Justia Drugs & Biotech Opinion Summaries

After plaintiff filed suit against Mentor and Mentor Corporation for compensatory and punitive damages for injuries she suffered as a result of the surgical implantation of a polypropylene mesh sling manufactured by Mentor to treat her stress urinary incontinence, a jury found Mentor liable and awarded $400,000 in compensatory and $4 million in punitive damages. The district court upheld the jury's verdict with respect to liability and compensatory damages, but concluded that the punitive damages award exceeded Florida's statutory cap, reducing the punitive damages award to $2 million.The Eleventh Circuit affirmed, holding that the trial court acted well within the bounds of its discretion in allowing the jury to consider an expert's testimony relating to specific causation and Mentor was not entitled to judgment as a matter of law. The court also held that, in this case, which was focused on the physiological response to a design defect in a medical device, the dose-response relation was not implicated and there was no abuse of discretion in admitting the testimony. The court considered Mentor's remaining evidentiary challenges and held that the district court at no point exceeded the bounds of its discretion. Therefore, Mentor was not entitled to a new trial. Finally, the court affirmed the district court's reduction of the punitive damages award where evidence that Mentor knew of a high incidence of injury was not sufficient for finding a specific intent to harm. View "Taylor v. Mentor Worldwide, LLC" on Justia Law

Non-small cell lung cancer (NSCLC) was the leading cause of cancer deaths in 2000. The standard for treating NSCLC was chemotherapy, which ameliorated some lung cancer-related symptoms, but was limited in use due to toxicity. In response to a need for a therapy that would effective and well-tolerated, investigators pursued targeted therapies as alternatives to chemotherapy. A great majority of alternative therapies for NSCLC failed in clinical trials. One compound that ultimately gained FDA approval was erlotinib. OSI markets erlotinib under the name Tarceva®, which is covered by the 221 patent, which issued in 2005. On inter partes review, the Patent Board found certain claims unpatentable under 35 U.S.C. 103, in light of prior art and the 10-K disclosure filed by OSI with the Securities and Exchange Commission. The Federal Circuit reversed. Substantial evidence did not support the Board’s finding that the asserted combinations of prior art or prior art and the 10-K disclosures each would have provided a person of ordinary skill with a reasonable expectation of success in using erlotinib to treat NSCLC in a mammal. View "OSI Pharmaceuticals, LLC v. Apotex Inc" on Justia Law

In July 2012, Dr. William Sullivan prescribed Remicade, a medication manufactured by Janssen Biotech, Inc. ("JBI"), to Tim McKenzie as a treatment for Tim's psoriatic arthritis. Tim thereafter received Remicade intravenously every two weeks until November 2014, when he developed severe neuropathy causing significant weakness, the inability to walk without assistance, and the loss of feeling in, and use of, his hands and arms. Although Tim stopped receiving Remicade at that time, he and his wife, Sherrie, alleged they were not told that Remicade was responsible for his injuries. In December 2015, Tim traveled to the Mayo Clinic in Rochester, Minnesota, to receive treatment for his neuropathy. The McKenzies stated that while at the Mayo Clinic, Tim was eventually diagnosed with demyelinating polyneuropathy, and doctors told them that it was likely caused by the Remicade. In 2016, the McKenzies sued JBI and Dr. Sullivan in Alabama Circuit Court, asserting failure-to-warn, negligence, breach-of-warranty, fraud, and loss-of-consortium claims. The complaint filed by the McKenzies was not signed, but it indicated it had been prepared by Sherrie, who was not only a named plaintiff, but also an attorney and active member of the Alabama State Bar. Keith Altman, an attorney from California admitted pro hac vice in November 2017, assisted with the preparation of the complaint. The Alabama Supreme Court found it apparent from even a cursory review of the complaint, that it was copied from a complaint filed in another action. The complaint included numerous factual and legal errors, including an assertion that Tim was dead even though he was alive, and claims invoking the laws of Indiana even though that state had no apparent connection to this litigation. The trial court struck the McKenzies' initial complaint because it was not signed as required by Rule 11(a) and because it contained substantial errors and misstatements of fact and law. The trial court later dismissed the failure-to-warn and negligence claims asserted by the McKenzies in a subsequent amended complaint because that amended complaint was not filed until after the expiration of the two-year statute of limitations applicable to those claims. Because the trial court acted within the discretion granted it by Rule 11(a) when it struck the McKenzies' initial complaint and because the McKenzies did not establish that the applicable statute of limitations should have been tolled, the trial court's order dismissing the McKenzies' claims as untimely was properly entered. View "McKenzie v. Janssen Biotech, Inc." on Justia Law

Plaintiff Robert Kenney was a former employee of Defendant Helix TCS, Inc. (“Helix”), which provided security services for businesses in Colorado’s state-sanctioned marijuana industry. Kenney filed this lawsuit against Helix under the Fair Labor Standards Act (“FLSA”), alleging that Helix misclassified him and similarly situated workers as exempt from the FLSA’s overtime obligations. Helix moved to dismiss Kenney’s claim based on the Controlled Substance Act (“CSA”), arguing that Kenney’s employment activities were in violation of the CSA and are thus not entitled to FLSA protections. The Tenth Circuit concluded Helix wanted it to interpret the CSA in a manner implicitly repealing the FLSA’s overtime mandate for employers in the marijuana industry. The Tenth Circuit determined the “case law is clear that employers are not excused from complying with federal laws” because of their other federal violations. “Moreover, the purposes of the FLSA do not conflict with the CSA quite as directly as Helix implies. Helix cherry-picks among the enumerated purposes of the FLSA, citing only those most favorable to its arguments.” The Tenth Circuit did not draw conclusions about the merits of Kenney’s FLSA claims. Rather, the Court held only that Kenney and similarly situated individuals were not categorically excluded from FLSA protections. It therefore affirmed the denial of Helix’s motion to dismiss. View "Kenney v. Helix TCS" on Justia Law

RDC is a direct purchaser and wholesaler of Remicade, the brand name of infliximab, a “biologic infusion drug” manufactured by J&J and used to treat inflammatory conditions such as rheumatoid arthritis and Crohn’s disease. For many years, Remicade was the only infliximab drug available. That position was threatened when the FDA began approving “biosimilars,” produced by other companies and deemed by the FDA to have no clinically meaningful differences from Remicade. RDC alleged that J&J sought to maintain Remicade’s monopoly by engaging in an anticompetitive “Biosimilar Readiness Plan,” which consisted of imposing biosimilar-exclusion contracts on insurers that either require insurers to deny coverage for biosimilars altogether or impose unreasonable preconditions governing coverage; multi-product bundling of J&J’s Remicade with other J&J drugs, biologics, and medical devices; and exclusionary agreements and bundling arrangements with healthcare providers. RDC’s own contractual relationship with J&J is limited to a 2015 Distribution Agreement, which is not alleged to be part of J&J’s Plan. The Agreement contains an arbitration clause, applicable to any claim “arising out of or relating to the Agreement. Reversing the district court, the Third Circuit held that RDC’s antitrust claims do “arise out of or relate to” the Agreement and must be referred to arbitration. View "In re: Remicade (Direct Purchaser) Antitrust Litigation" on Justia Law

This case arose from the FDA's seizure from Hi-Tech a substantial quantity of products containing 1,3-dimethylamylamine or DMAA, which is used in fitness products aimed at bodybuilders and other athletes. The district court granted the FDA's motion for summary judgment, holding that the seizure of DMAA was both substantively and procedurally proper.The Eleventh Circuit affirmed and held that DMAA is not an "herb or other botanical" and is not a "constituent" of an herb or other botanical under the Dietary Supplement Health and Education Act of 1994. Furthermore, the court held that DMAA is not generally recognized by qualified experts, as adequately shown through scientific procedures, to be safe under the conditions of its intended use. The court also held that the district court did not abuse its discretion when it declined to reopen discovery, and Hi-Tech was afforded the full range of procedural due process available in federal court. View "United States v. Hi-Tech Pharmaceuticals, Inc." on Justia Law

Quidel Corporation (Quidel) petitioned for a writ of mandate and/or prohibition to direct the trial court to vacate its order granting summary judgment. Quidel contended the trial court incorrectly concluded a provision in its contract with Beckman Coulter, Inc. (Beckman) was an invalid restraint on trade in violation of Business and Professions Code section 16600. In 1996, Biosite Inc. (Biosite; Quidel is the successor in interest to Biosite) licensed patent rights and know-how related to a B-type natriuretic peptide (BNP), which can be measured in a person's blood. The semi-exclusive licensing agreement allowed Biosite to develop an immunoassay to determine the level of BNP in a person's blood sample, to help diagnose congestive heart failure. After acquiring the intellectual property rights and know-how, Biosite developed and created a BNP assay for use with its point-of-care analyzer device, and it obtained regulatory approval. By 2003, Beckman had developed a laboratory analyzer, but it did not have a license for a BNP assay compatible with its analyzer. Around this same time, other companies were also pursuing BNP assays for use with their larger analyzers, which could run multiple, different immunoassays at higher volumes than the point-of-care analyzer Biosite had. Collaborating would mean Biosite could expand its customer base to those who wanted to use the larger capacity laboratory analyzers and Beckman could include the BNP assay in its menu of immunoassay offerings. Biosite and Beckman negotiated the Agreement over several months, and they exchanged numerous drafts before executing it. The Agreement prohibited Biosite from engaging other manufacturers to provide the BNP assay for their competing lab analyzers. The term of the Agreement was negotiated to coincide with the term of a related licensing agreement Biosite had with another company, Scios. Section 5.2.3 of the Agreement prohibited Beckman from researching or developing an assay that detected the presence or absence of the BNP or NT-proBNP proteins or markers for use in diagnosing cardiac disease until two years before the Agreement's expiration. Beckman sued Quidel for declaratory relief for violation of section 16600 and violation of the Cartwright Act, asking the Court to declare section 5.2.3 of the Agreement was void and unenforceable and to issue a permanent injunction preventing the enforcement of section 5.2.3 of the Agreement. Quidel argued the trial court improperly extended the holding from Edwards v. Arthur Andersen LLP, 44 Cal.4th 937 (2008) beyond the employment context to section 5.2.3 of the Agreement. The Court of Appeal determined the trial court's per se application of section 16600 to section 5.2.3 of the Agreement between Quidel and Beckman was not correct, granted Quidel’s petition and issued a writ instructing the trial court to vacate the December 7, 2018 order granting summary adjudication on the first cause of action. View "Quidel Corporation v. Super. Ct." on Justia Law

Allergan’s patents, entitled “Combination of Brimonidine and Timolol for Topical Ophthalmic Use,” the Patents-in-Suit share a common specification that relates “to the topical ophthalmic use of brimonidine in combination with timolol . . . for treatment of glaucoma or ocular hypertension.” Allergan sued Sandoz, asserting that Sandoz’s Abbreviated New Drug Application (ANDA) for a generic version of Allergan’s ophthalmic drug Combigan® infringed those patents. The district court granted Allergan a preliminary injunction. The Federal Circuit affirmed, limiting a number of “wherein” clauses in the patents. Both Allergan and the Examiner explicitly relied on the “wherein” clauses to distinguish the claimed methods over the prior art during prosecution. The “wherein” clauses were neither unnecessary nor irrelevant. View "Allergan Sales, LLC v. Sandoz, Inc." on Justia Law

Arthrex’s 541 patent describes a surgical suture anchor used to reattach soft tissue to bone. The disclosed “fully threaded suture anchor” includes “an eyelet shield that is molded into the distal part of the biodegradable suture anchor.” In an inter partes review, the Patent Trial and Appeal Board ruled two claims invalid. In doing so, the Board employed different language than Smith & Nephew, Inc.’s petition to explain why a person of ordinary skill in the art would have been motivated to combine the teachings of the prior art. The Federal Circuit affirmed. The Board’s minor variation in wording does not violate the safeguards of the Administrative Procedure Act and did not deprive Arthrex of an opportunity to be heard. The Board’s findings have substantial evidence support, its claim constructions are correct, and Arthrex has not articulated a cognizable constitutional challenge to inter partes review for its patent. View "Arthrex, Inc. v. Smith & Nephew, Inc." on Justia Law

Plaintiffs own cats with health problems. Their veterinarians prescribed Hill’s cat food. They purchased this higher-priced cat food from PetSmart stores using their veterinarian’s prescriptions before learning that the Prescription Diet cat food is not materially different from non-prescription cat food and no prescription is necessary. Plaintiffs filed a class-action lawsuit under the Illinois Consumer Fraud and Deceptive Business Practices Act. The district judge dismissed the claim as lacking the specificity required for a fraud claim and barred by a statutory safe harbor for conduct specifically authorized by a regulatory body (the FDA). The Seventh Circuit reversed. The safe-harbor provision does not apply. Under the Food, Drug, and Cosmetic Act, 21 U.S.C. 301, pet food intended to treat or prevent disease and marketed as such is considered a drug and requires FDA approval. Without FDA approval, the manufacturer may not sell it in interstate commerce and the product is deemed adulterated and misbranded. FDA guidance recognizes that most pet-food products in this category do not have the required approval and states that it is less likely to initiate an enforcement action if consumers purchase the food through or under the direction of a veterinarian (among other factors). The guidance does not specifically authorize the conduct alleged here, so the safe harbor does not apply. Plaintiffs pleaded the fraud claim with the particularity required by FRCP 9(b). View "Vanzant v. Hill's Pet Nutrition, Inc." on Justia Law