Philadelphia Personal Injury Attorney Blog | Pomerantz Perlberger & Lewis LLP

In another embarrassing news story for pharmaceutical companies, the Food and Drug Administration (FDA) issued a warning letter to Merck over conditions at its West Point, Pennsylvania plant. The plant had recalled two batches of vaccines in December because there was concern that the vaccines were not sterile.

The warning letter comes after an extensive round of inspections at the plant, from November 26 to January 17. The letter says that it found "significant objectionable conditions" in the manufacturing process for vaccines and drug ingredients at the plant. Then, it said, Merck did not respond appropriately to the concerns, which included a lack of written procedures, tests, or laboratory controls to ensure the purity, strength, quality, or even identity of the drugs it was manufacturing. However, the FDA said the concerns did not represent a safety threat from the products, despite the recalled vaccines in December.

The FDA said the public letters were a useful way to "achieve voluntary compliance" among drug manufacturers, and Merck has pledged that it is "committed to working with the FDA to ensure that all these issues are addressed." However, one wonders at the level of commitment that necessitated the publishing of the letter. And one also wonders whether compliance following a public censure can be considered "voluntary."

If you have been injured by a defective product, the chances are the company will tell you it is "committed" to your safety, too, but this does not mean that they actually are. Contact the experienced product liability attorneys at Pomerantz, Perlberger, and Lewis, LLP, today for a free initial consultation and case evaluation.