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

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

CPSC Commissioners Abstain from Retracting Infant Sleep Product Statements

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

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

Alabama Legislature Says No to Innovator Liability

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

Alabama Legislature Says No to Innovator Liability

California’s Green Chemistry Initiative continues to build momentum.  On April 16, 2015, the California Department of Toxic Substances Control (DTSC) released its final April 2015 Priority Product Work Plan for 2015–2017 (“Work Plan”).  The Work Plan is the first step in identifying the next set of Priority Products for regulation under California’s Safer Consumer Products Act.  It sets forth seven new product categories, examples, and potential candidate chemicals regarding the types of products that may be evaluated over the next three years.  The product categories, examples, and potential candidate chemicals are:<ul><li>Beauty/Personal Care/Hygiene: Skin Products, Personal Hygiene Products, Hair Products, and Cosmetics and Fragrances (Aldehydes, Formaldehyde; Alkylphenol Ethoxylates (APEs); Azo Dyes, Coal Tars, Lead, and Lead Acetate; Phthalates; Triclosan; and Toluene);</li><li>Building Products (Painting Products, Adhesives, Sealants, and Flooring): Adhesives and Glues, Carpeting and Carpet Padding, Engineered Wood and Laminate Flooring, Paints and Primers, Paint and Graffiti Removers, Roof Coatings, Sealants, and Vinyl Flooring (Brominated or Chlorinated Organic Compounds, Organophosphates; Isocyanates; Metals, such as Chromium VI; Perfluorochemicals; Phthalates; and Volatile Organic Compounds (VOCs), such as Formaldehyde, n-hexane, n-methyl-pyrrolidone, Toluene);</li><li>Household/Office Funiture/Furnishings with PFCs, FRs: Bedding, Curtains, Fabric and Textile Furnishings, and Household and Office Seating (Chlorinated and Brominated Organic ompounds, Organophosphates; and Perfluorochemicals);</li><li>Cleaning Products: Fresheners and Deodorizers, Cleaners, Laundry, and Surface Care (APEs; Hydrogen Fluoride; Phthalates; and Triclosan);</li><li>Clothing: Full Body Wear, Lower Body Wear and Bottoms, Sleepwear, Sportswear, Underwear, and Upper Body Wear and Tops (APEs; Aromatic Amines and Azo Dyes; Perfluorochemicals, Formaldehyde; Phthalates; and Triclosan);</li><li>Fishing and Angling Equipment: Fishing Weights (Metals); and</li><li>Office Machinery (Consumable Products): Inks and Toners, and Thermal Paper (Azo Dyes; Bisphenols; Phthalates: and VOCs such as Hexane, Toluene and Xylene).</li></ul>Prior to the release of the final Work Plan, DTSC received comments on its draft September 14, 2014 Priority Product Work Plan (“draft Work Plan”).  (See prior MoFo client alert).  Substantive comments requested:<ul><li>Adding product categories (notably, food packaging and automotive products) or refining or dropping existing ones, specifically building products and fishing and angling equipment;</li><li>Adding chemicals to the Candidate Chemicals List (e.g., chlorinated and organophosphate flame retardants) or narrowing the scope of chemicals under considerations; and</li><li>Prioritization of specific products during the Work Plan cycle.</li></ul>Some of the changes made to the final Work Plan from the draft Work Plan include:<ul><li>Addition of carpet padding and insulation, as well as wall coverings with flame retardants, as examples in the “Building Products” category narrative;</li><li>Addition of wall coverings with flame retardants as an example in the “Household/Office Furniture and Furnishings” category narrative;</li><li>Revision of the “Clothing” product category narrative, clarifying that the category does not include protective wear for occupational safety purposes.</li></ul>DTSC did not add any new chemicals to the Candidate Chemicals List, nor did it add any new product categories to, or remove any categories from, the final Work Plan.  In 2017, DTSC plans to issue its next Priority Product Work Plan covering the time period 2018 – 2020.  DTSC continues to be behind schedule in moving forward with its plans to regulate its first set of Priority Products.  The final Work Plan shows, however, that the agency has not backed away from its plans to press forward with the Green Chemistry Initiative and to continue to broaden its reach to other consumer products.

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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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

California’s Green Chemistry Agency Issues New Guidance to Identify Future Consumer Products for Regulation

California’s Green Chemistry Initiative continues to build momentum.  On April 16, 2015, the California Department of Toxic Substances Control (DTSC) released i

California’s Green Chemistry Agency Issues New Guidance to Identify Future Consumer Products for Regulation

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

FDA Proposed Rule in Flux?

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

FDA Proposed Rule in Flux?

Over the weekend the FAA issued a much-anticipated Notice of Proposed Rulemaking (NPRM) for small UAS—i.e., drones weighing less than 55 pounds.  The oft-delayed NPRM comes three years after Congress—through the FAA Modernization and Reform Act of 2012 (the “2012 Act”)—directed the FAA to develop and implement “comprehensive” regulations to safely integrate drones into the national airspace.  The NPRM initiates what is expected to be a years-long process of rulemaking to establish the regulatory regime for drones of all shapes and sizes.By and large, the NPRM represents a practical approach to allowing low-risk UAS operations during the day in uncongested airspace within the visual line of sight of the operator, and subject to speed, altitude, and weight restrictions.  The NPRM also creates a new class of UAS pilot qualifications, recognizing that the FAA’s current process for pilot certification is not a good fit for UAS.  For the most part, the restrictions proposed by the NPRM are a somewhat more relaxed version of those the FAA has been imposing on operators who sought early permission to operate through the Section 333 Exemption process.  Additionally the NPRM contemplates the possibility of adopting much less stringent restrictions for UAS weighing less than 4.4 pounds, recognizing the reduced risk profile associated with these “Micro UAS.”  It’s likely that, on balance, the NPRM will be viewed by many with an interest in commercial and other uses of drones as a step in the right direction.Practical as it may be, it’s worth noting that this NPRM is not the “comprehensive” set of regulations that Congress mandated the FAA issue in Section 332 of the 2012 Act.  In fact, the NPRM uses Section 333 of the 2012 Act as the basis for its authority to issue the present NPRM, not Section 332(b), which mandates the “comprehensive” rulemaking.  Section 333 merely permits the FAA to allow some UAS operations in the national airspace before the comprehensive rulemaking required by Section 332(b) takes place.  In view of this, it makes sense that the restrictions proposed by the NPRM in some respects mirror those in recent Section 333 Exemption grants.  Essentially, this NPRM creates a blanket Section 333 Exemption for certain categories of operations that the FAA has deemed to be safe.  The NPRM is the FAA’s way of incrementally permitting limited UAS operations in advance of its comprehensive effort to fully integrate UAS into the national airspace.What is notable about this approach is the FAA’s signaling that a comprehensive set of rules to address what the FAA views as more advanced, higher-risk operations is still to come.  This future “comprehensive” rulemaking will likely address UAS operations that would not be authorized by the rules proposed in the current NPRM, including autonomous operations beyond the visual line of the sight of the operator and those that require sense and avoid technology.The FAA’s incremental approach is likely to please operators with low-risk profiles.  It permits limited UAS operations, buying the FAA time to understand the state of advanced UAS technology, create a plan to incorporate UAS into its NextGen implementation, and oversee the development (likely in partnership with NASA) of “highways in the sky” for advanced UAS operations in more crowded airspace.  It also shows, however, just how far behind the industry the FAA actually is, in not authorizing—at least for now—the use of advanced UAS technology that could revolutionize how business is done.How We Got HereThe road to the NPRM has been long and winding, starting with FAA’s 2007 Policy Statement, “Unmanned Aircraft Operations in the National Airspace System.”  There, the FAA laid out a blanket prohibition on UAS operations:  “No person may operate a UAS in the National Airspace System without specific authority[.]”  According to the FAA, there was only one way to obtain that authority:  “apply directly to the FAA for permission to fly.”<a href="#_ftn1" name="_ftnref1">[1]</a>  The 2007 Policy Statement recognized that “[r]egulatory standards need to be developed to enable current technology for unmanned aircraft to comply with Title 14 Code of Federal Regulations[.]”In 2012, Congress formalized the FAA’s regulatory mission:  “provide for the safe integration of civil unmanned aircraft systems into the national airspace system[.]”  But the FAA lagged (and continues to lag) behind the ambitious schedule that Congress set for it.  Indeed, the present NPRM is merely a first step towards integration in a “phased” approach that is likely to take the FAA years to complete.  As noted above, the proposed rule does not purport to implement Congress’s mandate in the 2012 Act to issue comprehensive regulations.The NPRM’s Provisions and Restrictions:  Operational Limitations and Operator Qualifications for Small UASThe NPRM’s key provisions affecting operations for UAS weighing up to 55 pounds can be placed into two categories:  those concerning the operation of the UAS and those concerning the operator of the UAS.With regard to the first category—operational limitations—the FAA essentially stuck to the existing Section 333 exemption script, with a few minor adjustments.  Operations must be conducted during the daytime, and the operator must have the UAS in his visual line of sight (if operating the UAS alone), or be capable of having the UAS in his visual line of sight (if operating with the aid of a visual observer).  Operations cannot be conducted over people who are not involved in the operations, and must be done at less than 100 mph (87 knots) and no more than 500 feet above the ground.  These parameters should allow for many rural and contained uses of UAS, including applications for industrial-scale agriculture; energy generation, transmission, production, and pipeline facilities; transportation infrastructure, including railways, roads, ports, and waterways, and the rolling stock, vehicles, and vessels that use them; private and public emergency response (e.g., fire, flooding); and resource assessment, monitoring, and compliance.With regard to the second category—operator qualifications—the FAA departed from its past Section 333 Exemptions (and from what many expected) by not requiring that a UAS operator have a private pilot’s license.  Recognizing that requiring a private or commercial license would pose an “undue burden” on UAS operators and would have “limited relevance to the nature of small UAS operations,” the FAA instead opted to create a new category of airman certificate for small UAS operators.  In order to be certified, an operator would have to (i) be at least 17 years old; (ii) pass an initial knowledge test; (iii) be vetted by the TSA; (iv) obtain an unmanned aircraft operator certificate with a small UAS rating; (v) pass recurrent testing; and (vi) make the UAS available to the FAA for inspections, as well as report accidents to the FAA and conduct certain pre-flight inspections.Different Standards for Micro UASThe FAA is also seeking comment on whether it should adopt a different set of rules for Micro UAS—i.e., drones weighing up to 4.4 pounds that are made out of frangible materials that break or yield on impact, so as to present a minimal hazard to persons or structures with which the Micro UAS may collide.  The key proposed operational limitations for Micro UAS would be:  (i) a maximum airspeed of 30 knots; (ii) a maximum altitude of 400 feet above ground level; (iii) a maximum distance from the operator of 1,500 feet within the unaided visual line of sight of the operator; and (iv) operations conducted in Class G (unrestricted) airspace only.  These limitations are, in large part, based on the rules already adopted by Transport Canada.Most importantly, the NPRM contemplates that Micro UAS operations may be conducted “directly over people not involved in the operation.”  Authorizing such operations directly over uninvolved individuals may have significant implications for many urban operations, which—simply put—would not be permitted under the proposed rules applicable to UAS weighing between 4.5 and 55 pounds.  The Micro UAS rules are also likely to raise additional privacy concerns not present when operations are not permitted over uninvolved people.The operator qualifications for Micro UAS would also be different than those for other small UAS.  The FAA is contemplating that no knowledge testing would be required in order to obtain a Micro UAS rating; instead, the operator would simply be required to submit a signed statement to the FAA stating that he has familiarized himself “with all the areas of knowledge that are tested on the initial aeronautical knowledge test” applicable to a small UAS rating.Absent from the NPRM:  An Express Preemption ProvisionAlso important is what the NPRM lacks.  For example, it does not propose an express preemption provision, despite significant lobbying, including a formal petition filed with the FAA, by certain groups for such a provision.  This leaves open the possibility that state and local governments may attempt to regulate UAS operations differently from the way proposed by the FAA in the NPRM.  Absent an express preemption provision in the final rules, such state and local regulation would not be foreclosed at the threshold, but would instead have to be analyzed under existing conflict preemption principles on a case-by-case basis.<a href="#_ftn2" name="_ftnref2">[2]</a>Participation in the ProcessRelease of the NPRM commences a 60-day comment period.  That period may be extended by the FAA to allow interested parties additional time to comment on the proposed rule.  The FAA specifically requests comments on a number of important issues that seem to reflect the agency’s recognition that further regulation should take account of the rapid advances in UAS technology and be open to the burgeoning commercial uses of UAS.  These include whether:<ul><li>Regulation should be performance-oriented;</li><li>Operating restrictions should be relaxed based on new UAS technology;</li><li>Package delivery for payment should be permitted;</li><li>Special air carrier certification should be specified; and</li><li>Micro UAS classification and provisions should be developed.</li></ul>After the comment period closes, the FAA is expected to take additional time to analyze the comments and implement necessary changes before issuing the final rules.Issuance of final rules, however, will not be the end the story.  We expect to see at least some judicial challenges to the final rule.  These challenges may come in two forms:  (i) challenging enforcement actions taken pursuant to the regulations, and (ii) direct challenges to the rule itself.  Challenges to the rule itself are likely to be heard faster, as they’ll be filed and heard directly in the courts of appeals.  See 49 U.S.C. § 46110.  Challenges to enforcement actions would necessitate a longer process, as administrative remedies will need to be exhausted before seeking judicial relief.  See 14 C.F.R. § 406.179.What’s Next?Interested stakeholders should be cautiously optimistic with the approach suggested by the NPRM.  Those supporting commercial and other uses of drones should plan to participate in this rulemaking, both to endorse the positive aspects of the FAA’s proposals and to critique those that are overly restrictive.  Comments providing discussion of real-world, socially and economically beneficial uses of this technology, and how the proposed rules could encourage or hinder them, would be particularly powerful.  Industry should also continue to put pressure on the FAA to issue the comprehensive regulations mandated by Congress, lest the FAA fall even further behind the technology, causing additional delay in the rulemaking process.Companies should also continue to file individual Section 333 Exemption applications while the NPRM process is underway.  It is not known when the FAA will issue final rules, and it could take a considerable amount of time.  So those with an immediate desire to use UAS in their operations should seek authority to do so before the rulemaking is complete.Finally, interested parties should be cognizant of privacy and other issues raised by the NPRM.  In conjunction with the FAA issuing the NPRM, President Obama issued a <a href="http://www.whitehouse.gov/the-press-office/2015/02/15/presidential-memorandum-promoting-economic-competitiveness-while-safegua">Presidential Memorandum</a> to the executive departments and agencies of the federal government highlighting steps that the federal government should take to protect privacy, civil rights, and civil liberties in operating UAS domestically.  For example, the Presidential Memorandum requires that executive agencies that collect information through UAS have policies and procedures that limit such collection, as well as the retention and disclosure of any information that is collected.  The Presidential Memorandum also establishes a multi-stakeholder process to be led by the National Telecommunications and Information Administration to develop best practices for privacy, accountability, and transparency in the commercial and private use of UAS.  As a result, even though the FAA will not address privacy issues in its rulemaking, the President has put in place a process to address these issues in a non-regulatory manner, absent Congress enacting legislation on the issue.   <a href="#_ftnref1" name="_ftn1">[1]</a> The 2007 Policy Statement was not itself legally binding.  To this day, it remains an open question whether drone flights for commercial purposes are ipso facto prohibited by federal law.<a href="#_ftnref2" name="_ftn2">[2]</a> See prior "May State and Local Governments Control Low-Flying Drones?" client alert.

Drones: Much Anticipated Small UAS Notice of Proposed Rulemaking Released by FAA

Over the weekend the FAA issued a much-anticipated Notice of Proposed Rulemaking (NPRM) for small UAS—i.e., drones weighing less than 55 pounds.  The oft-delaye

Drones:  Much Anticipated Small UAS Notice of Proposed Rulemaking Released by FAA

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

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

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

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

Copycat lawsuits appear to be increasing in food labeling cases. The Coca-Cola Company (“Coca-Cola”) is the latest company to be targeted with a copycat suit in California. A putative class action, Phelps v. The Coca-Cola Co., No. BC547592, filed in Los Angeles Superior Court on June 3, 2014, alleges that Coca-Cola misleadingly promoted its Simply Orange brand juices as “fresh,” “100% Orange Juice,” and “100% Pure Squeezed,” when, according to the plaintiff, those juices are actually the product of a complex engineering process and use artificial flavoring.More specifically, the named plaintiff, Gwen Phelps, alleges that Simply Orange juices are “engineered from multiple batches of oranges and orange products eight months to a year old with algorithms and flavor packs, concocted via an unnatural process.” Plaintiff claims that this process involves stripping the juice of its color and flavor, and then “adding back into the juice natural flavors and fragrances captured during squeezing,” along with “flavor packs” created by fragrance companies. She accuses Coca-Cola of concealing its use of this process and of misleading her and others into purchasing Simply Orange products. Plaintiff has asserted claims for intentional misrepresentation, negligent misrepresentation, fraud, and violation of California’s Unfair Competition Law (UCL), False Advertising Law (FAL), and Consumers Legal Remedies Act (CLRA) on behalf of a class of all California residents that purchased Simply Orange products in the last ten years.More than a dozen similar cases were filed against Coca-Cola in federal courts around the country in 2012, and later consolidated in a multidistrict litigation proceeding in the Western District of Missouri, In re Simply Orange Orange Juice Marketing & Sales Practices Litigation, No. 12-md-02361 (W.D. Mo.).  Indeed, the Phelps complaint appears to largely duplicate the allegations made by these federal plaintiffs. This copycat suit was likely spurred by Coca-Cola’s unsuccessful attempt to dismiss the consolidated complaint in the Multidistrict Litigation (MDL).  There, Judge Fernando J. Gaitan denied Coca-Cola’s arguments that: (1) the claims were non-actionable puffery; (2) the plaintiffs failed to allege “injury-in-fact”; and (3) the claims were preempted by existing FDA food labeling regulations.Phelps falls in line with a recent wave of food misbranding lawsuits filed in California state courts which are largely duplicative, if not identical, to cases already pending in federal courts.  This trend may stem from the view that California law is more favorable to consumer class actions.  And plaintiffs are catching on that, win or lose the first time around, another forum often provides another chance.

Phelps v. Coca-Cola: Orange Juice Misbranding “Copycat” Suit Finds Its Way Into State Court

Copycat lawsuits appear to be increasing in food labeling cases. The Coca-Cola Company (“Coca-Cola”) is the latest company to be targeted with a copycat suit in

Phelps v. Coca-Cola: Orange Juice Misbranding “Copycat” Suit Finds Its Way Into State Court

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

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

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

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

Today, a divided Supreme Court issued a highly anticipated Clean Air Act (the “Act”) decision in Utility Air Regulatory Group v. EPA.  In an opinion authored by Justice Scalia, the Court rejected EPA’s application of the Act to require stationary sources to obtain a Prevention of Significant Deterioration (PSD) permit or Title V “major source” permit based solely on their potential greenhouse gas (GHG) emissions.  At the same time, the Court upheld EPA’s determination that for sources that would otherwise require PSD permits—known as “anyway” sources—EPA can require compliance with “best available control technology” (BACT) emission standards for greenhouse gases.The decision is both a win and a loss for EPA.  The win was the Court’s confirmation of EPA’s ability to regulate GHGs under the Clean Air Act and preservation of the majority of EPA’s rule, which is a critical element of President Obama’s efforts to implement climate change regulations without the need for Congressional action.  After the Supreme Court’s 2007 decision in Massachusetts v. EPA, which concluded that GHG emissions from motor vehicles constituted “air pollutants” under the Act and therefore were subject to EPA regulation, EPA embarked upon a rule-making process that ultimately regulated GHG emissions from stationary sources.  Recognizing that existing statutory emissions thresholds under the Act of 100 or 250 tons of GHGs would sweep in too many small stationary sources, EPA issued regulations raising these thresholds to 75,000 to 100,000 tons per year—known as the “tailoring” rule—to ensure that GHG-based PSD and Title V permitting requirements would apply only to the largest industrial sources of GHG emissions.The majority’s opinion concluded that EPA could impose GHG BACT on sources that would otherwise be subject to PSD review.  Because the Act states that BACT is required “for each pollutant subject to regulation” under the Act, EPA’s decision to require BACT for “anyway” sources was a permissible statutory interpretation.  Justice Scalia’s statement from the bench announcing the decision noted that this holding would allow EPA to regulate sources responsible for 83 percent of GHG emissions from stationary sources, just short of the 86 percent of emissions that would have been regulated if the Court had upheld EPA’s “triggering” rule.  Accordingly, both commentators and the EPA itself have already characterized the Court’s decision as a victory for those who want to regulate GHG emissions from stationary sources.The loss for EPA was the Court’s rejection of its creative effort to construe the Clean Air Act to allow EPA to use its administrative power to interpret the Act to include larger GHG sources and exclude smaller sources from regulation.  Overturning the decision of the United States Court of Appeals for the D.C. Circuit, the Court concluded that the Act neither compelled nor permitted EPA to determine that GHG emissions alone could trigger PSD or Title V permitting requirements.  The Court noted that although Massachusetts v. EPA held that the Act’s definition of “air pollutant” included GHGs, EPA has routinely ascribed a narrower meaning to that term based on context, and could have done so here.  EPA had argued in the alternative that, even if the Act did not compel its determination, EPA nonetheless justifiably and reasonably interpreted the Act.  The Court rejected this argument as well, concluding that EPA’s interpretation would both strain limited governmental resources and create an unwarranted expansion of regulatory authority without authorization from Congress.  Finally, the Court concluded that EPA lacked authority to “tailor” existing, unambiguous statutory emissions thresholds to exclude smaller stationary sources.  Four justices dissented from this portion of the opinion, and would have permitted EPA to interpret the statute to allow GHG emissions to trigger permitting requirements for large stationary sources.  The practical effect of the Court’s decision was to exclude some smaller sources of GHGs that were proposed for regulation under EPA’s rule.Thus, the industry challengers were able to obtain two of their objectives in the case.  First, the Court excluded the smaller of the subject GHG sources from regulation.  Second, the Court further clarified EPA’s regulatory discretion under the Clean Air Act and rejected the agency’s attempt to reinterpret the threshold that triggers those requirements.  There is, however, a significant element of irony in the case, where industry in part opposed EPA’s efforts to regulate fewer sources than the law would otherwise permit under the PSD and Title V programs.

Supreme Court Rules Out Clean Air Act Permits for Stationary Sources Based on Greenhouse Gas Emissions…Unless You Are Getting a Permit “Anyway”

Today, a divided Supreme Court issued a highly anticipated Clean Air Act (the “Act”) decision in Utility Air Regulatory Group v. EPA.  In an opinion authored by