Actavis to Pay $118.6M for Medicaid Fraud
January 12, 2012 by casey
On January 4, 2012, Bloomberg News reported that units of Actavis Group Hf agreed to pay $118.6 million to resolve claims that they caused the U.S. and four state governments to overpay for drugs.
The settlement, filed Dec. 29 in federal court in Boston, followed an $84 million accord announced a day earlier in a lawsuit by the state of Texas, bringing the total to $202.6 million. In February, a state court jury in Austin ordered units of the Iceland-based company to pay $170 million for inflating billings to the Texas Medicaid program.
In the larger accord, Actavis settled with the U.S., New York, Florida, South Carolina and Iowa. The U.S., Florida and Texas cases were filed by Ven-A-Care of the Florida Keys Inc., a specialty pharmacy which prosecuted them civilly.
Ven-A-Care sued under the U.S. False Claims Act and similar statutes in Florida and Texas, which lets whistle-blowers sue on behalf of the government and share in any recovery. The states pursued their cases separately.
Ven-A-Care claimed that Actavis defrauded the U.S. and state governments by falsely reporting inflated prices of drugs. Actavis knew that the governments would use those false reports to set higher reimbursement rates for Medicaid, Ven-A-Care claimed. Actavis denied wrongdoing in the settlements.
The Justice Department didn’t join the case, although it recovered $108 million. Between the two cases, Ven-A-Care collected $15.6 million, court records show.
If you are seeing fraud on the government, contact us by calling 800-377-1812 for strictly confidential advice from experienced counsel, with no fee obligation.
Merck to Pay $950 Million for Illegal Marketing of Vioxx
December 11, 2011 by casey
Merck is also entering into a civil settlement agreement under which it will pay $628,364,000 to resolve additional allegations regarding off-label marketing of Vioxx® and false statements about the drug’s cardiovascular safety. Of the total civil settlement, $426,389,000 will be recovered by the United States, and the remaining share of $201,975,000 will be distributed to the participating Medicaid states. The settlement and plea conclude a long-running investigation of Merck’s promotion of Vioxx®, which was withdrawn from the marketplace in September 2004.
Under the provisions of the FDCA, a company is required to specify the intended uses of a product in its new drug application to FDA. Once approved, the drug may not be marketed or promoted for so-called “off-label” uses – any use not specified in an application and approved by FDA – unless the company applies to the FDA for approval of the additional use. Merck’s criminal plea relates to misbranding of Vioxx® by promoting the drug for treating rheumatoid arthritis, before that use was approved by the Food and Drug Administration (FDA). The FDA approved Vioxx® for three indications in May 1999, but did not approve its use against rheumatoid arthritis until April 2002. In the interim, for nearly three years, Merck promoted Vioxx® for rheumatoid arthritis, conduct for which it was admonished in an FDA warning letter issued in September 2001.
The parallel civil settlement covers a broader range of allegedly illegal conduct by Merck. The settlement resolves allegations that Merck representatives made inaccurate, unsupported, or misleading statements about Vioxx’s cardiovascular safety in order to increase sales of the drug, resulting in payments by the federal government. It also resolves allegations that Merck made false statements to state Medicaid agencies about the cardiovascular safety of Vioxx, and that those agencies relied on Merck’s false claims in making payment decisions about the drug. Finally, like the criminal plea, the civil settlement also recovers damages for allegedly false claims caused by Merck’s unlawful promotion of Vioxx for rheumatoid arthritis.
“We will continue to work with our law enforcement partners to aggressively investigate and prosecute pharmaceutical companies – no matter how large – when they improperly market their products,” said Daniel R. Levinson, Inspector General of the United States Department of Health and Human Services. “Merck’s comprehensive corporate integrity agreement requires top company officials to complete annual compliance certifications, and obligates Merck to post information about physician payments on its website.”
If you are seeing fraud on the government, contact us by calling 800-377-1812 for strictly confidential advice from experienced counsel, with no fee obligation.
Sandoz Agrees to Pay $150 Million to Resolve Drug-Price Case
December 11, 2011 by casey
On November 23, 2011, Bloomberg News announced the settlement of a False Claims Act case in which Novartis AG’s Sandoz unit agreed to pay $150 million to resolve claims that it caused the U.S. and state governments in California and Florida to overpay for drugs.
The U.S. will recover $86.5 million, California will get $40 million and Florida will receive $15.2 million under the agreement filed Nov. 16 in federal court in Boston.
Ven-A-Care of the Florida Keys Inc., a specialty pharmacy, sued Sandoz under the U.S. False Claims Act, as well as similar laws in California and Florida. Ven- A-Care will get $8.3 million from Florida and California. Its share of the U.S. recovery wasn’t stated in court documents.
If you are seeing fraud on the government, contact us by calling 800-377-1812 for strictly confidential advice from experienced counsel, with no fee obligation.
Pfizer to Pay $14.5 Million for Off-Label Promotion of Detrol
October 26, 2011 by casey
On October 21, 2011, the US Department of Justice announced that the American pharmaceutical company Pfizer Inc. agreed to pay $14.5 million to resolve False Claims Act allegations related to its marketing of the drug Detrol.
The settlement addresses allegations that Pfizer illegally marketed Detrol, a drug for the treatment of overactive bladder, for use in male patients suffering from benign prostatic hypertrophy and several allied conditions, for which the Food and Drug Administration (FDA) had not approved the drug as safe and effective.
Under the terms of the settlement, the $14.5 million recovery will be divided between the United States and participating state Medicaid programs, with $11,878,846 going to the federal government and $2,621,154 going to state Medicaid programs. Under the qui tam provisions of the False Claims Act, whistleblowers will receive a $3,282,019 share of the federal recovery.
“Whistleblowers play an important role in protecting taxpayer funds from fraud and abuse,” said Tony West, Assistant Attorney General of the Justice Department’s Civil Division. “Settlements like this one help maintain the integrity of FDA’s drug approval process and support important federal and state health care programs.”
If you are seeing fraud on the government, contact us by calling 800-377-1812 for strictly confidential advice from experienced counsel, with no fee obligation.
