Federal data shows nearly 70 percent of Americans are taking at least one prescription drug. More than half take two. These medications are often necessary for patient’s health and well-being – and sometimes even survival.
However, defective drugs – whether prescription or over-the-counter – can cause serious physical, psychological or emotional injury, and possibly even death. Injuries could result from:
- A defect inherent in the design of the drug;
- An error/ defect in a specific batch of the drug during the manufacturing process;
- Failure to properly label the product or sufficiently warn of possible adverse side effects.
At The Ansara Law Firm, our Fort Lauderdale defective drug attorneys know that even FDA approval is no guarantee that a drug is safe.FDA Approval and Testing Process Weaknesses
Although the U.S. Food and Drug Administration approval process is supposed to be quite rigorous, an increasing number of pharmaceutical companies are bypassing this with a Premarket Notification 510(k). This allows companies to avoid the careful testing that’s normally required so long as the manufacturer can show the medication is “substantially equivalent” to another product already on the market.
Additionally, the FDA has a program that allows companies to speed up the availability of their products. These include: Priority Review, Breakthrough Therapy, Accelerated Approval and Fast Track.
While the entire drug development process is supposed to take 8 to 12 years, we are seeing more companies finding ways to push drugs onto the market much faster than that – without adequate testing. That deprives consumers of the right of informed consent. Patients deserve to know the possible risks associated with the medications they are taking.
What’s more, the FDA does not conduct safety testing on new drugs. In most cases, it’s not even a neutral, third-party researcher. Instead, it is the manufacturer of the medication that is trusted to test for quality and safety. Numerous issues have emerged with this process. That seem like an obvious outcome when you consider that investor-owned companies with responsibility to maximize shareholder profits are also in charge of objective evaluation of these medications.
It works like this:
- Drug companies sponsor the clinical trials that have to be submitted to the FDA. (These trials can be designed in a manger that makes a favorable outcome more likely.)
- FDA approves the product based on the outcome of those few (likely biased) clinical trials. (The part of the FDA that reviews these applications is paid “user fees” by the companies whose drugs are being evaluated, further calling into question the veracity of the findings.)
- Drug companies publish favorable trial results and then start heavily marketing the drugs.
- Doctors and the public believe FDA-approved, prescription drugs are a lot safer than they actually are.
Even when outside companies are used to test drug quality, things can go sideways. Take, for example, the numerous issues with compounding pharmacies (in charge of making custom medications) several years ago. As The Washington Post reported after a scourge of deadly meningitis outbreaks tied to tainted steroid injections, five labs in charge of testing those products were cited by the FDA for 70 safety problems. Those issues included repeat appearance of bacteria in areas that were supposed to be sterile.
Compounding pharmacies only started using independent labs to test their products back in 2001, when it was discovered a compounding pharmacy in Missouri was diluting chemotherapy medications to less than 40 percent their prescribed strength.Responsibility of Drug Manufacturers
Pharmaceutical companies have two primary responsibilities in managing the safety of their products. They are responsible to:
- Investigate, collect, and be proactive in evaluating any and all information relating to “adverse events” or side effects that some or all patients may experience during clinical trials.
- Be vigilant in monitoring health outcomes and notify the FDA of any and all evidence of adverse effects.
They must include any potential side effects and warnings on the label.
While doctors and pharmacists are responsible for ensuring patients receive accurate doses of the correct medication for their specific conditions, product liability laws hold manufacturers, wholesalers and distributors responsible when they develop and dispense drugs that are defective.
Recent pharmaceutical litigation has involved drugs like:
- Actos – Diabetes medication linked to increased bladder cancer and heart disease.
- Crestor – High cholesterol medication linked to cardiomyopathy and diabetes.
- Xarelto/ Eliquis/ Pradaza – Anticoagulants linked to elevated risk of uncontrolled bleeding.
- Lipitor – High cholesterol medication linked to risk of diabetes.
- Testosterone replacement – Linked to elevated risk of heart problems.
- Yaz – Birth control linked to elevated risk of blood clots.
- Rezulin – Diabetes drug linked to liver failure.
This is by no means an exhaustive list of potentially dangerous medications. If you or a loved one has suffered negative and unexpected side effects as a result of taking a defective drug, we can help.
Contact Fort Lauderdale Defective Product Attorney Richard Ansara at The Ansara Law Firm by calling toll-free (888) 267-2728.