Surgical mesh made by a company in Delhi, India found to be counterfeit
Surgical mesh, said to have been made by Murray Hill, N.J. based C.R. Bard Inc., – a well-known surgical device manufacturer – was actually made by a company in Delhi, India.
In 2010 the FDA announced that it was investigating claims that a product used to reinforce soft tissue was being falsely marketed in the U.S. under Bards name. According to the FDA, the counterfeit mesh samples were not sterile and were made in a way that could cause the mesh to unravel.
The mesh used for hernia repairs was bought by Medline Industries Inc. (a North suburban medical products supplier) from Ram Medical Inc. However the mesh was actually made by a company in New Delhi, India. Medline is now facing a growing number of lawsuits filed by people who received the defective mesh.
The lawsuits include two separate class actions which were consolidated into a single action in U.S. District Court in New Jersey. Patients are alleging that the product was not FDA approved and that the companies (Medline and Ram Medical) failed to determine if the mesh was sterile and free of defects.
On December 7th, Richard Mazon (Ram Medical’s founder and owner) entered a guilty plea on behalf of Ram Medical in the U.S. District Court in Newark, N.J., to one count of introducing adulterated medical devices into interstate commerce and one count of introducing mis-branded medical devices into interstate commerce.
In May, Ram Medical was sentenced to three years probation and ordered to pay $100,000 fine and nearly $73,000 in restitution. Richard Mazon has not been charged with any criminal wrongdoing.
The combined class-action case against Medline has been dismissed. Medline has spent $375,000 defending against the mesh suits and expects to exceed $500,000 within a matter of months, according to the company’s complaint filed July 11 in U.S. District Court in Chicago.
The litigation shows us that it is difficult for even well-established suppliers to determine the safety of the products they use.
“Unfortunately a lot of these products change hands several times,” said Kevin Stout, executive director of the Medical Device Supply Chain Council. “Just trying to track them is a challenge. So in this particular case, part of the challenge is, who’s responsible for this?”
If you believe that you or a loved one has suffered injury or death due to a defective or dangerous pharmaceutical, you may have a right to compensation for your injuries. The Maher Law Firm would like to help. We invite you to contact our trial-tested dangerous drug attorneys today.
