Justia Drugs & Biotech Opinion Summaries

The Eleventh Circuit denied the petition for review of the DEA's denial of Jones Pharmacy and SND Healthcare's application for certificates of registration to dispense controlled substances under the Controlled Substances Act (CSA), 21 U.S.C. 801 et seq. The court held that substantial evidence supported the DEA's determination that Jones Pharmacy's owner did not credibly accept full responsibility; the DEA's refusal to consider Jones Pharmacy's remedial measures did not render its decision arbitrary or capricious in this case; and the chosen sanction was not arbitrary or capricious. View "Jones Total Health Care Pharmacy, LLC v. DEA" on Justia Law

In 2005, the State of Mississippi filed suit against more than eighty prescription drug manufacturers alleging, among other things, that each committed common-law fraud and violations of the Mississippi Consumer Protection Act. The allegations primarily focused on whether the prescription-drug manufacturers inflated reported prices, which caused the Mississippi Division of Medicaid to reimburse pharmacies at inflated rates. The cases were eventually severed; this appeal involved only Watson Laboratories, Inc., Watson Pharma Inc., and Watson Pharmaceuticals, Inc. (collectively “Watson”). Following a bench trial, the Chancery Court concluded that Watson had committed common-law fraud and had violated the Mississippi Consumer Protection Act. As a result, the chancery court awarded the State a total of $30,262,052 in civil penalties, compensatory damages, and punitive damages. The chancery court also awarded post-judgment interest of three percent on the compensatory and punitive damages. Watson appealed, challenging the chancery court’s decision; the State also filed a cross-appeals relating to damages. After review, the Mississippi Supreme Court affirmed the chancery court’s judgment in favor of Mississippi Medicaid. Further, the Court affirmed the ruling on the State’s cross-appeal. View "Watson Laboratories, Inc. v. Mississippi" on Justia Law

In this appeal from the judgment of the court of appeals in which the court concluded that the Industrial Commission of Ohio should not have denied the application of Appellee for permanent total disability compensation, the Supreme Court affirmed the judgment to the extent that it granted a limited writ of mandamus. The Commission denied Appellee's application, in part, based on Appellee’s refusal to participate in rehabilitative services. The court of appeals issued the limited writ ordering the Commission to address the merits of Appellee’s application without relying on his alleged refusal to accept vocational-rehabilitation services. The Supreme Court affirmed in part and ordered the Commission to consider all the evidence in the record that is related to vocational-rehabilitation services before determining whether Appellee was entitled to permanent total disability compensation. View "State ex rel. Gulley v. Industrial Commission of Ohio" on Justia Law

The Supreme Court vacated the district court’s order granting Respondent’s petition for judicial review filed under Nev. Rev. Stat. 233B, the Nevada Administrative Procedure Act (APA), holding that the application process provided by Nev. Rev. Stat. 453A.322 does not constitute a contested case as defined by Nev. Rev. Stat. 233B.032, and therefore, the district court did not have authority to grant APA-based relief.Respondent petitioned for judicial review of the Nevada Department of Health and Human Service’s decision not to issue it a Las Vegas registration certificate authorizing it to operate a medical marijuana dispensary. Respondent’s petition was based exclusively on the Nevada APA. The Department moved to dismiss, arguing that the APA only affords judicial review in contested cases, which the marijuana dispensary application process does not involve. The district court granted judicial review and directed the Department to reevaluate Respondent’s application. The Supreme Court vacated the judgment of the district court, holding that the APA did not afford Respondent the right of review it sought. View "State, Department of Health & Human Services v. Samantha Inc." on Justia Law

To seek redress for an opioid epidemic, characterized by the Court of Appeal as having placed a financial strain on state and local governments dealing with the epidemic’s health and safety consequences, two California counties sued (the California Action) various pharmaceutical manufacturers and distributors, including the appellants in this matter, Actavis, Inc., Actavis LLC, Actavis Pharma, Inc., Watson Pharmaceuticals, Inc., Watson Laboratories, Inc., and Watson Pharma, Inc. (collectively, “Watson”). The California Action alleged Watson engaged in a “common, sophisticated, and highly deceptive marketing campaign” designed to expand the market and increase sales of opioid products by promoting them for treating long-term chronic, nonacute, and noncancer pain - a purpose for which Watson allegedly knew its opioid products were not suited. The City of Chicago brought a lawsuit in Illinois (the Chicago Action) making essentially the same allegations. The issue presented by this appeal was whether there was insurance coverage for Watson based on the allegations made in the California Action and the Chicago Action. Specifically, the issue was whether the Travelers Property Casualty Company of America (Travelers Insurance) and St. Paul Fire and Marine Insurance Company (St. Paul) owe Watson a duty to defend those lawsuits pursuant to commercial general liability (CGL) insurance policies issued to Watson. Travelers denied Watson’s demand for a defense and brought this lawsuit to obtain a declaration that Travelers had no duty to defend or indemnify. The trial court, following a bench trial based on stipulated facts, found that Travelers had no duty to defend because the injuries alleged were not the result of an accident within the meaning of the insurance policies and the claims alleged fell within a policy exclusion for the insured’s products and for warranties and representations made about those products. The California Court of Appeal concluded Travelers had no duty to defend Watson under the policies and affirmed. View "The Traveler's Property Casualty Company of America v. Actavis, Inc." on Justia Law

Abilify is approved to treat schizophrenia, Bipolar Disorder, major depressive disorder and irritability associated with autism. There are no disapproved treatments for elderly patients, but the FDA has included a warning since 2007 that Abilify is associated with increased mortality in elderly patients with dementia-related psychosis. Relators, former BMS employees, alleged in a qui tam suit that BMS and Otsuka engaged in a scheme to encourage providers to prescribe Abilify for unapproved (off-label) uses and improperly induced providers to prescribe Abilify in violation of the Anti-Kickback Statute. Nearly identical allegations were leveled against the companies years earlier. In 2007-2008, the companies each entered into an Agreement as part of a settlement of qui tam actions concerning improper promotion of Abilify. Relators allege that, despite those agreements, the companies continued to promote Abilify off-label and offer kickbacks, causing claims for reimbursement for the drug to be submitted to the government, in violation of the False Claims Act (FCA), 31 U.S.C. 3729. The district court dismissed in part. The Sixth Circuit affirmed; the complaint did not satisfy Rule 9(b)’s requirement that relators adequately allege the entire chain to fairly show defendants caused false claims to be filed. As sales representatives, relators did not have personal knowledge of provider’s billing practices.The alleged plan was to increase Abilify prescriptions through improper promotion, which does not amount to conspiracy to violate the FCA. View "Ibanez v. Bristol-Myers Squibb Co." on Justia Law

Abilify is approved to treat schizophrenia, Bipolar Disorder, major depressive disorder and irritability associated with autism. There are no disapproved treatments for elderly patients, but the FDA has included a warning since 2007 that Abilify is associated with increased mortality in elderly patients with dementia-related psychosis. Relators, former BMS employees, alleged in a qui tam suit that BMS and Otsuka engaged in a scheme to encourage providers to prescribe Abilify for unapproved (off-label) uses and improperly induced providers to prescribe Abilify in violation of the Anti-Kickback Statute. Nearly identical allegations were leveled against the companies years earlier. In 2007-2008, the companies each entered into an Agreement as part of a settlement of qui tam actions concerning improper promotion of Abilify. Relators allege that, despite those agreements, the companies continued to promote Abilify off-label and offer kickbacks, causing claims for reimbursement for the drug to be submitted to the government, in violation of the False Claims Act (FCA), 31 U.S.C. 3729. The district court dismissed in part. The Sixth Circuit affirmed; the complaint did not satisfy Rule 9(b)’s requirement that relators adequately allege the entire chain to fairly show defendants caused false claims to be filed. As sales representatives, relators did not have personal knowledge of provider’s billing practices.The alleged plan was to increase Abilify prescriptions through improper promotion, which does not amount to conspiracy to violate the FCA. View "Ibanez v. Bristol-Myers Squibb Co." on Justia Law

This appeal involved two antipsychotic drugs primarily used to treat schizophrenia and bipolar disorder: Abilify Maitena, manufactured by Otsuka; and Aristada, manufactured by Alkermes. Otsuka sought judicial review, contending that the FDA's same-moiety limitation on the scope of a drug's marketing exclusivity conflicted with the Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. 355(a). The DC Circuit affirmed the district court's grant of summary judgment for the FDA and Alkermes, holding that the FDA's same-moiety test was a reasonable construction of the statute and was consistent with the agency’s regulations. View "Otsuka Pharmaceutical Co. v. Price" on Justia Law

Masters filed suit challenging the DEA's 2014 decision to revoke the company's certificate of registration, without which it cannot sell controlled substances. The DC Circuit denied the petition for review, holding that the Administrator's conclusions -- that whenever an order for controlled substances was held by the SOMS Computer Program, that order was presumptively "suspicious" under 21 C.F.R. 1301.74(b), and Masters' employees rarely undertook the investigation required to dispel the suspicion surrounding held orders -- were well founded. The court held that Masters failed to identify any prejudicial errors in the Administrator's decision. View "Masters Pharmaceutical, Inc. v. DEA" on Justia Law

The State of New Hampshire moved to enforce administrative subpoenas served on defendants Actavis Pharma, Inc., Endo Pharmaceuticals, Inc., Janssen Pharmaceuticals, Inc., Purdue Pharma L.P., and Teva Pharmaceuticals USA, Inc. The State was investigating defendants’ role in allegedly causing health care providers to prescribe opioids to treat chronic pain. Defendants resisted, arguing the Office of the Attorney General’s (OAG) engagement of outside counsel was unlawful. In addition, defendants moved for a protective order, seeking to “bar the Attorney General from engaging contingent fee counsel to: (a) participate in or assume responsibility for any aspect of the State’s investigation of alleged violations of the Consumer Protection Act . . . ; or (b) participate in or assume responsibility for any subsequent enforcement action pertaining to alleged CPA violations.” Defendants argued that the OAG’s fee agreements with the firm Cohen Milstein: (1) violated RSA 21-G:22 and :23 (2012) (amended 2016); (2) violated New Hampshire common law; (3) were ultra vires because the OAG did not comply with RSA 7:12 (2013) (amended 2016) or :6-f (Supp. 2016); (4) violated the doctrine of separation of powers; (5) violated the New Hampshire Rules of Professional Conduct; and (6) violated due process under the New Hampshire and United States Constitutions. The State replied that an objection to the Attorney General’s use of outside counsel was not appropriate justification for refusing to comply with lawful subpoenas, and that defendants lacked standing to raise that complaint. The trial court denied the State’s motion to enforce the subpoenas and granted the defendants’ motion for a protective order “to the extent that the OAG and Cohen Milstein’s contingency fee agreement is invalid.” The trial court determined that the defendants had demonstrated standing to bring their claims, that the fee agreement was void, and therefore denied the State’s motion to enforce the subpoenas on that basis. The New Hampshire Supreme Court concluded defendants lacked standing to challenge the outside counsel agreement. It reversed and remanded the matter for further proceedings. View "New Hampshire v. Actavis Pharma, Inc." on Justia Law