Justia Drugs & Biotech Opinion Summaries

Petitioners Wages and White Lion Investments, LLC, d/b/a Triton Distribution (“Triton”) and Vapetasia, LLC (“Vapetasia”) sought to market flavored nicotine-containing e-liquids for use in open-system e-cigarette devices. Petitioners needed to submit premarket tobacco product applications as required by 21 U.S.C. Section 387j—which the Food and Drug Administration (“FDA”) deemed applicable to e-cigarette tobacco products. FDA denied the requested marketing authorizations, finding that Petitioners failed to offer reliable and robust evidence (such as randomized controlled trials or longitudinal studies) to overcome the risks of youth addiction and show a benefit to adult smokers. Petitioners sought review of those marketing denial orders (“MDOs”), and prior to the consolidation of the two cases. Petitioners argued that the FDA lacks the authority to impose a comparative efficacy requirement and that FDA acted arbitrarily and capriciously by “requiring” scientific studies.   The Eleventh Circuit denied the petitions for review. The court explained that Congress passed the Family Smoking Prevention and Tobacco Control Act (“TCA”) in an active effort to protect public health. Relevant here, the Deeming Rule subjected e-cigarette manufacturers to the TCA’s prior authorization requirement—manufacturers of “new tobacco product[s]” must submit premarket tobacco product applications (“PMTAs”). The court held that the FDA’s consideration of the lack of cessation as a risk and comparing that risk between new tobacco products and old tobacco products “fall[s] squarely within the ambit of the FDA’s expertise and merit[s] deference.”  As such, the court cannot say that FDA acted arbitrarily and capriciously by disagreeing with Petitioners as to the significance of the evidence they presented. View "Wages and White Lion Investmen v. FDA" on Justia Law

The patents share the same specification and are entitled “Non-Invasive Diagnosis of Graft Rejection in Organ Transplant Patients.” They discuss diagnosing or predicting organ transplant status by using methods to detect a donor’s cell-free DNA (cfDNA). When an organ transplant is rejected, the recipient’s body, through its natural immune response, destroys the donor cells, releasing cfDNA from the donated organ’s dying cells into the blood. These increased levels of donor cfDNA—which occur naturally as the organ’s condition deteriorates—can be detected and then used to diagnose the likelihood of an organ transplant rejection.In an infringement action, the district court found the patents ineligible under 35 U.S.C. 101. The Federal Circuit affirmed. The court applied the Supreme Court’s two-part “Alice” test to determine whether the claims were patent-eligible applications of laws of nature and natural phenomena or claims that impermissibly tie up such laws and phenomena. The claims boil down to collecting a bodily sample, analyzing the cfDNA using conventional techniques, including PCR, identifying naturally occurring DNA from the donor organ, and then using the natural correlation between heightened cfDNA levels and transplant health to identify a potential rejection, none of which was inventive. This is not a case involving a method of preparation or a new measurement technique. View "CareDx, Inc. v. Natera, Inc" on Justia Law

The First Circuit affirmed the judgment of the district court resentencing Defendant while applying two sentencing enhancements under the United States Sentencing Guidelines, holding that both enhancements applied.Defendant, a former supervising pharmacist at the New England Compounding Center (NECC), was convicted for his conduct in connection with a criminal investigation into a 2012 deadly nationwide outbreak of fungal meningitis that was traced to the NECC's shipments of contaminated drugs. The district court sentenced Defendant to a term of imprisonment of ninety-six months. On appeal, the First Circuit vacated and remanded Defendant's sentence. On remand, the district court held that two enhancements applied to Defendant and resentenced him to a 126-month term of imprisonment. The First Circuit affirmed, holding that the district court did not err in applying the two enhancements. View "United States v. Chin" on Justia Law

To treat her endometriosis, Paulsen received Lupron injections in 2004 from her physician in Georgia. Shortly afterward she began experiencing health problems, including severe bone and joint pain, memory loss, and fevers. In April 2010, Paulsen filed a personal injury suit. Paulsen voluntarily dismissed her claims in 2014. In 2015, Paulsen filed a second lawsuit asserting product liability, negligence, breach of warranty, and misrepresentation. After several amended complaints and the addition of a defendant, two claims remained: a strict liability failure-to-warn claim against AbbVie and Abbott; and a negligent misrepresentation claim against Abbott. Limited discovery was permitted.The district court subsequently applied Illinois procedural law and Georgia substantive law, reasoning that Paulsen’s injury occurred in Georgia, and Illinois lacked a stronger relationship to the action, then granted the defendants summary judgment. The court ruled that Paulsen’s strict liability failure-to-warn claim was time-barred by Georgia’s 10-year statute of repose. Georgia does not recognize a stand-alone misrepresentation claim in product liability cases. Even if this cause of action did exist, the court reasoned, Paulsen’s misrepresentation claim would fail because “the undisputed evidence show[ed] that Abbott did not make any representations regarding Lupron.” The Seventh Circuit affirmed. The court noted extensive evidence that Paulsen’s claims accrued before April 2008 and are barred by the Illinois two-year statute of limitations for personal injuries. View "Terry Paulsen v. Abbott Laboratories" on Justia Law

Novartis markets a 0.5 mg daily dose of fingolimod hydrochloride under the brand name Gilenya, for treating relapsing-remitting multiple sclerosis, a debilitating immune-mediated demyelinating disease. There is currently no cure for MS. The disease is managed by reducing or preventing relapses and thereby slowing disability. HEC filed an Abbreviated New Drug Application (ANDA) seeking approval to market a generic version of Gilenya. Novartis sued, alleging that HEC’s ANDA infringes all claims of its patent. The Federal Circuit initially affirmed a holding that the patent is not invalid and that HEC’s ANDA infringes that patent.On rehearing, the Federal Circuit reversed. Because the Novartis patent fails to disclose the absence of a loading dose, the district court clearly erred in finding that the negative claim limitation “absent an immediately preceding loading dose” added during prosecution to overcome prior art satisfied the written description requirement of 35 U.S.C. 112(a). The specification nowhere describes “initially” administering a daily dosage. View "Novartis Pharmaceuticals Corp. v. Accord Healthcare, Inc." on Justia Law

In this case concerning the medical marijuana licensing and regulatory process the Supreme Court affirmed in part and dismissed in part this interlocutory appeal from the circuit court's denial of Defendants' motion to dismiss this action on the basis of sovereign immunity, holding that the circuit court erred in its ruling.Plaintiff brought this complaint seeking a writ of mandamus and declaratory relief to compel Defendants - the Arkansas Department of Finance and Administration, the Arkansas Alcoholic Beverage Control Division, and the Arkansas Medical Marijuana Commission - to revoke a cultivation facility license granted to another company and instead award it to Plaintiff. The circuit court denied Defendants' motion to dismiss on the doctrine of sovereign immunity. The Supreme Court remanded the action, holding (1) the circuit court did not err in denying the motion to dismiss the writ of mandamus on the basis of sovereign immunity; (2) the circuit court erred in denying gate State's motion to dismiss Plaintiff's claim of declaratory relief; and (3) to the extent that Appellants were seeking relief under the APA the case must be dismissed for lack of subject matter jurisdiction. View "Arkansas Department of Finance & Administration v. 2600 Holdings, LLC" on Justia Law

Donaldson sought treatment for stress urinary incontinence and anterior pelvic organ prolapse. In 2010, to remedy these conditions, Dr. Schultheis surgically implanted in Donaldson two transvaginal polypropylene mesh medical devices. Both were manufactured by a subsidiary of Johnson & Johnson. In 2014, Donaldson sought treatment for injuries resulting from erosion of the mesh into her bladder, vagina, and adjacent tissues, causing scarring, bladder stones, and abdominal pain, among other problems. Information sheets packaged with the devices warned of the risks of erosion but Donaldson never saw the warnings and contends that Dr. Schultheis did not inform her of these risks. Dr. Schultheis testified that he was aware of the possible complications and that he believed that the benefits of the devices outweighed the risks. He also testified that, in implanting the devices, he followed all of the manufacturer’s instructions.The Seventh Circuit affirmed summary judgment in favor of the manufacturers. Although there is no doubt that Donaldson suffered severe and painful complications after the devices were implanted, she failed to produce sufficient evidence to avoid summary judgment in her case for non-specific defects under Illinois product liability law. There was no evidence eliminating abnormal use or secondary causes, or that the device failed to perform as expected. View "Donaldson v. Johnson & Johnson" on Justia Law

Petitioner, a pharmaceutical company, is a drug manufacturer seeking to market various strengths and formulations of generic theophylline, a drug used to treat asthma and other respiratory conditions. To that end, Petitioner submitted a supplemental abbreviated new drug application to the Food and Drug Administration (“FDA”). This application remains pending. As part of the FDA’s review process, an agency division sent Nostrum a so-called “complete response letter” that flagged deficiencies in the application and explained how Nostrum could remedy them. Petitioner sought reconsideration of only a portion of the complete response letter, which the division denied.   Petitioner petitioned for review of the complete response letter and the denial of reconsideration. The DC Circuit rejected Petitioner’s application for reconsideration, holding that it lacks jurisdiction because neither agency action constitutes a final rejection of the application. Rather, a complete response letter is an interim step in the FDA’s consideration of an application. More must happen before the FDA’s final determination on the application is made. The facts of this case underscore the unfinished nature of the agency process at the complete-response-letter stage. Since petitioning this court for review, Petitioner has continued to press for approval of its still-pending application before the agency. View "Nostrum Pharmaceuticals LLC v. FDA" on Justia Law

The United States District Court for the Western District of Washington certified a question to the Washington Supreme Court, asking whether Washington law recognized an exception to the "learned intermediary doctrine" when a prescription drug manufacturer advertises its product directly to consumers. Under the learned intermediary doctrine, a prescription drug manufacturer satisfies its duty to warn patients of a drug’s risks when it adequately warns the prescribing physician. The Supreme Court answered the question in the negative: there was no direct-to-consumer advertising exception. "The policies underlying the learned intermediary doctrine remain intact even in the direct-to-consumer advertising context. Further, existing state law sufficiently regulates product warnings and prescription drug advertising. Accordingly, we hold regardless of whether a prescription drug manufacturer advertises its products directly to consumers, the manufacturer satisfies its duty to warn a patient when it adequately warns the prescribing physician of the drug’s risks and side effects." View "Dearinger v. Eli Lilly & Co." on Justia Law

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