1st Circ. Panel Wary Of FCA Suit Against Medtronic Unit

A former sales rep for what is now a Medtronic subsidiary faced a seemingly skeptical panel of First Circuit judges Wednesday in his bid to revive False Claims Act suit accusing the device maker of off-label marketing and defrauding the U.S. Food and Drug Administration. 

Counsel for Jeffrey D'Agostino, who formerly worked for ev3 Inc. — since acquired by Medtronic — asked the panel to reverse a lower court's dismissal of allegations surrounding the company's Onyx and Axium products. His suit claims that ev3 lied to the FDA to obtain approval for Onyx, that the Axium device was defective, and that the products, meant to treat vascular diseases, were aggressively marketed off-label despite FDA concerns about patient safety. read more »

Whistleblower: Collapse of ITT offers ‘a final sense of justice’

A former dean at ITT Technical Institutes, who filed a whistleblower suit against the school, said he’s happy to see the company brought to justice after what he says were years of mistreatment of students.

Rodney Lipscomb accused ITT of luring students under false pretenses or who weren’t prepared for school all in the name of securing more federal financial aid funding in a lawsuit originally filed in 2014. In the suit, Lipscomb claimed that ITT enrolled a blind student in a computer networking program that required students to identify cords by color and read codes. He also claimed the school enrolled a student who struggled to write a coherent sentence, among other allegations. read more »

Coastal Spine and Pain agrees to $7.4 million fine

Physicians Group Services, P.A., doing business as Coastal Spine and Pain, has agreed to pay $7.4 million to the government to resolve allegations that the company violated the False Claims Act by performing medically unnecessary drug screening procedures.

The settlement relates to Coastal’s use of “Quantitative Drug Tests,” tests that identify and count particles of illicit drugs in patients’ urine. The use of quantitative drug tests – tests that are very specific and also very expensive – is appropriate only if there is reason to doubt the more general and cheaper qualitative drug test screens.

The government contends that Coastal appropriately performed qualitative drug tests for its patients. However, the U.S. contends that, regardless of the result of the less expense qualitative test, Coastal performed and billed for quantitative drug tests for all patients. The government contends this was medically unnecessary, as there was no reason to question or further confirm previous qualitative urine drug testing screens. read more »

House Panel Subpoenas VA Over Blowout On Hospital Project

The House Veterans Affairs Committee on Wednesday voted to subpoena the U.S. Department of Veterans Affairs, a move intended to prompt the agency to cough up information on a long-overdue hospital construction project, expected to cost more than $1 billion over its initial budget.

In a brief executive business meeting Wednesday, members of the committee voted by voice to subpoena the VA, seeking the agency's entire, unredacted investigative file related to the troubled project to build a medical center in Aurora, Colorado, saying the agency had wrongly dragged its feet in providing the requested documents. In addition, the subpoena asks for further information on the agency's spending on artwork for its facilities. read more »

Celgene Knocks Feds' Support Of $40B Off-Label FCA Suit

The federal government’s statement supporting a whistleblower’s $40 billion False Claims Act suit against Celgene Corp. over the off-label promotion of cancer drugs Thalomid and Revlimid doesn’t dismantle the company’s arguments for dismissal because there’s still no evidence of wrongdoing, Celgene told a California federal court Tuesday.

Celgene said the government wrongly interpreted the statutes governing Medicare to determine whether the Centers for Medicare & Medicaid Services are allowed to reimburse off-label uses and then improperly stated that higher court rulings on implied certification are relevant to the case. As there were no false certifications, neither the U.S. Supreme Court’s decision in United Health Services v. Escobar nor the Ninth Circuit's decision in Ebeid v. Lungwitz matter, the response states. read more »