Justia Drugs & Biotech Opinion Summaries

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

The patents involve topical compositions for protecting pets from fleas and ticks. The 940 patent, now expired, claimed fipronil for pest control by direct toxicity. Merial, as exclusive licensee, developed compositions sold as Frontline. Merial also devised compositions, covered by the 329 patent, combining fipronil with an insect growth regulator, sold as Frontline Plus, the leading flea and tick treatment. In 2007 Merial sued Cipla and other internet retailers, alleging infringement. No defendant responded. The district court found that the patents were not invalid, that Cipla had infringed each patent, and entered a permanent injunction barring Cipla from directly or indirectly infringing the patents. In 2008 Cipla filed an informal communication, not intended to constitute an appearance, denying infringing or having any presence in the U.S., and requesting dismissal. The district court entered final judgment. Velcera, led by former Merial executives, engaged with Cipla to develop, test, manufacture, and distribute products to compete with Merial. Both Velcera and Cipla entered into development and supply agreements with various companies. In 2011, they began selling PetArmor Plus. The district court held Velcera and Cipla in contempt. The Federal Circuit affirmed, rejecting challenges to jurisdiction and to the contempt order’s application to Velcera. View "Merial, Ltd. v. Cipla, Ltd." on Justia Law

The patent is entitled “Ultra High Molecular Weight Polyethylene Molded Article for Artificial Joints and Method of Preparing the Same.” The examiner rejected a reissue application as obvious, finding that it would have been obvious to a person of ordinary skill in the art to use cross-linked UHMWPE in the method of making the UHMWPE products disclosed by a reference, given the teaching of another reference that cross-linking prior to compression deformation results in improved transparency, an increased melting point, and excellent dimensional stability. The examiner further found that one of ordinary skill in the art would have had a reasonable expectation of success in obtaining those enhanced properties by combining the techniques taught by the two references. The Board affirmed, rejecting an argument that there would have been no motivation to combine the teachings because the references are directed to different products. The Federal Circuit affirmed. View "In Re: Hyon" on Justia Law

In 2004, plaintiff had arthroscopic surgery to treat pain and instability in his shoulder joint. The doctor implanted a pain-pump catheter and, over the next two days, a Stryker pain pump delivered a regular dose of a local anesthetic, bupivicaine, to the joint. Plaintiff’s condition improved after surgery but worsened over time, and in 2008 he learned he no longer had any cartilage remaining in his shoulder, a condition called chondrolysis. He sued, alleging strict liability, negligence and breach of warranty. The district court concluded that Stryker could not reasonably have known about the risk of chondrolysis in 2004 and thus had no duty to warn of the risk and held that Plaintiff failed as a matter of law to prove causation. The Sixth Circuit affirmed. Plaintiff did not present any evidence that Stryker knew or should have known that the use was dangerous or that a warning on Stryker's pain pump would have caused the doctor not to use the device in his joint space. View "Rodriguez v. Stryker Corp." on Justia Law

Zimmer manufactures orthopaedic reconstructive devices. One product, a replacement hip socket, was subject to a report of high failure rates. Zimmer announced preliminary findings in 2008, attributed the failures to improper surgical technique, stopped selling the product in the U.S. while preparing new instructions for implantation, and returned the item to the market. Owners of Zimmer stock sued, claiming that the problem was poor design or quality control, that Zimmer pretended otherwise to avoid hurting the price of its stock, and that Zimmer delayed revealing quality-control problems at its plant until after its 2008 quarterly report and earnings call. Zimmer had projected 10% to 11% revenue growth for the year and net earnings of $4.20 to $4.25 per share; months later it cut this projection to 8.5% to 9% growth and net earnings of $4.05 to $4.10 per share. The district court dismissed under the pleading standards of the Private Securities Litigation Reform Act of 1995, 15 U.S.C. 78u-4. The Seventh Circuit affirmed, holding that plaintiffs failed to establish scienter. The FDA has never concluded that the product was defectively designed or made and never issued a warning or caution; quality control issues at pharmaceutical and medical-device producers are endemic. View "Plumbers & Pipefitters Local Union 719 Pension Fund v. Zimmer Holdings Inc." on Justia Law

Plaintiffs, a putative nationwide class of third-party payors and a putative nationwide class of individual patient-consumers who paid for prescriptions, sued pharmaceutical manufacturers alleging that they paid for oncology and hepatitis drugs that were ineffective or unsafe for the off-label uses for which they were prescribed and that defendants pursued illegal marketing campaigns to persuade physicians to prescribe the drugs for those uses. While physicians are not prohibited from prescribing drugs for off-label uses, manufacturers are generally prohibited by the Federal Food, Drug and Cosmetic Act, 21 U.S.C. 301, from manufacturing, marketing, or selling for off-label use. Defendant had pled guilty to a criminal charge brought by the FDA and agreed to pay fine of $180 million and to pay $255 million to resolve civil claims that it defrauded Medicare, Medicaid, and the VA. The district court dismissed, for lack of standing, claims under the Racketeer Influenced and Corrupt Organizations Act, 18 U.S.C. 1961, the New Jersey RICO statute, N.J.S. 2C:41-1, and other state statutory and common law causes of action. The Third Circuit affirmed, finding that plaintiffs failed to establish a causal connection between the alleged misconduct and the alleged harm. View "In Re: Schering Plough Corp." on Justia Law

Plaintiffs in consolidated cases claim that, during their tenures as pharmaceutical sales representatives employed by Lilly and Abbott, they were misclassified as exempt employees and denied overtime pay in violation of the Fair Labor Standards Act, 29 U.S.C. 201-19. The employers argued that the administrative exemption and the outside sales exemptions removed the sales representatives from overtime protections. The two district courts reached opposite conclusions. After considering an amicus brief from the Department of Labor, the Seventh Circuit held that, under regulations of the Department of Labor, the pharmaceutical sales representatives are classified properly within the administrative exemption to overtime requirements. The court did not address the outside sales exemption. The sales representatives were compensated on a salary basis and their work is directly related to the general business operations of the pharmaceutical companies; they were required to exercise a significant measure of discretion and independent judgment, despite the constraints placed on them, and on all representatives of the pharmaceutical industry, by the regulatory environment in which they work. View "Schaefer-LaRose v. Eli Lilly & Co." on Justia Law

Montgomery filed the 824 application in 2005, claiming priority to United Kingdom applications 9722026.3 (October 1997) and 9810855.8 (May 1998). The application is directed to inhibitors of the renin-angiotensin system (RAS), important in control of blood pressure and regulation of salt and water metabolism. The claims recite administering RAS inhibitors to patients diagnosed as in need of stroke treatment or prevention. The examiner rejected these claims as anticipated by each of prior art references. The Board of Patent Appeals and Interferences affirmed. The Federal Circuit affirmed. The contested claim elements were administration of ramipril, a known RAS inhibitor, to a patient diagnosed as in need of stroke treatment or prevention, where such administration is for treatment or prevention of stroke or its recurrence. Prior art discloses both requirements. View "In Re Montgomery" on Justia Law

The FDA last approved a typical antipsychotic in 1975. Despite drawbacks, typical antipsychotics are still used to treat schizophrenia. In the early 1960s, researchers discovered clozapine, the first "atypical" antipsychotic, useful for treating both positive and negative symptoms. Clozapine had serious potential side effects and was withdrawn from clinical trials. The FDA approved no new antipsychotic drugs between 1976 and 1989, finally approving clozapine in 1990, only for certain patients, subject to blood testing. The FDA approved risperidone, an atypical antipsychotic, in 1994, and, since then, has approved seven other atypical antipsychotics, including aripiprazole. These are as effective as typical antipsychotics for treating positive symptoms, while also treating negative symptoms and causing fewer side effects than clozapine. Every approved atypical antipsychotic has chemical structure related either to clozapine or risperidone, except aripiprazole, the active ingredient in "Abilify," marketed by plaintiff for treatment of schizophrenia, bipolar disorder, irritability associated with pediatric autistic disorder, and as add-on treatment for depression. Anticipating expiration of the patent, companies submitted FDA Abbreviated New Drug Applications for approval of generic aripiprazole. The district court ruled in favor of plaintiff on patent infringement, 35 U.S.C. 103. The Federal Circuit affirmed, rejecting claims of obviousness and of nonstatutory double patenting. View "Otsuka Pharm. Co., Ltd. v. Sandoz, Inc." on Justia Law