Defective Medical Devices
By Aaron Larson
March, 2005
Contents
Defective Medical Devices
When people seek medical treatment, and more to the point consent to the use of a particular medical device or the installation of an implant within their body, they expect that the treatment will be safe. They expect that the medical device or implant will work as expected, and will help facilitate the medical procedure or alleviate a medical problem. Unfortunately, in some circumstances a defect in the design, manufacture, or use of a medical device or implant will result in injury to the patient, potentially providing a basis for product liability litigation.
Causes of Defects
While a medical device or implant may prove defective for a number of reasons, common causes include:
Design Error - The device or implant may not be adequately designed, such that a defect or shortcoming in the product will cause it to fail prematurely, or to pose other dangers to the patient.
Manufacturing Error - Although properly designed, a problem during manufacture creates a defect within the medical device or implant which poses risk of harm to the patient.
Failure of Quality Control - Sometimes a manufacturing process will have a known error rate, and a quality control system will be constructed to locate any potentially defective products. Where such a quality control system fails, a defective product may reach the market.
Contamination - Contamination may be introduced into a medical device or implant at any stage in the manufacturing process, including the potential that one of the raw materials used to construct the device was contaminated. Contamination may also occur due to inadequate or deficient packaging, mishandling, or user error.
Examples
Examples of product liability cases that involved medical devices or implants include:
Baxter Dialyzers - Baxter International recalled certain dialyzers, used in kidney dialysis, after reports of patient deaths. Baxter has expressed belief that the product failure resulted from a perfluorohydrocarbon-based performance fluid used during the manufacture of the dialyzers.
Guidant Ancure Endograft Device - Guidant produced this device for the treatment of abdominal aortic aneurisms, but the device suffered an enormous failure rate with substantial risk to patients. Guidant ultimately pleaded guilty to criminal charges in relation to its cover-up of the defect, and withdrew the device from the market.
Guidant Defibrillators - Guidant changed its manufacturing process for its Ventak Prizm 2 DR Model 1861 Defibrillator (also known as the Prizm 2 DR) in April, 2002, to reduce the chance of electrical short-circuits. It is alleged that their failure to disclose the defect, and their position that doctors should not perform surgery to replace the older unit, was deceptive to the public and endangered high risk patients.
Sulzer Hip and Knee Implants - Due to contamination during the manufacturing process, approximately 40,000 hip implants and 1,600 knee implants were recalled by Sulzer Medica Ltd., unfortunately after the majority of the implants had already been installed in patients. Sulzer attributes the product failure to trace amounts of mineral oil on the coating of the implant shells such that the implants did not bond with the patients' bone tissue.