Nearly nine years after the accident, the lawsuit was settled for $2.9 million, a settlement that was likely both diminished by, and made possible by, a pre-trial motion which excused GE Healthcare as a defendant to the suit.

The county-owned hospital, which almost immediately asserted its responsibility for the accident, ultimately settled the case on behalf of all of the remaining defendants, which included the head of radiology and the technologist who administered the boy’s scan.

Perhaps now, with the lawsuit resolved, we can actually learn something about the events that precipitated this tragedy, beyond the fragmentary slivers of information gleaned from court documents and news accounts.

That’s right, despite the fact that this one event has become the touchstone for MRI safety, there has not been a single root-cause analysis to inform MRI suite design, departmental operations, regulatory and accreditation frameworks… at least not one that has been shared with the public.

Hopefully, with the lawsuit resolved and jeopardy attached for all defendants, we can have an open conversation about what contributed to the accident and what can be done, at the thousands of MRI suites across the country, to help see that this sort of accident never recurs. Based on recent news accounts and last year’s shocking collection of ferromagnetic projectile accidents, the lessons from the Colombini tragedy are still profoundly needed.

If we are willing to explore this darkest chapter in the brief history of MRI, we may learn lessons that will help protect the 30 million Americans who will receive MRI’s this year, and next year, and the year after that.

If we fail, next year we’ll be able to look back at this moment, wistfully, and imagine young Michael getting his drivers’ license, or attending his junior prom, on the verge of adulthood. But he is forever trapped in 2001… a victim of circumstances he had no control over.

Let’s see what we can do, together, to help make sure that this never happens again.

My heartfelt thoughts and prayers are extended to the Colombini family.

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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.

If you’d like to read the article, “Risky Business: MRI accidents increase fourfold in as many years,” pick up your copy of RT-Image that looks like this (below):

RT-Image | August 3, 2009

Or you can simply click on the cover image (above) or right here to be taken to the online version of the article.

Thank you for your ongoing attention to improving MRI safety!

You can view the Aunt Minnie article by clicking here.

The first special event is a presentation that AHRA invited me to give entitled ‘MRI Safety, Liability, and Best Practice.’ If you received the conference program mailers a few weeks ago that indicated that I am giving this presentation on that first Sunday of the conference, don’t believe it! I am not giving this presentation on Sunday, but I am giving it on Monday, August 10th, from 2:30 – 4:00. (They’ve done a little juggling that changed a few scheduled presentations.)

The program will touch on a number of the MR safety developments of the last several years, though even more from a management perspective than any of my prior presentations to AHRA.

This is the first special invitation and I would very much love for you to join me on Monday afternoon. There are lots of other great sessions, however, and I understand if you have your eyes on another program scheduled for the same slot. I’ll miss you though, and will stare wistfully at your empty chair in the presentation.

Which brings me to my ½-event invitation. It’s actually a full event. It’s 90-minutes long, just like my Monday presentation. In fact, it’s almost exactly like the 90-minute Monday presentation because AHRA has asked me to offer this program twice! If you can’t make Monday afternoon, please come by Tuesday morning, from 8:00 – 9:30, to see ‘MRI Safety, Liability, and Best Practice’. I’ll actually feel much better on Monday if you’re not there, since we have this opportunity to meet up on Tuesday. And if you’re a glutton for punishment, or if you just want to see what I do to mix it up from one day to the next, you’re welcome to attend both sessions.

The last special event to which this post invites you is actually a revolving, ongoing set of conversations that I would love to share with you. When I’m not on the podium in front of large audiences, I will be in the Mednovus booth on the exhibit hall floor (booth #828 / 830), having one-on-one and small group conversations. I invite you to come by and join in a personal conversation with me and my colleagues about how best to prepare your MRI facility for the rapid-fire changes that are in process.

Though it’s only 4 weeks until AHRA, the great people at Mednovus are diligently working on special announcements that will be released in the lead-up to the annual meeting. Please stay tuned to be among the first to learn of what’s going on.

I hope to have the chance to see you at the annual meeting. Please do join me in one (or both) of my presentations, and do visit with me and my colleagues in our booth. I’m really looking forward to it.

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

The full presentation was 90 minutes, including an extensive audience Q&A, but I’ve pulled out one particular section that is particularly relevant to our topic at hand, ferromagnetic detection for MRI pre-screening.

The video excerpt below addresses forthcoming changes to the ‘Guidelines for Design and Construction of Health Care Facilities’, a poly-cyllabic mouthful that roughly translated means the healthcare building code, and changes regarding MRI suite design…

As mentioned in the video above, the proposed changes to the healthcare building code are currently open for public review and comment. The proposed language includes references to the ACR 4-zone principles as well as planning for ferromagnetic detection.

If you would like to see, review or even comment upon the proposed changes to the hospital and healthcare provider building code, public comment for the ‘Guidelines’ is open until December 15th, 2008.