Do you Have Information about Pharmaceutical Company Kickbacks or Off Label Use Promotions?
Some of the Biggest Whistleblower Awards Have Gone to Whistleblowers in the Pharmaceutical Industry
Under the U.S. False Claims Act a person with “original source” information on pharmaceutical marketing and sales, including kickbacks to doctors or off label use promotion, can become a whistleblower and claim a very substantial reward. The claims process is quite precise and you will need an experienced pharma fraud False Claims Act lawyer to assure your role as a legitimate claimant.
We have former pharmaceutical insiders in-house to knowledgeably and confidentially evaluate your claim in conjunction with our award record-holding False Claims Act lawyers.
Call Mahany Law to confidentially learn your rights in a no-cost consult.
Off Label Marketing of Prescription Drugs
Often the largest whistle blower cases deal with Off Label Marketing of Prescription Drugs. Some awards have exceeded $100 million dollars! (We have helped two whistleblowers each receive approximately $50 million.)
Under U.S. law, all prescription drugs must be approved by the Food & Drug Administration before they can be sold to the public. The FDA approves not only the drug but also its intended uses.
Once approved, physicians are permitted to use drugs for unapproved use. This is commonly called “off label” use. A common example is minoxidil (brand name Rogaine). Originally approved for treating blood pressure, some doctors learned it could help with hair loss.
Although a doctor can prescribe a drug for an off label use, pharmaceutical companies are prohibited from marketing or promoting a drug for a non-FDA approved use. If a drug company promotes off label use and Medicare or Medicaid winds up picking up the tab, the company can be liable for triple damages and up to $11,000 per prescription.
Because each off label prescription submitted to Medicare can be considered a “false claim” under the False Claims Act, it is easy to see how quickly fines can accrue and whistle blower awards to the people who are first to report the fraud are a percentage of that amount.
Connect with an experienced off-label marketing whistle blower lawyer at Mahany Law to learn your options. We offer a no-fee confidential consult.
Kickbacks to Doctors, Hospitals or Insurance Companies – Direct or Indirect: It’s Illegal
It is also highly illegal for drug manufacturers to pay kickbacks to doctors. Medicare and Medicaid rules prohibit paying kickbacks or giving inducements to physicians or hospitals to favor or prescribe specific drugs. Healthcare decisions should be solely based on the needs of the patients, not who pays the biggest bribes.
Drug companies often try to skirt the law by offering research stipends and consulting contracts to doctors who favor their products. In addition to stipends and vacations, we have seen many of attempts to get around the anti kickback laws, e.g. Stark Law including:
- Free lunches to physician office staff;
- Golf outings;
- Sporting event tickets and hard to get concert seats;
- Paying physicians to attend or present at conferences;
- Participation in sham drug trials;
- Free samples (especially when doctors sell though samples);
- Phony research grants
It’s not just physicians that receive illegal kickbacks. Medicare regulations prohibit kickbacks or inducements to hospitals and insurance companies. The latter are sometimes paid to include a specific drug on their approved formulary list.
Learn your rights as a first to report whistle blower, you may be entitled to a substantial cash reward. Call Mahany Law for a confidential analysis at no-cost of your information.
Examples of Successful False Claims Act Cases in the Pharmaceutical Industry
The largest Medicare fraud case to date has been against drug maker GlaxoSmithKline. In 2012, the company agreed to pay $3 billion to settle criminal and civil claims related to several of its drugs. Two of those drugs, Wellbutrin and Paxil, were being promoted for off label uses.
The company was also charged with paying illegal kickbacks to doctors including bribing doctors with “educational” trips to Hawaii.
Johnson & Johnson paid $2.2 billion to resolve off-label use and kickback charges related to Risperdal, Invega and Natrecor.
Pfizer paid $2.3 billion to settle criminal and civil charges related to a number of its drugs. $1 billion of that recovery was under the False Claims Act.
Whistleblowers, Pharma and the False Claims Act
Whistleblowers under the False Claims Act can receive awards of up to 30% of whatever the government collects from the wrongdoer. In pharmaceutical cases, awards of $1 million or more are the norm.
More than the awards, however, whistleblowers play a vital role in helping to contain healthcare costs and delivering the best quality care to patients. It is very often that we see successful David vs. Goliath stories anymore. The False Claims Act, however, is the great equalizer and helps ordinary people do extraordinary things.
To become a whistleblower, one needs inside or “original source” information about fraud involving pharmaceuticals sales and marketing. This discussion centered on illegal off label marketing and kickbacks but pharma fraud can occur in many other ways. Poor quality drugs, violations of current good manufacturing practices (called cGMP), violations of best pricing rules and sales of adulterated products can also give rise to whistleblower awards.
Call us to see whether you have a case. Awards are typically given to the first to file so do not delay! MahanyLaw: