Justia Government Contracts Opinion SummariesArticles Posted in Drugs & Biotech
Kennedy v. Novo A/S
Kennedy worked for Novo, promoting a new diabetes drug, Victoza. FDA approval of Victoza included specific conditions concerning a possible risk of thyroid cancer. According to Kennedy, in preparation for Victoza’s commercial launch, she was directed to market the drug in ways inconsistent with those FDA limitations. Kennedy filed a False Claims Act (FCA) complaint, alleging that Novo caused people to submit millions of dollars in false claims for payment under federal health care programs. Several such cases were consolidated in the District of Columbia. The government intervened. Novo, the government, and Kennedy reached a settlement for $46.5 million.The government filed a separate complaint against Novo, under the Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. 301, alleging Victoza was an unlawfully “misbranded” drug. In the FDCA Settlement, Novo admitted that it had trained its employees to undermine the risks and agreed to pay the government $12,150,000. Kennedy was not a party to the FDCA litigation.Kennedy sought a share of the FDCA Settlement, arguing that it was an “alternate remedy” under the FCA, 31 U.S.C. 3730(c)(5). The D.C. Circuit reversed Kennedy’s award. The FCA confines qui tam plaintiffs to recoveries only for claims seeking relief based on fraud or falsehoods covered by that statute. The government’s separate FDCA enforcement action did not involve the type of claim cognizable under the FCA, nor did it allege a false or fraudulent effort to obtain money or property from the government. Kennedy received an agreed-upon FCA payment with knowledge of the separate action and is not entitled to further recovery. View "Kennedy v. Novo A/S" on Justia Law
Dolt, Thompson, Shepherd & Conway, P.S.C.
In this case related to the disbursement of Purdue Pharma funds, the Supreme Court reversed the court of appeals' grant of summary judgment for the Office of the Attorney General (OAG) and Dolt Thompson declaring that a contract was enforceable and a payment to Dolt, Thompson, Shepherd & Kinney, P.S.C. (Dolt Thompson) was proper, holding that the circuit court did not err.The then-attorney general filed a lawsuit against Purdue Pharma regarding the OxyContin epidemic. The OAG selected Dolt Thompson to assist in the Commonwealth's litigation against Purdue Pharma. After the OAG settled with Purdue Pharma it paid Dolt Thompson in part. The Legislature then passed a 2016 budget bill directing payment of attorney's fees and expenses in the Purdue Pharma case. The OAG filed a complaint seeking a declaration that the payment to Dolt Thompson was proper. The Finance Cabinet filed an action against Dolt Thompson. The circuit court consolidated the cases and entered summary judgment for the OAG and Dolt Thompson. The court of appeals reversed and ordered the circuit court to allow the Cabinet to conduct discovery. The Supreme Court reversed, holding that the Legislature acted within its authority in stating that the attorney's fees should be paid prior to any other disbursement of the Purdue Pharma funds. View "Dolt, Thompson, Shepherd & Conway, P.S.C." on Justia Law
Acetris Health, LLC v. United States
Acetris obtains its pharmaceutical products from Aurolife, which makes them in a New Jersey facility, using an active pharmaceutical ingredient made in India. Acetris had contracts to supply the VA with several pharmaceutical products, including Entecavir (used to treat hepatitis B). The VA requested that Acetris recertify its compliance with the Trade Agreements Act of 1979 (TAA), which bars the VA from purchasing “products of” certain foreign countries, such as India. Ultimately, the VA requested that Acetris obtain a country-of-origin determination. Customs concluded that the Acetris products were products of India. Acetris agreed to cancel its Entecavir contract. The VA issued a new solicitation seeking proposals for Entecavir, indicating that it would continue to rely on the Customs determination. Acetris filed suit, challenging the VA’s interpretation of the TAA. The VA awarded the Entecavir contract to Golden, consistent with its policy to award contracts to the lowest-price technically acceptable bid. The government moved to dismiss the suit, arguing that Acetris lacked standing because Acetris would not have won the contract regardless of the interpretation of the TAA and that Acetris’ earlier-filed Court of International Trade suits divested the Claims Court of jurisdiction under 28 U.S.C. 1500.The Claims Court denied the government’s motions and rejected the government’s interpretation of the TAA. The Federal Circuit affirmed in part, holding that the suit is justiciable and agreeing with the Claims Court. The court remanded for the entry of a declaratory judgment and injunction. View "Acetris Health, LLC v. United States" 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
Solis v. Millenium Pharmaceuticals, Inc.
Solis alleged that his former employers violated the federal False Claims Act (FCA) by promoting dangerous off-label uses of a cardiovascular drug, Integrilin, and by paying physicians kickbacks to prescribe Integrilin and an antibiotic drug, Avelox. The district court found that Solis’s FCA claims were foreclosed by the public disclosure bar, which deprives federal courts of subject matter jurisdiction over FCA suits when the alleged fraud has already been publicly disclosed unless the relator is deemed an original source. The Ninth Circuit affirmed in part, holding that Solis’s Integrilin claims were substantially similar to those in prior public disclosures, and were close enough in kind and degree to have put the government on notice to investigate the alleged fraud before Solis filed his complaint. The court vacated the dismissal of Solis’s Integrilin claims and remanded for a determination of whether Solis qualified for the “original source” exception, 31 U.S.C. 3730(e)(4). Concerning Solis’s Avelox claims, the court held that the district court clearly erred in finding that the Avelox claims were publicly disclosed based on court complaints that never mentioned Avelox but affirmed the dismissal of Solis’s Avelox claims on the alternative ground of failure to plead with particularity as required by Fed.R.Civ.P. 9(b). View "Solis v. Millenium Pharmaceuticals, Inc." on Justia Law
Ibanez v. Bristol-Myers Squibb Co.
Abilify is approved to treat schizophrenia, Bipolar Disorder, major depressive disorder and irritability associated with autism. There are no disapproved treatments for elderly patients, but the FDA has included a warning since 2007 that Abilify is associated with increased mortality in elderly patients with dementia-related psychosis. Relators, former BMS employees, alleged in a qui tam suit that BMS and Otsuka engaged in a scheme to encourage providers to prescribe Abilify for unapproved (off-label) uses and improperly induced providers to prescribe Abilify in violation of the Anti-Kickback Statute. Nearly identical allegations were leveled against the companies years earlier. In 2007-2008, the companies each entered into an Agreement as part of a settlement of qui tam actions concerning improper promotion of Abilify. Relators allege that, despite those agreements, the companies continued to promote Abilify off-label and offer kickbacks, causing claims for reimbursement for the drug to be submitted to the government, in violation of the False Claims Act (FCA), 31 U.S.C. 3729. The district court dismissed in part. The Sixth Circuit affirmed; the complaint did not satisfy Rule 9(b)’s requirement that relators adequately allege the entire chain to fairly show defendants caused false claims to be filed. As sales representatives, relators did not have personal knowledge of provider’s billing practices.The alleged plan was to increase Abilify prescriptions through improper promotion, which does not amount to conspiracy to violate the FCA. View "Ibanez v. Bristol-Myers Squibb Co." 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
Booker v. Pfizer, Inc.
In 2009, Pfizer, settled claims that it had violated the False Claims Act (FCA), 31 U.S.C. 3729, and entered into a Corporate Integrity Agreement with the U.S. Department of Health and Human Services. Months later, Booker and Hebron, former Pfizer sales representatives, brought a qui tam action, allegedly on behalf of the United States and several states, asserting that Pfizer had continued to violate the FCA and state analogues. They alleged that Pfizer had continued to knowingly induce third parties to file false claims for payment for Pfizer drugs with government programs like Medicaid by marketing the drug Geodon for off-label uses, in violation of 21 U.S.C. 301, and paying doctors kickbacks for prescribing the drugs Geodon and Pristiq, in violation of the Anti-Kickback Statute, 42 U.S.C. 1320a-7b(b), (g). They also alleged that Pfizer had violated the FCA "reverse false claims" provision, 31 U.S.C. 3729(a)(1)(G), by failing to pay the government money owed it under Pfizer's Agreement with HHS, and that Pfizer had violated the FCA's anti-retaliation provision, by terminating Booker's employment. All of these claims were resolved against relators, one on a motion to dismiss and the rest on summary judgment. None of the sovereigns intervened. The First Circuit affirmed the merits decisions and found no error in its management of discovery. The court found relators’ data “woefully inadequate to support their FCA claim.” View "Booker v. Pfizer, Inc." on Justia Law
Townsend v. Bayer HealthCare Pharm. Inc.
Townsend worked as an Arkansas pharmaceutical sales representative for Bayer, selling Mirena, a contraceptive device. Townsend visited physicians, including Dr. Shrum. Townsend learned Shrum was importing from Canada a version of Mirena that was not FDA-approved, at half the cost of the approved version. Shrum had submitted Medicaid claims at the same rate as the approved version and bragged about $50,000 in extra profit. Townsend sought guidance from his superiors. Bayer told Townsend not get involved. Townsend called the Medicaid Fraud Hotline, although he feared losing his job. Shrum was charged with Medicaid fraud. Meanwhile, Bayer changed its method of reimbursing sales expenses. Not understanding the change, Townsend’s wife spent funds intended for those expenses, causing Townsend’s account to be closed temporarily. Although Townsend's account had been reactivated, Bayer fired him, claiming his closed account prevented him doing his job. Townsend sued, citing anti-retaliation provisions of the False Claims Act, 31 U.S.C. 3730(h).). A jury awarded Townsend back pay, doubled to $642,746, and $568,000 in emotional distress damages. The court denied front pay and ordered Bayer to reinstate Townsend. The Eighth Circuit affirmed on all issues except the emotional distress damage award and remanded to allow Townsend the option of accepting a remittitur of $300,000, or a new trial on emotional distress damages. View "Townsend v. Bayer HealthCare Pharm. Inc." on Justia Law
Schumann v. Astrazeneca Pharm., L.P.
Schumann, as a qui tam relator under the False Claims Act (FCA), 31 U.S.C. 3729, and corresponding state laws, alleged that the drug company defendants improperly induced Medco Health, his employer, to offer certain of defendants’ drugs in its mail-order pharmacies and in health plans it managed; did not include those inducements when calculating the best price for their drugs, and thus submitted inaccurate best price reports to the government; overcharged the government based on those inaccurate best prices; and underpaid rebates owed based on those inaccurate best prices. The district court dismissed, holding that it lacked subject matter jurisdiction over Schumann’s claims because he did not have the requisite direct and independent knowledge to satisfy the original source exception to the FCA’s public disclosure bar. The Third Circuit affirmed. Schumann’s knowledge was not direct because it came from reviewing documents and discussing them with colleagues who participated in the underlying events. View "Schumann v. Astrazeneca Pharm., L.P." on Justia Law