Justia Drugs & Biotech Opinion Summaries

Pharmacy benefit managers (PBMs) reimburse pharmacies for the cost of drugs covered by prescription-drug plans by administering maximum allowable cost (MAC) lists. In 2015, Arkansas passed Act 900, which requires PBMs to reimburse Arkansas pharmacies at a price at least equal to the pharmacy’s wholesale cost, to update their MAC lists when drug wholesale prices increase, and to provide pharmacies an appeal procedure to challenge MAC reimbursement rates, Ark. Code 17–92–507(c). Arkansas pharmacies may refuse to sell a drug if the reimbursement rate is lower than its acquisition cost. PCMA, representing PBMs, sued, alleging that Act 900 is preempted by the Employee Retirement Income Security Act (ERISA), 29 U.S.C. 1144(a).Reversing the Eighth Circuit, the Supreme Court held that Act 900 is not preempted by ERISA. ERISA preempts state laws that “relate to” a covered employee benefit plan. A state law relates to an ERISA plan if it has a connection with or reference to such a plan. State rate regulations that merely increase costs or alter incentives for ERISA plans without forcing plans to adopt any particular scheme of substantive coverage are not preempted. Act 900 is a form of cost regulation that does not dictate plan choices. Act 900 does not “refer to” ERISA; it regulates PBMs whether or not the plans they service fall within ERISA’s coverage. Allowing pharmacies to decline to dispense a prescription if the PBM’s reimbursement will be less than the pharmacy’s cost of acquisition does not interfere with central matters of plan administration. The responsibility for offering the pharmacy a below-acquisition reimbursement lies first with the PBM. Any “operational inefficiencies” caused by Act 900 are insufficient to trigger ERISA preemption, even if they cause plans to limit benefits or charge higher rates. View "Rutledge v. Pharmaceutical Care Management Association" on Justia Law

The Second Circuit affirmed the district court's grant of summary judgment in favor of defendants and dismissal of plaintiffs' products liability claims after precluding, pursuant to Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993), the opinions of plaintiffs' expert witnesses as to general causation.The court concluded that, not only was it appropriate for the district court to take a hard look at plaintiffs' experts' reports, the court was required to do so to ensure reliability. Furthermore, plaintiffs' contention that the district court impermissibly focused on plaintiffs' experts' conclusions instead of their methodologies is similarly unavailing. Even assuming that the district court required experts to back their opinions with studies definitely supporting their conclusions, the district court did not err in doing so. Therefore, the district court appropriately undertook a rigorous review of each of plaintiffs' experts, and based on that review reasonably found that the experts' methods were not sufficiently reliable and that their conclusions were not otherwise supported by the scientific community.The court also concluded that the district court correctly granted summary judgment in favor of defendants where no reasonable juror could find that it was more likely than not that general causation had been established based on plaintiffs' admissible evidence. The court was not persuaded that the district court erred in holding that there is a general causation requirement across all states. Furthermore, the court rejected plaintiffs' contention that the district court prevented them from obtaining and presenting evidence of general causation. In this case, plaintiffs failed to explain how admitting portions of the expert reports would have established general causation; the district court did not abuse its broad discretion in excluding differential-diagnosis evidence; and the district court did not abuse its broad discretion in managing discovery. View "In Re: Mirena IUS Levonorgestrel-Related Products Liability Litigation" on Justia Law

E-cigarette manufacturers and retailers, as well as a nonprofit organization, challenged the FDA's Deeming Rule, which deemed e-cigarettes to be "tobacco products" subject to the Family Smoking Prevention and Tobacco Control Act's requirements, under the Appointments Clause and the First Amendment of the Constitution.The DC Circuit affirmed the district court's grant of summary judgment to the FDA and held that appellants' Appointments Clause challenge lacks merit and their First Amendment challenge is foreclosed. In this case, even assuming for purposes of argument, that Associate Commissioner for Policy Kux's issuance of the Deeming Rule violated the Appointments Clause and that FDA Commissioner Califf's general ratification of prior actions by the FDA as part of an agency reorganization was invalid, FDA Commissioner Gottlieb's ratification cured any Appointments Clause defect. Furthermore, appellants' challenge to the Act's preclearance pathway for modified risk tobacco products as violative of the First Amendment is foreclosed by Nicopure Labs, LLC v. FDA, 944 F.3d 267, 271 (D.C. Cir. 2019). In Nicopure Labs, the court found unpersuasive the objection that appellants make now, namely that the Deeming Rule violates the First Amendment because it places the burden on manufacturers to show that certain of their marketing claims are truthful and not misleading before they make them. View "Moose Jooce v. Food & Drug Administration" on Justia Law

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 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

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

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

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 (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

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