Medical providers must be held liable for their products that harm the consumer. They must also be held liabel for government fraud. The products GranuFlo and Naturalyte manufactured by Fresenius has been causing cardiac arrest in Dialysis patients and it appears Fresenius Clinics knew of the potential risk and continued the fraud. This is just one of the fraud practices perpetuated by Fresenius. See the article below.
Fresenius Dialysis Provider Will Pay $486 Million to Settle Criminal and Civil Fraud Charges
By MILT FREUDENHEIM
Published: January 20, 2000
Fresenius Medical Care A.G., the nation's largest provider of kidney dialysis services, said yesterday that it would pay $486 million to settle federal civil and criminal fraud charges involving Medicare and other government programs.
Government officials said both the civil settlement of $385 million and the $101 million in criminal fines were the largest in a five-year antifraud campaign involving blood-testing laboratories and other heath care companies.
The campaign has returned more than $2 billion to the Medicare Trust Fund since 1995, said June Gibbs Brown, inspector general of the Department of Health and Human Services. The biggest previous settlements included $379 million from National Medical Enterprises, a hospital chain; $325 million from a laboratory unit of SmithKline Beecham, and $255 million from First American Health Care, a laboratory business based in Georgia.
Fresenius, based in Bad Homburg, Germany, provides blood cleansing services for more than 60,000 Americans with kidney problems. The charges involved disputed payments by government programs, not the quality of patient care.
Ben Lipps, an American who is chief executive of Fresenius, said the company was pleased to turn the page on the disputes with the Justice Department, Medicare and state Medicaid programs and the Inspector General's office. Fresenius is still in discussions about payments with its commercial insurance companies, he said.
In the settlement, the company agreed to plead guilty to criminal conspiracy charges involving three units: LifeChem Inc. laboratories, NMC Homecare Inc. and NMC Medical Products Inc.
The three units were accused of conspiring to defraud government payers by charging for disputed intravenous feeding of dialysis patients, charging for blood tests deemed unnecessary and violating anti-kickback laws by providing payments, discounts, yacht trips and bear-hunting excursions in Alaska to attract potential customers for the LifeChem blood-testing business.
The government complaint said the home care unit falsely attributed patients' weight loss to kidney-related problems. In one case, it said, weight loss resulting from the amputation of a patient's leg was misattributed.
Three former Fresenius officials have been indicted in federal district court in Boston in the investigation. They are K. Glenn Shaw, former president; Louis Verde, a former manager of the products unit, and Eileen B. Aird, former president of LifeChem.
Margaret S. Telgheder, a former executive of the medical products and lab units, pleaded guilty to Medicare fraud charges last June. David Charles Weber, a former vice president in medical products, pleaded guilty to kickback charges in December 1998. They have not been sentenced.
Fresenius ''inherited'' the investigation, Mr. Lipps said, when it bought National Medical Care from W. R. Grace & Company in 1996 for $4.4 billion. Mark W. Pearlstein, first assistant United States attorney in Boston, said Fresenius had cooperated with the investigators.
The company, which had about $3.6 billion in 1999 revenues, has sold the home care unit. It closed the LifeChem and NMC Medical Products units under the agreement and transferred their functions to the company's Spectra laboratories unit and the German parent's own products lines.
Nine people who filed whistle-blower lawsuits linked to the investigation will receive $65.8 million of the civil settlement. They include a former home care unit employee in Mexico, Mo., and a pharmacy in Key West, Fla., that competed with National Medical Care.
Under the False Claims Act, whistle-blowers and their lawyers can share up to 30 percent of settlements in federal investigations linked to their charges, said Judy Holz, a spokeswoman for the Inspector General's office.
Ms. Gibbs said Fresenius had agreed to install a stringent corporate integrity program, including special audits and training over eight years to prevent recurrences. Fresenius hired John Markus, a former regulations compliance executive at Oxford Health Plans, to head the new integrity program.
Fresenius took a pretax charge against earnings of $590 million for the expected settlement.
If you or a loved one has been injured by GranuFlo or Naturalyte contact www.classactionlawyernetwork.com for a GranuFlo Dialysis medication lawyer.