Find The Right Kugel Lawyer To Handle Your Recalled Hernia Patch Lawsuit

Why Did Bard Wait So Long To Recall Their Kugel Hernia Patches?

The New York Times takes a hard look at Bard’s actions leading up to the recall of the Kugel hernia patches.

Bard officials said recently in a statement that they had not recalled the product sooner because complaints about failures were too few and unrelated to raise any alarms. The company also said that both it and the subsidiary, Davol Inc., had reacted responsibly.

But when F.D.A. officials inspected Davol in early 2006, they apparently found other reasons that company officials and the agency might not have been alerted earlier. For example, inspectors reported “discrepancies” and “inconsistencies” in how Davol tracked and analyzed device-related complaints.

And, in several instances, Davol also did not accurately report the possible severity of complaints to the agency, a copy of an inspection report obtained by The New York Times under the Freedom of Information Act shows.

Bard officials, who declined to be interviewed, said in a statement that they have since addressed the agency’s concerns, and agency officials said they are monitoring the company’s progress.

Source: History of Hernia Patch Raises Questions on Implant Recalls - New York Times

Kugel Hernia Patch Lawsuit Filed In New Jersey

On April 17th of 2009, the lawsuit of Hernandez v. Davol, Inc. and C.R. Bard, Inc. was filed in New Jersey.  The lawsuit alleges that the Kugel hernia patch was defectively designed and manufactured:

11. Defendant Davol designed, manufactured and distributed the Kugel Patch, a hernia mesh patch that was inserted into Plaintiffs body.

12. Defendant Davol, through its agents, servants and employees, participated in the manufacture and delivery of the Kugel Patch that was inserted into Plaintiffs body.

13. The Defendants submitted their 510k Application to the Federal Drug Administration (hereinafter referred to as the “FDA”) on January 22, 2001. Following this 510k Application the Kugel Patch was authorized by the FDA as a Class II medical device.

14. Defendants participated in the marketing, distribution and sale of the Kugel Patch as safe for its intended purpose, fully and properly tested for safety and potential risks, and free from the kinds of risks and hazards that the Kugel Patch actually posed to the public, including Plaintiff.

15. The mesh of the Kugel Patch consists of two components: 1) a polypropylene (“PPM”) layer that faces the area of incision and is to adhere to the abdominal wall; and 2) an expanded Polytetrafluoroethylene (“ePFTE” or “expanded Teflon”) layer which faces away from the incision and is to minimize tissue attachment to the patch. In most Kugel Patches, the PPM layer is a “dual mesh” that joins two different materials. In addition, many Kugel Patches have a “memory recoil ring” embedded near and along the circumference of the Kugel Patch which is to pop the Kugel Patch into shape in preparation for attachment.

16. The Kugel Patch hernia repair product implanted in Plaintiff was designed, manufactured, sold and distributed by Davol to be used by surgeons for hernia repair surgeries and was further represented by Davol to be an appropriate, cost-effective and suitable product for such purpose.

If you think you received a defective or recalled Kugel Hernia Patch, contact me and I’ll put you in touch with a Kugel attorney.