Justia Drugs & Biotech Opinion SummariesArticles Posted in U.S. 3rd Circuit Court of Appeals
In Re: Diet Drugs Prod. Liab. Litig.
Between 1994 and 1997 Wyeth’s predecessor sold fenfluramine and dexfenfluramine, prescription weight loss drugs. After the drugs were linked to valvular heart disease and an FDA public health advisory, Wyeth withdrew the drugs from the market in 1997. Thousands of individuals filed suit; the cases were consolidated. In 1999, Wyeth entered into a Settlement Agreement; in 2000, the court certified the class, approved the Agreement, and retained jurisdiction. The Agreement enjoins class members from suing Wyeth for diet drug-related injuries, but allows class members to sue Wyeth if they can demonstrate that they developed PPH (a condition that deprives the lungs of oxygen) at a specified level through the use of the diet drugs. In 2011, Cauthen sued, alleging that she developed PPH. She produced a pulmonary consultation prepared by Fortin, a cardiologist. Because Cauthen’s report showed that lung capacity of less than 60 percent of predicted at rest, Wyeth sought to enjoin the state court lawsuit for failing to satisfy the precondition provided by the Agreement. Dr. Fortin asserted that comparing individual lung capacity with average capacity of persons having a similar demographic profile is not determinative in diagnosing PPH. The district court enjoined the suit. The Third Circuit affirmed. View "In Re: Diet Drugs Prod. Liab. Litig." on Justia Law
Ethypharm SA France v. Abbott Labs
Ethypharm, a French corporation, contracted with Reliant, an American company. Ethypharm would manufacture and provide its drug (Antara®); Reliant would obtain approval and market the drug. Reliant sought FDA approval under 21 U.S.C. 505(b)(2), using data from an approved, fenofibrate drug, TriCor®, developed by Fournier and distributed in the U.S. by Abbott. Antara received approval. Reliant began marketing and sought a declaration of non-infringement or unenforceability of Abbott’s patents. Abbott counterclaimed. In 2006, the companies settled: Abbott and Fournier would license the patents to Reliant and Reliant would pay royaltys. The agreement prohibited Reliant from assigning its rights to or partnering with specific companies. Reliant sold its rights to Oscient, which was not a prohibited purchaser. Losing market share to generic fenofibrate, Oscient discontinued promotion of Antara and filed for bankruptcy. Ethypharm sued Abbott, alleging antitrust and sham litigation under 15 U.S.C. 1, asserting that the settlement agreement was designed to ensure that Antara would be marketed by a company with “limited resources and a relatively small sales force,” so that it could not effectively compete with TriCor and that the royalty payment weakened Antara’s profitability. The district court granted Abbott summary judgment. The Third Circuit vacated, holding that Ethypharm lacked standing under the Sherman Act. View "Ethypharm SA France v. Abbott Labs" on Justia Law
In Re: Pharmacy Benefit Mgrs. Antitrust Litig.
AdvancePCS is a prescription benefits manager for plans sponsored by employers, unions, and others and is retained to achieve savings by negotiating discounts from drug manufacturers, providing mail order service, contracting with retail pharmacies, and electronic processing and paying of claims. Plaintiffs are retail pharmacies that entered into agreements with AdvancePCS that include an agreed reimbursement rate and an arbitration clause. In 2003, plaintiffs filed suit, asserting that AdvancePCS engaged in an unlawful conspiracy with plan sponsors to restrain competition in violation of the Sherman Act, 15 U.S.C. 1; that AdvancePCS used the economic power of its sponsors to reduce the contractual amount it pays below levels prevailing in a competitive marketplace; and that the agreements impose other limitations. For almost a year, AdvancePCS litigated without mentioning arbitration. After denial of a motion to dismiss and reconsideration, AdvancePCS filed an answer with affirmative defenses, then sought to compel arbitration. The court granted the motion. Plaintiffs did not initiate arbitration, but sought dismiss pending appeal. A different judge vacated the order compelling arbitration. The Third Circuit remanded with directions to reinstate the order compelling arbitration. On remand, a third judge granted dismissal. The Third Circuit ruled in favor of plaintiffs, holding that AdvancePCS waived its right to arbitrate. View "In Re: Pharmacy Benefit Mgrs. Antitrust Litig." on Justia Law
Borrome v. Att’y Gen. of the U.S.
Borrome, a citizen of the Dominican Republic, and, since 1996 a lawful permanent resident of the U.S. pled guilty in 2002 to violations of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 301-399d, prohibitions on unlicensed wholesale distribution of prescription “drugs” in interstate commerce. He was sentenced him to four months’ imprisonment followed by four months’ home confinement. In 2010 he was served with a notice of removal and the IJ reasoned that because Borrome’s offense involved unauthorized distribution of a Schedule II controlled substance (Oxycontin ), it is an aggravated felony under 8 U.S.C. 1101(a)(43)(B) pursuant to the “hypothetical federal felony test,” so that Borrome was removable under 8 U.S.C. 1227(a)(2)(B)(i) as an alien convicted of violating any law “relating to a controlled substance.” The Board of Immigration Appeals affirmed. Borrome has been removed from the United States. The Seventh Circuit reversed, concluding that violation of the FDCA wholesale distribution provisions does not constitute an aggravated felony and that those laws are not laws relating to a controlled substance. View "Borrome v. Att'y Gen. of the U.S." on Justia Law
In Re: K-Dur Antitrust Litigation
Schering held a patent on the controlled release coating applied to potassium chloride crystals for treatment of potassium deficiencies. Potential generic manufacturers filed an abbreviated application for approval (ANDA),Hatch-Waxman Act, 21 U.S.C. 301-399, asserting that the Schering patent was invalid or would not be infringed by their new generic drugs. Schering’s subsequent infringement suits were resolved through agreements in which it paid the generic manufacturers to drop patent challenges and refrain from producing a generic drug for a specified period. Congress amended Hatch-Waxman to require pharmaceutical companies who enter into such settlements to file for antitrust review. The FTC filed an antitrust action with respect to Schering’s settlements. Plaintiffs sued on behalf of a class of purchasers of the drug. The Third Circuit affirmed the district court’s certification of the class, but reversed its presumption that Schering’s patent was valid and gave Schering the right to exclude infringing products until the end of its term, including through reverse payment settlements. The court directed use of a “quick look rule of reason analysis” based on economic realities of the settlement rather than labels. The court must treat any payment from a patent holder to a patent challenger who agrees to delay entry into the market as prima facie evidence of unreasonable restraint of trade, rebuttable by showing that the payment was for a purpose other than delayed entry or offers some pro-competitive benefit. View "In Re: K-Dur Antitrust Litigation" on Justia Law
Humana Med. Plan Inc. v. GlaxoSmithKline LLC
Humana sued, alleging that Glaxo was obligated to reimburse Humana for expenses Humana had incurred treating its insureds’ injuries resulting from Glaxo’s drug, Avandia. Humana runs a Medicare Advantage plan. Its complaint asserts that, pursuant to the Medicare Act, Glaxo is in this instance a “primary payer” obligated to reimburse Humana as a “secondary payer.” The district court dismissed, agreeing with Glaxo that the Medicare Act did not provide Medicare Advantage organizations with a private cause of action to seek such reimbursement. The Third Circuit reversed and remanded. The Medicare Secondary Payer Act, in 42 U.S.C. 1395y(b)(3)(A), provides Humana with a private cause of action against Glaxo. Even if the provision is ambiguous, regulations issued by the Centers for Medicare and Medicaid Services make clear that the provision extends the private cause of action to MAOs. View "Humana Med. Plan Inc. v. GlaxoSmithKline LLC" on Justia Law
In Re: Schering Plough Corp.
Plaintiffs, a putative nationwide class of third-party payors and a putative nationwide class of individual patient-consumers who paid for prescriptions, sued pharmaceutical manufacturers alleging that they paid for oncology and hepatitis drugs that were ineffective or unsafe for the off-label uses for which they were prescribed and that defendants pursued illegal marketing campaigns to persuade physicians to prescribe the drugs for those uses. While physicians are not prohibited from prescribing drugs for off-label uses, manufacturers are generally prohibited by the Federal Food, Drug and Cosmetic Act, 21 U.S.C. 301, from manufacturing, marketing, or selling for off-label use. Defendant had pled guilty to a criminal charge brought by the FDA and agreed to pay fine of $180 million and to pay $255 million to resolve civil claims that it defrauded Medicare, Medicaid, and the VA. The district court dismissed, for lack of standing, claims under the Racketeer Influenced and Corrupt Organizations Act, 18 U.S.C. 1961, the New Jersey RICO statute, N.J.S. 2C:41-1, and other state statutory and common law causes of action. The Third Circuit affirmed, finding that plaintiffs failed to establish a causal connection between the alleged misconduct and the alleged harm. View "In Re: Schering Plough Corp." on Justia Law
United States v. Mullinix
Defendants, who operated what purported to be online pharmacies, were convicted on a 42-count indictment alleging crimes arising from a multi-national, internet-based, controlled-substance-distribution scheme. They have appealed multiple decisions of the trial court and appealed their conviction. The Third Circuit affirmed. Among other challenges, the court rejected arguments: that the money-laundering convictions impermissibly merge with underlying predicate felonies; that the district court should have suppressed evidence from untimely-sealed surveillance records; that the indictment, evidence, and jury instructions were insufficient to sustain a Continuing Criminal Enterprise conviction; and that the court erred in calculating sentences; the the alleged conduct, distribution of controlled substances via the internet, was not illegal at the time charged; that the money laundered was obtained by lawful means; and that certain convictions were misdemeanors, not felonies. View "United States v. Mullinix" on Justia Law