Justia Drugs & Biotech Opinion SummariesArticles Posted in Public Benefits
T.S. v. Secretary of Health & Human Services
In 2009, six-month-old Trystan received vaccines, including DTaP-HepB-IPV. Hours later, Trystan developed a fever and was in pain; he developed a hot lump on his thigh. Trystan’s mother took him to urgent care, where he was diagnosed with a “common cold.” Trystan’s arm contortions continued. At his one-year exam, Trystan could not stand, crawl, grasp, hold his head up while sitting, or attempt to move his lower extremities. Trystan received additional vaccinations. His arm contortions returned. Trystan had muscle spasms, developmental delays, seizures, dystonia, and other neurologic issues. In 2014, Trystan was diagnosed with Leigh’s syndrome, a severe neurological disorder that often presents in the first year of life, is characterized by progressive loss of mental and movement abilities, and typically results in death. Genetic testing showed that Trystan has two associated disease-causing mutations.His parents sought compensation under the Vaccine Act, 42 U.S.C. 300aa–1. The Claims Court upheld determinations that Trystan did not experience neurologic deterioration until many weeks after his 2009 vaccination and that Trystan’s genetic mutations solely caused his Leigh’s syndrome. The Federal Circuit reversed. Because the contortions began within two weeks of his vaccinations, Trystan has shown a logical chain of cause and effect between his vaccination and his neurodegeneration, satisfying his burden. He is entitled to compensation unless the Secretary establishes the injury was due to factors unrelated to the vaccine. There is no evidence that Trystan’s mutations would have resulted in the same progression and severity of his Leigh’s syndrome absent the vaccine. View "T.S. v. Secretary of Health & Human Services" on Justia Law
Sharpe v. Secretary of Health and Human Services
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
In re HIPAA Subpoena
The First Circuit affirmed the district court's judgment reversing the magistrate's order that had quashed an administrative subpoena duces tecum as to the recordings of certain telephone conversations, holding that the magistrate judge clearly erred in finding that Appellants met their burden of proving that an employer's interception of the telephone calls was intentional.When investigating whether Patient Services, inc. (PSI) had engaged in an illegal kickback scheme, the Government issued an administrative subpoena duces tecum to PSI for all recorded conversations of PSI officers and employees. This appeal concerned conversations that were recorded on the extension of Karen Middlebrooks. Middlebrooks's telephone conversations were recorded while she was working in PSI's call center on the second floor where calls were regularly recorded. At issue was whether PSI intentionally continued recording Middebrooks's calls after her transfer to the third floor, where calls were not regularly recorded, in violation of Title III of the Omnibus Crime Control and Safe Streets Act. The magistrate judge ruled that the recordings violated Title III. The district court reversed. The First Circuit affirmed, holding that the magistrate judge clearly erred in finding that Appellants met their burden of proving that PSI's interception of calls from Middlebrooks's extension after her move to the third floor was intentional. View "In re HIPAA Subpoena" on Justia Law
Silver v. Omnicare Inc
Silver’s qui tam action, filed under the False Claims Act (FCA), 31 U.S.C. 3729–33, alleged that PharMerica, which owns and operates institutional pharmacies serving nursing homes, unlawfully discounted prices for nursing homes’ Medicare Part A patients (reimbursed by the federal government to the nursing home on a flat per-diem basis) in order to secure contracts to supply services to patients covered by Medicare Part D and Medicaid (reimbursed directly to the pharmacy by the government on a cost basis) in the same nursing homes--a practice called swapping. The district court dismissed, based on the FCA’s public disclosure bar. The Third Circuit reversed. The district court improperly determined that documents publicly describing the generalized risk of swapping in the nursing home industry served to bar his specific claim, which depended on non-public information that PharMerica was actually engaging in swapping in specific contracts. The district court also erred in concluding, on the basis of Silver’s testimony, that he relied upon certain publicly available information to reach his conclusion and that the information itself disclosed the fraud, without independently determining that the relevant public document did, in fact, effectuate such a disclosure. View "Silver v. Omnicare Inc" on Justia Law
Mississippi v. Walgreen Co.
This matter stemmed from a lawsuit filed by the State of Mississippi against the defendant pharmacies. The State alleged deceptive trade practices and fraudulent reporting of inflated “usual and customary” prices in the defendant’s reimbursement requests to the Mississippi Department of Medicaid. The State argued that Walgreens, CVS, and Fred’s pharmacies purposefully misrepresented these prices to obtain higher prescription drug reimbursements from the State. Finding that the circuit court was better equipped to preside over this action, the DeSoto County Chancery Court transferred the matter to the DeSoto County Circuit Court in response to the defendants’ request. Aggrieved, the State timely filed an interlocutory appeal disputing the chancellor’s decision to transfer the case. After a thorough review of the parties’ positions, the Mississippi Supreme Court found that though the chancery court properly could have retained the action, the chancellor correctly used his discretion to transfer the case, allowing the issues to proceed in front of a circuit-court jury. As a result, the Supreme Court affirmed the chancellor’s decision. View "Mississippi v. Walgreen Co." on Justia Law
Watson Laboratories, Inc. v. Mississippi
In 2005, the State of Mississippi filed suit against more than eighty prescription drug manufacturers alleging, among other things, that each committed common-law fraud and violations of the Mississippi Consumer Protection Act. The allegations primarily focused on whether the prescription-drug manufacturers inflated reported prices, which caused the Mississippi Division of Medicaid to reimburse pharmacies at inflated rates. The cases were eventually severed; this appeal involved only Watson Laboratories, Inc., Watson Pharma Inc., and Watson Pharmaceuticals, Inc. (collectively “Watson”). Following a bench trial, the Chancery Court concluded that Watson had committed common-law fraud and had violated the Mississippi Consumer Protection Act. As a result, the chancery court awarded the State a total of $30,262,052 in civil penalties, compensatory damages, and punitive damages. The chancery court also awarded post-judgment interest of three percent on the compensatory and punitive damages. Watson appealed, challenging the chancery court’s decision; the State also filed a cross-appeals relating to damages. After review, the Mississippi Supreme Court affirmed the chancery court’s judgment in favor of Mississippi Medicaid. Further, the Court affirmed the ruling on the State’s cross-appeal. View "Watson Laboratories, Inc. v. Mississippi" on Justia Law
Petratos v. Genentech Inc
Qui tam relator failed to satisfy the False Claims Act’s materiality requirement in alleging that the manufacturer of a widely-prescribed cancer drug, Avastin, suppressed data that caused doctors to certify incorrectly that Avastin was “reasonable and necessary” for certain at-risk Medicare patients. Avastin is FDA-approved and has accounted for $1.13 billion a year in Medicare reimbursements. The relator, formerly the head of healthcare data analytics for the manufacturer, claimed the company ignored and suppressed data that would have shown that Avastin’s side effects for certain patients were more common and severe than reported and that such analyses would have required the company to file adverse event reports with the FDA, and could have resulted in changes to Avastin’s FDA label. He claimed the company caused physicians to submit Medicare claims that were not “reasonable and necessary.” The Third Circuit affirmed dismissal of the claim, stating the allegations may be true but a False Claims Act suit is not the appropriate way to address them. The manufacturer followed all pertinent statutes and regulations. If those laws and regulations are inadequate to protect patients, it falls to the other branches of government to reform them. View "Petratos v. Genentech Inc" on Justia Law
D’Agostino v. EV3, Inc.
Plaintiff filed filed a qui tam action against a corporation and its subsidiary, both of whom manufacture and market medical devices, alleging that Defendants violated the False Claims Act in selling two particular medical devices to hospitals that seek reimbursement from the federal government through, for example, the Center for Medicare and Medicaid Services. Through two subsequent amendments, both with permission of the court, Plaintiff added several defendants and retooled his claims. Plaintiff then requested leave to amend fourth amended complaint. The district court applied the “good cause” standard from Fed. R. Civ. P. 16(b) to that request and struck the amended complaint. The First Circuit originally held that the district court should have evaluated Plaintiff’s fourth amended complaint under the standard set forth in Fed. R. Civ. P. 15(a). On remand, the district court concluded that Plaintiff’s desired amendment failed under that standard. The First Circuit affirmed, holding that Plaintiff’s request for leave to file his fourth amended complaint was properly denied as futile because none of the claims in Plaintiff’s fourth amended complaint was adequately pled. View "D'Agostino v. EV3, Inc." on Justia Law
Vitreo Retinal Consultants v. U.S. Dep’t of Health & Human Servs.
VRC filed suit against HHS and the Secretary, seeking the recoupment of payments VRC returned to Medicare after it was issued notice of an overpayment. At issue is the reimbursement rate of the intravitreal injection of Lucentis. VRC did not follow the Lucentis label’s instructions limiting dosage to one per vial. Instead, VRC treated up to three patients from a single vial. Because VRC was extracting up to three doses from a single vial, it was reimbursed for three times the average cost of the vial and three times the amount it would have received had it administered the drug according to the label. The court affirmed the denial of recoupment, concluding that VRC's charge to Medicare did not reflect its expense and was not medically reasonable; the Secretary's decision was supported by substantial evidence; and VRC is liable for the overpayment. View "Vitreo Retinal Consultants v. U.S. Dep't of Health & Human Servs." on Justia Law
Moriarty v. Sec’y of Health & Human Servs.
Eilise was born in 1996 and had problems with gross motor skills and language development. After therapy, Eilise showed dramatic improvement. In 2001, Eilise received three vaccinations, including her second dose of the measles, mumps, and rubella vaccine. Five days later, Eilise’s brother witnessed her arching her back, thrusting her head back, rolling her eyes, and jerking. He did not know what was happening. Her parents, who did not witness the seizure, noted that Eilise was feverish and lethargic. Eilise had a grand mal seizure at school. She was taken to a hospital. She had another seizure there. Eilise’s MRI results were generally normal, but her EEG results were “consistent with a clinical diagnosis of epilepsy.” She continued to suffer seizures until she started a ketogenic diet. Her parents filed suit under the National Childhood Vaccine Injury Compensation Program, 42 U.S.C. 300aa, alleging that Eilise suffered from autism as a result of her vaccinations; they later amended to allege, instead, that Eilise suffered from a “seizure disorder and encephalopathy.” The Claims Court affirmed denial of her petition. The Federal Circuit vacated: in certain cases, a petitioner can prove a logical sequence of cause and effect between a vaccination and the injury with a physician’s opinion where the petitioner has proved that the vaccination can cause the injury and that the vaccination and injury have a close temporal proximity. View "Moriarty v. Sec'y of Health & Human Servs." on Justia Law