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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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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In a surprising turn of events, Pacira Pharmaceuticals, Inc. and the Food and Drug Administration (FDA)
announced that they have settled their dispute regarding

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New Settlement Highlights FDA’s Diminishing Power Over Off-Label Promotion

New Settlement Highlights FDA’s Diminishing Power Over Off-Label Promotion | Class Dismissed

Erin M. Bosman

Brittany Scheinok

In a surprising turn of events, Pacira Pharmaceuticals, Inc. and the Food and Drug Administration (FDA) announced that they have settled their dispute regarding the off-label promotion of Exparel, one of Pacira’s anesthetic drugs. This settlement represents the latest marker of the FDA’s diminishing power to regulate off-label promotion.BackgroundOff-label promotion is the promotion of a drug for indications not approved by the FDA, which the FDA contends is a violation of the Federal Food, Drug, and Cosmetic Act (FDCA). The FDCA prohibits the introduction into interstate commerce of any drug that is misbranded.<a name="_ftnref1" href="#_ftn1">[1]</a> Under the FDCA, a drug may be misbranded for a number of reasons, including false or misleading labeling or labeling that fails to include adequate directions for use.<a name="_ftnref2" href="#_ftn2">[2]</a>Recent case law developments have drawn attention to the issue of off-label promotion. In 2012, the Second Circuit issued a ruling in United States v. Caronia, a case involving First Amendment challenges to the regulation of off-label promotion.<a name="_ftnref3" href="#_ftn3">[3]</a> The court held that the government cannot criminally prosecute pharmaceutical manufacturers and their representatives under the FDCA for truthful, non-misleading speech promoting the off-label uses of FDA-approved drugs.<a name="_ftnref4" href="#_ftn4">[4]</a>More recently, the pharmaceutical company Amarin secured a preliminary injunction against the FDA in another case involving off-label promotion and the First Amendment.<a name="_ftnref5" href="#_ftn5">[5]</a> In Amarin, a federal district court confirmed that the FDA may not bring a misbranding action based on truthful promotional speech alone. These decisions have led many to believe that the FDA’s ability to regulate off-label promotion may be waning.Pacira’s Lawsuit Against the FDA and Subsequent ResolutionPacira’s anesthetic drug Exparel was approved by the FDA in 2011. During the approval process, Exparel was evaluated in two clinical trials involving surgery for the removal of bunions and surgery for the removal of hemorrhoids. The “Indications and Usage” section of Exparel’s label stated that Exparel is a “local anesthetic, indicated for administration into the surgical site to produce postsurgical analgesia.” However, after listing the clinical trials that evaluated Exparel, the “Clinical Studies” section of the label stated that Exparel “has not been demonstrated to be safe and effective in other procedures.”Despite this language, some of Pacira’s promotional materials suggested that Exparel could be used in various surgical procedures other than those involving the removal of bunions or hemorrhoids. In September 2014, the FDA issued a warning letter to Pacira, stating that these promotional materials misbranded the drug within the meaning of the FDCA. According to the FDA, Pacira’s promotional materials violated the FDCA by stating that Exparel was intended for new uses for which it lacked FDA approval.In September 2015, Pacira filed a lawsuit against the FDA seeking declaratory and injunctive relief. In its complaint, Pacira claimed that the FDA had violated its First Amendment rights by restricting truthful and non-misleading speech and had violated the Administrative Procedure Act by failing to observe required procedures for modifying a drug’s label. Additionally, Pacira’s complaint alleged that the FDA’s regulations were vague and operated as a retroactive, ex post facto penalty, thus violating due process under the Fifth Amendment.On December 15, 2015, Pacira announced that it had reached an amicable resolution with the FDA. In the settlement agreement, the FDA reversed its position with respect to Exparel’s approved uses. The agreement reached by the parties stated that Exparel has, since 2011, been approved for administration in a variety of surgeries, not limited to those studied in its clinical trials. Thus, the parties dismissed the lawsuit and the FDA agreed that Pacira is not restricted to marketing Exparel only for use in the surgeries tested in the drug’s clinical trials.Likely Impact of the Pacira and FDA SettlementFollowing the decisions in Caronia and Amarin, this settlement agreement may be another sign of the FDA’s waning power to regulate off-label promotion, especially in the face of First Amendment challenges. However, several factors may limit the implications of this resolution.Unsurprisingly, the FDA itself is attempting to limit the implications of the settlement agreement. The FDA noted in a statement that “this resolution is specific to the parties involved in this matter.” Furthermore, this settlement may be attributable to the existing broad language in Exparel’s label. For example, the label stated that Exparel was “indicated for administration into the surgical site to produce postsurgical analgesia.” The FDA may not have agreed to settle with Pacira if Exparel’s label did not already include this broad language of indication, which arguably included indications of use beyond those specifically tested in the clinical trials.The full impact of this resolution is yet to be seen. However, the settlement certainly continues the trend of limiting the FDA’s ability to regulate truthful, non-misleading statements regarding off-label uses.   <a name="_ftn1" href="#_ftnref1">[1]</a> 21 U.S.C. § 331(a).<a name="_ftn2" href="#_ftnref2">[2]</a> 21 U.S.C. §§ 352(a), (f).<a name="_ftn3" href="#_ftnref3">[3]</a> United States v. Caronia, 703 F.3d 149 (2d Cir. 2012).<a name="_ftn4" href="#_ftnref4">[4]</a> For more information on United States v. Caronia, see our previous client alert.<a name="_ftn5" href="#_ftnref5">[5]</a> Amarin Pharma, Inc. v. FDA, No. 1:15-cv-03588 (S.D.N.Y. Aug. 7, 2015).