The Cochran Firm Legal Blog

Diane Conetta, a Rhode Island resident, received a Kugel Mesh hernia patch during a 2005 hernia operation. In 2007, Davol Incorporated, the manufacturer of the Kugel Mesh Patch, recalled the device after receiving reports that the plastic ring inside the patch was prone to breaking, resulting in bowel perforations and other serious injuries.

However, it was only recently that Ms. Conetta learned about the recall through a newspaper article. She was never informed by the medical device manufacturer, the hospital, or her surgeon that the hernia patch implanted in her body during her surgery was defective and may potentially result in a serious injury. Ms. Conetta is now part of a class action defective product lawsuit being filed against Davol Incorporated in relation to the defective hernia patch.

Unfortunately, this situation is all too common in our country. When defective medical devices are recalled, there is often no chain of communication which reaches patients affected by the recall. As a result, thousands of patients across the country may be living with defective medical devices implanted in their body without even knowing that their health is in danger.

Who is Responsible for Informing Patients?

In this particular instance, Davol notified hospitals using the defective medical device of the recall, but not the patients. Some doctors were informed of the recall by the device manufacturer, but many were not. Instead, it was left to the hospitals to notify their surgeons. Some hospitals relayed this information to surgeons, others did not.

It was then the responsibility of hospitals and doctors to sift through medical records to determine which patients received these defective hernia patches and inform all affected patients of the recall.

There were several reasons why many patients were never made aware of the recall:

• Many doctors never found out about the recall, and therefore did not know of the need to notify their patients of a potential problem
  
• The process of sifting through medical records is quite long and tedious, and many hospitals simply failed to follow through with this process
  
• There is no clearly defined protocol as to who is responsible for informing patients, resulting in confusion on the part of hospital staff as to how to proceed with relaying this information
  

According to an FDA spokesperson, it is the responsibility of the medical device manufacturer to inform hospitals and doctors of the recall, who then must notify patients. However, there is no one to enforce this protocol to ensure that every patient receives this vital information.

Clearly, there is a serious breakdown in the communication process between medical device manufacturers, hospitals, doctors, and patients which has prevented patients from learning of important defective product recalls which may impact their health and safety. It is time our government took steps to improve the process in order to ensure greater patient safety and awareness.

If you have not been properly made aware of the use of a defective medical device as part of your surgical procedure, you may be entitled to receive compensation through a personal injury lawsuit. The experienced defective product lawyers at The Cochran Firm can help you receive the compensation you deserve.

Please contact The Cochran Firm today to schedule your free initial consultation. We serve clients nationwide.