Justia Drugs & Biotech Opinion Summaries

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

Pountney was indicted for theft, identity fraud, and two counts of drug possession—one involving fentanyl and one involving acetaminophen with codeine. Pountney stipulated to the charges of theft, identity fraud, and possession of acetaminophen with codeine. Count 4 alleged that Pountney knowingly obtained, possessed or used at least five but not more than 50 times the "bulk amount" of fentanyl, R.C. 2925.11(A), a second-degree felony under R.C. 2925.11(C)(1)(c). The “bulk amount” of a Schedule II opiate or opium derivative, like fentanyl, is an amount equal to or exceeding 20 grams or five times the maximum daily dose in the usual dose range specified in a standard pharmaceutical reference manual. Pountney stipulated that he knowingly obtained 10 three-day transdermal fentanyl patches; each delivered 50 micrograms of fentanyl per hour. If the state proved that 10 patches equaled or exceeded five times the bulk amount of transdermal fentanyl, Pountney would be guilty of a second-degree felony; otherwise, he would be guilty of a fifth-degree felony. The court found Pountney guilty on all counts, including second-degree-felony aggravated possession of fentanyl. The Eighth District reversed with instructions to enter a finding of guilty on Count 4 as a fifth-degree felony. The Supreme Court of Ohio affirmed. Although there is no usual dose range of fentanyl, the state may not rely upon the usual dose range of morphine, the prototype opiate, to establish the bulk amount of fentanyl under R.C. 2925.01(D)(1)(d). View "State v. Pountney" on Justia Law

In this appeal arising from a demurrer, Plaintiffs could allege a cause of action against Novartis Pharmaceuticals Corporation for warning label liability.The Supreme Court affirmed the Court of Appeal, which directed the trial court to enter an order sustaining Novartis’s demurrer with leave to amend Plaintiffs’ negligence and negligent misrepresentation causes of action. Plaintiffs claimed, inter alia, that Novartis knew or should have known that its warning label failed to alert pregnant women or their doctors to the risk Brethine posed to fetal brain development. Novartis filed a demurrer, arguing that it had no duty to Plaintiffs. The trial court sustained the demurrer without leave to amend. The Court of Appeal reversed and directed that the order sustaining the demurrer be modified to grant Plaintiffs leave to amend their causes of action for negligence and negligent misrepresentation. The Supreme Court affirmed, holding (1) brand-name drug manufacturers have a duty to use ordinary care in warning about the safety risks of their drugs, regardless of whether the injured party was dispensed the brand-name or generic version of the drug; and (2) a brand-name manufacturer’s sale of the rights to a drug does not terminate its liability for injuries foreseeably and proximately caused by deficiencies present in the warning label prior to the sale. View "T.H. v. Novartis Pharmaceuticals Corp." 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 granted a writ of prohibition sought by Bayer Corporation and related entities (collectively, Bayer) directing the circuit court to dismiss nonresident Plaintiffs’ claims in a petition alleging personal injures from Essure, a female contraceptive device Bayer manufactures and distributes. Specifically, Bayer alleged that Missouri had no specific personal jurisdiction over eighty-five out of ninety-two plaintiffs, who were nonresidents of Missouri and did not allege that their injury occurred in Missouri. The Supreme Court vacated the circuit court’s order overruling Bayer’s motion to dismiss, holding that the petition did not assert any recognized basis for personal jurisdiction over Bayer with respect to nonresident Plaintiffs. View "State ex rel. Bayer Corp. v. Honorable Joan L. Moriarty" 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

A jury found William Scully guilty of mail and wire fraud and conspiracy to commit mail and wire fraud, conspiracy to defraud the United States through the introduction of misbranded drugs into interstate commerce, introduction of misbranded drugs into interstate commerce, receipt of misbranded drugs into interstate commerce and delivery thereof for pay, introduction of unapproved drugs into interstate commerce, and unlicensed wholesale distribution of prescription drugs. He was sentenced principally to 60 months in prison. The main issue on appeal was whether the district court properly excluded evidence relating to Scully’s advice-of-counsel defense. Because the Second Circuit found that the evidence was admissible and its exclusion was not harmless error, it vacated the district court’s judgment and remanded for further proceedings. View "United States v. Scully" on Justia Law

Sanofi’s patents describe and claim compositions and uses of the cardiovascular (antiarrhythmic) drug dronedarone. The 800 patent, which expires in 2019, claims pharmaceutical compositions containing dronedarone. The 167 patent, which expires in 2029, claims methods of reducing hospitalization by administering dronedarone to patients having specified characteristics. In 2009, Sanofii received New Drug Application approval for 400 mg tablets of dronedarone, sold as Multaq®. Both patents are listed in the FDA publication Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) as patents claiming either Multaq® or a method of using Multaq®. Defendants, hoping to market generic versions of Multaq®, filed abbreviated new drug applications with the FDA, certifying under 21 U.S.C. 355(j)(2)(A)(vii)(IV), their beliefs that both patents were invalid and/or that the manufacture, use, and sale of the proposed generic drugs would not infringe either patent. Sanofi sued for infringement under 35 U.S.C. 271(e)(2)(A). The district court ruled, and the Federal Circuit affirmed, that as to the 167 patent, Sanofi proved that sale of the proposed generic drugs, with the proposed labels, would induce physicians to infringe, and defendants did not prove that any asserted claims were invalid for obviousness. As to the 800 patent, the courts rejected the non-infringement argument. View "Sanofi v. Watson Laboratories 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

Petitioner, by and through her mother and next friend, was one of nineteen minor plaintiffs who alleged that they sustained birth defects as a result of their mothers’ use of the prescription medication Zoloft. The Mass Litigation Panel granted summary judgment to Respondents - Pfizer, Inc., Roerig, a division of Pfizer, Inc., and Greenstone, LLC - upon concluding that there existed no genuine issue of material fact and that Pfizer was entitled to judgment as a matter of law. The Supreme Court affirmed, holding that the Panel correctly concluded that (1) Michigan law governed Petitioner’s claims; (2) federal law operated to preempt the exception to Michigan’s failure to warn immunity where Zoloft has received FDA approval; (3) no genuine issues of material fact remained in the case; and (4) Respondents were entitled to judgment as a matter of law. View "M.M. v. Pfizer, Inc." on Justia Law