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

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

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

<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

Zak is an associate in the Litigation Department in Morrison Foerster’s New York office.Zak’s practice focuses on class actions, commercial litigation, white collar defense, government investigations, and antitrust litigation and counseling. He has represented clients before federal and state courts in complex commercial matters, as well as in arbitration tribunals.Zak received his J.D. from New York University School of Law in 2018, where he was inducted into the Order of the Barristers. During law school, Zak also served as the Marden executive editor for the NYU Law Moot Court Board. In 2013, Zak received his B.A. and M.A. in political science from Yale University, receiving honors in his major and the Ellsworth Prize for Best Senior Essay in the Social Sciences.

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Associate

Zak Newman

Mitchell A. Hokanson is an associate in the Litigation Department of Morrison Foerster’s San Diego office.Mitchell’s practice focuses on commercial litigation and consumer class actions. He has extensive experience with civil litigation, including managing day-to-day strategy, propounding and responding to discovery, taking and defending depositions, and engaging in motion practice. He also has experience providing regulatory advice to clients, including pro bono partners and multinational corporations. Mitchell maintains an active pro bono practice.After law school, Mitchell worked as a judicial clerk for Justice Susan M. Carney of the Alaska Supreme Court, where he drafted bench memoranda and opinions on a wide range of state and federal law topics. Prior to joining MoFo, Mitchell worked for another international law firm, where he was a member of the Complex Civil Litigation practice group, in Los Angeles, California.Mitchell received his J.D. from Columbia Law School, where he was honored as a James Kent Scholar and Harlan Fiske Stone Scholar. While in law school he was the senior executive editor of the Columbia Journal of Environmental Law and worked as a judicial intern for Judge Sandra S. Ikuta of the United States Court of Appeals for the Ninth Circuit and Judge George B. Daniels of the United States District Court, Southern District of New York. Prior to that, Mitchell earned his B.A. from Stanford University.

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Mitchell Hokanson

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Morrison Foerster’s Class Dismissed blog provides insights and reports on the latest news, developments, and trends that affect consumer-facing companies. Subscribe to receive the latest updates by attorneys from our nationally recognized Consumer Class Action and Product Liability practices.

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In a recent win for vaccine manufacturers, a district court found that federal law preempted claims against Merck, arising out of alleged injuries from the Gardasil vaccine. Herlth v. Merck & Co., Inc., No. 3:21-cv-438 (JAM), 2022 WL 788669 (D. Conn., Mar. 15, 2022). This ruling shows that plaintiffs making vague allegations of injury will not satisfy Iqbal and Twombly.BackgroundApproved by the Food and Drug Administration (“FDA”) in 2006, Merck’s Gardasil vaccine helps protect individuals against human papillomavirus infection, a viral infection associated with cervical cancer. With her mother’s consent, the plaintiff in Herlth received the first two doses of the vaccine at the age of 15. The plaintiff allegedly experienced side effects. She was diagnosed with various disorders, including chronic fatigue syndrome and postural orthostatic tachycardia syndrome, a condition that affects the body’s ability to adjust the heart rate and regulate blood flow. The plaintiff filed a petition for compensation in the “Vaccine Court” (i.e., the Office of the Special Masters of the U.S. Court of Federal Claims)—a prerequisite for bringing a civil action. Only after receiving an unfavorable outcome at the Vaccine Court may an individual sue the manufacturer. Here, the Vaccine Court dismissed the plaintiff’s claim for insufficient proof. The plaintiff then sued in federal court, alleging state law failure to warn, manufacturing defect, negligence, and common law fraud claims. The crux of the plaintiff’s complaint was her failure to warn claim. She alleged that her mother believed the vaccine was safe based on Gardasil television advertisements and other marketing material.The District Court’s DecisionIn granting Merck’s motion to dismiss, the court concluded that all claims were either preempted or inadequately pled. Federal law preempted the failure to warn claim, the plaintiff failed to plausibly plead a manufacturing defect, the plaintiff failed to plead fraud with particularity, and federal law preempted the fraud on the FDA claim.With respect to the failure to warn claim, the court held that the Food, Drug, and Cosmetic Act (“FDCA”) preempts a state law failure to warn claim against a drug manufacturer. FDA approves the text of vaccine labels. Manufacturers may change the label only with FDA approval, unless the changes reflect “newly acquired information” about warnings or adverse reactions, among other things. 21 CFR §601.12(f)(2)(i). A unilateral label change requires reasonable evidence of a causal link between the newly acquired information and the adverse reaction at issue. 21 CFR §201.57(c)(6)(i). Under this standard, the plaintiff had to sufficiently plead that Merck had newly acquired information (i.e., information received after the FDA’s approval of Gardasil) related to the plaintiff’s alleged injuries that justified a label change.Here, the plaintiff failed to meet her burden. She relied on conclusory allegations about risks of Gardasil that bore no concrete relationship to her alleged injuries. Her complaint also referred to scientific studies and news articles linking Gardasil to her alleged injuries without explaining how the studies supported her allegations. Even worse, many of the studies were published well after the plaintiff received her vaccine. Merck could not have relied on them to effect a label change before the plaintiff was allegedly injured.The court also rejected the plaintiff’s argument that drug labeling preemption principles apply only to design defect claims and not failure to warn claims. The plaintiff based this argument on the Vaccine Act’s express preemption of state law design defect claims against vaccine manufacturers. In rejecting this argument, the court reasoned that Congress did not intend to make it more difficult to bring design defect claims, while also, opening the “floodgates” for failure to warn claims. The court thus found that the Vaccine Act preempts both state law design defect and failure to warn claims.As to the manufacturing defect claim, the court found that the design defect claim was in fact a “dressed up” manufacturing defect claim; the plaintiff did not allege a mistake or flaw in the manufacturing process.The rest of the plaintiff’s claims failed for similar reasons. Under her negligence claim, the plaintiff lumped together various disparate theories that sounded in fraud, which requires a heightened pleading standard. The plaintiff failed to meet her burden. For instance, the plaintiff’s references to Merck’s advertisements merely described the advertisements. She did not point to specific statements in the advertisements made with knowing falsity.Finally, even if the plaintiff could have satisfied pleading standards for her fraud on the FDA claim, Buckman preemption applied, barring state law claims alleging fraud on the FDA. See Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341, 348 (2001). As the court noted, the Second Circuit further clarified that the FDCA preempts state tort law claims only when the cause of action assigns liability “solely on the basis” of fraud against the FDA. Desiano v. Warner-Lambert & Co., 467 F.3d 85, 98 (2d Cir. 2006). Since the plaintiff sought to assign liability “solely on the basis” of purported fraud against the FDA, the FDCA preempted her fraud on the FDA claim.TakeawaysThis ruling is one of the first major vaccine preemption decisions since FDA authorized the COVID-19 vaccines, which spurred much public attention and discussion around vaccines. Herlth makes clear that there is a high bar for successfully pleading vaccine products liability claims. Under Twombly and Iqbal, showing that a vaccine manufacturer acquired new information regarding possible side effects requires more than vague and conclusory allegations.

An orthopedic implant company

A children&rsquo;s monthly subscription service product

A fertility company

A major technology company

A smart fitness equipment company

Fitbit

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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

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

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, autom

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Pleading and Preemption: Immunization Against Vaccine Products Liability Claims

Pleading and Preemption: Immunization Against Vaccine Products Liability Claims

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In a recent win for vaccine manufacturers, a district court found that federal law preempted claims against Merck, arising out of alleged injuries from the Gard

Drug & Medical Device

Product Liability

Legal 500 US 2021 has named Erin Bosman, David Fioccola, Jessica Grant, Julie Park, James Schurz, William Tarantino, and Claudia Vetesi among their top product liability and class action practitioners nationwide. The publication also recognized Morrison & Foerster as a top Tier 1 Firm in Product Liability, Mass Tort, and Class Action (Defense) for Consumer Products.<img src="https://media2.mofo.com/v3/images/blt5775cc69c999c255/bltfb9918f1567d3c2f/627315df220ab5285f51903d/210708-legal-500-product-liability.jpg?format=auto&quality=60" class="img-responsive" alt="Legal 500 Infographic" type="asset" sys-style-type="download">

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Morrison & Foerster Is Recognized As Tier 1 Firm in Product Liability, Mass Torts, and Class Action for Consumer Products

Legal 500 US 2021 has named Erin Bosman, David Fioccola, Jessica Grant, Julie Park, James Schurz, William Tarantino, and Claudia Vetesi among their top product 

Morrison & Foerster Is Recognized As Tier 1 Firm in Product Liability, Mass Torts, and Class Action for Consumer Products

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MoFo is a proud sponsor of the American Conference Institute’s <a target="_blank" href="https://www.americanconference.com/drug-medical-device-litigation/">Drug & Medical Device Litigation Conference</a>, the premier products liability litigation event for the pharmaceutical and medical device industries for the past 24 years, to be held virtually on December 8 – 9, 2020.<a href="https://www.mofo.com/people/erin-bosman.html">Erin Bosman</a>, co-chair of the Class Actions + Mass Torts Practice Group, will lead a session entitled, “Analyzing the Implications of Prep Act Immunity on Future Drug and Device Litigation and Assessing Potential Covid-19 Related MDLs.” She will examine the impact of COVID-19 on existing and future litigation, discuss PREP Act immunity, consider what types of drug and device product liability claims stemming from COVID 19 are likely to turn into MDLs, and identify specific considerations for PPE product liability claims. Join Erin on Tuesday, December 8, from 10:30-11:30 a.m. ET.Partner <a href="https://www.mofo.com/people/julie-park.html">Julie Park</a> will speak on a breakout session entitled, “Strengthening Your Future Crisis Management Capabilities: Lessons Learned from Covid-19 on Combatting Business Disruption and Enhancing Your Crisis Management Response.” This panel will discuss how an organization can most effectively focus its response to a crisis while minimizing business disruption. Join Julie on Tuesday, December 8, from 3:15-4:15 p.m. ET.<a target="_blank" href="https://www.americanconference.com/drug-medical-device-litigation/pricing/">Register</a> for the Drug & Medical Device Litigation Conference and save 15% off your fees by entering MoFo’s discount code (P15-999-MORR21) during checkout.<a target="_blank" href="https://www.americanconference.com/drug-medical-device-litigation/agenda/">View the full agenda of the conference</a>.

Fertility Center Litigation

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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Co-Chair, Litigation Department

Erin Bosman is the global co-chair of Morrison Foerster’s litigation department. Erin is also the founder and co-head of the Artificial Intelligence group and former chair of the Complex Litigation + Advisement practice 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 the Global Co-Chair of Morrison Foerster’s Litigation Department. Erin is also the founder and co-head of the Artificial Intelligence Group and former chair of the Complex Litigation + Advisement Practice 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

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Join Us: Drug & Medical Device Litigation Conference

Join Us: Drug & Medical Device Litigation Conference 

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MoFo is a proud sponsor of the American Conference Institute’s Drug & Medical Device Litigation Conference, the premier products liability litigation event for 

Join Us: Drug & Medical Device Litigation Conference

Coronavirus (COVID-19)

Public Readiness and Emergency Preparedness Act (PREP Act)

When we discussed the Public Readiness and Emergency Preparedness (PREP) Act earlier this year, we predicted that its tort liability protections would reassure manufacturers and distributors of novel COVID-19 drugs and medical products. So far, so good: the first court decisions interpreting PREP Act immunity in the COVID-19 setting have emphasized that the protection applies to those who actually use medical countermeasures, not where injuries arise from parties not using countermeasures. By extension, these cases establish that certain negligence claims may escape the scope of PREP Act immunity and can be properly heard in state court—even if those claims are related to COVID-19.Read more on <a href="https://lifesciences.mofo.com/topics/First-decisions-limit-PREP-act-immunity-in-coronavirus-context.html">MoFo Life Sciences</a>.

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First Decisions Limit PREP Act Immunity in Coronavirus Context

Using Waivers to Curb COVID-19 Legal Exposure

When we discussed the Public Readiness and Emergency Preparedness (PREP) Act earlier this year, we predicted that its tort liability protections would reassure 

First Decisions Limit PREP Act Immunity in Coronavirus Context

The Henry Schein arbitration battle is making its way to the Supreme Court again. The Court recently <a href="https://www.supremecourt.gov/docket/docketfiles/html/public/19-963.html">granted</a> Henry Schein, Inc.’s certiorari petition to answer the question of “Whether a provision in an arbitration agreement that exempts certain claims from arbitration negates an otherwise clear and unmistakable delegation of questions of arbitrability to an arbitrator.” Henry Schein, Inc. v. Archer & White Sales, Inc., No. 19-963 (2019). In other words, if an arbitration agreement carves out certain claims (like injunctive relief), does that create a loophole that allows the district court to decide the arbitrability of those claims?Round 1As we <a href="https://classdismissed.mofo.com/consumer-products/leave-arbitration-to-the-arbitrator/">explained</a> last year, the case started when Archer & White Sales, Inc., a small business that distributes dental equipment, sued a dental equipment manufacturer and Schein, a major distributor of the equipment, for alleged antitrust violations. The parties’ agreement provided that disputes “arising under or relating to” the agreement “shall be resolved by binding arbitration in accordance with the rules of the American Arbitration Association [AAA].” Henry Schein, Inc. (“Schein”) invoked the FAA and sought to compel arbitration. In opposition, Archer & White relied on a court-created exception permitting the court to decide arbitrability—notwithstanding a contractual delegation to the arbitrator—where the court finds the argument for arbitration to be “wholly groundless.” The trial court agreed and denied arbitration, and the Fifth Circuit <a href="http://www.ca5.uscourts.gov/opinions/pub/16/16-41674-CV0.pdf">affirmed</a>, 878 F.3d 488 (5th Cir. 2017). The Supreme Court vacated the decision, unanimously <a href="https://www.supremecourt.gov/opinions/18pdf/17-1272_7l48.pdf">concluding</a> that the “wholly groundless” exception was inconsistent with the FAA and the Court’s precedents, 139 S. Ct. 524 (2019). The decision suggested that the Court as constituted remains firmly on a pro-arbitration path and will continue to strictly adhere to the FAA.Round 2 On <a href="http://www.ca5.uscourts.gov/opinions/pub/16/16-41674-CV1.pdf">remand</a>, the Fifth Circuit again refused to compel arbitration, 935 F. 3d 274 (5th Cir. 2019). The Fifth Circuit acknowledged that the parties had delegated at least some questions of arbitrability to the arbitrator. But because the arbitration agreement carved out injunctive relief claims, the agreement did “not clearly and unmistakably delegate[] the question of arbitrability to an arbitrator.” The Fifth Circuit therefore concluded that the court—and not the arbitrator—was responsible for determining the arbitrability of the claims at issue. It then held that the action was one “seeking injunctive relief” and thus exempt from arbitration under the parties’ agreement.  Schein filed a <a href="https://www.supremecourt.gov/DocketPDF/19/19-963/130539/20200131112522163_Henry_Schein_cert_petition.pdf">petition for writ of certiorari</a>, which the Supreme Court granted.[1]As Schein’s petition pointed out, courts are divided on the question presented. Some hold that the question of whether the provision exempts a particular claim from arbitration is itself a question of arbitrability, and the arbitrator must decide that question once the moving party has demonstrated the existence of a clear and unmistakable delegation. Others, like the Fifth Circuit, hold that the presence of a carve-out provision negates an otherwise clear and unmistakable delegation. Schein argues that this approach “threatens to render even the clearest and most unmistakable delegation ineffective,” allowing courts to easily override a contract’s delegation of authority to the arbitrator. The Supreme Court’s decision is expected to provide much-needed clarity in this matter. In the meantime, Morrison & Foerster’s <a href="https://www.mofo.com/capabilities/class-actions-mass-torts.html">Class Actions and Mass Torts</a> attorneys can provide further insight on the implications of this action.[1] The Court denied a cross-petition by Archer & White Sales, which asked the Court to decide (1) whether an arbitration agreement that identifies a set of arbitration rules to apply if there is arbitration clearly and unmistakably delegates to the arbitrator disputes about whether the parties agreed to arbitrate in the first place; and (2) whether an arbitrator or a court decides whether a nonsignatory to an arbitration agreement can enforce the arbitration agreement through equitable estoppel.

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Schein On: Supreme Court to Decide Key Arbitration Delegation Question

U.S. Supreme Court’s Decision to Review a Pair of FTCA Cases Could Spell a Sea Change in FTC’s Enforcement Authority

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The Henry Schein arbitration battle is making its way to the Supreme Court again. The Court recently granted Henry Schein, Inc.’s certiorari petition to answer 

Schein On: Supreme Court to Decide Key Arbitration Delegation Question

Antitrust

Arbitration

A bipartisan group of experts in economics, health, technology, and ethics recommended that the U.S. scale up COVID-19 testing—5 million per day by June, 20 million per day by midsummer—in order to fully re-mobilize the economy.Consistent with this, FDA has taken various steps to accelerate the availability of testing, as we have <a href="https://lifesciences.mofo.com/topics/FDA-uses-EUAs-broadly-in-the-fight-against-Covid-19.html" target="_blank" rel="noopener noreferrer">previously reported</a>. Notably, in its <a href="https://www.fda.gov/media/135659/download" target="_blank" rel="noopener noreferrer">Policy for Diagnostic Tests for Coronavirus Disease-2019</a> (last updated May 11), FDA describes circumstances under which CLIA-certified laboratories that develop and validate tests for coronavirus can use the tests before the agency has completed review of the lab’s EUA.Read more on <a href="https://lifesciences.mofo.com/topics/FDA-signals-flexibility-with-COVID-19-tests.html">MoFo Life Sciences</a>.

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FDA Signals Flexibility with COVID-19 Tests

A bipartisan group of experts in economics, health, technology, and ethics recommended that the U.S. scale up COVID-19 testing—5 million per day by June, 20 mil

FDA Signals Flexibility with COVID-19 Tests

Emergency Use Authorization (EUA)

On June 21, the Food and Drug Administration (FDA) released a report titled “Statement on agency’s efforts to increase transparency in medical device reporting.” This report describes updates to FDA’s Medical Device Reporting (MDR) Program, namely the conclusion of the Alternative Summary Reporting (ASR) Program. In conjunction with the end of the program, FDA also published 20 years of reports submitted through the ASR Program that had not previously been disclosed to the public, leaving manufacturers with potentially massive amounts of data to sort through regarding their products.Read our <a href="https://protect-us.mimecast.com/s/AEKyCyPJ7zfZWVJRFQzirL">client alert</a>.

Committed to Clarity: FDA’s Dedication to Transparency with the End of ASR

On June 21, the Food and Drug Administration (FDA) released a report titled “Statement on agency’s efforts to increase transparency in medical device reporting.

Committed to Clarity: FDA’s Dedication to Transparency with the End of ASR

The United States Supreme Court continued the pro-arbitration trend in its jurisprudence, as well as its strict construction of the Federal Arbitration Act, in its unanimous decision in Henry Schein, Inc. v. Archer & White Sales, Inc., No. 17-1272, 2019 WL 122164 (U.S. Jan. 8, 2019).  Resolving a division in the Circuits on the issue, the Court held that where the parties delegate the “gateway” issue of arbitrability to the arbitrator, the court may not apply a judicially created “wholly groundless” exception to avoid delegation.<a name="_ftnref1" href="#_ftn1">[1]</a>Case BackgroundArcher and White Sales, Inc., a small business that distributes dental equipment and the plaintiff below, sued a dental equipment manufacturer and Schein, a major distributor of the equipment, for federal and state law antitrust violations.  The relevant agreement between the parties provided that disputes “arising under or relating to” the agreement “shall be resolved by binding arbitration in accordance with the rules of the American Arbitration Association [AAA].”  Schein invoked the FAA and sought to compel arbitration.Archer and White opposed, relying on an exception in the arbitration provision for actions seeking injunctive relief.  It argued that because its complaint sought injunctive relief in addition to damages, the dispute was not arbitrable.  Schein argued that because the AAA rules provide that arbitrators have the power to resolve threshold issues of arbitrability, under applicable case law the contract required that the arbitrator, not the court, decide whether the dispute was subject to arbitration.In response, Archer and White relied on a court-created exception recognized in the Fifth Circuit (and several other Circuits) permitting the court to decide arbitrability, notwithstanding a contractual delegation to the arbitrator, where the court finds the argument for arbitration to be “wholly groundless.”  The trial court agreed and denied arbitration, and the Fifth Circuit affirmed.The DecisionWith Justice Kavanaugh writing his first opinion for the Court, the Supreme Court vacated the decision and remanded.  The opinion emphasizes strict interpretation under the FAA:  “We must interpret the Act as written, and the Act in turn requires that we interpret the [arbitration] contract as written.”  Schein, 2019 WL 122164, at *4.  The Supreme Court had held in prior opinions that who decides whether a dispute may be arbitrated is itself a matter of contract, and the parties thus may agree that an arbitrator and not the court will decide.  See, e.g., Rent-A-Center, W., Inc. v. Jackson, 561 U.S. 63, 68-70 (2010).The Court concluded in Schein that the “wholly groundless” exception was inconsistent not only with the express terms of the FAA, but with the Court’s precedents.  Justice Kavanaugh noted that AT&T Technologies, Inc. v. Communications Workers of America, 475 U.S. 643, 649-50 (1986), held that the FAA precludes a court from ruling on the merits of a dispute that has been delegated to an arbitrator, even if the claim appears to be wholly frivolous.  Justice Kavanaugh concluded that this principle applied with equal force to the issue of arbitrability:  just as the court cannot decide a merits claim that the parties have delegated to an arbitrator, neither can it decide an arbitrability claim that the parties have similarly delegated.  Schein, 2019 WL 122164, at *4.Schein summarily rejected each of respondent’s additional four arguments:<ul><li>Respondent argued that §§ 3 and 4 of the FAA, which respectively set forth the standards for the court’s determination to stay litigation pending arbitration and for compelling arbitration, mean that a court must always make an initial determination of arbitrability. But “that ship has sailed” in light of the Court’s consistent holdings that threshold arbitrability issues can be delegated to the arbitrator.  2019 WL 122164, at *4.</li><li>Respondent’s reliance on § 10 of the FAA, which provides for “back-end” judicial review if the arbitrator has exceeded his or her powers, was similarly misplaced. Congress designed the statute in a specific way, and the Court had no power to redesign it.</li><li>The argument that it is inefficient to send a matter to an arbitrator where the argument for arbitration is “wholly meritless” fared no better. The Court could not engraft its own exceptions on the FAA.  Moreover, the Court was “dubious” that the “wholly groundless” exception would save time, since it would likely spark time-consuming collateral litigation.  Nor was it proper to assume that if a court would find the basis for arbitration “wholly frivolous,” so would an arbitrator, rendering referral to the arbitrator a waste of time.  “It is not unheard-of for one fair-minded adjudicator to think a decision is obvious in one direction but for another fair-minded adjudicator to decide the matter the other way.”   at *5.</li><li>Finally, the argument that the “wholly groundless” exception was necessary to deter frivolous motions to compel arbitration failed, among other reasons, because the Court may not rewrite the statute to accommodate policy concerns, and because arbitrators can dispose of frivolous cases by quickly holding the dispute non-arbitrable and may be able to award sanctions.</li></ul>The Court thus rejected the “wholly groundless” objection.  The Court expressed no view about whether the contract at issue in fact delegated the arbitrability determination to the arbitrator.  Indeed, Justice Kavanaugh emphasized that courts “should not assume that the parties agreed to arbitrate arbitrability unless there is clear and unmistakable evidence that they did so.”  Id. at *6 (citing First Options of Chi., Inc. v. Kaplan, 514 U.S. 938, 994 (1995).Key TakeawaysAlthough the decision in Schein was not a surprise, it confirms that the Court as constituted will remain firmly on a pro-arbitration path and will continue to strictly adhere to the provisions of the FAA.  The decision also suggests that parties who desire arbitration may want to expressly delegate the gateway issue of arbitrability to the arbitrator.  (Incorporation of the AAA rules likely has that effect, but the Supreme Court has not ruled on the issue.)  Unlike a court, the arbitrator’s decision is not subject to review, which will give some potential litigants pause.  Nonetheless, the Schein opinion suggests that for parties who strongly desire arbitration, this may be a benefit.<a name="_ftn1" href="#_ftnref1">[1]</a> Just one week later, however, in New Prime Inc. v. Oliveira, No. 17-340, 2019 WL 189342 (U.S. Jan. 15, 2019), the Supreme Court held that a court, not an arbitrator, must decide the threshold question of whether the contract at issue is within the scope of the FAA and not within an exception.  Because §§ 3 and 4 of the FAA confer authority on a court to stay litigation and compel arbitration only where the contract comes within the scope of the FAA as defined in § 2 of that Act, the court must first resolve the scope issue even where the contract otherwise delegates arbitrability determinations to the arbitrator.  In New Prime, because the Supreme Court concluded that the transportation worker exception contained in § 1 of the FAA applied to independent contractors, the matter was not arbitrable.

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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 pro