U.S. Gives Warning to Synthes on Medical Device Violations
Regulators with the U.S. Food and Drug Administration (FDA) have given Swiss medical device maker Synthes Inc. a warning over violations at its Pennsylvania manufacturing plant, and added that if the company does not fix all of the listed problems, it may have to pay a fine.
Reuters reports Synthes, which is currently in the process of being taken under the wing of Johnson and Johnson, was found to have no way of monitoring and investigating complaints about its medical devices. The manufacturing problem comes shortly after soon-to-be parent company Johnson and Johnson had its own slew of highly reported product recalls and problems with quality control, including issues with medicines such as Tylenol for babies and artificial hip implants.
The agency wrote a letter to the company on February 16, in which it stated it had failed to report serious complaints about devices manufactured in the Pennsylvania plant within 30 days – a time frame required by law.
“Failure to promptly correct these violations may result in regulatory action being initiated by the Food and Drug Administration without further notice,” wrote Kirk Sooter, director of the FDA’s Philadelphia district office, in a letter to the company.
Synthes spokesman Gilgian Eisner responded in an email, stating that the company “will co-operate and work diligently with the FDA until these deficiencies are fully resolved.”
According to the Philadelphia Inquirer, how the company responds to the warning will determine the extent of the punishment. While a fine is possible, the largest punishment the FDA could give would be to exclude the company from programs like Medicare and Medicaid, as many healthcare companies could not exist without this federal money.
Synthes, which makes plates, rods, screws, nails and other products used to fix broken bones, has been in the spotlight for dangerous and recalled medical devices before.
The media outlet states the company continued with trials of its bone cement despite being unapproved for use in a specific spine procedure. The company then allegedly ignored getting approved for testing on humans, which resulted in three patients dying while the tests were being conducted. Of the three families, two have filed civil lawsuits regarding the matter.
Since the incident, company executives Michael Huggins, Thomas Higgins, Richard Bohner and John Walsh have been sentenced to prison after pleading guilty to charges related to the unapproved testing.