Justia Drugs & Biotech Opinion Summaries

The First Circuit affirmed both of Defendant's federal racketeering-related convictions but vacated and remanded the prison sentence, forfeiture order, and restitution order, holding that the district court erred in several respects.Defendant was convicted of racketeering, racketeering conspiracy, federal mail fraud, and violating the Federal Food, Drug and Cosmetic Act (FDCA), 21 U.S.C. 331(a), 333(a). The district court sentenced Defendant to ninety-six months' imprisonment, issued a forfeiture order in the amount of $175,000, and ordered restitution. On appeal, Defendant challenged his convictions for racketeering and racketeering conspiracy and his sentence. The First Circuit remanded the case, holding (1) the convictions were supported by sufficient evidence; (2) the district court erred in its reasoning declining to apply certain enhancements; (3) neither of the two reasons the district court gave for limiting the forfeiture order was sustainable; and (4) the district court too narrowly construed who counts as a "victim" under the Mandatory Victims Restitution Act. View "United States v. Chin" on Justia Law

Plaintiffs, three cigar and pipe tobacco industry associations, filed suit challenging various provisions of the FDA's Deeming Rule, which subjects newly regulated tobacco products, including cigars and pipe tobacco, to requirements akin to those previously imposed by statute on cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco. Plaintiffs contend that the warning requirements for cigars and pipe tobacco violate the Tobacco Control Act and the Administrative Procedure Act because the FDA did not adequately consider how the warnings would affect smoking. Plaintiffs also argued that the warning requirements violate the First Amendment.The DC Circuit held that Congress required the FDA to consider whether any regulation under section 906(d)(1) of the Federal Food, Drug, and Cosmetic Act would likely affect the number of tobacco users. In promulgating the warning requirements for cigars and pipe tobacco, the court held that the FDA failed to satisfy that obligation. Therefore, the court reversed the district court's grant of summary judgment to the FDA and the denial of summary judgment to plaintiffs. The court dismissed as moot plaintiffs' appeal from the denial of their motion for a preliminary injunction. Finally, the court remanded for further proceedings. View "Cigar Association of America v. Food and Drug Administration" on Justia Law

Genentech manufactures and sells bevacizumab, a biological product used to treat certain types of cancer, under the name Avastin. Amgen filed a biologics license application, 42 U.S.C. 262(k) to market a biosimilar version of Avastin—Mvasi. Mvasi received FDA approval effective September 2017. In October, Amgen notified Genentech of its intent to commercially market Mvasi starting no earlier than 180 days from the date of the letter. In August 2018, Amgen filed a third supplement to its Mvasi application to add a manufacturing facility and a fourth supplement to change its drug label. By July 2019, Amgen decided it would commercially launch Mvasi, intending to market it immediately. Genentech filed motions, seeking to preclude Amgen from commercially marketing Mvasi until Amgen “provides notice of its intent to commercially market such product” pursuant to 42 U.S.C. 262(l)(8) and 180 days have elapsed,” arguing that Amgen’s third and fourth supplements resulted in new and distinct applications that require new notices. The Federal Circuit affirmed the denial of the motions, reasoning that Amgen’s October 2017 commercial marketing notice for Mvasi satisfied Section 262(l)(8)(A)’s notice requirements. View "Genentech, Inc. v. Immunex Rhode Island Corp." on Justia Law

Plaintiffs filed suit against Mentor, alleging causes of action for negligence and negligence per se based on Mentor's negligent failure to warn and negligent manufacturing of breast implants, strict products liability for failure to warn, and strict products liability for manufacturing defects.The Court of Appeal reversed the trial court's judgment and entered an order overruling the demurrer to the third amended complaint. The court held that the tort claims in this case survive preemption because they are premised on conduct that both violates the Medical Device Amendments (MDA) to the Food, Drug, and Cosmetics Act and would give rise to a recovery under state law even in the absence of the MDA. The court also held that plaintiffs pleaded the requisite causal connection between their injuries and Mentor's tortious acts to survive a demurrer. Finally, the trial court erroneously sustained Mentor's demurrer to the loss of consortium claim because it was derivative of the other claims. View "Mize v. Mentor Worldwide LLC" on Justia Law

The patents at issue are directed to the fusion protein etanercept and methods of making the same. Etanercept is the active ingredient in Immunex’s biologic drug Enbrel®, which is primarily indicated for reducing the signs and symptoms of moderately to severely active rheumatoid arthritis, an autoimmune disorder. Sandoz filed an abbreviated Biologics License Application (aBLA), seeking approval to market Erelzi, a biosimilar version of Enbrel®. In a patent infringement suit under the Biologics Price Competition and Innovation Act, Sandoz stipulated to infringement of the asserted claims of the patents-in-suit. The district court held that Sandoz had failed to prove that the asserted claims of the patents-in-suit were invalid. The Federal Circuit affirmed, rejecting claims of obviousness-type double patenting; failure to meet the written description requirement; and obviousness. View "Immunex Corp v. Sandoz Inc." on Justia Law

In July 2010, L.M. was born at full-term and developed normally for six months. In February 2011, L.M. received childhood vaccines, including the diphtheria-tetanus-acellular pertussis vaccination. By that evening, L.M. had a fever, was lethargic, had poor muscle tone, and would not eat., Any disturbance caused L.M. to scream. L.M. began to have several seizures a day. At seven years of age, L.M. could crawl and walk with the assistance of a walker. She had a poorly coordinated grasp, suffered cortical visual impairments, and was nonverbal, though she could use a few signs to express ideas such as “yes,” and “no.” Testing revealed that L.M. had a genetic mutation.In a claim under the National Vaccine Injury Compensation Program, L.M. alleged that the vaccinations administered to L.M. in February 2011, significantly aggravated L.M.’s pre-existing condition under two alternative theories. The Special Master denied the petition, finding that L.M.’s genetic mutation was “the most compelling explanation for her predisposition to develop a seizure disorder.” The Federal Circuit affirmed the denial of an “on-table” claim, finding no support for an argument that most encephalopathies do not become acute until after vaccination. The court vacated and remanded the denial of an “off-table” claim, which requires determining whether the child’s receipt of vaccinations significantly aggravated her seizure disorder in the face of an underlying genetic mutation. View "Sharpe v. Secretary of Health and Human Services" on Justia Law

Drug manufacturers challenged the Department's rule that broadly requires drug manufacturers to disclose in their television advertisements the wholesale acquisition cost of many prescription drugs and biological products for which payment is available under Medicare or Medicaid.The DC Circuit affirmed the district court's judgment in favor of the drug manufacturers, holding that the Department acted unreasonably in construing its regulatory authority to include the imposition of a sweeping disclosure requirement that is largely untethered to the actual administration of the Medicare or Medicaid programs. The court explained that, in the overwhelming majority of cases, the price that the rule compels manufacturers to disclose bears little resemblance to the price beneficiaries actually pay under the Medicare and Medicaid programs. Therefore, the court held that there is no reasoned statutory basis for the Department's far-flung reach and misaligned obligations, and thus the rule is invalid and is hereby set aside. View "Merck & Co., Inc. v. United States Department of Human and Health Services" on Justia Law

The First Circuit affirmed the district court's judgment reversing the magistrate's order that had quashed an administrative subpoena duces tecum as to the recordings of certain telephone conversations, holding that the magistrate judge clearly erred in finding that Appellants met their burden of proving that an employer's interception of the telephone calls was intentional.When investigating whether Patient Services, inc. (PSI) had engaged in an illegal kickback scheme, the Government issued an administrative subpoena duces tecum to PSI for all recorded conversations of PSI officers and employees. This appeal concerned conversations that were recorded on the extension of Karen Middlebrooks. Middlebrooks's telephone conversations were recorded while she was working in PSI's call center on the second floor where calls were regularly recorded. At issue was whether PSI intentionally continued recording Middebrooks's calls after her transfer to the third floor, where calls were not regularly recorded, in violation of Title III of the Omnibus Crime Control and Safe Streets Act. The magistrate judge ruled that the recordings violated Title III. The district court reversed. The First Circuit affirmed, holding that the magistrate judge clearly erred in finding that Appellants met their burden of proving that PSI's interception of calls from Middlebrooks's extension after her move to the third floor was intentional. View "In re HIPAA Subpoena" on Justia Law

Essure--permanent birth control for women--originally was manufactured and developed by Conceptus, a California corporation. Bayer bought Conceptus. Bayer marketed Essure as safer and more effective than other birth control. Two residents of Madison County, Illinois, filed personal injury complaints, alleging that Essure caused debilitating pain, heavy bleeding that necessitated medication, and autoimmune disorders. including 179 plaintiffs from at least 25 states. Months later, the U.S. Supreme Court issued its “Bristol-Myers” decision. Bayer argued that, following Bristol-Myers, a court cannot exercise specific personal jurisdiction over an out-of-state defendant as to the claims of out-of-state plaintiffs when the conduct giving rise to the claims did not occur in the forum state. The plaintiffs argued Illinois courts had specific personal jurisdiction over Bayer because it “created the Essure Accreditation Program and the marketing strategy for Essure in Illinois,” conducted clinical trials in Illinois, and used Illinois as a testing ground for its physician training program. The appellate court affirmed the denials of motions to dismiss: Bayer “conducted a part of its general business in Illinois, and [p]laintiffs’ claims arose out of" trials conducted, in part, in Illinois.The Illinois Supreme Court reversed. The nonresident plaintiffs identified no jurisdictionally relevant links between their claims and Illinois. The nonresidents have not explained how Illinois could be a convenient location for this litigation; they were not implanted with their devices here and have identified no other activity that would connect their specific claims to Illinois. Many nonresident plaintiffs initiated duplicate actions in California, indicating that the interests of judicial economy are not furthered by permitting their claims to proceed in Illinois. A corporation’s continuous activity of some sort within a state is not enough to render the corporation subject to suits unrelated to that activity. View "Rios v. Bayer Corp." on Justia Law

Plaintiffs, two adolescents who were prescribed the antipsychotic drug risperidone after it was approved by the FDA to treat behavioral symptoms in children with autism, filed suit against Janssen for failure to adequately warn of the risk of gynecomastia on the drug's label.In the published portion of the opinion, the Court of Appeal held that the trial court was correct to decide the issue of preemption without submitting any purported underlying factual questions to a jury. The court also held that Janssen did not meet its burden to establish its preemption defense and that plaintiffs' claims based on the information in table 21, studies 41 and 70, are not preempted. In this case, Janssen did not meet its burden to show by clear evidence that it fully informed the FDA and, in turn, the FDA rejected a proposed label change. View "Risperdal and Invega Cases" on Justia Law