Lawsuit over counterfeit surgical mesh rumbles on

A US court has rejected requests by two medical device distributors to dismiss a lawsuit holding them accountable for injury arising from the use of counterfeit surgical mesh they supplied to a medical facility.

The US Food and Drug Administration (FDA) warned that counterfeit versions of C. R. Bard's flat polypropylene meshes sold under the Bard or Davol brand names were in circulation and being used in place of genuine product for procedures such as the repair of hernias and chest wall defects (see Counterfeit surgical mesh confirmed as health risk).

The lawsuit was filed against Ram Medical and Medline Industries, which were involved in supplying the mesh to the medical facility that carried out a surgical procedure on patient Heyward Thomas Jones. The case raises interesting considerations about the potential liability for interim actors in the medical product supply chain in cases of security breaches.

Jones went on to develop a severe infection as a result of the use of the mesh, which required repeated surgeries to treat. Other samples of the counterfeits tested by the FDA were found not to be sterile.

The FDA's investigation into the case suggests that Ram Medical initally bought the illegal product and re-sold it to at least six other distributors.

The suit alleges negligence, product liability, breach of warranty, fraud, violation of state trade practices and violation of federal racketeering laws. Jones' attorneys maintain that Ram Medical and Medline knowingly and negligently sold the mesh, despite FDA warnings that counterfeits were in circulation.

Once the fakes were discovered the FDA issued warnings that healthcare professionals should not use any surgical mesh labelled as C.R. Bard with a specific set of lot numbers.

The plaintiffs attorney's estimate that at least 150 patients may have been treated with the counterfeit mesh.