Morrison Foerster’s Class Dismissed blog provides insights, recommendations, and timely reports on the latest defense news, developments, and trends in the most current class actions lawsuits and product liability issues that affect consumer-facing companies. Through Class Dismissed, attorneys from our nationally recognized Consumer Class Action and Products Liability practices offer a real-time assessment of the developments in matters that are shaping the industry. This blog examines the full spectrum of consumer-related class action and product liability lawsuits ranging from false advertising, privacy, consumer product safety, ADA, food misbranding, TCPA, environment, retail, and government actions as well as nationwide and multidistrict litigation class actions.<h2>ABOUT MORRISON FOERSTER</h2>Morrison Foerster is a leading global law firm that transforms complexity into advantage for its clients. Our clients include some of the largest financial institutions, banks, consulting and accounting firms, and Fortune 100, technology, and life sciences companies. Highlighting the firm’s commitment to client service, leadership in market-changing deals and impact litigation, and values-based culture, Morrison Foerster has been repeatedly recognized as one of the top 10 firms on The American Lawyer’s A-List. Year after year, the firm receives significant recognition from Chambers and The Legal 500 across their various guides, including Global, USA, Asia‑Pacific, Europe, UK, Latin America, and FinTech Legal. Our lawyers passionately care about delivering legal excellence while living our values. Morrison Foerster has a long-standing commitment to creating a culture that respects and celebrates differences, while providing an inclusive environment. The firm has achieved Mansfield Certification Plus since 2018 as a result of successfully reaching at least 30 percent women, communities of color, and LGBTQ+ lawyer representation in a notable number of current leadership roles and committees. The firm also has a long history of commitment to the community and society through providing pro bono legal services, including litigating for civil rights and civil liberties, improving public education and fostering the wellbeing of children, advocating for veterans, promoting international human rights, enforcing the right to asylum, and safeguarding the environment.

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Partner

Julie Park protects her clients’ products no matter what kind of product issue they face—whether it is planning for new product development, recalling an existing product, or defending clients against product liability or consumer class actions. Drawing on her deep technical and legal expertise, Julie counsels clients on consumer product safety regulation and pharmaceutical and medical device preemption while also managing complex and multijurisdictional litigation both in state and federal court.

Julie Y. Park

<div class="videoWrapper"><iframe frameborder="0" class="sticky-video" allowfullscreen="1" title="Meet Penny Preovolos, Litigation Partner" src="https://www.youtube-nocookie.com/embed/hv7hYn-Bl7c?rel=0&showinfo=0;vq=hd1080" title="iframe"></iframe></div>Penelope has served as lead counsel in major consumer class actions and antitrust cases for more than 35 years, successfully representing high-profile defendants in antitrust, consumer fraud, and product defect matters. Her clients span a range of industries, including consumer electronics, technology, retail, publishing, food and beverage, cosmetics, and household products. According to Chambers USA, Penelope has a “great reputation for antitrust and product liability work” and is a “superb all-around antitrust lawyer.”Penelope was named the 2019 Antitrust Lawyer of the Year by the Antitrust, UCL, and Privacy Section of the California Lawyers Association. She was co-chair of MoFo’s antitrust practice for 14 years. She has served as chair of the Antitrust and Trade Regulation Section of the State Bar of California and as a member of the Ninth Circuit Advisory Committee on Local Rules and Operations. She is an editor of and frequent contributor to Morrison & Foerster’s <a href="https://classdismissed.mofo.com/">Class Dismissed blog</a>, as well as a frequent speaker about class action and antitrust issues.More About PenelopePenelope clerked for the Honorable Charles M. Merrill, United States Court of Appeals for the Ninth Circuit. She graduated cum laude from Harvard Law School, where she was executive editor of the Harvard Civil Rights – Civil Liberties Law Review. Penelope was a member of Phi Beta Kappa at the University of California, Berkeley. She was awarded the University Medal, the highest undergraduate honor at the university, as well as the English Departmental Citation (awarded to the outstanding graduate in that department).

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Senior Counsel

Penelope has served as lead counsel in major consumer class actions and antitrust cases for more than 35 years, successfully representing high-profile defendants in antitrust, consumer fraud, and product defect matters. Her clients span a range of industries, including consumer electronics, technology, retail, publishing, food and beverage, cosmetics, and household products.

Penelope A. Preovolos

Claudia focuses her practice on the defense of consumer class actions and on complex commercial litigation, including unfair business competition, false advertising, product liability, and privacy matters. She is currently representing numerous consumer goods manufacturers and retailers in false advertising and mislabeling class action lawsuits. Claudia also regularly counsels clients in the food, cosmetics, retail, and technology industries. She represents companies in false advertising disputes before the National Advertising Division (NAD) of the Council of Better Business Bureaus, Inc.<h5>More about Claudia</h5>Claudia is active in MoFo’s pro bono efforts, and recently traveled to El Paso, Texas, to work with families separated and detained at the border. She is also supervising a pro bono collaboration with Equal Rights Advocates, a nonprofit fighting for gender justice in work places and schools across the country. The initiative will help students who have been victims of sexual assault, attempted assault, or harassment find support and seek justice. Claudia is also a board member of Bay Area Legal Aid and a former board member of Equal Rights Advocates. Claudia is an editor and frequent contributor to MoFo’s <a href="https://classdismissed.mofo.com/">Class Dismissed</a> blog, which provides reports about the latest defense news, developments, and trends in class action lawsuits and product liability issues that affect consumer-facing companies. Her perspectives are also respected in the larger legal community: Claudia has published articles about class action and false advertising issues, and is a co-author of Chapter 7 — “Unfair Competition in California Business Litigation 2016” — of The Recorder. She also regularly speaks at conferences on class action and advertising trends. Claudia is currently serving as a Lawyer Representative for the Northern District of California. She received her J.D. degree in 2004 from Berkeley Law (Boalt Hall School of Law), where she was an associate editor of the Berkeley Technology Law Journal.

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Claudia focuses her practice on the defense of consumer class actions and on complex commercial litigation, including unfair business competition, false advertising, product liability, and privacy matters. She is currently representing numerous consumer goods manufacturers and retailers in false advertising and mislabeling class actions.

Claudia M. Vetesi

Alexandra Barlow is a partner in the Litigation Department of Morrison Foerster’s San Diego office.Alexandra litigates product liability matters involving medical devices, pharmaceuticals, consumer products, automobiles, and AI. Alexandra's litigation expertise spans the entire case life cycle in both state and federal courts. She handles all phases of discovery, including fact investigation and expert discovery. Alexandra has taken over twenty-five depositions, including experts, plaintiffs, treating physicians, and third-party witnesses. She drafts and argues motions of all types, including motions for summary judgment, motions to quash, and motions for preliminary injunction.Alexandra has significant trial experience. She has first-chaired a one-week jury trial and second-chaired a five‑week jury trial, both involving multiple claims and witnesses. She also has extensive experience in alternative dispute resolution, representing clients at mediations, mandatory settlement conferences, and early neutral evaluations.Alexandra enjoys tracking developments and keeping her clients updated on product liability and personal injury claims, frequently writing or presenting on emerging areas such as autonomous vehicles and smart devices. Alexandra’s experience also extends to professional liability, warranty claims, eminent domain, and construction law.Alexandra earned her J.D. from the University of San Diego School of Law. While in law school, the San Diego Law Review published her comment on the recovery of damages by plaintiffs in a persistent vegetative state, and she also served as a comment editor. She received her B.A. from the University of California, Los Angeles, where she majored in Political Science and minored in Spanish. A San Diego native, she attended a Spanish immersion school through the eighth grade. Alexandra is active in the San Diego community, advising students at a local college. She is also a member of several legal organizations in San Diego, including Lawyer’s Club, the Association of Business Trial Lawyers, and Wallace Inn of Court.

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Alexandra Barlow is a partner in the Litigation Department of Morrison Foerster’s San Diego office. Alexandra litigates product liability matters involving medical devices, pharmaceuticals, consumer products, automobiles, and AI. Alexandra’s litigation expertise spans the entire case life cycle in both state and federal courts. She handles all phases of discovery, including fact investigation and expert discovery. Alexandra has taken over twenty-five depositions, including experts, plaintiffs, treating physicians, and third-party witnesses. She drafts and argues motions of all types, including motions for summary judgment, motions to quash, and motions for preliminary injunction.

Alexandra Barlow is a partner in the Litigation Department of Morrison Foerster’s San Diego office. Alexandra litigates product liability matters involving medical devices, pharmaceuticals, automobiles, AI, and robotics. Alexandra's litigation expertise spans the entire case life cycle in both state and federal courts. She handles all phases of discovery, including fact investigation and expert discovery. Alexandra has taken over twenty-five depositions, including experts, plaintiffs, treating physicians, and third-party witnesses. She drafts and argues motions of all types, including motions for summary judgment, motions to quash, and motions for preliminary injunction.

Alexandra Barlow

Adam J. Hunt is a partner in the Litigation Department of Morrison Foerster’s New York office. His practice focuses on complex litigation, with an emphasis on class action and commercial litigation.Mr. Hunt has extensive experience representing consumer products companies, financial institutions, and technology firms in class action cases and complex commercial disputes before state and federal trial courts, as well as in arbitrations. Clients seek Mr. Hunt’s counsel for his creative, strategic thinking in high-stakes, high-profile matters. He has represented clients facing claims under false advertising, antitrust, and privacy laws throughout the country, securing wins at the pleading stage, summary judgment, and trial, in addition to negotiating favorable settlements, often early in the case. Representative experience includes successfully securing rulings dismissing two putative false advertising class action cases against one of the best-known consumer electronics companies in the world; obtaining a complete win on summary judgment for a major shipping and logistics company in a multimillion-dollar commercial dispute; appearing as counsel at trial for a leading financial institution in a $100 million commercial dispute, winning a bench trial verdict; and prevailing on motions to dismiss false advertising class actions against a leading Greek yogurt company.Mr. Hunt is also an editor of the firm’s <a href="https://classdismissed.mofo.com/" target="_self">Class Dismissed blog</a>, which provides insights, recommendations, and timely reports on the latest defense news, developments, and trends in the most current class action lawsuits that affect consumer-facing companies.Mr. Hunt maintains an active pro bono practice and is the recipient of the New York State Bar Association’s 2017 President’s Pro Bono Service Award for the First Judicial Department, the 2018 Public Service Award from New York University School of Law, and Morrison Foerster’s Kathi Pugh Award for Pro Bono Services.Mr. Hunt received his B.A. with honors from Swarthmore College and his J.D. cum laude from New York University.

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Adam Hunt is a partner in the Litigation Department of Morrison Foerster’s New York office. His practice focuses on complex litigation, with an emphasis on class action and commercial litigation.

Adam Hunt

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Alexandra Preece Barlow

Adam J. Hunt

Right-to-Repair Laws: The Trend Continues

The Future of Section 230: Protection Against Product Liability Claims?

New Wave of PFAS Legislation Aimed at Consumer Products

CPSC Releases Annual Report on Deaths and Injuries Involving Nursery Products

CPSC Proposes New Safety Rules for Infant Rockers

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The U.S. Food and Drug Administration (FDA) recently released a draft guidance document with the goal of facilitating certain updates to abbreviated new drug application (ANDA) labels. In particular, the draft guidance addresses updates to ANDA labels where the product’s reference listed drug (RLD) was withdrawn for reasons other than safety or effectiveness, providing insight on the responsibilities of ANDA holders to update their drug labels and the processes for doing so.

Fertility Center Litigation

Fitbit

MicroPort

Leading Healthcare, Pharmaceutical, and Medical Device Company

Lethal Injection Matters – Major Pharmaceutical Company

Pain Pump Matters – Large Pharmaceutical Company

Major Technology Company

Leading Chemical Company

Security Device Company

In re Air Crash Near Peixoto de Azevedo, Brazil

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Erin Bosman is chair of MoFo’s Class Actions and Mass Torts Practice Group and is a founder and co-head of the Artificial Intelligence Group. Clients value her business strategy, seeking her comprehensive counsel throughout the product life cycle, especially in high-stakes litigation and product recalls.

Erin M. Bosman

Erin Bosman is chair of MoFo’s Class Actions and Mass Torts Practice Group and is a founder and co-head of the Artificial Intelligence Group. Clients value her business strategy, seeking her comprehensive counsel throughout the product life cycle, especially in high-stakes litigation and product recalls.

Erin Bosman

An orthopedic implant company

A children&rsquo;s monthly subscription service product

A fertility company

A major technology company

A smart fitness equipment company

Julie Park provides analytic and strategic counsel for issues in product life cycle, product liability and defective products, consumer class actions, and more.

Julie Park

Julie Park | Product Liability Lawyer

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Brittany Scheinok is an associate in the Litigation Department of the firm’s San Diego office.

Brittany Scheinok

FDA Releases Draft Guidance For Updating Generic Drug Labels

The U.S. Food and Drug Administration (FDA) recently released a draft guidance document with the goal of facilitating certain updates to abbreviated new drug ap

FDA Releases Draft Guidance For Updating Generic Drug Labels

The FDA recently announced that it would once again delay promulgation of its proposed rule for generic drug labeling obligations. This action followed introduction of a spending bill that would have blocked funding for the rule in its current form.The rule, originally proposed in 2013, directly responds to the holding in PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011). There, the Supreme Court held that federal law preempts certain failure-to-warn claims against generic drug manufacturers because generic labels cannot deviate from their brand-name equivalents. Consumer groups felt this was an unjust result. In many cases it left those injured by generic drugs without any remedy.In order to address what the Supreme Court labeled the “unfortunate hand that federal drug regulation has dealt” to generic drug users, the FDA’s proposed rule would allow generic drug manufacturers to update product warnings with new safety information, even if the revised labeling differs from the branded labeling. This would drastically change the pharmaceutical landscape, as currently only brand-name drug makers can revise warning labels without prior FDA approval. While the proposed rule would “permit” generic drug manufacturers to update their labels, in reality such a change would constitute a requirement due to the likely liability implications should a generic drug manufacturer fail to do so.This latest delay follows on the heels of recent congressional action directed toward the proposed rule. In April, the House Appropriations Committee introduced a congressional spending bill for 2017 that creates a serious roadblock for the proposed rule. The bill states that no funds will be made available to the FDA to finalize or implement the proposed rule unless the final version requires prior FDA approval for any change to a generic drug label. Clearly, members of the predominately Republican House Appropriations Committee agree with those industry groups and companies who have expressed grave concerns over the rule as currently drafted. Those who disagree with the proposed rule believe it would cause confusion and jeopardize patient safety due to the potential for conflicting labels. Requiring prior FDA approval would ensure consistency while still requiring generic manufacturers to maintain responsibility for safety warnings.On May 18, the FDA issued a notice that the date of publication of the rule has been extended until April 2017. This is the third delay since the FDA originally proposed the rule in 2013.<a name="_ftnref1" href="#_ftn1">[1]</a> An FDA spokeswoman commented that the extension reflects “ongoing work” but was not more specific. While the FDA has not commented on the spending bill, it seems highly likely that the latest delay is directly related and that the rule will be revised before it is finalized. We will continue to monitor future progress and provide updates accordingly. <a name="_ftn1" href="#_ftnref1">[1]</a> FDA Proposed Rule in Flux?; $4 Billion Price Tag for Pleasing Plaintiffs’ Bar? New Study Estimates Costs of FDA’s Proposed Rule on Generic Drug Labeling; Goodbye to Generic Preemption? FDA Publishes Proposed Rule.

Still Waiting—FDA Delays Rulemaking

The FDA recently announced that it would once again delay promulgation of its proposed rule for generic drug labeling obligations. This action followed introduc

Still Waiting—FDA Delays Rulemaking

As we have previously reported, FDA is currently seeking public comments on the use of the term “natural” on food labeling (see our previous post <a href="http://classdismissed.mofo.com/food-misbranding/california-supreme-court-opens-the-door-to-organic-mislabeling-claims/">here</a>).  The announcement came as a surprise since FDA had previously declined requests from consumers, the food industry, and federal judges to define the term.  In another surprise move, on April 12, 2016, FTC announced that four companies advertising their personal care products as “all natural” or “100% natural” agreed to settle FTC charges that their ads were false and misleading because the products contained synthetic ingredients.<a href="#_ftn1" name="_ftnref1">[1]</a>The products included:<ul><li>ShiKia’s “All Natural Hand and Body Lotion” and “All Natural Moisturizing Gel,” which allegedly contain dimethicone, dthyhexyl glycerin, and/or phenoxyethanol;</li><li>Rocky Mountain Sunscreen’s “Natural Face Stick,” advertised as “all natural,” which allegedly contains dimethicone, polyethylene, and other synthetic ingredients;</li><li>EDEN BodyWorks’ “Coconut Shea All Natural Styling Elixir” and “Jojoba Monoi All Natural Shampoo,” which allegedly contain polyquaternium-37, phenoxyethanol, caprylyl glycol, and polyquaternium-7;</li><li>Beyond Coastal’s “Natural Sunscreen SPF 30,” advertised as “100% natural,” which allegedly which allegedly contains dimethicone; and</li><li>California Naturel, Inc.’s “all natural sunscreen,” which allegedly contains dimethicone.</li></ul>Under the proposed settlements, the companies may not make “all natural” or “100% natural” claims unless they have proper substantiation, i.e., competent and reliable evidence to substantiate any ingredient-related, environmental, or health claims they make.  FTC made it clear that the terms “all natural” or “100% natural” may only be used if there is nothing artificial or synthetic in the product.The FTC’s action is unexpected not only because FDA is currently addressing the use of the term “natural” on food labels, but because FDA does not have an informal policy regarding the use of “natural” on personal care products (as it has for food).  Given the absence of applicable regulations or policies, companies should take note of FTC’s action and its strict interpretation of “all natural” and “100% natural.”<a href="#_ftnref1" name="_ftn1">[1]</a> The FTC also issued a complaint against a fifth company for making similar “natural” representations.

Nature's Path Foods

Suja Juices

Unilever USA Inc.

Nature’s Path Foods and Sprouts Farmers Market

Iovate Health Sciences, International

Claudia focuses her practice on the defense of consumer class actions and on complex commercial litigation, including unfair business competition, false advertising, product liability, and privacy mat

Claudia Vetesi

FTC Targets “All Natural” and “100% Natural” Claims on Personal Care Products

As we have previously reported, FDA is currently seeking public comments on the use of the term “natural” on food labeling. The announcement came as a surprise 

FTC Targets “All Natural” and “100% Natural” Claims on Personal Care Products

We’ve recently reported on numerous district court—and even Ninth Circuit—stays in false advertising actions. Many of these stays have been based on FDA’s consideration of food labeling issues, such as those involving evaporated cane juice (ECJ), the term “natural” or the presence of partially hydrogenated oils (PHOs) in food products. But courts have also stayed cases pending the Ninth Circuit’s review of class certification decisions in misbranding cases, finding that appellate guidance will aid in courts’ consideration of these issues.Now, a mislabeling action against Bimbo Bakeries has been stayed on the latter ground:  Ang v. Bimbo Bakeries USA, Inc., No. 13-cv-01196-HSG (N.D. Cal. March 31, 2016) (Dkt. No. 161) (“Order”). Bimbo is at least the sixteenth Northern District decision to put mislabeling claims on hold pending the Ninth Circuit’s review.What’s on the Ninth Circuit’s Docket? In the upcoming year, the Ninth Circuit will review a number of the misbranding cases that have flooded this Circuit. The two key class action cases where district courts are awaiting guidance, however, are:  Jones v. ConAgra Foods, Inc., No. 14-16327 (9th Cir. Nov. 24, 2014), which addresses the ascertainability requirement, and Brazil v. Dole Packaged Foods, LLC, No. 14-17480 (9th Cir. Dec. 18, 2014), which addresses the proper standard for damages models under Comcast Corp. v. Behrend. Brazil, which was dismissed on summary judgment, also raises issues regarding required proof of consumer deception as well as reliance and materiality requirements for claims sounding in fraud.<a href="#_ftn1" name="_ftnref1">[1]</a>Judge Puts Bimbo Bakeries Action on Hold. On March 25, 2016, Northern District of California Judge Haywood Gilliam issued an order to show cause why plaintiffs’ mislabeling action against Bimbo Bakeries should not be stayed pending resolution of these two appeals. In doing so, he noted that several courts in the District have stayed cases in light of the pending appeals in Jones and Brazil. The parties submitted a joint statement in response, indicating that neither opposed the stay.After analyzing factors courts use in considering stays, Judge Gilliam concluded that a stay was warranted. Because both parties agreed to the stay, neither would be harmed. Most importantly, “it would be an inefficient and imprudent use of judicial resources to rule on the pending motion for class certification when the Ninth Circuit may offer ‘substantial guidance, if not new law, that will materially impact the Court’s discussion in the instant case.’”  (Order at 2:10-14 (citation omitted).) The court accordingly stayed the entire action pending the Jones and Brazil appeals.“Food Court” Is Quiet. Bimbo and other district court stays of misbranding actions have caused the Northern District, previously dubbed the “food court,” to be relatively quiet on the false advertising front, at least for now. <a href="#_ftnref1" name="_ftn1">[1]</a> Both the Brazil and Jones appeals will be heard together along with another food misbranding class certification decision, Briseno v. ConAgra Foods, Inc., No. 15-55727.  Briseno also involves ascertainability and classwide damages issues.

Bimbo Bakeries Suit On Hold Pending Ninth Circuit Class Certification Appeals

We’ve recently reported on numerous district court—and even Ninth Circuit—stays in false advertising actions. Many of these stays have been based on FDA’s consi

Bimbo Bakeries Suit On Hold Pending Ninth Circuit Class Certification Appeals

Northern District of California Judge Maxine Chesney recently granted Nestlé’s motion to dismiss a challenge to partially hydrogenated oil (PHO) in Nestlé’s Coffee-mate® coffee-creamer products, finding plaintiff’s claims were preempted by federal regulations set to be implemented three years from enactment.  Backus v. Nestle USA, Inc., No. C-15-1963 MMC, 2016 WL 879673 (N.D. Cal. Mar. 8, 2016). The decision is a big win for Nestlé and may have broader implications for defendants facing “misbranding” allegations premised on evolving FDA standards.Plaintiff’s PHO Challenge. Challenges to PHOs are not new; we’ve reported on them before. (See, e.g., “<a href="http://classdismissed.mofo.com/fda/court-stays-away-from-trans-fat-in-general-mills-case/">Court Stays Away from Trans Fat in General Mills Case</a>.”) And plaintiff Troy Backus is a repeat player in PHO litigation:  We recently reported on the Ninth Circuit’s rejection of his appeal in another PHO case. (See “<a href="http://classdismissed.mofo.com/consumer-products/ninth-circuit-no-relief-from-stay-in-general-mills-trans-fats-case-pending-fda-action/">Ninth Circuit:  No Relief from Stay in General Mills’ Trans Fats Case Pending FDA Action</a>.”)Plaintiff’s challenge to Nestlé’s Coffee-mate® products is the same as the claims in the earlier cases: that PHO is an “‘illegal, dangerous additive’ for which there is ‘no safe level’ of consumption[.]”  Backus, 2016 WL 879673, at *1 (citation omitted). Plaintiff claimed Nestlé acted unlawfully by including PHO in its product, and misled consumers by claiming the product contain “0g Trans Fat.”FDA’s PHO Position. On June 17, 2015, the FDA published a declaratory order finding “‘there is no longer a consensus among qualified experts’” that PHOs “are generally recognized as safe (GRAS) for any use in human food.” Id. at *3 (citing 80 Fed. Regs. 34650-01, 34650 (June 17, 2015)). FDA required discontinuation of PHO additives, but encouraged submissions of exemptions based on specific uses of the substance. Id. FDA set a compliance date of June 18, 2018, “‘to allow time for such petitions and their review.’” Id.Congress thereafter enacted the Consolidated Appropriations Act, 2016 (H.R. 2029), which addressed PHOs. The statute confirmed that no PHO shall be deemed unsafe—or food containing such substance deemed adulterated—until the June 2018 compliance date set by the FDA. Id. (citing Pub. L. No. 114-113, § 754, 129 Stat. 2242, 2284 (2015).)Court Says No to PHO Claims. The court rejected plaintiff’s claims. It found that, by seeking to make PHO illegal now, plaintiff’s claims “would effectively negate the FDA’s order setting a compliance date in 2018 and ‘stand[] as an obstacle to the accomplishment and execution of the full purposes and objectives’ of the FDA in adopting that order.”” Id. at *4 (citation omitted). Plaintiff’s characterization of PHOs as being “unsafe in any circumstance” was inaccurate. FDA simply found that there was no longer a consensus as to whether they are safe. Indeed, FDA confirmed it needed three years to review applications showing PHOs are safe in some circumstances.Because Plaintiff’s attempt to retroactively apply FDA regulations undermined FDA’s goal in issuing the standards, his claims were preempted. The court dismissed plaintiff’s claims with prejudice.<a href="#_ftn1" name="_ftnref1">[1]</a>PHO Takeaway. A narrow reading of Backus may suggest it is limited to the facts: When the FDA and/or Congress enact regulations prohibiting the use of certain substances by a certain future date, a plaintiff cannot try to retroactively apply such regulations to punish use of the substance now. But a broader reading suggests Backus applies any time a plaintiff seeks to apply a new regulation to suggest a product did not comply in the past. Backus prohibits such hindsight. This decision is a solid win for companies defending against mislabeling claims that may change in the future. <a href="#_ftnref1" name="_ftn1">[1]</a> The court also held that plaintiff’s challenge to “0-Trans Fat” statement on the products’ front label was preempted. Federal regulations require that products containing less than .5 gram of trans fat list the amount as “zero” on the ingredient panel. FDA has expressed its preference that statements outside of a box match the inside. The court noted that other courts, including the Ninth Circuit, have accordingly found such claims preempted. Id. at *7. The Court agreed and dismissed these claims as well.

Cut the Fat . . . Just Not Yet: Court Rules that PHO Claims Are Preempted

Northern District of California Judge Maxine Chesney recently granted Nestlé’s motion to dismiss a challenge to partially hydrogenated oil (PHO) in Nestlé’s Cof

Cut the Fat . . .  Just Not Yet: Court Rules that PHO Claims Are Preempted

There has been much recent discussion of the primary jurisdiction doctrine, as well as stay motions based on the doctrine, related to FDA’s review of its evaporated cane juice (ECJ) draft guidance. Now, in its recent memorandum disposition in Kane v. Chobani, LLC, No. 14-15670 (“Order”), the Ninth Circuit has entered the “primary jurisdiction” debate, coming down on the side of defendants seeking stays. But, given the panel’s limited analysis, the full import of Kane is unclear.Judge Koh Rejects Plaintiffs’ Alleged “Reliance” Below. The plaintiffs in Kane argued that that Chobani’s yogurt labelling was false and misleading because the yogurts contain ECJ and include “all natural” claims. After giving plaintiffs three chances to meet pleading requirements to show standing, Northern District of California Judge Lucy Koh ultimately held that plaintiffs failed to plead reliance necessary for standing with plausibility or particularity.Specifically, Judge Koh rejected plaintiffs “illegal product theory”—e.g. plaintiffs’ claim that they need not prove reliance for claims under the UCL’s “unlawful” prong. Like all courts that have confronted similar arguments, Judge Koh held that because plaintiffs’ entire complaint sounded in fraud, they therefore must allege reliance for all of their claims, and do so with particularity. Kane v. Chobani, Inc., 973 F. Supp. 2d 1120, 1131 (N.D. Cal. 2014).Judge Koh then found that plaintiffs failed to adequately plead reliance for either their ECJ or “all natural” claims. As for ECJ, Judge Koh found it implausible that plaintiffs did not know that ECJ was not a sweetener, as allegations in their complaint undermined their claims.  Id. at 1134. As for “all natural,” the court held that plaintiffs failed to provide sufficient allegations describing why challenged ingredients were not natural, as required to demonstrate they relied on the term and were deceived.  Id. at 1137. Because plaintiffs had tried—and failed—to meet these pleading requirements three times, Judge Koh concluded that amendment would be futile.  She accordingly dismissed the case with prejudice.  Id. at 1139.The Ninth Circuit Pivots to Primary Jurisdiction. The Ninth Circuit did not address the standing or reliance requirements in Kane.  Instead, its unpublished memorandum opinion focused solely on primary jurisdiction. Citing to its recent decision in Astiana v. Hain, the panel held that:The delineation of the scope and permissible usage of the terms ‘natural’ and ‘evaporated cane juice’ in connection with food products ‘implicates technical and policy questions that should be addressed in the first instance by the agency with regulatory authority over the relevant industry rather than by the judicial branch.’Order at 2 (citations omitted). The panel noted that FDA is currently addressing both issues:  FDA issued a notice requesting comments regarding the term “natural” in November 2015, and confirmed in a letter to Northern District Court of California Judge Chen that it expected to finalize its ECJ guidance by the end of 2016. Id. at 3. Given FDA’s ongoing proceedings regarding these issues, the Ninth Circuit held that the primary jurisdiction applied. The panel vacated and remanded, instructing the district court to stay the action pending resolution of the FDA’s “natural” and “evaporated cane juice” proceedings.Unanswered Questions. The Ninth Circuit’s affirmation of primary jurisdiction is helpful. But it leaves many questions unanswered.  Is the “illegal product theory” a viable argument? Were plaintiffs’ bare bones allegations sufficient to plead reliance? Kane does not provide the definitive answers on these arguments. But more Ninth Circuit misbranding arguments are up ahead. Stay tuned.

Ninth Circuit Revives Chobani Yogurt Action, But Puts Claims on Ice and Leaves Questions Unanswered

There has been much recent discussion of the primary jurisdiction doctrine, as well as stay motions based on the doctrine, related to FDA’s review of its evapor

Ninth Circuit Revives Chobani Yogurt Action, But Puts Claims on Ice and Leaves Questions Unanswered

Last week, a federal court in Utah granted Aventis Inc.’s motion for summary judgment based on federal preemption of failure-to-warn claims. Cerveny v. Aventis, Inc., 2016 U.S. Dist. LEXIS 34182 (D. Utah Mar. 16, 2016). The court found that the FDA’s rejection of additional warnings and consistent approval of labeling contrary to plaintiff’s demands constituted “clear evidence” of a conflict between federal and state law, and therefore served as grounds for preemption.BackgroundPlaintiff Victoria Cerveny was prescribed and used Clomid in 1992. Following her Clomid use, Mrs. Cerveny became pregnant and gave birth to a son, who was missing two fingers and had a congenital dislocation of the left radial head on his left elbow. The Cervenys alleged that the defects were caused by the residual Clomid in Mrs. Cerveny’s body during conception and organogenesis, and that Aventis breached its duty to warn of potential birth defects associated with Clomid use before pregnancy.Aventis moved for summary judgment on the basis of conflict preemption, arguing that it was impossible for Aventis to comply with federal and state requirements for labeling because the FDA would not have permitted Aventis to include the exact warnings the Cervenys demanded should be added to the label. Specifically, Aventis relied on evidence that the FDA had previously considered Plaintiff’s argument and determined that using Clomid before pregnancy posed no heightened risk of future birth defects. In sum, the Cervenys argued that Aventis should have changed the label and Aventis responded that its hands were tied by the FDA—even if Aventis had sought the requested change, the FDA would not have approved it.Changing a Drug LabelThe central dispute was Aventis’s ability to add the warnings that the Cervenys sought. In general, manufacturers bear responsibility for the content of drug warning labels, but cannot change the labeling of a drug without seeking prior approval from the FDA.  See 21 C.F.R. § 314.70(b). In limited circumstances, however, a drug manufacturer can strengthen warnings without prior approval through a changes being effected (CBE) supplement, but the FDA retains authority to reject those changes.The FDA also has a process whereby interested parties may submit “citizen petitions” seeking modifications to a drug’s labeling. Parties may submit these petitions accompanied by scientific and other evidence of potential health risks associated with a drug’s use. Although a causal relationship is not required, FDA standards mandate that if there is “reasonable evidence of an association of a serious hazard with a drug,” the drug’s label should be revised to include a warning. 21 C.F.R. § 201.80(e). Sometimes, “newly acquired information” (i.e., testing performed subsequent to a drug label’s approval or reports of negative drug reactions) is included in these reports and leads the FDA to require stronger warnings.In 2007 and again in 2009, the FDA received citizen petitions about Clomid and its association with birth defects. Both petitions embodied the exact failure-to-warn theories presented by the Cervenys and included supplemental scientific research, seeking the same additional warnings that the Cervenys sought.  Ultimately, the FDA rejected both petitions. Importantly, both of these petitions came many years after Mrs. Cerveny’s Clomid use.Clear EvidenceTo demonstrate conflict preemption, a defendant must present “clear evidence” of a conflict between federal and state law. The “clear evidence” standard was first enunciated in Wyeth v. Levine, 555 U.S. 555 (2009) but was not defined.  Ever since, courts have grappled with this legal standard, which remains anything but clear.The Cerveny court shed welcome new light on this “clear evidence” standard. Specifically, Judge Benson found that Aventis met its burden with evidence that the FDA had denied the two previous requests for strengthened warnings in the form of citizen petitions, “based on the same theories and substance on which Plaintiff’s case relies.” In fact, “every piece of scientific literature cited in the Plaintiffs’ Amended Complaint was presented to the FDA” in the 2007 citizen petition.The court found additional “clear evidence” of the FDA’s position because the FDA “consistently approved Clomid labeling that includes affirmative rejections of the Plaintiffs’ theories.” Specifically, since 1994, Clomid’s FDA-approved label stated that “Clomid exposure prior to pregnancy does not cause birth defects at a rate greater than that observed in the general population.” Thus, not only did the FDA previously consider Plaintiff’s argument, but it also determined that drug ingestion before pregnancy raised no additional risk of future birth defects. This determination was clear from the FDA’s prior approval of Clomid labeling.The court’s ruling represents a step in the right direction for pharmaceutical defendants, especially in light of the recent Dolin decision muddying the “clear evidence” burden of proof on defendant manufacturers arguing for preemption. Defendant manufacturers should also note that this court found that both the rejection of the citizen petitions and the FDA’s consistent approval of Clomid’s labels operated as independent sources of clear evidence to support conflict preemption. This is a clear departure from the Dolin court’s ruling, which seems to require an actual denial by FDA of a label change. As courts continue to analyze what “clear evidence” is without concrete guidance, the Cerveny ruling sets a favorable precedent and provides new guideposts to follow.

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Federal Preemption Claims: Clear Evidence and an Unclear Standard

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Last week, a federal court in Utah granted Aventis Inc.’s motion for summary judgment based on federal preemption of failure-to-warn claims. The court found tha

Federal Preemption Claims: Clear Evidence and an Unclear Standard

We recently reported on developments in evaporated cane juice (ECJ) stays pending the FDA’s finalized guidance on the ingredient. (See <a href="http://classdismissed.mofo.com/food-misbranding/reviving-a-forgotten-fad/">Reviving a Forgotten Fad: Three Judges Lift Stays of Evaporated Cane Juice Claims</a>.) In March 2014, FDA announced that it would revise its ECJ draft guidance, and many courts in the Northern District stayed ECJ claims as a result. FDA has not yet completed this process. In our recent post, we noted that, while the majority of courts to stay ECJ cases have maintained stays despite this two year lapse, some courts are becoming impatient with FDA’s review and have consequently lifted stays.Recently, Judge Chen joined the latter camp, but took a different approach. Rather than lift stays in two ECJ cases before him, he asked FDA whether it planned to issue further ECJ guidance within the next six months, noting that the parties have been waiting since May 2014 for FDA’s final position.This is Judge Chen’s second request to FDA for updates on its draft guidance. In May 2015, he asked the agency the same question. FDA responded in July 2015, noting it “anticipated” finalizing its guidance by the end of 2016.We will update readers with FDA’s response to Judge Chen’s latest request.

The (Not So) Sweet Sound of FDA’s Silence: Judge Seeks Answers from FDA on ECJ Draft Guidance

We recently reported on developments in evaporated cane juice (ECJ) stays pending the FDA’s finalized guidance on the ingredient. In March 2014, FDA announced t