Justia Drugs & Biotech Opinion Summaries

In 2008, Michigan passed the MMMA, Comp. Laws 333.26421, to protect medical marijuana. Any “qualifying patient” who possesses a registry identification card is not “subject to arrest, prosecution, or penalty of any manner, or denied any right or privilege, including but not limited to civil penalty or disciplinary action by a business.” Plaintiff was employed by Wal-Mart for five years before he was terminated after testing positive for marijuana, in violation of the company’s drug use policy. The test was administered on the day after Plaintiff injured his knee at work. Plaintiff was diagnosed with sinus cancer and an inoperable brain tumor at age 17; he experiences constant pain and side effects of medications. In 2008, Plaintiff’s oncologist recommended marijuana; Plaintiff obtained a registry card and maintains that he followed state laws, never used marijuana at work, nor did he work under the influence. Plaintiff sued in state court for wrongful discharge and MMMA violation; defendants removed to federal court based on diversity. The district court denied remand and dismissed. The court held that the store manager, a Michigan resident, was fraudulently joined and that the MMMA does not regulate private employment. The Sixth Circuit affirmed, noting that the manager had no potential liability. View "Casias v. Wal-Mart Stores, Inc." on Justia Law

Genentech manufactured and sold the psoriasis medication Raptiva, approved by the FDA in 2003. Raptiva works by suppressing T-cells ; because T-cells help fight infections, suppression has the potential to cause potentially life-threatening side effects. Following reports of adverse health effects, including a rare brain infection, Genentech voluntarily removed Raptiva from the market in 2009. Marsh began using Raptiva in 2004 and subsequently suffered viral meningitis and a collapsed lung. She sued in 2011, alleging strict products liability under design-defect and failure-to-warn theories, negligence, breach of warranty, and fraud. She claimed that, before and after FDA approval, Genentech knew of dangerous side effects that it concealed and did not include in the drug’s label. The district court dismissed, holding that Genentech was immune from suit because neither statutory exception to immunity for drug manufacturers applied. Marsh argued that immunity does not apply because failure to submit updated information rendered Raptiva noncompliant with FDA approval when it left Genentech’s control and that her claim was not preempted because it was premised on non-compliance rather than fraud or bribery. The Sixth Circuit affirmed. Allegations underlying Marsh’s argument that immunity does not apply are essentially the type of claim that is preempted.View "Marsh v. Genetech Inc." on Justia Law

Appellants, researchers in the field of adult stem cells who oppose the use of federal funding for the development of embryonic stem cell (ESC) research, filed a complaint seeking declaratory and injunctive relief against the Secretary's implementation of regulations allowing federal funding of such research. The court, applying Chevron analysis, held that the NIH had reasonably interpreted the Dickey-Wicker Amendment's ban on funding "research in which . . . embryos are destroyed" to allow federal funding of ESC research. Further, the preliminary-injunction exception was not applicable to the law-of-the-case preclusion. The court also held that the NIH's interpretation of the Dickey-Wicker Amendment's actual language was reasonable and the NIH's decision to dismiss the comments categorically objecting to ESC was not arbitrary or capricious. Accordingly, the court affirmed summary judgment in favor of the government. View "Sherley, et al. v. Sebelius, et al." on Justia Law

Wake Forest is the owner of asserted patents, and KCI are the exclusive licensees of the patents, which claim methods and apparatuses for treating difficult-to-heal wounds by applying suction or negative pressure. In response to S&N’s 2008 announcement that it was launching a new foam-based negative pressure wound treatment product, Wake Forest and KCI asserted that S&N infringes two apparatus claims of the patent and induces infringement of four method claims. Rejecting the jury’s findings of non-obviousness, the district court found obviousness, based on prior art, and rejected infringement claims. The Federal Circuit reversed and remanded. The objective evidence strongly supported the jury’s findings under the first three Graham factors and cut against the view that the claimed inventions were an obvious combination of known elements from the prior art. View "Kinetic Concepts, Inc. v. Smith & Nephew, Inc." on Justia Law

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

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

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

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