Justia Drugs & Biotech Opinion Summaries

In 2009, six-month-old Trystan received vaccines, including DTaP-HepB-IPV. Hours later, Trystan developed a fever and was in pain; he developed a hot lump on his thigh. Trystan’s mother took him to urgent care, where he was diagnosed with a “common cold.” Trystan’s arm contortions continued. At his one-year exam, Trystan could not stand, crawl, grasp, hold his head up while sitting, or attempt to move his lower extremities. Trystan received additional vaccinations. His arm contortions returned. Trystan had muscle spasms, developmental delays, seizures, dystonia, and other neurologic issues. In 2014, Trystan was diagnosed with Leigh’s syndrome, a severe neurological disorder that often presents in the first year of life, is characterized by progressive loss of mental and movement abilities, and typically results in death. Genetic testing showed that Trystan has two associated disease-causing mutations.His parents sought compensation under the Vaccine Act, 42 U.S.C. 300aa–1. The Claims Court upheld determinations that Trystan did not experience neurologic deterioration until many weeks after his 2009 vaccination and that Trystan’s genetic mutations solely caused his Leigh’s syndrome. The Federal Circuit reversed. Because the contortions began within two weeks of his vaccinations, Trystan has shown a logical chain of cause and effect between his vaccination and his neurodegeneration, satisfying his burden. He is entitled to compensation unless the Secretary establishes the injury was due to factors unrelated to the vaccine. There is no evidence that Trystan’s mutations would have resulted in the same progression and severity of his Leigh’s syndrome absent the vaccine. View "T.S. v. Secretary of Health & Human Services" on Justia Law

Johnson & Johnson, Ethicon, Inc., and Ethicon US, LLC (collectively, Ethicon) appealed after a trial court levied nearly $344 million in civil penalties against Ethicon for willfully circulating misleading medical device instructions and marketing communications that misstated, minimized, and/or omitted the health risks of Ethicon’s surgically-implantable transvaginal pelvic mesh products. The court found Ethicon committed 153,351 violations of the Unfair Competition Law (UCL), and 121,844 violations of the False Advertising Law (FAL). The court imposed a $1,250 civil penalty for each violation. The Court of Appeal concluded the trial court erred in just one respect: in addition to penalizing Ethicon for its medical device instructions and printed marketing communications, the court penalized Ethicon for its oral marketing communications, specifically, for deceptive statements Ethicon purportedly made during one-on-one conversations with doctors, at Ethicon-sponsored lunch events, and at health fair events. However, there was no evidence of what Ethicon’s employees and agents actually said in any of these oral marketing communications. Therefore, the Court of Appeal concluded substantial evidence did not support the trial court’s factual finding that Ethicon’s oral marketing communications were likely to deceive doctors. Judgment was amended to strike the nearly $42 million in civil penalties that were imposed for these communications. View "California v. Johnson & Johnson" on Justia Law

Congestive heart failure can be treated by resynchronization therapy, using electrical pacing leads to help keep the two sides of the heart contracting with regularity and in sync. According to Niazi's 268 patent, physicians previously accomplished resynchronization by inserting a catheter into the coronary sinus and its branch veins to place pacing leads on the hearts of patients; it can be “difficult to pass a lead” into the coronary sinus and its branch veins using a catheter. The 268 patent describes a double catheter, comprising an outer and inner catheter, for cannulating the coronary sinus “without significant manipulation.” Niazi sued for patent infringement, accusing combinations of St. Jude’s products of directly infringing the 268 patent and accusing St. Jude of inducing infringement.The Federal Circuit reversed the district court’s determination that all but one of the asserted patent claims are invalid as indefinite; when read in light of the intrinsic evidence, a person of ordinary skill in the art would understand the scope of the claims with reasonable certainty. Niazi failed to prove direct infringement—a necessary element of Niazi’s inducement claim. The court affirmed the entry of monetary sanctions and the exclusion of portions of Niazi’s technical expert and damages expert reports because Niazi failed to disclose predicate facts during discovery. The court upheld the exclusion of portions of Niazi’s damages expert report as unreliable. View "Niazi Licensing Corp. v. St. Jude Medical S.C., Inc." on Justia Law

Under "loyalty contracts," Physician Buying Groups (PBGs) members are entitled to discounts if they buy a large enough percentage of their vaccines from Merck. The loyalty contracts include an arbitration provision. Membership contracts between PBGs and medical practices give medical practices discounts on Merck vaccines for enrolling in PBGs. PBGs contract with both Merck and medical practices and are middlemen but PBGs never possess the vaccines. Medical practices buy their vaccines directly from Merck, receiving discounts for belonging to a PBG. The Pediatricians, members of PBGs that contracted with Merck, never signed contracts containing an arbitration clause.The Pediatricians filed federal suits alleging Merck’s vaccine bundling program was anticompetitive. Merck moved to compel arbitration. On remand, following discovery, the district court again denied Merck’s motion and granted the Pediatricians summary judgment, reasoning that the Pediatricians were not bound under an agency theory. The Third Circuit reversed. The PBG membership contract made the PBG a “non-exclusive agent to arrange for the purchase of goods and services,” and the PBG acted on this authority by executing the loyalty contract with Merck that included the arbitration clause. The Pediatricians simultaneously demonstrated intent to create an agency relationship and exercised control over the scope of the PBG’s agency by contract. View "In re: Rotavirus Vaccines Antitrust Litigation v." on Justia Law

The Supreme Court held that the federal Defend Trade Secrets Act (DTSA) prohibits disclosure, under the Nevada Public Records Act (NPRA), of documents from pharmaceutical companies and pharmacy benefit managers collected under S.B. 539.The Nevada Independent (TNI) filed a petition with the district court seeking an order directing the Department of Health and Human Services (DHHS) to release the documents at issue. The district court concluded that the documents were not subject to disclosure under the NPRA because the information contained in them comprised trade secrets protected under the DTSA. The Supreme Court affirmed, holding (1) because the DTSA classifies the requested documents, obtained pursuant to S.B. 539, as confidential trade secrets, the documents were exempt from disclosure under the NPRA; and (2) TNI's remaining allegations of error were without merit. View "Nevada Independent v. Whitley" on Justia Law

Almirall’s patent relates to methods of treating acne or rosacea with dapsone formulations that include an acrylamide/sodium acryloyldimethyl taurate copolymer (A/SA) thickening agent and the solvent diethylene glycol monoethyl ether (DGME), which allows compositions to be prepared with increased solubilized concentrations of dapsone. A polymeric viscosity builder such as an A/SA, can minimize the yellowing of the composition and can reduce the particle size, and minimize a gritty feel upon application. The Almirral patent includes 62 generalized composition embodiments and eight specific example formulations.On inter partes review, the Patent Trial and Appeal Board agreed that claims 1–8 would have been obvious over prior art at the time the alleged invention was made. The Federal Circuit affirmed. The Board’s decision sets forth factual findings of similarity between carbomers and A/SA agents that support its conclusion that prior art discloses a range for each component of the composition that either fully encompasses or overlaps/abuts the ranges and amounts for those components recited in the challenged claims, sufficient to create a presumption of obviousness. The court upheld the Board’s analysis of whether a skilled artisan would have had a reasonable expectation of success in combining prior art teachings to achieve the claimed invention. View "Almirall, LLC v. Amneal Pharmaceuticals, LLC" on Justia Law

Adapt’s patents-in-suit claim methods of treating opioid overdose by intranasal administration of a naloxone formulation, and devices for intranasal administration. Naloxone—the active ingredient in Adapt’s NARCAN® Nasal Spray—is an opioid receptor antagonist that blocks opioids from reaching the opioid receptors, helping reverse the effects of opioid overdose. Before the priority date of the patents-in-suit, numerous naloxone products had been used to treat opioid overdose. The patents-in-suit are listed in the FDA’s “Approved Drug Products with Therapeutic Equivalence Evaluations” “Orange Book.” Teva submitted to the FDA Abbreviated New Drug Application (ANDA) seeking approval to manufacture and sell a generic version of NARCAN®., with a Paragraph IV certification asserting that the patents-in-suit are invalid, unenforceable, and/or not infringed, 21 U.S.C. 355(j)(2)(A)(vii)(IV).Adapt sued Teva for infringement under 35 U.S.C. 271(e)(2). The Federal Circuit affirmed a holding that the asserted claims of the patents-in-suit would have been obvious in view of prior art. The district court’s findings, supported by ample evidence, provide a detailed explanation as to why a skilled artisan would have been motivated to combine the prior art references to arrive at the claimed invention. Prior art, as a whole, did not teach away from the claimed invention. The court rejected Adapt’s argument that its evidence of unexpected results, copying, skepticism, long-felt need, and failure of others indicated nonobviousness. View "Adapt Pharma Operations Ltd. v. Teva Pharmaceuticals USA, Inc." on Justia Law

An attorney sought guidance on how a physician could administer psilocybin to a terminally ill patient without incurring liability under the Controlled Substances Act (CSA), specifically asking the Drug Enforcement Administration (DEA) how the CSA would accommodate the Right to Try Act (amending the Food, Drug, and Cosmetic Act) to give patients the possibility of access to new investigational drugs under certain circumstances. The DEA responded by identifying the available exemptions in the CSA and indicating that the Right to Try Act did not create any additional exemptions.The Ninth Circuit dismissed a petition for review for lack of jurisdiction, reasoning that DEA’s response was not a final decision of the Attorney General under 21 U.S.C. 877. To be considered final, the agency action must mark the consummation of the agency’s decision-making process and must be one where rights or obligations have been determined, or from which legal consequences flow. The DEA’s response was the sort of advice letter that agencies prepare multiple times a year. There was no indication that the letter represented the consummation of a decision-making process. The letter did not lead to legal consequences for the prescribing physician but only provided guidance about the interaction of the Right to Try Act and the CSA. View "Advanced Integrative Medical Science Institute v. United States Drug Enforcement Administration" on Justia Law

The First Circuit affirmed the judgment of the district court ordering compliance with an administrative subpoena issued to Appellant by the United States Drug Enforcement Administration (DEA) pursuant to 21 U.S.C. 876, to produce certain prescription drug records of an individual, holding that there was no error.The instant subpoena was issued by the DEA pursuant to 21 U.S.C. 876 to produce the prescription drug records kept by New Hampshire's Prescription Drug Monitoring Program (the PDMP) of an individual. The district court ordered Appellant, who was then the PDMP program manager, to comply with the subpoena. The First Circuit affirmed, holding (1) the district court did not abuse its discretion in concluding that the subpoena was enforceable under 21 U.S.C. 876(c); and (2) the third-party doctrine applied to this case. View "U.S. Dep't of Justice v. Jonas" on Justia Law

The First Circuit affirmed the judgment of the district court dismissing a relator's qui tam action brought under the False Claims Act (FCA), 31 U.S.C. 3729 through 3733, holding that the district court did not err in dismissing the action.At issue before the First Circuit was the function of the hearing provided by statute when the government files a motion to dismiss a relator's FCA qui tam action over the relator's objections. The Court held (1) the government must provide its reasons for seeking dismissal such that the relator can attempt to convince the government to withdraw its motion at the hearing; (2) if the government does not agree to withdraw its motion, the district court should grant the motion unless the relator can show that, in seeking dismissal, the government is transgressing constitutional limitations or perpetrating a fraud on the court; and (3) the district court properly granted the government's motion to dismiss this case. View "Borzilleri v. Bayer AG" on Justia Law