Justia Drugs & Biotech Opinion Summaries

Plaintiff sued OMJP and others for failing to warn adequately of the risk of tendon rupture in patients who, like plaintiff, were elderly and taking concomitant corticosteroids. A jury found OMJP primarily liable, awarding plaintiff compensatory and punitive damages. OMJP appealed the district court's denial of its motions for judgment as a matter of law (JMOL) and a new trial. The court held that the district court did not err in denying OMJP's motions for JMOL or a new trial based on the jury's award of compensatory damages where the district court found sufficient evidence of causation, reasoning that the jury finding was not against the preponderance of the evidence. The evidence was neither clear nor convincing, as a matter of law, that OMJP deliberately disregarded the safety of the users of Levaquin. Accordingly, the district court erred in denying JMOL for OMJP on punitive damages. View "Schedin v. Ortho-McNeil-Janssen Pharmaceuticals, Inc." on Justia Law

Plaintiffs, groups of investors who purchased the securities of KV, brought this class action lawsuit alleging that KV and some of its individual officers committed securities fraud. Plaintiffs alleged that KV made false or misleading statements about its compliance with Food and Drug Administration (FDA) regulations governing the manufacture of pharmaceutical products, and made false or misleading statements about earnings resulting from pharmaceutical products allegedly manufactured in violation of FDA regulations. The court concluded plaintiffs' complaint adequately set forth the reasons why KV's statements about is compliance were false, or at least misleading, at the time they were made; the district court did not err when it determined the investors' complaint did not sufficiently plead that KV made false or misleading statements about earnings tied to the manufacture of generic Metoprolol; the district court correctly dismissed the scheme liability claims against the two individual KV officers; but the district court erred in denying the motion to amend the complaint. Accordingly the court affirmed in part, reversed in part, and remanded for further proceedings. View "Public Pension Fund Group, et al. v. KV Pharmaceutical Co., et al." on Justia Law

Plaintiff filed suit against BIP alleging tort claims based upon BIP's marketing and sales of pramiprexole, a drug commonly prescribed as Mirapex. Plaintiff took Mirapex from 2002 to 2007 to treat symptoms of Restless Leg Syndrome. Plaintiff alleged that his use of Mirapex caused compulsive behaviors, such as gambling and hypersexuality. BIP moved for summary judgment, which the district court granted and plaintiff subsequently appealed. The court held that the district court correctly determined that plaintiff's claims accrued as of October 2007, and thus the statute of limitations period began to run at that time; with the exception of the strict liability claim, the court did not need to address plaintiff's argument that longer statute of limitations periods applied because he waived this argument on two occasions; and Nevada's two-year personal injury statute of limitations period applied to the strict liability claim. Accordingly, the court affirmed the judgment. View "Ridenour, et al. v. Boehringer Ingelheim Pharmaceuticals, Inc., et al." on Justia Law

Plaintiffs, citizens of New York, sued pharmaceutical companies (defendants) in New York state court claiming that defendants' hormone replacement therapy drugs caused plaintiffs to develop breast cancer. At issue was whether dismissal of plaintiffs' actions as time-barred under New York law precluded assertion of the same claims in a federal court diversity action in a State where the claims would not be time-barred. The court held that under New York claim preclusion law as articulated in Smith v. Russell Sage College and the many New York appellate decisions applying Russell Sage, the prior grant of summary judgment dismissing plaintiffs' New York claims as time-barred precluded the assertion of the same claims in these federal diversity actions in Minnesota. Therefore, the district court properly applied the Full Faith and Credit Statute in these cases, even if the New York Court of Appeals declined in the future to apply statute-of-limitations claim preclusion to more sympathetic plaintiffs. View "Rick, et al. v. Wyeth, Inc., et al." on Justia Law

Defendant was found guilty of two federal offenses: one count of aiding and abetting a violation of the so-called Medicare anti-kickback statute, in violation of 42 U.S.C. 1320a-7b(b)(2) and 18 U.S.C. 2, and one count of aiding and abetting the falsification of a document, in violation of 18 U.S.C. 1519 and 2. Defendant raised several claims on appeal. The court held that the district court did not err in admitting testimony concerning statements made by defendant's wife during her interview with the FBI; in admitting evidence under Federal Rule of Evidence 404(b) that defendant stole funds from previous employers in the healthcare industry; in denying defendant's motion to dismiss count one of the second superseding indictment, which charged a violation of the anti-kickback statute; by refusing to hold an evidentiary hearing on defendant's motion to suppress statements and to declare his proffer agreement unenforceable; and by granting in part the spouse's attorneys' motion to quash a subpoena requiring one of the representatives to produce his entire file regarding the representation of the spouse who was now deceased. The court also held that the district court's jury instructions regarding count one were not erroneous. The court held, however, that the district court erred in calculating the amount of loss under Guidelines 2B4.1 when it used the loss to the victims, rather than the benefit to defendant, as the measure of loss. Therefore, the court concluded that there was procedural error and defendant's sentence was vacated. The court finally vacated the restitution order and remanded for further proceedings. The court rejected defendant's remaining claims. View "United States v. Yielding" on Justia Law

Appellant sued his former employer, alleging that it wrongfully terminated his employment by violating Missouri's public policy exception to the state's at-will employment doctrine. Appellant alleged that the employer discharged him either because he refused to "validate" adulterated drugs or because he acted as a "whistle blower" by reporting that the employer manufactured adulterated drugs. The court held that appellant failed to create a genuine fact issue as to whether the employer's validation processes violated a clearly established stated public policy. Therefore, the court affirmed the district court's grant of summary judgment to the employer. View "Bazzi v. Tyco Healthcare Group" on Justia Law

The FTC sued Lundbeck, Inc., alleging that its acquisition of the drug NeoProfen violated the Federal Trade Commission Act, 15 U.S.C. 41 et seq., the Sherman Act, 15 U.S.C. 1-7, the Clayton Act, 15 U.S.C. 12-27, the Minnesota Antitrust Law of 1971, and unjustly enriched Lundbeck. At issue was whether the district court properly determined that the FTC failed to identify a relevant market where the FTC did not meet its burden of proving that the drugs Indocin IV and Neoprofen were in the same product market. The court held that the district court's finding was not clearly erroneous and affirmed the judgment. View "Federal Trade Commission v. Lundbeck, Inc." on Justia Law

Wife, suing on behalf of her deceased husband, (plaintiff) filed tort claims and a breach of warranty claim against pharmaceutical companies, alleging that the prescription Mirapex that husband used to treat his Parkinson's disease lead him to compulsively gamble. At issue was whether the district court properly granted summary judgment to defendants because plaintiff's claims were time-barred. The court held that the district court correctly determined that plaintiff's claim accrued more than two years before he brought his suit and thus was time-barred. The court also held that because husband became aware of the effect of the Mirapex more than two years before he filed suit, the continuing tort doctrine did not save his claim; that the open courts provision did not operate to save plaintiff's claim; that the district court did not err in determining that the facts were sufficiently developed to establish a concrete injury in 2006 for the purpose of determining ripeness; that the affidavits at issue did not raise a genuine issue of fact as to whether husband's behavioral problems and side effects were so severe as to render him legally incompetent and therefore, the tolling provisions of section 16.0001 of the Texas Civil Practice and Remedies Code were unavailable; and that plaintiff had not satisfied the requirement that purchasers gave notice of a breach of warranty claim prior to filing suit and therefore, the district court did not err in granting summary judgment to defendant on that claim. Accordingly, the judgment was affirmed. View "Gazal v. Boehringer Ingelheim Pharmaceuticals, et al." on Justia Law