Last year, the United States Supreme Court decided that medical device manufacturers that had gone through the trial-by-fire of a FDA pre-market review are immune from civil action in the state courts for product liability (Riegel v. Medtronic). Just a few weeks ago, the Court threw what many considered to be a major curve-ball when they decided that comparable protections do NOT apply to pharmaceutical manufacturers (Levine v. Wyeth). What does this suggest to MRI providers (Technologists, Radiologists and Administrators)?
It suggests that, legally, you’re out on your own.
Let’s contrast this with two situations, starting with an adverse Gadolinium contrast reaction.
If a site were to inject a patient with impaired renal function with Gadolinium contrast and that patient developed NSF (God forbid), and the damages were determined to be $10 million, that patient could conceivably sue the pharmaceutical manufacturer for failing to make the NSF warning sufficiently bold on the packaging (by the way, watch for news reports of lawsuits mimicking this hypothetical model following this decision). Yes, the provider would likely have a piece of the $10 million pie, but the liability would move up and down the ‘food chain’.
If, on the other hand, a catastrophic SAR accident in MRI facility were to critically injure a patient, and the damages for that accident were similarly determined to be $10 million, the Supreme Court decision suggests that the device manufacturer can not be held liable in a state suit. This reasoning concludes that the sum-total of any liability, malfunction, or negligence is laid at the feet of the MRI provider.
Personally, I think that these two decisions bracket the area where the law should be on this issue, but they are both so far from the rational middle-ground that it will require at least one more case before we can begin to make sense of this.
In the meantime, what this suggests to me is that MRI providers are out in the legal forest with no ‘Hansel and Gretel’ breadcrumb trail back to others who share their responsibility to patient safety.
What does this mean, in terms of how these facts should influence our behavior?
For a multitude of reasons (including the specter of legal liability), MRI providers should proactively look at their MRI safety protocols and provisions. All sites should follow the ACR and JCAHO recommendations and use ferromagnetic-only screening instruments. If you are Joint Commission accredited, take a look at the new EC Standards and Sentinel Event Alert #38. All MRI providers should also scrutinize the ACR Guidance Document as the basis for their own safety manuals.
A combination of these new 21st century MRI safety technologies, updated accreditation standards, and the industry-standard practices documents, should guide providers to help deploy the greatest protection for patients and staff (and liability protection for themselves).
Until this legal-liability disparity is resolved between pharmaceutical and device manufacturers, it seems to me that the most prudent course of action is to take the additional steps needed to provide the recommended safety solutions as indicated by the ACR and JCAHO. These would include careful adherence to established screening protocols and the use of recommended ferromagnetic detection systems.Tobias Gilk, President & MRI Safety Director Mednovus, Inc. Tobias.Gilk@Mednovus.com www.MEDNOVUS.com
PS: you might be interested in a similar article I wrote for The Health Care Blog