Justia Drugs & Biotech Opinion Summaries
United States v. Elmer
Elmer owned and operated multiple healthcare-related companies including Pharmakon, a compounding pharmacy that mixes and distributes drugs—including potent opioids like morphine and fentanyl—to hospitals across the U.S.. Pharmakon conducted its own internal potency testing and contracted with a third party to perform additional testing to evaluate whether its compounded drugs had too little of the active ingredient (under-potent) or too much (over-potent). In 2014-2016, testing showed 134 instances of under- or over-potent drugs being distributed to customers. Elmer knew the drugs were dangerous. Rather than halting manufacturing or recalling past shipments, sales continued and led to the near-death of an infant. Elmer and Pharmakon lied to the FDA.Elmer was charged with conspiracy to defraud the FDA (18 U.S.C. 371); introducing adulterated drugs into interstate commerce (21 U.S.C. 331(a), 333(a)(1) & 351); and adulterating drugs being held for sale in interstate commerce (21 U.S.C. 331(k), 331(a)(1) & 351). Pharmakon employees, FDA inspectors, and Community Health Network medical staff testified that Elmer was aware of and directed the efforts to conceal out-of-specification test results from the FDA. The district court sentenced Elmer to 33 months’ imprisonment. The Seventh Circuit affirmed, rejecting challenges to rulings related to the evidence admitted at trial and Elmer’s sentence. The evidence before the jury overwhelmingly proved Elmer’s guilt. The sentence was more than reasonable given the gravity of Elmer’s crimes. View "United States v. Elmer" on Justia Law
Vectura Ltd. v. GlaxoSmithKline, LLC
Vectura sued GSK in 2016, alleging direct infringement of claim 3 of the 991 patent, which concerns the production of “composite active particles” for use in pulmonary administration, such as in dry-powder inhalers. The composite active particles described in the patent consist of additive material that is adhered to particles of the active ingredient. The active ingredient produces the desired chemical or biological effect, while the additive particles promote the dispersion and delivery of the active ingredient into the lungs when the inhaler is activated.The Federal Circuit affirmed holdings that the patent was infringed and not invalid. The court rejected arguments that Vectura failed to present substantial evidence that the accused inhalers use additive material that “promotes the dispersion” of the active material, that the district court’s construction of the term “composite active particles” was erroneous, that there were flaws in the calculation of the royalty proposed by Vectura’s damages expert, and that Vectura made prejudicial references to GSK’s sales and advanced an improper “pennies on the dollar” argument in comparing Vectura’s royalty request to GSK’s sales. View "Vectura Ltd. v. GlaxoSmithKline, LLC" on Justia Law
Roane v. Barr
In July 2019, the Department of Justice announced a revised protocol for execution by lethal injection using a single drug, pentobarbital. Plaintiffs, federal death row inmates, sought expedited review of three of the district court's rulings, and two plaintiffs with upcoming execution dates moved for stays of execution pending appeal.The DC Circuit held that the district court did not err in granting summary judgment for the government on plaintiffs' Federal Death Penalty Act (FDPA) claim. In this case, plaintiffs had pointed to several alleged discrepancies between the 2019 Protocol and state statutes dictating different methods of execution or aspects of the execution process. The court agreed with the district court's conclusion that there was no conflict, either because the government had committed to complying with the state statutes at issue or because no plaintiff had requested to be executed in accordance with them.However, the court reversed the district court's dismissal of plaintiffs' Eighth Amendment challenge for failure to state a claim. The court held that, by pleading that the federal government's execution protocol involves a "virtual medical certainty" of severe and torturous pain that is unnecessary to the death process and could readily be avoided by administering a widely available analgesic first, plaintiffs' complaint properly and plausibly states an Eighth Amendment claim. The court denied Plaintiffs Hall and Bernard's request for a stay of execution based on the Eighth Amendment claim. The court also held that the district court should have ordered the 2019 Protocol to be set aside to the extent that it permits the use of unprescribed pentobarbital in a manner that violates the Federal Food, Drug & Cosmetic Act (FDCA). Finally, the court affirmed the district court's denial of a permanent injunction to remedy the FDCA violation. View "Roane v. Barr" on Justia Law
Ferring B.V. v. Allergan, Inc.
Fein was a consultant for Ferring Pharmaceuticals, involved in a project involving desmopressin, a synthetic analog of the naturally occurring hormone arginine vasopressin, which regulates the body’s retention of water. Fein suggested administration as a waterless orodispersible form to improve the bioavailability of the desmopressin. In 2002, Ferring filed a Great Britain Patent Application, covering an orodispersible desmopressin formulation but did not list any inventors. When Ferring experienced production delays, it undertook another clinical study with an intravenous desmopressin formulation. Fein was selected to oversee the U.S. study and suggested certain changes. After Ferring terminated Fein’s consulting agreement, both parties continued to test various formulations. Both Ferring and Fein filed patent applications. Fein’s company sold the right to commercialize a low-dose desmopressin intranasal spray.Ferring unsuccessfully requested reexamination of Fein’s patent, then filed a complaint asserting state law claims and claims for correction of inventorship of the Fein patents under 35 U.S.C. 256. The district court granted the defendants summary judgment, finding that conduct occurring before the issuance of Fein's patents could give rise to equitable estoppel of claims for correction of inventorship. The court noted Ferring’s inaction for over seven years following letters from Fein’s attorney. On counterclaims for correction of inventorship of Ferring’s patents, the court granted Ferring judgment. The Federal Circuit vacated and remanded for further development of the record, noting the fact-laden equitable issue and the need to avoid a rush to judgment. View "Ferring B.V. v. Allergan, Inc." on Justia Law
C R Bard Inc. v. AngioDynamics, Inc.
Bard and AngioDynamics both manufacture vascular access ports, devices implanted underneath a patient’s skin that allow the injection of fluid into the patient’s veins on a regular basis without starting an intravenous line each time. Vascular access ports were traditionally used to administer injections at low pressure and flow rates. Certain procedures, like computed tomography (CT) imaging, required the injection of fluids into patients at high pressure and high flow rates (power injection). As of 2005, vascular access ports were not FDA-approved for power injection but certain medical providers were using existing ports for power injection; in some cases, the pressure ruptured the port, seriously injuring the patient. Bard obtained FDA approval for PowerPort as the first vascular access port labeled for power injection and obtained the patents-in-suit. AngioDynamics then obtained FDA approval to market its own vascular access port products as suitable for power injection.Bard sued AngioDynamics for infringement. During the trial, the court granted judgment that the asserted claims were not infringed, were not willfully infringed, and were invalid as directed to printed matter. The Federal Circuit reversed. There was substantial evidence to support a jury finding of infringement and willfulness; the asserted claims are not directed solely to printed matter and are patent-eligible under 35 U.S.C. 101. A genuine dispute of material fact precludes summary judgment as to anticipation. View "C R Bard Inc. v. AngioDynamics, Inc." on Justia Law
Quidel Corporation v. Super. Ct.
Quidel Corporation (Quidel) petitioned for a writ of mandate and/or prohibition to direct the trial court to vacate its order granting summary adjudication. Quidel contended the trial court incorrectly concluded a provision in its contract with Beckman Coulter, Inc. (Beckman) was an invalid restraint on trade in violation of Business and Professions Code, section 16600. Quidel argued the trial court improperly extended the holding from Edwards v. Arthur Andersen LLP, 44 Cal.4th 937 (2008) beyond the employment context to a provision in the parties’ 2003 BNP Assay Agreement (the Agreement). In its original, published opinion, the Court of Appeal concluded it was not, granted the petition and issued a writ instructing the trial court to vacate the December 2018 order granting summary judgment on the first cause of action. The California Supreme Court then granted review of the Court of Appeal's opinion and ordered briefing deferred pending its decision in Ixchel Pharma, LLC v. Biogen, Inc., S256927. On August 3, 2020, the Supreme Court issued Ixchel Pharma, LLC v. Biogen, Inc., 9 Cal.5th 1130 (2020), which held “a rule of reason applies to determine the validity of a contractual provision by which a business is restrained from engaging in a lawful trade or business with another business.” The Quidel matter was transferred back to the Court of Appeals with directions to vacate its previous opinion and reconsider the case in light of Ixchel. The appellate court issued a new opinion in which it concluded the trial court’s decision was incorrect. The trial court was directed to vacate the December 7, 2018 order granting summary adjudication on the first cause of action. View "Quidel Corporation v. Super. Ct." on Justia Law
Boone v. Boehringer Ingelheim Pharmaceuticals, Inc.
The Supreme Court affirmed the judgment of the trial court in favor of Defendants, Boehringer Ingelheim Pharmaceuticals, Inc. and Boehringer Ingelheim International, GmbH, on claims brought by Plaintiff, the executrix of the decedent's estate, that an oral anticoagulant medication wrongfully caused the decedent's death, holding that the trial court did not err.Specifically, the Supreme Court held that the trial court did not improperly (1) preclude evidence and arguments related to spoliation; (2) prevent Plaintiff from using an excerpt from a particular deposition on rebuttal; (3) grant Defendants' motion for summary judgment on a design defect claim relating to the absence of a reversal agent; and (4) issue a curative instruction to the jury after closing arguments. View "Boone v. Boehringer Ingelheim Pharmaceuticals, Inc." on Justia Law
Valeant Pharmaceuticals North America LLC v. Mylan Pharmaceuticals Inc.
The Valeant plaintiffs reside in Japan, Ireland, and Delaware. The defendants are incorporated and have principal places of business in West Virginia, Pennsylvania, and India. The brand-name FDA-approved drug Jublia® has nine patents listed in the Orange Book. Defendant, a generic drug company, executed an Abbreviated New Drug Application (ANDA) seeking approval to market a generic version of Jublia®, sending the ANDA from its West Virginia office to the FDA in Maryland. Valeant sued for infringement in the District of New Jersey, alleging that the district is a likely destination for the generic solution; each defendant does business in New Jersey and is registered to do so; each defendant has previously submitted to the court's jurisdiction and has a place of business in New Jersey; the generic drug will be “purposefully directed at … New Jersey. The district court dismissed for improper venue, finding that the ANDA was submitted from West Virginia, rendering venue proper there, while acknowledging that MLL, a foreign entity, was subject to venue in every judicial district.The Federal Circuit affirmed in part, citing the 2017 Supreme Court “TC Heartland” holding: the general venue provision in 28 U.S.C. 1391, which provides that a corporation is deemed to “reside” in any judicial district in which it is subject to personal jurisdiction, does not modify the term “resides” in 28 U.S.C. 1400, the specific patent venue statute; “resides” refers only to a corporation’s state of incorporation. A corporation may be sued for patent infringement in districts in the state of its incorporation and those in which it has a regular and established place of business and an act of infringement has occurred. In Hatch-Waxman Act, 35 U.S.C. 271(e)(2)(A) infringement cases, section 1400 “acts of infringement” occur only in districts where actions related to the ANDA submission occur, not in all locations where future distributions of the products specified in the ANDA is contemplated. The court remanded the dismissal of the foreign defendant. View "Valeant Pharmaceuticals North America LLC v. Mylan Pharmaceuticals Inc." on Justia Law
Russell v. Johnson & Johnson Inc.
In this lawsuit brought against Johnson & Johnson, Inc. and other entities (collectively, Defendants) alleging state tort claims due to injuries caused by a Class III medical device the Supreme Court reversed the judgment of the trial court granting Defendants' motion for judgment on the pleadings based on federal preemption of all claims, holding that, under Kentucky's notice pleading standards, the motion for judgment on the pleadings should have been denied.In their complaint, Plaintiffs asserted claims for, inter alia, strict liability negligence, and lack of informed consent. Defendants moved for judgment on the pleadings based on federal preemption of all claims. The trial court granted the motion and dismissed all of Plaintiffs' claims. The court of appeals affirmed. The Supreme Court reversed, holding that, under Kentucky's notice pleading standard, Plaintiffs' complaint sufficiently put Defendants on notice of parallel claims under Kentucky law that may not be preempted. View "Russell v. Johnson & Johnson Inc." on Justia Law
Bristol-Myers Squibb Co. v. Connors
After the State of Hawaii filed suit against several pharmaceutical companies in state court for allegedly deceptive drug marketing related to the medication Plavix, the companies turned to federal court, seeking an injunction against the state court litigation based on a violation of their First Amendment rights.The Ninth Circuit agreed with the district court that the state court litigation is a quasi-criminal enforcement proceeding and that Younger v. Harris, 401 U.S. 37 (1971), bars a federal court from interfering with such a proceeding. The panel explained that, even though the state proceeding is being litigated by private counsel, it is still an action brought by the State of Hawaii. The panel stated that what matters for Younger abstention is whether the state proceeding falls within the general class of quasi-criminal enforcement actions—not whether the proceeding satisfies specific factual criteria. Looking to the general class of cases of which this state proceeding is a member, the panel concluded that Younger abstention is appropriate here. In this case, the State's action has been brought under a statute that punishes those who engage in deceptive acts in commerce, and the State seeks civil penalties and punitive damages to sanction the companies for their allegedly deceptive labeling practices. Because the companies' First Amendment concerns do not bring this case within the scope of Younger's extraordinary circumstances exception, they have no bearing on the application of Younger. Accordingly, the panel affirmed the district court's dismissal of the action. View "Bristol-Myers Squibb Co. v. Connors" on Justia Law