Pharmaceutical Fraud Lawyers
Representing whistleblowers to fraud involving drug manufacturers, suppliers, pharmacies and the pharmacists who dispense medicines to Medicare, Medicaid, TRICARE, or VA beneficiaries.
The pharmaceutical industry is one of the largest in the world, bringing in well over 900 billion dollars each year. Millions of Americans depend on pharmaceuticals as a part of their health care, with doctors prescribing drugs to help deal with myriad medical conditions, such as chronic pain, heart conditions, diabetes or cancer. These drugs help many people live better, healthier lives – however, with such a large industry in place, the potential for fraud becomes increasingly large, and with so many depending on doctors to do what is right for them the dangers of deceptive business practices in the pharmaceutical industry are a growing concern.
With Medicare and Medicaid helping millions of Americans and their families with the cost of medical expenses, and the Affordable Care Act expanding the scope of Government involvement in the medical coverage of its citizens, the False Claims Act is finding more and more application in the pharmaceutical industry. The Government has a large stake in making sure that unscrupulous business practices amongst pharmaceutical companies are uncovered and proven in court, so that the best interests of the taxpayer – and those relying on Government health care programs – are defended. Court decisions have resulted in hefty damage payouts (and, consequently, large bounties paid to whistleblowers for bringing the cases forward), which is no surprise, considering that not only is taxpayer money at stake, but also the health and well being of millions of Americans who depend on pharmaceuticals.
There are a number of unscrupulous and illegal business practices that are addressed in False Claims Act cases. The following are just a few examples related to pharmaceutical fraud:
- Good Manufacturing Practice (GMP) Fraud
Because the chemical composition of pharmaceuticals is directly related to their health benefits (or harm), there are a number of statues and requirements in place to determine whether or not a particular drug is fit for distribution and use. These Good Manufacturing Practices assume that drugs are free from contamination and potency defects and that they are properly bioavailable, and that they meet all required standards set by the FDA. If a pharmaceutical company were to ignore these practices and falsify documents in order to bypass regulations, then that constitutes fraud.
- Clinical Trial Fraud
Clinical trials are part of the rigorous testing required to determine how a drug fights a certain disease and what its effects – and side effects – on the human body are, and how effective different types of drugs are at treating the same diseases. In many cases, usually when conducted by government bodies or other neutral entities, these trials are blind or double-blind, in order to prevent bias from skewing how the results are determined. However, some pharmaceutical companies sponsor the clinical trials of their own drugs, providing a large incentive for them to manipulate the data. It isn’t surprising, therefore, to find that in the vast majority of sponsored clinical trials, the drug produced by the sponsor was determined to be the most effective. This manipulation of data can be used to gain FDA approval fraudulently, resulting in patients being treated with drugs that are ineffectual or potentially harmful, instead of getting the medicine they need.
- Off-label Marketing
Drugs are often grouped together in ‘therapeutic classes’ with similar drugs that treat the same ailments or have similar chemical compounds. These classes are primarily a tool for doctors, to make similar drugs easy to identify. Some pharmaceutical companies, however, attempt to exploit this taxonomy by using the assertion that drugs of a single therapeutic class behave the same way in order to skirt the normal scientific testing required by the FDA to determine what the drugs actual indications are. This lets the pharmaceutical company expand the sales of a certain drugs without the costs associated with FDA testing. However, since even drugs of the same therapeutic class can behave in drastically different ways, this practice exposes patients to the dangers of using a drug that may not actually help their condition, while exposing them to unknown and unpredictable side effects.
It is prohibited by federal law for doctors to take money from pharmaceutical companies for prescribing their drugs over those manufactured by their competition. Doctors must have the best interest of their patients at heart, and if they are receiving money to promote one type of drug over another, the patient is no longer receiving the best care, merely that which is more lucrative for the doctor. Some pharmaceutical companies, however, attempt to find ways to secretly bribe doctors into supporting their products over others, including hiring doctors as consultants for fraudulent drug studies, paying them “”speaker fees”” for marketing in the guise of lectures, giving out falsified grants, or holding ‘investigator’ or ‘advisory board’ meetings that amount to lavish weekend getaways, all to ensure that doctors show the pharmaceutical company preferential treatment when prescribing drugs to their patients.
- Good Manufacturing Practice (GMP) Fraud
These, and any other forms of fraud, can have costly, potentially fatal consequences to patients who use drugs that are not properly tested or not indicated to treat their ailments, and can cost the Government and the taxpayer billions each year. This makes the False Claims Act one of the most powerful tools the Government has available for defending its interests and the interests of its people.
Contact Our Experienced Pharmacy Fraud Attorneys
If you are aware of pharmaceutical fraud being committed against Medicare, Medicaid, TRICARE, or VA beneficiaries, contact our offices to speak to one of our skilled trial attorneys. We understand the bravery required to step forward to blow the whistle on fraud and we fight to obtain fair and just compensation for our clients efforts.