’s R.J. Reynolds Tobacco Co. v. FDA decision. There, the court held in a facial challenge that the tobacco warnings violated the companies’ First Amendment rights. DOJ’s decision not to pursue reversal leaves in place a powerful precedent which businesses in other industries might deploy in situations where government labeling or warning requirements go beyond disclosure of pure, noncontroversial facts. The Washington Post story noted that FDA said it would “go back to the drawing board and ‘undertake research to support a new rulemaking consistent with the Tobacco Control Act.’” So that’s the end of the controversy for now, right?

Not necessarily. The government has until Friday to respond to a petition in the Supreme Court that it review another challenge to the graphic warnings, this one an “as applied” challenge rather than a “facial” challenge. The Sixth Circuit upheld the graphic warnings in American Snuff Co. v. United States. No doubt, the Solicitor General will argue that its decision not to appeal R.J. Reynolds Tobacco Co. obviates the need for the Court to grant certiorari in American Snuff. Will the justices take the government at its word that it now realizes the warnings can’t survive First Amendment scrutiny and that FDA will “go back to the drawing board”? If one were to look at the FDA web page on the graphic health warnings, one might question FDA’s interest in giving up the fight.

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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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Alabama Justices Court Litigation Inc.’s Business with Drug Liability Ruling

Alabama Supreme Court

Alabama Supreme Court

Anyone who watches ESPN or virtually any other cable show has likely seen advertisements from law firms recruiting clients who believe they suffer from tardive dyskinesia. Lawsuits against the makers of Reglan and its generic equivalent, the long-term use of which is alleged to cause this condition, have been a growth area for Litigation Inc. In fact, if one types “tardive dyskinesia” into a search engine, the first result is http://www.tardivedyskinesia.com/, a site which according to the small print at the bottom of the home page is sponsored by The Peterson Firm.

Lawyers representing alleged dyskinesia patients have argued for years that even if their clients were prescribed the generic version of Reglan, the brand name producer of the drug should be liable under either a product liability or misrepresentation theory for failing to warn of the drug’s long-term effects. Although a few federal and state courts have accepted the theory, they have heretofore been considered outliers.

On Friday in Wyeth v. Weeks, the Alabama Supreme Court, answering a question certified to it by the U.S. District Court for the Middle District of Alabama, ruled that under Alabama law, plaintiffs can sue a brand drug maker for its alleged failure to warn patients’ physicians of harmful side effects of the drug’s generic equivalent.

Six justices concurred with Justice Bolin’s opinion, with Justice Murdock’s dissent, according to the published majority opinion “to follow.”

While you await the dissent, we encourage you to read the “majority opinion” from Washington Legal Foundation’s court opinion-style On the Merits paper from last January, where Ropes & Gray partner Douglas Hallwell-Driemeier explained why the brand drug company’s arguments should prevail.