Dechert Re:Torts - Key Developments in Product Liability and Mass Torts

Issue 2 - February 2023

Dechert Re:Torts is a monthly newsletter covering news and developments related to product liability and mass torts litigation.

In this issue:

Federal Appeals Court Dismisses Challenge to Interim PFAS Guidance, Leaving Important Questions Unresolved
European Union Proposes to Significantly Restrict PFAS
Governor Kathy Hochul Vetoes New York Wrongful Death Bill
First Circuit Affirms Summary Judgment in Zofran MDL
FDA Cybersecurity Requirements for Medical Devices Passed into Law
FDA Publishes Final Guidance on REMS Programs for Prescription Drugs

Environmental Edit

Federal Appeals Court Dismisses Challenge to Interim PFAS Guidance, Leaving Important Questions Unresolved

The D.C. Circuit Court of Appeals dismissed a challenge to EPA’s issuance of interim drinking water health advisories for certain perfluoroalkyl substances (“PFAS”). Order, Am. Chemistry Council v. Env’t Prot. Agency, No. 22-1177 (D.C. Cir. Jan. 23, 2023), Doc. No. 1982598. Those advisories markedly reduced the limits for two PFAS compounds and issued new advisories for others. The D.C. Circuit’s decision leaves key questions unanswered about the consequences of the advisories and the science and procedure behind their development.

The industry trade association American Chemistry Council (“ACC”) challenged EPA’s PFOA and PFOS advisories as “scientifically flawed and procedurally improper.” Petition for Review, at 2. According to the ACC, the updated advisories did not rely on best available science and were impossible to implement because the lowered thresholds were below current detection limits. Id. at 2-3, 8-9. With the current technology, “[e]ven water that registers no detectable level of PFOA or PFOS cannot be confirmed to be in compliance.” Id. at 9. While the PFOA and PFOS advisories were nominally “provisional,” “non-enforceable,” and “non-regulatory” in nature, PFOA Advisory at 1; PFOS Advisory at 1, several states “automatically incorporate” or otherwise rely on the advisories for setting their regulatory standards. Petition for Review at 4-5 & n.3. Likewise, federal and state agencies adopt advisories as the standards for site remediation and cleanup orders. Id. at 7. The common law can also look to regulatory standards to inform the scope of tort liability. See, e.g., Restatement (Second) of Torts § 286.

On EPA’s motion, the D.C. Circuit issued a summary order dismissing the petition for lack of standing. Though the ACC contended that it had associational standing to challenge the interim advisories on behalf of its members, Opp. to Mot. to Dismiss (Oct. 11, 2022), at 20-22, the court held that the ACC had “neither alleged that the challenged conduct affects all of its members nor identified any specific member” with a concrete injury. Jan. 23 Order. Instead, the ACC pointed only to “alleged harm facing an indirect subsidiary of one of its members.” Id. And while plaintiffs in tort cases against ACC members were citing the interim advisories, the court determined that the ACC had not shown a “substantial probability” that ACC members incurred costs to defend those lawsuits because of the advisories. Id.

Takeaway: The D.C. Circuit’s decision highlights the obstacle that standing can pose to mounting a legal challenge to interim agency actions, despite actual consequences to these advisories highlighted by the ACC briefing. The merits of the ACC’s arguments remain undecided and likely will remain so until it addresses the D.C. Circuit’s standing concerns.

Learn more about PFAS development on Dechert’s PFAS website.

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European Union Proposes to Significantly Restrict PFAS

On February 7, the European Union’s European Chemical Agency (“ECHA”) proposed to severely restrict the use of any per- and polyfluoroalkyl substances (“PFAS”). The proposal was the result of a three-year investigation into potential concerns with the persistence of PFAS in the environment as well as reports of possible associations of PFAS exposure and certain health effects. This proposal is likely to have broad impacts, particularly for companies who buy or sell products that may contain PFAS from Europe.

ECHA’s increased focus on regulating PFAS tracks that of U.S. EPA, which continues to pursue a variety of regulatory objectives from its PFAS Strategic Roadmap. While some of EPA’s proposals focused on particular PFAS, such as perfluorooctanoic acid (“PFOA”) and perfluorooctane sulfonic acid (“PFOS”), others have focused on the broader class of thousands of individual chemicals that comprise PFAS. ECHA’s proposal appears to be part of the latter trend, as it would prohibit the manufacture, use, or marketing of any substance, mixture, or article containing the sum of all PFAS exceeding 250 parts per billion, or of any single PFAS exceeding 25 parts per billion, based on a targeted analysis of PFAS. The proposal would additionally prohibit PFAS exceeding 50 parts per million in the situation where a targeted analysis is not applicable. The proposal presents two alternative approaches to restricting PFAS. In the first alternative, an industrywide restriction would restrict PFAS use above the specified limits after a transition period. Proposal at 2. The second alternative, deemed the “most balanced option” by ECHA, also contains an industrywide transition period, followed by a certain suspension of the restriction for designated uses and specified time periods, based on whether and the extent to which alternatives to PFAS have been developed in each industry. Id. at 3.

ECHA’s scientific committees still need to confirm that the proposal meets the legal requirements under the European Union’s regulation on the Registration, Evaluation, Authorisation and Restriction of Chemicals (“REACH”). ECHA will then engage in a six-month public consultation period, which will include an online information session, on April 5, to further explain the process to enact the restrictions.

Takeaway: ECHA’s recent proposal to significantly restrict the use of PFAS should be monitored by companies who use PFAS or PFAS-containing materials, particularly companies that import from or sell products to countries in the European Union. Companies should remain informed of continuing regulatory developments in this space and evaluate potential business impacts from expanding PFAS regulatory efforts.

Learn more about PFAS development on Dechert’s PFAS website.

Hot Topics

Governor Kathy Hochul Vetoes New York Wrongful Death Bill

On January 30, 2023, Governor Kathy Hochul vetoed a bill that would have expanded wrongful death benefits in New York State.

Senate Bill S74A, or the “Grieving Families Act,” would have revised the state’s existing wrongful death statute for the first time in 175 years by (1) extending the statute of limitations from 2 to 3.5 years, (2) expanding the scope of damages to allow for emotional damages, and (3) enlarging the categories of beneficiaries eligible to recover. The bill would have applied retroactively to wrongful death claims currently pending in the state.

Supporters of the revised wrongful death legislation argue that it was critical to bringing New York in line with other states—all states except New York, Alabama and Delaware allow courts to consider the value of lost relationships in imposing damages on defendants in wrongful death actions. However, the majority of states do not permit claims for grief and mental anguish resulting from a wrongful death as New York’s vetoed bill would have allowed.

While Governor Hochul’s veto statement demonstrated sympathy for the purpose of the legislation, she echoed concerns raised by the business community. Governor Hochul explained that the bill might have “significant unintended consequences,” suggesting that more study of the bill’s potential effect on the economy, businesses and the healthcare system was needed before it was signed into law.

Governor Hochul’s veto may not represent the end of the wrongful death debate in New York. In an opinion piece in The Daily News, she invited the state legislature to revise the bill and resubmit it for consideration, suggesting an exemption for medical malpractice claims as one potential modification.

Takeaway: With Governor Hochul’s veto of the Grieving Families Act, New York’s wrongful death law will remain unchanged, for now.

Learn about Dechert's Product Liability and Mass Torts services.

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First Circuit Affirms Summary Judgment in Zofran MDL

In affirming summary judgment for GlaxoSmithKline (“GSK”), the First Circuit held federal preemption bars failure-to-warn claims where FDA approves labeling that is directly contrary to the warning plaintiffs allege is required under state law. In re Zofran (Ondansetron) Prod. Liab. Litig., 57 F.4th 327 (1st Cir. 2023).

Following submission of GSK’s New Drug Application in 1990, Zofran was approved to treat nausea resulting from chemotherapy. The FDA-approved labeling indicated that animal studies showed no evidence of harm to the fetus from maternal use of Zofran.

After approval, Zofran was often prescribed off-label for pregnancy-related nausea. FDA was aware of Zofran’s off-label use, and Zofran’s pregnancy-related labeling was revisited over the years. Most recently, while the litigation was pending, FDA approved updated Zofran labeling, stating animal data revealed “no significant effects of [Zofran] on maternal animals or the development of the offspring.” Id. at 342.

The plaintiffs’ claims were based on three animal studies conducted in the late 1980s and sponsored by GSK, but not submitted in full to FDA at the time. The studies were listed in an annual submission to FDA in 1991 and were submitted in full after litigation began. Plaintiffs alleged that (a) the studies should have been submitted in 1991 as “newly acquired information” under FDA’s Changes Being Effected labeling update process, and (b) had the studies been submitted, FDA would have allowed a label change to warn that Zofran caused birth defects in animals.

The court concluded that the unsubmitted studies were not “newly acquired information” because they were not significantly different from the studies GSK previously submitted. The court also declined to consider the plaintiffs’ expert testimony, stating it was likely inadmissible and would provide little, if any, assistance in determining whether something is “newly acquired information.” The court further held that FDA’s most recent approval of Zofran labeling was clear evidence that FDA would have rejected the plaintiffs’ proposed warning because FDA was aware of the three studies at issue when it approved language contrary to that warning. As such, plaintiffs’ failure-to-warn claims were preempted.

Takeaway: Federal preemption does not require FDA to expressly reject a label change when FDA approves a label change directly contrary to, and with full knowledge of, the warning sought by plaintiffs. FDA necessarily rejects the contention that the data reveal effects when it formally approves a statement that the data reveal no effects.

Learn about Dechert's Product Liability and Mass Torts services.

Regulatory Review

FDA Cybersecurity Requirements for Medical Devices Passed into Law

H.R. 2617, the Consolidated Appropriations Act of 2023, was signed into law by President Biden on December 29, 2022. It mandates cybersecurity controls for certain internet-connected medical devices and authorizes FDA to establish cybersecurity standards for manufacturers of “cyber devices.” Prior to the Act, in 2014 and most recently in April 2022, FDA released non-binding guidance on the cybersecurity of medical devices.

A “cyber device” must comply with the new requirements if it: (1) includes software which is validated, installed, or authorized by the sponsor; (2) can connect to the internet; and (3) contains any technological characteristics that could be vulnerable to cybersecurity threats. Section 524B(c) of the Federal Food, Drug, and Cosmetic Act (“FDCA”). This broad definition includes many wearable devices such as smartwatches and implantable devices that are monitored remotely by health care providers, such as insulin pumps, cardiac and blood sugar monitors, intracardiac defibrillators, and pacemakers.

After the Act takes effect, a manufacturer or sponsor’s application or premarket submission to FDA must include certain information related to the cybersecurity of the device, including:

a plan to monitor, identify, and address post-market cybersecurity vulnerabilities and exploits, including coordinated vulnerability disclosure (i.e., gathering information from vulnerability finders, coordinating the sharing of that information between relevant stakeholders, and disclosing the existence of software vulnerabilities and their mitigations to various stakeholders including the public); and

a Software Bill of Materials that includes commercial, open-source, and off-the-shelf software components used by the device.

The manufacturer must also design, develop, and maintain processes and procedures to ensure the device and related systems are cybersecure, and must make available post-market updates and patches to the device and related systems to address: (a) known unacceptable vulnerabilities on a reasonably justified regular cycle; and (b) out of cycle, critical vulnerabilities that could cause uncontrolled risks as soon as possible. These requirements apply only to future applications and premarket submissions, not to devices already on the market.

In addition, the Act (1) makes it a “prohibited act” under 21 U.S.C. 331 to fail to comply with any requirement related to ensuring device cybersecurity, (2) authorizes FDA to exempt certain devices, or categories or types of devices, from meeting these new requirements, and (3) directs FDA to issue updated cybersecurity guidance within two years.

Takeaway: The new Act underscores the importance of device cybersecurity. Device manufacturers should review their current cybersecurity controls and FDA guidance documents with an eye toward compliance with the new regulations. Although many of the new Act’s requirements apply only to newly submitted devices, manufacturers and sponsors of all previously approved or cleared devices would be well-served to examine the robustness of their own cybersecurity measures.

Learn about Dechert's Product Liability and Mass Torts services.

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FDA Publishes Final Guidance on REMS Programs for Prescription Drugs

On January 5, 2023, FDA published its Final Guidance on Risk Evaluation and Mitigation Strategy (“REMS”) programs for prescription drugs, entitled “Format and Content of a REMS Document: Guidance for Industry.” REMS is a drug safety program that FDA can require for medications with potentially serious safety concerns to help ensure that the medication’s benefits outweigh its risks. REMS are designed to prevent, monitor and/or manage a medication’s risk(s) by informing, educating and/or encouraging actions to reduce the frequency and/or severity of the risk(s). REMS programs can include, among other requirements, medication guides or manuals, patient package inserts, and communication outreach.

The recently issued Guidance finalizes the 2017 draft guidance of the same name and provides updated recommendations for the format and content of REMS documents to ensure they are clearly articulated and in a standardized format that aligns with FDA’s Structured Product Labeling (“SPL”) format.

Changes from the 2017 guidance include: (1) revising the REMS document to add and clarify requirements that participants and applicants must meet to comply with the REMS, (2) adding a reference to a new authority to require certain packaging and safe disposal technologies for drugs that pose a serious risk of abuse, (3) adding a new section listing the statutory elements of the REMS, and (4) adding a prompt to identify the risk(s) addressed by the REMS.

REMS can impact the liability risk for prescription medication manufacturers. First, because REMS often require additional warnings for certain risks, they can provide additional protection for manufacturers. Second, REMS can preempt state law labeling requirements. Under Merck Sharp & Dohme Corp. v. Albrecht, 139 S. Ct. 1668 (2019), an FDA-adopted REMS document constitutes federal law that preempts any potential state law requirements.

Takeaway: In January 2023, FDA published its Final Guidance on REMS, which provides recommendations for drafting proposed REMS documents and converting an already-approved REMS document to a new, standardized format that is clearer, more informative and compliant with FDA’s Structured Product Labeling format.

Learn about Dechert's Product Liability and Mass Torts services.

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