Notable Wins

False Claims Act Case Against Johnson & Johnson/Scios, Inc. – Our law firm filed this qui tam case on behalf of Joe Strom, a former Scios Area Manager.  After eight years, including years long litigation, both Defendants agreed to pay $184 million to resolve the allegations that they unlawfully promoted their cardiac drug Natrecor for off-label uses. In addition, Scios agreed to pay an $85 million criminal fine and plead guilty to a misdemeanor charge of introducing misbranded Natrecor into interstate commerce.  This settlement was announced by the United States as part of a $2.2 billion global settlement between the federal government and Johnson & Johnson. Please click here to watch a short online video about this settlement. The firm’s press release is available here.

False Claims Act Case Against Genentech & OSI Pharmaceuticals – This qui tam case was brought by our law firm on behalf of our client, Brian Shields, a former Genentech product manager. Mr. Shields alleged that Genentech and OSI supplied healthcare providers with inflated survival data that caused physicians to prescribe their lung cancer drug (“Tarceva”) broadly in the first-line setting, off-label, including to patients who did not have a known EGFR mutation. After 4 years, the Defendants agreed to settle the case and pay over $67 million. The conduct covered under the Settlement Agreement provides that, through Defendants’ distribution, marketing, and sale of the prescription drug Tarceva for NSCLC for a period of five years, the Defendants made misleading representations to physicians and other healthcare providers about Tarceva’s effectiveness to treat certain NSCLC patients when there was little evidence to show that Tarceva was effective, unless the patients also had an EFGR mutation or unless they had never smoked.  As a result, Defendants knowingly caused false or fraudulent claims for Tarceva to be submitted to, or caused purchases by, Federal Healtcare Programs for Tarceva to treat NSCLC, as a first line of therapy, in current or former smokers classified as ECOG PS 0 or 1 who did not have a known EFGR mutation, when such first-line use was not approved by the FDA, was not a medically accepted indication as defined by applicable law, or was not covered by the United States and state Medicaid programs. Read the U.S. Department of Justice press release here. Read the Nolan Auerbach & White press release here.

False Claims Act Case Against Dignity Health (formerly known as Catholic Healthcare West) – Our law firm filed this qui tam case on behalf of Kathleen Hawkins, a former Dignity Health Director of Medical Management. 5 years after initially filing the lawsuit, Dignity Health agreed to pay nearly $37 million to resolve Ms. Hawkins’ case. The settlement included the resolution of allegations that 13 of Dignity’s Hospitals, for a 5-year period, knowingly submitted or caused to be submitted claims for payment to the Federal Healthcare Programs for scheduled cardiovascular procedures, billing these services as inpatient procedures when they should have been billed as outpatient procedures. Read this U.S. Department of Justice press release here. The Nolan Auerbach & White’s press release is available here.

False Claims Act Case Against Odyssey Healthcare, Inc. –  Approximately three years after filing a qui tam lawsuit on behalf of our client, Bryan Dingus, a former Executive Director, Odyssey agreed to pay $25 million to resolve allegations that it submitted false claims to Medicare for continuous home care services that were not provided in accordance with requirements of the Medicare Program. In addition, Odyssey entered into a five year corporate integrity agreement with the United States Department of Health and Human Services Office of the Inspector General. Read this U.S. Department of Justice press release.

False Claims Act Case Against Alere, Inc., et al. – This qui tam case was brought by our law firm on behalf of Amanda Wu, a former Alere San Diego senior process analyst. 7 years after filing the case, the DOJ and our law firm successfully resolved her civil False Claims Act case (and employment claims) against the diagnostic medical device manufacturer for over $33 million. Formerly known as Biosite, Inc., Alere San Diego, Inc. was a wholly-owned subsidiary of Alere, Inc., until both companies were acquired by Abbott Laboratories in October 2017. The 2018 Settlement Agreement’s Covered Conduct explain that between January 1, 2006 and June 12, 2012, Alere SD knowingly submitted or caused the submission of false or fraudulent claims for its Triage devices and other devices to Medicare, Medicaid, TRICARE, and the VA. Our law firm also resolved Ms. Wu’s allegations of damages for wrongful termination of employment under the whistleblower provisions of the False Claims Act, although its terms are confidential. Click here to read Nolan Auerbach & White’s press release, as well as the U.S. Department of Justice Press Release.

False Claims Act Case Against Universal Health Services, Inc. – The Firm filed the case on behalf of our client, Bruce Moilan, Sr., against McAllen Hospitals, L.P., d/b/a South Texas Health System, a wholly owned subsidiary of Universal Health Services, Inc. After several years of investigation and furtherance of the lawsuit, the Defendants agreed to enter into a Settlement Agreement pursuant to which they paid $27.5 million to resolve claims concerning violations of the Stark and Anti-kickback laws. McAllen Hospitals, L.P., d/b/a South Texas Health System owned and/or operated multiple healthcare facilities in McAllen, Texas, including McAllen Medical Center, McAllen Heart Hospital, Edinburg Regional Medical Center, and the South Texas Behavioral Health Center. Our client received a $5.5 million relator share, 20% percent of the $27.5 million qui tam settlement. To read the Department of Justice Press Release, click here.

False Claims Act Case Against Novartis Pharmaceuticals Corporation – Our firm filed this eventually-consolidated case on behalf of 3 principled sales representatives.  After years of investigations, pharmaceutical manufacturer Novartis Pharmaceuticals Corporation paid $237.5 million to resolve our clients’ civil allegations that it unlawfully promoted its drug Trileptal for unapproved uses and that it paid illegal remuneration to healthcare providers to induce them to prescribe the company’s products. In addition, the company paid a $185 million criminal fine and to plead guilty to a misdemeanor charge of introducing misbranded drugs into interstate commerce. Nolan Auerbach & White represented three of the key whistleblowers in the consolidated cases, which were brought under the qui tam, or whistleblower, provisions of the False Claims Act. The settlement resolved two other qui tam actions raising similar allegations. Click here to read the U.S. Department of Justice press release. For the Nolan Auerbach & White press release, click here.

False Claims Act Case Against Pharmaceutical manufacturer Allergan, Inc. – Nolan Auerbach & White represented two of the whistleblowers in this case, brought under the qui tam, or whistleblower, provisions of the False Claims Act. After a significant period of time and work, Allergan, Inc. paid $225 million to resolve civil allegations that it unlawfully promoted its drug Botox® Therapeutic for unapproved uses and that it paid illegal remuneration to healthcare providers to induce them to prescribe Botox Therapeutic. In addition, the company paid a $375 million criminal fine and pled guilty to a misdemeanor charge of introducing this misbranded drug into interstate commerce. This settlement also resolved two other qui tam actions raising similar allegations. For the Department of Justice press release, click here. For the Nolan Auerbach & White press release, click here.

False Claims Act Case Against Daiichi Sankyo –This qui tam case was brought by our law firm on behalf of our client Kathy Fragoules, a former Daiichi Sankyo sales representative. The complaint alleged that Daiichi Sankyo had various programs utilized by its sales representatives to induce physicians to use its pharmaceuticals, including Welchol, Azor, Benicar, and Benicar HCT. The complaint also alleged that Daiichi Sankyo started a program called “Physician Opinion Discussions” (or “PODs”), in which sales representatives targeted high decile physicians to be POD speakers to small groups of 3 or more fellow physicians. The complaint further alleged that the only qualifications to lead a POD were that the physician was a “high decile” physician, and that all physicians in the POD eventually were able to lead their POD, up to five times per year, with physician leaders receiving $500 or more per session. The complaint, which describes the scheme in detail, concluded that the PODs were for one purpose:  to increase prescriptions. 5 years after our law firm filed the Complaint on Ms. Fragoules’ behalf, and having reviewed and analyzed tens of thousands of documents in furtherance of the case, Daiichi Sankyo agreed to pay over $39million plus interest to resolve Ms. Fragoules’ qui tam lawsuit. Click here to read the U.S. Department of Justice press release. Nolan Auerbach & White’s press release is available here.

False Claims Act Case Against Forest Laboratories, Inc., and its subsidiary Forest Pharmaceuticals, Inc. – Several years after Nolan, Auerbach & White filed a qui tam case on behalf of former CMS policy manager, Constance Conrad, these pharmaceutical manufacturers paid $42.5 million to resolve allegations that they illegally marketed and sold the drug Levothroid, even though the FDA had never approved Levothroid for safety and efficacy. Nolan Auerbach & White represented the key whistleblower in this case, brought under the qui tam, or whistleblower, provisions of the False Claims Act. It was one of the country’s first and largest False Claims Act recovery for allegations involving pharmaceutical companies selling unapproved drugs. The settlement also resolved two other qui tam actions, which, in total, resulted in a $149 million civil recovery for federal and state governments. In addition, Forest paid a $150 million criminal fine, agreed to forego $14 million in disputed payments, and pled guilty to a misdemeanor charge of introducing this misbranded drug into interstate commerce. Click here to read the U.S. Department of Justice press release. For the Nolan Auerbach & White press release, click here.

False Claims Act Case Against Schwarz Pharma and a subsidiary, Kremers Urban. – In another unapproved drug case, our client’s breakthrough case eventually resulted in a $22 million recovery. The complaint alleged that the Defendants submitted false quarterly reports to the government related to a pair of drugs, Deponit and Hyoscyamine Sulfate Extended Release. The complaint further alleged that Schwarz and Kremers misrepresented the regulatory status of both drugs and failed to advise CMS that these unapproved drugs did not qualify for coverage under state and federal healthcare programs.

False Claims Act Case Against St. Jude Medical, Inc. – Our law firm filed this qui tam case on behalf of Chuck Donigian, a former sales representative for the Defendant.  Several years after preparing and filing the lawsuit, the Defendant paid $16 million to resolve our client’s allegations that it paid kickbacks to physicians to prescribe its products. The Complaint maintained that St. Jude Medical made payments to doctors ostensibly for the collection of data in connection with post-market clinical studies of the company’s products; however, these payments were designed and used as a means of increasing sales of its devices over competitors, not as bona fide scientific research. The Complaint also alleged that St. Jude Medical shelled out payments to doctors for entertainment, tickets to sporting events, and other gifts and benefits; that these practices caused government healthcare programs to pay millions of dollars for prescriptions that were tainted by illegal kickbacks. Click here to read the Department of Justice Press Release. For the Nolan Auerbach & White press release, click here.

Select Medical Corporation paid $7.5 million to settle our client Beatrix Maitland’s qui tam allegations that Select paid suspect “Medical Director” payments to several Ohio physicians. Select operates over 100 long-term, acute-care hospitals, known as “LTACHs,” nationwide. As part of the settlement, Select Specialty Hospital System entered into a Corporate Integrity Agreement that mandates strict reporting and monitoring requirements.

KV Pharmaceutical Company, the parent company of now-defunct Ethex Corporation, paid $17 million to resolve allegations that Ethex continued to manufacture and market Nitroglycerin Extended Release Capsules and Hyoscyamine Sulfate Extended Release Capsules without FDA approval. Our client’s Complaint maintained that Ethex intentionally failed to notify the Centers for Medicare & Medicaid Services that these medications were not “covered outpatient drugs.” This was the latest settlement from a multiple Defendant, industry-changing qui tam action, filed by our law firm, alleging that dozens of pharmaceutical companies had been allowed to sidestep the FDA pharmaceutical approval process and manufacture and distribute unapproved pharmaceutical products, ultimately prescribed to Medicaid patients, jeopardizing the safety of millions of Americans and thwarting federal law. This multi-defendant lawsuit led to the recovery of over $100 million for the Medicaid Program. Click here to read the Department of Justice Press Release.

Schering Plough Corporation and a related company paid $435 million regarding accusations that it improperly marketed drugs for unapproved uses and lied to the government about drug prices. Under the settlement, Schering Sales, Corp. pled guilty to conspiracy and paid a criminal fine of $180 million. Its parent company, Schering-Plough Corp., paid another $255 million to resolve civil aspects of the case, including our clients’ qui tam lawsuit, which, inter alia, alleged that Schering-Plough marketed drugs off-label for uses that had not been approved by the Food & Drug Administration. One drug was Temodar, approved at the time, only to treat a rare type of brain tumor called anaplastic astrocytoma. The company also promoted the unapproved use of Intron A for the treatment of cancer on the surface of the bladder. Two of the three whistleblowers in this case were clients of Nolan Auerbach & White, and the final relator share recovery by our two clients was over $12 million. 

Victory Memorial Hospital agreed to a settlement to resolve claims that the hospital defrauded the Medicare program stemming from a Medicare overpayment to the hospital. In the qui tam complaint, our client alleged that Victory Memorial submitted cost reports  that understated certain revenues for patient care, known as “charges.” This resulted in Victory Memorial having a higher Cost-to-Charge ratio for those years, which in turn resulted in Victory Memorial obtaining higher reimbursements from Medicare. Our client’s case resulted in a New York City hospital payment of $12 million to settle allegations that it knowingly received in error more than $14 million in two Medicare payments from Empire Blue Cross and Blue Shield relating to its GME program, and then failed to disclose them, as required by law. Our client, Joseph Lee, a former employee of Victory Memorial, received a multi-million dollar Relator share. Click here to read the Department of Justice Press Release.

Vencor, Inc., now known as Kindred Healthcare, one of the nation’s largest nursing home chains  and Ventas, Inc. a related real estate investment trust paid $104.5 million to resolve civil claims that Vencor knowingly submitted false claims to Medicare, Medicaid, and TRICARE, the military’s healthcare program. Our courageous clients’ case recovery included more than $54 million for improper claims made on Vencor’s hospital Medicare cost reports; that Vencor inappropriately included on its Medicare costs report the revenue and the expenses of running a separate business. That business supplied its nursing homes with special contracted services such as respiratory therapy. Vencor was thus able to inflate both the revenue and expense lines at its hospitals which, under Medicare’s formulas, improperly boosted its reimbursements from Medicare.

In United States v. Gold Star Medical Services, et al. our law firm together with our client, Gary Flewelling successfully recovered in concert with the Government over $62 million from multiple DME companies and individuals through recoveries and judgments in repayment for false claims for wheelchairs and other durable medical equipment. The complaint alleged and the Government contended that the claims (1) were for services that were medically unnecessary; (2) were for items or services that were more expensive and complex than the DME or DME-related services or products ordered by the prescribing physicians or actually provided by the defendants (i.e. the claims were upcoded), or (3) were submitted for services and items never provided. While the Government intervention in this case dated back to over 20 years ago, our client continued to receive Relator share payments for nearly a decade.

Our client’s case against Orthofix, a Texas-based medical device manufacturer, resulted in a large medical equipment provider payment of $1.75 million, to settle allegations that the company inappropriately violated TRICARE healthcare insurance requirements due to the “off-label” sales of one of its products. The complaint alleged that FDA had not approved the electrical bone growth stimulation device for use on the cervical, or neck region part of the spine. Our client received a sizeable Relator share in this case – one of the first medical device off-label cases ever brought.

Lifeline Health Care paid $3.1 million in settlement of a case concerning allegations of false claims made to federal healthcare programs for patients who did not qualify for home healthcare. Specifically the complaint alleged that defendant Lifeline Health Care (1) submitted fraudulent claims to Medicare for home health visits to patients who were not home bound, and home health care visits that were not medically necessary; and (2) submitted fraudulent documents to Medicare for home health services without adequate or proper physician orders, and without the requisite documentation supporting the performance and medical necessity of the services billed. Our whistleblower clients were four concerned and courageous clinicians.

Nova Southeastern University paid $4.1 million to settle our client Alan Kent’s lawsuit concerning false claims for psychological services. Our client, a psychologist at the mental health center, had complained internally for years about overbilling and unlicensed students performing services and no one listened. The settlement of the lawsuit vindicated our client and resolved the university’s compliance issues at the time.

Long-term care pharmacy Remedi Seniorcare, Inc., paid $1.27 million to resolve our client’s whistleblower lawsuit filed in Federal Court, in the District of Maryland, United States ex rel. Thompson v. Woodhaven Pharmacy Services, LLC d/b/a Remedi Seniorcare, Inc. This was a unique and important whistleblower case alleging that, instead of disposing unused medications, the pharmacy unlawfully recycled, repackaged, redistributed and re-billed thousands of drugs to Medicare and Medicaid beneficiaries. Click here to read the U.S. Department of Justice Press Release. For the Nolan Auerbach & White press release, click here.

Eon Labs, Inc. became the first defendant to enter into a settlement agreement to resolve our client’s case against multiple defendants based upon the sale of unapproved drugs to Medicaid. Eon paid $3.48 million to resolve claims that it represented to CMS that is oral nitroglycerin products were “Covered Outpatient Drugs,” when the products were marketed without FDA approval and despite the FDA’s previous finding that there was a lack of evidence to support effectiveness. Click here to read the Department of Justice Press Release.