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FDA Cites Serious Manufacturing Violations at EpiPen Facility

FDA Cites Serious Manufacturing Violations at EpiPen Facility image courtesy of https://www.theatlantic.com/health/archive/2016/08/epi-pens/497126/

The U.S. Food and Drug Administration (FDA) described significant violations of current good manufacturing practice in a warning letter to a unit of Pfizer Inc. that manufactures the EpiPen, which is a life-saving drug for those with allergic reactions. According to a report on Marketwatch.com, FDA officials say Meridian Medical Technologies Inc. failed to properly investigate serious component and product failures including those what were associated with patient deaths and severe illness.

FDA officials reportedly inspected a Missouri manufacturing facility between February and March of this year. The FDA’s letter also stated that Meridian failed to expand the scope of its investigations into these serious and life-threatening failures or take appropriate corrective actions until FDA officials inspected the facility.

Dangerous and Defective Products

One of the most serious violations occurred in February 2016 when Meridian found that one unit of an EpiPen component that ensures that the product delivers the right dose of epinephrine did not work. The company did reject that lot and another one. However, it continued to manufacture its products while the investigation continued through October 2016, the FDA letter stated.

In the meantime, the company continued to receive hundreds of complaints about EpiPens failing to operate in emergencies including some situations in which patients died because of the defective products. FDA officials said the company failed not only to conduct a proper investigation of consumer complaints, but also to remove these defective products from the marketplace.

After the FDA raised this issue, Meridian reopened an investigation it had closed in June 2016. But the company only issued a recall for the EpiPens after the FDA’s inspection closed and after the federal agency had “extensive discussions” with the drug maker. Thirteen of the recalled lots distributed in the U.S consisted of about 260,000 devices. Mylan came under criticism last year for hiking the price of the EpiPen six-fold in the last few years.

Liability Issues

Drug makers have a responsibility to not only manufacture products that are safe for consumers to use, but to also promptly warn consumers if there is a danger associated with their products. It is outrageous that this company decided to hike the price of this life-saving drug by 500 percent. On top of that, they manufactured defective products, which they did not remove from the market in time and didn’t warn consumers about – apparently resulting in deaths.

There is no question that Meridian should be held accountable for such negligence. If you have been affected by these or other defective products, contact an experienced product defect attorney who can provide you with more information about pursuing your legal rights.

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