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

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

CPSC Commissioners Abstain from Retracting Infant Sleep Product Statements

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Advertisers and purveyors of sugar-sweetened beverages can rest a little easier now.  The Ninth Circuit recently ordered a district court to issue a preliminary injunction to enjoin the 2015 San Francisco Ordinance requiring inclusion of a warning on all advertisements for sugar-sweetened beverages.<a href="#_ftn1" name="_ftnref1">[1]</a>  The Ninth Circuit found that the required warning likely impinged on the beverage purveyors’ First Amendment rights and would impermissibly chill commercial speech.<a href="#_ftn2" name="_ftnref2">[2]</a>The Ordinance:  In June 2015, San Francisco enacted a citywide ordinance requiring that advertisements for sugar-sweetened beverages within San Francisco include the following statement:WARNING: Drinking beverages with added sugar(s) contributes to obesity, diabetes, and tooth decay. This is a message from the City and County of San Francisco.S.F. Health Code § 4203(a).  Not only was the warning required on all advertisements, the ordinance also mandated it to take up 20% of the advertisement and be set out with a black rectangular border.  Id. § 4203.The Holding:As an initial matter, the Ninth Circuit found that framework set out in Zauderer v. Office of Disciplinary Counsel of Supreme Court of Ohio, 471 U.S. 626 (1985) extended beyond the consumer protection context and applied it to the challenged ordinance.<a href="#_ftn3" name="_ftnref3">[3]</a>Zauderer’s general rule is that a purely factual and uncontroversial disclosure that is not unduly burdensome will withstand First Amendment scrutiny so long as it reasonably related to a substantial government interest.<a href="#_ftn4" name="_ftnref4">[4]</a>In applying the Zauderer framework, the Ninth Circuit found that:<ul><li>The warning was at least controversial, because it conveyed that the beverages would necessarily contribute to the named health conditions regardless of quantity of consumption, which is contrary to statements by FDA that added sugars are generally recognized as safe;<a href="#_ftn5" name="_ftnref5">[5]</a></li><li>The warning was also misleading, because it focused on one product, suggesting that sugar-sweetened beverages were more likely to cause weight gain than other products with equal or greater amounts of added sugars and calories, which is not supported by the weight of evidence;<a href="#_ftn6" name="_ftnref6">[6]</a> and</li><li>The warning was unduly burdensome, because the required warning would effectively take over the message of any advertisement.<a href="#_ftn7" name="_ftnref7">[7]</a></li></ul> What’s Next?<ul><li>The Ninth Circuit’s ruling may open the door to challenges to other required disclosures.</li><li>The San Francisco City Attorney has vowed to fight on…</li></ul><a href="#_ftnref1" name="_ftn1">[1]</a> <a href="http://cdn.ca9.uscourts.gov/datastore/opinions/2017/09/19/16-16072.pdf">Am. Beverage Ass’n v. City and Cnty of San Francisco, No. 16-16072 (9th Cir. Sept. 19, 2017)</a><a href="#_ftnref2" name="_ftn2">[2]</a> Id., Slip Op. at 24-25.<a href="#_ftnref3" name="_ftn3">[3]</a> Slip Op. at 14-15.<a href="#_ftnref4" name="_ftn4">[4]</a> Id. at 14 (citing Zauderer, 471 U.S. at 651.)<a href="#_ftnref5" name="_ftn5">[5]</a> Slip Op. at 20 (citing 21 C.F.R. § 184.1866; 81 Fed. Reg. 33, 742, 33,760 (May 27, 2016)<a href="#_ftnref6" name="_ftn6">[6]</a> Id. at 21-22.<a href="#_ftnref7" name="_ftn7">[7]</a> Id. at 23.

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Ninth Circuit Nixes San Francisco Soda Warning

Expiring Soon: Temporary BPA Warning Regs Under Prop. 65

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Advertisers and purveyors of sugar-sweetened beverages can rest a little easier now.  The Ninth Circuit recently ordered a district court to issue a preliminary

Ninth Circuit Nixes San Francisco Soda Warning

One year ago, the federal government test drove its first set of self-driving policies with a four-part <a href="https://www.transportation.gov/AV-factsheet" target="_blank" rel="noopener">announcement </a>from the U.S. Department of Transportation. In twelve months, much has changed, but the wheels are still turning.The U.S. House of Representatives earlier this month passed the bipartisan Safely Ensuring Lives Future Development and Research in Vehicle Evolution (SELF DRIVE) Act. The SELF DRIVE Act continues the work of clarifying state and federal government roles as well as the federal government’s responsibilities with regard to safety, cybersecurity, privacy, and consumer education.Although SELF DRIVE has now launched, the engine is still heating up: The U.S. Senate is still developing its approach to federal policy in this space. Last week, the U.S. Senate held a hearing to this end, inviting experts on self-driving trucks to <a href="https://www.commerce.senate.gov/public/index.cfm/pressreleases?ID=BAC7FBCE-424B-4C61-8082-71B3E3D9333B" target="_blank" rel="noopener">testify </a>before its Commerce Committee. This latest action built on a set of bipartisan “principles” for <a href="https://www.commerce.senate.gov/public/index.cfm/pressreleases?ID=3319E728-1F3A-4316-8F7E-8CAF66000F8C" target="_blank" rel="noopener">legislation </a>that the U.S. Senate had released in June.The Executive Branch has also announced a change to its approach. Specifically, U.S. Department of Transportation Secretary Chao unveiled <a href="https://www.nhtsa.gov/sites/nhtsa.dot.gov/files/documents/13069a-ads2.0_090617_v9a_tag.pdf" target="_blank" rel="noopener">“A Vision for Safety: 2.0” i</a>n Michigan <a href="https://www.transportation.gov/briefing-room/av-summit" target="_blank" rel="noopener">last week. </a>As Secretary Chao noted, this “replaces the Federal Automated Vehicle Policy Version 1.0” released last year, but it is not the Department’s final word: “DOT and NHTSA are already planning for Version 3.0 in 2018!”In short, for federal self-driving policy, the wheels are still turning – and the regulatory landscape will most certainly continue to evolve over the coming weeks and months.

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Wheels Are Turning on Federal Self-Driving Policy

Wheels Are Turning on Federal Self-Driving Policy

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One year ago, the federal government test drove its first set of self-driving policies with a four-part announcement from the U.S. Department of Transportation.

In a unanimous vote, the U.S. Consumer Product Safety Commission (CPSC) eliminated third-party testing for compliance with CPSC’s phthalates prohibitions for seven plastics.  The Commission decided that these plastics with specified additives do not contain concentrations above 0.1% of the phthalates prohibited in children’s toys and child care articles.Phthalates are sometimes used in children’s products as plasticizers, which work to soften plastic components.  The Consumer Product Safety Improvement Act of 2008 (CPSIA) prohibits the manufacture for sale, offer for sale, distribution in commerce, or importation into the United States of any children’s toy or child care article that contains concentrations above 0.1% of specified phthalates.  Children’s toys and child care articles subject to these restrictions are required to satisfy third-party compliance testing before the items can enter the stream of commerce.The rule approved by CPSC, which will go into effect on September 29, 2017, establishes that the following plastics with specified additives do not contain statutorily prohibited phthalates in concentrations above 0.1%, and third-party testing is therefore not necessary to ensure compliance with the CPSIA:<ul><li>Polypropylene (PP)</li><li>Polyethylene (PE)</li><li>General Purpose Polystyrene (GPPS)</li><li>Medium-Impact Polystyrene (MIPS)</li><li>High-Impact Polystyrene (HIPS)</li><li>Super High-Impact Polystyrene (SHIPS)</li><li>Acrylonitrile Butadiene Styrene (ABS)</li></ul>Children’s toys and child care articles containing concentrations of more than 0.1% of six prohibited phthalates will continue to be regulated under the CPSIA; however, this decision will significantly reduce the burden of third-party testing and certification for companies that manufacture, sell, or distribute children’s products.  <a href="https://media2.mofo.com/v3/assets/blt5775cc69c999c255/bltc26da982c278df46/6273156cb5ad5f2863c59558/150128phthalateban.pdf" target="_blank" rel="noopener noreferrer">Click here</a> for more information regarding CPSC’s phthalate requirements.

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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Associate

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

Brittany Scheinok

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CPSC Removes Third-Party Testing Requirements for Children’s Products with Certain Plastics

CPSC Removes Third-Party Testing Requirements for Children’s Products with Certain Plastics

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In a unanimous vote, the U.S. Consumer Product Safety Commission (CPSC) eliminated third-party testing for compliance with CPSC’s phthalates prohibitions for se

Last month, the U.S. Supreme Court clarified the scope of specific personal jurisdiction in Bristol-Myers Squibb Co. v. Superior Court of California, San Francisco Cty., 137 S. Ct. 1773 (2017) (“BMS”). Mass tort defendants have wasted little time in moving to dispose of claims from nonresident plaintiffs under this ruling.As previously reported, on June 19, 2017, the Supreme Court decided a longawaited specific jurisdiction question in favor of Bristol-Myers Squibb Co. This case arose when a group of consumers — consisting of 86 California residents and 592 residents from 33 other states — brought tort claims in California state court, alleging injuries from using Plavix, a prescription drug that thins blood and inhibits blood clotting.Please see our full article as published on <a href="https://media2.mofo.com/v3/assets/blt5775cc69c999c255/bltfcf96f27d9e40dc8/6273156d5f7b601eaaebcf5e/170803-bristol-myers-squibb.pdf" target="_blank" rel="noopener noreferrer">Law360</a>.

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Bristol-Myers Squibb: The Aftermath

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Last month, the U.S. Supreme Court clarified the scope of specific personal jurisdiction in Bristol-Myers Squibb Co. v. Superior Court of California, San Franci

Bristol-Myers Squibb: The Aftermath

A year from now, dramatic changes to California’s Proposition 65 warning regulations take full effect. The new regulations (formally published by the State in August 2016) significantly alter the “safe harbor” rules for providing Prop 65 warnings. Companies that have not yet started preparing for the implications of these new rules will need to do so before the new regulations go into full effect on August 30, 2018.Under Prop 65, businesses with 10 or more employees must provide “clear and reasonable warning”  before knowingly and intentionally exposing individuals in California to a chemical listed by the state as known to cause cancer or reproductive toxicity. The Prop 65 regulations provide a safe harbor for warning language and methods of transmission officially deemed “clear and reasonable.” That safe harbor will shrink significantly under the new regulations. A generic Prop 65 warning that does not identify a specific chemical will no longer be sufficient in most circumstances. Many warnings will also have to contain the exclamation point within a triangle symbol shown left and be given in multiple languages. Finally, virtually all warnings will need to include either the URL “<a href="http://P65Warnings.ca.gov">P65Warnings.ca.gov</a>,” or the food-product-specific “<a href="http://P65Warnings.ca.gov/food">P65Warnings.ca.gov/food</a>.”

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Warning: New Proposition 65 Warning Regulations Taking Effect

WARNING: Proposition 65 Farce About to Repeat Itself for Vulnerable Foods and Flavorings

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A year from now, dramatic changes to California’s Proposition 65 warning regulations take full effect. The new regulations (formally published by the State in A

Warning: New Proposition 65 Warning Regulations Taking Effect

The Tenth Circuit recently upheld a Utah district court’s finding that a branded drug manufacturer could not be held liable for failing to warn consumers about alleged birth defect risks when the FDA had previously rejected a citizen’s petition calling for the same warnings.  Cerveny v. Aventis, Inc., No. 16-4050 (10th Cir. May 2, 2017).Factual BackgroundPlaintiffs (mother, father, and their child) alleged that the fertility drug Clomid led to the child’s birth defects due to the mother’s use of the drug before becoming pregnant.  They sued under Utah tort claims, including failure to warn, breach of implied warranty, negligent misrepresentation, and fraud.Relying on the doctrine of impossibility preemption, the district court granted the defendant’s motion for summary judgment, holding that, because the FDA “would not have approved the drug warnings that the Cervenys allege are required under Utah law,” it was impossible for Aventis to comply with both FDA regulations and state law.On appeal, the plaintiffs relied on a 1987 proposed FDA warning that “Clomid may cause fetal harm when administered to pregnant women.”  Although Aventis did not adopt the FDA’s proposed warning, and even though it only applied to those who took the drug while pregnant (unlike the plaintiff in this case), the Cervenys contended that (1) the proposed warning demonstrated the FDA’s willingness to approve warnings for women taking Clomid before becoming pregnant, and (2) Ms. Cerveny would not have taken Clomid before her pregnancy if Aventis had used the proposed warning.Impossibility PreemptionThe Cerveny court began with a discussion of basic preemption principles.  The court explained that federal law will preempt a state law when (1) the language of the federal law reveals an express congressional intent to preempt state law (express preemption); (2) federal regulation is so all-encompassing that Congress must have intended to leave no room for a state to supplement it (field preemption); or (3) compliance with both the federal and state laws is a physical impossibility (conflict preemption).  When a state’s regulations for drug labels conflict with the FDA’s, preemption issues arise.Impossibility preemption is at play when state law is preempted because compliance with both the federal and state laws is a physical impossibility – the laws are inapposite such that complying with state law necessarily results in a violation of federal law.  In Cerveny, Aventis made that very argument: it only needed to comply with the FDA regulations and not Utah state law because complying with both would be impossible.In Wyeth v. Levine, 555 U.S. 555 (2009), the Supreme Court established a loose framework for determining when federal law could preempt state law failure-to-warn claims against branded drug manufacturers.  Specifically, the defendant must present “clear evidence” that the FDA would have rejected the desired label change in order to preempt a state law failure-to-warn claim.  Id. at 571.Wyeth did not define “clear evidence,” but instead left the question to the lower courts.  A recent Third Circuit case interpreted Wyeth’s not-so-clear “clear evidence” language.  According to In re Fosamax Alendronate Sodium Prods. Liab. Litig., 852 F.3d 268, 285 (3rd Cir. 2017), the phrase “clear evidence” sets forth a standard of proof synonymous with “clear and convincing evidence” and involves a question of fact rather than a question of law.In order to preempt the state law failure-to-warn claim, a manufacturer needs to convince a factfinder that it was “highly probable” that the FDA would not have approved a change to the drug’s label.  The Cerveny court adopted this interpretation.The Court’s “Clear Evidence” AnalysisAs clear evidence that the FDA would not have approved plaintiffs’ suggested warnings, Aventis pointed to (1) the FDA’s history of approving Clomid for use by women before becoming pregnant, and (2) the FDA’s rejection of a citizen’s petition.Although the court determined that Clomid’s regulatory history did not, in and of itself, constitute clear evidence, the FDA’s rejection of a citizen’s petition did provide the requisite evidence.  In 2007, a citizen petition was filed demanding stronger Clomid warnings regarding the potential risks of fetal harm when a woman takes Clomid prior to becoming pregnant.  The FDA first denied the petition in 2009 and in 2012 declined to reconsider its original denial, reasoning that the original denial had “appropriately applied the standards in the [Federal Food, Drug, and Cosmetic Act] and FDA regulations regarding drug safety, warnings, and potential safety hazards.”The standard used by the FDA in rejecting the citizen’s petition was the same standard the FDA would have applied in evaluating a proposed label change to Clomid.  Because the FDA concluded in evaluating the citizen’s petition that the requested additional warnings were unjustified as to risks related to taking Clomid prior to pregnancy, the court determined that, had Aventis sought FDA approval to include stronger pre-pregnancy warnings, the FDA would have denied the request, just as it did the citizen’s petition.The plaintiffs argued that when the FDA considers proposed label changes, it treats manufacturers more favorably than citizen’s petitions, which “leads the FDA to accord greater deference to changes proposed” by manufacturers than those proposed in citizen petitions.  In rejecting this argument, the court explained that the FDA standard for revising a warning label “does not discriminate” between proposals submitted by manufacturers and proposals submitted by citizens.The Cervenys attempted to use the 1987 FDA proposed label change regarding use during pregnancy to argue that Ms. Cerveny would not have taken Clomid prior to becoming pregnant if Aventis had adopted the 1987 proposed label.  They argued that the proposed label would have warned women more directly about the potential harm to a fetus when a woman takes Clomid during pregnancy.  The district court agreed with Aventis that, even if Aventis accepted the proposed label change, Ms. Cerveny took Clomid prior to her pregnancy and therefore the label would not have applied to her.  Under Utah law, a plaintiff cannot allege as a defect in a label a warning that would not have applied to her.Aventis moved for summary judgment based solely on preemption.  While the Cervenys urged the district court to ignore Aventis’s state-law argument, the district court granted Aventis’ motion for summary judgment without explaining why or how a state law defense fell within the scope of the motion that was based solely on preemption.The appellate court remanded the issue because the district court did not “consider whether it could rest on [state] law when deciding a summary judgment motion that had relied solely on federal preemption.”  This leaves open the possibility that this claim could similarly be rejected based on federal preemption at the district court level.Looking ForwardThis ruling clarifies a defendant’s burden of proof in establishing a preemption defense.  It establishes that the FDA’s denial of a sufficiently similar citizen’s petition satisfies the clear-evidence standard required to successfully preempt a failure-to-warn claim.  Therefore, branded drug manufacturers have an additional evidentiary tool even when no other form of FDA decision-making exists to demonstrate that the FDA would have rejected a label change.Ultimately, if other circuits follow the Tenth Circuit’s lead, pharmaceutical companies may no longer need to demonstrate an attempt to provide the kind of warning allegedly required under state law.  We anticipate that going forward parties will disagree on the issue of how similar a citizen’s petition needs to be in order to have this preemptive effect.  Identical?  Virtually identical?  Substantially similar?  In Cerveny, the Tenth Circuit acknowledged that the citizen’s petition was “virtually identical” to the warnings the Cerveny’s advocated; however, we anticipate that courts may still find a preemptive effect when a citizen’s petition is substantially similar to proposed warnings.  So long as the substance of the proposed warning is the same, as well as its effect on the consuming public, it is unlikely that a decision will turn on semantics.*Co-author Karina Pundeff is a summer associate in our San Diego office.

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FDA’s Denial of Citizen’s Petition “Clear” Enough for Preemption of Failure-to-Warn Claims

FDA’s Denial of Citizen’s Petition “Clear” Enough for Preemption of Failure-to-Warn Claims

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The Tenth Circuit recently upheld a Utah district court’s finding that a branded drug manufacturer could not be held liable for failing to warn consumers about 

California took two important steps forward to implement its new Green Chemistry Initiative, also known as the Safer Consumer Products (SCP) Program, to regulate and encourage replacement of toxic chemicals in consumer products.  First, it adopted new regulations for its first priority product, children’s foam-padded sleeping products that contain the flame retardants TDCPP or TCEP, including:<div class="container-fluid main"><div class="row body"><div class="body-container "><div class="col-md-8 col-md-push-2 col-sm-12 col-xs-12"><ul><li>Nap mats and cots</li><li>Sleep positioners</li><li>Travel beds</li><li>Bassinet foam</li><li>Portable crib mattresses</li><li>Playpens</li><li>Car bed pads</li></ul></div></div></div></div>