Undergoing surgery can be a traumatic experience for many people, especially if the outcome of the surgery is uncertain. However, any Pennsylvania product liability lawyer knows in some types of surgeries that involve implantation of devices, where the operation was successful and the patient appears to have fully recovered, it can come as a shock when injury later occurs-this time due to a defect in the device.
Recently, the U.S. Food and Drug Administration (FDA) issued a Class I recall of a reconstructive knee device manufactured by DePuy Orthopaedics, which is a unit of Johnson & Johnson.
A Class I recall is the most serious type of recall. According to the FDA, these are issued when there is a “reasonable probability” that using the product “will cause serious adverse health consequences or death.”
When a product is defective and that defect causes injury to a person, that person may be able to bring a product liability claim against the manufacturer under several different legal theories, including negligence and strict liability. Strict liability can render manufacturers liable for defects that happen during the manufacturing process, as well as where the manufacturer failed to provide proper warnings.
This recall comes on the heels of a major 2010 recall of hip replacement devices. The ASR Total Hip System was voluntarily recalled by DuPuy after research showed an unacceptably high failure rate. These failures are the basis for thousands of product liability lawsuits against DePuy Orthopaedics and Johnson & Johnson, including one by a Pennsylvania man. That suit alleges that the companies knew of the defect in the hip replacement device and could have prevented the plaintiff’s pain and suffering by issuing a warning about the dangers of the device.
Source: NewJerseyNewsroom.com, “Johnson & Johnson Knee Replacement Recall Adds to Mounting Troubles,” Brittney Noonan, Feb. 26, 2013