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

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Plaintiffs have begun serving Proposition 65 notices of violation alleging unwarned exposures to furfuryl alcohol (FFA). Like acrylamide, which has been the subject of significant Proposition 65 litigation already, FFA is present in a wide variety of foods and flavorings and forms as a byproduct of cooking.California’s Office of Environmental Health Hazard Assessment (OEHHA) added FFA to the list of chemicals subject to Proposition 65 on September 30, 2016. The OEHHA listing was based on the U.S. Environmental Protection Agency’s 2014 finding of likely human carcinogenicity because “furfuryl alcohol causes increased incidences of rare malignant nasal tumors in male rats, and rare malignant and combined malignant and benign kidney tumors in male mice.” Companies became presumptively obligated to provide Proposition 65 cancer warnings for exposures to FFA at the start of the fourth quarter of 2017. In addition to its industrial applications, FFA can be found in various foods and flavorings.

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WARNING: Proposition 65 Farce About to Repeat Itself for Vulnerable Foods and Flavorings

WARNING: Proposition 65 Farce About to Repeat Itself for Vulnerable Foods and Flavorings

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Plaintiffs have begun serving Proposition 65 notices of violation alleging unwarned exposures to furfuryl alcohol (FFA). Like acrylamide, which has been the sub

Environmental Law

Product Liability

Consumer Products

Last Monday, a federal judge temporarily barred California from requiring cancer warnings on products that contain detectable amounts of glyphosate—the main ingredient in Monsanto’s flagship herbicide Roundup. Trace residues of glyphosate in food products had already become a potential target of Proposition 65 bounty hunters, who presumably had already begun testing foods purchased in California grocery stores to determine which companies would receive their first round of 60-day intent to sue notices.The preliminary injunction by U.S. District Court Judge William B. Shubb declined to remove glyphosate on the Proposition 65 list of chemicals “known to the State of California to cause cancer,” but, at least for now, bars the State from imposing the corresponding warning requirement while the case challenging its listing proceeds on its merits. The court’s ruling is based on a First Amendment, compelled false speech analysis—Judge Shubb determined that a Prop 65 cancer warning on glyphosate or glyphosate residues could mislead a reasonable consumer since the vast majority of scientific and health organizations have found no evidence that glyphosate causes cancer in humans.The preliminary injunction is a win for glyphosate manufacturers, agriculture, and food companies as trace amounts of glyphosate—one of the most widely used herbicides in agriculture—can remain on crops after they are harvested. Residues of it can be detected in a variety of produce, processed commodities, and finished food products. Indeed, testing by the U.S. Food and Drug Administration and environmental groups have detected trace amounts of glyphosate in an assortment of agricultural commodities and food products, including in soybeans, corn, oats, and baby food to name just a few.

Drawing on his considerable experience in environmental health, William (Bill) focuses his practice on environmental and consumer protection law, with an emphasis on climate-related goals and claims, hazardous substances, mass torts, and consumer product safety.

William Tarantino

Drawing on his considerable experience in environmental health, William (Bill) focuses his practice on environmental and consumer protection law, with an emphasis on hazardous substances, mass torts, and consumer product safety.

William F. Tarantino

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Round One Goes to Roundup: Court Temporarily Enjoins Proposition 65 Warnings for Glyphosate and Glyphosate Residues in Foods

Round One Goes to Roundup: Court Temporarily Enjoins Proposition 65 Warnings for Glyphosate and Glyphosate Residues in Foods

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Last Monday, a federal judge temporarily barred California from requiring cancer warnings on products that contain detectable amounts of glyphosate—the main ing

With regulatory frameworks around autonomous vehicles (AVs) under development at the federal, state, and local levels, new autonomous technology frontiers are emerging for rulemakers. The latest is personal delivery devices (PDDs) – essentially small autonomous vehicles designed primarily for last-mile logistics using sidewalks and driveways, rather than public roads and highways.Regulation of PDDs is truly nascent. Today, a limited number of states have, or are soon to have, PDD-specific statutes or regulations, including Arizona, Florida, Idaho, Ohio, Utah, Virginia, and Wisconsin. Each of these statutes has a few common features: Requirements related to size, speed, and weight limits, and active control and monitoring by an operator. Similar frameworks are also being developed at the city level, including in Washington, D.C. and Walnut Creek, CA.

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Tessa J. Schwartz, partner, has extensive experience in complex intellectual property and technology law, copyright law, and patent litigation. Tessa is also the founder and co-chair of the firm’s Artificial Intelligence Group.

Tessa J. Schwartz, partner, has extensive experience in complex intellectual property and technology law, copyright law, and patent litigation.

Tessa Schwartz

Tessa Schwartz has an active practice counseling companies on intellectual property and technology transactions issues, and negotiating complex intellectual property and commercial agreements.

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Personal Delivery Devices (PDD): New Transportation Frontiers Emerge for Autonomous Vehicle Rulemakers

Personal Delivery Devices (PDD): New Transportation Frontiers Emerge for Autonomous Vehicle Rulemakers

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With regulatory frameworks around autonomous vehicles (AVs) under development at the federal, state, and local levels, new autonomous technology frontiers are e

Autonomous Vehicles & Robotics

On February 26, 2018, the California Department of Motor Vehicles (DMV) announced new regulations allowing fully driverless cars to be tested on California roads as of April 2, 2018. The announcement culminates a multi-year process undertaken by DMV.The new regulations mark a significant change. Although DMV has already issued permits to 50 manufacturers and technology companies allowing for autonomous vehicle (AV) testing on California roads under its existing regulations, the new regulations are among the first in the nation allowing for AV testing without a human driver present in the vehicle. They represent a critical next step in the deployment of fully driverless vehicles to the public. In fact, the new regulations anticipate deployment once testing has been successfully completed. They not only provide for permits to allow testing of AVs without a human driver (at §227.38), but also provide for permits to allow post-testing deployment of AVs (at §228.06).

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California Opens the Road to Fully Driverless Cars; Federal Policymaking Slowly Rolls Forward

California Opens the Road to Fully Driverless Cars; Federal Policymaking Slowly Rolls Forward

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On February 26, 2018, the California Department of Motor Vehicles (DMV) announced new regulations allowing fully driverless cars to be tested on California road

California’s Green Chemistry Initiative has taken another step towards regulating a widely available consumer product.  On February 15, 2018, the California Department of Toxic Substances Control (DTSC) released a discussion draft document entitled "Product – Chemical Profile for Perfluoroalkyl and Polyfluoroalkyl Substances (PFASs) in Carpets and Rugs (Profile)", which proposes to list carpets and rugs containing PFASs as a Priority Product.  Under the Initiative, also known as the Safer Consumer Products (SCP) Program, DTSC must identify product-chemical combinations that meet the identification and prioritization criteria set forth in the SCP regulations before initiating a rulemaking.   Those criteria include the following:<ul><li>There must be potential public and/or aquatic, avian, or terrestrial animal or plant organism exposure to the Candidate Chemical(s) in the product; and</li><li>There must be the potential for one or more exposures to contribute to or cause significant or widespread adverse impacts.</li></ul>In the Profile, DTSC sets forth its rationale for its proposal to list carpets and rugs containing PFASs as a Priority Product.The Candidate Chemical and ProductFor purposes of this Profile designation, PFASs include:<ul><li>Perfluoroalkyl acids (PFAAs);</li><li>PFAA precursors;</li><li>Perfluoropolyethers (PFPEs); and</li><li>Fluoropolymers</li></ul>A large number of PFASs are used to treat carpets and rugs by conferring stain-, soil-, oil-, or water-resistance.The Profile covers carpets and rugs made from natural or synthetic fabric to be used as floor coverings in residential or commercial buildings—including carpeted door mats used indoors and outdoors—but does not include: carpets and rugs for outdoor use; carpets and rugs for use inside trains, planes, buses, automobiles, or any other indoor environment besides buildings; resilient floor coverings (e.g., vinyl tile and linoleum); artificial turf; table mats; wall hangings and coverings; or camping sleeping mats.Use and Regulation of PFASsAccording to the Profile, “[c]arpets and rugs contribute to widespread environmental contamination and exposures, as do other consumer products such as food packaging, cosmetics, and waterproof clothing.  Once released to the environment [i.e., air, water, and soil] during product manufacture, use, or disposal [e.g., landfilling], PFASs become part of a virtually closed cycle leading to chronic, lifelong human and ecological exposures. . . Because PFAAs and other persistent PFASs lack a natural degradation route, their levels in the environment, humans, and biota may continue to rise for as long as PFASs are used in consumer products.”Notably, perfluorooctanoic acid (PFOA) and related substances have been listed as Substances of Very High Concern (SVHC) under the European Union’s REACH regulation, and several related PFASs are listed as SVHCs or as REACH restricted substances due to their persistent, bioaccumulative, and toxic properties.  Distributors of articles in the EU (including rugs) are obliged to advise downstream users when an SVHC is used above 0.1 percent by weight.Both PFOA and perfluorooctane sulfonate (PFOS) were added to the Proposition 65 list of developmental toxicants on November 10, 2017.  Products that contain PFOS or PFOA will be subject to Proposition 65’s warnings requirement as of November 10, 2018.Alternatives to PFASsSome non-chemical alternatives to PFASs in carpets and rugs include:<ul><li>Modifying the shape of the yarn and use of thicker lobes, making the carpet or rug inherently soil-resistant and more durable;</li><li>Use of polypropylene fibers, which are inherently soil-resistant and may not require chemical treatment;</li><li>Use of wool fibers, which resist water-based stains, but not soil- or oil-based stains;</li><li>Use of polyethylene terephthalate (PET) fibers, which are stain-resistant; and</li><li>Use of polytrimethylene terephthalate (PTT) fibers, which are more stain-resistant than nylon.</li></ul>A chemical alternative is:<ul><li>Sulfonation, which blocks fiber dye sites with colorless sulfonates, making it difficult to stain a carpet or rug by acidic colorants.</li></ul>Other chemical alternatives identified by DTSC include Invista’s non-fluorinated Duratech® and Tandus Centiva’s Eco-Ensure; however, DTSC has not evaluated these for safety and does not have complete chemical content information on these alternatives.Workshop and Comment PeriodDTSC now seeks public comment and information that will further shape its regulatory proposal.   Interested stakeholders and other potentially regulated parties should consider engaging in the process now.  DTSC is holding a public workshop on March 7, 2018 in Sacramento and via a webcast.  It is also accepting public comments on the Profile until March 23, 2018.  Morrison and Foerster has worked with regulators and clients on the Green Chemistry Initiative since its inception and can provide additional detailed information about the Priority Product listing and the consequences to business.

In re Lumber Liquidators Chinese Laminate Litigation

Maxus Energy Corporation

In re Hydroxycut Personal Injury and Class Action Litigation

Los Angeles World Airport (LAWA)

Environmental Law Foundation v. Beech-Nut Nutrition Corp., et al

Fitbit Force Recall 

People of the State of California v. The Coca-Cola Company

Seagate Technology LLC

Clif Bar, Inc.

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California Proposes Next Group of Priority Products Under Its Green Chemistry Initiative

California Proposes Next Group of Priority Products Under Its Green Chemistry Initiative

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California’s Green Chemistry Initiative has taken another step towards regulating a widely available consumer product.  On February 15, 2018, the California Dep

On February 8, 2018, the California Department of Toxic Substances Control (DTSC) released a <a href="https://media2.mofo.com/v3/assets/blt5775cc69c999c255/blt14a86328dcb93273/62730e0a0d4d8e1d7f10f012/180213-dtsc-draft-priority-product-work.pdf">Draft Three-Year Priority Product Work Plan (2018-2020)</a> (new Work Plan) under its Safer Consumer Products (SCP) Program. The SCP Program is an innovative regulatory scheme to evaluate and require safer substitutes for hazardous chemicals in consumer products. The new Work Plan identifies the product categories that DTSC will evaluate during the next three years in order to identify the next set of Priority Products it will regulate under the SCP regulations.Following on the heels of the prior 2015-2017 Priority Product Work Plan (Prior Work Plan), the new Work Plan identifies seven product categories from which DTSC will propose future Priority Products for regulation. The new Work Plan also describes DTSC’s considerations in selecting the product categories and provides selected examples of Candidate Chemicals found in products within these categories.

California’s Green Chemistry Agency Issues Its Draft 2018-2020 Three-Year Priority Product Work Plan

On February 8, 2018, the California Department of Toxic Substances Control (DTSC) released a Draft Three-Year Priority Product Work Plan (2018-2020) (new Work P

California’s Green Chemistry Agency Issues Its Draft 2018-2020 Three-Year Priority Product Work Plan

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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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

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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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.