The International Journal of Health Services says that over the last 18 years, 17 different drugs were approved for patient use in the U.S. and later pulled because they were unsafe. That may not sound like much but those 17 drugs were prescribed 112 million times. Chances are great that you or a loved one has taken a dangerous drug.
Add to this number the millions of pills and injectable drugs that are dispensed each year in the U.S. that are adulterated, contaminated, under potency or over strength. Eighty – five percent of the prescriptions dispensed in the United States are manufactured outside the country and many of those are made in India and China, two countries with notoriously poor quality control.
These numbers should scare you.
Defective and unsafe products are sold every day in the U.S. With many products we can often see or check those products and quickly detect when something is awry. If your car’s brakes are squealing, you can take the car to a shop for inspection. But if your doctor prescribes chemo for cancer, how do you know what is really in the IV? How could you possible tell if the medication was fake? Over potent? Or “cut” several times by an unscrupulous middleman?
100,000 Americans Die Annually because of Adverse Drug Reactions and Errors
Approximately 100,000 people die each in the U.S because of adverse drug reactions. Many more suffer but manage to survive. You are three times more likely to die from bad drugs or a bad drug reaction than from an automobile accident. (33,000 people died on the road in 2014.)
Why don’t most people know these statistics? The answer is simple. We tend to see and hear more about those things we can control. For example, we can all do something to stop car accidents or at least minimize their harmful impacts. (Think of seat belt campaigns, roadside signs warning of texting, etc.) But what we can do about bad drugs? Since there is little most of us can do, we don’t hear of the problems.
When it comes to prescription drugs, we rely on the FDA. The FDA, however, primarily relies on the industry to self police. Yes, the FDA does inspections but in foreign countries, where the vast majority of the drugs are manufactured, inspections only happen roughly every two years. Worse, the inspections are often pre-announced or leaked in advance by corrupt local authorities.
Obviously, manufacturers are always on their best behavior at inspection time. Recently I met a company at an international pharmaceutical convention that specializes in getting plants ready for inspections and hiding problems!
Despite leaked information from the inspection authorities in foreign countries and chronic understaffing, the FDA still manages to do a fair job… that is on pharmaceutical manufacturing facilities. The problems, however, are often with the companies that produce the “API” or active pharmaceutical ingredients for these drugs. These are largely regulated by the locals and often that regulation is nonexistent. Many are drug component are produced in open air facilities located in third world countries.
There are two primary causes of the huge number of drug reaction deaths each year. The first are problems in manufacturing… under potency, over potency, adulterated and contaminated products. These are functions of manufacturing conditions, assembly and supply line quality control.
A second problem comes from withheld safety data. Today, drug companies advertise their products on television and in magazines. Turn on TV and you will find dozens of ads for drugs that treat erectile dysfunction, bladder control, shingles, migraines, etc. Drugs are raced to market much faster. New drugs go to market without years’ worth of safety data and clinical trials, either.
There is something to be said for getting drugs to market quicker. If you are dying and your only hope is an experimental drug, you want that drug immediately.
The FDA is much faster now in approving new drugs. When adverse reactions and drug interactions are found, however, drug companies are required to immediately report those to the FDA. Unfortunately, that doesn’t always happen. Sometimes big pharma knows about problems or potential problems but keeps its mouth shut.
Big tobacco was forced to pay billions of dollars to settle claims regarding the health effects of cigarettes. The tobacco companies knew there was a link between cigarettes and cancer but remained silent for years. Some drug companies follow that same broken and twisted business model.
FDA and Whistleblowers – First Line of Defense
So who is best able to stop these manufacturing problems and safety / testing issues? The FDA plays a big role, of course. The real solutions, however, are the men and women who work in these companies. Under the False Claims Act (FCA), people with inside information about dangerous or adulterated drugs being sold on the U.S. market are eligible for huge, multi-million whistleblower awards.
Just like the problems with deaths caused by pharmaceutical drugs is largely hidden from the public’s eye, so is the government’s whistleblower program. That is a bit surprising since Congress passed the FCA in 1863. That’s right. America’s most successful and long running whistleblower program was passed by Congress during the Civil War and signed into law by Abraham Lincoln. It pays hundreds of millions of dollars in awards each year but most pharma workers have never heard of it. Even better, the law pays awards even if the whistleblower is not a U.S. citizen.
The False Claims Act comes with a catch. The law can only pay awards if the drugs are sold to the government or purchased with government funds. Medicare, Tricare and Medicaid satisfy that hurdle, however. Virtually every prescription drug sold in the U.S. is approved for Medicare meaning awards are widely available.
How to Earn a Whistleblower Award
To earn a whistleblower award, one needs inside (“original source”) information about the fraud. Hearsay (“a friend of a friend said…”) and what you read online don’t count. You also must be the first to file your claim.
“Filing” means filing a sealed lawsuit in federal court. The case remains secret or “sealed” while the government investigates. If the case is ultimately successful, the whistleblower can receive an award of between 15% and 30% of what the government recovers. There are also strong anti-retaliation provisions in the law.
To date, our clients have received over $100 million in whistleblower reward monies. Those awards are very real.
More than the money, healthcare whistleblowers save lives. The earlier a bad drug is taken off the shelf, the better for everyone.
If you work in the pharmaceutical industry and are interested in becoming a whistleblower, call us. The consultation is always free and without obligation. All inquiries are protected by the attorney – client privilege. And there is never a fee for our services unless we collect money for you.
We are interested in whistleblower tips relating to manufacturing defects (cGMP), faulty clinical trials, drugs being marketed for unapproved uses and any other information that endangers public safety or is evidence of fraud and greed.
The lawyers at MahanyLaw sincerely thank our many whistleblower clients and the federal agencies and prosecutors we have partnered with over the years. Whistleblowers are the true heroes – unsung heroes – in the battle to improve patient care.
Need more information? Contact attorney Brian Mahany at or by telephone at (414) 704-6731. Not sure you are ready to call just yet? Visit our pharmaceutical whistleblower page or our friends at the Pharmaceutical Integrity Coalition. If you are interested in an award, however, don’t call the FDA or Medicare’s hotline. The hotlines generally can only pay $1000 awards. The large percentage awards are reserved for those who file their whistleblower complaint in court.