FDA Warns of Malfunctioning EpiPens and What’s Behind EpiPen Recalls
Concerns surrounding defective EpiPens come to light in warning letter sent by FDA.
Just last month, the Food and Drug Administration (FDA) issued a warning letter to Meridian Medical Technologies, a unit of Pfizer, outlining several key concerns regarding defective EpiPens and how the company seemingly continues to mishandle consumer complaints. This is extremely alarming considering EpiPens are used in the event an individual is having a severe allergic reaction. A malfunctioning EpiPen can easily mean that the individual in need would suffer serious or even fatal injury at the hands of the defective product.
The FDA was particularly concerned with the company’s failure to properly investigate reports of malfunctioning EpiPens. Consumers of EpiPens had apparently sent the company defective EpiPens. Some such defective EpiPens were involved in patient deaths or led to a patient becoming extremely ill after it failed to function properly. Many of the consumer complains concerned a mechanism in the EpiPen that is supposed to insure that it fires and delivers a proper dose of epinephrine to stop an allergic reaction. The FDA reports that Meridian Medical not only failed to properly investigate these reports, but also failed to recall bad batches of EpiPens and follow-up on problems found.
The warning letter sent by the FDA specifically notes that during an inspection that took place earlier this years, Meridian employees stated that they did not examine the “vast majority” of defective devices sent back to them by consumers. Meridian received 171 of these defective devices between 2014 and 2017. While Meridian has issued recalls of some potentially defective batches of EpiPens, about 80,000 were recalled in the Australian market this year, the FDA warnings seem to let Meridian know that not enough has been done for the company to ensure they are putting a safe product on the market.
Companies have a duty to the public to make every reasonable effort to ensure they are putting out safe products. People are literally putting their lives in the hands of companies like Meridian. IMS Health data reports that 3.6 million people are annually prescribed EpiPen products. Schools carry them in cases of emergencies. Consumers depend on a reliable product in the direst of circumstances. When companies fail to take proper precautions in developing and manufacturing their products and people are injured as a result of the defective product, the law gives those injured individuals the right to seek compensation for their losses.
If you or a loved one has suffered due to a defective EpiPen, the dedicated Nashville personal injury attorneys at Bednarz Law are here to fight for you. The effects of a defective EpiPen can be devastating. Serious illness or even death may be the result. While nothing can really replace what has been lost, our attorneys are committed to getting you the monetary compensation that will help you pay expenses and get your life back on track. Contact us today by calling 615-590-7276 or go online.