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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MAHA Commission Publishes Report to Highlight Childhood Chronic Disease Drivers

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

Setting Consumer Standards for Lithium-Ion Batteries Act

The Future of Food: Exploring the World of Cell-Cultivated Cuisine

New California Law Redefines E-Bikes

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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

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