A federal appeals court recently found that a man who received a defective hip implant can move forward with his defective manufacturing-based state law claims.
Hip implants are one of the most common types of medical devices sold. Unfortunately, hip implant failure is common and often provides the basis for defective medical device lawsuits. One of the most recent defective medical device lawsuits arising out of an allegedly defective hip implant was filed against Stryker Orthopaedics.
The patient who brought the lawsuit alleges that he received a hip replacement with parts manufactured by Stryker. Like many defective hip implant recipients, the patient followed his doctor’s instructions after his surgery, but still experienced increasing pain. The patient in this case lived with his pain for two years until doctors determined that his hip implant was loose and needed to be revised.
The patient’s lawsuit alleges the looseness of his implant was due to manufacturing residuals on the hip implant shell that prevented any bony in-growth into the shell.
Stryker argued that the patient’s state law-based claims should be dismissed because they were superseded, or pre-empted, by federal law. A federal appeals court recently found that the patient’s claims were not pre-empted by the Medical Device Amendments of 1976 to the federal Food, Drug and Cosmetics Act because he successfully pleaded a “parallel claim.”
Typically, a state law tort claim to recover for injuries allegedly caused by a medical device is pre-empted under two conditions:
- The federal government has established requirements applicable to the allegedly defective device.
- The patient’s claims are based on state law requirements that are “different from or in addition to” federal ones and that relate to the device’s safety and effectiveness.
It is important to note that this pre-emption rule does not prevent a patient from filing a state law claim regarding a defective medical device that violates Food and Drug Administration (FDA) regulations. Such a claim can go forward if a state’s duties in such a case “parallel,” rather than add to, federal requirements.
Devices that pass through the FDA’s rigorous premarket approval procedures automatically satisfy the “federal requirements” prong of the pre-emption test. But the appeals court in the Stryker case noted that state common law claims “are not pre-empted, provided that such claims are premised entirely on violation of the applicable federal requirements.”
The court found that the Stryker hip implant patient sufficiently pleaded parallel claims to the extent that the claims were based upon manufacturing defects resulting from violations of federal regulations.
Specifically, the patient pleaded the following facts:
- The patient received a hip implant that had a shell manufactured by Stryker.
- The FDA had previously warned Stryker of bioburden in excess of FDA regulations in its final rinse of the shells.
- After the patient’s surgery, Stryker ultimately voluntarily recalled the shells, including the shell that was specifically used in the patient’s hip implant.
- The patient suffered from a loose shell due to a lack of bony in-growth.
- The lack of bony in-growth is a known effect of an excess of bioburden and manufacturing residuals on shells.
The patient’s state law claims were “parallel” and not pre-empted because he pleaded the existence of a manufacturing defect caused by a violation of federal regulations and allegations connecting the manufacturing defect to his specific injury.
The court went on to give an example of another type of medical device case that would be considered “parallel” and therefore not pre-empted by federal law:
“To illustrate, suppose a manufacturer had represented to the FDA in its preapproval documentation that each hip implant component would be sterilized for 10 minutes at 800 degrees. We would accept a parallel claim that pleaded that the manufacturer instead sterilized the component at only 200 degrees for five minutes, as that would ‘violate’ what it told the FDA.
“However, if the plaintiff’s claim was that proper sterilization required 20 minutes at 1,000 degrees or some other method of sterilization altogether, this claim would not be allowed, as it would ‘add to’ the regulatory requirements.”
This case highlights the complicated interaction of state and federal law in defective medical device cases. There are times when state law claims will provide for longer statute of limitations periods or better punitive damages than federal claims or claims based on another state’s law. That is why it is important for a patient injured by a defective device to consult with an attorney experienced in complex litigation who is able to choose both the venue and type of action most beneficial to the patient’s interests in a particular case.
Case Link: Bass v. Stryker Corp., 669 F.3d 501, U.S. Court of Appeals, 5th Circuit. Jan. 31, 2012