Justia Drugs & Biotech Opinion Summaries

Stryker, a manufacturer of medical devices, sued its umbrella insurer XL, seeking coverage for claims stemming from the implantation of expired artificial knees. The dispute concerned the precise "defect" that triggers batch coverage under the Medical Products Endorsement. The district court held that XL was liable under the policy for the entirety of Stryker’s losses on both direct claims brought against Stryker, as well as claims brought against Pfizer that Stryker was obligated to reimburse under an asset purchase agreement. The court found that the items were defective if they were available in Stryker’s inventory for implantation by physicians beyond their shelf-life of five years. The Sixth Circuit affirmed XL’s liability for the full amount of Stryker’s losses and pre-judgment interest. XL’s payment to Pfizer applies to exhaust the policy with respect to the direct claims. The court reversed the holding that the aggregate limit of liability of the XL policy does not apply to the judgments on the direct claims and remanded for determination of what portion, if any, of the total liability for those judgments beyond $15 million represents consequential damages as defined under Michigan contract law. View "Howmedica Osteonics, Corp. v. Nat'l Union Fire Ins. Co." on Justia Law

TIG issued a $25 million excess policy to Stryker, a manufacturer of medical devices. Coverage attached above the underlying (XL) umbrella policy, with a limit of $15 million. Stryker sued XL, seeking defense and indemnification for claims related to replacement knees (first suit). Pfizer then sued Stryker, seeking indemnification with respect to claims based on Uni-Knees; the companies had an asset purchase agreement. The court ruled in favor of Pfizer. When XL denied coverage, Stryker sued both insurers. In 2008, the district court held that XL was liable for all of Stryker's liabilities with respect to both suits and also granted declaratory judgment against TIG. XL settled directly with Pfizer, and obtained a ruling that this satisfied its obligations. TIG moved to remove the declaratory judgment ruling, arguing that the ruling that XL was responsible with respect to both suits made it impossible to subject TIG to liability. The district court denied this motion. The Sixth Circuit affirmed that the case is not moot, noting that the claims may exhaust the XL policy; reversed a ruling that TIG is precluded from raising coverage defenses on remand, noting that TIG was not a party to the first suit; and remanded. View "Stryker Corp. v. Nat'l Union Fire Ins. Co." on Justia Law

In 2004, plaintiff had arthroscopic surgery to treat pain and instability in his shoulder joint. The doctor implanted a pain-pump catheter and, over the next two days, a Stryker pain pump delivered a regular dose of a local anesthetic, bupivicaine, to the joint. Plaintiff’s condition improved after surgery but worsened over time, and in 2008 he learned he no longer had any cartilage remaining in his shoulder, a condition called chondrolysis. He sued, alleging strict liability, negligence and breach of warranty. The district court concluded that Stryker could not reasonably have known about the risk of chondrolysis in 2004 and thus had no duty to warn of the risk and held that Plaintiff failed as a matter of law to prove causation. The Sixth Circuit affirmed. Plaintiff did not present any evidence that Stryker knew or should have known that the use was dangerous or that a warning on Stryker's pain pump would have caused the doctor not to use the device in his joint space. View "Rodriguez v. Stryker Corp." on Justia Law

Plaintiffs, a putative nationwide class of third-party payors and a putative nationwide class of individual patient-consumers who paid for prescriptions, sued pharmaceutical manufacturers alleging that they paid for oncology and hepatitis drugs that were ineffective or unsafe for the off-label uses for which they were prescribed and that defendants pursued illegal marketing campaigns to persuade physicians to prescribe the drugs for those uses. While physicians are not prohibited from prescribing drugs for off-label uses, manufacturers are generally prohibited by the Federal Food, Drug and Cosmetic Act, 21 U.S.C. 301, from manufacturing, marketing, or selling for off-label use. Defendant had pled guilty to a criminal charge brought by the FDA and agreed to pay fine of $180 million and to pay $255 million to resolve civil claims that it defrauded Medicare, Medicaid, and the VA. The district court dismissed, for lack of standing, claims under the Racketeer Influenced and Corrupt Organizations Act, 18 U.S.C. 1961, the New Jersey RICO statute, N.J.S. 2C:41-1, and other state statutory and common law causes of action. The Third Circuit affirmed, finding that plaintiffs failed to establish a causal connection between the alleged misconduct and the alleged harm. View "In Re: Schering Plough Corp." on Justia Law

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