Just how much is the settlement? Well that’s (temporarily) subject to a little ‘good news – bad news’ dichotomy.

The good news is that the settlement is not confidential and will be part of the public record. The bad news is that we will have to wait a month or so until all of the formal paperwork is filed with the court to become part of the public record. The parties to the suit (and now the settlement) have agreed to keep everything on the down-low and not seek any publicity associated with the resolution. In short, they’re not talking.

My understanding is that Westchester Medical Center’s parent organization settled on behalf of itself, and the director of radiology / owner of the MRI management company, and the technologists who had been named. This settlement may, ironically, have been both enabled and motivated by the fact that GE had been dismissed as a defendant to the suit in a pre-trial motion.

I can’t begin to fathom the difficulty for the family, reliving their greatest loss through nearly a decade of incessant litigation. In that context, I can fully appreciate the desire to resolve the suit and avoid a trial. I have made no secret, however, of the fact that I wanted a public trial, replete with special reports from Sanjay Gupta televised on CNN.

Why would I want to shine such a glaringly bright light on our industry? Not out of any lack of sympathy for the family. Not to feed an irrational panic about what is one of the safest medical services available. But to focus attention on how we can eliminate at least 90% of all the MRI accidents through changes to operations and protocols. I even had a ‘dream team’ list of non-monetary concessions I wanted to see from the various parties.

From Westchester Medical Center: I wanted the hospital to honor the original promise of transparency made by then-hospital President and CEO, Edward Stolzenberger. I wanted articles, presentations, papers, that explained what went wrong, and what interventions they’ve developed (or that others have developed that they support). I’d like to see a real failure mode effects analysis (FMEA) for this accident.

From GE Healthcare: I wanted to see a new corporate policy that every MRI projectile accident for magnets under GE’s care of which they’re notified (as in “please come and pull out this wheelchair,” or, “we got the wheelchair out, but we need to have this busted coil replaced,” or, “did we ever tell you about what happened here last week?”) to be recorded. Three things should happen. The event should be recorded in the magnet’s service history. A letter should be sent to the client site, notifying them that the record of this accident (and the grave safety risk that it presented) has been entered in the service history. And an incident report should be filed with the FDA for their Medwatch database.

The Colombini family: I do know that one of the principal motivations for the family was to try and make sure that similar accidents don’t happen to other families. I would like to see them lend their name to the development of a fund dedicated to the promotion of MRI safety. In fact, it could be something like an endowed faculty position, but with an ad hoc expert paid to provide presentations or develop materials free from institutional bias. I can even think of someone I’d nominate for the ‘Colombini MR Safety Chair’… the name (absurdly) rhymes with “banal.”

Do I think that these things can still happen without their having been a trial and jury verdict? Yes, they can. My fear, however, is that each of the parties involved would like nothing more than for this entire event to ‘slip quietly into the night’ and fade from everyone’s memory. And while I understand that motivation, I’m afraid that this will rob us of the ability to leverage meaningful change from the MRI industry that would make the next fatality less likely.

UPDATE: Details of the lawsuit settlement are available here.

The first of the three motions decided was from GE Healthcare, seeking to be excused, altogether, as a defendant in the case. The trial judge granted GE’s motion, citing (primarily) Riegel v. Medtronic which gives manufacturers of medical devices very broad protections in state courts because the devices have been vetted for safety at the federal level.

The second outstanding motion, which was one filed by the Colombini family’s attorney, sought the ability to reinstate punative damages claims against GE Healthcare for their involvement in the accident. This motion was rendered moot when the judge granted GE’s motion to be excused from the case, entirely.

The last of the decided motions was a smorgasbord of requests of the remaining (non-GE) defendants to dismiss claims against assorted defendants, to disallow punitive damages against some defendants, and to disallow claims of ‘emotional distress’ by the father of the boy.

• The judge dismissed all causes of action against the senior MR technologist in the suite at the time of the accident because (1) it was not demonstrated that he bore any responsibility for a safe suite environment (in fact the judge’s decision defines the limits of his responsibility to the scanner room, itself), and (2) he was not the tech administering the scan for the boy and therefore had no direct responsibility for his care. The judge’s notes also diminish the technologists’ role in safety by stating that they are not MD’s and had minimal safety training.
• The judged refused to dismiss claims agains New York Medical College (affiliated with the hospital) based on the College’s contention that NYMC had no direct role in training of persons involved in the accident, allowing this issue to be tried in court.
• The judge dismissed claims associated with the father’s contention that he suffered emotional distress based on the legal definition which requires that the person filing the claim feel “unreasonbly threatened by bodily harm” directly to them. That the father felt that his son was unreasonably threatened falls outside the legal definition for the basis of a claim of emotional distress.
• The judge refused to dismiss claims for punitive damages against UIMA, the company that ran the MRI unit for the hospital, allowing that the failure to provide complete and effective safety training may ammount to “utter indifference or conscious disregard for the safety of others.”
• The judge stated that she thought that the technologist administering the scan exaggerated her job duties when she had previously stated that technologists were the MRI suite “gatekeepers” with responsibility to keep a “watchful eye” to prevent ferromagnetic material from being brought in. Since, per the judge, overall suite safety was NOT deemed a reasonable responsibility of a technologist, the judge disallowed the possibility of punitive damages against the tech that administered the scan.
• Finally, the judge dismissed any action for punitive damages against the radiologist who served both as the hospital’s Director of Radiology and president of UIMA, the contractor providing MRI services to the hospital, because he “had no experience supervising MRI facilities . . . and did not view himself as having taken on any supervisory responsibilities with respect to the MRI facility. . .”

If we accept that some level of MRI safety should be a basic right of everyone inside the MRI suite (including staff), then we need to identify who has a role in making sure that MRI safety is actually implemented.

My view is that all parties involved in providing and administering MRI exams have an obligation to the safety of the patient. This includes the organizations who own and operate the scanners for establishing standards and providing applicable training and verifying competencies, directors / administrators / safety officers who have broad duties on behalf of the organization for the protection of patient safety, any person — whether MD, RN or technologist — who works in the MR environment, sites where accidents occur to report incidents in which there was a reasonable potential for harm, and MR equipment manufacturers to actively collect, report, and distribute details of accidents that might help others to better protect against these risks. These responsibilities are both institutional and individual.

If the judge’s decisions on these motions are not challenged (as has happened previously in this case), we should be inching closer towards a real trial date. As of the date of this post, the case is still scheduled to be fully resolved by early January of 2010. It remains to be seen whether that deadline will hold, or be pushed back.

If you would like to read this most recent decision by the judge on the three pre-trial motions she decided, it is available for download. Just click here to download the judge’s decision in Word format (.doc) from the blog site New York Injury Cases. To see the blog site, just click here.

Of course, if you come back here to the ‘MRI Metal Detector’ blog, or subscribe to the RSS updates (click here for more information on the free RSS subscription), I’ll provide you with any and all updates as I get them.

UPDATE: Details of the finalized lawsuit settlement are available here.

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.

PS: you might be interested in a similar article I wrote for The Health Care Blog