The post Biz Groups Back State Suit Discovery Stays, High Court Told appeared first on Washington Legal Foundation.
—Cory Andrews, WLF General Counsel & Vice President of Litigation
Click HERE for WLF’s brief.
(Washington, DC)—Washington Legal Foundation (WLF) today asked the U.S. Supreme Court to vacate a decision of the Court of Appeal for the State of California, First Appellate District, in a securities class action with far-reaching implications. WLF’s amicus brief was prepared with the pro bono assistance of Lyle Roberts, George Anhang, and Stephen Janick of Shearman & Sterling LLP.
The Private Securities Litigation Reform Act of 1995 (PSLRA) stays discovery during the pendency of a motion to dismiss in “any private action” under the Securities Act of 1933. The discovery stay is a key component of Congress’s overall statutory scheme for private securities actions. Congress was concerned that plaintiffs bringing meritless securities suits were using abusive discovery as leverage to bolster their cases, avoid dismissal, and force settlements. Those policy concerns, and the accompanying mandatory discovery stay, apply equally no matter if a securities suit if filed in state or federal court.
The California court failed to apply the PSLRA’s mandatory discovery stay in this case. It held that the law’s discovery stay is procedural, not substantive, and so does not apply in state court. But as WLF explains it its amicus brief, the PSLRA’s plain language, overall statutory scheme, and animating public-policy concerns all confirm that the mandatory stay applies in all Securities Act cases, including those brought in state court. A contrary holding would permit plaintiffs to simply file parallel actions in state court to circumvent the discovery stay in federal court. As WLF shows, that is precisely what many plaintiffs’ counsel have been doing for years.
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Commerce Committee Announces August 23 Subcommittee Field Hearing on Space and Science in Colorado Springs, CO
WASHINGTON, D.C. — U.S. Senator John Hickenlooper, Chair of the Subcommittee on Space and Science, will convene a field hearing titled “Collaboration and Competition in Space: Ushering in a New Era” on Monday, August 23, 2021 at 2pm MDT in Colorado Springs, Colorado.
The United States has long been the global leader in space exploration and has benefitted from robust, peaceful international collaboration. Other nations, such as China and Russia, have announced their own space ambitions, and desire to build their own international collaborations. This hearing will examine actions to promote the competitiveness of the U.S. commercial and civil space sectors and to attract and maintain strong international partnerships that deliver tangible benefits back here on Earth.
- Hon. Jim Bridenstine, Former NASA Administrator
- Mary Lynne Dittmar, Executive Vice President for Government Affairs, Axiom Space
- Mike Gold, Executive Vice President for Civil Space and External Affairs, Redwire Space
Monday, August 23, 2021
2:00 p.m. MDT (4:00 p.m. EDT)
The Broadmoor (Broadmoor Theater in the main building)
1 Lake Ave
Colorado Springs, CO 80906
Frank Cruz-Alvarez is a Partner with Shook, Hardy & Bacon L.L.P. in the firm’s Miami, FL office, and Britta Stamps Todd is an Associate in the firm’s Kansas City, Mo office. Mr. Cruz-Alvarez is the WLF Legal Pulse’s Featured Expert Contributor on Civil Justice/Class Actions.
What began as a patent litigation case spurred an antitrust case and ended with the Fourth Circuit’s latest reversal of class certification in In re Zetia (Ezetimibe) Antitrust Litigation. Luckily, no expertise in pharmaceutical patent litigation or antitrust law is required to break down the court’s clarification of Federal Rule of Civil Procedure 23’s numerosity requirement. In short, Merck developed a cholesterol-lowering drug that it patented and marketed under the name Zetia, with its patent giving Merck the exclusive right to develop the drug through April 2017. In 2006, another pharmaceutical company, Glenmark, sought FDA approval to market a generic version of Zetia on the basis that Merck’s patent was invalid. Merck promptly sued Glenmark for patent infringement, and the two companies eventually settled the case with an agreement that Glenmark could launch its generic version of the drug in December 2016. Alleging violations of federal antitrust law, the plaintiffs in the present case sued both Merck and Glenmark on behalf of a putative class that included drug wholesalers who purchased Zetia directly from Merck.
But the list of drug wholesalers who purchased Zetia directly from Merck and therefore comprised the putative class only includes thirty-five entities. Still, the three class representatives moved for class certification. Following the recommendation of a magistrate judge, the district court granted class certification under Rule 23(b)(3). As relevant to the numerosity requirement of Rule 23(a), the district court looked to the Third Circuit’s “non-exhaustive list” of factors, including “judicial economy, the claimants’ ability and motivation to litigate as joined plaintiffs, the financial resources of class members, [and] the geographic dispersion of class members.” In re Modafinil Antitrust Litig., 837 F.3d 238, 253 (3d Cir. 2016). Reasoning that multiple individual trials would be required unless the class was certified, the district court concluded that the numerosity requirement had been met, along with the other Rule 23(a) requirements, and certified the class.
Pointing to the low number of class members, all of which were sophisticated business entities, Merck and Glenmark appealed the certification decision to the Fourth Circuit. While no specific number of putative class members has been defined as a threshold for meeting Rule 23(a)’s numerosity requirement, courts have generally held that fewer than 20 putative class members is insufficient, but more than 40 members generally qualifies. The 35 putative class members in the present case fall squarely in the “gray area” between 20 and 40 members, requiring the district court to take into consideration the totality of the circumstances of the particular case to determine whether joinder of the putative class members is impracticable.
The district court’s rationale diverged from Rule 23’s actual language in its interpretation of the word “impracticable.” Adopting the magistrate judge’s reasoning, the district court concluded that judicial economy would be best served by class certification to avoid “multiple individual trials” involving “the same theories of liability and largely the same evidence.” The Fourth Circuit went so far as to agree that compared to joinder, “class certification will often be preferable from a judicial economy perspective.” But that does not equate to joinder being impracticable. Reminding district courts that Rule 23(a) is a “high standard,” the court reiterated that the balance of factors must make “joinder not only uneconomical but also economically impracticable.”
Again focusing on the economics of individual suits, the district court further found that class certification was warranted given “evidence from other cases regarding class members’ motivation to pursue claims on their own.” But the plaintiffs offered no evidence that it would be uneconomical for the smaller claimants to individually join a traditional suit. The Fourth Circuit clarified that whether some claimants may be economically unmotivated to pursue a claim via joinder is only one of many factors to be considered for numerosity. The focus must be on the impracticability of joinder, not the impracticability of individual suits. Because the district court concentrated its attention on the challenges of individual suits rather than the practicability of the 35 putative class members being joined in one traditional lawsuit, the Fourth Circuit reversed and remanded for the district court to decide the case with its fresh guidance in mind. The 35 putative class members may very well satisfy the numerosity requirement on remand, but the district court must consider the impracticability of joinder in its rationale for certification.
Writing separately in a concurring opinion, Judge Niemeyer offered additional practical measures of numerosity. He advised that a class with fewer than 30 members “should be exceptional.” Expanding on the “geographic dispersion” factor considered by some courts, he reasoned that if putative class members are “especially scattered” or “notably concentrated,” this factor should be afforded extra weight. And where putative class members may refrain from joining a traditional lawsuit out of fear of possible reprisals by the defendant, the individual class members’ motivation should be heavily considered. The concurrence also looked at the judicial economy factor from a granular perspective: courtroom space and correlated staffing concerns increase when 35 plaintiffs each have 2 or 3 attorneys in the courtroom to litigate a traditional lawsuit, compared to a few attorneys representing the entire class in a class action. Finally, Judge Niemeyer cautions against consideration of sunk costs of discovery that has already been completed—while future discovery may be considered as a factor, a class should not be certified simply because the putative class’s counsel has already conducted voluminous discovery.
While Merck and Glenmark also appealed other aspects of the class certification decision, the Fourth Circuit quickly rejected the remaining points of adequacy of class representatives and predominance. Although the Fourth Circuit only referenced antitrust standing in passing in its brief discussion of Rule 23(b)(3)’s predominance inquiry, antitrust standing can also bear on Rule 23(a)’s numerosity requirement. In addition to traditional Article III standing, private antitrust plaintiffs must establish antitrust standing as well. This creates an additional hurdle for class representatives trying to meet the magic number to achieve numerosity. In conjunction with the wave of cases in various federal circuits about class members’ standing, antitrust defendants should consider any possible challenges to a plaintiff’s antitrust standing to attack both numerosity and predominance in opposition to class certification.
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Stories of heroism in the U.S. Coast Guard are part of the service’s legacy. Indeed, the Coast Guard conducts an average of 45 search and rescue missions per day. But those rescue missions are just one part of a highly capable and diverse agency that protects our national security, enables safe shipping and trade, and safeguards the maritime environment.
The motto of the Coast Guard is “always ready,” and the men and women who serve as Coasties live up to that motto every day. What often goes unreported, however, is the woeful lack of resources supporting the Coast Guard’s missions.
In too many cases, the Coast Guard operates out of trailers in parking lots, uninhabitable buildings and crumbling piers. It is time to give this branch of our armed forces its rightful attention and support.
The Coast Guard facilitates diplomacy in the Indo-Pacific region, partners with the Navy in the South China Sea, delivers maritime security in the Middle East, provides a surface presence in the Arctic and deters illegal fishing in international waters. It enforces our domestic fisheries laws, keeps our rivers open, and protects U.S. ports and waterways.
Without a doubt, the Coast Guard is one of America’s most versatile and valuable assets. Its funding should reflect this important role.
As Coast Guard Commandant Adm. Karl Schultz has stated, every mission begins on shore and at the waterfront. However, more than half of all Coast Guard facilities are beyond their service life, with over 5,000 facilities suffering from unfunded deferred maintenance. As of June 2021, the Coast Guard’s maintenance and infrastructure backlog had reached a staggering $3 billion. Without adequate bases, buildings and piers, the Coast Guard cannot continue to fulfill its responsibilities effectively.
In February of this year, I wrote to President Joe Biden in support of increased funding for the Coast Guard. I was disappointed when his fiscal 2022 budget failed to address these needs. The 2021 Infrastructure Investment and Jobs Act, negotiated by President Biden and a small group of senators, will be another missed opportunity to provide our Coast Guard with the funding it deserves. I sponsored and co-sponsored several amendments to boost funding for the service and have been disappointed by the Senate’s lack of interest in adopting these measures.
In addition to these amendments, I recently introduced the Unwavering Support for our Coast Guard (USCG) Act to address some of the Coast Guard’s longstanding challenges. This bill would provide full funding to eliminate the shore-side facility maintenance backlog and build resiliency into these facilities. It would also support renovations to the Coast Guard Yard in Maryland. As the Coast Guard’s only shipyard, this facility is responsible for most long-term fleet maintenance and is in urgent need of modernization. Without these upgrades, the shipyard will be unable to maintain and service the current and future fleet.
The USCG Act would also protect pay and allowances for Coast Guard members through any gap in federal funding. During the most recent government shutdown, Coast Guard members were the only service members who went without pay while continuing to serve. My bill would ensure that Washington’s failures do not impact the men and women who keep us safe.
Since 2010, the Coast Guard has seen only a modest 8 percent increase in operation and support funding. By comparison, all other services have seen increases between 28 and 42 percent. Having the Coast Guard clearly identify its needs will inform Congress about how to modernize and recapitalize our Coast Guard fleet to meet its mission requirements.
It is popular for members of Congress to publicly support the Coast Guard, as evidenced by the 34 senators who tweeted birthday wishes on Aug. 4. Adequate funding of Coast Guard needs would be a much more meaningful show of support.
This op-ed was orginally ran in Defense News.
“Daubert motion” has become de rigeur slang among federal practitioners when referring to a motion to exclude an expert witness. Courts also frequently use that nomenclature, making statements such as “Now before the Court is a Daubert Motion filed by Defendants to strike or limit the purported expert testimony of Plaintiffs’ witnesses[.]” But these descriptions are inaccurate: Federal Rule of Evidence 702, not the Daubert holding, sets the admissibility standard. Many courts mistakenly take their guidance about the gatekeeping function from prior court rulings, rather than the rule. This preference has developed into a problem because, perhaps surprisingly, many district court and even some circuit court rulings describe the expert admissibility standard in ways that actually contradict Rule 702. References to “Daubert motions” reinforce courts’ misunderstanding by incorrectly signaling that caselaw, rather than the text of the rule, governs the assessment of opinion-testimony admissibility.
The Committee on Rules of Practice and Procedure unanimously voted on June 22, 2021 to publish for comment and potential enactment a proposed amendment to Rule 702 clarifying that courts must follow the text of the rule and disregard inconsistent caselaw statements. Analysis undertaken in the rulemaking process shows how courts often err by relying on prior decisions that fail to apply the gatekeeping approach that Rule 702 established. To overcome this ongoing problem, courts must recognize Rule 702’s authoritative status and internalize that fact. To keep attention focused on the applicable standard and avoid the distraction of outdated caselaw, litigants should describe challenges to the admissibility of opinion testimony as what they truly are: Rule 702 motions.
To continue reading, please click on the PDF button above.
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Featured Expert Contributor: Mass Torts—Asbestos
Robert H. Wright is a Partner with Horvitz & Levy LLP in Los Angeles, CA.
Although courts across the country have issued conflicting opinions about the “bare metal” defense, the Iowa Court of Appeals has affirmed a judgment under a state statute that encompasses and extends that defense, and the Iowa Supreme Court has granted review to decide the issue.
Under the “bare metal” defense at common law, a product manufacturer is not liable for injuries caused by asbestos-containing products made by others. As my prior posts have noted (here and here), courts have split on application of that defense. The United States Supreme Court rejected the defense to products liability claims in maritime cases. Air & Liquid Systems v. DeVries, 139 S. Ct. 986, 991 (2019). But the highest courts in some states have embraced the defense. E.g., Coffman v. Armstrong Int’l, Inc., 615 S.W.3d 888, 890 (Tenn. 2021); O’Neil v. Crane Co., 266 P.3d 987, 991 (Cal. 2012); Simonetta v. Viad Corp., 197 P.3d 127, 132-33 (Wash. 2008). Most recently, the Tennessee Supreme Court concluded earlier this year that the manufacturers of equipment could not “be held liable for injuries resulting from products they did not make, distribute, or sell.” Coffman, 615 S.W.3d at 900.
In 2017, Iowa enacted the Asbestos and Silica Claims Priorities Act. See Iowa Code § 686B. That statute creates something akin to the bare metal defense, but applies it to all defendants, not just product manufacturers. Iowa Code § 686B.7(5) states that a “defendant in an asbestos action or silica action shall not be liable for exposures from a product or component part made or sold by a third party.”
In Beverage v. Alcoa, Inc., No. 19-1852, 2021 WL 1016602 (Iowa Ct. App. Mar. 17, 2021), the Court of Appeals applied the defense. Charles Beverage worked inside an aluminum plant where he was allegedly exposed to asbestos. After Charles’s death, his estate and children filed asbestos-related claims against both the owner of the plant and an installer of insulation The Court of Appeals held that the statute barred plaintiffs’ claims. Id. at *1.
The Beverage plaintiffs argued that the statute applied only to manufacturers. The Court of Appeals disagreed, noting that the statute, by its terms, applies to any “defendant.” Id. at *2. The Court of Appeals held that the term “defendant” should be given its common, ordinary meaning in the context of civil litigation and that all of the parties the plaintiffs had sued were defendants. Id. at *2-3.
The Beverage plaintiffs argued that, “while not directly stated in the statute,” its “meaning and purpose” were “quite clearly the establishment of the ‘bare metal defense.’ ” Id. at *3. The Court of Appeals concluded the statute was not so limited. It recognized that the immunity afforded by the statute “may overlap or even encompass the protections available under a ‘bare metal’ defense,” but nonetheless found no reason to conclude that the provision “was a mere codification of that defense.” Id. at *4. As the Court of Appeals stated, if “ ‘the legislature intended’ to merely codify a common-law ‘bare metal’ defense, the legislature ‘could easily have so stated.’ ” Id.
The Court of Appeals held that the “plain purpose” of the Iowa statute was “to narrow asbestos litigation by protecting defendants against liability for exposure to products that were ‘made or sold by a third party.’ ” Id. at *4. That effect “will naturally tend to refocus asbestos litigation on more culpable targets, such as asbestos manufacturers.” Id. The Court of Appeals stated there was “nothing absurd about this.” Id. The Iowa Supreme Court has granted review in the case and will have the final word.
The Iowa statute seems to be the first of its kind. Although the statute shares the same name and some of the same provisions as a model act by the American Legislative Exchange Council, the provision at issue does not appear in the model act. Moreover, my research did not disclose a similar provision in any other state statute.
The Iowa statute may not remain unique. The Georgia Legislature is considering a bill with similar language, which would provide that a “product liability defendant in an asbestos action shall not be liable for exposures from a product or component part made or sold by a third party.” 2021 Georgia House Bill No. 638, § 3. Now that the Court of Appeals has given effect to the Iowa statute, it could become a model for legislation in Georgia and beyond.
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GSA, USDA Partnership Transformed the Digital Experience for USDA Customers and Avoided $50M+ in Burdensome Costs
The post Legal Group Tells Justices Federal Law Overtakes ABC Test appeared first on Washington Legal Foundation.
Jurgita Ashley is a securities and corporate governance partner with Thompson Hine LLP, co-chair of the firm’s Public Companies group, and co-chair of the firm’s ESG Collaborative. David Wilson is an internal investigations, government enforcement, and securities and shareholder litigation partner with Thompson Hine LLP and partner in charge of the firm’s Washington, D.C. office.*
Calls for increased environmental, social and corporate governance (ESG) disclosures are growing exponentially. When providing them, companies should put in place systems to ensure that the disclosures are accurate and complete and implement litigation and enforcement safeguards.
Adding to demands from investors, employees and ESG rating organizations; legislative action in Europe and the United States; climate-based activity at state level; and the Biden administration’s focus on ESG issues is the U.S. Securities and Exchange Commission’s (SEC) new emphasis on climate and ESG disclosures. On March 4, 2021, the SEC announced the formation of a Climate and ESG Task Force in the Division of Enforcement. Soon thereafter, on March 15, 2021, the SEC announced a blueprint for reinvigorating climate and ESG-related disclosures in light of investor demand. Then SEC Chair Gary Gensler and other Commissioners released statements regarding ESG expertise on boards of directors and what form the climate and human capital disclosures may take in SEC filings. While the SEC has yet to initiate any definitive rule changes, proposed ESG rulemaking is currently on its agenda for October 2021, and its recent actions demonstrate a clear direction toward heightened sustainability reporting.
The SEC’s Climate and ESG Task Force is expected to initially focus on “identify[ing] any material gaps or misstatements in issuers’ disclosure of climate risks under existing rules,” “analyz[ing] disclosure and compliance issues relating to investment advisers’ and funds’ ESG strategies,” and pursuing whistleblower tips on ESG-related issues. In addition, according to Law360, in July 2021, SEC Acting Director of Enforcement Melissa Hodgman noted that more ESG disclosure-related enforcement actions might be coming, potentially in cases “where there was a misstatement or something that wasn’t disclosed to investors that they needed to know to make [an] investment decision.”
Where disclosures are made in this burgeoning area as companies respond to the growing demands for ESG disclosures and navigate the challenges of what to disclose and how to disclose it, litigation is sure to follow. Litigation and regulatory activity related to ESG issues has already begun to take shape and is likely to evolve in the coming months and years. Potential areas for litigation include companies’ operations and governance arrangements, reporting, and officer and director claims for breach of fiduciary duties. Companies also have been subjected to “greenwashing” claims that dispute disclosures or claims that products or processes are environmentally friendly. Some recent lawsuits have challenged climate change disclosures and whether boards have adequately monitored their companies’ food safety practices, and others have alleged breaches by directors of their duty to ensure their companies’ commitments to diversity and anti-discrimination.
Particularly when including ESG disclosures in SEC filings, companies should recognize increased liability risks and ensure that the disclosures are accurate, appropriately cautioned, consistent with the company’s statements in sustainability reports and other forums, and carefully incorporated into the company’s disclosure controls and procedures. Some companies may see claims alleging that omitting certain ESG disclosures now rises to the level of a “material omission” or that general statements about ESG achievements include “material misstatements,” particularly during offerings or other transactional activities or when there are significant fluctuations in stock prices.
Now is the time to implement disclosure controls and prepare for what is on the horizon.
*The views expressed in this article are attributable to the authors and do not necessarily reflect the views of Thompson Hine LLP or its clients. This publication is provided for educational and informational purposes only and is not intended and should not be construed as legal advice.
Jim Wedeking is Counsel to Sidley Austin LLP in the firm’s Washington, DC office.
The EPA has listed, per- and polyfluoroalkyl substances, known as “PFAS,” on a draft version of its fifth Chemical Candidate List (“CCL 5”). 86 Fed. Reg. 37,948 (July 19, 2021). PFAS, a grouping of over 4,000 synthetic organofluourine chemicals, were used in hundreds of products since the 1940s due to their ability to repel water and oil, reduce friction, and their temperature resistance. Id. at 37,962. At their zenith, PFAS chemicals could be found in firefighting foams, clothing, cosmetics, furniture, and food packaging among other products. Dubbed “forever chemicals,” PFAS chemicals resist natural breakdown and can accumulate over time. PFAS chemicals migrated from landfills, manufacturing plants, firefighting foam uses, or other sources to drinking water. See generally, EPA, Basic Information on PFAS. Lawsuits against PFAS manufacturers allege that that long-term exposure to PFAS chemicals may lead to health problems. As a result, these once obscure industrial miracle additives have led to a litany of state attorney general and personal injury suits.
Although U.S. companies voluntarily phased out PFAS production in the late 2000s, their multitudinous uses over approximately 60 years means that they are commonly found in the environment. Environmental groups and members of Congress have criticized EPA’s delay in regulating PFAS chemicals, especially the chemicals perfluorooctane sulfonic acid (“PFOS”) and perfluorooctanoic acid (“PFOA”). Formal regulation under several environmental statutes has inched along, partly due to the complex statutory processes for studying and listing substances for regulation. On July 19th, EPA took another small step towards regulating PFAS by including it in the draft of CCL 5.
How the Chemical Candidate Lists Work
The Safe Drinking Water Act (“SDWA”) authorizes EPA to establish binding limitations for contaminants in public drinking water systems called maximum contaminant levels and non-binding maximum contaminant level goals. 42 U.S.C. § 300g-1(a). But the SDWA does not specify what substances are regulated; that is EPA’s job.
Listing decisions begin, in part, with the Unregulated Contaminant Monitoring Rule. SDWA requires EPA to issue a list of no more than 30 unregulated contaminants to be monitored by public drinking water systems serving more than 10,000 people and, under certain circumstances, smaller public drinking water systems serving between 3,300 and 10,000 people. 42 U.S.C. §§ 300j-4(a)(2), (j)(1)(A). Even smaller public water systems—those serving less than 3,300 persons—are sampled on a nationally representative basis. Id. § 300j-4(j)(1)(B). The results are then considered in generating the Chemical Contaminant List. Id. § 300g-1(b)(1)(B). Of the 30 contaminants monitored under the fourth Unregulated Contaminant Monitoring Rule (called UMCR 4), 17 were included in CCL 4 and 13 in the draft CCL 5. The most recent proposed Unregulated Contaminant Monitoring Rule, published on March 11, 2021, 86 Fed. Reg. 13,846, would include 29 PFAS substances to be monitored from 2023 through 2025.
The SDWA requires EPA to publish a Chemical Contaminant List every five years. 42 U.S.C. § 300g-1(b)(1)(B)(i)(I). The CCL includes unregulated chemical or microbial contaminants that are typically known to be present in public drinking water systems regulated under the SDWA, such as through the Unregulated Contaminant Monitoring Rule. Potential candidates include hazardous substances listed under Section 101(14) of the Comprehensive Environmental Compensation Response and Liability Act (commonly known as “CERCLA”) and registered pesticides that are not regulated under the SDWA. Id. § 300g-1(b)(1)(B)(i)(II).
Once listed on a Chemical Candidate List, the candidates are evaluated based on their potential health effects and their occurrence in public water systems. 42 U.S.C. § 300g-1(b)(1)(B)(ii)(II). EPA must identify those chemicals or microbial contaminants of the greatest public health concern from exposure through drinking water. Id. § 300g-1(b)(1)(C). This includes an evaluation of sensitive populations that face greater risks from exposure, such as infants and children, pregnant women, and those with suppressed immune systems. Id. Based on this review, EPA must select at least five contaminants from the list and make a determination, positive or negative, as to whether it will begin the process of regulation. Id. § 300g-1(b)(1)(B)(ii)(I). A positive determination means that EPA must begin the process of creating maximum contaminant levels and maximum contaminant level goals for the contaminant. Id. § 300g-1(b)(1)(E).
What Inclusion on the Draft CCL 5 Means for PFAS
PFAS is only one group of chemicals on a draft list that includes two other chemical groups, 12 microbial contaminants, and 66 individual chemicals. 86 Fed. Reg. at 37,948. EPA’s proposal seeks comments on the draft CCL 5 listings, meaning that the inclusion of PFAS for further evaluation is not yet final. Once finalized, and assuming that PFAS stays on the CCL 5 list (which is likely), the chances of any particular contaminant being selected for regulation is relatively low. The CCL is only a screening tool intended to prioritize EPA’s research. Id. at 37,950. The inclusion of a contaminant on the CCL does not mean that it will be regulated, only that it will be studied. Id. Once EPA studies the listed contaminants, it must make a positive or negative determination for only five of them. The chances of PFAS receiving a positive determination is not very high based on the history of the CCL program. And even if EPA issued a positive determination, it would be several years before any PFAS regulations are final.
The first CCL, designated CCL 1 in 1998, included 50 chemical and 10 microbial contaminants or groups based on recommendations by the National Drinking Water Advisory Council. 63 Fed. Reg. at 10,274 (Mar. 2, 1998). After five years of study, EPA only had sufficient data to make a regulatory determination for nine of the 60 candidates. 68 Fed. Reg. at 42,897 (July 18, 2003). It issued a negative determination for all nine, although EPA issued non-binding guidance documents or health advisories for four of the candidates. The remaining 51 contaminants were carried over to CCL 2, released in 2005. 70 Fed. Reg. at 9,071 (Feb. 24, 2005). After three years of additional study, EPA issued another seven negative determinations with five non-binding health advisories. 73 Fed. Reg. 44,251 (July 30, 2008).
CCL 3, released in 2009, listed 104 chemical contaminants or contaminant groups and 12 microbial contaminants. 74 Fed. Reg. 51,850 (Oct. 8, 2009). EPA issued a single determination in 2011, finding that it would regulate perchlorate—the first since the CCL process began. 76 Fed. Reg. 7,762 (Feb. 11, 2011). However, the rulemaking process for regulating perchlorate inched along, culminating in a proposed rulemaking, 84 Fed. Reg. 30,524 (June 26, 2019), that was ultimately withdrawn. 85 Fed. Reg. 43,990 (July 21, 2020). As for the CCL 3, EPA had only made one out of the statutorily required five determinations. In 2016, seven years after EPA issued CCL 3, it made four negative determinations to complete the cycle. 81 Fed. Reg. 13 (Jan. 4, 2016). The remaining 99 contaminants from CCL 3, with some exceptions and new additions, carried over to CCL 4, released later in 2016. 81 Fed. Reg. 81,099 (Nov. 17, 2016). Five years later, EPA issued positive determinations for PFOA and PFOS and negative determinations for six other candidates. 86 Fed. Reg. 12,272 (Mar. 3, 2021). EPA will now embark on formulating a proposed rulemaking for public comment.
The history of the CCL illustrates how slowly EPA can move and how rarely it will determine to regulate any particular drinking water contaminant. Should EPA decide to keep PFAS on the draft CCL 5 list, the issuance of final drinking water standards, if any, are still several years away.
PFAS Drinking Water Regulations More Likely to Come from Elsewhere
Although EPA may eventually regulate PFAS under the SDWA, others will likely beat EPA to the punch. The SDWA does not preempt state drinking water standards. In fact, states are free to issue drinking water regulations more stringent than federal regulations. 42 U.S.C. § 300g-2(a)(1). Several have already set their own PFAS standards. New Jersey was the first state to do so, imposing a maximum contaminant level of 13 parts per trillion (“ppt”) for perfluorononanoic acid (“PFNA”), 14 ppt for PFOA, and 13 ppt for PFOS. Since then, Massachusetts, Michigan, New York, New Hampshire, and Vermont imposed enforceable drinking water limitations for one or more PFAS substances. Other states may also pass their own PFAS drinking water standards before EPA completes its CCR 5 review and any regulations it may undertake thereafter.
Congress may also resort to legislative action before EPA issues PFAS drinking water regulations. It already revamped SDWA in 1996 after a perceived lack of administrative action. In the intervening 25 years, EPA has made a total of three positive determinations, none of which have resulted in any actual drinking water regulations to date. H.R. 3684, a transportation spending bill called the INVEST in America Act, includes provisions that would not only award states grant money to treat PFAS contamination (Sec. 13109), but would amend the SDWA to mandate that EPA set maximum contaminant levels for PFOS and PFOA within two years and other PFAS chemicals within 18 months thereafter (Sec. 13202). This is just one of several bills in the 117th Congress that would regulate PFAS in drinking water.
The inclusion of PFAS on the draft version of CCL 5 is the first step on a long road. Should EPA eventually prescribe drinking water standards for PFAS, whether through the existing SDWA process or one amended by Congress, it would likely serve only to fill gaps where states have not already issued their own PFAS regulations. Should EPA issue its PFAS drinking water limitations, several years from now, the list of states with their own standards will likely have grown.
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—John Masslon, WLF Senior Litigation Counsel
Click here for WLF’s brief.
WASHINGTON, DC— Washington Legal Foundation (WLF) today urged the U.S. Supreme Court to hear a case in which the Ninth Circuit placed state law over federal law. In an amicus brief, WLF argues that Supreme Court review is necessary to clarify how federal preemption advances federalism principles and to vindicate Congress’s goals in passing the Federal Aviation Administration Authorization Act (FAAAA).
The case arises from a declaratory judgment action filed by owner-operator truck drivers and a trucking association. California uses the ABC test to classify workers as independent contractors or employees. Because truck drivers are key to motor carriers’ businesses, the ABC test classifies all truck drivers as employees. The plaintiffs argued that the FAAAA preempts applying the ABC test to motor carriers. The Ninth Circuit rejected this argument and held that California could apply the ABC test to motor carriers.
In its brief supporting the petitioners, WLF argues that Supreme Court review is needed to clarify how federal preemption of state laws like the ABC test advances core federalism principles. Because the States ceded power over interstate commerce to the federal government, no vertical federalism concerns arise. Preemption also advances horizontal federalism principles by stopping California from imposing its views on other States.
WLF’s brief also explains how holding that the FAAAA preempts California from applying the ABC test to motor carriers advances one of Congress’s aims in passing the preemption provision—promoting free enterprise. WLF therefore urges the Supreme Court to hear this case and remind the Ninth Circuit that federal law trumps state law.
Celebrating its 44th year, WLF is America’s premier public-interest law firm and policy center advocating for free-market principles, limited government, individual liberty, and the rule of law.
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The post If FDA Won’t Rethink Rules on Off‐Label Drug Use, Courts Should appeared first on Washington Legal Foundation.
“At a time when Texas businesses are already under tremendous economic strain, Texas trial courts should not allow the trial bar to impose additional unfair burdens.”
—Cory Andrews, WLF General Counsel & Vice President of Litigation
Click here for WLF’s brief.
(Washington, DC)—Washington Legal Foundation (WLF) today filed an amicus curiae brief urging the Texas Supreme Court to grant mandamus relief by directing the trial court to limit discovery to the threshold question of foreseeability in a major premises-liability case. WLF’s brief was prepared with the generous pro bono assistance of Allyson N. Ho and Elizabeth Kiernan of Gibson, Dunn & Crutcher LLP in Dallas.
The case arises from one of the most horrific killing sprees in U.S. history. In August 2019, a lone gunman drove 600 miles and 11 hours to massacre 23 shoppers at a random Walmart store in El Paso, Texas. The victims’ families naturally want someone to answer for that unspeakable crime; but this lawsuit unfortunately directs their sorrow and anger at the wrong target.
The law of premises liability in Texas holds that a retail store has no legal duty to protect customers from the criminal acts of others unless those acts were foreseeable. Under the Texas Supreme Court’s decision in Timberwalk Apartments, Partners, Inc. v. Cain, before a premises-liability plaintiff can subject a defendant to free-ranging and burdensome discovery, she first must show that the defendant could have reasonably foreseen her injury.
The trial court here refused to apply that principle. It derided Timberwalk as “too restrictive” and faulted the Texas Supreme Court for what it viewed as inadequate guidance. In short, it refused to apply the law. In its brief, WLF urges the Texas Supreme Court to step in now and relieve Walmart of the need to produce massive amounts of burdensome discovery unrelated to the threshold issue of foreseeability.