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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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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Health care apps are one of the most important and growing segments in the ecosystem known as the Internet of Things (IoT). After the recent amendments to the Health Insurance Portability and Accountability Act (HIPAA) that, among other things, broadened the definition of a “Business Associate,” many technology companies found themselves wondering whether they were, or were not, subject to HIPAA. Health and Human Services (HHS) recently issued some guidance, Health App Use Scenarios & HIPAA, that attempts to provide some clarity on these issues for app developers.

Fertility Center Litigation

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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

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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HIPAA and Health Care Apps: Is Your App Covered?

HIPAA and Health Care Apps: Is Your App Covered?

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Health care apps are one of the most important and growing segments in the ecosystem known as the Internet of Things (IoT). After the recent amendments to the H

The FDA’s recently issued draft guidance on “<a href="http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm482022.pdf" target="_blank">Postmarket Management of Cybersecurity in Medical Devices</a>” seeks to address some of the increasing concerns that medical device providers, regulators, and consumers have about postmarket cybersecurity standards related to medical devices. Because the consequences of cybersecurity breaches related to medical devices can be serious, manufacturers, health care facilities, and providers should take precautions to ensure that cybersecurity policies and protocols are thorough and up-to-date. It should be noted that this draft guidance is still in draft form and not to be implemented yet.Imagine this scenario: A rogue agent gains access to the serial number on the Vice President’s pacemaker. The agent sends the number to an associate who remotely hacks his way through the device’s security framework and accelerates the Vice President’s heart rate, inducing a heart attack. Sound familiar? Fortunately, this was not a news report; rather, it was a plot line during the second season of Showtime’s television series Homeland. But like many science fiction predictions, this one has already found roots in reality. With the rapidly expanding Internet of Things, and with millions of medical devices now connected to the Internet, hackers have more devices to target every day. Many of these devices, like the pacemaker in Homeland, are essential to a customer’s health, and as a result security breaches should not be taken lightly.BackgroundIn February 2013, President Obama issued <a href="https://www.whitehouse.gov/the-press-office/2013/02/12/executive-order-improving-critical-infrastructure-cybersecurity" target="_blank">Executive Order 13636</a>, which stated that cyber threats to national security are among the most serious our nation faces. Additionally, <a href="https://www.whitehouse.gov/the-press-office/2013/02/12/presidential-policy-directive-critical-infrastructure-security-and-resil" target="_blank">Presidential Policy Directive – 21</a> tasks Federal agencies to strengthen the security and resilience of critical infrastructure against physical and cyber threats. The FDA’s draft guidance borrows principles from these directives and represents the FDA’s current efforts to help strengthen cybersecurity in the rapidly-growing medical device market. Moreover, the FDA encourages manufacturers to apply the voluntary National Institute of Standards and Technology (“NIST”) framework in the development and implementation of their cybersecurity controls. Although the NIST framework only applies to critical infrastructure, the FDA encourages applying its principles broader than critical infrastructure and offers guideposts for companies to improve their cybersecurity posture.Although the FDA’s guidance does not establish legally enforceable responsibilities, it does paint a picture of the FDA’s “current thinking” on this topic, though it should be noted that the draft guidance does not establish any rights for any person, and it is not binding on the public or the FDA, and medical device manufacturers retain the ability to use alternative approaches.Focusing primarily on patient safety, the FDA recommends that medical device manufacturers monitor, identify, and respond to cybersecurity vulnerabilities and exploits during the postmarket management of their devices. The draft document also provides some guidance concerning reporting duties related to cybersecurity breaches.General Principles Concerning Postmarket RegulationThe FDA states that its position is that medical device cybersecurity is a shared responsibility that implicates not just the manufacturer of medical devices, but also health care facilities, patients, and providers, though manufacturers are likely to be on the front line of any litigation.The FDA stated its view that due to the continuing evolution of cybersecurity risks associated with medical devices, it is not possible to eliminate risks through premarket controls alone. Accordingly, manufacturers should[1] increase their postmarket cybersecurity risk management measures. The draft guidance suggests that medical device manufacturers focus on certain aspects, including:<ol><li>Identify problem areas in cybersecurity framework. This can be achieved through analysis of complaints, returned products, service records, and other sources of data that may help identify existing and potential cybersecurity risks. Many medical devices now contain or share internal records, statistics, and incident reports related to their performance. These metrics can be crucial for manufacturers to identify potential weaknesses in their cybersecurity armor before they are exploited.</li><li>Characterize and assess the identified vulnerabilities with regards to exploitability and potential severity of impact to health. This includes establishing and communicating the process for receiving and managing vulnerability reports. The FDA guidance provides additional detail and recommends using a cybersecurity vulnerability assessment tool or similar scoring system in this process.</li><li>Clearly define “essential clinical performance” of the medical device at issue in order to develop safeguards that protect, respond, and recover from the cybersecurity risk. Essential clinical performance is defined as “performance that is necessary to achieve freedom from unacceptable clinical risk.” In turn, an unacceptable clinical risk is one with high exploitability potential that poses a severe impact to health. The FDA admits that risk assessment may be difficult (i.e. manufacturers may struggle to categorize a risk as acceptable or unacceptable). Even so, the FDA recommends that manufacturers “make a binary determination that a vulnerability is either controlled or uncontrolled using an established process that is tailored to the product, its essential clinical performance, and the situation.”</li><li>Adopt a coordinated vulnerability disclosure policy and practice. Clearly defining user expectations and allocating risks appropriately can save manufacturers time and money in the long run.</li><li>Deploying mitigations that address cybersecurity risk early and prior to exploitation. If possible, risks should be addressed before they are exploited. Not only will early action protect customers, it may also limit potential damage claims down the road. The FDA notes that “acceptable mitigations will vary according to the device’s essential clinical performance”—i.e., manufacturers should apply a sliding scale analysis. For example, the FDA notes that more significant mitigation may be necessary for a vulnerability affecting an insulin pump than one affecting a thermometer.</li></ol>The FDA recognizes that even in the most sophisticated cybersecurity programs, vulnerabilities may arise and complete security is impossible. The FDA’s guidance focuses only on those vulnerabilities that may affect safety. Manufacturers should be cognizant that other issues beyond the scope of the draft guidance could become the focus of other regulating bodies and/or plaintiffs’ attorneys.ReportingThe FDA document also provides some guidance to manufacturers with regard to reporting cybersecurity vulnerabilities and breaches to the FDA. Generally, the FDA does not plan to require premarket review or approval of “cybersecurity routine updates and patches” to medical device software.Additionally, the FDA does not plan on requiring reporting when changes to a device are made to address vulnerabilities associated with controlled risks. Controlled risks are those that present “sufficiently low residual risk that the device’s essential clinical performance could be compromised by the vulnerability.” Reporting is also not necessary when these changes are implemented “solely to strengthen cybersecurity.” However, the FDA suggests that companies report newly acquired information about cybersecurity vulnerabilities and device changes made as part of a cybersecurity routine update or patch in an annual report when they concern a premarket approval (or Class III) medical device (one that supports or sustains human life).The draft guidance provides a relevant example where manufacturers may not have to report an action to mitigate a controlled risk. In this example, a manufacturer becomes aware of an “open communication port” on its device. However, a design feature prevents unauthorized remote firmware from being downloaded onto the device. This requirement for physical access to the device substantially mitigates the threat; therefore, the risk is considered by the FDA to be controlled and acceptable. The manufacturer then enhances the device’s security by closing the open communication port and notifying users. These actions would be considered a cybersecurity routine update or patch and may not require reporting under federal standards. However, if this were a Class III device, the manufacturer would need to report the changes to the FDA in its annual report.On the other hand, when manufacturers implement risk control measures to account for uncontrolled risks to essential clinical performance, the FDA’s view is different, and reporting might be necessary. However, the FDA does not intend to enforce these reporting requirements when:  (1) there are no known serious adverse events or deaths associated with the vulnerability; (2) within 30 days, the manufacturer identifies and implements device changes and/or compensating controls to bring the residual risk to an acceptable level and notifies users; and (3) the manufacturer is a participating member of an Information Sharing Analysis Organization (“ISAO”)[2], such as the National Health Information Sharing & Analysis Center.The FDA’s drafters may have been Homeland fans as the guidance contains a familiar example where reporting may be necessary:  a manufacturer becomes aware of a vulnerability in a Class III medical device (i.e. a pacemaker) that allows it to be reprogrammed by an unauthorized user. The manufacturer performs a risk assessment and concludes that the vulnerability is moderately exploitable and the risk to the device’s essential clinical performance is uncontrolled. The manufacturer notifies the relevant stakeholders and distributes an emergency patch to mitigate the risk. The manufacturer is not a member of an ISAO. Even if the manufacturer is unaware of any incidents, because this vulnerability could result in severe injury or death, reporting may be necessary.ConclusionEven in light of the FDA’s guidance, manufacturers will likely struggle to categorize risks associated with cybersecurity vulnerabilities. Consequently, determining reporting requirements (contingent on whether a risk is uncontrolled or controlled) may also present challenges unique to each medical device at issue. Manufacturers will be well served by factoring in the FDA guidance into their existing cybersecurity plans. [1] The use of the word should in Agency guidance means that something is suggested or recommended, but not required.[2] An “ISAO” is a group created to gather, analyze, and disseminate critical infrastructure information. See <a href="https://www.whitehouse.gov/the-press-office/2015/02/13/executive-order-promoting-private-sector-cybersecurity-information-shari" target="_blank">Exec. Order No. 13691 (Feb. 13, 2015)</a>.

An orthopedic implant company

A children&rsquo;s monthly subscription service product

A fertility company

A major technology company

A smart fitness equipment company

FDA Embraces Internet of Things: New Draft Guidance on Postmarket Cybersecurity for Medical Devices

The FDA’s recently issued draft guidance on “Postmarket Management of Cybersecurity in Medical Devices” seeks to address some of the increasing concerns that me

FDA Embraces Internet of Things: New Draft Guidance on Postmarket Cybersecurity for Medical Devices

Earlier this month, a federal district court in Illinois denied GlaxoSmithKline’s (GSK) renewed summary judgment motion based on federal preemption of failure-to-warn claims in an opinion setting tough standards for brand drug manufacturers. Judge Zagel found that GSK had not shown “clear evidence” that the FDA would have rejected the heightened warning label sought by plaintiff. Therefore, plaintiff’s claims were not preempted.This ruling comes from the same court that held in 2014 that GSK, the brand drug manufacturer, owed a duty of care to a patient who took only the generic version of its drug. Dolin v. SmithKline Beecham Corp., No. 1:12-cv-06403 (N.D. Ill. Feb 28, 2014).BackgroundPlaintiff Wendy Dolin sued GSK for her husband’s death. Mr. Dolin was a prominent attorney in Chicago who died in an apparent suicide six days after he began taking paroxetine, a generic form of Paxil, to treat work-related anxiety.The complaint alleged that paroxetine caused akathisia, a condition characterized by agitation and restlessness, and that akathisia is associated with suicidal behavior. Plaintiff alleged that GSK failed to warn that paroxetine was associated with an increased risk of suicide in adults.GSK had previously moved for summary judgment on product liability and negligence claims on the grounds that it did not manufacture the product that Mr. Dolin ingested. In denying GSK’s motion, Judge Zagel reasoned that GSK owed Mr. Dolin a duty of care because “it was well understood that any generic manufacturer would be required by law to use GSK’s design and warning label.”Preempting Failure-to-warn ClaimsAfter discovery, GSK renewed its motion for summary judgment on the grounds that the plaintiff’s failure-to-warn claims were preempted. In the renewed motion, GSK attacked the negligence claim, which alleged that GSK failed to effectively warn consumers of the risk of Paxil-specific adult suicide. GSK argued that the failure-to-warn claim was preempted by FDA regulations governing drug labels.Judge Zagel denied the motion, finding that the claims were not preempted because GSK had failed to demonstrate with “clear evidence” that the FDA would not have approved a Paxil-specific adult warning regarding the risk of suicide. The court began its preemption analysis by recognizing that preemption in this context is a demanding defense. Citing Wyeth v. Levine, the court found that “[t]o meet this demanding burden, GSK is required to produce ‘clear evidence’ that, had it added a Paxil-specific adult suicidality warning, that change would have been rejected by the FDA or deemed a misbranding of the drug.”“Clear Evidence”Front and center in this dispute was the issue of what such “clear evidence” might be. GSK had put forth substantial evidence regarding the FDA’s own studies of suicide risks for the entire class of selective serotonin reuptake inhibitor (SSRI) drugs. GSK also cited its extensive correspondence with the FDA on what changes should be made to the Paxil label in light of the FDA’s changes to all SSRI drugs. But the court focused only on one transaction: on June 22, 2007, the FDA invited GSK to discuss the option of altering the language on its warning label. According to GSK’s brief, the letter stated:As for your first question, the Agency has reviewed your proposed changes, and we do not believe that your product specific analysis should be included in class labeling revisions since the labeling is targeted at the class of drugs. If you would like to discuss this matter further, please submit a formal meeting request.Despite the vast record showing the FDA’s heavy hand in shaping SSRI labeling in general, and Paxil labeling in particular, the court simply noted that GSK did not follow up to discuss the matter further and sought no further labeling changes. This factual record, the court found, was insufficient to support GSK’s assertion “that the FDA has considered and rejected an adult suicide warning during the relevant period.”Judge Zagel’s ruling departs from the Wyeth standard, as it potentially requires a defendant to demonstrate by clear evidence not that the FDA would have rejecteda proposed warning label, but instead that the FDA actually did reject the label.ImplicationsThe ruling leaves open questions as to the defendant’s burden of proof in establishing a preemption defense. Rather than adding clarity to pharmaceutical labeling requirements, this opinion muddies the water. It brings defendants closer to having to disprove that an entire chain of events would have occurred leading to the FDA’s rejection of a strengthened warning—precisely the type of “Mouse Trap game” that Justice Thomas found should not be within the purview of the courts.PLIVA, Inc. v. Mensing, 131 S. Ct. 2567, 2578 (2011).Should plaintiff prevail at trial, we expect and hope that this opinion would be reversed on appeal based on the clear evidence that the FDA took control over the content of the label.We will continue to monitor these developments and provide further updates on the legal landscape for pharmaceutical failure-to-warn claims.

Liability for Brand Drug Manufacturers All But Clear

Earlier this month, a federal district court in Illinois denied GlaxoSmithKline’s (GSK) renewed summary judgment motion based on federal preemption of failure-t

Liability for Brand Drug Manufacturers All But Clear

A recent decision from the Central District of California demonstrates the challenges serial plaintiffs may have with pursuing similar class actions and showcases the primary jurisdiction doctrine. On December 29, 2015, in Red v. General Mills, Inc., et al., Case No. 2:15-cv-02232-ODW(JPR), U.S. District Judge Otis D. Wright granted defendants’ motion to dismiss due to plaintiff’s lack of standing and stayed the case under the primary jurisdiction doctrine. Red challenged General Mills’ use of partially hydrogenated oils (PHOs) in their food products, asserting Unfair Competition Law (UCL), public nuisance, and breach of the implied warranty of merchantability claims. The plaintiff alleged that PHOs increase the risk of a variety of diseases and that the scientific community has concluded that there is no safe consumption level for artificial transfats.Standing: The court held that, while the plaintiff had Article III standing based on the alleged “immediate physical injury” of consuming PHOs, she lacked standing to assert injuries based on alleged long-term health risks. The plaintiff’s future injury allegations failed because she did not demonstrate that her past level of consumption substantially increased her risk of future health complications.The court, however, dismissed the plaintiff’s UCL claim for lack of standing because the plaintiff failed to plead adequate “economic injury.” Notably, the plaintiff had previously brought three other trans-fat lawsuits where she alleged she knew that PHOs were unhealthy, knew that food products sold in California contained PHOs, and knew that she could review the label to determine whether a product contained PHOs (but did not allege whether she looked at the label or not). The court also soundly rejected her allegation that, even if PHOs were listed as an ingredient on the label, it was unreasonable to expect her to read the label prior to purchase. The court found that the plaintiff’s “self-inflicted harm” was precisely the type that the Ninth Circuit had rejected for purposes of standing. However, the court granted the plaintiff leave to amend.Primary Jurisdiction: Despite permitting the plaintiff to amend her UCL claim, the court ultimately concluded that the case should be stayed under the primary jurisdiction doctrine. The complexity of determining the health effects of PHOs warranted an initial determination by the FDA, because whether, and in what amount, a particular chemical substance posed a serious public health risk was precisely the type of complex question that required a uniform answer from the dedicated agency, rather than piecemeal and potentially conflicting decisions from courts. The court noted that Congress had bestowed on the FDA the authority to comprehensively regulate food safety, and, while the FDA had recently determined that PHOs were no longer generally recognized as safe, it had withheld judgment on whether certain uses of PHOs could be approved and noted it would likely decide the issue within three years.

Court Stays Away from Trans Fat in General Mills Case

A recent decision from the Central District of California demonstrates the challenges serial plaintiffs may have with pursuing similar class actions and showcas

Court Stays Away from Trans Fat in General Mills Case

We’ve all heard about food fads:  Paleo, artisanal, farm-to-table.  But what about food litigation fads?  Plaintiffs’ lawyers must scour the same grocery aisles, judging from their past “sweet tooth” obsession with “evaporated cane juice” (ECJ).  But—with most courts in this District staying ECJ cases pending the U.S. Food and Drug Administration’s (FDA’s) review of its ECJ draft guidance—the ECJ litigation fad appeared to have faded as abruptly as it began.Not so fast, Plaintiffs’ lawyers will say.  While the majority of courts have maintained stays pending FDA’s final review, recent decisions to the contrary may portend the revival of this forgotten trend.  Will ECJ have another “moment”?We provide further background and discuss the implication of these decisions below.Plaintiffs’ ECJ Allegations. Plaintiffs bringing ECJ claims allege that ECJ is actually sugar, so listing ECJ as an ingredient misleads consumers into believing that these products are healthier than those listing sugar as an ingredient. Plaintiffs assert that FDA has explicitly stated that ECJ is not a common or usual name for sugar, and thus cannot be listed as an ingredient at all.FDA’s Position. Despite these assertions, FDA’s position on ECJ is in flux. Although FDA issued draft guidance in 2009 suggesting that ECJ is not the common or usual name for sugar, as we have previously posted, FDA subsequently issued a notice in 2014 reopening the comment period for its draft guidance, indicating that it would reconsider the issue.ECJ Stays. Following FDA’s notice, courts facing ECJ claims stayed or dismissed the claims pursuant to the primary jurisdiction doctrine, finding that, based on FDA’s authority over product labeling and its expertise in the area, courts should permit FDA to at least finalize its stance on ECJ before passing judgment. At least 18 ECJ claims were dismissed or stayed between 2014 and 2015.After issuing stays, one Northern District court judge who had stayed an ECJ case—Judge Chen—requested an update from FDA on the status of its review. In July 2015, FDA confirmed that it anticipated finalizing its guidance by the close of 2016. At least six Northern District courts continued stays since that update — all over plaintiffs’ objections. One court, however, departed from the trend: in August 2015, Judge Chhabria lifted a stay in an ECJ case.  See Gitson et al. v. Trader Joe’s Company, No. 3:13-cv-01333-VC (N.D. Cal. Aug. 18, 2015), Dkt. No. 123.Updates. Until recently, Judge Chhabria was the lone dissenter in the ECJ debate. But on January 4 and 5, 2016, Judges Henderson and Donato, respectively, also lifted ECJ stays. See Figy v. Lifeway Foods, Inc., No. 3:13-cv-4828-TEH (N.D. Cal. Jan. 4, 2016), Dkt. No. 57; Swearingen v. Pacific Foods of Oregon, Inc., No. 13-cv-04157 (N.D. Cal. Jan. 5, 2015), Dkt. No. 61. While neither decision contains substantial analysis, Judge Donato did note that he considered the issues “in light of the FDA’s continued delay in providing final guidance.” Id. at 1:18. These courts appear to have become impatient with the pace of FDA’s review.Two other courts, however, have continued stays subsequent to these three rulings. See, e.g., Gitson, et al. v. Clover-Stornetta Farms, Inc., Case No. 3:13-cv-01517-EDL (N.D. Cal. Jan. 7, 2016) (extending ECJ stay for an additional 180 days, until August 2016) (Laporte, J.); Swearingen v. Amazon Preservation Partners, Inc., Case No. 13-cv-04402-WHO (N.D. Cal. Jan. 11, 2016) (Orrick, J.) (extending ECJ stay and continuing case management conference until July 2016). The new year has thus brought divergence in Northern District courts’ treatment of ECJ cases.Implications. The future of ECJ claims is unclear: while Judges Orrick and Laporte’s decisions upholding stays suggest that the pendulum has not shifted towards reviving these claims, Judges Chhabria, Henderson, and Donato’s rulings to the contrary may suggest that ECJ stays will not remain in place indefinitely. This means that a slew of dormant ECJ claims could come back to life this year, especially if FDA fails to make headway on its draft guidance.  We may see a revival of the ECJ fad after all.But another trend may nonetheless keep these cases quiet. Many district courts have stayed misbranding cases pending the Ninth Circuit’s decisions in misbranding appeals, including Jones v. ConAgra, Brazil v. Dole, and Kosta v. Del Monte. These appeals concern class certification issues—including ascertainability and the proper measure of damages—that district courts must consider when assessing a plaintiff’s proposed class certification motion. Courts have therefore found it appropriate to wait for the Ninth Circuit’s guidance before deciding these issues. See, e.g., Ham v. Hain Celestial Grp., Inc., 3:14-cv-02044-WHO (N.D. Cal. Dec. 10, 2015), Dkt. No. 59. (staying putative class action pending Ninth Circuit appeals and collecting decisions in accord). ECJ cases are no exception. See Thomas v. Costco Wholesale Corp., No. 12-CV-02908-BLF, 2015 WL 6674696 (N.D. Cal. Nov. 2, 2015) (staying entire action based on Ninth Circuit appeals after staying ECJ claims in November 2014). Thus, even if FDA-based stays are lifted, Ninth Circuit stays may continue to keep ECJ claims at bay.

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Reviving a Forgotten Fad: Three Judges Lift Stays of Evaporated Cane Juice Claims

Reviving a Forgotten Fad: Three Judges Lift Stays of Evaporated Cane Juice Claims

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We’ve all heard about food fads:  Paleo, artisanal, farm-to-table.  But what about food litigation fads?  Plaintiffs’ lawyers must scour the same grocery aisles

The Ninth Circuit will not review district court stays, the appeals court recently held, because they are not “final orders” subject to immediate appeal. On January 26, 2015, the Ninth Circuit granted General Mills’ motion to dismiss plaintiff Troy Backus’ appeal of a district court order staying his putative class action against General Mills for its use of partially hydrogenated oils (PHOs) (also known as “trans fats”) in its baking mixes. Backus v. General Mills, Inc., Case No. 15-16658District Court Stay. Judge Henderson stayed the case based on the Food and Drug Administration’s (FDA’s) primary jurisdiction over the safety of trans fats. The court held that whether General Mills’ use of trans fats in food poses a significant safety risk “is both an important question of first impression, and a complicated issue that has been committed to the FDA.” No. 15-cv-01964-THE, 2015 WL 4932687, at *17 (N.D. Cal. Aug. 18, 2015).Plaintiff’s Appeal. The plaintiff appealed, arguing that the stay was effectively final because it was unclear when FDA would complete its review. In a one page order without discussion, the Ninth Circuit disagreed. The stay was not a “final or collateral order” subject to immediate appeal, the panel held, so the court lacked jurisdiction.Takeaway. Backus demonstrates that the Ninth Circuit will not provide immediate relief for plaintiffs facing stays pending FDA’s review of food or cosmetic regulations. Rather, plaintiffs must argue to district courts that stays should be lifted based on the slow pace of FDA’s review. As we describe in a <a href="http://classdismissed.mofo.com/food-misbranding/reviving-a-forgotten-fad/">related post on “evaporated cane juice” (ECJ) stays</a>, while this argument has gained traction with a few courts in this district — including Judge Henderson in a subsequent case, Figy v. Lifeway Foods, Inc., No. 3:13-cv-4828-TEH (N.D. Cal. Jan. 4, 2016), Dkt. No. 57—most courts have rejected it. Food and cosmetic misbranding cases stayed pursuant to the primary jurisdiction doctrine will likely have to wait for FDA’s review to run its course.

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Ninth Circuit: No Relief from Stay in General Mills’ Trans Fats Case Pending FDA Action

Ninth Circuit:  No Relief from Stay in General Mills’ Trans Fats Case  Pending FDA Action

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The Ninth Circuit will not review district court stays, the appeals court recently held, because they are not “final orders” subject to immediate appeal. On Jan

<div class="resource-detail">Litigation often involves lengthy battles over the proper scope of discovery. Defendants with substantial resources frequently find themselves on the receiving end of unreasonable discovery requests in an attempt to overwhelm the party and stall litigation. A recent district court decision in In re Xarelto, along with the latest amendments to the Federal Rules of Civil Procedure, may help to curb this practice in the future.</div><div class="richtext">Federal Rule of Civil Procedure 26 governs the scope and limits of discovery, allowing discovery into “any nonprivileged matter that is relevant to any party’s claim.”[1] As early as 1983, the Advisory Committee has addressed the “problem of over-discovery” and attempted to ameliorate this issue through amendments to the Federal Rules.[2] However, the problems associated with discovery overuse have only worsened over the years with the increased prevalence of electronically stored information. The most recent amendments to the Federal Rules attempt once again to address this problem.2015 Amendments to Rule 26The 2015 amendments included a significant change to Rule 26. The amended Rule includes an increased emphasis on the role of proportionality in discovery. Prior to this amendment, the discussion on proportionality was located in section 26(b)(2)(C). Section 26(b)(2) sets forth limitations on the frequency and extent of discovery. The 2015 amendments moved the proportionality requirement to section 26(b)(1), which governs the scope of discovery in general. By moving the language on proportionality to the general scope of Rule 26, the drafters indicated the importance of this requirement.The amended Rule still allows for discovery into relevant, nonprivileged matter, but adds that the information must also be “proportional to the needs of the case.” Proportionality is measured by several factors, including “the importance of the issues at stake in the action, the amount in controversy, the parties’ relative access to relevant information, the parties’ resources, the importance of the discovery in resolving the issues, and whether the burden or expense of the proposed discovery outweighs its likely benefit.”[3]This substantial amendment places more emphasis on the responsibility of the court and the parties to assess the importance of each discovery request, and to balance the importance of discovery against the burden on the producing party. Despite these substantial amendments, their practical effect depends on the extent to which courts implement these changes into the resolution of discovery disputes.In re XareltoA district court in Louisiana recently had the opportunity to interpret amended Rule 26 in the context of a discovery dispute.[4] The plaintiffs in this case sought to depose defendants’ employees and requested production of the employee personnel files. According to plaintiffs, the employee personnel files were relevant to employee bias and plaintiffs’ theory that the drug Xarelto was “rushed to the market.” Defendants opposed the discovery request, claiming the personnel files were not relevant to the claims and defenses in this case, and that the interest in discovery was outweighed by employee privacy interests.The court cited to amended Rule 26(b)(1) in its analysis of the case. Specifically, the court noted that “Rule 26(b) commands that all discovery be both relevant and proportional.” The court also cited to Fifth Circuit privacy law in balancing the interests of both parties. Noting that personnel files contain personal and potentially embarrassing material, the court concluded that the privacy concerns implicated by releasing personnel files to plaintiffs would be substantial. In contrast, plaintiffs had failed to demonstrate the relevancy and particularity of its requests under both Rule 26 and privacy law. Thus, the court denied plaintiffs’ discovery request for deponent personnel files.The court stated that plaintiffs could file a separate motion for in camera review of the personnel files. If this were requested, the court indicated that it would “balance privacy against the relevancy and particularity of the sought information” before it was released. This balancing of the burdens and benefits to each party is precisely what the Rule 26 amendments call for. The court in In re Xarelto denied an overbroad discovery request in favor of an appropriate balancing of interests. Accordingly, it sets a good example for proper interpretation of proportionality under the amended rules.Impact of Amended Rule 26 and In re XareltoPrior to these developments in the law governing discovery, defendants were often inundated with an enormous volume of discovery requests. Under amended Rule 26, it will be more difficult for plaintiffs to use discovery requests as a tactic in litigation. The court in In re Xarelto properly considered the changes to Rule 26 in determining that the discovery request at issue was overbroad. Due to the clarity of the intention behind the Rule amendments, federal courts should adopt this interpretation in the future.Parties should be diligent in objecting to discovery requests that are not proportional. However, the Advisory Committee Notes specifically state that “boilerplate objections” will not be permitted under the Rule.[5] Thus, parties faced with disproportional discovery requests should clearly indicate the reasons for their objections. At the very least, the amended Rules require courts to take a closer look at unduly burdensome discovery requests that were once commonplace. [1] Fed. R. Civ. P. 26(b)(1).[2] Advisory Committee’s Notes to 1983 Amendment.[3] Fed. R. Civ. P. 26(b)(1).[4] In re Xarelto (Rivaroxaban) Products Liability, 2016 WL 311762 (E.D. La. Jan. 26, 2016).[5] Advisory Committee’s Notes to 2015 Amendment.</div>

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Associate

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

Brittany Scheinok

Defendants Find Relief from Burdensome Discovery Requests

Litigation often involves lengthy battles over the proper scope of discovery. Defendants with substantial resources frequently find themselves on the receiving 

Defendants Find Relief from Burdensome Discovery Requests

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).

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

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

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

On November 10, the federal Food and Drug Administration (FDA) announced that it is seeking public comments on use of the term “natural” on food labeling. FDA, “Natural” on Food Labeling (Nov. 10, 2015). The agency explained that its actions were prompted by the “changing landscape of food ingredients and production, and in direct response to consumers who have requested that the FDA explore the use of the term ‘natural.’” The announcement came as a surprise since FDA had previously declined requests from consumers, the food industry, and federal judges to define the term.