Justia Drugs & Biotech Opinion Summaries

Plaintiff sought to develop a rapid, self-administered test to determine a person’s HIV status. The development process included collection of human blood and saliva samples. Plaintiff sued the United States under the Federal Tort Claims Act for the destruction of its blood and saliva specimens by the Food and Drug Administration. The specimens had been seized during a criminal investigation and the freezer in which they were stored broke down. The district court entered summary judgment that the suit arose from a law enforcement officer’s detention of property, excepting the claims from the FTCA waiver of sovereign immunity, 28 U.S.C. 2680(c). The Seventh Circuit affirmed. The government presented uncontroverted evidence that the officer detained the specimens as a law enforcement officer View "On-Site Screening, Inc. v. United States" on Justia Law

Borrome, a citizen of the Dominican Republic, and, since 1996 a lawful permanent resident of the U.S. pled guilty in 2002 to violations of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 301-399d, prohibitions on unlicensed wholesale distribution of prescription “drugs” in interstate commerce. He was sentenced him to four months’ imprisonment followed by four months’ home confinement. In 2010 he was served with a notice of removal and the IJ reasoned that because Borrome’s offense involved unauthorized distribution of a Schedule II controlled substance (Oxycontin ), it is an aggravated felony under 8 U.S.C. 1101(a)(43)(B) pursuant to the “hypothetical federal felony test,” so that Borrome was removable under 8 U.S.C. 1227(a)(2)(B)(i) as an alien convicted of violating any law “relating to a controlled substance.” The Board of Immigration Appeals affirmed. Borrome has been removed from the United States. The Seventh Circuit reversed, concluding that violation of the FDCA wholesale distribution provisions does not constitute an aggravated felony and that those laws are not laws relating to a controlled substance. View "Borrome v. Att'y Gen. of the U.S." on Justia Law

Schering held a patent on the controlled release coating applied to potassium chloride crystals for treatment of potassium deficiencies. Potential generic manufacturers filed an abbreviated application for approval (ANDA),Hatch-Waxman Act, 21 U.S.C. 301-399, asserting that the Schering patent was invalid or would not be infringed by their new generic drugs. Schering’s subsequent infringement suits were resolved through agreements in which it paid the generic manufacturers to drop patent challenges and refrain from producing a generic drug for a specified period. Congress amended Hatch-Waxman to require pharmaceutical companies who enter into such settlements to file for antitrust review. The FTC filed an antitrust action with respect to Schering’s settlements. Plaintiffs sued on behalf of a class of purchasers of the drug. The Third Circuit affirmed the district court’s certification of the class, but reversed its presumption that Schering’s patent was valid and gave Schering the right to exclude infringing products until the end of its term, including through reverse payment settlements. The court directed use of a “quick look rule of reason analysis” based on economic realities of the settlement rather than labels. The court must treat any payment from a patent holder to a patent challenger who agrees to delay entry into the market as prima facie evidence of unreasonable restraint of trade, rebuttable by showing that the payment was for a purpose other than delayed entry or offers some pro-competitive benefit. View "In Re: K-Dur Antitrust Litigation" on Justia Law

Lupin submitted an Abbreviated New Drug Application (ANDA) to the Food and Drug Administration seeking approval to market a generic version of Fortamet, an extended-release tablet of metaformin hydrochloride. Shionogi, which markets Fortamet, sued Lupin for patent infringement under 35 U.S.C. 271(e)(2)(A) asserting, among others, the 866 patent), which is listed in the Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) entry for Fortamet. Lupin attempted to launch its generic Fortamet “at risk,”( without a final judgment on the merits in the litigation). Shionogi obtained a preliminary injunction. The Federal Circuit vacated and remanded. The district court incorrectly concluded that Lupin failed to raise a substantial question of validity regarding the asserted claims of the 866 patent, an abused its discretion by issuing a preliminary injunction. View "Sciele Pharma Inc. v. Lupin, Ltd." on Justia Law

Humana sued, alleging that Glaxo was obligated to reimburse Humana for expenses Humana had incurred treating its insureds’ injuries resulting from Glaxo’s drug, Avandia. Humana runs a Medicare Advantage plan. Its complaint asserts that, pursuant to the Medicare Act, Glaxo is in this instance a “primary payer” obligated to reimburse Humana as a “secondary payer.” The district court dismissed, agreeing with Glaxo that the Medicare Act did not provide Medicare Advantage organizations with a private cause of action to seek such reimbursement. The Third Circuit reversed and remanded. The Medicare Secondary Payer Act, in 42 U.S.C. 1395y(b)(3)(A), provides Humana with a private cause of action against Glaxo. Even if the provision is ambiguous, regulations issued by the Centers for Medicare and Medicaid Services make clear that the provision extends the private cause of action to MAOs. View "Humana Med. Plan Inc. v. GlaxoSmithKline LLC" on Justia Law

Stryker, a manufacturer of medical devices, sued its umbrella insurer XL, seeking coverage for claims stemming from the implantation of expired artificial knees. The dispute concerned the precise "defect" that triggers batch coverage under the Medical Products Endorsement. The district court held that XL was liable under the policy for the entirety of Stryker’s losses on both direct claims brought against Stryker, as well as claims brought against Pfizer that Stryker was obligated to reimburse under an asset purchase agreement. The court found that the items were defective if they were available in Stryker’s inventory for implantation by physicians beyond their shelf-life of five years. The Sixth Circuit affirmed XL’s liability for the full amount of Stryker’s losses and pre-judgment interest. XL’s payment to Pfizer applies to exhaust the policy with respect to the direct claims. The court reversed the holding that the aggregate limit of liability of the XL policy does not apply to the judgments on the direct claims and remanded for determination of what portion, if any, of the total liability for those judgments beyond $15 million represents consequential damages as defined under Michigan contract law. View "Howmedica Osteonics, Corp. v. Nat'l Union Fire Ins. Co." on Justia Law

TIG issued a $25 million excess policy to Stryker, a manufacturer of medical devices. Coverage attached above the underlying (XL) umbrella policy, with a limit of $15 million. Stryker sued XL, seeking defense and indemnification for claims related to replacement knees (first suit). Pfizer then sued Stryker, seeking indemnification with respect to claims based on Uni-Knees; the companies had an asset purchase agreement. The court ruled in favor of Pfizer. When XL denied coverage, Stryker sued both insurers. In 2008, the district court held that XL was liable for all of Stryker's liabilities with respect to both suits and also granted declaratory judgment against TIG. XL settled directly with Pfizer, and obtained a ruling that this satisfied its obligations. TIG moved to remove the declaratory judgment ruling, arguing that the ruling that XL was responsible with respect to both suits made it impossible to subject TIG to liability. The district court denied this motion. The Sixth Circuit affirmed that the case is not moot, noting that the claims may exhaust the XL policy; reversed a ruling that TIG is precluded from raising coverage defenses on remand, noting that TIG was not a party to the first suit; and remanded. View "Stryker Corp. v. Nat'l Union Fire Ins. Co." 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

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