Justia Drugs & Biotech Opinion Summaries

Articles Posted in Personal Injury
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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

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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

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Under California law, the donor's intent controls the disposition of his or her gametic material upon death. Plaintiff appealed the trial court's judgment sustaining demurrers to her causes of action alleged against defendants. After plaintiff's husband entered into an irreversible coma, she arranged to extract his sperm in hopes of one day conceiving a child with it. Plaintiff stored the sperm in a tissue bank that ultimately came under the control of defendants, and, ten years later, when she requested the sperm, defendants disclosed that they could not locate it. Plaintiff filed suit, alleging contract and tort claims based on the loss of her ability to have a child biologically related to her deceased husband.The Court of Appeal affirmed the trial court's judgment, holding that the complaint failed to adequately plead facts supporting tort damages. In this case, plaintiff's tort causes of action are all premised on the loss of her ability to conceive with her deceased husband's sperm. However, the court held that the complaint failed to allege facts establishing that plaintiff was legally entitled to use her husband's sperm to conceive a child after he died. In this case, plaintiff's status as his spouse did not entitle her to conceive with his sperm; absent an affirmative showing that the husband intended to allow plaintiff to conceive with his sperm, plaintiff was not entitled to do so; and thus the complaint failed to allege that it was the husband's intent that his sperm be used for posthumous conception. Finally, the court held that plaintiff cannot recover emotional distress damages on her breach of contract cause of action. View "Robertson v. Saadat" on Justia Law

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Kaiser had surgery to implant the Prolift Anterior Pelvic Floor Repair System, a transvaginal mesh medical device that supports the pelvic muscles. A few years later, Kaiser began experiencing severe pelvic pain, bladder spasms, and pain during intercourse. Her physician attributed these conditions to contractions in the mesh. Kaiser had surgery to remove the device, but her surgeon could not completely extract it and informed her that the complications she was experiencing were likely permanent. Kaiser sued Ethicon, Prolift’s manufacturer, under the Indiana Products Liability Act. A jury found Ethicon liable for defectively designing the Prolift device and failing to adequately warn about its complications and awarded $10 million in compensatory damages; the judge reduced a punitive award to $10 million. The Seventh Circuit affirmed, rejecting Ethicon’s claim of federal preemption. The requirements of the FDA’s premarket-notification process do not directly conflict with Indiana law. A reasonable jury could conclude that Prolift was unreasonably dangerous and could credit the physician’s assertion that additional warnings about complications would have led him to choose a different treatment plan. The court rejected challenges to the damages and to jury instructions. Seventh Circuit precedent interprets the Indiana Product Liability Act to require a plaintiff in a design-defect case to produce evidence of a reasonable alternative design for the product but the Indiana Supreme Court disagreed in 2010. The state supreme court’s decision controls on a matter of state law. View "Kaiser v. Johnson & Johnson and Ethicon, Inc." on Justia Law

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The Ninth Circuit reversed the district court's dismissal of civil Racketeer Influenced and Corrupt Organizations Act (RICO) claims based on lack of RICO standing in a putative class action brought against pharmaceutical companies. Plaintiffs filed suit alleging that the companies refused to change the warning label of their drug Actos or otherwise inform the public after they learned that the drug increased a patient’s risk of developing bladder cancer.The panel held that patients and health insurance companies who reimbursed patients adequately alleged the required element of proximate cause where they alleged that, but for defendant's omitted mention of a drug's known safety risk, they would not have paid for the drug. The panel agreed with the First and Third Circuits that plaintiffs' damages were not too far removed from defendants' alleged omissions and misrepresentations to satisfy RICO's proximate cause requirement. In this case, plaintiffs sufficiently alleged a direct relationship, and the Holmes factors weighed in favor of permitting their RICO claims to proceed. The panel explained that, although prescribing physicians served as intermediaries between defendants' fraudulent omission of Actos's risk of causing bladder cancer and plaintiffs' payments for the drug, prescribing physicians did not constitute an intervening cause to cut off the chain of proximate causation. The panel also held that plaintiffs have adequately alleged the reliance necessary to satisfy RICO's proximate cause requirement. View "Painters and Allied Trades District Council 82 Health Care Fund v. Takeda Pharmaceuticals Co." on Justia Law

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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

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The Ninth Circuit affirmed the district court's grant of summary judgment to Allergan in an action under state law alleging that plaintiff suffered injuries when her breast implants bled silicone into her body. Through the Medical Device Amendments (MDA) to the Food, Drug, and Cosmetic Act (FDCA), Congress permitted FDA oversight of medical devices; the MDA expressly preempts state law regulation of medical devices; and for a state law claim regarding a Class III medical device to survive express preemption by the MDA, a plaintiff must establish that the defendant violated an FDA requirement.In this case, the panel held that plaintiff failed to show that Allergan violated a federal requirement for its Style 20 breast implant. The panel held that plaintiff failed to raise a genuine dispute of material fact that Allergan violated the FDA's pre-market approval and Current Good Manufacturing Practices. Therefore, plaintiff has now shown a violation of an FDA requirement, which she must for her state law claims to fit through the narrow exception to MDA preemption. View "Weber v. Allergan, Inc." on Justia Law

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After plaintiff filed suit against Mentor and Mentor Corporation for compensatory and punitive damages for injuries she suffered as a result of the surgical implantation of a polypropylene mesh sling manufactured by Mentor to treat her stress urinary incontinence, a jury found Mentor liable and awarded $400,000 in compensatory and $4 million in punitive damages. The district court upheld the jury's verdict with respect to liability and compensatory damages, but concluded that the punitive damages award exceeded Florida's statutory cap, reducing the punitive damages award to $2 million.The Eleventh Circuit affirmed, holding that the trial court acted well within the bounds of its discretion in allowing the jury to consider an expert's testimony relating to specific causation and Mentor was not entitled to judgment as a matter of law. The court also held that, in this case, which was focused on the physiological response to a design defect in a medical device, the dose-response relation was not implicated and there was no abuse of discretion in admitting the testimony. The court considered Mentor's remaining evidentiary challenges and held that the district court at no point exceeded the bounds of its discretion. Therefore, Mentor was not entitled to a new trial. Finally, the court affirmed the district court's reduction of the punitive damages award where evidence that Mentor knew of a high incidence of injury was not sufficient for finding a specific intent to harm. View "Taylor v. Mentor Worldwide, LLC" on Justia Law

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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

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Plaintiff filed suit on behalf of his mother's estate against WellDyne and Exactus, asserting claims for negligence, negligence per se and breach of the implied warranty of fitness for a particular purpose against both defendants. Plaintiff also alleged Exactus was vicariously liable for the actions of WellDyne under agency and joint venture theories. In this case, plaintiff's mother died shortly after a hospital stay stemming from her ingestion of prescription medications that were erroneously mailed to her by WellDyne. The district court granted summary judgment in favor of WellDyne and Exactus as to all counts, finding that plaintiff's mother was contributorily negligent as a matter of law which completely barred her recovery in North Carolina.The court reversed the district court's judgment insofar as it granted summary judgment on the basis of contributory negligence and causation, remanding for the district judge to conduct a Daubert analysis of the expert opinions proffered by plaintiff to determine whether taking some of the misdirected medications was the cause of the mother's injuries and death. The court affirmed summary judgment to Exactus; affirmed summary judgment to WellDyne as to the claim for implied warranty of a particular purpose; and remanded. View "Small v. Welldyne, Inc." on Justia Law