The First Circuit reversed the district court’s certification of a class of all purchasers of Asacol, including purchasers who had not suffered any injury attributable to Defendants’ allegedly anticompetitive behavior, holding that the district court’s approach to certifying a class was at odds with both Supreme Court precedent and the law of this circuit. Drug manufacturer Warner Chilcott Limited’s coordinated withdrawal and entry of two drugs, Asacol and the similar drug called Delzicol, precluded generic manufacturers from introducing a generic version of Asacol, which would have provided a lower-cost alternative to Warner’s drugs, Delzicol and Asacol HD. Plaintiffs filed a class action alleging violations of the consumer protection and antitrust laws of twenty-five states and the District of Columbia. The district court certified a class of all Asacol purchasers who subsequently purchased Delzicol or Asacol HD in one of those twenty-six jurisdictions, finding that while ten percent of the class had not suffered any injury, those uninjured class members could be removed in a proceeding conducted by a claims administrator. The First Circuit reversed, holding that where injury-in-fact is a required element of an antitrust action, a class cannot be certified based on an expectation that the defendant will have no opportunity to press at trial genuine challenges to allegations of injury-in-fact. View "Teamsters Union 25 Health Services & Insurance Plan v. Warner Chilcott Limited" on Justia Law
Posted in: Antitrust & Trade Regulation, Class Action, Drugs & Biotech, US Court of Appeals for the First Circuit
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
Posted in: Antitrust & Trade Regulation, Civil Procedure, Class Action, Drugs & Biotech, US Court of Appeals for the First Circuit
United Food & Commercial Workers Unions & Employers Midwest Health Benefits Fund v. Novartis Pharmaceuticals Corp.
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
Posted in: Antitrust & Trade Regulation, Drugs & Biotech, Patents, US Court of Appeals for the First Circuit
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