More Than a Slap on the Wrist
The FDA sent Bard a lengthy warning letter in July 2015 outlining several concerns after inspectors visited Bard facilities in Queensbury, N.Y. and Tempe, AZ between October 2014 and January 2015. One of the most glaring concerns was that Bard misreported a complaint lodged in regard to its G2 IVC filter. According to the FDA, Bard filed the complaint as a “malfunction medical device report” rather than a “death report”. The complaint occurred after part of a G2 filter detached and led to severe bleeding in a patient’s lung, resulting in the patient’s death. There have been many Bard IVC filter lawsuits filed since, alleging serious side effects and complications that are fatal or cause permanent conditions.
In addition, Bard was cited for marketing its method of retrieving IVC filters, called the Bard Recovery Cone Removal System, without first obtaining FDA approval. The system is designed to allow a doctor to quickly take out an IVC filter once a patient no longer faces a risk for developing blood clots.
Bard also committed a violation for the way it cleans IVC filters during the manufacturing process. According to the FDA, the manufacture of IVC filters requires the use of several processing agents, including methanol, citric acid, nitric acid, glycolic acid and many others. The warning letter informed Bard that its cleaning protocols had been neither validated nor verified to show that they sufficiently reduced the levels of those potentially dangerous processing agents.
In a July 24, 2015 filing with the Securities and Exchange Commission (SEC), Bard acknowledged receipt of the warning letter and stated it intended to take the corrective actions necessary to address the FDA’s concerns. However, the company also stated that it could not guarantee the FDA would be fully satisfied with Bard’s response.
We will be keeping tabs to see how Bard addresses these concerns and what type of ramifications the company may face if it does not correct these violations to the FDA’s satisfaction.