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

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

Julie Y. Park

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

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Senior Counsel

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

Penelope A. Preovolos

Claudia focuses her practice on the defense of consumer class actions and on complex commercial litigation, including unfair business competition, false advertising, product liability, and privacy matters. She is currently representing numerous consumer goods manufacturers and retailers in false advertising and mislabeling class action lawsuits. Claudia also regularly counsels clients in the food, cosmetics, retail, and technology industries. She represents companies in false advertising disputes before the National Advertising Division (NAD) of the Council of Better Business Bureaus, Inc.<h5>More about Claudia</h5>Claudia is active in MoFo’s pro bono efforts, and recently traveled to El Paso, Texas, to work with families separated and detained at the border. She is also supervising a pro bono collaboration with Equal Rights Advocates, a nonprofit fighting for gender justice in work places and schools across the country. The initiative will help students who have been victims of sexual assault, attempted assault, or harassment find support and seek justice. Claudia is also a board member of Bay Area Legal Aid and a former board member of Equal Rights Advocates. Claudia is an editor and frequent contributor to MoFo’s <a href="https://classdismissed.mofo.com/">Class Dismissed</a> blog, which provides reports about the latest defense news, developments, and trends in class action lawsuits and product liability issues that affect consumer-facing companies. Her perspectives are also respected in the larger legal community: Claudia has published articles about class action and false advertising issues, and is a co-author of Chapter 7 — “Unfair Competition in California Business Litigation 2016” — of The Recorder. She also regularly speaks at conferences on class action and advertising trends. Claudia is currently serving as a Lawyer Representative for the Northern District of California. She received her J.D. degree in 2004 from Berkeley Law (Boalt Hall School of Law), where she was an associate editor of the Berkeley Technology Law Journal.

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Claudia focuses her practice on the defense of consumer class actions and on complex commercial litigation, including unfair business competition, false advertising, product liability, and privacy matters. She is currently representing numerous consumer goods manufacturers and retailers in false advertising and mislabeling class actions.

Claudia M. Vetesi

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

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

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

Alexandra Barlow

Adam J. Hunt is a partner in the Litigation Department of Morrison Foerster’s New York office. His practice focuses on complex litigation, with an emphasis on class action and commercial litigation.Mr. Hunt has extensive experience representing consumer products companies, financial institutions, and technology firms in class action cases and complex commercial disputes before state and federal trial courts, as well as in arbitrations. Clients seek Mr. Hunt’s counsel for his creative, strategic thinking in high-stakes, high-profile matters. He has represented clients facing claims under false advertising, antitrust, and privacy laws throughout the country, securing wins at the pleading stage, summary judgment, and trial, in addition to negotiating favorable settlements, often early in the case. Representative experience includes successfully securing rulings dismissing two putative false advertising class action cases against one of the best-known consumer electronics companies in the world; obtaining a complete win on summary judgment for a major shipping and logistics company in a multimillion-dollar commercial dispute; appearing as counsel at trial for a leading financial institution in a $100 million commercial dispute, winning a bench trial verdict; and prevailing on motions to dismiss false advertising class actions against a leading Greek yogurt company.Mr. Hunt is also an editor of the firm’s <a href="https://classdismissed.mofo.com/" target="_self">Class Dismissed blog</a>, which provides insights, recommendations, and timely reports on the latest defense news, developments, and trends in the most current class action lawsuits that affect consumer-facing companies.Mr. Hunt maintains an active pro bono practice and is the recipient of the New York State Bar Association’s 2017 President’s Pro Bono Service Award for the First Judicial Department, the 2018 Public Service Award from New York University School of Law, and Morrison Foerster’s Kathi Pugh Award for Pro Bono Services.Mr. Hunt received his B.A. with honors from Swarthmore College and his J.D. cum laude from New York University.

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

Adam Hunt

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Alexandra Preece Barlow

Adam J. Hunt

Right-to-Repair Laws: The Trend Continues

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

New Wave of PFAS Legislation Aimed at Consumer Products

CPSC Releases Annual Report on Deaths and Injuries Involving Nursery Products

CPSC Proposes New Safety Rules for Infant Rockers

In the high-risk Telephone Consumer Protection Act (TCPA) arena, the Ninth Circuit recently offered some respite. On January 10, 2018, the Ninth Circuit limited the potential liability that companies may unknowingly face for the communication practices of their upstream vendors. In Kristensen v. Credit Payment Services, Inc., No. 16-15823 (9th Cir. 2018), the Ninth Circuit affirmed summary judgment for defendant payday lenders, finding that the lenders were not vicariously liable for any unlawful text messages sent by a third-party lead generator. The TCPA plaintiff had received a text message from a company called AC Referral, which contained a link to a loan application website. AC Referral had contracted with lead generator Click Media, which in turn sold customer leads to a lead acquisition company LeadPile. The defendant lenders had hired LeadPile to help acquire customer leads for loans. In 2014, the District of Nevada certified a class of other similar text recipients. Even though the defendant lenders had no contact with the text sender, plaintiff argued that “defendants ratified AC Referral’s unlawful texting by accepting the benefits of the text messages sent by AC Referral while unreasonably failing to investigate its texting methods.” Applying principles of agency law, the Ninth Circuit concluded that the lenders could not be liable under a ratification theory. It was “undisputed that AC Referral did not enter into a contract with any of the lenders or with LeadPile” and “AC Referral did not communicate with or even know of the lenders or LeadPile before the lawsuit was filed.” Thus, because AC Referral never acted as an agent or purported agent of the defendants, there was no act that could be ratified. Summary judgment was also affirmed for the defendant intermediary company Click Media that actually contracted with AC Referral. Click Media’s contract stated that “AC Referral could use text message marketing and required AC Referral to comply with the TCPA.” The Ninth Circuit agreed that the plaintiff “presented no evidence that Click Media had actual knowledge” of the texting violation and “knowledge that an agent is engaged in an otherwise commonplace marketing activity [e.g., texting] is not the sort of red flag that would lead a reasonable person to investigate whether the agent was engaging in unlawful activities.” This ruling could reduce litigation risks for companies that are unaware and have no reason to suspect their vendors are sending communications that may not be in compliance with the TCPA.

CCPA and Data Breach Class Action for Leading Software Company

BIPA Class Action Against Gaming and Hospitality Company

TCPA and Other Class Actions for Major Technology Company

Data Breach Class Action for Technology Company

Wiretap Act action against a Major Consumer Electronics Manufacturer

TCPA Class Action Against National Chain

In re Pharmaceutical Industry Average Wholesale Price Litigation

In re Verizon Wireless Data Charges Litigation

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Clients seek out Tiffany for her successful track record in defending class action claims on behalf of clients in a broad range of industries, including technology, healthcare, and consumer product companies. She represents numerous Fortune 500 companies in high-stakes litigation involving privacy and marketing claims in courts throughout the United States.

Tiffany Cheung

Clients seek out Tiffany for her successful track record in defending class action claims on behalf of clients in a broad range of industries, including technology, healthcare, and consumer product companies. She represents numerous Fortune 500 companies in high-stakes litigation involving privacy and marketing claims in courts throughout the United States.

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TCPA Vicarious Liability Limited by Ninth Circuit in Texting Class Action

Federally-Backed Debt Collection Exception Not the Supreme Court’s Cup of T(CPA)

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In the high-risk Telephone Consumer Protection Act (TCPA) arena, the Ninth Circuit recently offered some respite. On January 10, 2018, the Ninth Circuit limited

TCPA Vicarious Liability Limited by Ninth Circuit in Texting Class Action

In December, the U.S. Food and Drug Administration (FDA) issued guidance on <a href="https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM499809.pdf?utm_campaign=CDRH%20New%202017-12-05&utm_medium=email&utm_source=Eloqua&elqTrackId=0143682DBD922C680E5ECEF5378087CA&elq=3ca3ce2d66164349a31507fefc45ff0c&elqaid=1630&elqat=1&elqCampaignId=1050" target="_blank" rel="noopener">Technical Considerations for Additive Manufactured Medical Devices</a>.  The guidance represents FDA’s efforts to provide regulatory direction about additive manufacturing (AM)—the broad field of 3D printing—of medical devices.  Specifically, AM makes objects by sequentially building 2-dimensional layers and joining each to the layer below.  AM enables diverse design models without the need to retool or create complex manufacturing machines to build components.  The FDA guidance focuses on technical aspects of AM, and is organized into two topics:  (1) design and manufacturing considerations; and (2) device testing considerations.  The guidance notes that FDA “does not comprehensively address all considerations or regulatory requirements to establish a quality system for the manufacturing” of AM devices.  Instead, FDA recommends testing and characterization for devices that include at least one additively‑manufactured component or additively‑fabricated step.  The guidance also reflects the agency’s current thinking on AM for medical devices.<a href="#_ftn1" name="_ftnref1">[1]</a>AM is a rapidly growing technology with numerous applications in medical devices.  Representing a step toward personalized medicine, AM can facilitate anatomically‑matched devices and surgical instrumentation by using the patient’s own medical imaging (these are referred to as “patient-matched devices”).  AM can create complex geometric structures that would otherwise be impossible to manufacture, or too costly to manufacture under traditional manufacturing approaches.  These technologies can prove life-saving.  For example, in 2012, after receiving emergency clearance from FDA, medical staff at the University of Michigan used AM processes to create a bioresorbable tracheal splint that they used to rescue an infant suffering from a collapsed bronchus due to severe tracheobronchomalacia.<a href="#_ftn2" name="_ftnref2">[2]</a>  The splint was implanted in the infant’s airway, expanding the bronchus and allowing for future proper growth.  Within weeks, the infant was off ventilator support and breathing normally.  AM saved the baby’s life.Recognizing the benefits of AM, FDA is preparing for “a significant wave of new technologies that are nearly certain to transform medical practice.”  The FDA Commissioner does recognize that novel aspects of the AM process lack substantial clinical histories and experimentation.<a href="#_ftn3" name="_ftnref3">[3]</a>  Accordingly, use of AM techniques in sensitive medical contexts poses challenges, and FDA anticipates that manufacturers may struggle in “determining optimal characterization and assessment methods for the final finished device, as well as optimal process validation and acceptance methods for these devices.”  So far, FDA has reviewed more than 100 medical devices that were manufactured using AM techniques.  FDA also recently approved a drug for seizures that was 3D-printed to create a more porous matrix than the drug would have had if manufactured using traditional means.  This allowed the drug to dissolve more rapidly in the mouth.  FDA further anticipates that AM can lead to treatments for burn wounds and even artificial replacement organs.<a href="#_ftn4" name="_ftnref4">[4]</a>Design and Manufacturing Process ConsiderationsFDA anticipates that its standard premarket submission process will apply in equal force to AM devices as it does to traditionally-manufactured devices.  Accordingly, for Class II and III devices (and select Class I devices), manufacturers “must establish and maintain procedures to control the design of the device in order to ensure that specified design requirements are met per 21 CFR 820.30 Design Controls.”  The FDA further expects manufacturers to “establish procedures including validation of the manufacturing process of AM devices to ensure that the device can perform as intended.”  Especially where the final result of a process cannot be fully verified by subsequent inspection and testing, the process must be “validated with a high degree of assurance and approved according to established procedures.”Because several AM technologies and processing steps can be used in medical devices, the guidance urges manufacturers to “clearly identify each step in the printing process.”  In this vein, FDA recommends use of production flow diagrams coupled with high-level summaries of each critical step to help ensure product quality.  Each described process step should include “a description of the process, and identification of the process parameters and output specifications.”  Delineated, step-by-step descriptions of each process should be well documented to allow the manufacturer to identify and remedy any root causes of failures from manufacturing defects; absent such detailed process instructions, defects can be difficult to pinpoint and correct.  Because AM processes can be quickly modified and adapted to specific use-scenarios, dimensional specifications for the final device or component, as well as manufacturing tolerances of the manufacturing machine, should be properly documented.Additional considerations come with patient-matched devices, which may not have a “standard‑sized template” (since they are contoured to individual patients) and may be modified by clinical staff, the device manufacturer, or third parties in response to clinical inputs.  Because of this customizability, manufacturers “should clearly identify clinically relevant design parameters, the pre-determined range (min/max) for these parameters, and which of these parameters can be modified for patient-matching.”  The guidance specifically recommends, to the extent applicable, that manufacturers address:  (1) effects and necessity of imaging; (2) clinical and patient interactions with design models; (3) maintenance of data integrity of complex design files; and (4) the (cyber)security of personally identifiable information.FDA provides that “AM typically involves interaction between several software packages, often from different manufacturers[.]”  As a result, errors in file conversions and software interactions can negatively impact the quality of the AM process and final device.  For this reason, FDA recommends that manufacturers “verify the critical attributes and performance criteria of [their] final products as part of the software workflow validation to ensure expected performance, especially for patient-matched devices.”Further, once a device design is complete, manufacturers should consider additional preparatory processes, including:<ul><li>placement, orientation, and packing density of devices or components within the build volume;</li><li>use of additional support material or structures for certain design features;</li><li>layer thickness of each “slice” created by the AM machine as related to the layer-by-layer printing process;</li><li>the build path, or path traced by the energy or material delivery system (e.g., laser or extruder);</li><li>required machine parameters and calibrations (e.g., build speed, total energy density, and focal point or nozzle diameter); and</li><li>environmental conditions within the build volume (e.g., temperature, pressure, and atmospheric compositions).</li></ul>FDA recommends that materials used in AM processes should be well documented and chosen based on the AM technology used, the intended use of the final medical product, and any other information available.  Reuse of certain materials (something possible when using AM technologies) is allowed but should be scrupulously documented.  Evidence should be provided that reuse will not adversely affect the final device.  Any post-processing steps of AM (manufacturing steps occurring after the printing process) that may affect device performance and material properties should also be well documented and include analysis of any effects such steps may have.As noted above, when a final result of a process cannot be fully verified by subsequent inspection and testing, the process must be validated with a high degree of assurance.  For such validation processes, monitoring and control methods of data must be documented.  Such methods may include monitoring and documenting parameters such as:<ul><li>temperature at the beam focus;</li><li>melt pool data;</li><li>build-space environmental conditions;</li><li>location in the build volume where a device or component was built; and</li><li>power of the energy delivery system.</li></ul>These same methods may also be helpful for processes that are not required to be validated.Device Testing ConsiderationsGenerally, FDA advises that AM product performance testing should be implemented in the same manner as if the device were manufactured using traditional manufacturing methods.  Depending on the device type, these testing methods may include: “material property testing such as modulus, yield strength, ultimate strength, creep/viscoelasticity, fatigue, or abrasive wear.”  Further, performance testing should be conducted on all finished devices following post-processing, cleaning, and sterilization steps.  Manufacturers should also conduct tests targeting the “worst-case combinations” of dimensions, features, orientations of the materials, and locations in the build space to ensure adequate product performance.  These tests should include a discussion of how the combinations were selected and why each test was conducted.  Manufacturers should create and maintain “test coupons” (a representative test sample of the device or component) when evaluating AM products.Recognizing that AM processes may lead to a wider variance in end products than traditional manufacturing methods, FDA recommends that manufacturers specify and adhere to pre-set dimensional tolerances by measuring representative product samples.  Manufacturers should address any variability due to orientation and build location if studies show variance based on these parameters.  In order to maintain consistency, product measurements should be made on samples from multiple build cycles and manufacturers are expected to provide justification for the sampling scheme used.  Finally, process validation information may help demonstrate negligible variability between products in different build cycles or batches.Because of the iterative nature of AM, starting materials may be exposed to partial re-melting and solidifications multiple times.  This may result in unexpected or undesired material compositions.  Because many AM medical devices will be used in sensitive medical contexts (often surgically implanted into a patient), manufacturers should conduct biocompatibility testing and incorporate guidance proffered in “<a href="https://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm348890.pdf" target="_blank" rel="noopener">Use of International Standard ISO 10993-1, ‘Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process’</a>” if necessary.  Specific testing (e.g., in vitro degradation testing) may be necessary if the AM device uses an absorbable material.One of the greatest advantages of AM devices is the ability to make highly complex components and end products.  With that advantage comes an inherent disadvantage—AM devices may be exceptionally hard to clean and sterilize.  AM also allows porous structures to be produced earlier in the manufacturing process than traditional methods, which may result in greater soiling by subsequent exposure to other AM materials.  Accordingly, manufacturers should create work-flows and be able to validate that any remaining material residue will not adversely affect the device’s quality.  A summary of this information should be included in premarket submissions to the agency.  Additionally, the guidance warns that many end-use facilities will not have access to the equipment or materials needed to implement on-site cleaning procedures designed to remove residual manufacturing materials.  Accordingly, only devices that are sufficiently cleaned should be provided to the end user.LabelingFinally, the guidance provides that AM device labeling “should be developed in accordance with applicable regulations, device-specific guidance documents, and consensus standards.”  Additional labeling is recommended for AM devices that are patient-matched.  FDA recommends that such labeling identify (1) the patient; (2) the products used (e.g., left distal femoral surgical guide); and (3) final design iteration or version used to produce the device.  Expiration dates for patient-matched devices should also be included.  Because it is possible that a patient may experience an event between imaging and surgery, FDA also recommends that manufacturers include a precaution in their labeling that the patient should be evaluated for potential anatomical changes prior to the procedure.ConclusionThough not binding, manufacturers should consider adopting the recommendations included in the FDA’s guidance on AM.  As with other FDA guidance documents, future regulations are likely to incorporate and expand on these existing guidelines.<a href="#_ftnref1" name="_ftn1">[1]</a>  The FDA categorized this document as “leap-frog” guidance because “it helps bridge where we are today with innovations of tomorrow.”<a href="#_ftnref2" name="_ftn2">[2]</a> Moore, Nicole, 3D Printed Splint Saves the Life of a Baby, Michigan Engineer News Center (May 22, 2013).<a href="#_ftnref3" name="_ftn3">[3]</a> Statement of FDA Commissioner Scott Gottlieb, M.D., on FDA ushering in new era of 3D printing of medical products (Dec. 4, 2017), <a href="https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm587547.htm" target="_blank" rel="noopener">https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm587547.htm</a>.<a href="#_ftnref4" name="_ftn4">[4]</a> Id.

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

Erin M. Bosman

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

Erin Bosman

An orthopedic implant company

A children&rsquo;s monthly subscription service product

A fertility company

A major technology company

A smart fitness equipment company

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

Julie Park

Julie Park | Product Liability Lawyer

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3D Printing Meets Medical Devices: FDA Weighs In On Additive Manufacturing

3D Printing Meets Medical Devices:  FDA Weighs In On Additive Manufacturing

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In December, the U.S. Food and Drug Administration (FDA) issued guidance on Technical Considerations for Additive Manufactured Medical Devices.  The guidance re

“My Google Home Mini was inadvertently spying on me 24/7 due to a hardware flaw,” wrote a tech blogger who purchased Google Inc.’s latest internet of things (IoT) device. Following the incident, a pact of consumer advocacy groups insisted the U.S. Consumer Product Safety Commission recall the Google smart speaker due to privacy concerns arising when the device recorded all audio without voice command prompts.The CPSC is charged with protecting consumers from products that pose potential hazards. Traditionally, this has meant hazards that may cause physical injury or property damage. But as internet-connected household products continue to proliferate, issues like the “always-on” Google Home Mini raise an important question: Where does cybersecurity of consumer IoT devices fit within the current legal framework governing consumer products?Please see our full article as published on <a href="https://media2.mofo.com/v3/assets/blt5775cc69c999c255/blta6b29dc043b75540/6273154ea1a1dd2aa9f6c96e/180105-connected-devices-liability-changes.pdf" target="_blank" rel="noopener">Law360</a>.

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Connected Devices Bring New Product Liability Challenges

New California IoT Law Requires Security for Connected Devices

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“My Google Home Mini was inadvertently spying on me 24/7 due to a hardware flaw,” wrote a tech blogger who purchased Google Inc.’s latest internet of things (Io

Connected Devices Bring New Product Liability Challenges

In our California Class Actions 2018 Update, we have outlined several key cases and trends that define the current class actions landscape. From “litigation tourism” to new definitions for unfair and fraudulent, we provide a rundown on the most-watched and influential recent cases.Please click <a href="https://media2.mofo.com/v3/assets/blt5775cc69c999c255/bltf3eba9236fc7ed3a/6273154f8e09542a15b7de53/180108-california-class-actions-2018-update.pdf">here</a> to open the California Class Actions 2018 Update.

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California Class Actions: 2018 Update

Nevada Enacts CCPA-Style Opt-Out Right for Consumers—but Similarities Are Few

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In our California Class Actions 2018 Update, we have outlined several key cases and trends that define the current class actions landscape. From “litigation tou

California Class Actions: 2018 Update

“Make fine lines and wrinkles disappear!”  “Reduce the visibility of fine lines and wrinkles!”  At first read, these claims sound one in the same.  But for decades, a slight difference in phrasing of cosmetics claims—created as a function of current cosmetics regulations—has been responsible for allegedly confusing customers and complicating regulations.  Lawmakers have tried and failed to reform federal cosmetics regulations in the past and are now gearing up for another attempt.Current FDA Regulation of Cosmetics (or Lack Thereof)The U.S. Food and Drug Administration (FDA) regulates both drugs and cosmetics under the Food, Drug, and Cosmetic Act (FDCA).  The FDCA defines a “cosmetic,” in part, as “articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance.”  21 U.S.C. § 321(i).  The FDCA’s definition of “drug” includes “articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man . . . ,” and “articles (other than food) intended to affect the structure or any function of the body of man . . . .”  21 U.S.C. § 321(g)(1).Certain products can meet the definitions of both cosmetics and drugs under the FDCA depending on their intended uses.  The claims made about a certain product are determinative of whether the product is regulated as a cosmetic, drug, or both.  For <a href="https://www.fda.gov/Cosmetics/GuidanceRegulation/LawsRegulations/ucm074201.htm">example</a>, a shampoo is a cosmetic because its intended use is to cleanse hair.  An anti-dandruff treatment is a drug because its intended use is to treat dandruff.  An anti-dandruff shampoo is therefore both a cosmetic and a drug, and is regulated by the FDA as both.  Unlike drugs or medical devices, however, cosmetic products and ingredients (with the exception of color additives) currently do not require FDA approval before they go to market.  For this reason, a cosmetic product containing the same ingredients as a drug product can enter the market without premarket oversight as long as the product is not advertised as having therapeutic uses.But drug claims and cosmetic claims can sound indistinguishable to a consumer.  Take anti‑aging products for <a href="https://www.fda.gov/Cosmetics/ProductsIngredients/Products/ucm388826.htm" target="_blank" rel="noopener">example</a>.  If a product is intended to make lines and wrinkles less noticeable by moisturizing the skin, it is a cosmetic because moisturizing is a cosmetic claim.  On the other hand, products intended to affect the structure of the skin are drugs even if they affect the appearance.  So a product that is intended to remove wrinkles or increase the skin’s production of collagen is a drug.  And the slight difference in the way these two products are advertised can create large disparities in the level of premarket regulations such as mandatory good manufacturing practices.Further, under present cosmetics regulations, cosmetics companies are not required to report postmarket adverse events.  The lack of premarket oversight and mandatory adverse event reporting has contributed to consumer concerns over the safety of the products they use every day.  For example, the FDA is currently investigating reports of hair loss and rashes linked to the use of WEN by Chaz Dean Cleansing Conditioner products.  By November 15, 2016, the FDA received 1,386 adverse event reports from consumers about these products, the largest number of reports ever associated with any cosmetic hair cleansing product.  However, the FDA also became aware of over 21,000 complaints reported directly to Chaz Dean, Inc. and the product distributor, Guthy Renker, LLC, during inspections of the companies’ facilities.  Had these companies been required to submit these reports to the FDA—as drug companies are—it is almost certain that far fewer customers would have been affected.Due to the fine line between the definitions of drugs and cosmetics, as well as the significant difference in FDA regulations for the two categories of products, stakeholders have been calling on lawmakers to reform cosmetics regulations for many years now.  Some believe this long‑overdue legislation is right around the corner.Two Senate Bills on Cosmetics Regulation ReformIn May 2017, Senator Dianne Feinstein (D-CA) reintroduced the Personal Care Products Safety Act, S. 1113, 115th Cong. § 1 (2017), which was originally introduced to the Senate in April 2015 with co‑sponsor Senator Susan Collins (R-ME).  Later in October 2017, Senator Orrin Hatch (R-UT) introduced the FDA Cosmetic Safety and Modernization Act, S. 2003, 115th Cong. § 1 (2017), to the Senate.  Both proposed bills include the following proposed regulations for cosmetics:Mandatory reporting requirements.  Both bills would require cosmetic manufacturers and distributors to report “serious adverse events” to the FDA within 15 business days of receipt of notice.  As defined by both bills, this would include adverse events associated with the use of a cosmetic product, ranging from disfigurement to death.  This is similar to the existing mandatory reporting requirement for drugs, see 21 C.F.R. § 314.80(c)(1), but adverse event reporting is currently voluntary for cosmetics.  The Feinstein‑Collins bill also includes an annual report requirement, under which companies would have to submit to the FDA a yearly report summarizing all adverse events for each cosmetic product marketed during that year.Registration of cosmetics facilities.  Both bills would require cosmetics manufacturing facilities to register with the FDA and would also give the FDA the authority to suspend a facility’s registration if its products have a reasonable probability of causing serious adverse health consequences or death.  The Feinstein‑Collins bill includes a registration fee based on a company’s annual gross sales of cosmetics.  By contrast, registration under the current regulatory scheme is voluntary, through a program that the FDA administers to collect information on product ingredient listings and registration of manufacturers, packers, and distributors on a voluntary basis.Submitting ingredients to the FDA.  The Feinstein‑Collins bill would also require companies to submit cosmetic ingredient statements for each cosmetic product to the FDA.  The Hatch bill does not contain an analogous provision.  Under the authority of the Fair Packaging and Labeling Act (FPLA), 15 U.S.C. § 1451 et seq., the FDA already requires a list of ingredients for cosmetics marketed on a retail basis to consumers.  21 C.F.R. § 701.3.  Cosmetics that fail to comply with the FPLA are considered misbranded under the FDCA.  15 U.S.C. § 1456.Ingredient review.  Both bills would require the FDA to review the safety of certain cosmetic ingredients and non-functional constituents (incidental components of the ingredients) through a notice and comment process.  The Feinstein‑Collins bill would require the FDA to review at least five ingredients a year and goes as far as to set out the first five ingredients for review:  (1) Diazolidinyl urea; (2) Lead acetate; (3) Methylene glycol/methanediol/formaldehyde, propyl paraben; and (5) Quaternium-15.  The Hatch bill, on the other hand, would have the FDA, in conjunction with industry and consumer groups, identify ingredients for safety review based on public health concerns.  The Hatch bill also provides for accredited third‑party review of these selected ingredients.Good manufacturing standards.  Under both bills, the FDA would be required to establish mandatory good manufacturing practices, and, under the Hatch bill, a cosmetics manufacturers’ noncompliance would constitute the cosmetics being adulterated.  The FDA’s good manufacturing practices for cosmetics manufacturers are currently voluntary.  Both bills would provide small businesses with additional time to comply with the good manufacturing practices—one year under the Feinstein‑Collins bill and two years under the Hatch bill.Mandatory recall authority.  The Feinstein‑Collins bill would give the FDA the authority to order mandatory recalls, while the Hatch bill does not.  The FDA only has the authority to oversee voluntary recalls at this time.Past Failures on Cosmetics Regulation ReformWhile some are encouraged by the bipartisan support for cosmetics regulation reform, the fact that similar bills have previously died in Congress casts doubt on whether either of the Senate bills have any hope of becoming law.Just earlier this year, Representative Pete Sessions (R‑TX) reintroduced his bill, the Cosmetic Modernization Amendments of 2017, as H.R. 575.  This bill was first introduced in November 2015 as the Cosmetic Modernization Amendments of 2015, H.R. 4075.  Before this, similar legislation included the Cosmetic Safety Amendments Act of 2012, introduced by Representative Leonard Lance (R‑NJ), H.R. 4395; the Cosmetics Safety Enhancement Act of 2012, introduced by Representative Frank Pallone (D‑NJ), H.R. 4262; and the Safe Cosmetics Act of 2011, introduced by Representative Jan Schakowsky (D‑IL), H.R. 2359.Not one of these bills has passed.Looking AheadCosmetics companies should consider proactively adopting some of the proposed practices described above regardless of whether either of the currently pending bills becomes law in the near future.  As the two proposed bills indicate, any future FDA regulation of cosmetics would build upon the existing voluntary programs for cosmetics and mandatory reporting schemes for drugs, including the Voluntary Cosmetic Registration Program, existing adverse event reporting system, and Good Manufacturing Practices guidelines.  Efforts to employ these programs therefore would not be in vain.  Early adopters can also develop compliance programs at a predictable pace as opposed to an accelerated or unknown schedule set by future legislation.  Lastly, there is little doubt that consumers are demanding self‑regulation in this space in the absence of government action.  Premarket considerations can effectively minimize costly litigation down the road.

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Makeup Shake Up: Potential New Federal Cosmetics Regulations

Makeup Shake Up:  Potential New Federal Cosmetics Regulations

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“Make fine lines and wrinkles disappear!”  “Reduce the visibility of fine lines and wrinkles!”  At first read, these claims sound one in the same.  But for deca