Justia Drugs & Biotech Opinion Summaries

The FDA last approved a typical antipsychotic in 1975. Despite drawbacks, typical antipsychotics are still used to treat schizophrenia. In the early 1960s, researchers discovered clozapine, the first "atypical" antipsychotic, useful for treating both positive and negative symptoms. Clozapine had serious potential side effects and was withdrawn from clinical trials. The FDA approved no new antipsychotic drugs between 1976 and 1989, finally approving clozapine in 1990, only for certain patients, subject to blood testing. The FDA approved risperidone, an atypical antipsychotic, in 1994, and, since then, has approved seven other atypical antipsychotics, including aripiprazole. These are as effective as typical antipsychotics for treating positive symptoms, while also treating negative symptoms and causing fewer side effects than clozapine. Every approved atypical antipsychotic has chemical structure related either to clozapine or risperidone, except aripiprazole, the active ingredient in "Abilify," marketed by plaintiff for treatment of schizophrenia, bipolar disorder, irritability associated with pediatric autistic disorder, and as add-on treatment for depression. Anticipating expiration of the patent, companies submitted FDA Abbreviated New Drug Applications for approval of generic aripiprazole. The district court ruled in favor of plaintiff on patent infringement, 35 U.S.C. 103. The Federal Circuit affirmed, rejecting claims of obviousness and of nonstatutory double patenting. View "Otsuka Pharm. Co., Ltd. v. Sandoz, Inc." on Justia Law

Plaintiff's doctor prescribed, for shoulder pain, sulindac, a non-steroid anti-inflammatory, under the brand-name Clinoril; her pharmacist dispensed generic sulindac. She developed a hypersensitivity reaction, toxic epidermal necrolysis, with which the outer skin layer on a patient's body has deteriorated, been burned off or turned into an open wound. Plaintiff spent 70 days at Massachusetts General Hospital, more than 50 in its burn unit, with 60-65 percent of her skin affected. Her "truly horrific" injuries include permanent near-blindness. Her claims against the manufacturer included breach of warranty, fraud, and negligence, and products liability claims: design defect, failure to warn, and manufacturing defect. By trial, the remaining theory of design defect was narrowed to a claim that sulindac's risks outweighed its benefits making it unreasonably dangerous to consumers, despite the FDA having never withdrawn its statutory "safe and effective" designation. A jury awarded $21.06 million in compensatory damages. The First Circuit affirmed, rejecting claims including that the district court misunderstood New Hampshire law on design defect claims; that such claims as to generic drugs are preempted under federal law; that causation was not proved; and that damages were excessive and required a new trial. .View "Bartlett v. Mut. Pharm. Co., Inc." on Justia Law

Plaintiffs sought compensation under the National Vaccine Injury Compensation Program, 42 U.S.C. 300aa, for injuries to their children allegedly caused by the Diptheria-Tetanus-acellular Pertussis vaccine. The children suffer a seizure disorder, known as Severe Myoclonic Epilepsy of Infancy. The same special master presided over both cases and determined that plaintiffs failed to show entitlement to compensation because evidence showed that a gene mutation present in both children was the sole cause of their injuries. The Court of Federal Claims affirmed. The Federal Circuit affirmed, noting considerable evidentiary support for the conclusion. View "Stone v. Sec'y of Health & Human Servs." on Justia Law

Plaintiffs are a dissident group, within a larger class of medical patient consumers in a case alleging fraud in overcharging for the medication Lupron. The patients, along with insurers and private health care providers, obtained a $150 million settlement agreement that was approved by the district court, of which $40 million was allocated to consumers. That agreement provided that if there were unclaimed monies from the $40 million consumer settlement pool after full recovery to consumer plaintiffs, all unclaimed funds would go into a cy pres fund to be distributed at the discretion of the trial judge. Dissident plaintiffs appealed distribution of the $11.4 million cy pres fund to the Dana Farber/Harvard Cancer Center and the Prostate Cancer Foundation for work on the treatment of the diseases for which Lupron is prescribed. They have already recovered more than 100% of their actual damages. The First Circuit affirmed. After expressing concern about distribution of such funds by judges and adding an audit requirement, the court noted the importance of avoiding windfalls for plaintiffs who have already been fully compensated. View "Rohn v. Dana Farber/Harvard Cancer Ctr." on Justia Law

The patent claims at issue covered processes that help doctors who use thiopurine drugs to treat patients with autoimmune diseases determine whether a given dosage level was too low or too high. The claims purported to apply natural laws describing the relationships between the concentration in the blood of certain thiopurine metabolites and the likelihood that the drug dosage would be ineffective or induce harmful side-effects. At issue was whether the claimed processes have transformed these unpatentable natural laws into patent-eligible applications of those laws. The Court concluded that they have not done so and that therefore the processes were not patentable. The steps in the claimed processes involved well-understood, routine, conventional activity previously engaged in by researchers in the field. At the same time, upholding the patents would risk disproportionately tying up the use of the underlying natural laws, inhibiting their use in the making of further discoveries. Therefore, the Court reversed the judgment of the Federal Circuit. View "Mayo Collaborative Services v. Prometheus Laboratories, Inc." on Justia Law

Plaintiffs opposed the use of vaccines that contain thimerosal, a mercury-based preservative, and believed that vaccines containing mercury harm young children and pregnant women. Plaintiffs filed an action alleging that the FDA, by allowing thimerosal-preserved vaccines, violated its statutory duty to ensure the safety of vaccines. Plaintiffs asked for a court order requiring the FDA to prohibit the administration of vaccines containing more than a trace level of thimerosal to young children and pregnant women and sought to force the FDA to remove thimerosal-preserved vaccines from the market. The district court dismissed the suit for lack of standing. The court concluded that plaintiffs were not required to receive thimerosal-preserved vaccines; they could readily obtain thimerosal-free vaccines; they did not have standing to challenge the FDA's decision to allow other people to receive the vaccines; and plaintiffs could advocate that the Legislative and Executive Branches ban the vaccines. But because plaintiffs were suffering no cognizable injury as a result of the FDA's decision to allow the vaccine, their lawsuit was not a proper subject for the Judiciary. Accordingly, the court affirmed the judgment of the district court. View "Coalition for Mercury-Free Drugs, et al. v. Sebelius, et al." on Justia Law

Defendant was the pharmacy director of a medical center and had influence over decisions concerning which drugs to stock. Levato was the local business manager of a pharmaceutical company. Levato agreed to pay defendant $18,000 not to switch away from his company's drug, and made computer entries recording nine nonexistent speeches given by defendant for the pharmaceutical company; defendant later received another $14,000 for more fictitious speeches. After investigation by an FDA agent, Levato and defendant were indicted. Levato plead guilty and testified against defendant. Defendant was convicted of solicitation and receipt of kickbacks and sentenced to 22 months in prison. The Seventh Circuit affirmed. Memoranda prepared by the Department of Health and Human Services, discovered by the prosecution after trial, did not constitute exculpatory material withheld by the prosecution. The court noted that the documents would have strengthened the prosecution case. View "United States v. Muoghalu" on Justia Law

Plaintiffs, citizens of New York, sued pharmaceutical companies (defendants) in New York state court claiming that defendants' hormone replacement therapy drugs caused plaintiffs to develop breast cancer. At issue was whether dismissal of plaintiffs' actions as time-barred under New York law precluded assertion of the same claims in a federal court diversity action in a State where the claims would not be time-barred. The court held that under New York claim preclusion law as articulated in Smith v. Russell Sage College and the many New York appellate decisions applying Russell Sage, the prior grant of summary judgment dismissing plaintiffs' New York claims as time-barred precluded the assertion of the same claims in these federal diversity actions in Minnesota. Therefore, the district court properly applied the Full Faith and Credit Statute in these cases, even if the New York Court of Appeals declined in the future to apply statute-of-limitations claim preclusion to more sympathetic plaintiffs. View "Rick, et al. v. Wyeth, Inc., et al." on Justia Law

Defendant was found guilty of two federal offenses: one count of aiding and abetting a violation of the so-called Medicare anti-kickback statute, in violation of 42 U.S.C. 1320a-7b(b)(2) and 18 U.S.C. 2, and one count of aiding and abetting the falsification of a document, in violation of 18 U.S.C. 1519 and 2. Defendant raised several claims on appeal. The court held that the district court did not err in admitting testimony concerning statements made by defendant's wife during her interview with the FBI; in admitting evidence under Federal Rule of Evidence 404(b) that defendant stole funds from previous employers in the healthcare industry; in denying defendant's motion to dismiss count one of the second superseding indictment, which charged a violation of the anti-kickback statute; by refusing to hold an evidentiary hearing on defendant's motion to suppress statements and to declare his proffer agreement unenforceable; and by granting in part the spouse's attorneys' motion to quash a subpoena requiring one of the representatives to produce his entire file regarding the representation of the spouse who was now deceased. The court also held that the district court's jury instructions regarding count one were not erroneous. The court held, however, that the district court erred in calculating the amount of loss under Guidelines 2B4.1 when it used the loss to the victims, rather than the benefit to defendant, as the measure of loss. Therefore, the court concluded that there was procedural error and defendant's sentence was vacated. The court finally vacated the restitution order and remanded for further proceedings. The court rejected defendant's remaining claims. View "United States v. Yielding" on Justia Law

The patents at issue relate to balloon-expandable stents, used to treat occluded blood vessels. Following a remand, the district court found that defendants did not literally infringe the patents and rejected claims that the patents were invalid for lack of description or due to inequitable conduct. The Federal Circuit affirmed. Based on the court's proper clarification of its construction of the term "undulating," there was not substantial evidence to support a finding of infringement, nor was there substantial evidence of inequitable conduct. View "Cordis Corp. v. Boston Scientific Corp." on Justia Law