Justia Drugs & Biotech Opinion Summaries

Merck’s 353 patent claims mometasone furoate monohydrate, the active ingredient in Merck’s Nasonex® nasal product. Amneal submitted an Abbreviated New Drug Application (ANDA) to the U.S. Food & Drug Administration (FDA) seeking approval to market a generic mometasone furoate nasal spray. In Merck’s infringement suit, the district court found that Merck failed to prove that Amneal’s ANDA product will infringe. The Federal Circuit affirmed, upholding the district court’s refusal to require Amneal to produce additional samples of its ANDA product for testing before trial. The court rejected a claim that the noninfringement finding must be reversed because it was not based on Amneal’s final commercial product. The district court did not clearly err in finding that a Raman spectroscopy three-peak analysis was required to confirm the infringing form of mometasone furoate in Amneal’s product. Raman spectroscopy is a vibrational spectroscopy technique. A laser is used to generate a Raman spectrum, which indicates the vibrational modes of molecules and can be used to differentiate crystalline forms. View "Merck Sharp & Dohme Corp. v. Amneal Pharmaceuticals LLC" on Justia Law

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

Testosterone replacement drugs have been FDA-approved prescription drugs for more than 60 years. In recent years, manufacturers have found a new market: older men. Numerous lawsuits were filed against manufacturers alleging that the drugs increase health risks. Cases alleging that the manufacturers failed to warn doctors and patients adequately about the risks, citing state product-liability laws, were consolidated for pretrial proceedings. The district court granted a motion to dismiss brought by Depo-T’s manufacturer, finding the failure-to-warn claims preempted by federal law. The court stated that DepoT’s manufacturers could not change their drug labels to add warnings because FDA regulations prohibit them from “making a unilateral labeling change.” The Seventh Circuit affirmed. In Wyeth v. Levine, the Supreme Court held that claims against a manufacturer of a brand-name prescription drug for failure to warn adequately of the drug’s dangers were not preempted by federal law.; in PLIVA v. Mensing, the Court held that such failure-to-warn claims against manufacturers of generic drugs are preempted. The Court cited the different regulatory requirements and processes for approving and labeling prescription drugs. Depo-T “does not fit neatly into the colloquial dichotomy between brand-name and generic drugs” so the Seventh Circuit focused on whether the FDA approved public sale of its drugs through the “new drug application” or through the “abbreviated new drug application” (ANDA) and stated that the FDA-approved label defines an ANDA holder’s duty of sameness and the lines of federal preemption. View "Guilbeau v. Pfizer Inc." 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

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