Morrison Foerster’s Class Dismissed blog provides insights, recommendations, and timely reports on the latest defense news, developments, and trends in the most current class actions lawsuits and product liability issues that affect consumer-facing companies. Through Class Dismissed, attorneys from our nationally recognized Consumer Class Action and Products Liability practices offer a real-time assessment of the developments in matters that are shaping the industry. This blog examines the full spectrum of consumer-related class action and product liability lawsuits ranging from false advertising, privacy, consumer product safety, ADA, food misbranding, TCPA, environment, retail, and government actions as well as nationwide and multidistrict litigation class actions.<h2>ABOUT MORRISON FOERSTER</h2>Morrison Foerster is a leading global law firm that transforms complexity into advantage for its clients. Our clients include some of the largest financial institutions, banks, consulting and accounting firms, and Fortune 100, technology, and life sciences companies. Highlighting the firm’s commitment to client service, leadership in market-changing deals and impact litigation, and values-based culture, Morrison Foerster has been repeatedly recognized as one of the top 10 firms on The American Lawyer’s A-List. Year after year, the firm receives significant recognition from Chambers and The Legal 500 across their various guides, including Global, USA, Asia‑Pacific, Europe, UK, Latin America, and FinTech Legal. Our lawyers passionately care about delivering legal excellence while living our values. Morrison Foerster has a long-standing commitment to creating a culture that respects and celebrates differences, while providing an inclusive environment. The firm has achieved Mansfield Certification Plus since 2018 as a result of successfully reaching at least 30 percent women, communities of color, and LGBTQ+ lawyer representation in a notable number of current leadership roles and committees. The firm also has a long history of commitment to the community and society through providing pro bono legal services, including litigating for civil rights and civil liberties, improving public education and fostering the wellbeing of children, advocating for veterans, promoting international human rights, enforcing the right to asylum, and safeguarding the environment.

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Partner

Adam Hunt is a partner in the Litigation Department of Morrison Foerster’s New York office. His practice focuses on complex litigation, with an emphasis on class action and commercial litigation.

Adam Hunt

Alexandra Barlow is a partner in the Litigation Department of Morrison Foerster’s San Diego office.Alexandra litigates product liability matters involving medical devices, pharmaceuticals, consumer products, automobiles, and AI. Alexandra's litigation expertise spans the entire case life cycle in both state and federal courts. She handles all phases of discovery, including fact investigation and expert discovery. Alexandra has taken over twenty-five depositions, including experts, plaintiffs, treating physicians, and third-party witnesses. She drafts and argues motions of all types, including motions for summary judgment, motions to quash, and motions for preliminary injunction.Alexandra has significant trial experience. She has first-chaired a one-week jury trial and second-chaired a five‑week jury trial, both involving multiple claims and witnesses. She also has extensive experience in alternative dispute resolution, representing clients at mediations, mandatory settlement conferences, and early neutral evaluations.Alexandra enjoys tracking developments and keeping her clients updated on product liability and personal injury claims, frequently writing or presenting on emerging areas such as autonomous vehicles and smart devices. Alexandra’s experience also extends to professional liability, warranty claims, eminent domain, and construction law.Alexandra earned her J.D. from the University of San Diego School of Law. While in law school, the San Diego Law Review published her comment on the recovery of damages by plaintiffs in a persistent vegetative state, and she also served as a comment editor. She received her B.A. from the University of California, Los Angeles, where she majored in Political Science and minored in Spanish. A San Diego native, she attended a Spanish immersion school through the eighth grade. Alexandra is active in the San Diego community, advising students at a local college. She is also a member of several legal organizations in San Diego, including Lawyer’s Club, the Association of Business Trial Lawyers, and Wallace Inn of Court.

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Alexandra Barlow is a partner in the Litigation Department of Morrison Foerster’s San Diego office. Alexandra litigates product liability matters involving medical devices, pharmaceuticals, consumer products, automobiles, and AI. Alexandra’s litigation expertise spans the entire case life cycle in both state and federal courts. She handles all phases of discovery, including fact investigation and expert discovery. Alexandra has taken over twenty-five depositions, including experts, plaintiffs, treating physicians, and third-party witnesses. She drafts and argues motions of all types, including motions for summary judgment, motions to quash, and motions for preliminary injunction.

Alexandra Barlow is a partner in the Litigation Department of Morrison Foerster’s San Diego office. Alexandra litigates product liability matters involving medical devices, pharmaceuticals, automobiles, AI, and robotics. Alexandra's litigation expertise spans the entire case life cycle in both state and federal courts. She handles all phases of discovery, including fact investigation and expert discovery. Alexandra has taken over twenty-five depositions, including experts, plaintiffs, treating physicians, and third-party witnesses. She drafts and argues motions of all types, including motions for summary judgment, motions to quash, and motions for preliminary injunction.

Alexandra Barlow

<div class="videoWrapper"><iframe frameborder="0" class="sticky-video" allowfullscreen="1" title="Meet Penny Preovolos, Litigation Partner" src="https://www.youtube-nocookie.com/embed/hv7hYn-Bl7c?rel=0&showinfo=0;vq=hd1080" title="iframe"></iframe></div>Penelope has served as lead counsel in major consumer class actions and antitrust cases for more than 35 years, successfully representing high-profile defendants in antitrust, consumer fraud, and product defect matters. Her clients span a range of industries, including consumer electronics, technology, retail, publishing, food and beverage, cosmetics, and household products. According to Chambers USA, Penelope has a “great reputation for antitrust and product liability work” and is a “superb all-around antitrust lawyer.”Penelope was named the 2019 Antitrust Lawyer of the Year by the Antitrust, UCL, and Privacy Section of the California Lawyers Association. She was co-chair of MoFo’s antitrust practice for 14 years. She has served as chair of the Antitrust and Trade Regulation Section of the State Bar of California and as a member of the Ninth Circuit Advisory Committee on Local Rules and Operations. She is an editor of and frequent contributor to Morrison & Foerster’s <a href="https://classdismissed.mofo.com/">Class Dismissed blog</a>, as well as a frequent speaker about class action and antitrust issues.More About PenelopePenelope clerked for the Honorable Charles M. Merrill, United States Court of Appeals for the Ninth Circuit. She graduated cum laude from Harvard Law School, where she was executive editor of the Harvard Civil Rights – Civil Liberties Law Review. Penelope was a member of Phi Beta Kappa at the University of California, Berkeley. She was awarded the University Medal, the highest undergraduate honor at the university, as well as the English Departmental Citation (awarded to the outstanding graduate in that department).

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Senior Counsel

Penelope has served as lead counsel in major consumer class actions and antitrust cases for more than 35 years, successfully representing high-profile defendants in antitrust, consumer fraud, and product defect matters. Her clients span a range of industries, including consumer electronics, technology, retail, publishing, food and beverage, cosmetics, and household products.

Penelope A. Preovolos

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

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Associate

Zak Newman

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

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Mitchell Hokanson

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Software Gains New Status as a Product Under Strict Liability Law

MAHA Commission Publishes Report to Highlight Childhood Chronic Disease Drivers

Tenth Circuit Denies Challenge to CPSC Rule Regulating High-Powered Magnets

Ousted CPSC Democrats Fight Back Against President Trump

Setting Consumer Standards for Lithium-Ion Batteries Act

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Last month, the Sixth Circuit affirmed a complete defense verdict for Abbott Laboratories Inc. which was based in part on branded drug preemption. Rheinfrank v. Abbott Laboratories Inc., Case No. 16-3347, 2017 WL 680349 (6th Cir. Feb. 21, 2017). This defense decision is another step toward limiting liability for manufacturers that could not prevent these types of claims even if they endeavored to.Please see our full article as published on <a href="https://media2.mofo.com/v3/assets/blt5775cc69c999c255/bltd2eccee2c43452d8/62731588b5ad5f2863c59560/170403-preemption-case-law.pdf">Law360</a>.

Co-Chair, Litigation Department

Erin Bosman is the global co-chair of Morrison Foerster’s litigation department. Erin is also the founder and co-head of the Artificial Intelligence group and former chair of the Complex Litigation + Advisement practice group. Clients value her business strategy, seeking her comprehensive counsel throughout the product life cycle, especially in high-stakes litigation and product recalls.

Erin M. Bosman

Erin Bosman is the Global Co-Chair of Morrison Foerster’s Litigation Department. Erin is also the founder and co-head of the Artificial Intelligence Group and former chair of the Complex Litigation + Advisement Practice Group. Clients value her business strategy, seeking her comprehensive counsel throughout the product life cycle, especially in high-stakes litigation and product recalls.

Erin Bosman

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

Julie Park

Julie Park | Product Liability Lawyer

Julie Park protects her clients’ products no matter what kind of product issue they face—whether it is planning for new product development, recalling an existing product, or defending clients against product liability or consumer class actions. Drawing on her deep technical and legal expertise, Julie counsels clients on consumer product safety regulation and pharmaceutical and medical device preemption while also managing complex and multijurisdictional litigation both in state and federal court.

Julie Y. Park

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Another Step Toward Reasonable Preemption Case Law

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Last month, the Sixth Circuit affirmed a complete defense verdict for Abbott Laboratories Inc. which was based in part on branded drug preemption. Rheinfrank v.

Another Step Toward Reasonable Preemption Case Law

Drug & Medical Device

Product Liability

President Trump recently announced his intent to nominate a new commissioner of the U.S. Food and Drug Administration (FDA), likely sealing the fate of FDA’s proposed generic drug labeling rule.  The proposed rule would give generic drug manufacturers responsibility for maintaining the accuracy of their abbreviated new drug application (ANDA) labels, allowing them to make changes that differ from the product’s reference listed drug label and without obtaining prior FDA approval.  While proponents of the rule argue that it promotes patient health and safety, those in the industry have strongly opposed the rule, recognizing that it would result in conflicting labels, thereby likely opening the floodgates to failure to warn litigation based on conflicting labels.The proposed rule, which has received enormous pushback and delay, appears even less likely to survive in light of Trump’s nominee for FDA commissioner, Scott Gottlieb.  Gottlieb previously served as a deputy commissioner at the FDA and has been vocal in opposing the proposed labeling rule.  He argues that the rule would increase healthcare costs and expose generic drug manufacturers to failure to warn lawsuits.  The rule has faced numerous delays since it was first proposed in 2013, and is unlikely to be finalized in April as currently scheduled.  If confirmed by the Senate, Gottlieb will almost certainly attempt to halt the rule.

Fertility Center Litigation

Fitbit

MicroPort

Leading Healthcare, Pharmaceutical, and Medical Device Company

Lethal Injection Matters – Major Pharmaceutical Company

Pain Pump Matters – Large Pharmaceutical Company

Major Technology Company

Leading Chemical Company

Security Device Company

In re Air Crash Near Peixoto de Azevedo, Brazil

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An orthopedic implant company

A children&rsquo;s monthly subscription service product

A fertility company

A major technology company

A smart fitness equipment company

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Brittany Scheinok is a partner in the Litigation Department of the firm’s San Diego office.

Brittany Scheinok

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Trump’s Nominee for FDA Commissioner Likely Dooms Generic Drug Labeling Rule

Trump’s Nominee for FDA Commissioner Likely Dooms Generic Drug Labeling Rule

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President Trump recently announced his intent to nominate a new commissioner of the U.S. Food and Drug Administration (FDA), likely sealing the fate of FDA’s pr

Earlier this month, the Washington Supreme Court saddled medical device manufacturers with a new duty to warn under Washington law—the duty to warn hospitals about potential risks their products may pose—and eroded exemptions from strict liability afforded to manufacturers of certain “unavoidably unsafe” products.<a href="#_ftn1" name="_ftnref1">[1]</a>  This decision comes as a surprise and represents an unexpected shift in the law with regard to medical device manufacturers.Background  Intuitive Surgical, Inc. (Intuitive) manufactures and markets the da Vinci System robotic device—a device that has been used for robotic laparoscopic surgeries for nearly two decades.  Due to its complexity, the da Vinci System may only be used by credentialed surgeons.In this case, Intuitive sold the da Vinci System to a hospital in Washington State.  Separately, Intuitive provided a user’s manual with warnings to the doctors that would use the device.  A credentialed doctor used the da Vinci System to treat Plaintiff’s prostate cancer in September 2008.  According to the opinion, the doctor did not follow all of the warnings, and Plaintiff experienced complications during the procedure.  As a result, Plaintiff alleged that his quality of life was reduced.Plaintiff sued the doctor who performed his surgery, his partner and their medical practice, the hospital that purchased the da Vinci Robot, and Intuitive.  Plaintiff settled with the medical provider defendants before trial, leaving Intuitive as the only defendant.  The trial court granted summary judgment in Intuitive’s favor on all claims except Plaintiff’s failure-to-warn claim under the Washington Product Liability Act (WPLA).  The case went to trial.  The jury returned a verdict for Intuitive, specifically finding it was not negligent in providing warnings or instructions to the doctor who performed the surgery.  On appeal, Plaintiff pursued a number of arguments, including that the trial court (1) erred in declining to instruct the jury that Intuitive had a duty to warn the hospital and (2) improperly applied a negligence standard to Plaintiff’s failure-to-warn claims (rather than strict liability).  The case was affirmed on appeal and the Washington Supreme Court granted review.Evolving LawThe Washington Supreme Court made two significant holdings, finding the trial court erred by:  (1) not instructing the jury on Intuitive’s duty to warn the purchasing hospital; and (2) improperly applying the negligence standard, rather than strict liability, to Plaintiff’s failure to warn claim.A New Duty to Warn HospitalsThe court created a new duty to warn hospitals.  The court reasoned that this duty arises from the WPLA, which requires manufacturers to warn of risks to “purchasers” of dangerous products.  But even the court could not decide whether the text of the statute supports this duty.  At one point the court admits that “the duty [to warn hospitals] is not explicitly stated in the text of the [WPLA].”  Yet in another part of the opinion the court agrees with plaintiff’s argument “that the manufacturer’s duty to warn exists in the plain text of the WPLA.”<a href="#_ftn2" name="_ftnref2">[2]</a>  Ultimately, the court reasoned that the text of the WPLA requires manufacturers to provide warnings “with” products and therefore the purchaser (here, the hospital) is owed product warnings “with” the product.  The court conceded that the “physician is in the best position to make a decision regarding the patient’s treatment,” but noted that “the hospital is not completely absent from the process.”<a href="#_ftn3" name="_ftnref3">[3]</a>  Following this unprecedented path, the court held that the warnings provided to the credentialed doctor should also have been given to the hospital.  Rather than rely on legal precedent, however, the court leaned on policy and logic arguments, as well as dicta from other cases.  The result opens a Pandora’s Box of questions for manufacturers seeking to warn end users and learned intermediaries about its products.  For example, what entities or individuals in various distribution chains require warnings?  And who qualifies as a purchaser?In fashioning this new duty, the court held that the learned intermediary doctrine did not apply here because the manufacturer’s duty ran to the hospital.  By contrast, the learned intermediary doctrine allows manufacturers to discharge their duty to warn the patient by warning the doctors prescribing the products.  The dissenting Justice noted that the court lost sight of how the duty to warn translates to liability.  Specifically, this unprecedented duty to warn the hospital, even if supported in law, is only a duty owed to the hospital and should not form the basis for recovery by the Plaintiff/patient.  Id. at *37 (“[Plaintiff] cannot invoke a duty owed to [the hospital] to recover damages from Intuitive.”)Comment k Protections InapplicableUnfortunately, the court also reinterpreted and limited the protections provided to certain manufacturers of unavoidably unsafe products.  Comment k to the Restatement (Second) of Torts, § 402A concerns unavoidably unsafe products (products incapable of being made safe that are not unreasonably dangerous given the public benefit they offer).  Recognizing the public policy benefits of keeping such products on the market, comment k exempts manufacturers from strict liability if they produce unavoidably unsafe products so long as the products are “properly prepared and marketed, and proper warning is given.”<a href="#_ftn4" name="_ftnref4">[4]</a>  In short, manufacturers of unavoidably unsafe products are held to negligence, not strict liability standards.  Ignoring cases that applied this negligence standard, and finding “no binding precedent in Washington” on the issue, the court determined that “proper warnings are a prerequisite to application of the exception” provided by Comment k.<a href="#_ftn5" name="_ftnref5">[5]</a>  The court reasoned that because Intuitive did not provide warnings to the hospital, application of the Comment k protection was improper and Intuitive should be judged on a strict liability basis.ConclusionIn sum, the Washington Supreme court (1) expanded medical device manufacturers’ duty to warn to hospitals, and (2) stripped away a layer of protection offered to manufacturers of unavoidably unsafe products.  Fortunately, this case appears to be an outlier, and is unlikely to be followed in other jurisdictions that adhere to traditional principles of product liability law.<a href="#_ftnref1" name="_ftn1">[1]</a> Taylor v. Intuitive Surgical, Inc., No. 92210-1, 2017 Wash. LEXIS 200, at *2 (Feb. 9, 2017)<a href="#_ftnref2" name="_ftn2">[2]</a> Id. at *11-12<a href="#_ftnref3" name="_ftn3">[3]</a> Id. at *14-15<a href="#_ftnref4" name="_ftn4">[4]</a> Restatement 2d of Torts, § 402A (2nd 1979)<a href="#_ftnref5" name="_ftn5">[5]</a> Taylor, No. 92210-1, 2017 Wash. LEXIS 200, at *25, 28

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Expanding Duties and Eroding Protections for Medical Device Manufacturers

Expanding Duties and Eroding Protections for Medical Device Manufacturers

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Earlier this month, the Washington Supreme Court saddled medical device manufacturers with a new duty to warn under Washington law—the duty to warn hospitals ab

Defendants successfully argued “fraudulent joinder” in Bahalim v. Ferring Pharmaceuticals, Inc., winning dismissal of the case in its entirety.<a href="#_ftn1" name="_ftnref1">[1]</a>  The case was decided on Plaintiffs’ motion to remand and Defendants’ motions to dismiss after Defendant Ferring Pharmaceuticals removed the suit to federal court based on diversity jurisdiction.  The court rejected Plaintiffs’ argument that the forum defendant rule applied and ultimately dismissed the case.BackgroundFerring manufactures and distributes Bravelle, a drug designed to treat infertility in women.  Plaintiffs, who were citizens of Texas and Utah, sued Ferring and Stericycle in Illinois state court.  They alleged that Ferring recalled multiple lots of the drug that did not meet potency specifications and that Stericycle administered the recall.  Plaintiffs further alleged that they consumed Bravelle from the recalled lots and asserted claims based on negligence, strict liability, product liability, and express and implied warranties.Ferring removed the case to federal court based on complete diversity of citizenship.  Plaintiffs argued in a motion to remand that removal was improper under the forum defendant rule, which prohibits removal premised on diversity in cases where at least one defendant is a citizen of the forum state.  Although Stericycle was a citizen of the forum state Illinois, Ferring argued Plaintiffs had fraudulently joined Stericycle, and therefore removal was proper.Fraudulent Joinder DoctrineTo establish fraudulent joinder, a defendant must prove that the plaintiff cannot establish a cause of action against the forum state defendant after resolving all issues of fact and law in favor of the plaintiff.  The court considered the policy interests articulated in Morris v. Nuzzo, a Seventh Circuit opinion that considered fraudulent joinder in the context of the forum defendant rule.<a href="#_ftn2" name="_ftnref2">[2]</a>The court concluded that:  a plaintiff’s interest in selecting the forum is less compelling when he or she joins a non-diverse defendant; improperly joining a forum defendant lessens the weight provided to a plaintiff’s choice of forum; and neither plaintiff here was an Illinois citizen, thus weakening the court’s deference to plaintiffs’ choice of forum.  Furthermore, the forum defendant rule only applies where a resident defendant is properly joined and served—but a fraudulently joined forum defendant is not a properly joined defendant.  Therefore, the court concluded that the interest in confining federal jurisdiction to its appropriate statutory limits weighed in favor of Defendants.Finally, the court determined that Plaintiffs could not maintain a failure to warn or negligence claim against Stericycle, and had improperly joined Stericycle for the sole purpose of avoiding removal to federal court.  In support of its conclusion, the court noted that Stericycle did not manufacture, promote, distribute, or sell Bravelle.  Therefore, Plaintiffs could not bring a product liability failure to warn claim against Stericycle under the applicable state laws.  Plaintiffs’ negligence claims against Stericycle were similarly without merit.ConclusionHaving concluded that the fraudulent joinder doctrine applied and that Plaintiffs’ claims against Stericycle had no chance of success, the court granted Stericycle’s motion to dismiss.  The court also granted Ferring’s motion to dismiss for lack of personal jurisdiction, holding that Ferring did not have sufficient minimum contacts in Illinois to establish specific jurisdiction.The fraudulent joinder doctrine is not commonly raised and may often be overlooked as a litigation tool for defendants.  Although applicable only in specific circumstances, Bahalim proves that it is worth asserting in appropriate cases.<a href="#_ftnref1" name="_ftn1">[1]</a> Bahalim v. Ferring Pharmaceuticals, Inc., Case No. 16 C 8335, 2017 WL 118418 (N.D. Ill. Jan. 12, 2017).<a href="#_ftnref2" name="_ftn2">[2]</a> Morris v. Nuzzo, 718 F.3d 660 (7th Cir. 2013).

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Plaintiffs’ Fraudulent Joinder Tactic Results in Dismissal

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

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Defendants successfully argued “fraudulent joinder” in Bahalim v. Ferring Pharmaceuticals, Inc., winning dismissal of the case in its entirety. The case was dec

Plaintiffs’ Fraudulent Joinder Tactic Results in Dismissal

The U.S. Food and Drug Administration (FDA) recently released a draft guidance document with the goal of facilitating certain updates to abbreviated new drug application (ANDA) labels. In particular, the draft guidance addresses updates to ANDA labels where the product’s reference listed drug (RLD) was withdrawn for reasons other than safety or effectiveness, providing insight on the responsibilities of ANDA holders to update their drug labels and the processes for doing so.

FDA Releases Draft Guidance For Updating Generic Drug Labels

The U.S. Food and Drug Administration (FDA) recently released a draft guidance document with the goal of facilitating certain updates to abbreviated new drug ap

FDA Releases Draft Guidance For Updating Generic Drug Labels

The FDA recently announced that it would once again delay promulgation of its proposed rule for generic drug labeling obligations. This action followed introduction of a spending bill that would have blocked funding for the rule in its current form.The rule, originally proposed in 2013, directly responds to the holding in PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011). There, the Supreme Court held that federal law preempts certain failure-to-warn claims against generic drug manufacturers because generic labels cannot deviate from their brand-name equivalents. Consumer groups felt this was an unjust result. In many cases it left those injured by generic drugs without any remedy.In order to address what the Supreme Court labeled the “unfortunate hand that federal drug regulation has dealt” to generic drug users, the FDA’s proposed rule would allow generic drug manufacturers to update product warnings with new safety information, even if the revised labeling differs from the branded labeling. This would drastically change the pharmaceutical landscape, as currently only brand-name drug makers can revise warning labels without prior FDA approval. While the proposed rule would “permit” generic drug manufacturers to update their labels, in reality such a change would constitute a requirement due to the likely liability implications should a generic drug manufacturer fail to do so.This latest delay follows on the heels of recent congressional action directed toward the proposed rule. In April, the House Appropriations Committee introduced a congressional spending bill for 2017 that creates a serious roadblock for the proposed rule. The bill states that no funds will be made available to the FDA to finalize or implement the proposed rule unless the final version requires prior FDA approval for any change to a generic drug label. Clearly, members of the predominately Republican House Appropriations Committee agree with those industry groups and companies who have expressed grave concerns over the rule as currently drafted. Those who disagree with the proposed rule believe it would cause confusion and jeopardize patient safety due to the potential for conflicting labels. Requiring prior FDA approval would ensure consistency while still requiring generic manufacturers to maintain responsibility for safety warnings.On May 18, the FDA issued a notice that the date of publication of the rule has been extended until April 2017. This is the third delay since the FDA originally proposed the rule in 2013.<a name="_ftnref1" href="#_ftn1">[1]</a> An FDA spokeswoman commented that the extension reflects “ongoing work” but was not more specific. While the FDA has not commented on the spending bill, it seems highly likely that the latest delay is directly related and that the rule will be revised before it is finalized. We will continue to monitor future progress and provide updates accordingly. <a name="_ftn1" href="#_ftnref1">[1]</a> FDA Proposed Rule in Flux?; $4 Billion Price Tag for Pleasing Plaintiffs’ Bar? New Study Estimates Costs of FDA’s Proposed Rule on Generic Drug Labeling; Goodbye to Generic Preemption? FDA Publishes Proposed Rule.

Still Waiting—FDA Delays Rulemaking

The FDA recently announced that it would once again delay promulgation of its proposed rule for generic drug labeling obligations. This action followed introduc

Still Waiting—FDA Delays Rulemaking

The Supreme Court case Spokeo, Inc. v. Robins reaffirmed and clarified the requirements necessary for plaintiffs to establish standing.<a href="#_ftn1" name="_ftnref1">[1]</a>  As evidenced by the recent First Circuit case Hochendoner v. Genzyme Corp., the analysis set forth in Spokeo is essential to determining the viability of products liability claims.<a href="#_ftn2" name="_ftnref2">[2]</a>  There, the two consolidated class action lawsuits involved products liability allegations against a drug manufacturer.  But because plaintiffs did not allege sufficiently specific harm, the First Circuit affirmed dismissal of the case on grounds of Article III standing.<a href="#_ftn3" name="_ftnref3">[3]</a>BackgroundThe plaintiffs and putative class members in Hochendoner all have Fabry disease, a rare genetic disorder that prevents the body from properly breaking down fats.  Fabry disease can lead to gastrointestinal issues, stroke, and heart and kidney failure.  Although there is no cure for Fabry, it can be effectively treated with Fabrazyme, the only FDA-approved enzyme replacement therapy for the disease.  Defendant Genzyme Corporation is the exclusive licensee of the Fabrazyme patent and is the only producer of Fabrazyme.  Various problems with Genzyme’s manufacturing facilities led to a shortage of Fabrazyme beginning in 2009.  Genzyme initiated a rationing plan and was unable to fully restore supplies of Fabrazyme until 2012.The plaintiffs in Hochendoner alleged several causes of action connected to the Fabrazyme shortage, including statutory violations, torts, breaches of warranty, breaches of contract, and losses of consortium.  Plaintiffs challenged the dismissal of two categories of claims on appeal: (1) plaintiffs’ claim that patients experienced an accelerated course of deterioration on the lower dose of Fabrazyme; and (2) plaintiffs’ claim that they experienced harm attributable to tainted Fabrazyme.  Although Genzyme challenged plaintiffs’ standing for the first time on appeal, the First Circuit noted that standing arguments may be raised at any stage of litigation.Standing AnalysisCiting Spokeo, the court recognized the Supreme Court’s recent articulation of Article III standing as having two distinct requirements:  concreteness and particularization.  While concreteness focuses on whether an injury actually exists, the particularization requirement ensures that a plaintiff has been personally affected by the injurious conduct.  Plaintiffs did not link the alleged injuries to any specific plaintiff, thus failing to satisfy the particularization requirement.  The complaints simply listed each plaintiff’s name and place of residence and alleged that each plaintiff had Fabry disease and had a history of taking Fabrazyme.  However, the complaints did not allege any specific information regarding the harm that was inflicted on each individual plaintiff.  With the exception of one named plaintiff, the court concluded that none of the plaintiffs had standing to assert claims based on their theories of injury because they failed “to plausibly allege that he or she suffered an injury in fact as a result of accelerated disease progression or receipt of a contaminated drug.”Future ImplicationsThis case is indicative of the implications that Spokeo will have on all cases, including those involving products liability claims.  The Court in Spokeo emphasized that plaintiffs must allege an injury that is both concrete and particular.  The particularization requirement will likely continue to be especially important in class actions asserting allegations against drug manufacturers.  Hochendoner set an important precedent in requiring plaintiffs to link alleged injuries to specific plaintiffs and to allege much more than generalized harms. <a href="#_ftnref1" name="_ftn1">[1]</a> Spokeo, Inc. v. Robins, No. 13-1339, slip op. (U.S. May 16, 2016).  The claims in Spokeo were related to statutory violations, but courts have found Spokeo to apply in a variety of cases.<a href="#_ftnref2" name="_ftn2">[2]</a> Hochendoner v. Genzyme Corp., Nos. 15–1446, 15–1447, 2016 WL 2962148 (1st Cir. May 23, 2016).<a href="#_ftnref3" name="_ftn3">[3]</a> The district court had dismissed the case not for lack of standing, but for failure to state a claim under Federal Rule of Civil Procedure 12(b)(6).

Generalized Products Liability Claims Not Viable Post-Spokeo

The Supreme Court case Spokeo, Inc. v. Robins reaffirmed and clarified the requirements necessary for plaintiffs to establish standing. As evidenced by the rece

Generalized Products Liability Claims Not Viable Post-Spokeo

Consumer Products

In an unusual turn of events, U.S. District Judge Cynthia Rufe recently granted defendants’ motion for summary judgment as to over 300 cases in the Zoloft MDL.<a href="#_ftn1" name="_ftnref1">[1]</a>  These cases were consolidated in 2012 and involved allegations that the antidepressant drug Zoloft causes birth defects.  Having conducted substantial discovery and two rounds of Daubert hearings, the defendants filed a motion for summary judgment in all pending cases.  Defendants argued that the plaintiffs failed to produce an expert who could establish general causation, and that as a result, plaintiffs could not prevail on any of their claims.  The court agreed.  Its decision essentially turned on plaintiffs’ failure to establish a causal link between Zoloft and the plaintiffs’ injuries.  In a detailed opinion, Judge Rufe summarized the prior Daubert hearings before analyzing each category of evidence offered by the plaintiffs.Previous Daubert HearingsIn the first round of Daubert hearings, plaintiffs offered the opinions of four expert witnesses on the issue of general causation.  The court rejected the plaintiffs’ first expert, an epidemiologist, because she failed to base her opinion upon scientifically valid methodology and failed to adequately address epidemiological studies that did not support her opinion.  The court determined that the plaintiffs’ remaining experts—a teratologist, a molecular developmental biologist, and an embryologist—could not testify that Zoloft caused birth defects in humans because the experts did not address the relevant epidemiological evidence.  The court granted plaintiffs’ subsequent motion for leave to introduce a fifth expert witness, a biostatistics professor, as an expert on general causation with regard to cardiac defects.  However, the court later excluded this expert’s report and testimony, in part because he similarly failed to adequately address all available epidemiological studies.General Causation EvidenceHaving summarized its decisions to exclude or limit plaintiffs’ experts, the court addressed whether plaintiffs were able to establish general causation without the excluded expert testimony.  The court first considered the role of epidemiological evidence in establishing general causation.  The court held that when epidemiological studies are inconsistent with a causation opinion, experts “must thoroughly analyze the strengths and weaknesses of the epidemiological research and explain why that body of research does not contradict or undermine their opinion.”  In other words, plaintiffs could not simply ignore inconsistent evidence.The court next addressed plaintiffs’ expert evidence submitted in opposition to the summary judgment motion.  The court reiterated that its Daubert rulings remained in effect.  Thus, the court would not allow plaintiffs to circumvent its previous rulings “under the guise of addressing specific causation or discussing new evidence.”  Finally, the court considered plaintiffs’ non-expert evidence.  This evidence included doctor and patient reports regarding adverse events that were perceived to occur after using Zoloft.  The court concluded that these documents, although relevant to the generation of study hypotheses, were insufficient to create a material question of fact regarding general causation.  Plaintiffs also submitted internal Pfizer documents discussing possible associations between Zoloft and birth defects and proposed changes to the Zoloft label.  Again, the court found that these documents did not raise a genuine issue of material fact as to general causation.ConclusionIn light of the preceding analysis, the court concluded that plaintiffs failed to raise a jury question as to whether Zoloft was capable of causing the birth defects at issue.  Central to its decision was the court’s recognition that the MDL had been extensively litigated for more than three years.  The court therefore rejected plaintiffs’ request to delay summary judgment or dismiss without prejudice.  Although MDLs have been struck summarily in the past, it is a rare occurrence.  This opinion highlights the opportunity for defendants to obtain a favorable judgment when plaintiffs fail to present adequate expert testimony or to account for unfavorable evidence. <a href="#_ftnref1" name="_ftn1">[1]</a> In re Zoloft (Sertralinehydrochloride) Prods. Liab. Litig., 2016 WL 1320799 (E.D. Penn. Apr. 5, 2016).

Defendants Secure Rare Summary Judgment in Zoloft MDL

In an unusual turn of events, U.S. District Judge Cynthia Rufe recently granted defendants’ motion for summary judgment as to over 300 cases in the Zoloft MDL. 

Defendants Secure Rare Summary Judgment in Zoloft MDL

Last week, a federal court in Utah granted Aventis Inc.’s motion for summary judgment based on federal preemption of failure-to-warn claims. Cerveny v. Aventis, Inc., 2016 U.S. Dist. LEXIS 34182 (D. Utah Mar. 16, 2016). The court found that the FDA’s rejection of additional warnings and consistent approval of labeling contrary to plaintiff’s demands constituted “clear evidence” of a conflict between federal and state law, and therefore served as grounds for preemption.BackgroundPlaintiff Victoria Cerveny was prescribed and used Clomid in 1992. Following her Clomid use, Mrs. Cerveny became pregnant and gave birth to a son, who was missing two fingers and had a congenital dislocation of the left radial head on his left elbow. The Cervenys alleged that the defects were caused by the residual Clomid in Mrs. Cerveny’s body during conception and organogenesis, and that Aventis breached its duty to warn of potential birth defects associated with Clomid use before pregnancy.Aventis moved for summary judgment on the basis of conflict preemption, arguing that it was impossible for Aventis to comply with federal and state requirements for labeling because the FDA would not have permitted Aventis to include the exact warnings the Cervenys demanded should be added to the label. Specifically, Aventis relied on evidence that the FDA had previously considered Plaintiff’s argument and determined that using Clomid before pregnancy posed no heightened risk of future birth defects. In sum, the Cervenys argued that Aventis should have changed the label and Aventis responded that its hands were tied by the FDA—even if Aventis had sought the requested change, the FDA would not have approved it.Changing a Drug LabelThe central dispute was Aventis’s ability to add the warnings that the Cervenys sought. In general, manufacturers bear responsibility for the content of drug warning labels, but cannot change the labeling of a drug without seeking prior approval from the FDA.  See 21 C.F.R. § 314.70(b). In limited circumstances, however, a drug manufacturer can strengthen warnings without prior approval through a changes being effected (CBE) supplement, but the FDA retains authority to reject those changes.The FDA also has a process whereby interested parties may submit “citizen petitions” seeking modifications to a drug’s labeling. Parties may submit these petitions accompanied by scientific and other evidence of potential health risks associated with a drug’s use. Although a causal relationship is not required, FDA standards mandate that if there is “reasonable evidence of an association of a serious hazard with a drug,” the drug’s label should be revised to include a warning. 21 C.F.R. § 201.80(e). Sometimes, “newly acquired information” (i.e., testing performed subsequent to a drug label’s approval or reports of negative drug reactions) is included in these reports and leads the FDA to require stronger warnings.In 2007 and again in 2009, the FDA received citizen petitions about Clomid and its association with birth defects. Both petitions embodied the exact failure-to-warn theories presented by the Cervenys and included supplemental scientific research, seeking the same additional warnings that the Cervenys sought.  Ultimately, the FDA rejected both petitions. Importantly, both of these petitions came many years after Mrs. Cerveny’s Clomid use.Clear EvidenceTo demonstrate conflict preemption, a defendant must present “clear evidence” of a conflict between federal and state law. The “clear evidence” standard was first enunciated in Wyeth v. Levine, 555 U.S. 555 (2009) but was not defined.  Ever since, courts have grappled with this legal standard, which remains anything but clear.The Cerveny court shed welcome new light on this “clear evidence” standard. Specifically, Judge Benson found that Aventis met its burden with evidence that the FDA had denied the two previous requests for strengthened warnings in the form of citizen petitions, “based on the same theories and substance on which Plaintiff’s case relies.” In fact, “every piece of scientific literature cited in the Plaintiffs’ Amended Complaint was presented to the FDA” in the 2007 citizen petition.The court found additional “clear evidence” of the FDA’s position because the FDA “consistently approved Clomid labeling that includes affirmative rejections of the Plaintiffs’ theories.” Specifically, since 1994, Clomid’s FDA-approved label stated that “Clomid exposure prior to pregnancy does not cause birth defects at a rate greater than that observed in the general population.” Thus, not only did the FDA previously consider Plaintiff’s argument, but it also determined that drug ingestion before pregnancy raised no additional risk of future birth defects. This determination was clear from the FDA’s prior approval of Clomid labeling.The court’s ruling represents a step in the right direction for pharmaceutical defendants, especially in light of the recent Dolin decision muddying the “clear evidence” burden of proof on defendant manufacturers arguing for preemption. Defendant manufacturers should also note that this court found that both the rejection of the citizen petitions and the FDA’s consistent approval of Clomid’s labels operated as independent sources of clear evidence to support conflict preemption. This is a clear departure from the Dolin court’s ruling, which seems to require an actual denial by FDA of a label change. As courts continue to analyze what “clear evidence” is without concrete guidance, the Cerveny ruling sets a favorable precedent and provides new guideposts to follow.

Federal Preemption Claims: Clear Evidence and an Unclear Standard

Last week, a federal court in Utah granted Aventis Inc.’s motion for summary judgment based on federal preemption of failure-to-warn claims. The court found tha

Federal Preemption Claims: Clear Evidence and an Unclear Standard

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>.

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