The last few years have not been good to people with severe food and insect allergies. Many people with severe allergies rely on epinephrine injector pens to save their lives in cases of emergency but there are only a few manufacturers of these pens. Recalls and price hikes have placed allergy sufferers in a precarious position, which got worse in September 2017 when Meridian EpiPen issued a voluntary recall.
In 2015, Sanofi owned Auvi-Q epinephrine injector pens. Sanofi realized that there were manufacturing defects in the product after receiving 24 complaints from consumers. Fast action saved lives but in 2016 the company was sold to Mylan Pharmaceutical.
Mylan brought back the Auvi-Q and hiked prices 400% on the EpiPen. Enormous backlash against Mylan had the company facing allegations of antitrust law violations by years end.
Many users of the Auvi-Q switched to the Meridian EpiPen, which ironically, was the same product. Meridian produces the EpiPen for Mylan at its Brentwood, Missouri factory. A warning letter from the U.S. Food and Drug Administration to Meridian Medical Technologies notes that the faulty medical devices in question are produced in the Brentwood facility.
The letter addresses issues dating back to early 2017. In March, Meridian issued a voluntary recall of 13 batches of EpiPen. This happened after the FDA inspectors found multiple problems with the manufacturing process.
The FDA investigative report noted five serious violations but made it clear that the letter was not inclusive of every violation. Investigators found multiple violations, which included a lack of action taken despite 171 complaint samples sent to the company.
Complaint samples involve a user sending the failed product to the company for inspection. The company then disassembles the defective medical device to learn of the flaws. The FDA found that Meridian inspected just four of the defective EpiPen devices. The report further noted that Meridian failed to identify the causes for the failures and failed to make changes to the manufacturing process.
Investigators further noted that previous violations in 2014 and 2015 and company proposed remediation went unaddressed.
If you or someone you love has been harmed because of a failed EpiPen or Auvi-Q product, contact a Philadelphia defective medical devices lawyers at Brookman, Rosenberg, Brown & Sandler. From our office in Philadelphia, Pennsylvania, we help clients throughout Philadelphia County, Delaware County, Chester County, and New Jersey. To schedule a consultation, complete our online form or call 215-569-4000 or 800-369-0899.