D.C. Circuit Affirms EPA’s PFAS CERCLA Designation, Denies Industry Oppositions
WASHINGTON, D.C. — Ruling that the U.S. Environmental Protection Agency “adequately considered and reasonably explained” a decision to uphold a final rule adding two widely used per- and polyfluoroalkyl substances (PFAS) to the list of hazardous substances covered by the Comprehensive Environmental Response, Compensation, and Liability Act, a District of Columbia Circuit U.S. Court of Appeals panel denied five consolidated petitions filed by the U.S. Chamber of Commerce and six trade associations seeking to overturn the designation due to various alleged errors.
Split 9th Circuit Reinstates FCA Claims As To Regeneron, Affirms Sanofi Dismissal
SAN FRANCISCO — A split Ninth Circuit U.S. Court of Appeals on Aug. 19 found that a lower court erred in dismissing False Claims Act (FCA) claims against Regeneron Pharmaceuticals Inc. because claims that the company violated the Anti-Kickback Statute (AKS) by paying physicians to prescribe its drugs were adequately pleaded; the court affirmed dismissal of the FCA conspiracy claim against Regeneron and dismissal of all claims against Sanofi Aventis US LLC.
Ga. High Court Clarifies Equitable Relief Without Opining On Medical Monitoring
ATLANTA — After considering two questions certified from a federal court in Georgia, the Georgia Supreme Court determined that exposure to a toxic substance without a present physical injury does not foreclose equitable relief, which instead turns on whether the plaintiff suffered any “legally cognizable injury” and the absence of an adequate remedy at law; however, the state high court did not rule on how this principle applied to the underlying conflict involving a toxic plume released from a chemical plant.
11th Circuit Talks Comparisons, Revives Imprudence Case Over Target Date Funds
ATLANTA — Saying in part that “some of the most objectively imprudent investments will lack an apples-to-apples comparison precisely because they are such objectively bad fiduciary decisions,” the 11th Circuit U.S. Court of Appeals revived an Employee Retirement Income Security Act class action focused on target-date funds (TDFs) that are proprietary to the investment manager of the retirement plan at issue.
FDA Ordered To Reconsider Whether Braille-Free Label Meets ‘Same As’ Requirement
WASHINGTON, D.C. — The District of Columbia Circuit U.S. Court of Appeals held that a district court erred in part in rejecting Vanda Pharmaceuticals Inc.’s challenge to the U.S. Food and Drug Administration’s approval of labeling for generic tasimelteon and directed the court to remand the matter to the agency without vacating the approval.
D.C. Circuit: Copyright Royalty Board Ruling Not Appealable Determination
WASHINGTON, D.C. — A District of Columbia Circuit U.S. Court of Appeals panel determined that a music service failed to establish jurisdiction for its challenge to the Copyright Royalty Board’s interpretation of licensing requirements, leaving it up to a District of Columbia federal judge to determine “what weight, if any, to assign to the Royalty Board’s non-binding regulatory interpretation” in an underlying royalties dispute.
Obviousness Of Nielsen’s Patent Claims Affirmed By Federal Circuit
WASHINGTON, D.C. — Substantial evidence supported the U.S. Patent Trial and Appeal Board’s (PTAB) finding that a publication describing facial-analysis research was analogous prior art, a Federal Circuit U.S. Court of Appeals panel held, affirming PTAB’s decision that claims of a patent held by television research entity Nielsen Co. (US) LLC were unpatentable as obvious.
Sanctions, Discovery Requests Denied In Dispute Over ‘Defective’ COVID Tests
NEWARK, N.J. — A New Jersey federal judge denied both parties’ requests for sanctions and affirmed a magistrate judge’s order denying the parties’ discovery requests in a breach of contract suit against a COVID-19 test manufacturer and supplier over alleged defective tests, finding that the magistrate judge correctly denied reopening discovery and that sanctions were not merited.
2nd Circuit: No New Evidence Of Falsity Of Agreement In Beverage IP Row
NEW YORK — A Second Circuit U.S. Court of Appeals panel on Aug. 18 affirmed a New York federal judge’s denial of beverage markers’ motion to vacate a bench trial finding in defendants-appellees’ favor in a dispute over beverage trademarks; the panel agreed that the plaintiff-appellant entities provided no new evidence that the judge was misled by a fraudulent account about a disputed operating agreement.
Judge Confirms Chapter 11 Plan For Ship Subcontractor Hopeman Brothers
RICHMOND, Va. — A Virginia federal judge on Aug. 18 confirmed a plan of reorganization for defunct ship subcontractor and Chapter 11 debtor Hopeman Brothers Inc. that establishes an asbestos personal injury trust that will be funded by nearly $50 million from the company’s insurers and by the debtor’s remaining assets.
7th Circuit Affirms Ruling Tossing FCA Suit Alleging Medicare Prescription Fraud
CHICAGO — The Seventh Circuit U.S. Court of Appeals affirmed a lower court ruling dismissing a relator’s complaint alleging violations of the False Claims Act (FCA), finding that the relator failed to plead with particularity the allegations regarding submitting claims to Medicare based on fraudulent prescriptions and that the complaint failed “to allege materiality.”