Justia Drugs & Biotech Opinion Summaries

The case involves hundreds of plaintiffs who allege that they were injured by the drug Fosamax, manufactured by Merck Sharp & Dohme Corp. (Merck), due to inadequate warnings about the risk of atypical femoral fractures. The plaintiffs claim that they would not have taken the drug if they had been properly warned. Merck contends that it proposed a label change to the Food and Drug Administration (FDA) to address this risk, but the FDA rejected the proposed change due to insufficient scientific support.The United States District Court for the District of New Jersey granted summary judgment in favor of Merck, concluding that the plaintiffs' state law claims were preempted by federal law. The court found that Merck had fully informed the FDA of the justifications for the proposed warning and that the FDA had rejected the proposed label change, thus preempting the state law claims. The court relied on the FDA's Complete Response Letter and other communications to determine that the FDA's rejection was based on a lack of sufficient scientific evidence linking Fosamax to atypical femoral fractures.The United States Court of Appeals for the Third Circuit reviewed the case and vacated the District Court's judgment. The Third Circuit concluded that the District Court erred in its preemption analysis by giving too little weight to the presumption against preemption. The appellate court found that the FDA's Complete Response Letter was ambiguous and that the District Court placed too much reliance on informal FDA communications and an amicus brief to interpret the letter. The Third Circuit emphasized that the presumption against preemption is strong and that Merck did not meet the demanding standard of showing that federal law prohibited it from adding any and all warnings that would satisfy state law. The case was remanded for further proceedings. View "In re: Fosamax" on Justia Law

Titus’s solo medical practice, in its last 13 months, earned $1.1 million by distributing more than 20,000 prescriptions for Schedule II drugs. Titus often did only cursory physical examinations before prescribing opioids. He kept prescribing drugs despite signs that his patients were diverting or abusing them. At least two of Titus’s patients overdosed. Other doctors filed professional complaints. Titus closed his practice. Federal agents raided the homes of Titus and two of his employees and found thousands of patient files. Titus was indicted on 14 counts of unlawfully dispensing and distributing controlled substances (based on 14 prescriptions) and maintaining drug-involved premises, 21 U.S.C. 841(a)(1), (b)(1)(C), 856(a)(1).The government's statistician, using the Prescription Monitoring Program, identified 1,142 patients for whom Titus had prescribed controlled drugs, drew a random sample of 300 patients, and extrapolated to conclude that Titus had provided 29,323 controlled substance prescriptions to 948 patients with at least one inconsistent drug test and 1,552 such prescriptions to 352 patients he had already discharged from his practice. The government’s medical expert reviewed 24 of those files and determined that Titus had written illegal prescriptions for 18 of the patients.The district court held Titus responsible for at least 30,000 kilos, citing “general trial evidence” and extrapolating from the 24-file sample. The Third Circuit affirmed Titus’s convictions but vacated his 240-month sentence. The government failed to prove that extrapolating from a small sample satisfied its burden to prove the drug quantity by a preponderance of the evidence. View "United States v. Titus" on Justia Law

Mylan regularly submitted abbreviated new drug applications (ANDAs) to the FDA, often including Paragraph IV certifications stating that the proposed generic drug at issue would not infringe valid patents. Mylan incurred tens of millions of dollars in legal fees defending itself in about 120 patent infringement suits, 35 U.S.C. 271(e)(2). Mylan incurred additional, much lower legal fees in preparing the notice letters associated with the Paragraph IV certifications. Mylan's fees were $46,158,403, $38,211,911, and $38,618,993 during 2012, 2013, and 2014, respectively, for preparing notice letters and litigating the ANDA suits. In tax filings, Mylan deducted those amounts in the years incurred. The IRS responded that Mylan could not deduct the nearly $130 million of legal expenses incurred from 2012-2014 and that its additional tax liability was about $50 million.The Tax Court considered expert testimony regarding internal FDA processes and the typical course of dealing between an ANDA applicant and the FDA during the submission process for an ANDA with a paragraph IV certification and held that the legal expenses Mylan incurred to prepare notice letters were required to be capitalized because they were necessary to obtain FDA approval of its generic drugs. The Third Circuit affirmed its holding that the legal expenses incurred to defend patent infringement suits were deductible as ordinary and necessary business expenses because the patent litigation was distinct from the FDA approval process. View "Mylan Inc v. Commissioner of Internal Revenue" on Justia Law

Vepuri is the de facto director of KVK-Tech, a generic drug manufacturer. He employed Panchal as its director of quality assurance. KVK-Tech manufactured and sold Hydroxyzine, a prescription generic drug used to treat anxiety and tension. The government alleges that Vepuri, Panchal, and KVK-Tech sourced active ingredient for the Hydroxyzine from a facility (DRL) that was not included in the approvals that they obtained from the FDA and that they misled the FDA about their practices.An indictment charged all three defendants with conspiracy to defraud and to commit offenses against the United States and charged KVK-Tech with an additional count of mail fraud. The district court dismissed the portion of the conspiracy charge that alleges that the three conspired to violate the Food, Drug, and Cosmetic Act (FDCA), which prohibits introducing a “new drug” into interstate commerce unless an FDA approval “is effective with respect to such drug,” 21 U.S.C. 355(a).The Third Circuit affirmed, rejecting an argument that a deviation from the approved drug application means that the approval is no longer effective. The approval ceases being effective only when it has been withdrawn or suspended. The indictment does not include any allegations that the KVK-Tech Hydroxyzine manufactured with active ingredients from DRL had a different composition or labeling than the KVK-Tech Hydroxyzine with the effective approval. View "United States v. Vepuri" on Justia Law

A group consisting primarily of union health and welfare insurance plans claims that Abbvie, the manufacturer of the drug Niaspan, paid off a potential manufacturer of a generic version of the drug to delay the generic’s launch. This putative class action was brought to recover damages based on the allegedly inflated prices charged by Abbvie in violation of state antitrust and consumer protection laws. The district court denied a motion for class certification, finding that the class was not ascertainable.The Third Circuit affirmed, declining to reconsider its “ascertainability” requirement. The court rejected an argument that the district court’s factual findings were clearly erroneous because the court misunderstood their proposed methodology, overstated the prevalence of intermediaries in the pharmacy benefit managers’ data, and failed to consider the use of affidavits as a means of identifying class members. The court further noted that the new suggestion concerning affidavits was not properly put before the district court. The district court properly concluded that the proposed data matching technique is unreliable. View "In Re: Niaspan Antitrust Litigation" on Justia Law

Liposomal bupivacaine is a nonopioid pain medication that Pacira manufactures under the name EXPAREL; it is a local anesthetic administered at the time of surgery to control post-surgical pain. As of 2020, EXPAREL sales represented nearly all of Pacira’s total revenue. Pacira complains that the defendants, the American Society of Anesthesiologists, its journal, its editor, and authors published statements in a variety of forms, conveying their view that EXPAREL is “not superior” to standard analgesics or provides “inferior” pain relief.The Third Circuit affirmed the dismissal of Pacira’s suit for trade libel. Opinion statements are generally nonactionable. A “fair and natural” reading of the statements at issue shows that these are nonactionable subjective expressions. Pacira’s allegations boil down to disagreements about the reliability of the methodology and data underlying the statements; “a scientific conclusion based on nonfraudulent data in an academic publication is not a ‘fact’ that can be proven false through litigation.” Pacira failed to identify any aspect of the Articles, a Continuing Medical Education program, or a Podcast that “bring their conclusions outside the protected realm of scientific opinion.” View "Pacira Biosciences Inc v. American Society of Anesthesiologists Inc" on Justia Law

Drug makers participating in Medicare or Medicaid must offer their drugs at a discount to certain “covered entities,” which typically provide healthcare to low-income and rural individuals, 42 U.S.C. 256b, 1396r-8(a)(1), (5) (Section 340B). Initially, few covered entities had in-house pharmacies. A 1996 HHS guidance stated that covered entities could use one outside contract pharmacy each; a 2010 HHS guidance stated that covered entities could use an unlimited number of contract pharmacies. Drug makers thought that contract pharmacies were driving up duplicate discounting and diversion and adopted policies to limit any covered entity’s use of multiple contract pharmacies. A 2020 HHS Advisory Opinion declared that Section 340B required drug makers to deliver discounted drugs to an unlimited number of contract pharmacies.In 2010, Congress told HHS to establish a process for drug makers and covered entities to resolve Section 340B–related disputes. In 2016, HHS issued a notice of proposed rulemaking and accepted comments on the proposed ADR Rule. HHS subsequently listed the proposed rule as withdrawn. In 2020, HHS stated that it had just “paus[ed] action on the proposed rule,” responded to the four-year-old comments. and issued a final ADR Rule.Drug companies sued. The Third Circuit held that Section 340B does not require drug makers to deliver discounted drugs to an unlimited number of contract pharmacies. HHS did not violate the APA by purporting to withdraw the proposed ADR Rule before later finalizing it. View "Sanofi Aventis US LLC v. United States Department of Health and Human Services" on Justia Law

Liquid Labs manufactures and sells e-liquids that generally contain nicotine and flavoring for use in e-cigarettes. The e-liquids qualify as “new tobacco product[s]” under the Family Smoking Prevention and Tobacco Control Act, 21 U.S.C. 387-387u, and may not be introduced into interstate commerce without the FDA’s authorization. The FDA must deny a premarket tobacco product application (PMTA) if the applicant fails to “show[] that permitting such tobacco product to be marketed would be appropriate for the protection of public health,” as determined with respect to the risks and benefits to the population as a whole, including users and non-users of the tobacco product.” FDA Guidelines have highlighted that flavored e-liquids’ had a “disproportionate appeal to children.”Liquid Labs submitted PMTAs covering 20 e-liquid products and submitted a marketing plan setting forth plans to discourage youths from using its products. The FDA denied the PMTAs, concluding that Liquid Labs had not shown that the benefits of the products sufficiently outweighed the risks they posed to youths. The documents indicated that evidence could have been provided through “randomized controlled trial[s] and/or longitudinal cohort stud[ies],” or other evidence that reliably and robustly evaluated the impact of the new flavored vs. tobacco-flavored products on adult smokers’ switching or cigarette reduction over time.” The Third Circuit denied a petition for review. The FDA’s order was within its statutory authorities and the Administrative Procedure Act. View "Liquid Labs LLC v. United States Food and Drug Administration" on Justia Law

Guaranteed was a “reverse distributor,” paid by healthcare providers to return unused or expired pharmaceutical drugs to the drug manufacturers, for refunds for the healthcare-provider clients. Refunds were wired directly to Guaranteed’s general operating account; the company then issued refund checks to the relevant clients, less a service fee. In 2001, the Department of Defense contracted with Guaranteed. The government began investigating Guaranteed after the District of Columbia noticed that it did not receive the full refund on a return of some of its pharmaceuticals. The investigation uncovered a series of schemes that Guaranteed used to defraud its clients.Guaranteed, its CEO, and its CFO, were convicted of multiple counts of wire fraud, mail fraud, conspiracy to launder money, and theft of government property. In addition to prison sentences, the court imposed more than $100 million in restitution and forfeitures. The Third Circuit reversed the money laundering convictions and remanded for resentencing. Viewing the evidence in the light most favorable to the government, there is not sufficient evidence to prove beyond a reasonable doubt that the alleged complex financial transactions—after the initial receipt of “commingled” fraudulent and lawfully obtained funds—were designed for "concealment money laundering." The court otherwise affirmed, rejecting challenges to a search warrant, the sufficiency of the evidence, the jury instructions, and the court’s refusal to permit proposed expert testimony. View "United States v. Fallon" on Justia Law

The Third Circuit vacated in part the order of the district court denying OptumRX's (Optum) motion to compel arbitration in the underlying action alleging breaches of contract and breaches of duties of good faith and fair dealing and violations of certain state statutes, holding that the district court erroneously applied the incorrect standard in ruling on Optum's motion.More than 400 pharmacies brought suit against Optum, a pharmacy benefits manager responsible for administering prescription drug programs on behalf of health-insurance plans. Optum moved to compel arbitration based on arbitration agreements found in various contracts covering the majority of the pharmacies. The district court denied the motion in full, concluding that compelling the pharmacies to proceed with arbitration would be procedurally unconscionable. The Sixth Circuit vacated the judgment in part, holding that the district court erred by not adhering to Guidotti v. Legal Helpers Debt Resolution, LLC, 716 F.3d 764 (3d Cir. 2013). View "Robert D. Mabe, Inc v. OptumRX" on Justia Law