Justia Drugs & Biotech Opinion Summaries

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

Plaintiff had no adverse reaction to receiving the hepatitis B vaccine in 1997 until after her third dose. At that time, her chest pain was not attributed to the vaccine. Plaintiff saw other doctors for various symptoms and, in 1998, doctors identified "post vaccine syndrome." Plaintiff has had unrelated medical problems, suffered the loss of a child, and has had jobs that involved working with chemicals and bodily fluids. Her 1999 claim for compensation under the Vaccine Act (42 U.S.C. 300aa-1) was denied. The Federal Circuit affirmed, stating that if was an "unfortunate case," in which plaintiff suffered a multitude of symptoms but could not prove they were caused by the vaccine. View "Lombard v. Sec'y of Health & Human Servs." 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 district court granted summary judgment that all of the claims in plaintiff's patents were ineligible under 35 U.S.C. 101, which excludes from patentability "laws of nature, natural phenomena, and abstract ideas" because they were directed to the "abstract idea" that there is a relation between the infant immunization schedule for infectious diseases and the later occurrence of chronic immune-mediated (non-infectious) disorders. The Supreme Court vacated the Sixth Circuit's 2008 decision. On remand the Federal Circuit affirmed with respect to one patent's ineligibility, but vacated a portion of the judgment granted under the "safe harbor" provision of 35 U.S.C. 271(e)(1). One set of claims did not include putting knowledge to practical use, but was directed to the abstract principle that variation in immunization schedules may have consequences for certain diseases. Others require the further act of immunization in accordance with a lower-risk schedule, moving from abstract scientific principle to specific application. View "Classen Immunotherapies, Inc. v. Biogen Idec" on Justia Law