Justia Drugs & Biotech Opinion Summaries

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

Plaintiff owns a patent on an FDA-approved (21 U.S.C. 355(b)(2) ) pharmaceutical nasal spray Fortical, used to treat osteoporsis, with the active ingredient salmon calcitonin. In its FDA filing, plaintiff identified the drug as bioidentical to Miacalcin. Defendant filed an Abbreviated New Drug Application with the FDA, stating intent to make, use, offer to sell, sell, and/or import a generic version of Fortical product before the expiration of plaintiff's patent. Plaintiff claimed infringement. Defendant alleged invalidity under 35 U.S.C. 101, 102, 103,and 112, noninfringement and inequitable conduct in failure to disclose an allegedly material piece of prior art and making allegedly misleading statements during patent prosecution. The district court found that the patent would not have been obvious at the time of invention, denied defendant's motion to breach the attorney-client privilege under the crime-fraud exception, and determined that defendant had waived several counter-claims. The Federal Circuit affirmed. Even accepting that there was a design need and market pressure to develop a pharmaceutical formulation bioequivalent to Miacalcin, there was no evidence that the claim would be an obvious solution to those motivations.View "Unigene Labs, Inc. v. Apotex, Inc." 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

The Mississippi Public Employees' Retirement System filed a class action, claiming that senior management of a publicly traded manufacturer of medical devices in which it invested, withheld material information and made misleading statements about devices for treating coronary artery disease, in violation of the Securities Exchange Act of 1934, 15 U.S.C. 78j(b), 78t(a), and Securities Exchange Commission Rule 10b-5, 17 C.F.R. 240.10b-5. In an earlier opinion, the First Circuit reversed dismissal, finding that the inference of scienter advanced by the plaintiff was at least as cogent and compelling as the contrary inference, satisfying the "strong inference" pleading standard of the Private Securities Litigation Reform Act. After discovery, the district court entered summary judgment in favor of defendants. The First Circuit affirmed, finding that plaintiff did not produce evidence that would support a reasonable inference of scienter. Given the statements and disclosures that defendants did make concerning the devices, they had no obligation to disclose the fact that they were working on an improvement that would reduce the very small number of no-deflate complaints that they received, and of which the market was aware. View "MS Pub.Emps. Ret. Sys. v. Boston Scientific Corp." on Justia Law

Shortly after Plaintiff Mark Rimbert's father began taking Prozac, he killed his wife and himself. Plaintiff brought a wrongful death action against Defendant Eli Lilly, the manufacturer of Prozac. Defendant moved for summary judgment on various grounds and to exclude the testimony of Plaintiff's sole expert witness on the question of causation. The motions were denied by the district judge initially assigned the case. Once the case was reassigned, Defendant moved for reconsideration. The second district judge granted Defendant's motion to exclude Plaintiff's expert witness. The court then entered summary judgment for Defendant, concluding that without the expert's testimony, Plaintiff had no case. Plaintiff brought this appeal to the Tenth Circuit, arguing that the district court erred by excluding the testimony of his expert. Upon review, the Tenth Circuit affirmed the district court's order excluding the testimony, but reversed the order granting summary judgment. The Court remanded the case for further proceedings. View "Rimbert v. Eli Lilly & Co." on Justia Law