Justia Drugs & Biotech Opinion Summaries

In 2017, Maryland enacted “An Act concerning Public Health – Essential Off-Patent or Generic Drugs – Price Gouging – Prohibition.” The Act, Md. Code, Health–General 2-802(a), prohibits manufacturers or wholesale distributors from “engag[ing] in price gouging in the sale of an essential off-patent or generic drug,” defines “price gouging” as “an unconscionable increase in the price of a prescription drug,” and “unconscionable increase” as “excessive and not justified by the cost of producing the drug or the cost of appropriate expansion of access to the drug to promote public health” that results in consumers having no meaningful choice about whether to purchase the drug at an excessive price due to the drug’s importance to their health and insufficient competition. The “essential” medications are “made available for sale in [Maryland]” and either appear on the Model List of Essential Medicines most recently adopted by the World Health Organization or are “designated . . . as an essential medicine due to [their] efficacy in treating a life-threatening health condition or a chronic health condition that substantially impairs an individual’s ability to engage in activities of daily living.” The Fourth Circuit reversed the dismissal of a “dormant commerce clause” challenge to the Act, finding that it directly regulates the price of transactions that occur outside Maryland. View "Association for Accessible Medicine v. Frosh" on Justia Law

The FDA approved Depakote for treating seizures, migraine headaches, and conditions associated with bipolar disorder. Physicians may prescribe it for other "off-label" uses, but a drug’s manufacturer can promote it only as suitable for uses the FDA has found safe and effective. Abbott, which makes Depakote, encouraged intermediaries to promote Depakote’s off-label uses for ADHD, schizophrenia, and dementia, hiding its own involvement. Abbott pleaded guilty to unlawful promotion and paid $1.6 billion to resolve the criminal case and False Claims Act suits, 31 U.S.C. 3729–33. Welfare-benefit plans that paid for Depakote’s off-label uses sought treble damages under the Racketeer Influenced and Corrupt Organizations Act, 18 U.S.C. 1964, for a class comprising all third-party payors. Following a remand, the court dismissed the suit on the ground that the plaintiffs could not show proximate causation, a RICO requirement. The Seventh Circuit affirmed, reasoning that the Payors are not the most directly, injured parties. Patients suffer if they take Depakote when it is useless and may be harmful and costly. Physicians also may lose, though less directly. Because some off-label uses of Depakote may be beneficial to patients, it is hard to treat all off-label prescriptions as injurious to the Payors; if they did not pay for Depakote they would have paid for some other drug. In addition, some physicians were apt to write off-label prescriptions whether or not Abbott promoted such uses. Calculation of damages would require determining the volume of off-label prescriptions that would have occurred absent Abbott’s unlawful activity. View "Sidney Hillman Health Center of Rochester v. Abbott Laboratories, Inc." on Justia Law

Consolidated appeals involve allegations that the patent-holders for Lipitor and Effexor XR delayed entry into the market by generic versions of those drugs by engaging in a monopolistic scheme that involved fraudulently procuring and enforcing the underlying patents, then entering into a reverse-payment settlement agreement with a generic manufacturer. In 2013, the Supreme Court recognized that reverse payment schemes can violate antitrust laws and that it is normally not necessary to litigate patent validity to answer the antitrust question. The district judge dismissed several claims. The Third Circuit remanded after rejecting an argument that plaintiffs’ allegations required transfer of the appeals to the Federal Circuit, which has exclusive jurisdiction over appeals from civil actions “arising under” patent law, 28 U.S.C. 1295(a)(1). Not all cases presenting questions of patent law necessarily arise under patent law; here, patent law neither creates plaintiffs’ cause of action nor is a necessary element to any of plaintiffs’ claims. Plaintiffs plausibly allege the existence of agreements between the patent holders and the generic manufacturers. The court remanded one of the Lipitor appeals, brought by California pharmacists, and involving claims solely under California law, for determination of whether remand to state court was appropriate. The Lipitor plaintiffs made plausible allegations of fraudulent patent procurement and enforcement, and other related misconduct. View "In re: Lipitor Antitrust Litigation" on Justia Law

Direct purchasers of Wellbutrin XL, a drug for treating depression, sued, alleging that GSK violated the Sherman Antitrust Act by entering into an unlawful conspiracy with Biovail, GSK’s partner in the development of Wellbutrin XL, to delay the launch of generic versions of the drug. Indirect-purchasers asserted similar theories under state law. The purchasers claim that GSK delayed the launch of generic versions by supporting baseless patent infringement suits and a baseless FDA Citizen Petition aimed at generic drug companies and by entering into an unlawful reverse payment settlement agreement with potential competitors. The district court granted GSK summary judgment, finding insufficient evidence that GSK’s patent litigation was a sham or that the settlement delayed the launch of generic Wellbutrin XL. The court granted GSK’s Daubert motion to exclude the testimony of the purchasers’ economic expert; decertified the indirect-purchaser class for lack of ascertainability; dismissed the indirect-purchaser claims brought under the laws of states that were not the home of a named class representative; and denied Aetna’s motion to intervene. The Third Circuit affirmed. After considering the Supreme Court’s 2013 decision, FTC v. Actavis, the court concluded that the purchasers failed to establish a genuine dispute of fact either as to whether GSK engaged in sham litigation or whether GSK’s actions delayed the launch of generic Wellbutrin XL. View "In re: Wellbutrin XL Antitrust Litigation" on Justia Law

The consolidated appeals involve allegations that the companies holding the patents for Lipitor and Effexor XR delayed entry into the market by generic versions of those drugs by engaging in an overarching monopolistic scheme that involved fraudulently procuring and enforcing the underlying patents and then entering into a reverse-payment settlement agreement with a generic manufacturer. In 2013, the Supreme Court recognized that reverse payment schemes can violate antitrust laws and that it is normally not necessary to litigate patent validity to answer the antitrust question. The district judge dismissed most of plaintiffs’ claims. The Third Circuit remanded after rejecting an argument that plaintiffs’ allegations required transfer of the appeals to the Federal Circuit, which has exclusive jurisdiction over appeals from civil actions “arising under” patent law, 28 U.S.C. 1295(a)(1). Not all cases presenting questions of patent law necessarily arise under patent law; here, patent law neither creates plaintiffs’ cause of action nor is a necessary element to any of plaintiffs’ well-pleaded claims. The court remanded one of the Lipitor appeals, brought by a group of California pharmacists and involving claims solely under California law, for jurisdictional discovery and determination of whether remand to state court was appropriate. View "In re: Lipitor Antitrust Litigation" on Justia Law

Amphastar Pharmaceuticals Inc. and its wholly owned subsidiary (collectively, Amphastar) and Sandoz Inc. were competitors in the U.S. market for generic enoxaparin, an anticoagulant. Momenta Pharmaceuticals Inc. served as Sandoz’s contract laboratory. Amphastar filed a complaint alleging antitrust violations by Sandoz and Momenta based on Defendants’ alleged misrepresentations to the United States Pharmacopeial Convention, a private standard-setting organization charged with ensuring the quality of drugs. Defendants brought an infringement suit against Amphastar, resulting in a temporary restraining order (TRO) and preliminary injunction prohibiting Amphastar from selling enoxaparin. The preliminary injunction was later vacated, but it did prevent Amphastar from selling its generic enoxaparin for approximately three months. Amphastar then filed this suit under the Sherman Act seeking damages for lost profits during the pendency of the TRO and injunction. The district court dismissed the complaint under the Noerr-Pennington doctrine, which immunizes good-faith petition of government entities from antitrust liability. The First Circuit reversed, holding that the district court erred in applying Noerr-Pennington. Remanded for the district court to consider Defendants’ other arguments in the first instance. View "Amphastar Pharmaceuticals, Inc v. Momenta Pharmaceuticals, Inc." on Justia Law

The district court certified eight classes, consisting of persons in Illinois and Missouri who take eye drops manufactured by six pharmaceutical companies for treatment of glaucoma. Plaintiffs claimed that the defendants’ eye drops are unnecessarily large and wasteful, in violation of the Illinois Consumer Fraud Act, 815 ILCS 505/1, and the Missouri Merchandising Practices Act, Mo. Rev. Stat. 407.010, so that the price of the eye drops is excessive and that the large eye drops have a higher risk of side effects. There was no claim that members of the class have experienced side effects or have been harmed because they ran out of them early. The Seventh Circuit vacated with instructions to dismiss. The court noted possible legitimate reasons for large drops, the absence of any misrepresentation or collusion, and that defendants’ large eye drops have been approved by the FDA for safety and efficacy. “You cannot sue a company and argue only ‘it could do better by us,’” nor can one bring a suit in federal court without pleading that one has been injured. The plaintiffs allege only “disappointment.” View "Eike v. Allergan, Inc." on Justia Law

Plaintiffs filed a class action alleging that Takeda prevented competitors from timely marketing a generic version of Takeda’s diabetes drug ACTOS by falsely describing two patents to the FDA. Plaintiffs claimed that these false patent descriptions channeled Takeda’s competitors into a generic drug approval process that granted the first-filing applicants a 180-day exclusivity period, which in turn acted as a 180-day "bottleneck" to all later-filing applicants. 9 out of 10 generic applicants took that route. Teva was prevented from seeking approval via another regulatory mechanism when the FDA announced that all generic manufacturers would be required to take the bottlenecked route. Plaintiffs alleged that they were wrongfully obligated to pay monopoly prices for ACTOS when Takeda's patent on the active ingredient in ACTOS expired when the mass of generic market entry occurred. The district court dismissed plaintiffs' antitrust claims. The court affirmed to the extent that plaintiffs' theory posits a delay in the marketing of generic alternatives to ACTOS by all the generic applicants other than Teva, because plaintiffs' theory presupposes that these applicants were aware of Takeda’s allegedly false patent descriptions when they filed their applications, which is not supported by well-pleaded allegations. However, the court concluded that plaintiffs' theory as to Teva does not require any knowledge of the false patent descriptions. Therefore, the court reached other issues as to Teva and found plaintiffs plausibly alleged that Takeda delayed Teva's market entry. Accordingly, the court affirmed in part, vacated in part, and remanded for further proceedings. View "In re ACTOS End-Payor Antitrust Litigation" on Justia Law

In 2009, Pfizer, settled claims that it had violated the False Claims Act (FCA), 31 U.S.C. 3729, and entered into a Corporate Integrity Agreement with the U.S. Department of Health and Human Services. Months later, Booker and Hebron, former Pfizer sales representatives, brought a qui tam action, allegedly on behalf of the United States and several states, asserting that Pfizer had continued to violate the FCA and state analogues. They alleged that Pfizer had continued to knowingly induce third parties to file false claims for payment for Pfizer drugs with government programs like Medicaid by marketing the drug Geodon for off-label uses, in violation of 21 U.S.C. 301, and paying doctors kickbacks for prescribing the drugs Geodon and Pristiq, in violation of the Anti-Kickback Statute, 42 U.S.C. 1320a-7b(b), (g). They also alleged that Pfizer had violated the FCA "reverse false claims" provision, 31 U.S.C. 3729(a)(1)(G), by failing to pay the government money owed it under Pfizer's Agreement with HHS, and that Pfizer had violated the FCA's anti-retaliation provision, by terminating Booker's employment. All of these claims were resolved against relators, one on a motion to dismiss and the rest on summary judgment. None of the sovereigns intervened. The First Circuit affirmed the merits decisions and found no error in its management of discovery. The court found relators’ data “woefully inadequate to support their FCA claim.” View "Booker v. Pfizer, Inc." on Justia Law

AstraZeneca, a drug manufacturer that owns the patents covering Nexium, a prescription heartburn medication, sued Ranbaxy for patent infringement after Ranbaxy announced that it sought to market a generic version of Nexium. The two companies reached a settlement agreement under which Ranbaxy agreed to delay the launch of its generic until a certain date in return for various promises from AstraZeneca. Plaintiffs - pharmaceutical retail outlets and certified classes of direct purchasers and end payers - filed suit, arguing that the terms of the settlement agreements violated federal antitrust laws and state analogues. The jury found that although Plaintiffs had proved an antitrust violation, Plaintiffs had not shown that they suffered an antitrust injury that entitled them to damages. The First Circuit affirmed, holding (1) the district court did not commit reversible error in its evidentiary rulings, the formulation of the special verdict form and jury instructions, or its judgment as a matter of law on overarching conspiracy; and (2) the jury verdict rendered harmless any error that may have occurred during the summary judgment proceedings. View "In re Nexium Antitrust Litigation" on Justia Law