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

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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>.

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In re Air Crash Near Peixoto de Azevedo, Brazil

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

Erin M. Bosman

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

Erin Bosman

An orthopedic implant company

A children&rsquo;s monthly subscription service product

A fertility company

A major technology company

A smart fitness equipment company

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

Julie Park

Julie Park | Product Liability Lawyer

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

<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

Last week, the Sixth Circuit Court of Appeals issued a groundbreaking opinion in Yates v. Ortho-McNeil-Janssen Pharmaceuticals, Inc. that could change the liability landscape for brand-name drug manufacturers. No. 15-3104 (6th Cir. Dec. 11, 2015). Yates is the first federal appellate authority to recognize “impossibility preemption” of design defect claims against brand-name drug manufacturers.BackgroundThe plaintiff in Yates was a teenager who used the brand-name ORTHO EVRA patch for birth control. She conceded that she was warned of the risk of stroke by her healthcare provider. She further admitted that she would have used the patch even if she had read the warnings regarding the increased risk of stroke and blood clots. One week after she started using the ORTHO EVRA patch, the plaintiff had a stroke.Despite the label’s clear disclosure of the risk of stroke and plaintiff’s awareness of the increased risk from her healthcare provider, plaintiff sued defendants for failure to warn. She also brought claims for manufacturing defect, negligence, and breach of implied and express warranties.The Sixth Circuit affirmed the district court’s grant of summary judgment on all claims. Most importantly, the court affirmed the district court’s ruling regarding the state-law design defect claims and held that “Yates’ state law design defect claims are preempted under Mutual Pharm. Co. v. Bartlett, 133 S. Ct. 2466 (2013).”Impossibility PreemptionThe court held that plaintiff’s state-law design defect claims were preempted by federal regulation, regardless of whether the alleged defect occurred pre- or post-FDA approval. In doing so, it became the first ever circuit court of appeals to find that federal law preempts design defect claims against brand-name drug manufacturers.The court began its preemption analysis with a discussion of preemption principles: “State law claims can be preempted expressly in a federal statute or regulation, or impliedly, where congressional intent to preempt state law is inferred.” The court explained that implied preemption exists where “(1) it is impossible for a private party to comply with both state and federal law, and (2) the state law is an obstacle to the accomplishment and execution of the full purposes and objectives of Congress.” The court noted, however, that such impossibility preemption “is a demanding defense.”Relying on Wyeth v. Levine, 555 U.S. 555, 571 (2009), the court pointed out that “plaintiffs injured by brand-name prescription drugs retain state-law tort remedies against the manufacturer of those drugs, provided it is not impossible for the drug manufacturer to comply with both state and federal law.”Pre- and Post-Approval Design Defect Claims PreemptedHere, though, impossibility preemption occupied the forefront of the court’s analysis. The court characterized plaintiff’s design defect claim as being of two types: (1) post-approval design defect, whereby the manufacturer should have lowered the dosage after FDA approval; and (2) pre-approval design defect, whereby the manufacturer should have created a different form of the drug in the first place. Both imposed state-law duties that were impossible to comply with while still complying with federal law. Therefore, both were preempted under Bartlett.Post-approval design defect. Plaintiff argued that the manufacturer could have lowered the dosage of the drug to make it safer. Under applicable New York law, a product is defectively designed if it was unreasonably dangerous and a safer design was feasible. But under FDA regulations, once a drug is approved, “the manufacturer is prohibited from making any major changes to the qualitative or quantitative formulation of the drug product . . . .” 21 C.F.R. § 314.70(b)(2)(i). Changing the dosage level clearly constituted a “‘major change’ such that prior FDA approval is necessary.”The court held that, “[b]ased on the plain meaning of the regulation . . . defendants could not have altered the dosage . . . without submission to the FDA and the agency’s approval prior to distribution of the product made using the change.” In short, the manufacturer could not have distributed an altered dosage of the drug without prior FDA approval. Therefore, it would have been impossible for the manufacturer to comply with FDA regulations and still distribute to plaintiff a lower-dosage form of the drug.Pre-approval design defect. Plaintiff argued that the manufacturer should have created a different formulation of the drug in the first place. This argument, the court found, was too attenuated. The court invoked the Supreme Court’s preemption opinion in PLIVA, Inc. v. Mensing, 131 S. Ct. 2567, 2578 (2011), which rejected the notion that a manufacturer might be required to play a “Mouse-Trap game” with the FDA. A pre-approval duty would require the court to predict the outcome of too long a chain of events: that the manufacturer designed the drug differently, that the FDA would have approved the alternative design, that plaintiff still would have selected that method of birth control, and that she still would have suffered a stroke.Simply put, “[i]n contending that defendants’ pre-approval duty would have resulted in a birth control patch with a different formulation, [plaintiff] essentially argues that defendants should have never sold the FDA-approved formulation . . . in the first place.”The court rejected plaintiff’s “never-start-selling” rationale just as the Supreme Court in Bartlett rejected the argument that a manufacturer must stop selling a drug if doing so is the only way to comply with state and federal regulation. If a drug manufacturer complies with federal law, it should not be compelled to stop selling or never to sell in the first place to comply with state law.Adequacy of WarningThe court also found that plaintiff failed to meet her burden on the failure-to-warn claim. She argued that (1) defendants’ warnings were inadequate because they failed to convey the level of risk of stroke, and (2) defendants had a duty to warn plaintiff directly pursuant to FDA regulations. Ultimately these claims failed, because the label clearly disclosed the risk of stroke and plaintiff conceded she was in turn warned by her healthcare provider.On the adequacy of the warnings, plaintiff argued that the warnings failed to convey the “degree of risk.” She essentially claimed that the label “should have stated that the risk of stroke was higher than other methods of birth control, namely birth control pills.” The court easily disposed of this argument, relying on DiBartolo v. Abbott Laboratories, 914 F Supp. 2d 601 (S.D.N.Y. 2012). As the DiBartolo court made clear, the requirement of identifying comparative risks “extends to patients with different underlying risk factors, not to different drugs treating the same ailment.”Notably, the court also rejected plaintiff’s argument that “a subsequent improvement to the label, even a change that is required by the FDA, is probative evidence of the label’s previous failure to warn.” Adopting the defendants’ reasoning, the court noted that “[w]arnings can always be made ‘better,’ but ‘better’ is not the standard New York law requires—adequacy is.” Here, the warnings in place at the time were adequate. As a result, the subsequent changes to the label were irrelevant.The court also found that defendants had no duty to warn plaintiff directly under the learned-intermediary doctrine. It is well established that, “[e]xcept where FDA regulations otherwise provide, the manufacturer’s duty is to warn the doctor, not the patient.” The record was clear that plaintiff’s healthcare provider was well aware of the risk of stroke, “and plaintiff admitted to being counseled about the risk of stroke associated with ORTHO EVRA.” Accordingly, the court granted summary judgment on the failure-to-warn claim.Manufacturing Defect, Negligence, and Breach of WarrantyThe court granted summary judgment on the remaining claims. Plaintiff could not sustain a claim for manufacturing defect, because there was no evidence that the patches she received differed from “either the manufacturing specifications or from other identical units.” Her negligence claim was preempted because, under New York law, claims of negligence are preempted per se when the article in question is regulated by federal law. Here, FDA regulations govern. Finally, plaintiff’s warranty claims failed because defendants adequately warned her prescribing physician of the risks, those risks were communicated to her, and there were no other representations to plaintiff of the drug’s safety or efficacy.ConclusionYates marks a key development in the evolution of case law regarding a branded drug manufacturer’s federal and state law liability. Bartlett made clear that certain design defect claims were preempted against generic manufacturers due to their inability to deviate from the brand manufacturer’s design, including warnings. Here, the Sixth Circuit has made clear that federal regulation controls the safety and adequacy of the actual composition and design of the drug itself.Brand-name drug manufacturers cannot be expected to comply with state law when doing so would require them to design a drug that is different from the one the FDA has approved for distribution and sale. Likewise, they cannot be required to alter the suggested dosage or administration of the drug subsequent to approval to comply with state law when doing so would violate the FDA regulation governing post-approval alterations to the drug’s formulation.After Levine, liability for brand-name drug manufacturers was fraught with “what-ifs,” as manufacturers struggled to predict which FDA-approved labels might be deemed inadequate under state law. Even after Bartlett, the question of design defect remained open for brand-name drug manufacturers. The Yates decision finally offers some certainty that seeking and obtaining FDA approval can cut off certain avenues of liability. We continue to monitor these important preemption cases, as they signal meaningful changes to future liability.

Sixth Circuit Sweeps State-Law Design Defect Claims Under the Rug of Impossibility Preemption

Last week, the Sixth Circuit Court of Appeals issued a groundbreaking opinion in Yates v. Ortho-McNeil-Janssen Pharmaceuticals, Inc. that could change the liabi

Sixth Circuit Sweeps State-Law Design Defect Claims Under the Rug of Impossibility Preemption

On April 29, 2015, the Alabama Senate passed a bill, SB80, “to provide that a manufacturer is not liable . . . for damages resulting from a product it did not design, manufacture, sell, or lease.” Sponsored by Senator Cam Ward, the bill supersedes the Alabama Supreme Court’s controversial holding in Wyeth, Inc. v. Weeks, No. 1101397, 2014 WL 4055813 (Ala. Aug. 15, 2014).<a name="_ftnref1" href="#_ftn1">[1]</a>Weeks represented the only instance in which a state supreme court held that a brand drug manufacturer, or innovator, could be liable for injuries caused by a generic version of the drug that the innovator did not manufacture because of the innovator’s primary labeling responsibilities. Weeks held that it was foreseeable that patients and medical practitioners would read and rely on the innovator’s label, regardless of whether the patient took the innovator’s drug or the generic. By so holding, the court set itself apart from the vast majority of jurisdictions, which have rejected innovator liability.The text of the bill reads as follows:In any civil action for personal injury, death, or property damage caused by a product, regardless of the type of claims alleged or the theory of liability asserted, the plaintiff must prove, among other elements, that the defendant designed, manufactured, sold, or leased the particular product the use of which is alleged to have caused the injury on which the claim is based, and not a similar or equivalent product. Designers, manufacturers, sellers, or lessors of products not identified as having been used, ingested, or encountered by an allegedly injured party may not be held liable for any alleged injury. A person, firm, corporation, association, partnership, or other legal or business entity whose design is copied or otherwise used by a manufacturer without the designer’s express authorization is not subject to liability for personal injury, death, or property damage caused by the manufacturer’s product, even if use of the design is foreseeable.The new law thus limits liability to entities in the chain of commerce for the product that allegedly caused injury. Under this new statutory regime, the brand manufacturers in Weeks would likely have succeeded in moving to dismiss the plaintiffs’ claims.According to media reports, Alabama Governor Robert Bentley is expected to sign the bill. Unfortunately for any brand drug companies currently defending claims of injury from generic drugs, the bill doesn’t go into effect for six months.The pharmaceutical industry will find this bill helpful in reducing liability exposure where the innovator drug company had no role in the underlying injury. This strong action by the Alabama legislature will also cut off a growing area of generic drug litigation, closing the door on one of the few viable causes of action for plaintiffs alleging injury from generic drugs. Plaintiffs’ counsel have been seeking new theories of liability since the Supreme Court’s landmark decision in PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011), which completely changed the litigation landscape. There, the Supreme Court held that failure-to-warn claims against generic drug companies were preempted because it was impossible for generic drug companies to independently change their labels.Three other states—California, Illinois, and Vermont<a name="_ftnref2" href="#_ftn2">[2]</a>—have had state or federal courts hold that innovator liability is a viable cause of action. It is unlikely that any of these states’ legislatures will follow Alabama’s lead in passing similar legislation. For now, brand drug companies can take comfort in the Alabama legislature’s quick and decisive reaction to what many viewed as the wrong result in Weeks.  <a name="_ftn1" href="#_ftnref1">[1]</a> For our previous commentary on Weeks, see “Weeks II: Innovator Liability Finds a Sweet Home in Alabama,” Morrison & Foerster Client Alert (Aug. 20, 2014); and “Weeks Defies Years of Jurisprudence, Allowing Innovator Liability for Generic Drugs,” Morrison & Foerster Client Alert (Jan. 16, 2013).<a name="_ftn2" href="#_ftnref2">[2]</a> Conte v. Wyeth, Inc., 168 Cal. App. 4th 89 (2008; Dolin v. SmithKline Beecham Corp., No. 12 C 6403, 2014 WL 804458 (N.D. Ill. Feb. 28, 2014); Kellogg v. Wyeth, Inc., 762 F. Supp. 2d 694 (D. Vt. 2010).[1] Conte v. Wyeth, Inc., 168 Cal. App. 4th 89 (2008; Dolin v. SmithKline Beecham Corp., No. 12 C 6403, 2014 WL 804458 (N.D. Ill. Feb. 28, 2014); Kellogg v. Wyeth, Inc., 762 F. Supp. 2d 694 (D. Vt. 2010).

Alabama Legislature Says No to Innovator Liability

On April 29, 2015, the Alabama Senate passed a bill, SB80, “to provide that a manufacturer is not liable . . . for damages resulting from a product it did not d

Alabama Legislature Says No to Innovator Liability

On Tuesday, the U.S. Food and Drug Administration (FDA) announced that it has reopened the comment period for its proposed rule on generic drug labeling. It has also scheduled a day-long public meeting to hear comments and discuss alternatives to the much-criticized rule, which would allow generic drug manufacturers to unilaterally update their warning labels. Comments and suggestions related to the rule will now be accepted through April 27, 2015, and the meeting will take place on March 27, 2015.PROPOSED RULEThe FDA proposed the rule in response to the Supreme Court’s opinion in PLIVA v. Mensing. PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011). Mensing held that generic drug manufacturers could not unilaterally change or strengthen their warnings. The end result was that most failure-to-warn claims were preempted as to generic manufacturers, though the corresponding claims against branded manufacturers survived. Justice Thomas memorably noted that the Supreme Court “will not distort the Supremacy Clause in order to create similar pre-emption across a dissimilar statutory scheme. As always, Congress and the FDA retain the authority to change the law and regulations if they so desire.” Id. at 2852.The proposed rule was no doubt a direct response to Justice Thomas’ plea. Under the proposal, holders of abbreviated new drug applications (ANDAs) would be allowed to update product labeling to reflect newly acquired safety information even if the updates differ from the reference listed drug (RLD). ANDA holders would be permitted to distribute a revised label to the market without prior FDA guidance or approval, while concurrently submitting the proposed label changes to the FDA. Additionally, ANDA holders would have an affirmative duty to notify the new drug application (NDA) holder about the supplemental revisions and pass along information forming the basis for the revision.The proposed rule further suggests that, upon receiving notification from an ANDA holder, the NDA holder is “expected” to submit its own revised label to the FDA along with its views as to whether the ANDA holder’s proposed supplement should be approved. The FDA would then evaluate the proposed labels and decide which should be approved. Upon approval, ANDA holders would have only 30 days to update their labels through an electronic process. The proposal then requires “timely distribution” of the product label “accompanied by an updated package insert as soon as feasible thereafter or at the time of next printing of the product labeling for packaging.”RESISTANCE TO PROPOSED RULEAs we’ve previously highlighted, the proposed rule has drawn ire from industry insiders and lawmakers who have voiced concerns over multiple potential issues, including excessive costs, uncertain potential liabilities, and decreased generic drug availability.<a name="_ftnref1" href="#_ftn1">[1]</a> Given the proposal’s potential impact on the entire pharmaceutical industry, it is no surprise that the Generic Pharmaceutical Association (GPhA) has already threatened to sue the FDA if the agency adopts the proposed rule.<a name="_ftnref2" href="#_ftn2">[2]</a>Although the FDA has insisted the proposed rule’s benefit to public health outweighs “concerns related to temporary differences in labeling,” the reopening of the comment period belies the strength of its position.NEW COMMENT PERIODThe FDA’s proposed rule, if adopted in its current form, would have a deleterious and widespread impact on the entire pharmaceutical industry. By reopening the comment period, the FDA has given the industry reason to believe that the rule could change significantly before final publication. This new comment period allows parties to submit guidance to the FDA as it attempts to achieve its goal of improving “communication of important safety information to prescribing health care providers and the public.” The FDA welcomes guidance and is accepting comments until April 27, 2015. We strongly urge affected parties to submit comments at <a href="http://www.regulations.gov">http://www.regulations.gov</a>, identified with Docket No. FDA-2013-N-0500-0081. Those interested in attending the public meeting on March 27, 2015, in Silver Spring, Maryland, may register by emailing <a href="mailto:CBESupplements.PublicMeeting@fda.hhs.gov">CBESupplements.PublicMeeting@fda.hhs.gov</a> by March 20, 2015.About Morrison & Foerster’s Product Liability Group:Morrison & Foerster’s Product Liability Group defends and provides counsel to product manufacturers and suppliers of all types of products. We serve as trial and national coordinating counsel in product liability and toxic tort cases, including class actions, multiparty serial tort litigation, mass tort litigation, and multidistrict litigation proceedings. We bring to every case a wealth of experience, a keen understanding of the multifaceted issues confronted by manufacturers, and the skills and knowledge to communicate scientific and medical defenses to juries.    <a name="_ftn1" href="#_ftnref1">[1]</a> See “Goodbye to Generic Preemption? FDA Publishes Proposed Rule,” Morrison & Foerster Client Alert (Nov. 13, 2013);  “$4 Billion Price Tag for Pleasing Plaintiffs’ Bar? New Study Estimates Costs of FDA’s Proposed Rule on Generic Drug Labeling,” Morrison & Foerster Client Alert (Feb. 26, 2014).<a name="_ftn2" href="#_ftnref2">[2]</a> Alexander Gaffney, Generic Drug Industry Threatens FDA With Lawsuit Over Drug Labeling Proposal, Regulatory Affairs Professionals Society (Oct. 7, 2014).

FDA Proposed Rule in Flux?

On Tuesday, the U.S. Food and Drug Administration (FDA) announced that it has reopened the comment period for its proposed rule on generic drug labeling. It has

FDA Proposed Rule in Flux?

On January 16, 2015, the Food and Drug Administration (FDA) promulgated a much-anticipated draft guidance<a href="#_ftn1" name="_ftnref1">[1]</a> concerning the classification and regulation of general wellness products.  The draft guidance is the FDA’s latest attempt to provide some regulatory clarity in the wake of the explosion in popularity of wearable wellness devices and general fitness products.  The draft guidance—which slightly loosens the FDA’s hold on general wellness products—comports with the FDA’s current policy of refocusing its resources on high-risk products and away from products that present low risk to the end-user.BackgroundHistorically, the FDA has not regulated devices intended to benefit a user’s overall health and wellness, unless those products made claims about disease prevention, treatment, mitigation, or cure.  In the FDA’s prior guidance of 1995, it stated that it would regulate fitness equipment only if the equipment was “intended to be used for medical purposes[.]”  On the other hand, if the equipment was to be used for “general physical conditioning,” the equipment was outside the FDA’s regulatory scheme.However, even if the equipment was only used for physical conditioning, it could still be subject to rigorous FDA regulation if the promotional materials made any medical claims or associated the device with improved medical outcomes.  Such regulation includes premarket notification requirements, labeling requirements, good manufacturing practices requirements, and Medical Device Reporting (MDR) requirements.  This left many wellness products with the choice of foregoing marketing activities that made reference to improved medical outcomes or facing onerous FDA regulation.The General Wellness Draft GuidanceThe January 2015 draft guidance concerning general wellness products finally clarifies what constitutes a “general wellness product” and allows for certain well-known promotional claims about health to be made by the manufacturers of these products.Under the draft guidance, a general wellness product is defined as one intended for general wellness use that presents a very low risk to users’ safety.  In order to qualify as low risk, the product must not be (i) invasive; (ii) involve an intervention or technology that may pose a risk to users’ safety (such as lasers, radiation exposure, or implants); (iii) raise novel questions of usability; or (iv) raise questions of biocompatibility. The FDA specifically lists exercise equipment, video games, software programs, and other products commonly available in retail stores as examples of devices likely to be included within the above definition of a general wellness product.If a product falls within definition of a general wellness product, it must also have one of two identified uses in order to be covered by the new draft guidance.  The product must have (1) “an intended use that relates to maintaining or encouraging a general state of health or healthy activity,” or (2) “an intended use claim that associates the role of healthy lifestyle with helping to reduce the risk or impact of certain chronic diseases or conditions and where it is well understood and accepted that healthy lifestyle choices may play an important role in health outcomes for the disease or condition.”The first identified “use” category of general wellness devices are those that make no reference to diseases or conditions, including products relating to weight management, physical fitness, sleep management, and self-esteem.  These types of devices have traditionally been, and continue to be, outside the FDA’s regulatory purview.More interesting is the second category of general wellness intended uses, which the draft guidance explains can be broken down into two subcategories: (i) those intended to be used to promote, track, and/or encourage choices that “as part of a healthy lifestyle, may help reduce the risk of certain chronic diseases or conditions,” and (ii) those intended to be used to track and/or encourage choices that, “as part of a healthy lifestyle, may help living well with certain chronic diseases or conditions.”According to the FDA, manufacturers of devices that fall into these subcategories may now, as part of their promotional materials, make claims that using the product may help reduce the risk of disease, or help someone live better should they suffer from a certain disease or condition.  The following types of claims are permissible under the draft guidance:  “Product X promotes physical activity, which, as part of a healthy lifestyle, may help you reduce the risk of high blood pressure”; or “Product Z tracks activity sleep patterns and promotes healthy sleep habits, which, as part of a healthy lifestyle, may help reduce the risk for developing type 2 diabetes.”  Another example of a permissible claim is the statement that a calorie tracker may promote a healthy weight and/or may help living well with type 2 diabetes, or may assist in healthy living with high blood pressure.  Notably, health-related claims in marketing materials (like the examples provided by the FDA) are only permissible under the draft guidance when it is well known that a healthy lifestyle is associated with the improved health outcome.The FDA has also provided a decision algorithm so manufacturers can determine if their product qualifies as a general wellness product under the draft guidance.Likely Impact of New Draft GuidanceThe shift presented by the draft guidance is significant; if implemented, general wellness device manufacturers would be able to say more about the well-known health benefits of their products without risking FDA regulation.  Indeed, under the draft guidance, manufacturers are permitted to link products to potential health outcomes, implying that the product itself may help mitigate or reduce the risk of certain diseases.  Such statements—though only permitted when it is “well understood and accepted” that a healthy lifestyle is associated with the improved outcome—were impermissible (or at best, questionable) under the FDA’s prior guidance.This change may prove particularly important for the wearable activity tracker market, which has experienced significant growth in the last year.  Under the guidance, promotional materials can now make specific health-related claims; manufacturers are no longer limited to marketing claims such as “helps you stay active” or “gives you feedback about your daily activity.”  Permitting a manufacturer to make specific health-related claims—such as “encourages activity that, as part of a healthy lifestyle, may help reduce high blood pressure”—likely opens up the market for consumer segments that may not have been interested in merely “tracking their daily activity” but are, for example, keenly interested in reducing their blood pressure.Given these likely benefits, manufacturers should consider commenting on the draft guidance to help further shape the final outcome and to ensure that the draft guidance is implemented.  Comments are due by April 20, 2015.The draft guidance is a step in the right direction for the FDA.  The shift away from needlessly regulating low-risk products, and toward allowing manufacturers to use well-known and accepted health benefits in their promotional marketing, is a welcome one.  <a href="#_ftnref1" name="_ftn1">[1]</a> FDA guidance documents do not establish legally enforceable responsibilities, but rather describe the FDA’s current thinking on a topic.

Regulating a Healthy Lifestyle? FDA Distributes New Draft Guidance on “General Wellness Products”

On January 16, 2015, the Food and Drug Administration (FDA) promulgated a much-anticipated draft guidance  concerning the classification and regulation of gener

Regulating a Healthy Lifestyle?  FDA Distributes New Draft Guidance on “General Wellness Products”

Last week the Food and Drug Administration (FDA) promulgated two much-anticipated draft guidance documents on using social media to present information about prescription drugs and medical devices.  The draft guidance documents, which were originally promised by the FDA in 2010, represent the FDA’s latest attempt to provide direction for drug and device manufacturers concerning how and when they may use social media.BackgroundDrug and device labeling and promotion are highly regulated activities, subject to onerous approval requirements enforced by the FDA under the Federal Food, Drug, and Cosmetic Act (the “Act”).  Under the Act, “labeling” includes “all labels and other written, printed, or graphic matter” that “accompany” a drug or device.  21 U.S.C. § 321(m); 21 C.F.R. § 1.3(a).  This definition has been broadly interpreted by the courts to include materials that supplement or explain a drug or device, even when there is no physical attachment to the drug.  See Kordel v. United States, 335 U.S. 345, 350 (1948).Rapidly growing Internet-based technologies have made it quicker and easier for both manufacturers and independent third parties to disseminate information about drugs and devices.  This has led to a host of issues including (1) what drug companies can say online about their drugs without violating the “misbranding” regulations; and (2) what drug companies can do with what third parties have said online about their drugs.  The guidance documents attempt to answer both of these questions.The Twitter Guidance:  “Internet/Social Media Platforms with Character Space Limitations – Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices”The FDA’s position concerning manufacturers presenting “benefit information” for regulated drugs on electronic platforms with character space limitations is laid out in the Twitter Guidance.  This Guidance instructs companies on the steps to take to avoid inadvertently “misbranding” a drug by providing information about a drug’s benefits without disclosing accompanying risks.  With that in mind, the Twitter Guidance provides the following direction for drug companies seeking to use space-limited social media platforms:<ul><li>Include the brand and established name, dosage form, and ingredient information;</li><li>Ensure that any benefit information provided is accurate;</li><li>Accompany benefit information with risk information;</li><li>Provide direct access to a more complete discussion of the risks associated with the drug or device. Notably, the Twitter Guidance says the link should lead to a page devoted “exclusively” to risk information; and</li><li>If both benefit and risk information cannot be communicated within the space limit, consider using a different platform.</li></ul>To prove that it is not impossible to provide the required information within Twitter’s 140 character limit (just very difficult), the Twitter Guidance provides the following – entirely fictional – example of an acceptable tweet:Notably, this example from the FDA might not prove helpful in reality, especially considering that many drugs would be required to list more than one risk.The main take-away from the Twitter Guidance is nothing new:  to avoid enforcement, provide “truthful, accurate, non-misleading, and balanced product promotion.”  If a company cannot achieve this delicate balance within Twitter’s space limitations, it should “reconsider using that platform for the intended promotional message.”The Misinformation Guidance:  “Internet/Social Media Platforms:  Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices”The Misinformation Guidance describes the “FDA’s current thinking” about how manufacturers and distributors “should respond, if they choose to respond, to misinformation” related to FDA-approved products, specifically when the misinformation is disseminated by third parties over the Internet.  Per the Guidance, “misinformation” is “positive or negative incorrect representations or implications” about a company’s drug or device that is created by someone who “is not under the firm’s control or influence.”  Thus, the Guidance does not apply when misinformation is created or disseminated by the firm itself.Companies can, however, breathe a small sigh of relief; the Misinformation Guidance makes it clear that companies have no independent obligation to correct third-party posted misinformation.  This may obviate the need for companies to continuously monitor and mine massive amounts of Internet data related to their products.Nonetheless, the FDA recognizes that it may “benefit the public health” for companies to have the ability to correct misinformation about their products.  With the public health benefit in mind, the Misinformation Guidance sets forth the following guidelines for companies that are seeking to voluntarily correct misinformation:<ul><li>Post the correction in the same area or forum where the misinformation is found. If that is not possible, reference the area where the misinformation can be found;</li><li>Disclose that the person making the correction is a company employee;</li><li>Include the package insert via PDF or link to the approved labeling;</li><li>Limit the correction to the scope of the misinformation;</li><li>Do not use the misinformation as a catalyst for promotional messaging; and</li><li>Record misinformation corrections in case the FDA has questions or concerns.</li></ul>The Misinformation Guidance’s bottom line is that “if a firm voluntarily corrects misinformation in a truthful and non-misleading manner,” then the “FDA does not intend to object if the corrective information . . . does not satisfy otherwise applicable regulatory requirements regarding labeling or advertising[.]”ConclusionAlthough the draft guidance documents provide some clarification on the FDA’s positions, it is not clear that they provide a noticeable benefit to the industry.  The strict requirements related to providing risk information, including linking to a page dedicated exclusively to risks, may sway companies away from using popular social media platforms at all.  Indeed, the guidance documents may have the unintended consequence of limiting, as opposed to expanding, the information available to the public about a given drug.Companies have 90 days from the publication to comment on the draft guidance documents.

Drugs and the Internet: FDA Distributes New Draft Guidance Regarding Social Media Platforms and Prescription Drugs

Last week the Food and Drug Administration (FDA) promulgated two much-anticipated draft guidance documents on using social media to present information about pr

Drugs and the Internet:   FDA Distributes New Draft Guidance Regarding Social Media Platforms and Prescription Drugs