There are three product liability theories under California law: manufacturing defect, product design defect and failure to warn. One recent failure to warn and negligence case was brought against Stryker Corp. and Howmedica Osteonics Corp. The lawsuit was brought by a patient who received a femoral endoprosthesis implant in 1994, when he was 15 years old. The patient's left femur was removed due to sarcoma, a cancer, and replaced by the prosthetic femur stem and joined pieces.
The patient alleged that the prosthetic femur was defective because instead of lasting a lifetime, it failed in February 2010. The failure of the medical device caused the patient to undergo corrective and replacement surgeries, and he sued to recover medical expenses, lost wages and general damages.
Pleading Medical Device Manufacturing Defect Claims
Extensive pleading is not always necessary when filing a medical device claim. A patient usually only needs to state sufficient facts to cover the necessary elements of a product liability action. Stryker and Howmedica sought to dismiss the patient's product liability claim as insufficiently pled, but a California district court recently upheld the patient's manufacturing defect claim as sufficiently stated.
The patient alleged that his implant was properly designed with the proper materials, but that a manufacturing defect caused the implant to have a weak spot that unexpectedly broke.
The court noted that the patient was not required to offer an extensive explanation of the implant manufacturing process or the flaws in the process that led to his injury. Such detail is usually required only for later stages of litigation because initial pleadings are required only to give a medical device company notice of the complaint's basic elements and how these apply to a patient's situation.
The Elements of a Negligence Claim Against a Medical Device Company
The court also found that the patient sufficiently pleaded a negligence claim against Stryker and Howmedica with the following facts:
- The medical device companies owed a duty of care to the patient.
- This duty was breached by the companies' negligence in the design, manufacture, production or testing of the femoral stem implant.
- The patient was injured as a result of this negligence when his implant broke.
The patient sufficiently alleged that the device manufacturers' negligence was the cause of his injury because the product was delivered to his physician without a substantial change in its condition and was used by the patient and his doctor in a manner that was anticipated by the manufacturers.
Source: Currier v. Stryker Corp., 2012 WL 1037940, U.S. District Court, E.D. California, March 27, 2012