U.S. Court in Florida Dismisses Whistleblower’s Complaint Against Nuclear Pharmacy

PS 4 Indest-2009-3By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

On September 28, 2017, the U.S. District Court for the Middle District of Florida dismissed a relator’s (whistle blower’s) False Claims Act (FCA) complaint against a nuclear pharmacy in Tampa. The court found that the relator failed to plead fraud with the required amount of specificity that the law requires.  The case awas filed against GE Healthcare, Inc.’s nuclear pharmacy.

The Allegations.

GE Healthcare operates 31 nuclear pharmacies in the United States, where it produces radiopharmaceuticals through a process of compounding drugs.  The relator was a board-certified nuclear pharmacist who formerly worked at GE Healthcare, Inc.’s nuclear pharmacy in Tampa, Florida. The relator’s allegations included the manner in which GE compounded and labeled radiopharmaceuticals. More specifically, the whistle blower claimed that GE sold diluted and expired drugs. Additionally, the whistle blower alleged that GE falsely inflated the reimbursement rate for certain drugs by providing false sales data to Medicare.

GE argued that the realtor’s claims should be dismissed pursuant to the FCA’s public disclosure bar because the allegations overlapped with an action filed by a different relator, James Wagel, in 2006. To read about this FCA case, click here.

The Court’s Decision. 

The court found that Sunil Patel’s allegations were not “based on” or “substantially the same as” the allegations in the prior public disclosures. However, the court dismissed the realtor’s claims on another ground:  failing to plead the allegedly fraudulent claims with sufficient particularity. According to the court, the allegations that defendant “presented or caused to be presented” a false claim fell “well short of alleging ‘exact billing data.'”  In other words, the relator failed to plead one or more false claims by giving the specifics, such as date, amount, patient, billing code, amount paid by the government, etc.  The court found that the relator identified no “particular facts about the ‘who,’ ‘what,’ ‘where,’ ‘when,’ and ‘how’ of fraudulent submissions to the government.”

The case is United States ex rel. Patel v. GE Healthcare Inc., No. 8:14-cv-120-T-33TGW (M.D. Fla. Sept. 28, 2017).

Click here to read one of my prior blogs on a similar FCA case involving a pharmaceutical company.

Specifics of the False Claims Are Required for Any Qui Tam Whistle Blower’s Case.

This is one of the biggest short comings we see in potential clients who contact us with information about false claims being submitted by their employers or other healthcare providers.  They do not have the specifics of any single false claim.  Yet the law requires this or a whistle blower’s case can get dismissed by the court outright.  You can do an awful lot of work investigating, pleading and litigating a whistle blower’s case only to have the court dismiss it without its ever getting anywhere near a trial.  Even if a scheme or system is inherently fraudulent, you must be able to show one or more claims that were submitted were actually false claims.

We advise health care professionals who consult us with possible False Claims Act/whistle blowers cases, be sure you have the details, and preferably copies of the documents, that show a false bill was submitted to the government.  This can be a CMS Form 1500 or an explanation of benefits that the patient and the insurer or facility receives back.  Sometimes you can get these form the patient if you do not have access to these from the employer.  But without a false claim and, preferably, a number of false claims, you don’t really have a False Claims Act suit.

Contact Health Law Attorneys Experienced with Qui Tam or Whistle Blower Cases.

Attorneys with The Health Law Firm also represent health care professionals and health facilities in qui tam or whistleblower cases both in defending such claims and in bringing such claims. We have developed relationships with recognized experts in health care accounting, health care financing, utilization review, medical review, filling, coding, and other services that assist us in such matters. We have represented doctors, nurses and others as relators in bringing qui tam or whistleblower cases, as well.

To contact The Health Law Firm, please call (407) 331-6620 or (850) 439-1001 and visit our website at http://www.TheHealthLawFirm.com

Sources:

Fraud and Compliance. “U.S. Court in Florida Dismisses Whistleblower Action Against Nuclear Pharmacy.” AHLA Weekly. (October 6, 2017). Web.

Mayo, Rebecca. “Evidence of likely submission not enough to prove FCA violation.” Wolters Kluwer Health Law Daily. (October 2, 2017). Web.

About the Author: George F. Indest III, J.D., M.P.A., LL.M., is Board Certified by The Florida Bar in Health Law.  He is the President and Managing Partner of The Health Law Firm, which has a national practice.  Its main office is in the Orlando, Florida area.  www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Ave., Altamonte Springs, FL 32714, Phone: (407) 331-6620.

KeyWords: Health care fraud defense attorney, legal representation for allegations of health care fraud, False Claims Act (FCA) attorney, FCA defense attorney, False Claims attorney, legal representation for FCA investigations, legal representation for FCA complaints, Whistleblower attorney, Whistleblower defense attorney, legal representation for Whistleblower investigations, legal representation for Whistleblower complaints, qui tam attorney, qui tam defense attorney, legal representation for qui tam cases, legal representation for qui tam investigations, FCA legal representation, relator attorney, relator defense attorney, health law defense attorney, The Health Law Firm, reviews of The Health Law Firm, The Health Law Firm attorney reviews

“The Health Law Firm” is a registered fictitious business name of and a registered service mark of The Health Law Firm, P.A., a Florida professional service corporation, since 1999.Copyright © 2017 The Health Law Firm. All rights reserved.

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Feds File Two Lawsuits Against Novartis for Allegedly Giving Kickback to Pharmacists and Physicians

11 Indest-2008-8By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

Novartis Pharmaceuticals Corporation (NPC) is currently fielding two different lawsuits, filed just days apart from each other, by the U.S. Department of Justice (DOJ). The first lawsuit was filed on April 23, 2013, alleging the company gave illegal kickbacks to pharmacists. A second lawsuit was filed on April 26, 2013, alleging illegal kickbacks were paid by NPC to health care providers. According to the DOJ, the government’s complaint seeks damages and civil penalties under the False Claims Act, and under the common law for paying kickbacks to doctors to induce them to prescribe NPC products that were reimbursed by federal health care programs.

Click here to read the entire press release from the DOJ.

Doctors and Pharmacists Allegedly Paid to Prescribe.

Both lawsuits allege NPC violated the Anti-Kickback Statute. In the April 23, 2013, complaint against NPC the lawsuit alleges the company gave kickbacks, in the form of rebates and discounts to pharmacies in exchange for the pharmacies’ cooperation in switching patients from competitors’ drugs to NPC products.

The April 26, 2013, lawsuit accuses NPC of paying doctors to speak about certain drugs at events that were allegedly social occasions. Many of the programs were allegedly held in circumstances in which it would be impossible to have a presentation. According to the DOJ, this included fishing trips off the Florida coast and meetings in Hooters restaurants. NPC is also accused of treating health care professionals to expensive dinners. The payments and dinners were apparently kickbacks to the doctors for writing prescriptions for NPC drugs.

Doctors in the Sunshine State Allegedly Involved.

The lawsuit alleges at least six Florida doctors of participating in the bogus conferences and taking thousands of dollars in kickbacks, according to the Tampa Bay Times. The doctors are not named or charged in the civil lawsuit.

To read the allegations listed in the lawsuit against Florida doctors, click here for the Tampa Bay Times article.

Novartis Claims Discounts and Physician Speaker Programs Were Legitimate.

In a press release, NPC disputes all of the government’s allegations. The pharmaceutical company states that discounts and rebates by pharmaceutical companies are a customary and legal procedure, as recognized by the government. It also addresses the physician speaker programs by saying the programs are also acceptable practices designed to inform physicians about the uses of different types of medicines. Click here to read the entire press release from NPC.

Kickbacks and The Law.

For years drug companies have paid doctors to speak about new drugs at educational conferences with other health care professionals. The practice is legal, but considered questionable.

Under the Anti-Kickback Statute, it’s a felony for health care professionals to accept bribes in exchange for recommending a drug or service covered by Medicare, Medicaid, TRICARE or the Department of Veterans Affairs health care program.

Whistleblower or Qui Tam Lawsuits Can Results in a Big Pay Day.

The original complaint against NPC was allegedly filed under the qui tam, or whistleblower, provisions of the False Claims Act by a former sales representative.

Individuals working in the health care industry, whether for hospitals, pharmacies, nursing homes, medical groups, home health agencies or others, often become aware of questionable activities.  Often they are even asked to participate in it. In many cases the activity may amount to fraud on the government.

In a two-part blog series on whistleblower/qui tam lawsuits I explain types of false claims, the reward programs for coming forward with a false claim, who can file a whistleblower/qui tam lawsuit, and more. Click here to read the first part of this blog, and click here for the second part.

The Health Law Firm Lawyers are Experienced with Qui Tam or Whistleblower Cases.

Attorneys with The Health Law Firm represent plaintiffs, patients, health care professionals and health facilities in qui tam or whistleblower cases. We have developed relationships with recognized experts in health care accounting, health care financing, utilization review, medical review, filling, coding, and other services that assist us in such matters.

To contact The Health Law Firm, please call (407) 331-6620 or (850) 439-1001 and visit our website at www.TheHealthLawFirm.com.

Sound Off.

Have you head about these two lawsuits? What are your thoughts? Please leave any thoughtful comments below.

Sources:

Masow, Julie. “Novartis Pharmaceuticals Corporation Disputes Allegations in Two US Government Lawsuits and Looks Forward to a Fair Discussion of the Facts.” Novartis Pharmaceuticals. (April 26, 2013). From: http://www.pharma.us.novartis.com/newsroom/pressreleases/137176.shtml

Davis, Brittany Alana. “Lawsuit: Pharmaceutical Company Gave Kickbacks to Florida Doctors.” Tampa Bay Times. (May 3, 2013). From: http://www.tampabay.com/news/courts/lawsuit-pharmaceutical-company-gave-kickbacks-to-florida-doctors/2119133

Department of Justice. “United States Files Complaint Against Novartis Pharmaceuticals Corp. for Allegedly Paying Kickbacks to Doctors in Exchange for Prescribing Its Drugs.” Department of Justice. (April 26, 2013). From: http://www.justice.gov/opa/pr/2013/April/13-civ-481.html

About the Author: George F. Indest III, J.D., M.P.A., LL.M., is Board Certified by The Florida Bar in Health Law.  He is the President and Managing Partner of The Health Law Firm, which has a national practice.  Its main office is in the Orlando, Florida, area.  www.TheHealthLawFirm.com  The Health Law Firm, 1101 Douglas Ave., Altamonte Springs, FL 32714, Phone: (407) 331-6620.

The Health Law Firm” is a registered fictitious business name of George F. Indest III, P.A. – The Health Law Firm, a Florida professional service corporation, since 1999.Copyright © 1996-2012 The Health Law Firm. All rights reserved.

Specialty Pharmacy Settles Lawsuit Over Illegal Kickbacks

Lance Leider headshotBy Lance O. Leider, J.D., and George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

The Department of Justice (DOJ) announced on December 27, 2012, that a specialty pharmacy, based in San Diego, California, has agreed to pay a $11.4 million settlement. That payment is to resolve allegations that the company used kickbacks to persuade doctors to write prescription for its products. The allegations came from a whistleblower lawsuit filed by a former employee.

Click here to read the press release from the DOJ.

Expensive Kickbacks Used on Doctors.

An article in Modern Healthcare states that the specialty pharmacy allegedly used tickets to sporting events, concerts, plays, spa outings, golf games and ski trips to bribe doctors to write prescriptions for its products. The company also had representatives schedule paid “preceptorships,” where the reps would follow doctors in their offices in an attempt to increase prescriptions written for their products.

To read the Modern Healthcare article, click here.

Settlement Details.

The specialty pharmacy company agreed to a forfeiture of $1.4 million to resolve the anti-kickback statue allegations. It will also pay $9.9 million to resolve false claims allegations, according to the DOJ. Representatives with the DOJ said that by entering the deferred prosecution agreement the company was able to avoid criminal and civil liability for the kickback and false claims violations.

Whistleblower Gets Reward.

According to the DOJ, the settlement resolves a False Claims Act lawsuit that was filed by a former sales representative for the specialty pharmacy. As part of the resolution, that whistleblower will receive $1.7 million.

Whistleblowers stand to gain substantial amounts, sometimes as much as thirty percent (30%), of the amount the government recovers under the False Claims Act (31 U.S.C. Sect. 3730). Such awards encourage employees and contractors to come forward and report fraud. You can learn more on the False Claims Act on the DOJ website.

Contact Health Law Attorneys Experienced with Qui Tam or Whistleblower Cases.

Attorneys with The Health Law Firm also represent health care professionals and health facilities in qui tam or whistleblower cases. We have developed relationships with recognized experts in health care accounting, health care financing, utilization review, medical review, filling, coding, and other services that assist us in such matters.

To contact The Health Law Firm, please call (407) 331-6620 or (850) 439-1001 and visit our website at www.TheHealthLawFirm.com.

What Do You Think?

What do you think of the settlement agreement? As a health professional are you tempted with kickbacks? Please leave any thoughtful comments below.

Sources:

Department of Justice. “Victory Pharma Inc. of San Diego Pays $11.4 Million to Resolve Kickback Allegations in Connection with Promotion of Its Drugs.” Department of Justice. (December 27, 2012). From: http://www.justice.gov/opa/pr/2012/December/12-civ-1547.html

Kutscher, Beth. “$11.4 Million Settlement in Pharma Kickback Case.” Modern Healthcare. (December 27, 2012). From: ttp://www.modernhealthcare.com/article/20121227/NEWS/312279957/

About the Authors: Lance O. Leider is an attorney with The Health Law Firm, which has a national practice. Its main office is in the Orlando, Florida, area. www.TheHealthLawFirm.com  The Health Law Firm, 1101 Douglas Avenue, Altamonte Springs, Florida 32714, Phone:  (407) 331-6620.

George F. Indest III, J.D., M.P.A., LL.M., is Board Certified by The Florida Bar in Health Law. He is the President and Managing Partner of The Health Law Firm, which has a national practice. Its main office is in the Orlando, Florida, area. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Ave., Altamonte Springs, FL 32714, Phone: (407) 331-6620.

“The Health Law Firm” is a registered fictitious business name of George F. Indest III, P.A. – The Health Law Firm, a Florida professional service corporation, since 1999.

Copyright © 1996-2012 The Health Law Firm. All rights reserved.