Archive for May, 2019

Endo Pharma Faces Suit for Opioid False Claims

TN Attorney General sues opioid maker Endo Pharmaceuticals (photo courtesy Times News)

Endo Pharmaceuticals, the same company which was at the center of a $193 million settlement with one of James Hoyer’s whistleblower clients, is now facing another major legal battle. The Tennessee Attorney General is suing Endo for making unlawful and false claims about the safety and benefits of its opioid products.

The AG’s office says Endo violated the Tennessee Consumer Protection Act and contributed to a devastating health crisis in Tennessee. Here are details from the news release by Attorney General Herbert Slatery’s office:

Attorney General Herbert H. Slatery III today sued Endo Pharmaceuticals and Endo Health Solutions Inc. (Endo) for making unlawful and false claims about the safety and benefits of its opioid products.

The State’s lawsuit, filed in Knoxville, alleges Endo violated the Tennessee Consumer Protection Act and contributed to a devastating public health crisis in Tennessee.

“Our Office has conducted an extensive investigation into Endo’s unlawful marketing practices which included targeting vulnerable populations like the elderly,” said Tennessee Attorney General Herbert H. Slatery III. “Endo has repeatedly refused to take responsibility for its unconscionable conduct, which is why we are taking this action.”

The allegations in the State’s 180-page complaint detail how Endo deceptively marketed its opioid products as being less addictive and more effective than others on the market. It did this despite evidence to the contrary, including the FDA’s explicit rejection of Endo’s claim that Opana ER was resistant to abuse as well as overwhelming evidence that Opana ER was being abused throughout Tennessee.

The Complaint alleges that Endo also knew the dangers of its opioid products, including increased risks of respiratory depression and death in elderly patients, and failed to clearly disclose those risks while it specifically targeted patients in that age group.

The State also has reason to believe Endo used the recommendations and educational materials of third-party groups like the American Pain Foundation without disclosing that Endo was by far the biggest donor to the Foundation and provided more than half of its total funding. Endo provided significant funding to other third-party groups and subsequently relied on material generated by those groups without disclosing the financial relationship.

The Attorney General requested the complaint be filed under a temporary seal because Endo claims the information produced during the State’s investigation is confidential. The order sealed by the judge allows the seal to expire in 10 days unless Endo acts to extend it.

The Attorney General believes the complaint should be made available to the public in its entirety and efforts to keep it confidential will only prolong and diminish Endo’s accountability for its conduct.

 

Generic Drug Price Fixing


Connecticut Attorney General William Tong interviewed on 60 Minutes

If you ever wondered why the price of generic drugs is getting so expensive, 60 Minutes gave us an inside look at the problem on its Sunday broadcast. The CBS program profiled the on-going battle of Connecticut Attorney General William Tong to hold big pharma accountable.

Connecticut and more than 40 other states filed a sweeping lawsuit accusing the biggest generic drug makers of engaging in an “industry-wide conspiracy” to fix the prices of generic drugs. They allege there is a massive, systematic scheme to bilk consumers and the government out of billions of dollars.

Based on evidence like text messages, emails, phone records, and documents, the prosecutors say sudden, dramatic, price spikes can be tied to drug makers colluding to profiteer, not a shortage of drugs. In a word “greed.”

The price hikes have affected 100’s of different, everyday prescriptions, driving up the costs for health insurance, Medicare and Medicaid. With 90-percent of all prescriptions filled with generic drugs, the impact on everyday American lives has been overwhelming.

Drug makers deny any wrong-doing and insist they will fight the lawsuits vigorously. Click here to watch the 60 Minutes report.

 

California legislators looking to expand False Claims Act to tax fraud

California Assembly Bill 1270 was introduced on February 21, 2019. If it becomes law, it would amend the state’s False Claims Act to remove the bar against tax-related false claims.

Read More…
 

Former CEO of Hospital Chain to Pay $3.46 Million to Resolve False Billing and Kickback Allegations

Gary D. Newsome, former CEO of Health Management Associates LLC (HMA),  a hospital chain that was headquartered in Naples, Florida, has agreed to pay the United States $3.46 million to settle allegations that he caused HMA to knowingly submit false claims to government health care programs by admitting patients who could have been treated on a less costly, outpatient basis, the Department of Justice announced. The settlement also resolves allegations that Newsome caused HMA to pay remuneration to Emergency Department (ED) physicians in return for referrals.  

“Those who bill federal health care programs for unnecessary hospital stays will be held accountable for wasting federal dollars,” said Assistant Attorney General Jody Hunt for the Department of Justice’s Civil Division. “Patients deserve the unfettered, independent judgment of their health care professionals. We will pursue those who cause hospitals to offer financial incentives to physicians in return for improper patient referrals that undermine the integrity of our health care system.”

“A physician’s health care decisions should be driven by what is in the patient’s best interest, not by what helps line a provider’s pockets,” said Barbara Bowens, the Acting U.S. Attorney for South Carolina for purposes of this case. “The U.S. Attorney’s Office will not tolerate false claims based on unnecessary hospital admissions, which drive up health care costs and can harm patients.”

“Providers are expected to closely follow rules and bill properly. Further, in this case, the government contended that Newsome directed illegal payments for referrals,” said Derrick L. Jackson, Special Agent in Charge of the Office of Inspector General of the U.S. Department of Health and Human Services. “Taxpayer money wasted is money stolen from vital government health programs.”

Read the entire press release from the Department of Justice by clicking here.

 

Pharmaceutical Company To Pay $17.5M To Resolve Allegations Of Kickbacks

US WorldMeds LLC founder and CEO Breckenridge Jones
US WORLDMEDS LLC

The Justice Department announced today that US WorldMeds LLC (USWM) has agreed to pay $17.5 million to resolve allegations that it violated the False Claims Act, 31 U.S.C. §§ 3729 et seq., by paying kickbacks to patients and physicians to improperly induce prescriptions of its drugs, Apokyn® and Myobloc®. USWM is a pharmaceutical manufacturer headquartered in Louisville, Kentucky. 

“The Department of Justice is committed to ensuring that physicians’ and patients’ selection of medications is not influenced by improper financial considerations,” said Assistant Attorney General Jody Hunt of the Department of Justice’s Civil Division. “The nation’s health care programs and taxpayers deserve health care companies that play by the rules, including the Anti-Kickback Statute.”

When a Medicare beneficiary obtains a prescription drug covered by Medicare Part D, the beneficiary may be required to make a partial payment, which may take the form of a copayment, coinsurance, or a deductible (collectively “copays”). Congress included copay requirements in the Medicare program, in part, to encourage market forces to serve as a check on health care costs, including the prices that pharmaceutical manufacturers can demand for their drugs. Under the Anti-Kickback Statute, a pharmaceutical company is prohibited from offering, directly or indirectly, any remuneration — which includes paying patients’ copay obligations — to induce Medicare patients to purchase the company’s drugs. 

Read the entire press release from the Department of Justice by clicking here.