Defective medical implant devices

posted on:
February 4, 2008

author:
Jere Beasley

As our population ages, the number of citizens with medical implants will increase. Medical implants are being used in almost every organ of the human body.

Medical implants have made it possible for millions of people to participate in activities their physical limitations would not otherwise allow.

For some, medical implants offer the means to remain independent of nursing homes, assisted living facilities or in-home service providers. Unfortunately, persons living with medical implants have to worry not only about prolonged security checks at the airport, but also about whether the medical implant will fail inside their bodies causing pain, additional surgeries, and/or death.

One would think that before a medical device is implanted inside someone’s body, the manufacturer would ensure that nothing could go wrong. Unfortunately, that is not the case. Almost monthly, we hear reports of yet another medical implant recall. Heart devices, cardiac pacemakers, silicone breast implants, intrauterine contraceptive devices, hip implants, joint replacements, defibrillators, and even jaw implants have been recalled by their manufacturers.

There are numerous problems with recalls; but, the primary problem is that recall notices are provided to hospitals and surgeons but not the patients. Consequently, a defective medical implant can be recalled but the patient remains ignorant until the device fails inside his or her body. If the failure does not lead to the death of the patient, the failure will require another operation or operations. The patient is subjected to more pain and suffering along with another recovery period. Finally, the patient is saddled with the costs of the corrective surgery and may lose wages from missing work.

Beasley Allen law firm is currently investigating a number of medical implant device failures. In one, the product was recalled, but the surgery occurred in California over five years ago. The client moved to Georgia and thus had no knowledge of the recall. If notice had been provided, the defective device could have been removed before it failed. Removal before failure still requires corrective surgery, but, a failure inside the body is more likely to lead to more severe injuries or death. Patients receiving medical implants or patients with existing medical implants should research their implants, the manufacturer, and the recall history of identical or similar products. Remember, because the manufacturer will not inform the patient of a recall, patients should check the FDA’s recall website at www.recalls.gov to see whether there is a recall on their device.

Additionally, patients with medical implants should report any complications immediately to their treating physician. Over eight years ago, our firm handled a case for a client with a defective knee replacement implant. The patient began to experience extreme pain approximately six months after the surgery. He consistently reported his pain and discomfort to the treating physician. After considerable time passed, the surgeon decided he had attempted enough non-invasive treatments and elected to remove the artificial knee for an analysis.

The artificial knee had begun to break down ,causing the patient’s bone to contact the metal parts of the device. The surgeon knew the knee was not supposed to break down and suggested the client maintain possession of the knee and call a lawyer. We filed the case, only to be thrown out on summary judgment because the client had came to us over two years after he first experienced pain.

One would expect the statute of limitations to begin to run in such cases when the doctor removed the artificial knee and advised the client that the device was the cause of his pain. But, a federal district court judge ruled the statute began to run as soon as the patient began to experience pain even though the patient’s doctor was telling the patient that his problem was unrelated to the artificial knee. Therefore, patients with implants not only have to monitor whether their implant is causing health problems or has been recalled, but must also be vigilant in seeking legal assistance. That surely seems to put responsibility in the wrong place given that manufacturers know about recalls and have the ability to issue appropriate notices.

Defective medical implants are serious threats to citizens of this country. As manufacturers continue to develop more implants, the frequency of recalls will continue to rise. Manufacturers and the government don’t believe it’s necessary to inform patients of defects and recalls; thus, patients are left to fend for themselves. That is a sad commentary on our times.

 

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