It seems every time you turn on the television there is another new commercial about a defective drug and the damage caused by it’s side effects. Drug makers are supposed to take steps to ensure the medications they manufacture, advertise, and sell are safe for their intended use. An important tool in determining if a drug is safe for use is the U.S. Food and Drug Administration’s (FDA) Adverse Event Reporting System.
The FDAs reporting system collects data collect by drug makers, healthcare professionals, and consumers to use when preparing future warnings about potential side effects or dangerous associated with a drug. These warnings can save lives and prevent injury; however, drug makers are compromising the usefulness of the system by providing incomplete reports.
Report Reveals Drug Makers Have Failing Grade on Case Reports
A recent report evaluated the completeness of case reports filed with the FDA in 2014. Case reports filed with the FDA should include information regarding the age and gender of the patient, the event date, and at least one medical term that described the event. During 2014, the FDA received 528,192 new case reports. Roughly 24,825 case reports were filed by healthcare professionals and consumers. Consumers and healthcare professionals filed complete reports over 86% of the time.
However, the remaining 503,367 new reports were filed by drug makers. Drug makers file two different types of reports – expedited and periodic. The drug makers filed complete expedited reports 40% of the time and complete periodic reports 51% of the time. In either case, drug makers failed miserably when it came to filing complete case reports when providing information to the FDA on serious adverse event reports.
When consumers hear about drug makers failing to file complete reports that could save lives and prevent future injuries combined with stories like the one about Johnson & Johnson and Bayer misleading the editors of the New England Journal of Medicine about one of their drugs, it is not surprising that the level of distrust consumers have for drug makers continues to increase.
Have You Been Injured By a Defective Drug?
If you have been injured by a defective drug in Louisiana or throughout the United States, the defective drug attorneys of The Olinde Firm can help. It is frustrating and frightening when you take a drug that is supposed to make you better but it makes you worse. When the drug maker has hidden the potential danger of a drug, failed to report findings about a drug, or was negligent in manufacturing the drug, it needs to be held accountable for the injuries caused by its negligence.
You should not have to bear the financial burden, in addition to the physical and emotional burden, of this company’s reckless actions alone. You deserve compensation for your injuries and damages.
Contact our office for a free case evaluation by calling (504) 587-1440 or 1-800-587-1889. Our pharmaceutical litigation attorneys and staff are here to help you as you struggle to overcome injuries caused by the harmful side effects of a defective drug.