Justia Drugs & Biotech Opinion Summaries

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

This appeal stemmed from a group of fourteen diversity cases that were consolidated by the Judicial Panel on Multidistrict Litigation and transferred to the Northern District of Oklahoma. The plaintiffs in all fourteen cases were cancer treatment providers who purchased multi-dose vials of Herceptin, a breast cancer drug, from defendant Genentech, Inc. (Genentech). Plaintiffs alleged that Genentech violated state law by failing to ensure that each vial of Herceptin contained the labeled amount of the active ingredient, and by misstating the drug concentration and volume on the product labeling. After the cases were consolidated, Genentech moved for summary judgment, arguing that plaintiffs’ claims were pre-empted by federal law. The district court agreed with Genentech and granted its motion for summary judgment. Plaintiffs appealed. The Tenth Circuit disagreed with the district court's conclusion that plaintiffs' claims were preempted, and consequently, reversed summary judgment and remanded for further proceedings. View "In re: MDL 2700 Genentech" on Justia Law

Dolin was prescribed Paxil, the brand-name version of the drug paroxetine, to treat his depression. The prescription was filled with a generic paroxetine product. Six days later, Dolin died by suicide. Federal law preempted an "inadequate labeling" state-law claim against the generic manufacturer. Mrs. Dolin sued GSK, the manufacturer of brand-name Paxil, arguing that GSK was responsible for the labeling for all paroxetine, no matter who made and sold it, and had negligently omitted an adult suicide risk. The Seventh Circuit reversed her jury verdict, based on preemption, citing the complex regulation of drug labels and of Paxil/paroxetine’s label in particular. GSK had attempted to change the Paxil label in 2007 to add an adult suicide warning. The FDA rejected that change. The court concluded that GSK lacked new information after 2007 that would have allowed it to add an adult-suicidality warning under the existing regulations.Eight days after denying Dolin certiorari, the Supreme Court decided another case, further explaining the “clear evidence” standard for impossibility preemption for prescription drug labels. Dolin filed an unsuccessful motion under FRCP 60(b)(6), arguing that the 2018 judgment should be set aside based on a change in law so that GSK could not establish its defense of impossibility preemption. The Seventh Circuit affirmed and did not impose sanctions. The Supreme Court provided important guidance but did not break new ground that would change the result in Dolin’s case. Her motion was not frivolous. View "Dolin v. GlaxoSmithKline LLC" on Justia Law

In this case involving the indictments of Dr. Frank Stirlacci and his office manager, Jessica Miller, for violations of the Controlled Substances Act and for submitting false health care claims to insurance providers, the Supreme Judicial Court affirmed in part and reversed in part the superior court's judgment dismissing several of the indictments, holding that there was sufficient evidence to indict Shirlacci on twenty-six counts of improper prescribing and to indict both defendants on twenty of the twenty-two counts of submitting false health care claims.The charges against Defendants included twenty-six counts each of improper prescribing, twenty counts each of uttering a false prescription, and twenty-two charges each of submitting a false health care claim. The trial judge dismissed the indictments for improper prescribing and uttering false prescriptions and dismissed six of the indictments against each defendant for submitting false health care claims. The Supreme Judicial Court reversed in part, holding (1) the evidence was sufficient to indict Stirlacci on all counts of improper prescribing, but Miller's status as a nonpractitioner precluded her indictment on improper prescribing; (2) there was insufficient evidence to indict either defendant for uttering false prescriptions; and (3) there was sufficient evidence to indict both defendants on twenty counts of submitting false health care claims. View "Commonwealth v. Stirlacci" on Justia Law

Health benefit plans sued GSK, the manufacturer of the prescription drug Avandia, under state consumer-protection laws and the Racketeer Influenced and Corrupt Organizations Act, 18 U.S.C. ch. 96 (RICO), based on GSK’s marketing of Avandia as having benefits to justify its price, which was higher than the price of other drugs used to treat type-2 diabetes. The district court granted GSK summary judgment, finding that the state-law consumer-protection claims were preempted by the Federal Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. ch. 9; the Plans had failed to identify a sufficient “enterprise” for purposes of RICO; and the Plans’ arguments related to GSK’s alleged attempts to market Avandia as providing cardiovascular “benefits” were “belated.” The Third Circuit reversed, applying the Supreme Court’s 2019 "Merck" decision. The state-law consumer-protection claims are not preempted by the FDCA. The Plans should have been given the opportunity to seek discovery before summary judgment on the RICO claims. Further, from the inception of this litigation, the Plans’ claims have centered on GSK’s marketing of Avandia as providing cardiovascular benefits as compared to other forms of treatment, so the district court’s refusal to consider the Plans’ “benefits” arguments was in error because those arguments were timely raised. View "In re: Avandia Marketing, Sales and Products Liability Litigation" on Justia Law

Appellants Jonathan Saksek and Joshua Winter challenged a superior court decision to affirm summary judgment in favor of Appellees Janssen Pharmaceuticals, Inc., Johnson & Johnson Company, and Janssen Research and Development, LLC (collectively, “Janssen”). Saksek and Winter were two of a large number of men who filed suit against Janssen, alleging that they developed gynecomastia as a result of their ingestion of Risperdal, an antipsychotic drug manufactured by Janssen. In 2014, Janssen filed two motions for summary judgment, which were nominally directed at Saksek’s and Winter’s cases, but had language affecting all Risperdal plaintiffs: the companies sought a global ruling that all claims accrued for statute of limitations purposes no later than October 31, 2006, when Janssen changed the Risperdal label to reflect a greater association between gynecomastia and Risperdal. The trial court ruled that all Risperdal-gynecomastia claims accrued no later June 31, 2009. The superior court disagreed, ruling that all such claims accrued no later than Janssen’s preferred date (October 31, 2006). Concluding that the superior court erred in granting summary judgment at all in Saksek’s and Winter’s cases, the Pennsylvania Supreme Court vacated its decision and remanded to the trial court for further proceedings. View "In Re: Risperdal Litig." on Justia Law

Forest Laboratories, LLC ("Forest"), filed a permissive appeal pursuant to Rule 5, Ala. R. App. P., of an Alabama circuit court's order denying it summary judgment. Forest manufactured and marketed Lexapro, a drug prescribed for depression, and Forest Pharmaceuticals, Inc. ("FPI") sold and distributed Lexapro. In 2015, Elias Joubran's physician prescribed Lexapro for Elias's depression. Elias's prescription was filled with generic escitalopram that was manufactured and sold by a company other than Forest. On December 30, 2015, Elias entered the house belonging to him and his wife, Sheila Joubran; he shot and killed Sheila, then shot and killed himself. Kevin Feheley, Sr., serving as personal representative of Shiela's estate, sued Mary Jourbran in her capacity as the personal representative of Elias's estate. Forest, FPI and several fictitiously named defendants were included in the suit. The complaint alleged that, at the time of the murder/suicide, Elias was under prescription for pharmaceuticals manufactured by defendants, including Forest and FPI, and that "Forest's Lexapro[] enhanced, enabled and aggravated [Elias's] depression and violent behaviors." The Alabama Legislature enacted section 6-5-530, Ala. Code 1975, "on the heels" of the Alabama Supreme Court's decision in Wyeth, Inc. v. Weeks, 159 So. 3d 649 (2014). In addressing the Weeks decision, section 6-5-530 specifically provided that a plaintiff who is suing based on personal injury, death, or property damage caused by a product "must prove ... that the defendant designed, manufactured, sold, or leased the particular product the use of which is alleged to have caused the injury on which the claim is based" regardless of the type of claims or theory of liability the plaintiff asserts. Because this case was a permissive appeal, the questions before the Supreme Court were limited to whether 6-5-530 effectively overruled Weeks, and whether a manufacturer could be held liable for an injury caused by a product it did not manufacture. The Court determined Section 6-5-530 abrogated Weeks: a pharmaceutical manufacturer cannot be held liable for injury caused by a product it did not manufacture. Based on the Court's answer to the trial court's certified question in the permissive appeal, it reversed the trial court's order denying Forest's motion for a summary judgment and remanded this case for further proceedings. View "Forest Laboratories, LLC v. Feheley, Sr." on Justia Law

In July 2012, Dr. William Sullivan prescribed Remicade, a medication manufactured by Janssen Biotech, Inc. ("JBI"), to Tim McKenzie as a treatment for Tim's psoriatic arthritis. Tim thereafter received Remicade intravenously every two weeks until November 2014, when he developed severe neuropathy causing significant weakness, the inability to walk without assistance, and the loss of feeling in, and use of, his hands and arms. Although Tim stopped receiving Remicade at that time, he and his wife, Sherrie, alleged they were not told that Remicade was responsible for his injuries. In December 2015, Tim traveled to the Mayo Clinic in Rochester, Minnesota, to receive treatment for his neuropathy. The McKenzies stated that while at the Mayo Clinic, Tim was eventually diagnosed with demyelinating polyneuropathy, and doctors told them that it was likely caused by the Remicade. In 2016, the McKenzies sued JBI and Dr. Sullivan in Alabama Circuit Court, asserting failure-to-warn, negligence, breach-of-warranty, fraud, and loss-of-consortium claims. The complaint filed by the McKenzies was not signed, but it indicated it had been prepared by Sherrie, who was not only a named plaintiff, but also an attorney and active member of the Alabama State Bar. Keith Altman, an attorney from California admitted pro hac vice in November 2017, assisted with the preparation of the complaint. The Alabama Supreme Court found it apparent from even a cursory review of the complaint, that it was copied from a complaint filed in another action. The complaint included numerous factual and legal errors, including an assertion that Tim was dead even though he was alive, and claims invoking the laws of Indiana even though that state had no apparent connection to this litigation. The trial court struck the McKenzies' initial complaint because it was not signed as required by Rule 11(a) and because it contained substantial errors and misstatements of fact and law. The trial court later dismissed the failure-to-warn and negligence claims asserted by the McKenzies in a subsequent amended complaint because that amended complaint was not filed until after the expiration of the two-year statute of limitations applicable to those claims. Because the trial court acted within the discretion granted it by Rule 11(a) when it struck the McKenzies' initial complaint and because the McKenzies did not establish that the applicable statute of limitations should have been tolled, the trial court's order dismissing the McKenzies' claims as untimely was properly entered. View "McKenzie v. Janssen Biotech, Inc." on Justia Law

T.L. consulted Dr. Jack Goldberg for a blood condition. In October 2010, Dr. Goldberg told T.L. about a new medication, Pegasys. After taking Pegasys, T.L. experienced a number of symptoms, but Dr. Goldberg advised that T.L. should continue taking Pegasys. T.L. began experiencing severe pain in her neck and both arms, requiring hospitalization and rehabilitation. T.L. was diagnosed with inflammation of the spinal cord and experienced partial paralysis on her right side. T.L. brought suit against Dr. Goldberg and his employer, Penn Medicine Cherry Hill. T.L. claimed that Dr. Goldberg deviated from accepted standards of care by prescribing Pegasys to her because she was diagnosed with, and took medication for, chronic depression. During Dr. Goldberg’s deposition, when asked whether he was aware of any studies in the Journal of Clinical Oncology pertaining to the use of Pegasys to treat patients with T.L.’s condition, Dr. Goldberg answered “no.” On T.L.’s motion, the court barred Dr. Goldberg from using any medical literature at trial that was not produced during the course of discovery. At trial, Dr. Goldberg testified that he prescribed Pegasys to T.L. because he relied upon a clinical trial, published in the Journal of Clinical Oncology in 2009, that included patients with a history of depression. T.L.’s counsel did not object. The jury found that Dr. Goldberg did not deviate from the applicable standard of care. T.L. was granted a new trial on grounds that Dr. Goldberg’s discussion of the 2009 publication constituted reversible error. Dr. Goldberg appealed as of right based on a dissenting justice in the Appellate Division's reversal of the trial court. The New Jersey Supreme Court reversed, finding there was no demonstration that the changed testimony caused prejudice to T.L., and the plain error standard did not compel reversal, "especially because counsel’s failure to object was likely strategic." Under the circumstances, T.L. was not entitled to a new trial. View "T.L. v. Goldberg" on Justia Law