Justia Health Law Opinion Summaries

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This case deals with the importation of two transcatheter heart valve systems by Meril Life Sciences Pvt. Ltd. and Meril, Inc. (collectively, "Meril") into the United States for a medical conference in San Francisco. The plaintiff, Edwards Lifesciences Corporation and Edwards Lifesciences LLC (collectively, "Edwards"), a competitor medical device company, alleged that this act constituted patent infringement. Meril argued that the importation was covered by the "safe harbor" provision of 35 U.S.C. § 271(e)(1), which exempts certain activities from being considered patent infringement if they are reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs.The district court granted summary judgment in favor of Meril, and Edwards appealed to the United States Court of Appeals for the Federal Circuit. The Court of Appeals affirmed the decision of the district court, noting that the undisputed evidence showed that the importation of the valve systems was reasonably related to submitting information to the United States Food and Drug Administration. The court rejected Edwards' arguments that the district court had disregarded contemporaneous evidence, applied the safe harbor with an objective standard, and relied improperly on declarations from Meril employees. The court affirmed the district court's conclusion that there was no genuine dispute of material fact and that Meril was entitled to judgment as a matter of law. View "EDWARDS LIFESCIENCES CORPORATION v. MERIL LIFE SCIENCES PVT. LTD. " on Justia Law

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The Supreme Court of North Carolina ruled on a case involving Halikierra Community Services LLC (Halikierra), a provider of home personal care services to Medicaid beneficiaries and the North Carolina Department of Health and Human Services (DHHS). DHHS had placed Halikierra on Medicaid reimbursement prepayment review following several overbilling complaints, leading to several post-payment audits. The audits revealed that Halikierra had erroneously received excess Medicaid reimbursement funds on multiple occasions and found suspicious reimbursement claims.Halikierra filed a lawsuit against DHHS, alleging that the decision to place them on prepayment review violated their substantive due process and equal protection rights under the North Carolina Constitution. The trial court granted summary judgment in favor of DHHS, leading to an appeal from Halikierra.The Supreme Court of North Carolina affirmed the trial court's decision, holding that summary judgment was properly entered against Halikierra. The Court found that Halikierra’s evidentiary forecast failed to disclose any genuine issues of material fact in support of its claims. The Court concluded that DHHS's actions were not arbitrary or capricious, as the prepayment review was rationally related to a legitimate government interest, namely combating Medicaid fraud and ensuring that claims meet the requirements of federal and state laws and regulations. The Court also found no evidence of unequal treatment of Halikierra compared to other Medicaid providers. View "Halikierra Cmty. Servs. LLC v. N.C. Dep't of Health & Hum. Servs" on Justia Law

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The Supreme Court of the State of Illinois reviewed a case where a defendant, Ramon Torres, was convicted of predatory criminal sexual assault of his four-year-old daughter. The State’s evidence included testimony that Torres tested positive for chlamydia in 2013 and again in 2016. On appeal, Torres argued that his trial counsel was constitutionally ineffective for failing to object to the admission of evidence of these two test results. He maintained that the test results fell under the purview of the physician-patient privilege statute and that none of the statutory exceptions to the physician-patient privilege applied.This case required the court to interpret the physician-patient privilege statute and whether the test results would have been excluded from evidence at his jury trial had his attorney objected. The appellate court disagreed with Torres and affirmed his conviction and sentence. The Supreme Court of the State of Illinois affirmed the lower courts’ judgments.The court held that the physician-patient privilege statute did not apply to the 2016 test results as Torres submitted to testing in 2016 not for the purpose of seeking medical treatment, but because he was ordered to do so by the Department of Children and Family Services. Therefore, the privilege and the exceptions to the privilege were irrelevant to the admissibility of the 2016 test results.Regarding the 2013 test results, the court found that the physician-patient privilege statute does apply. The court, however, determined that the exception set out in subsection (7) authorizes physicians to disclose information subject to the physician-patient privilege “in actions, civil or criminal, arising from the filing of a report in compliance with the Abused and Neglected Child Reporting Act.” Therefore, the 2013 chlamydia test results were admissible even though the physician-patient privilege attached to those test results. The court concluded that the defendant has not satisfied the first prong of the Strickland standard, and his claim of ineffective assistance of counsel fails. View "People v. Torres" on Justia Law

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The United States Court of Appeals for the Fifth Circuit affirmed the conviction and sentence of defendant Vincent Marchetti, Jr., who was found guilty of one count of conspiracy to commit illegal remunerations in violation of 18 U.S.C. § 371. Marchetti was involved in a scheme wherein Vantari Genetics LLC, a medical laboratory, paid distributors to attract Medicare referrals to Vantari. Marchetti, who operated Advanced Life Sciences LLC, was one of the distributors and had a network of sub-distributors. The court found sufficient evidence that Marchetti was knowingly and actively participating in a scheme involving CodonDx, another entity, that violated the Anti-Kickback Statute. The court rejected Marchetti's challenges regarding the sufficiency of the evidence, the district court's failure to submit his theory of defense instruction, the court's alleged constructive amendment of the indictment, and the court's application of the sentencing guidelines. The court also dismissed his claim for a new trial based on cumulative error. View "USA v. Marchetti" on Justia Law

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This case was heard in the United States Court of Appeals for the Fourth Circuit and involved the Estate of Arturo Giron Alvarez and 773 other plaintiffs, who brought claims against The Rockefeller Foundation (TRF), alleging the foundation's involvement in nonconsensual human medical experiments in Guatemala from 1946 to 1948. The experiments involved exposing people to sexually transmitted diseases (STDs) to study the diseases and potential treatments. The defendants had previously filed a motion for summary judgment, which was granted by the district court. The plaintiffs appealed this decision, specifically challenging the decision relating to TRF.The appeal hinged on the question of whether Dr. Soper, an Associate Director of TRF who was assigned to the Pan-American Sanitary Bureau (PASB) in Guatemala during the time of the experiments, was acting as an agent of TRF, thus making TRF liable for his actions. The court found that despite TRF paying Dr. Soper's salary during his time at the PASB, there was no indication that TRF was directing or controlling Dr. Soper’s work. Furthermore, the evidence showed that Dr. Soper considered himself no longer with TRF, and the PASB's constitution prohibited him from taking outside direction.The court concluded that TRF's connection to the experiments was too tenuous to be held liable for them. It affirmed the district court's grant of summary judgment in favor of TRF, stating that Dr. Soper was not an agent of TRF during the time of the experiments. View "In re Estate of Alvarez v. Rockefeller Foundation" on Justia Law

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In this case, the court dealt with the suspension and subsequent resignation of a licensed obstetrician and gynecologist, Plaintiff Dr. Vardui Asiryan, from the defendant Glendale Adventist Medical Center and its Medical Staff. The Medical Staff suspended Asiryan’s privileges at the hospital without holding a hearing or giving her prior notice. Asiryan sued both entities, alleging they failed to comply with statutory and common law procedural requirements in connection with suspending her privileges at the hospital. She further claimed that the Medical Staff lied to her regarding their obligations to report her suspension and resignation to the state licensing board.The Court of Appeal of the State of California, Second Appellate District, Division One, held that the trial court correctly concluded that the Business and Professions Code is the sole source of procedural protections in connection with hospital peer review, and that the common law doctrine of fair procedure does not supplement those protections with additional guarantees. Therefore, the court correctly granted the nonsuit on Asiryan’s common law peer review claims and correctly rejected her proposed jury instructions regarding peer review.As for the court's order awarding attorney fees, the Court of Appeal held that given the court’s rulings denying certain portions of defendants’ summary judgment and nonsuit motions, a hypothetical reasonable attorney could have deemed Asiryan’s peer review claims against the Medical Staff tenable and reasonably decided to take them to trial. This same logic does not apply to the fees awarded to GAMC, because the court disposed of the claims against GAMC on summary judgment. The Court of Appeal therefore reversed the court’s fee order to the extent it awards fees to the Medical Staff, but affirmed the order as it applies to GAMC. View "Asiryan v. Medical Staff of Glendale Adventist Medical Center" on Justia Law

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The United States Court of Appeals for the Fourth Circuit addressed a case where an inmate with celiac disease sued a doctor for depriving him of a gluten-free diet. The district court had granted summary judgment to the doctor because the plaintiff did not have an expert witness to testify about the standard treatment for celiac disease or the causal link between the doctor’s conduct and the plaintiff’s alleged harm. The appeals court held that no expert testimony was needed to avoid summary judgment in this case. The court found that the plaintiff had presented sufficient evidence to create a genuine dispute of material fact about the doctor's knowledge of his celiac disease and the excessive risk it posed by failing to respond reasonably, even without an expert.The court also clarified that expert testimony is not necessary to establish an Eighth Amendment claim of deliberate indifference. The court held that while determining whether medical professionals responded reasonably to a particular risk can involve an examination of the relevant standard of care, the fact that expert testimony may be necessary in some cases does not mean it was in this one. The court vacated the district court’s judgment and remanded the case for further proceedings. View "Phoenix v. Amonette" on Justia Law

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This case was before the United States Court of Appeals for the Fourth Circuit where the City of Huntington and Cabell County Commission (plaintiffs) brought a suit against AmerisourceBergen Drug Corporation, Cardinal Health, Inc., and McKesson Corporation (defendants), three distributors of opioids. The plaintiffs alleged that these companies perpetuated the opioid epidemic by repeatedly shipping excessive quantities of opioids to pharmacies, thus creating a public nuisance under West Virginia common law. The district court ruled in favor of the distributors, holding that West Virginia’s common law of public nuisance did not cover the plaintiffs’ claims.After a bench trial in 2021, the district court held that the common law of public nuisance in West Virginia did not extend to the sale, distribution, and manufacture of opioids. The court found that the application of public nuisance law to the sale, marketing, and distribution of products would invite litigation against any product with a known risk of harm, regardless of the benefits conferred on the public from proper use of the product. The court also rejected the plaintiffs’ proposed remedy, a 15-year “Abatement Plan” developed by an expert in opioid abatement intervention. The court held that this relief did not qualify as an abatement as it did not restrict the defendants' conduct or their distribution of opioids but generally proposed programs and services to address the harms caused by opioid abuse and addiction.The plaintiffs appealed the decision to the United States Court of Appeals for the Fourth Circuit, which certified the following question to the Supreme Court of Appeals of West Virginia: Under West Virginia’s common law, can conditions caused by the distribution of a controlled substance constitute a public nuisance and, if so, what are the elements of such a public nuisance claim? View "City of Huntington v. Amerisourcebergen Drug Corporation" on Justia Law

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The United States Court of Appeals for the Ninth Circuit ruled in a case involving a claimant who was denied Social Security benefits. The claimant, who had undergone surgery to treat a brain condition known as Arnold-Chiari malformation, testified to experiencing severe and frequent headaches. However, the Administrative Law Judge (ALJ) rejected his testimony regarding the severity of his headaches, asserting that his headache symptoms were inconsistent with the medical evidence and his daily activities.The court of appeals found that the ALJ failed to provide clear and convincing reasons for rejecting the claimant's symptom testimony regarding his headaches. It noted that the ALJ did not specify which of the claimant's symptoms were inconsistent with the record evidence. The court also rejected the argument that a claimant must provide independent medical evidence to establish the severity of headaches.Furthermore, the court found that the claimant's daily activities were not inconsistent with his testimony about the severity and frequency of his headaches. The district court's affirmation of the ALJ's decision based on the claimant's conservative treatment was also found erroneous since the ALJ did not consider this factor. Consequently, the court reversed the judgment of the district court, remanding it back to the ALJ to reconsider the credibility of the claimant's headache symptom testimony. View "Ferguson v. O'Malley" on Justia Law

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The case involved an appeal by two brothers, Jonathan and Daniel Markovich, who were convicted for operating fraudulent drug rehabilitation clinics in Florida. They were found guilty of various charges, including health-care fraud, wire fraud, kickbacks, money laundering, and bank fraud, resulting in fraudulent claims of over $100 million.The brothers appealed their convictions on several grounds. They argued that the district court violated their constitutional rights by denying their motion to compel the prosecution to obtain and disclose confidential medical records possessed by third parties. They also claimed that the court violated Federal Rules of Evidence by admitting unreliable and confusing expert testimony about the clinics' medical and billing practices. Additionally, they argued that the court abused its discretion by admitting lay summary testimony about medical and billing records.The United States Court of Appeals for the Eleventh Circuit affirmed the convictions. The court ruled that the prosecution had no duty to seek out potentially exculpatory evidence not in its possession. It also determined that the expert testimony was clear and reliable, and the summary testimony was proper. The court found that any challenge to bank-fraud counts was forfeited due to a lack of explanation or supporting legal authority. Finally, the court ruled that the district court did not abuse its discretion by denying the brothers' motion for a new trial based on newly discovered evidence. View "United States v. Markovich" on Justia Law