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

Issue 8 - August 2023

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

Inside this issue:

Advances in Videoconferencing Do Not Change the Subpoena Power of the Court
California Codifies Standard for Defense Experts’ Alternative Causation Opinions
New MDLs Created for Bard Implants and Insulin Price Fixing
EPA Issues Gatekeeping Framework for New PFAS and New Uses of Existing PFAS
NYDOH’s Proposed Regulations Expand Notification Requirements for PFAS in Drinking Water
EPA Releases White Paper Explaining Approach to Part 2 of Asbestos Risk Evaluation

Hot Topics

Advances in Videoconferencing Do Not Change the Subpoena Power of the Court

In In re Kirkland, 2023 WL 4777937 (9th Cir. July 27, 2023), the Ninth Circuit held that a district court could not subpoena testimony outside the geographic scope of Federal Rule of Civil Procedure 45(c), even if the witness could appear remotely via videoconferencing.

Under Rule 45(c), a district court has the power to compel a witness to testify at trial if the trial takes place: (A) within 100 miles of where the person resides, is employed, or regularly transacts business in person; or (B) within the state where the person resides, is employed, or regularly transacts business in person, if the person is a party or commanded to attend trial. Rule 43(a) permits courts “[f]or good cause and compelling circumstances” to allow for testimony by videoconference.

In In re Kirkland, witnesses who had previously testified in a related case when they resided in California had since relocated to the U.S. Virgin Islands. One party sought to introduce that prior testimony before the bankruptcy court, arguing the witnesses were unavailable and making the prior testimony admissible hearsay. The bankruptcy court concluded the “unavailability” had been engineered for strategic purposes and that the prior testimony was insufficient to address certain issues. Id. at *3. Noting the court’s “positive experiences” with remote testimony during the COVID-19 pandemic, the bankruptcy court concluded that remote testimony via videoconference “is an adequate substitute for in-person testimony,” therefore, “good cause and compelling circumstances warranted ordering the [witnesses] to testify remotely.” Id. Although it was undisputed that the bankruptcy court could not compel live witness testimony, id. at *7, the trial court concluded that when compelling remote testimony, the “place of compliance” under Rule 45(c) moved from the courthouse to the location of the witnesses.

The Ninth Circuit disagreed. According to the Ninth Circuit, Rule 45(c) is properly read to govern the court’s power to require a witness to testify at trial, while Rule 43(a) governs the mechanics of how trial testimony is presented. A district court must first determine the limits of the court’s power to compel testimony under Rule 45(c), then proceed to determine the mechanics of how such testimony is to be presented under Rule 43. Id. at *7. Under the Ninth Circuit’s holding, a court can only compel witnesses who are within the geographic subpoena power of the court. Rule 43 does not expand that power, but rather “it gives court discretion to allow a witness otherwise within the scope of its authority to appear remotely if the requirements of Rule 43(a) are satisfied.” Id. at *8.

Takeaway: Videoconferencing can be a useful tool to alleviate the burdens of travel in litigation. However, under the Ninth Circuit’s holding in In re Kirkland, the availability of remote testimony does not expand the subpoena power of the court beyond the geographic limits contemplated by Rule 45(c).

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

Experts Examined

California Codifies Standard for Defense Experts’ Alternative Causation Opinions

On July 13, Governor Gavin Newsom signed into law California Senate Bill 652 (“SB 652”), which added new provisions to the Evidence Code governing expert testimony. Specifically, under Evidence Code Section 801.1, Defense experts may either:

(a) Offer expert opinions that an alternative cause or causes were the source of a Plaintiff’s injury only if those opinions are offered to a reasonable degree of medical probability; or
(b) Offer expert opinions that a Plaintiff’s experts’ opinions do not meet a reasonable degree of medical probability by pointing to other possible causes of a Plaintiff’s injury.

The Consumer Attorneys of California sponsored SB 652 on the heels of Kline v. Zimmer, Inc., 79 Cal. App. 5th 123 (2022). In Kline, the Court of Appeal held that a Defendant’s expert’s opinion need not be held to a reasonable degree of medical certainty when the opinion is offered to rebut a Plaintiff’s experts’ causation opinions. Id. at 132. In those circumstances, a Defendant “should [be] permitted” to offer expert opinions “to less than a reasonable medical probability that [a Plaintiff’s] injuries may have been attributable to other causes.” Id.

While sponsors of SB 652 claim that it abrogates Kline, the text of the bill proves otherwise. Under the bill, Defense experts may opine that another cause was more likely than not the cause of a Plaintiff’s injury only if that opinion is offered to a degree of medical certainty. But Defense experts may nevertheless still opine on potential alternative causes to challenge the medical certainty with which a Plaintiff’s expert is able to offer a causation opinion. And nothing prohibits Defendants from cross-examining Plaintiffs’ experts on other causes that they purport to rule out. Rather than abrogating Kline, SB 562 speaks to the purposes for which Defense experts can offer alternative causation opinions.

Takeaway: SB 652 codifies the ways in which Defense experts can point to alternative causes, either by offering affirmative alternative cause opinions to a reasonable degree of medical certainty or by pointing to potential alternative causes to rebut Plaintiff’s experts’ opinions.

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

MDL Minute

New MDLs Created for Bard Implants and Insulin Price Fixing

After its July hearing session, the JPML created two new MDLs in early August, rejecting Defendants’ arguments against centralization. The JPML found that pretrial proceedings would be effectively streamlined through coordination.

Bard Implanted Port Catheter, Hon. David G. Campbell (D. Ariz.) – alleging that excessive barium sulfate in components of a port catheter caused infection, migration, and fracture of the catheter, as well as thrombosis. MDL No. 3081, In re Bard Implanted Port Catheter Products Liability Litigation.
Insulin Pricing Litigation, Hon. Brian R. Martinotti (D.N.J.) – alleging a scheme between insulin manufacturers and pharmacy benefit managers to inflate the price of insulin and other diabetes medications. MDL No. 3080, In re Insulin Pricing Litigation.

In both actions, Defendants opposed forming MDLs using arguments that echo class-certification Defenses: arguing that individual factual issues (e.g., varying injuries and products) and state questions would outweigh common ones. The JPML, however, noted “the assertion of different legal claims or additional facts is not significant where, as here, the actions arise from a common factual core.” In re Insulin, Dkt. 91, at *2; see also In re Bard, Dkt. 65, at *2. Defendants in both cases also argued that the parties could informally coordinate, as they had done previously. But the JPML disagreed and was skeptical of informal coordination considering the large number of cases across dozens of districts.

The Bard Defendants raised merits Defenses to the underlying cases and argued that forming an MDL would reward the filing of meritless cases. But the JPML rejected this argument as well noting that centralization before one court allows that transferee court the ability to dispense with spurious claims with greater speed and efficiency. In re Bard Implanted Port Catheter, Dkt. 65, at *2 (citing e.g., In re Xarelto (Rivaroxaban) Prods. Liab. Litig., 65 F. Supp. 3d 1402, 1405 (J.P.M.L. 2014).

As to Bard, the JPML assigned a judge with a prior related MDL. In re Bard Implanted Port Catheter, Dkt. 65, at *3 (noting Judge Campbell currently presides over a case involving medical devices made by Bard). And as to the insulin price-fixing litigation, the JPML highlighted that Judge Martinotti already presides over three advanced actions alleging insulin price fixing as well as a proposed related nationwide settlement. In re Insulin, Dkt. 91, at *4.

Takeaway: Over Defendants’ objections, the JPML created two new MDLs following the July session.

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

Environmental Edit

EPA Issues Gatekeeping Framework for New PFAS and New Uses of Existing PFAS

On June 29, EPA issued a framework for reviewing new per- and polyfluoroalkyl substances (“PFAS”) and significant new uses of existing PFAS before they enter commerce. This framework was developed under the Toxic Substances Control Act (“TSCA”) New Chemicals Program and augments existing TSCA regulations generally requiring a company to submit a pre-manufacture notice (“PMN”) or significant new use notice (“SNUN”) before manufacturing (or importing) a new substance or using an existing substance in a new manner. These notices enable EPA to take preemptive regulatory action. While the PMN and SNUN requirement is not new, the framework was developed in light of the large number of PFAS and regulatory concern about PFAS exposures. Further, the framework will apply to future PMNs and SNUNs and those that are currently under EPA review.

After determining that the chemical at issue meets the framework’s definition of PFAS, which requires the existence of at least one of three chemical structures, EPA will review all available data on the particular PFAS. The party applying for EPA’s approval must submit all information it has in its possession that can inform the evaluation of the potential human health or environmental effects of the PFAS.

Recognizing that new PFAS “present a challenge” “to evaluate because there is often insufficient information to quantify the risk they may pose,” EPA has stated that the framework will be used to “qualitatively” assess whether the PFAS is a persistent, bioaccumulative, and toxic (“PBT”) chemical. This qualitative assessment will include an evaluation of the potential extent of exposures to the general population, consumers, and the environment. If EPA determines that a particular PFAS is a PBT chemical, then EPA will then make a finding as to the potential risk, which may lead to further testing and assessment before the PFAS can be introduced into commerce. While EPA “generally expects that most PFAS will be PBT,” PFAS that do not fall into that category will go through EPA’s typical new chemicals’ assessment process. Based on its evaluation, EPA may limit the specific use of a PFAS, such as in the context of consumer products, or prohibit its use or manufacture altogether.

EPA’s new framework, on which EPA will hold a webinar on September 6, is yet another demonstration of heightening regulatory oversight of PFAS, which altogether comprise thousands of chemicals. For decades, PFAS have been used by a variety of industries in a wide range of products, such as paper products, wire insulation, surface coatings, and personal care products like cosmetics and shampoo, among numerous others. While research will continue as to whether certain new PFAS will be useful and economical in these kinds of wide-ranging applications, EPA has indicated that it will closely review new PFAS or significant new uses of existing PFAS.

Takeaway: Companies who use PFAS or PFAS-containing materials, or who rely on companies in their supply chain who do so, should stay informed of continuing updates regarding EPA’s framework for evaluating new PFAS or significant new uses of existing PFAS.

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

___________________________________

NYDOH’s Proposed Regulations Expand Notification Requirements for PFAS in Drinking Water

Last year, the New York State legislature issued a mandate for the New York Department of Health (“NYDOH”) to consult with the New York State Drinking Water Quality Council (“DWQC” or “Council”) and assess whether additional per- and polyfluoroalkyl substances (“PFAS”) and other compounds should be listed as emerging contaminants that would receive enhanced notification and testing requirements. That amendment to Public Health Law (“PHL”) 1112 originally listed 23 PFAS and asked the Council to recommend those that should have a Maximum Contaminant Level (“MCL”) and those that should have established Notification Levels.

In May of 2022, the Council recommended that four PFAS receive MCLs and that the remaining 19 be retained on the emerging contaminant list with Notification Levels. In October 2022, NYDOH issued proposed regulations that, if enacted, would memorialize the Council’s findings and recommendations, including: (1) establishing MCLs for perfluorodecanoic acid (“PFDA”) perfluoroheptanoic acid (“PFHpA”), perfluorohexane sulfonic acid (“PFHxS”) and perfluorononanoic Acid (“PFNA”); and (2) establishing Notification Levels for the other 19 PFAS.

PHL 1112 tasks both DOH and DWQC with setting MCLs and Notification Levels. Exceeding an MCL places the Public Water System in noncompliance and requires that the Public Water System timely notify consumers (often within 30 days) and undertake remedial actions. Currently, New York only has MCLs (and corresponding notice requirements) for two PFAS – perfluorooctanoic acid (PFOA) and perfluorooctane sulfonate (PFOS). Exceeding a Notification Level requires that the Public Water System notify its consumers within 90 days. For most consumers, this will mean that they will receive a letter in the mail that explains which emerging contaminant exceeded its Notification Level, the date the samples were collected, available information related to potential health effects, any actions required by the local health department, and phone numbers both for the water system owner or operator and the local health department.

To date, the proposed regulations remain pending, though the Council briefly addressed them, among other PFAS topics, during its June 28, 2023 meeting. The next Council meeting will likely be in September, after which we may learn more about the future of the proposed regulations. Notably, NYDOH has until October 5, 2023, to adopt the regulations in full or in part before they expire.

Takeaway: Although increased global scrutiny, regulation, and limitations on PFAS previously focused on the more common PFOA and PFOS, that appears to be changing. New York’s proposed regulations, if adopted, would be another example of an increasing trend addressing a broader set of PFAS. An expanded regulatory focus could significantly impact stakeholders’ business, litigation, and compliance risks.

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

Back to top

___________________________________

EPA Releases White Paper Explaining Approach to Part 2 of Asbestos Risk Evaluation

On August 2, 2023, the Environmental Protection Agency (“EPA” or the “Agency”) released a white paper setting out proposed research and assumptions it plans to use in Part 2 of the Agency’s ongoing risk assessment of asbestos and human health. The white paper, Quantitative Human Health Approach to be Applied in the Risk Evaluation for Asbestos Part 2 - Supplemental Evaluation including Legacy Uses and Associated Disposals of Asbestos, is open for public comment through October 2023, after which the Agency’s proposals will be evaluated by an independent panel of scientists.

The EPA has a long history evaluating potential risks of and regulating asbestos. The Toxic Substances Control Act (“TSCA”), which is implemented by EPA’s Office of Pollution Prevention and Toxics (“OPPT”), provides the EPA with broad authority to require reporting, record-keeping and testing requirements, and restrictions relating to chemical mixtures and/or substances. In December 2016, pursuant to TSCA section 6(b)(2)(A), asbestos was designated as one of the first 10 chemical substances for OPPT’s initial risk evaluations.

In December 2020, OPPT released Risk Evaluation for Asbestos Part 1: Chrysotile Asbestos, which focused on inhalation exposure and cancer risks associated with chrysotile asbestos. Part 1 did not review oral or dermal exposure to chrysotile asbestos, non-cancer effects of chrysotile asbestos, or non-chrysotile asbestos. Part 2 of the EPA’s assessment is specifically intended to address these factors as to chrysotile asbestos and offer a more comprehensive look at asbestos in general (including non-chrysotile “legacy” asbestos) and its effects.

In its August white paper, the EPA explains the methodology it proposes using to identify, screen, and evaluate epidemiologic data for use in Part 2 of its asbestos review, including dose-response information for cancer and non-cancer effects. Following public comment and peer review of this methodology, the EPA will implement this approach and release Part 2 of its asbestos evaluation.

Takeaway: EPA’s proposed methodology for the continued evaluation of the risks of asbestos is undergoing peer review and public comment and is expected to thereafter be implemented.

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

View News & Insights from Dechert's Product Liability Group