Fatal Allergic Reactions Leads to Anemia Drug Omontys Recall

The Food and Drug Administration (F.D.A.) has posted a notice that Affymax and Takeda Pharmaceuticals have recalled their drug, Omontys, or peginesatide, designed to treat anemia. It has received 19 reports of a severe allergic reaction, where three patients died and others required medical intervention. The pharmaceutical companies have explained that hypersensitivity to the drug has been shown for 2 of every 1000 patients, and that the reactions have occurred upon the first dose. Those patients who have had more than one dose have not had an allergic reaction.

Prescription pharmaceuticals must undergo a development and approval process by the F.D.A. Before a drug goes on the market for sale, the company must test the product and provide the results of the test to F.D.A.’s Center for Drug Evaluation and Research. The drug must be shown to be safe and effective for its intended use. Benefits must outweigh the possible risks. The F.D.A. does not test the drug itself, it only looks at the data provided by the company. However, as discussed recently on this blog, some companies, like Celebrex, have withheld information from the public and the F.D.A regarding the effectiveness of their drug.

A patient who was harmed by a medical device or drug can find legal relief in Florida for the injuries suffered from a defective product. Knowledge of the testing practices and the science behind the creation of the drugs is essential in a successful civil action. Witnesses providing testimony in such a specialized field must have a background that shows they can competently testify about the subject matter. An experienced litigation attorney is needed to deftly challenge a drug company witness’s ability to testify about the testing method and what is considered safe in the industry.

Proving what compensation is needed can also be tricky and require specialized medical knowledge. Often, a defective medical product exacerbates an already present medical problem and someone who can pinpoint how an adverse reaction, like anaphylaxis, occurred and why it occurred is crucial. This type of testimony can influence how much compensation is awarded for past and future medical bills, past and future lost wages from missing work or the inability to return to work, loss of enjoyment of life, and past and future pain and suffering.

The South Florida defective drug attorneys at Friedman, Rodman & Frank have over 100 years of combined experience litigating claims against pharmaceutical companies, holding them accountable for the injuries or death caused as a result of their product. We have worked with several industry-leading experts, including former FDA employees and know how to thoroughly investigate your claim. Each case is prepared aggressively, so that the opposing side knows that we are ready and willing to take your case to trial. If you have been injured or have a family member who has died as a result of a defective drug, call or contact us online for a free, private consultation with our skilled litigators today.