The U.S. Food and Drug Administration (FDA) received 228 reports of EpiPen failures in 2016. During that period, seven fatalities and 35 hospitalizations were attributed to the failure of EpiPen, an epinephrine-containing device used to stabilize potentially fatal allergic reactions. Mylan NV, the seller of EpiPen, controls about 70 percent of the market for emergency allergy treatments and has recently been accused of anti-competitive conduct. The company now faces allegations that its product does not work properly.
According to Bloomberg data, approximately four million prescriptions for EpiPens were filled last year. There were 105 complaints of EpiPen failures in 2016. The president of the National Center for Health Research describes these complaints as significant, particularly because EpiPen is a lifesaving product. These malfunctions, including epinephrine leaking out of the device and injectors not working properly, resulted in a recall of some units earlier in the year.
Mylan claims that the defect was extremely rare. However, according to the FDA, complaints of malfunction have been increasing since 2014, when there were 67 reports of failure as compared to 12 reports the previous year. Many consumers are not aware that they are permitted to submit adverse event complaints, and the full extent of the issue is yet to be realized.
According to the FDA, Pfizer-owned Meridian Medical Technologies, the company that manufactures the auto-injector for Mylan, received 171 product samples that were sent back with complaints, but failed to inspect the clear majority of them without explanation. Pfizer stated that when a product is administered by those who are not medically trained, consumer complaints are not unusual. The manufacturer also asserts that adverse event complaints do not always confirm that the product caused the incident. Pfizer noted in a statement that adverse events may be due to the epinephrine itself, which may cause several side effects as noted on the label. The company also specified that anaphylaxis is not always treatable by epinephrine, even when administered correctly and from a fully functional device.
Mylan expressed confidence in EpiPen’s safety and reported that defective units have not yet been identified in lots impacted by the recall. The company also claims that all adverse event complaints have been investigated and reported to the FDA. According to Mylan, there is no causal connection between reported patient fatalities and its EpiPen products.
The FDA stated that it did not discover any defective EpiPens on the market and it advises consumers to continue using their prescribed epinephrine auto injectors. The agency further noted that publicization of safety issues like the current recall has led to increased adverse event reports in the past. However, the FDA says it will continue to investigate all adverse event reports it receives.
If you or someone you love was harmed due to an effective EpiPen or other medical device, contact the Philadelphia defective medical device lawyers at Williams Cedar. Our experienced attorneys will fight for justice and your legal right to compensation. We represent clients throughout Pennsylvania and New Jersey. To schedule a free consultation, contact us online or call us at 215-557-0099.