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Presented by Hodgson Russ, the Whistleblower Blog is written by a team of lawyers experienced in successfully guiding both whistleblowers and companies accused by whistleblowers of wrongdoing through the False Claims Act process.
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Showing 14 posts in Pharmaceutical Fraud.
DOJ’s $678 Million Novartis Settlement for False Claims Act and Anti-Kickback Statute Violations—Changing Big Pharma’s Expectations for Compliance Programs
Roopa Chakkappan authored an article titled, "DOJ’s $678 Million Novartis Settlement for False Claims Act and Anti-Kickback Statute Violations—Changing Big Pharma’s Expectations for Compliance Programs," which was posted on the American Health Law Association's (AHLA) website.
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DOJ Now Requires Certain Factors Be Met Before Pursuing Off-Label Cases
Over the years, the Department of Justice has vigorously pursued off-label sales of pharmaceuticals by some of the largest pharma companies in the world. By statute, pharma companies cannot market a product “off-label,” while a physician may prescribe off-label, if he or she believes a particular medicine is effective. This rule created a tension between pharma and physicians.
46 States Reach Settlement With Medtronic for FCA Violations
According to a recent press release, New York, most other states, and the District of Columbia have settled a False Claims Act case with Medtronic. The whistleblower case alleged that “Medtronic improperly induced physicians to recommend Medtronic devices to treat cardiac rhythmic disease.” The qui tam relator who brought the FCA case will share in the proceeds. In this case, venued in a federal court in California, several states and the federal government cooperated to resolve the matter and reach a favorable outcome. New York’s attorney general thanked the relator for bringing the matter to the government’s attention.
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John Sinatra is a partner in the Business Litigation
Practice at Hodgson Russ LLP. You can reach him at jsinatra@hodgsonruss.com.
Medical Devices: Fertile for Future Whistleblower Activity
Recent gatherings of False Claims Act attorneys —who represent whistleblowers, the government, and the defense — revealed a consensus that medical devices offer fertile ground for future whistleblower activity. Medical device fraud can take at least three forms and may arise for durable medical equipment as well.
- First, defective medical devices, sold in connection with Medicare or Medicaid reimbursement, may lead to FCA liability. On this point, manufacturer quality management systems, supplier controls and monitoring, attention to customer complaints, and corrective measures are all key issues that may impact FCA liability. Medical devices that are not safe, effective, and reliable create FCA risk for their manufacturers.
- Second, off-label promotion of medical devices brings up issues similar to off-label pharmaceutical promotions. FCA approval of devices should guide marketing. If marketing goes off-label, there may be FCA liability.
- Third, kickbacks paid to medical professionals in connection with medical device sales would trigger FCA liability.
Federal government spending on health care is ever-growing. The government frauds in this area, along with qui tam activity, are expected to increase as well.
John Sinatra is a partner in the Business Litigation Practice at Hodgson Russ LLP. You can reach him at jsinatra@hodgsonruss.com.
How Risperdal Whistleblowers Made Millions From J&J
In the article “How Risperdal Whistle-Blowers Made Millions From J&J,” Bloomberg News profiles a few of the whistleblowers involved in the government’s investigation of claims that pharmaceutical giant Johnson & Johnson illegally marketed the drug Risperdal for off-label uses. In November, the U.S. Department of Justice announced that Johnson & Johnson settled the investigation for $2 billion, a portion of which went to the whistleblowers profiled. Dan Oliverio, who contributes to this blog and is quoted in the Bloomberg article, leads a team of Hodgson Russ attorneys that represents two of those whistleblowers.
Reetupama (Reena) Dutta is a senior associate in the Business Litigation Practice at Hodgson Russ LLP. You can reach her at rdutta@hodgsonruss.com.
Hodgson Russ Helps Plaintiffs False Claims Act Settlement
The Justice Department announced last week that Johnson & Johnson will pay $1.273 billion to the federal government and most states to settle a civil False Claims Act investigation into its off-label marketing of its antipsychotic drug Risperdal. J&J will settle a criminal investigation into the matter for an additional $800 million.
Hodgson Russ is proud to represent two of the plaintiffs who blew the whistle on J&J. The team, led by Daniel C. Oliverio, included Joseph V. Sedita and Robert J. Fluskey, Jr.
Hodgson Russ Client Receives $15 Million FCA Settlement
Keith Schenker, MD, a client of Hodgson Russ, will receive a substantial portion of the $15 million settlement ISTA Pharmaceuticals will pay to resolve allegations that the company aggressively and systematically promoted the off-label use of the prescription drug Xibrom, resulting in the submission of fraudulent claims to the United States for Medicare and Medicaid reimbursement.
Par Pharmaceutical Pays $45 Million to Resolve Liability
According to the Justice Department, Par Pharmaceutical Companies Inc. recently pleaded guilty and agreed to pay $45 million to resolve its liability for the promotion of prescription drug Megace ES “for uses not approved as safe and effective by the Food and Drug Administration (FDA) and not covered by federal health care programs.” The court fined Par $18 million and ordered $4.5 million in criminal forfeiture. Par also agreed to pay $22.5 million to resolve its civil liability.
Justice Department Announce Record False Claim Recovery Year
The Justice Department yesterday reported $4.9 billion in False Claims Act recoveries for fiscal year 2012, which is the largest single-year recovery in history.
The recoveries spanned several sectors of the economy. In the health care arena, the Justice Department reports that, “[e]nforcement actions involving the pharmaceutical and medical device industry were the source of some of the largest recoveries this year.” The department recovered nearly $2 billion in cases alleging false claims for drugs and medical devices under federally insured health programs and, in addition, returned $745 million to state Medicaid programs.” The recoveries from major pharmaceutical companies addressed several drugs allegedly marketed for off-label use. They also addressed cases involving the alleged payment of kickbacks to physicians to prescribe certain drugs. Some of the cases addressed alleged false and misleading statements concerning drug safety and the alleged underpayment of rebates owed under the Medicaid Drug Rebate Program, and they include cases alleging inaccurate, unsupported, or misleading statements about drug safety to increase sales.
Health Care False Claims Act Settlements Increasing
March 1, 2012, was a big day for New York State taxpayers, as both the state and federal governments announced significant settlements impacting the state. First, New York Attorney General Schneiderman announced two large settlements under the New York False Claims Act. Both settlements involve pharmaceutical companies, Dava Pharmaceuticals, Inc. and KV Pharmaceutical Company, with Dava misclassifying drugs to evade payments to Medicaid, and KV failing to advise the Centers for Medicare & Medicaid Services (CMS) that two unapproved drugs were not covered by federal and state health care programs, thereby improperly receiving reimbursement for those drugs. You can read the details of the Dava and KV pharmaceutical settlements here.
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