Cross-posted at WLF’s Forbes.com contributor site
When some future legal scholar writes the history of how the public health activist-plaintiffs’ bar-government regulator axis of paternalism tried to use litigation to alter America’s food choices, S.F. v. Archer Daniels Midland et al. may not even merit a mention. But for now, it stands as the most notorious illustration of how a baseless lawsuit can effectively demonize one disfavored food ingredient.
The Complaint. S.F. is the mother of S.E.F., a fourteen-year old who suffers from Type 2 diabetes. Archer Daniels Midland (ADM) and the other three defendants (Cargill, Ingredion Inc., and Tate & Lyle Ingredients Americas) make up the entire corn refiners industry. They refine corn into, among other things, high fructose corn syrup (HFCS), a food ingredient public health activists have long vilified. In her complaint, S.F. rattled off inflammatory allegation after another, including such unsubstantiated charges as “HFCS is a toxin.” She eventually got around to asserting that HFCS is “unreasonably dangerous” and caused her daughter’s diabetes. She demanded $5 million in damages.
The suit achieved its immediate, and perhaps only, goal of garnering sympathetic media attention. Most reports parroted the plaintiff’s outlandish statements and quoted professional food activists who are attacking HFCS in others venues, such as before the Food and Drug Administration (FDA). Of course only scant reporting has been done on the suit since, with just a few stories in the trade press about the defendants’ motions to dismiss, documents which have effectively exposed the suit as legally and factually baseless.
Undeniable Legal Flaws. The legal flaws in the plaintiff’s case, detailed in the defendants’ initial motion to dismiss and their November 1 reply memo, are abundant and clear, so we’ll only briefly summarize them here: Continue reading
Last Friday just prior to the Veterans’ Day weekend, the Food and Drug Administration (FDA) issued a highly anticipated notice of proposed rulemaking which addresses the U.S. Supreme Court’s 2012 decision, PLIVA v. Mensing. The proposal, Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products, was introduced by Dr. Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research, in an FDA Voice blog post. The proposal, according to her, is “intended to improve the communication of important drug safety information about generic drugs to both prescribers and patients.”
As emphasized in a New York Times story about the proposal, “The rule would also pave the way for lawsuits from patients who could now claim that generic companies did not sufficiently warn them of a drug’s dangers.”
As WLF’s Rich Samp argued here last August in Can FDA Lawfully Overrule SCOTUS Generic Drug Preemption Decision Through Regulation?, WLF doubts that FDA has the authority under federal law to take such an action. We look forward to participating in the regulatory process and the accompanying debate that will intensify now that FDA has formally proposed the rule.
Cross-posted at WLF’s Forbes.com contributor page
For the past two years, plaintiffs’ lawyers have nourished The Legal Pulse with a steady diet of all-natural lawsuits. And by that we mean class actions alleging that the use of “natural” or “all natural” on a food product label is false or misleading under state law (normally, California law). Other than the occasional decision to put a lawsuit on hold so the Food & Drug Administration (FDA) can provide a formal definition for “natural” (which it has yet to do), these claims have mostly survived defendants’ efforts to dismiss them.
However, with four courts issuing decisions favorable to defendants in the past three months, these “all natural” claims may have become less appetizing.
Claims Rejected at Motion to Dismiss Stage. In order to prevail on claims that defendants’ use of “natural” violated California law, plaintiffs must prove that “reasonable consumers” relied on the claim and were deceived by it. Whether a business practice is deceptive normally presents a question of fact for a jury. But under California case law, judges in some instances can determine that as a matter of law, consumers are unlikely to be deceived. One area where judges have taken such action at the motion to dismiss stage is product packaging claims.
We’ve previously discussed Northern District of California Judge Koh’s opinion in Kane v. Chobani, the first of two recent rulings to dismiss a “natural” claim. Judge Koh ruled that because yogurt labels clearly disclosed the use of fruit or vegetable juice concentrate, the plaintiffs could not plausibly have been misled by Chobani’s “all natural” representation. Continue reading
Cross-posted at Forbes.com’s WLF contributor page
Washington Legal Foundation, along with other organizations, business, and individuals with an interest in the Supreme Court and free enterprise cases before it, watched with great anticipation this morning as the justices issued their first new list of certiorari grants since the Court adjourned last June (the so-called Long Conference). We came away from the big cert grant morning, as likely did many other interested parties, wanting more.
The orders list is here. The grants include a tax case, United States v. Quality Stores addressing whether severance payments made to employees whose employment was involuntarily terminated are taxable. Two other grants relate to the standard of review the U.S. Court of Appeals for the Federal Circuit uses when assessing a district court’s determination that a case is “exceptional” for purposes of imposing attorneys’ fees and other sanctions. Those cases are Octane Fitness v. Icon Health and Fitness and Highmark Inc. v. Allcare Management Systems Inc.
The final cert grant impacting free enterprise is Petrella v. MGM, which involves the movie Raging Bull and the defense of laches against claims of copyright infringement. Marcia Coyle at National Law Journal discussed the interesting facts of the case in a September 16 story.
The bigger story from the big cert grant morning was which petitions the Court did not act on. WLF filed amicus briefs in support of review in a number of the cases, which we’ll indicate below (all noted on SCOTUSblog’s “Petitions we Are Watching” page).
Failure to act on these and other petitions does not mean that the Court cannot reconsider them in a future “conference,” and it does not mean that they have been denied. The Court will be issuing an order list on First Monday, October 7, but that order traditionally has only contained cert denials.
by Chip English, Davis Wright Tremain LLP
Childhood obesity is a substantial problem worthy of serious discussion. Unfortunately, legislators also appear to see it as an issue worthy of unsound and unconstitutional legislative action. On July 25, 2013, Representative DeLauro, together with Representatives Lee, Defazio, Clay and Grijalva, introduced the most recent example of this food police problem. H.R. 2831 would “deny any [IRS tax] deduction for marketing directed at children to promote the consumption of food of poor nutritional quality.” The proposed legislation is both vague and overbroad and, more importantly, is an unconstitutional content, speaker, and audience targeted “tax on knowledge.” H.R. 2831 cannot withstand First Amendment scrutiny. Moreover, the proposal raises equal protection and arbitrary and capricious government action issues because government Speech Police would determine which marketing is “directed at children” and which food is of “poor nutritional quality.”
HR 2831 would amend the Internal Revenue Code to deny a broad array of travel, goods or services, gifts and other promotional expense deductions associated with “marketing directed to children” (persons under the age of 18) of “poor nutritional quality” foods. The Secretary of the Treasury, in consultation with the Secretary of Health and Human Services, would determine which foods are of poor nutritional quality by considering which foods are “inconsistent with the most recent Dietary Guidelines for Americans under section 301 of the National Nutrition Monitoring and Related Research Act of 1990 (7 U.S.C. § 5341).” Leaving aside the policy question of whether the IRS, which is still dealing with determinations of which organizations qualify for charitable organization status, should be involved in determining which foods are of poor nutritional quality, government determinations of what marketing is “directed at children” and what food products are “inconsistent” with Dietary “Guidelines”, will inevitably be arbitrary and capricious because those terms are vague and ambiguous. Continue reading
Cross-posted at WLF’s Forbes.com contributor page
With the October 1 date for open enrollment in ObamaCare health insurance exchanges rapidly approaching, the handful of states which agreed to run the exchanges are relying on everything from football teams to storied folk legends to spread the word. In the 36 other states that the federal government is in charge for now, outreach and education will be done by “Navigators,” a fancy term for taxpayer-funded community helpers. Though the Navigator program has yet to begin, many elected officials have raised serious concerns over whether it sufficiently prevents Navigators from helping themselves to sensitive consumer information. October 1 is just 26 days away, and those valid privacy concerns remain unaddressed.
$67 Million with Scant Privacy Strings Attached. The Department of Health and Human Services, which just two weeks ago doled out $67 million to 100 organizations for ObamaCare navigation, has ignored letters from congressional committee chairmen and state attorneys general criticizing the Navigator program’s severe privacy shortcomings. The rule governing the Navigator program, finalized just this past July, offers broad principles and platitudes about data quality and integrity, but few clear standards for ensuring the privacy of health records, social security numbers, and other patient information. It neither requires background checks nor dictates that any prior criminal act (such as, perhaps, identify theft) would per se disqualify a Navigator applicant. There are no licensing requirements, no obligations that Navigators or their employers carry liability insurance, and no provisions holding any entity, including HHS, responsible for data breaches. It’s not even clear whether HHS will assist an ObamaCare insurance exchange customer who is defrauded. Continue reading
Cross-posted at WLF’s Forbes.com contributor page
Last week, pharmaceutical products and services company Novo Nordisk petitioned the U.S. Court of Appeals for the Federal Circuit to rehear en banc a June 18 Federal Circuit panel ruling that invalidated a Novo patent (Novo Nordisk A/S v. Caraco Pharm. Labs; 2-1 with Judge Newman in dissent). Because the panel misapplied Patent Act § 103‘s standards for obviousness to Novo’s “combination drug,” the Federal Circuit should agree to rehear the case en banc and reverse the three-judge panel.
Background. In 1994, a Novo scientist conceived of an unorthodox way to improve a drug-based therapy for Type II diabetes. The scientist combined metformin, a compound that targets the liver’s sensitivity to insulin, with an insulin stimulator compound called repaglinide. The goal was to extend the amount of time that metformin worked in a patient’s body. The use of repaglinide was controversial for two reasons: 1) combinations of metformin and other insulin stimulators from a “genus” different from that of repaglinide (such as sulfonylurea) offered mixed results; and 2) research showed that repaglinide was eliminated from the body within one hour of use.
Hence, the synergy of the 1994 metformin-repaglinide combination was astonishing. The combination was eight times more effective than administering metformin alone. In other words, it led to an 800% increase in reducing diabetes patients’ fasting plasma glucose (FPG) over an eight-hour period. To this day, there is no scientific explanation for this synergistic effect. Continue reading
Cross-posted at WLF’s Forbes.com contributor page
In its June 2013 decision Mutual Pharmaceutical Co. v. Bartlett, the Supreme Court forcefully repeated what it said in 2011: federal law bars States from imposing tort liability on the manufacturer of a generic drug for providing allegedly inadequate warnings regarding health risks associated with use of the drug. The federal government—which embraces the tort bar’s mantra that every injured consumer ought to have a sporting chance of recovering damages from at least one deep-pocketed defendant—immediately responded by announcing plans to propose new regulations designed to overrule Bartlett. The details of the new regulations have not yet been disclosed. It is nonetheless highly unlikely that such regulations could survive a court challenge. The Hatch-Waxman Act, adopted by Congress in 1984, simply does not authorize the Food and Drug Administration to adopt the sort of regulations that it apparently has in mind.
Bartlett determined that federal law preempts the state-law failure-to-warn cause of action at issue in the case because the latter conflicts with federal law: it would be impossible for the generic manufacturer (Mutual Pharmaceutical Co.) to comply with the labeling requirements imposed on it by state law while also complying with federal law. The plaintiff was a New Hampshire resident who developed toxic epidermal necrosis, which caused much of her skin to burn off, after taking generic sulindac manufactured by Mutual. A jury awarded her $21 million in damages because, it determined, sulindac was defectively designed in light of Mutual’s failure to provide adequate warnings regarding the drug’s side effects. Continue reading
by Neha Casturi, a 2013 Judge K.K. Legett Fellow at the Washington Legal Foundation and a student at Texas Tech School of Law.
A federal district court in California is addressing an important issue of first impression: whether the “learned intermediary” doctrine applies in a consumer class setting. In Saavedra v. Eli Lilly & Co., the plaintiffs alleged that the warning labels on a popular anti-depression, anti-anxiety drug, Cymbalta, were inadequate. The June 13th ruling discussed the viability of the learned intermediary defense in consumer class actions, and also focused the parties on whether the court could certify the class under federal procedural rules.
The allegedly defective Cymbalta label warned consumers that in clinical trials, adverse effects upon “abrupt or tapered” discontinuation were possible. Additionally, the label warned that other Cymbalta-like drugs had the tendency to produce adverse effects upon discontinuation. The Saavedra plaintiffs allege that those warnings did not adequately inform consumers or healthcare providers of the “frequency, severity, and/or duration” of withdrawal symptoms. Plaintiffs have brought their suit under the consumer protection laws of four different states and seek certification of a class action.
Eli Lilly sought summary judgment, and Judge Wilson of the Central District of California instructed the parties to limit their motions to whether the learned intermediary doctrine applied. This doctrine holds, as the Saavedra court related, that a “drug manufacturer cannot be liable for failing to warn the ultimate consumer of potential side-effects of prescription medication, so long as adequate warnings are given to the prescribing physician.” Continue reading
by Sara Norman, a 2013 Judge K.K. Legett Fellow at the Washington Legal Foundation and a student at Texas Tech School of Law.
New Yorkers will still be able to purchase large fountain drinks at restaurants, movie theaters, and stadiums thanks to the New York State Supreme Court, Appellate Division’s unanimous opinion that the Portion Cap Rule was an overreach of executive power.
The brain child of New York City Mayor Michael Bloomberg and City Health Commissioner Thomas Farley, the Portion Cap Rule (aka “soda ban”) would have prohibited the sale of sugary sodas and energy drinks over 16 ounces in many, but not all, city venues. The city officials viewed large soft drinks as an unnecessary evil that contribute to obesity.
The appeals panel took a different approach to the soda ban than did Justice Milton Tingling in her lower court opinion. Whereas Justice Tingling struck the ban down as arbitrary and capricious, Justice Renwick relied upon the separation of powers doctrine in her ruling. She held that the power to impose such a ban resides solely with the legislature (the New York City Council, in this instance) rather than an administrative agency such as the Department of Health. WLF had similarly warned in its comments on the soda ban that the Mayor and his agencies could not engage in such legislative action.
As Justice Renwick pointedly reminded the Department, “14 members of the New York City Council wrote to the Mayor opposing the proposal and insisting that, at the very least, it should be put before the Council for a vote. This did not occur.” Continue reading