Justia U.S. 2nd Circuit Court of Appeals Opinion Summaries

Articles Posted in Drugs & Biotech
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Plaintiffs filed suit against Pfizer and others, alleging violations of federal securities laws because Pfizer made fraudulent misrepresentations and fraudulently omitted to disclose information regarding the safety of two of its drugs, Celebrex (celecoxib) and Bextra (valdecoxib). On appeal, plaintiffs argued that the district court abused its discretion in excluding the testimony of plaintiffs' expert regarding loss causation and damages. The court concluded that the district court abused its discretion by excluding the expert's testimony in its entirety; the district court erred in concluding that the expert needed to disaggregate the effects of Pfizer’s allegedly fraudulent conduct from Searle’s or Pharmacia’s, regardless of whether Pfizer is ultimately found liable for the latters’ statements; the testimony could have been helpful to the jury even without such disaggregation; as to the expert's adjustment to the price increases, the district court did not abuse its discretion in concluding that this change was not sufficiently reliable to be presented to a jury; the expert's error did not render the remainder of his testimony unreliable and the district court should have prevented him from testifying about the adjustment, but otherwise allowed him to present his findings on loss causation and damages; the district court erred in concluding, as a matter of law, that Pfizer had insufficient authority over certain Searle and Pharmacia statements as to have “made” them; but, however, the court's finding that the district court abused its discretion in excluding the expert's testimony does not turn on the question of Pfizer’s ultimate liability for these statements. Accordingly, the court vacated the district court's grant of summary judgment for Pfizer and remanded. View "In re Pfizer Inc. Securities Litigation" on Justia Law

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Plaintiffs filed suit under federal securities laws and state blue sky laws, alleging that Sanofi made materially false or misleading statements regarding its breakthrough drug, Lemtrada, designed to treat multiple sclerosis. The district court granted defendants' motion to dismiss for failure to state a claim. The court agreed with the district court's reasoning and holding. The court writes principally to examine the impact of the Supreme Court’s decision in Omnicare, Inc. v. Laborers District Council Construction Industry Pension Fund, decided after the district court rendered its decision. Given the sophistication of the investors here, the FDA’s public preference for double‐blind studies, and the absence of a conflict between defendants’ statements and the FDA’s comments, the court concluded that no reasonable investor would have been misled by defendants’ optimistic statements regarding the approval and launch of Lemtrada. Issuers must be forthright with their investors, but securities law does not impose on them an obligation to disclose every piece of information in their possession. As Omnicare instructs, issuers need not disclose a piece of information merely because it cuts against their projections. Accordingly, the court affirmed the judgment. View "In re Sanofi Sec. Litig." on Justia Law

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Plaintiff, a physician and airplane pilot, filed suit contending that LabCorp and other drug testing companies, engaged to administer a random drug test in accordance with federal regulations governing aviation safety, mishandled the test. The court reserved decision and certified the following questions to the New York Court of Appeals: whether drug testing regulations and guidelines promulgated by the FAA and DOT create a duty of care for drug testing laboratories and program administrators under New York negligence law; and whether a plaintiff may establish the reliance element of a fraud claim under New York law by showing that a third party relied on a defendantʹs false statements resulting in injury to the plaintiff. View "Pasternack v. Laboratory Corporation" on Justia Law

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Plaintiffs, three health-benefit plans (HBPs), filed suit under the Racketeer Influenced and Corrupt Organizations Act (RICO), 18 U.S.C. 1961 et seq., and state laws, claiming that Aventis engaged in a pattern of mail fraud by failing to disclose the true risks of the antibiotic drug telithromycin, marketed as “Ketek.” The district court denied plaintiffs' motion to certify a class of all HBPs that paid for Ketek prescriptions on the theory that such HBPs were injured as a result of paying for Ketek prescriptions that would not have been written if Aventis had not concealed Ketek’s safety risks. The court concluded that UFCW Local 1776 v. Eli Lilly & Co. (Zyprexa) does not foreclose class certification for all RICO mail‐fraud claims brought against a drug manufacturer. However, the court concluded that Zyprexa’s reasoning applies to this case, and bars plaintiffs’ attempt to certify a class. While it may be possible for a class of plaintiffs to prove the causation element of a pharmaceutical fraud claim such as this one with generalized proof, plaintiffs have failed to offer such proof here. Therefore, class certification was correctly denied. The court's certification decision necessarily disposes of the summary judgment question as well: if plaintiffs’ RICO claims cannot be proved by generalized proof and plaintiffs have adduced no individualized proof, plaintiffs' claims cannot survive summary judgment. Further, the court agreed with the district court’s dismissal of the state‐law claims. Accordingly, the court affirmed the judgment. View "Sergeants Benevolent Ass'n v. Sanofi-Aventis US" on Justia Law

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Gnosis appealed the district court's entry of judgment in favor of Merck on its Lanham Act, 15 U.S.C. 1125(a), false advertising and contributory false advertising claims; award to Merck of damages, attorneys' fees and costs, and prejudgment interest; and order that Gnosis engage in a corrective advertising campaign. Merck had filed suit against Gnosis, claiming misleading advertising in connection with its use of the pure Isomer Product chemical name and properties in its marketing materials for Extrafolate. At issue on appeal was the court's false advertising jurisprudence. The court concluded that where, as here, the parties operate in the context of a two-player market and literal falsity and deliberate deception have been proved, it is appropriate to utilize legal presumptions of consumer confusion and injury for the purposes of finding liability in a false advertising case brought under the Lanham Act; in a case where willful deception is proved, a presumption of injury may be used to award a plaintiff damages in the form of defendant's profits, and may, in circumstances such as those presented here, warrant enhanced damages; and, therefore, the court affirmed the judgment of the district court. View "Merck Eprova AG v. Gnosis S.P.A." on Justia Law

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Plaintiff filed a complaint seeking damages and injunctive relief, alleging that defendants violated, inter alia, the Lanham Act, 15 U.S.C. 1125(a)(1), and New York General Business Law 349 when defendants published a scientific article reporting research results related to plaintiff's production of surfactants. The court concluded that, as a matter of law, statements of scientific conclusions about unsettled matters of scientific debate could not give rise to liability for damages sounding in defamation. The court also concluded that the secondary distribution of excerpts of such an article could not give rise to liability, so long as the excerpts did not mislead a reader about the conclusions of the article. Therefore, the district court correctly concluded that plaintiff failed to state a claim based on publication of the article itself because the challenged statements were protected scientific opinion and plaintiff failed to adequately allege that defendants Chiesi and Cornerstone distributed misleading excerpts of the article. Accordingly, the court affirmed the judgment. View "ONY, Inc. v. Cornerstone Therapeutics, Inc." on Justia Law

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Plaintiff brought a putative class action against defendants, alleging that defendants violated Section 10(b) and Section 20(a) of the Securities and Exchange Act of 1934, 15 U.S.C. 78u-4(b)(2)(A), by issuing a misleading press release concerning the results of a clinical trial for a drug called bapineuzumab. Plaintiff appealed from the district court's dismissal of his amended complaint with prejudice for failure to state a cause of action under Rule 12(b)(6) and denying leave to amend. The court concluded that, in the context of the full presentation of the details surrounding the study of the drug, nothing omitted from the press release rendered it false or misleading to a reasonable investor. Moreover, the court held that plaintiff offered insufficient additional allegations to cure this deficiency. Accordingly, the court affirmed the judgment of the district court. View "Kleinman v. Elan Corp., PLC" on Justia Law

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Plaintiff appealed from the district court's grant of summary judgment in favor of Merck and the dismissal of her products liability claim for failure to provide an adequate warning regarding the risks associated with Fosamax. Fosamax has allegedly been linked to osteonecrosis of the jaw and plaintiff claimed that Merck should have known of a possible link between the drug and the condition. At issue was whether the district court erred in granting Merck's summary judgment motion after discrediting expert testimony from plaintiff's treating physician. Because the physician's expert testimony contained contradictions that were unequivocal and inescapable, unexplained, arose after the motion for summary judgment was filed, and were central to plaintiff's failure-to-warn claim, the court held that the district court did not err in determining that there was no genuine dispute of material fact raised by the later testimony. View "In Re: Fosamax Products Liability Litigation" on Justia Law

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Kentucky commenced this action in Kentucky state court against Purdue, alleging that Purdue violated Kentucky law by misleading health care providers, consumers, and government officials regarding the risks of addiction associated with the prescription drug OxyContin, which Purdue manufactures, markets, and sells. Following transfer from the Eastern District of Kentucky to the Southern District of New York, the district court granted Kentucky's motion to remand, concluding that it lacked subject-matter jurisdiction because the suit did not meet the Class Action Fairness Act of 2005's (CAFA), Pub. L. No. 109-2, 119 Stat. 4, requirements. Purdue appealed the remand order under 28 U.S.C. 1453(c)(1). The court held that the district court correctly determined that Kentucky's action was not a class action as defined in CAFA, and therefore the case was properly remanded. Accordingly, the petition for leave to appeal was denied. View "Purdue Pharma, L. P. v. Commonwealth of Kentucky" on Justia Law

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Defendant appealed from a conviction of conspiracy to introduce a misbranded drug into interstate commerce, a misdemeanor violation of 21 U.S.C. 331(a) and 333(a)(1). Defendant, a pharmaceutical sales representative, promoted the drug Xyrem for "off-label use." The court agreed with defendant that he was convicted for his speech -- for promoting an FDA-approved drug for off-label use -- in violation of his right of free speech under the First Amendment. The court limited its holding to FDA-approved drugs for which off-label use was not prohibited. Accordingly, the court vacated and remanded. View "United States v. Caronia" on Justia Law