Articles Posted in Drugs & Biotech

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Defendants manufacture and distribute FDA-approved prescription eye drop medications for treating conditions such as glaucoma. Bottles are pre-packaged with a fixed volume of medication; labeling does not indicate how many doses or days of treatment a patient can extract from the bottle. The dimensions of the bottle’s dropper tip dictate the size of the drop dispensed. Scientific research indicates that a normal adult’s inferior fornix – the area between the eye and the lower eyelid – has a capacity of approximately 7-10 microliters (µLs) of fluid. If a drop exceeding that capacity is placed into an eye, excess medication is expelled, providing no pharmaceutical benefit to the patient. Expelled medication also may flow into a patient’s tear ducts and move into his bloodstream, increasing the risk of certain harmful side effects. These studies conclude that eye drops should be 5-15 µLs. Defendants’ products emit drops that are considerably larger so that at least half of every drop goes to waste. The Third Circuit reversed dismissal of a putative class action (Class Action Fairness Act, 28 U.S.C. 1332) under state consumer protection statutes. The consumers’ allegations of injury were sufficient to confer standing. Plaintiffs claim economic interests in the money they spent on medication that was impossible for them to use; their concrete and particularized injury claims fit comfortably in categories of “legally protected interests” readily recognized by federal courts. View "Cottrell v. Alcon Laboratories" on Justia Law

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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

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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

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In multi-district litigation involving 315 product liability claims, plaintiffs alleged that Pfizer’s drug, Zoloft, a selective serotonin reuptake inhibitor (SSRI), caused cardiac birth defects. The Plaintiffs’ Steering Committee introduced several experts to establish causation. The testimony of each of these experts was excluded in whole or in part. In particular, Nicholas Jewell, Ph.D., a statistician, used the “Bradford Hill” criteria to analyze existing literature on the causal connection between Zoloft and birth defects. The district court conducted a Daubert hearing, excluded Jewell's testimony, and granted summary judgment to defendants, stating that Jewell: “failed to consistently apply the scientific methods he articulates, has deviated from or downplayed certain well-established principles of his field, and has inconsistently applied methods and standards to the data so as to support his a priori opinion.” The Third Circuit affirmed, holding that the district court did not require replication of significant results to establish reliability, but merely made a factual finding that teratologists generally require replication of significant results, and this factual finding did not prevent it from considering other evidence of reliability. View "In Re: Zoloft t (Sertraline Hydrochloride) Products Liability Litigation" on Justia Law

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Qui tam relator failed to satisfy the False Claims Act’s materiality requirement in alleging that the manufacturer of a widely-prescribed cancer drug, Avastin, suppressed data that caused doctors to certify incorrectly that Avastin was “reasonable and necessary” for certain at-risk Medicare patients. Avastin is FDA-approved and has accounted for $1.13 billion a year in Medicare reimbursements. The relator, formerly the head of healthcare data analytics for the manufacturer, claimed the company ignored and suppressed data that would have shown that Avastin’s side effects for certain patients were more common and severe than reported and that such analyses would have required the company to file adverse event reports with the FDA, and could have resulted in changes to Avastin’s FDA label. He claimed the company caused physicians to submit Medicare claims that were not “reasonable and necessary.” The Third Circuit affirmed dismissal of the claim, stating the allegations may be true but a False Claims Act suit is not the appropriate way to address them. The manufacturer followed all pertinent statutes and regulations. If those laws and regulations are inadequate to protect patients, it falls to the other branches of government to reform them. View "Petratos v. Genentech Inc" on Justia Law

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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

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Hundreds of plaintiffs sued the drug manufacturer Merck, alleging that the osteoporosis drug Fosamax caused them to suffer serious thigh bone fractures. Each brought a state-law tort claim alleging that Merck failed to add an adequate warning of the risk to Fosamax’s FDA-approved drug label. Many also brought claims including defective design, negligence, and breach of warranty. Plaintiffs’ suits were consolidated in multi-district litigation in the District of New Jersey. Following discovery and a bellwether trial, the court granted Merck summary judgment, based on the Supreme Court’s holding in Wyeth v. Levine, that state-law failure-to-warn claims are preempted when there is “clear evidence” that the FDA would not have approved the warning that plaintiffs claim was necessary. The Third Circuit vacated. Preemption is an affirmative defense; Merck did not carry its burden to prove that it is entitled to that defense. The Wyeth “clear evidence” standard is demanding and fact-sensitive. It requires a court sitting in summary judgment to anticipate the range of conclusions that a reasonable juror might reach and the certainty with which the juror would reach them. Here, plaintiffs produced sufficient evidence for a reasonable jury to conclude that the FDA would have approved a properly-worded warning about the risk of thigh fractures—or to conclude that the odds of FDA rejection were less than highly probable. View "In Re: Fosamax Products Liability Litigation" on Justia Law

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Generic drug manufacturers (plaintiffs) originally sued name-brand drug companies (defendants) that manufacture and sell “Doryx,” the delayed-release doxycycline hyclate, an oral antibiotic of the tetracycline class used to treat severe acne. Tetracyclines are a broad category of antibiotics, the most common being doxycycline monohydrate and minocycline, which vary in their use and efficacy. Plaintiffs claimed that defendants conspired to protect their position in the market through “product hopping,” by making four critical changes to Doryx, all of which required generics to go through a cumbersome regulatory approval process if they wanted to continue to benefit from state substitution laws. Several plaintiffs settled their cases and the district court rejected, on summary judgment, remaining claims of unlawful monopoly and attempted monopolization under section 2 of the Sherman Act; agreement in restraint of trade under section 1 of the Sherman Act; and tortious interference with prospective contractual relationships under Pennsylvania law. The Third Circuit affirmed, finding that defendants’ conduct was not anticompetitive, and that, even if it was, it was not established that defendants had the requisite market power in the relevant product market. Adoption of plaintiffs’ theory of “anticompetitive product redesign” could have adverse, unintended consequences, including slowing innovation. View "Mylan Pharma. Inc v. Warner Chilcott Pub. Ltd. Co." on Justia Law

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Cephalon’s patent, issued in 1997, claimed a specific distribution of modafinil, used to treat sleep disorders. Cephalon obtained Reissue Patent 516 in 2002. Cephaolon’s use of modafinil was patent-protected until April 2015. In 1998, the FDA approved Cephalon’s New Drug Application (NDA) for the brand-name drug Provigil and granted New Chemical Entity exclusivity until December 2005, as an orphan drug. Cephalon later obtained six months of pediatric exclusivity, 21 U.S.C. 355a(c). Without the patent, Cephalon’s exclusivity would have ended in June 2006. In December 2002, four generic drug each independently filed an Abbreviated NDA seeking to sell generic modafinil. All four were treated as the first filer. Each application certification “automatically counts as patent infringement,” 35 U.S.C. 271(e)(2)(A)), so Cephalon sued all four, then entered into “reverse-payment settlements” to keep each out of the market. A putative class of wholesalers who purchased Provigil directly from Cephalon filed suit, alleging a global conspiracy involving Cephalon and the generic manufacturers, 15 U.S.C. 1; four separate conspiracies; and monopolization, 15 U.S.C. 2. A motion for class certification was filed after eight years of litigation. One month later the court granted defendants summary judgment on the antitrust conspiracy claim. The court certified the class after three defendants settled for $512 million. The Third Circuit vacated the class certification order and remanded for further consideration of whether joinder of all class members is impracticable. Plaintiffs have not met their burden of showing that the numerosity requirement of Rule 23(a)(1) was satisfied. View "In Re: Modafinil AntiTrust Litig." on Justia Law

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Hartig filed a putative class action, alleging antitrust violations involving medicated eyedrops manufactured by the Defendants. Hartig claimed that the Defendants’ wrongful suppression of generic competition resulted in supracompetitive pricing of those eyedrops. Although not a direct purchaser of the medications, Hartig claimed it had standing to sue because of an assignment of rights from Amerisource, a direct purchaser. The district court dismissed for lack of subject matter jurisdiction, finding that an anti-assignment clause in a distribution agreement between Allergan (the assignee of the named inventors) and Amerisource barred any assignment of antitrust claims from Amerisource to Hartig. The Third Circuit vacated; the district court erred in treating antitrust standing as an issue of subject-matter jurisdiction. The court distinguished between Article III standing and antitrust standing and stated that, when the correct procedures are followed, the court may consider the impact of the anti-assignment clause. View "Hartig Drug Co., Inc v. Senju Pharma. Co., Ltd" on Justia Law