Justia Drugs & Biotech Opinion Summaries

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

Plaintiff, engaged in treatment and disposal of regulated biomedical waste, had trouble with its shredder and obtained approval from the Puerto Rico Environmental Quality Board to use autoclaves. After a few years, an inspector recommended that plaintiff's facility be shut down and ordered a landfill to stop accepting plaintiff's waste. Unable to resolve the matter with EQB, plaintiff sought a federal court injunction. The injunctions were denied, but plaintiff resumed handling waste. When a second shredder broke, an inspector again ordered the landfill to stop accepting waste and rejected several proposals for dealing with accumulated waste. Plaintiff's suit alleges more favorable treatment of a competitor and other constitutional violations. The district court dismissed for failure to link allegations to any particular defendant. The First Circuit affirmed, finding failure to meet minimal pleading standards. The complaint failed the plausibility test "spectacularly." View "Redondo Waste Sys., Inc.v. Lopez-Freytes" on Justia Law

In the first appeal in a case regarding clopidogrel bisulfate tablets, sold by plaintiff under the brand name Plavix®, the Federal Circuit affirmed the district court's grant of a preliminary injunction concerning defendants' generic product. In the second appeal, the court affirmed a judgment that the patent-in-suit is not invalid, was infringed, and not unenforceable. The district court then awarded prejudgment interest and denied defendants' motion for leave to file a supplemental answer, affirmative defenses, and counterclaims pleading patent misuse and breach of contract. The Federal Circuit reversed in part. The district court erred by awarding prejudgment interest in addition to actual damages specified in a settlement agreement. The court affirmed the district court’s holding that defendant is jointly and severally liable for all damages and denial of defendant's motion. View "Sanofi-Aventis v. Apotex" on Justia Law

Plaintiff claims that fiber identified on the nutrition label (required by 21 U.S.C. 343(q)(1))of "chewy bars" made and sold by defendants is inferior to unprocessed fiber and can be harmful. The district judge held that the suit was precluded by the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 343-1(a)(5), which forbids states to impose "any requirement respecting any claim of the type . . . made in the label or labeling of food that is not identical to the requirement of section 343(r)." The Act does not create a private right of action; suit was filed under the Illinois Consumer Fraud and Deceptive Business Practices Act, 815 ILCS 505, and the Deceptive Trade Practices Act, 815 ILCS 510. The Seventh Circuit affirmed the dismissal. The labeling of the challenged products is compliant with the statute and FDA regulations. The disclaimers that the plaintiff wants added are not identical to the labeling requirements imposed by federal law, and so they are barred. The court further noted that plaintiff failed to state claim under Illinois law. View "Turek v. General Mills, Inc." 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

The companies are direct competitors in importing and distributing pharmaceutical ingredients manufactured in China. Plaintiff claimed that defendant intentionally interfered with one of its contracts and sought damages. In court-ordered settlement negotiations, plaintiff demanded $675,000. Defendant made a counter-offer, demanding that plaintiff pay it $444,444.44 in order to settle the case and avoid a motion for sanctions and a suit for malicious prosecution. The court noted that the peculiar amount was due to the fact that the number four is considered an unlucky number in Chinese culture because it is homophonous with the Chinese word for death, but concluded that it was not a death threat and declined to impose sanctions. The court later entered summary judgment for defendant. The First Circuit affirmed the court's refusal to impose sanctions under FRCP 11. Plaintiff's claims were not patently frivolous. View "CQ Int'l Co., Inc. v. Rochem Int'l, Inc., USA" on Justia Law

In 1992 two companies began a joint venture to develop peptide compounds. The agreement provides that inventions created by joint efforts are jointly owned, but inventions attributable to a single party are owned by that party and that disputes will be arbitrated. In court-ordered arbitration, a panel decided that a certain group of patents are jointly owned, but that another group is owned by defendant. The district court confirmed those rulings, but vacated a ruling in defendant's favor on foreign patents. Holding that appeal is authorized by 9 U.S.C. 16(a)(1)(E), and that the dispute does not concern patent law, but is a contract issue, the Seventh Circuit reversed. The Federal Arbitration Act authorizes a court to vacate an award for any of four reasons, 9 U.S.C. 10(a); a conclusion that the arbitrators disregarded the law by failing to discuss the foreign patents separately from the domestic patents did not justify vacating the award. The judge mistakenly inferred from silence that the arbitrators must have had an extra-contractual ground; the arbitrators had no reason to discuss the foreign patents separately from the domestic patents. View "Affymax, Inc. v. Ortho-McNeil-Janssen Pharmaceuticals, Inc." on Justia Law

The patents at issue relate to balloon-expandable stents, used to treat occluded blood vessels. Following a remand, the district court found that defendants did not literally infringe the patents and rejected claims that the patents were invalid for lack of description or due to inequitable conduct. The Federal Circuit affirmed. Based on the court's proper clarification of its construction of the term "undulating," there was not substantial evidence to support a finding of infringement, nor was there substantial evidence of inequitable conduct. View "Cordis Corp. v. Boston Scientific Corp." on Justia Law

Plaintiffs developed tardive dyskinesia as a result of use of generic metoclopramide, a drug prescribed for treatment of gastroesophageal reflux disease. They filed individual suits against manufacturers, alleging failure include adequate information on product labels concerning the risks of taking the drug long-term. They also named as parties manufacturers of the name-brand form of metoclopramide, alleging fraud and tortious misrepresentation. The district court dismissed plaintiffs' tort claims against the generic defendants on preemption grounds, finding conflict with federal regulation of generic drugs. The court also dismissed claims against name-brand defendants for failure to allege that they had ingested Reglan, a threshold requirement for a products-liability action under Kentucky law. The Sixth Circuit affirmed, stating that name-brand manufacturers have no duty to individuals who have never taken the drug they manufacture. View "Morris v. Wyeth, Inc." on Justia Law

Appellants filed a class action, alleging that defendant, a chemical manufacturer, sold thiodiglycol (TDG) to Saddam Hussein's Iraqi regime, which then used it to manufacture mustard gas to kill Kurdish enclaves in northern Iraq during the late 1980's. At issue was whether appellants have alleged viable claims under the Torture Victim Protection Act (TVPA), 28 U.S.C. 1350, or the Alien Tort Statute (ATS), 28 U.S.C. 1350. The court held that the TVPA excluded corporations from liability. The court also held that the ATS imposed liability for aiding and abetting violations of international law, but only if the attendant conduct was purposeful. Appellants, however, have failed to plead facts sufficient to support the intent element of their ATS claims. Accordingly, the court affirmed the district court's grant of defendant's motion to dismiss under Rule 12(b)(6). View "Aziz, et al. v. Alcolac, Inc., et al." on Justia Law