Justia U.S. 1st Circuit Court of Appeals Opinion Summaries

The First Circuit held that federal law requires prior FDA approval for a manufacturer of prescription eye drops to change the medication’s bottle so as to alter the amount of medication dispensed into the eye, and therefore, state law claims challenging the manufacturers’ refusal to make this change are preempted.Plaintiff sued in federal court on their own behalf and on behalf of a putative class of prescription eye solution purchasers, asserting that Defendants deliberately designed their dispensers to emit unnecessarily large drops. Plaintiffs alleged that Defendants’ practice was “unfair” under Massachusetts state law and twenty-five other states and allied claims for unjust enrichment and for “money had and received.” The district court dismissed the complaint without ruling on the merits, finding that FDA regulations preempted Plaintiffs’ suit. The First Circuit affirmed, holding (1) changing a product bottle so as to dispense a different amount of prescription eye solution is a “major change” under 21 C.F.R. 314.70(b); and (2) therefore, Plaintiffs’ state law claims were preempted. View "Gustavsen v. Alcon Laboratories, Inc." on Justia Law

In these consolidated appeals from orders dismissing two putative antitrust class actions, the First Circuit affirmed the judgment of the district court holding that purchasers of a brand-name prescription drug had not plausibly alleged that either exception to Noerr-Pennington immunity applied to the alleged conduct of the drug maker and, on that basis, dismissing the putative class actions for failure to state a claim.Plaintiffs filed these antitrust actions alleging that Defendant unlawfully delayed the entry of generic versions of the drug at issue into the United States market by a fraud on the United States Patent and Trademark Office. Defendant moved to dismiss the actions, arguing that there was no fraud and claiming that it was immune from antitrust liability based on the Noerr-Pennington doctrine. See United Mine Workers of America v. Pennington, 381 U.S. 657 (1965). The district court dismissed the putative class actions under Fed. R. Civ. P. 12(b)(6), concluding that Noerr-Pennington immunity applied to Defendant’s alleged conduct and that the two exceptions to the immunity did not apply here. The First Circuit affirmed, holding that there was no reason to disturb the district court’s ruling dismissing Plaintiffs’ antitrust suits for failure to state a claim. View "United Food & Commercial Workers Unions & Employers Midwest Health Benefits Fund v. Novartis Pharmaceuticals Corp." on Justia Law

The First Circuit agreed with the judgment of the district court that the facts in this case alleging unlawful monopolization could not subject San Juan Cable LLC, doing business as “OneLink,” to liability under the so-called “sham” exception to the Noerr-Pennington immunity.Puerto Rico Telephone Company (PRTC) sought permission from the Puerto Rico Telecommunications Regulatory Board (TRB) to offer internet protocol television services to Puerto Rico residents. OneLink, which provided cable television service to residents of several municipalities in Puerto Rico, petitioned the TRB and other governmental tribunals and officials, to impede PRTC’s efforts. PRTC eventually obtained the requested permission from the TRB. Thereafter, PRTC filed this antitrust action claiming that OneLink’s interference with its permitting efforts constituted unlawful monopolization and attempted monopolization. The district court granted summary judgment to OneLink, concluding that OneLink’s actions were immune from suit under the Noerr-Pennington doctrine, which conditionally protects the right to petition the government. On appeal, PRTC argued that the facts could support a finding that OneLink abused its right to petition and could be found liable under the sham exception to Noerr-Pennington immunity. The First Circuit affirmed, holding that the facts in this case could not subject OneLink to liability under the sham exception. View "Puerto Rico Telephone Co. v. San Juan Cable LLC" on Justia Law

Arabian Support & Services Co. (ASASCO), a Saudi Arabian business, sought compensation for assisting Textron Systems Corporation in its pursuit of a weapons deal in Saudi Arabia. ASASCO claimed that Textron backed away from its promises to supplement the modest fees paid under the parties’ written consulting agreements through an “offset” arrangement linked to the weapons sale. ASASCO’s complaint alleged breach of contract, tortious interference with ASASCO’s business and contractual relationship, and violations of Chapter 93A, the Massachusetts Deceptive Trade Practices Act. After limited discovery, the district court granted summary judgment for Textron on all of ASASCO’s claims. The First Circuit vacated the summary judgment in part, holding that the district court erred in dismissing ASASCO’s Chapter 93A misrepresentation claim based solely on the failure of the contract claim. Remanded for further proceedings on ASASCO’s misrepresentation theory. View "Arabian Support & Services Co. v. Textron Systems Corp." on Justia Law

Amphastar Pharmaceuticals Inc. and its wholly owned subsidiary (collectively, Amphastar) and Sandoz Inc. were competitors in the U.S. market for generic enoxaparin, an anticoagulant. Momenta Pharmaceuticals Inc. served as Sandoz’s contract laboratory. Amphastar filed a complaint alleging antitrust violations by Sandoz and Momenta based on Defendants’ alleged misrepresentations to the United States Pharmacopeial Convention, a private standard-setting organization charged with ensuring the quality of drugs. Defendants brought an infringement suit against Amphastar, resulting in a temporary restraining order (TRO) and preliminary injunction prohibiting Amphastar from selling enoxaparin. The preliminary injunction was later vacated, but it did prevent Amphastar from selling its generic enoxaparin for approximately three months. Amphastar then filed this suit under the Sherman Act seeking damages for lost profits during the pendency of the TRO and injunction. The district court dismissed the complaint under the Noerr-Pennington doctrine, which immunizes good-faith petition of government entities from antitrust liability. The First Circuit reversed, holding that the district court erred in applying Noerr-Pennington. Remanded for the district court to consider Defendants’ other arguments in the first instance. View "Amphastar Pharmaceuticals, Inc v. Momenta Pharmaceuticals, Inc." on Justia Law

In 2009, Pfizer, settled claims that it had violated the False Claims Act (FCA), 31 U.S.C. 3729, and entered into a Corporate Integrity Agreement with the U.S. Department of Health and Human Services. Months later, Booker and Hebron, former Pfizer sales representatives, brought a qui tam action, allegedly on behalf of the United States and several states, asserting that Pfizer had continued to violate the FCA and state analogues. They alleged that Pfizer had continued to knowingly induce third parties to file false claims for payment for Pfizer drugs with government programs like Medicaid by marketing the drug Geodon for off-label uses, in violation of 21 U.S.C. 301, and paying doctors kickbacks for prescribing the drugs Geodon and Pristiq, in violation of the Anti-Kickback Statute, 42 U.S.C. 1320a-7b(b), (g). They also alleged that Pfizer had violated the FCA "reverse false claims" provision, 31 U.S.C. 3729(a)(1)(G), by failing to pay the government money owed it under Pfizer's Agreement with HHS, and that Pfizer had violated the FCA's anti-retaliation provision, by terminating Booker's employment. All of these claims were resolved against relators, one on a motion to dismiss and the rest on summary judgment. None of the sovereigns intervened. The First Circuit affirmed the merits decisions and found no error in its management of discovery. The court found relators’ data “woefully inadequate to support their FCA claim.” View "Booker v. Pfizer, Inc." on Justia Law

AstraZeneca, a drug manufacturer that owns the patents covering Nexium, a prescription heartburn medication, sued Ranbaxy for patent infringement after Ranbaxy announced that it sought to market a generic version of Nexium. The two companies reached a settlement agreement under which Ranbaxy agreed to delay the launch of its generic until a certain date in return for various promises from AstraZeneca. Plaintiffs - pharmaceutical retail outlets and certified classes of direct purchasers and end payers - filed suit, arguing that the terms of the settlement agreements violated federal antitrust laws and state analogues. The jury found that although Plaintiffs had proved an antitrust violation, Plaintiffs had not shown that they suffered an antitrust injury that entitled them to damages. The First Circuit affirmed, holding (1) the district court did not commit reversible error in its evidentiary rulings, the formulation of the special verdict form and jury instructions, or its judgment as a matter of law on overarching conspiracy; and (2) the jury verdict rendered harmless any error that may have occurred during the summary judgment proceedings. View "In re Nexium Antitrust Litigation" on Justia Law

Evergreen Partnering Group, Inc. processed used polystyrene products into a recycled polystyrene resin, which it sold to converters to use in a “green foam” line of products. Evergreen sued Defendants - the five largest converters of polystyrene products and a trade association - arguing that Defendants illegally agreed to refuse to deal with Evergreen in order to prevent polystyrene recycling from becoming viable and to maintain their market positions. The district court entered summary judgment in favor of Defendants, concluding that Evergreen failed to present evidence that tended to exclude the possibility that each polystyrene manufacturer independently chose not to partner with Evergreen as required by caselaw. The First Circuit affirmed, holding that no genuine issue of material fact existed as to whether there was a conspiracy. View "Evergreen Partnering Group v. Pactiv Corp." on Justia Law

John Fanning founded Jerk LLC (Jerk) and Jerk.com in 2009. From 2009 to 2014, Jerk operated Jerk.com. In 2014, the Federal Trade Commission (Commission) filed an administrative complaint charging Jerk and Fanning with engaging in deceptive acts or practices in or affecting commerce in violation of the Federal Trade Commission Act. The Commission entered a summary decision finding Fanning personally liable for misrepresentations contained on Jerk.com. Fanning petitioned for review. The First Circuit (1) affirmed the Commission’s finding of liability and the recordkeeping provisions and order acknowledgement requirement of the Commission’s remedial order; but (2) vacated Fanning’s compliance monitoring provisions, holding that these provisions were overbroad and not reasonably related to Fanning’s violation. View "Fanning v. Fed. Trade Comm'n" on Justia Law

Flovac, Inc. and Airvac, Inc. both fabricate vacuum sewer systems. Flovac filed suit against Airvac seeking relief under both federal and Puerto Rico antitrust laws and alleging that Airvac’s conduct in marketing its vacuum sewer systems was anticompetitive. Flovac also brought claims of tortious interference with advantageous economic relations under Puerto Rico’s general tort statute. The district court granted summary judgment in favor of Airvac on all claims. The First Circuit affirmed, holding (1) because the summary judgment record disclosed a relevant market much broader than Flovac claimed and a market where Defendant lacked market dominance, summary judgment was properly granted on Flovac’s antitrust claims; and (2) Flovac’s claim of tortious interference with advantageous economic relations was time-barred. View "Flovac, Inc. v. Airvac, Inc." on Justia Law