You may have heard about how DePuy used the FDA's "premarket notification process," also referred to as the "510(k) process," to allow the ASR XL Acetabular System and the ASR Hip Resurfacing System onto the market without subjecting either implant to clinical trials. Shocking though it is, there may be some silver lining to lax government regulation of defective metal-on-metal hip implants. State-law-based tort claims (as opposed to claims made under federal laws, which can be more limited in scope) might not be "preempted" (that is, disallowed by federal laws) specifically because DePuy"s ASR devices were given approval by the FDA under an accelerated program. Whereas in the typical scenario, a plaintiff might be able to bring only certain claims under federal laws (possibly only in federal courts, moreover), recipients of ASR devices might have much more freedom to sue in more convenient (for them) courts, and to make a wider variety of claims against DePuy.
"Preemption" here means that the federal government has passed a law that supersedes any relevant laws made by state or local governments. Most Americans associate preemption with significant social advances in American history, such as the Civil Rights Act abolishing discriminatory laws made by state governments, or major economic reforms that forbid child labor. However, preemption can also be used to strengthen corporate interests in the face of progressive state laws. In the context of medical implants, FDA regulations sometimes preempt recipients from being able to use their state courts to file
lawsuits against medical device manufacturers.
The inability to use friendly state laws would hamper the lawsuits of recalled hip implant recipients, as would requiring recipients to go to federal court when they may not want to. Yet, because DePuy used the 510(k) process to avoid subjecting its hip implants to scientific testing, preemption may not apply, so state law tort claims remain an option for those affected by DePuy's hip implant recall.
