Device Makers Push Product Guarantees Due to Slow Sales, but How Patients will Benefit is Unclear

Device Makers Push Product Guarantees Due to Slow Sales

Medical device manufacturers are trying to boost their sales by making bigger product guarantees, Reuters reports. Companies are offering more compensation to hospitals if their devices do not perform properly.

According to Reuters, Medtronic, Johnson & Johnson and St. Jude Medical are among the first to beef up product guarantees. Under some of these agreements, the companies offer to pay part of the follow-up treatment related to their heart devices. But hospital officials want a greater reassurance for a product’s performance, including promises to pay for the cost of a surgery when a device needs to be replaced.

Failed devices usually end up costing patients and insurers, frequently leading to personal injury lawsuits in court. Devices such as metal-on-metal hip implants and transvaginal mesh have resulted in thousands of lawsuits filed on behalf of individuals who suffered serious injuries allegedly caused by these products. In many metal hip implant cases, patients were forced to undergo a revision surgery to remove the device when it failed. A number of plaintiffs in the pelvic mesh litigation allege that they had to undergo multiple surgeries to remove the mesh, often without success. Such products have come under intense scrutiny in light of evidence that they were defectively designed or manufactured.

Reuters reports that hospitals are increasingly bearing the brunt of unsuccessful procedures as Medicare lowers reimbursements for elderly patients who are being re-admitted. It is unclear, however, how individual patients or insurers will be affected for the cost of a second operation. “I would feel a lot better if the company would come right out and say I will pay for the product and the replacement if something goes wrong,” said Lisa McGiffert, Director of the Consumers Union’s Safe Patient Project. The group has called on hip and knee implant manufactures to provide warranties to patients directly. Additionally, legal experts tell Reuters that the new agreements won’t reduce the likelihood of patients filing lawsuits over injuries. Rick Boothman, executive director of clinical safety and chief risk officer for the University of Michigan Health System, said “The manufacturer can’t limit its liability toward the patient through a contract like this,” according to Reuters.