First Amendment, False Claims, and Off-Label Promotion Allegations

The Drug & Device Law blog recently posted an analysis of an interesting case, United States ex rel. Solis v. Millennium Pharmaceuticals, Inc., that takes an issue the government has fought in the past – off-label promotion – and attempts to provide a link between it and the false claims issues that relators bring under the government’s name. Solis asserts that the dissemination of certain published medical articles on the part of the defendant constituted off-label promotion and resulted in the submission of false claims for federal reimbursement.

As Reed Smith partner Jim Beck discusses in his post, False Claims Act (FCA) litigation may provide drug and medical device counsel with ample opportunity to cite the First Amendment as a means of defense. The defense in Solis – supported in an amicus curiae brief filed by the Pharmaceutical Research and Manufacturers of America– argues that the dissemination of the medical articles was not “false” in that it did not present incorrect or misleading information, was protected by First Amendment, and did not lead to the submission of any false claims.

Manufacturer, Group Payment Organization, and Physician Financial Information Slated For Disclosure, May Spur False Claims Act Activity

As mentioned on our Health Industry Washington Watch blog, pharmaceutical and medical device manufacturers and group purchasing organizations (GPO) are currently in the process of submitting detailed 2013 payment and investment interest data to the Centers for Medicare & Medicaid Services. The submission of this data, as dictated by the Physician Payment Sunshine Act, is intended to highlight certain financial relationships between the manufacturers and GPOs and physicians. With some exceptions, this data will become public by September 1, 2014, at which time the Department of Health and Human Services’ Office of the Inspector General, Department of Justice, and relators’ attorneys will likely analyze the data to initiate investigations and support complaints under the federal False Claims Act. To read the entire post, click here.

Whistleblower Cannot Rely on Stolen Patient Records

This post was written by Andrew Bernasconi & Nathan Fennessy.

A recent decision by the United States District Court for the Southern District of Ohio may make it much harder for qui tam relators to rely upon stolen medical records or patient information in False Claims Act (“FCA”) whistleblower actions. See Cabotage v. Ohio Hospital for Psychiatry, No. 11-cv-50 (S.D. Ohio July 27, 2012). In Cabotage, the district court held that a registered nurse was not permitted to support her allegations of FCA violations by relying on confidential protected health information that she surreptitiously removed from the hospital where she was employed.

The nurse in Cabotage purportedly removed the confidential protected health information as part of an “investigation” of alleged fraudulent conduct by the Medical Director. She subsequently provided this information to an investigator from the Department of Health and Human Services, but the agency declined to pursue a claim. After the nurse was terminated for other reasons, she commenced an action against her former employer under the FCA whistleblower provisions and the Ohio Whistleblower’s Act. During the course of discovery, the hospital learned about the nurse’s removal of confidential protected health information. After repeated requests to return the information were declined, the hospital filed a Motion for Return of Confidential Health Information.

The district court denied the motion on the grounds that the Health Insurance Portability and
Accountability Act of 1996 (“HIPAA”) did not vest the court with jurisdiction to provide the remedy sought by the hospital. The court concluded, however, that it possessed inherent authority to issue an order preventing the nurse from using the confidential information in the instant action because the information was confidential, potentially privileged, and had been obtained outside the discovery process governed by the court.

The court’s decision is qualified and stops short of creating a new rule applicable to whistleblower cases, but nonetheless provides a step in the right direction for defendants facing whistleblowers who have inappropriately used or taken confidential information from their employer.

 

FCA Qui Tam Relator Sanctioned for Destroying Evidence on Company-Issued Laptop

This post was written by Andrew Bernasconi and Nathan Fennessy.

In yet another reminder about the importance of maintaining evidence on company-issued laptops, blackberries, or other electronic devices; the United States District Court for the Northern District of California recently sanctioned a qui tam relator for destroying more than 10,000 documents on his company-issued laptop. Moore v. Gilead Sciences, Inc., No. C 07-03850 SI, 2012 WL 669531 (N.D. Cal. Feb. 29, 2012).

To read the full post on Reed Smith's Global Regulatory Enforcement Law Blog, click here.