Justia Civil Procedure Opinion Summaries

The Cervenys sued the manufacturer of Clomid (Aventis, Inc.), asserting various tort claims under Utah law: failure to warn under theories of strict liability and negligence, breach of implied warranty, negligent misrepresentation, and fraud. They presented two theories, pointing to two types of warning labels that Aventis had allegedly failed to provide: (1) a label that warned of risks to the fetus when a woman takes Clomid before becoming pregnant; and (2) a label that unmistakably warned about harm to the fetus when Clomid is taken during pregnancy. The district court rejected the Cervenys’ claims based on preemption. The Tenth Circuit held that the district court ruling was correct on the Cervenys’ first theory, because the undisputed evidence showed that the FDA would not have approved a warning about taking Clomid before pregnancy. But on the second theory, the Tenth Circuit found the district court did not explain why a state claim based on the FDA’s own proposed language would be preempted by federal law. The district court also erred in failing to distinguish the remaining claims (breach of implied warranty, negligent misrepresentation, and fraud) from the failure-to-warn claims. These claims are based at least partly on affirmative misrepresentations rather than on a failure to provide a warning. The district court failed to explain why claims involving affirmative misrepresentations would have been preempted. View "Cerveny v. Aventis, Inc." on Justia Law

The consolidated appeals involve allegations that the companies holding the patents for Lipitor and Effexor XR delayed entry into the market by generic versions of those drugs by engaging in an overarching monopolistic scheme that involved fraudulently procuring and enforcing the underlying patents and then entering into a reverse-payment settlement agreement with a generic manufacturer. In 2013, the Supreme Court recognized that reverse payment schemes can violate antitrust laws and that it is normally not necessary to litigate patent validity to answer the antitrust question. The district judge dismissed most of plaintiffs’ claims. The Third Circuit remanded after rejecting an argument that plaintiffs’ allegations required transfer of the appeals to the Federal Circuit, which has exclusive jurisdiction over appeals from civil actions “arising under” patent law, 28 U.S.C. 1295(a)(1). Not all cases presenting questions of patent law necessarily arise under patent law; here, patent law neither creates plaintiffs’ cause of action nor is a necessary element to any of plaintiffs’ well-pleaded claims. The court remanded one of the Lipitor appeals, brought by a group of California pharmacists and involving claims solely under California law, for jurisdictional discovery and determination of whether remand to state court was appropriate. View "In re: Lipitor Antitrust Litigation" on Justia Law

The district court certified eight classes, consisting of persons in Illinois and Missouri who take eye drops manufactured by six pharmaceutical companies for treatment of glaucoma. Plaintiffs claimed that the defendants’ eye drops are unnecessarily large and wasteful, in violation of the Illinois Consumer Fraud Act, 815 ILCS 505/1, and the Missouri Merchandising Practices Act, Mo. Rev. Stat. 407.010, so that the price of the eye drops is excessive and that the large eye drops have a higher risk of side effects. There was no claim that members of the class have experienced side effects or have been harmed because they ran out of them early. The Seventh Circuit vacated with instructions to dismiss. The court noted possible legitimate reasons for large drops, the absence of any misrepresentation or collusion, and that defendants’ large eye drops have been approved by the FDA for safety and efficacy. “You cannot sue a company and argue only ‘it could do better by us,’” nor can one bring a suit in federal court without pleading that one has been injured. The plaintiffs allege only “disappointment.” View "Eike v. Allergan, Inc." on Justia Law

In July 2003, plaintiff Andrew McCarrell filed a products-liability action alleging that Hoffmann-La Roche, Inc. (Roche) had failed to provide adequate warnings about the risks and side effects associated with taking Accutane. Plaintiff timely filed this products-liability action within New Jersey's statute of limitations, but Alabama's limitations period had expired by the time of the filing. The issue is which state's statute of limitations applied under New Jersey s choice-of-law jurisprudence. Roche moved for summary judgment, citing Alabama's two-year statute of limitations. The trial court denied the motion, finding that the governmental-interest test set forth in "Gantes v. Kason Corp.," (145 N.J.478 (1996)), directed that New Jersey's statute of limitations governed the case. The jury found in favor of McCarrell on the failure-to-warn claim, but the Appellate Division reversed based on evidentiary issues. The Appellate Division approved the trial court's application of New Jersey's statute of limitations to the case, however, and the Court denied Roche's petition for certification. After a new trial, a jury found Roche liable for failure to warn, awarding McCarrell $25,159,530. Roche challenged the verdict on the ground that the governmental-interest test had been supplanted by the most-significant-relationship test of sections 146, 145, and 6 of the Second Restatement of Conflicts of Law and argued that, under this test, Alabama's statute of limitations applied. The trial court denied the challenge as untimely. An appellate panel expressly declined to apply section 142 of the Second Restatement, vacated the jury's verdict and award, dismissed McCarrell's complaint as untimely, and did not reach the remaining issues raised by Roche on appeal. McCarrell's petition for certification was granted. The Supreme Court reversed and reinstated the jury's verdict and award. Analysis under section 142 of the Second Restatement lead to the conclusion that New Jersey's statute of limitations was properly applied to this action. The matter was remanded to the Appellate Division for consideration of unaddressed issues remaining on appeal. View "McCarrell v. Hoffmann-La Roche, Inc." on Justia Law

The 856 patent generally relates to “huMab4D5 ANTI-ErbB2 antibody-maytansinoid conjugates.” The claimed methods of treatment purport to combat a variety of cancers. ImmunoGen provided Genentech with a “worldwide exclusive license,” which Genentech uses to produce the drug Kadcyla®TM. Phigenix, “a for-profit discovery stage biotechnology, pharmaceutical, and biomedical research company” that focuses “on the use of novel molecular therapeutics” designed to fight cancer, sought inter partes review. The Patent Board found the asserted claims of the 856 patent nonobvious. The Federal Circuit dismissed an appeal for lack of standing, finding that Phigenix has not offered sufficient proof establishing that it has suffered an injury in fact. Phigenix does not contend that it faces risk of infringing the 856 patent, that it is an actual or prospective licensee of the patent, or that it otherwise plans to take any action that would implicate the patent. Phigenix only claimed that it has suffered an actual economic injury because the 856 patent increases competition between itself and ImmunoGen; “‘[i]ncreased competition represents a cognizable Article III injury,’” View "Phigenix, Inc. v. Immunogen, Inc." on Justia Law

Plaintiff filed filed a qui tam action against a corporation and its subsidiary, both of whom manufacture and market medical devices, alleging that Defendants violated the False Claims Act in selling two particular medical devices to hospitals that seek reimbursement from the federal government through, for example, the Center for Medicare and Medicaid Services. Through two subsequent amendments, both with permission of the court, Plaintiff added several defendants and retooled his claims. Plaintiff then requested leave to amend fourth amended complaint. The district court applied the “good cause” standard from Fed. R. Civ. P. 16(b) to that request and struck the amended complaint. The First Circuit originally held that the district court should have evaluated Plaintiff’s fourth amended complaint under the standard set forth in Fed. R. Civ. P. 15(a). On remand, the district court concluded that Plaintiff’s desired amendment failed under that standard. The First Circuit affirmed, holding that Plaintiff’s request for leave to file his fourth amended complaint was properly denied as futile because none of the claims in Plaintiff’s fourth amended complaint was adequately pled. View "D'Agostino v. EV3, Inc." on Justia Law

Wagner, a licensed attorney proceeding pro se, took both brand‐name and generic hormone therapy drugs as prescribed by her gynecologist to treat her post‐menopausal endometrial hyperplasia. After taking the drugs, Wagner developed breast cancer. Wagner sued multiple pharmaceutical companies that designed, manufactured, promoted and distributed the drugs she took, asserting Wisconsin state law tort claims, all based upon allegations that the defendants sold dangerous products and failed to adequately warn of their risks. Defendants moved for Rule 12(c) judgment on the pleadings, arguing that federal law preempted Wagner’s claims. In response, Wagner asserted, for the first time, that the defendants delayed updating their generic brand labels to match the updated, stricter labels on the brand‐name drug. The district judge granted the motion, finding that the Food, Drug, and Cosmetics Act, 21 U.S.C. 301, preempted the state law claims. The Seventh Circuit affirmed: Wagner’s complaint lacked the requisite factual allegations to support a failure to update theory and federal law preempts her Wisconsin state‐law claims. View "Wagner v. Teva Pharmaceuticals USA, Inc." on Justia Law

Hartig filed a putative class action, alleging antitrust violations involving medicated eyedrops manufactured by the Defendants. Hartig claimed that the Defendants’ wrongful suppression of generic competition resulted in supracompetitive pricing of those eyedrops. Although not a direct purchaser of the medications, Hartig claimed it had standing to sue because of an assignment of rights from Amerisource, a direct purchaser. The district court dismissed for lack of subject matter jurisdiction, finding that an anti-assignment clause in a distribution agreement between Allergan (the assignee of the named inventors) and Amerisource barred any assignment of antitrust claims from Amerisource to Hartig. The Third Circuit vacated; the district court erred in treating antitrust standing as an issue of subject-matter jurisdiction. The court distinguished between Article III standing and antitrust standing and stated that, when the correct procedures are followed, the court may consider the impact of the anti-assignment clause. View "Hartig Drug Co., Inc v. Senju Pharma. Co., Ltd" on Justia Law

Eight separate complaints were filed in San Francisco Superior Court by or on behalf of 678 individuals. Eighty-six of those individuals were California residents and the remainder were nonresidents. All of the plaintiffs were allegedly prescribed Plavix, a drug created and marketed by Bristol-Myers Squibb Company (BMS), and allegedly suffered adverse consequences. BMS, which conducts significant business and research activities in California but is neither incorporated nor headquartered in the state, moved to quash service of summons on the ground that the court lacked personal jurisdiction over it to adjudicate the claims of the nonresident plaintiffs. The superior court denied BMS’s motion. BMS petitioned the Court of Appeal for a writ of mandate, naming the nonresident plaintiffs as real parties in interest. The Court of Appeal denied the writ, concluding that BMS was subject to the personal jurisdiction of the California courts on the basis of specific jurisdiction. The Supreme Court affirmed, holding that, in light of BMS’s extensive contacts with California, courts may exercise specific personal jurisdiction over the nonresident plaintiffs’ claims in this action, which arise from the same course of conduct that gave rise to the California plaintiffs’ claims. View "Bristol-Myers Squibb Co. v. Superior Court of San Francisco County" on Justia Law

Xolair, an injected drug approved by the FDA for treating allergies, is co-promoted in the United States by Genentech, Inc. and Roche Holdings, Inc. (Genentech) and Novartis Pharmaceuticals Corp. and Novartis Corp. (Novartis). Relators brought qui tam actions against Genentech and Novartis under the False Claims Act (FCA) and related state statutes, alleging that Defendants caused healthcare providers to submit false claims to the government for reimbursement for Xolair. The district court dismissed the federal claims with prejudice and then declined to exercise jurisdiction over the state-law claims and dismissed those claims with prejudice. The First Circuit affirmed in part and vacated in part, holding that the district court (1) did not abuse its discretion in denying Relators’ motion to amend; (2) did not err in dismissing the federal claims with prejudice; and (3) erred in dismissing the pendant state-law claims with prejudice. Remanded. View "Garcia v. Novartis Pharms. Corp." on Justia Law