“Why — now — ten years later would you post these documents?”

Excellent question! Here’s why I didn’t publish these long ago…

I didn’t have them.

Yes, the civil suit had been underway for years. Yes, individual documents had been filed and made public during the course of the civil litigation, but the civil suit was only resolved a year ago and it took several months for the last of the documents to be made public through the Westchester County Clerk’s Office (who, by the way, were profoundly helpful in accessing these public records).

Here’s why I am publishing them now… Despite the fact that this is the watershed event in MR safety, the degree to which the industry has really dissected this event and identified the causative factors has been wanting. Desperately wanting.

I’m currently working with a colleague on a root-cause-analysis of this event, drilling down through the simple (don’t have ferrous oxygen tanks in the MR suite) to get at more meaningful elements of this accident that we can work to prevent similar accidents. It promises to be unlike anything you’ve learned about why this accident happened.

Given the trajectory of MR accidents and adverse events, this sort of analysis appears to be desperately needed.

So, what are the documents? They are transcripts of the depositions of many of the key people involved in the accident and couple of ‘official’ reviews. These are the source materials. The news accounts you’ve previously read are all synthesized from these (or from others’  interpretations of these). If you’re so inclined, you can download and read these for yourself.

The essential elements of the sequence of events for the accident are these:

• Michael Colombini, a young boy, was injured from a playground accident
• The ER had a head CT run, which revealed an unknown / asymptomatic brain tumor
• The boy had surgery very shortly thereafter to remove the tumor
• Prior to discharge, the boy was sent for a baseline MRI as a reference for future monitoring
• The boy was sedated prior to the exam and placed in the MR with a cannula to deliver oxygen
• Before the exam began, the anesthesiologist observed a decline in O2 saturation, and realized that the oxygen from the wall outlet was not flowing, despite his attempts to turn it up
• The anesthesiologist called the technologist who was to administer the exam to the door of the MR room, instructing her to find and fix the source of the problem with the oxygen flow
• This technologist was not familiar with the oxygen supply system, which — in apparent violation of codes — was fed to only the MR exam room from a bulk cylinder without any pressure or flow alarms
• The technologist sought her colleague who she believed knew the oxygen system and together they entered the MR equipment room to try and fix the supply problem
• The anesthesiologist cried out for help, though the technologists in the MR equipment room could not hear this
• A nurse (who had accompanied an earlier patient to the MR suite was returning to retrieve an item she had left) heard the anesthesiologist’s cries for help and handed him a portable cylinder near the door to the MR exam room
• The anesthesiologist turned to approach the boy with the oxygen tank when the magnetic attractive force of the MRI pulled the cylinder from the doctor’s grasp
• The tank flew into the MRI where it struck the boy in the face and head, inflicting fatal wounds

The following PDF documents vary in size from 1 MB to 25 MB, and will take a few minutes to download, depending on your connection speed.

Deposition of Patricia Lauria, technologist who was to have administered the Colombini scan
Deposition of Paul Daniels, other technologist on duty who assisted in the repair of the oxygen supply
Deposition of Jian Hou, MD, anesthesiologist who sedated / monitored Colombini for the MR exam
Deposition of Terrence Matalon, MD, Radiologist who was simultaneously the hospital’s Director of Radiology and president of the private company subcontracted by the hospital to provide operations for the MRI service
New York State Department of Health incident report
Westchester Medical Center incident review

As you might suspect, these documents are but the tip of the iceberg of the body of the court filings in this civil suit. However, for those interested in what happened and why (as opposed to the legal maneuvering), these documents are the most illuminating.

In the months ahead, the 10th anniversary of the 2001 Colombini fatality will include a deeper look into this accident and the changes that have taken place (and those that are still needed if we wish to avoid repeating this accident). This has begun, slowly, with the new building code requirements that are being adopted by various US states and the Joint Commission, but may pick up steam with federal government intervention.

Please check back periodically for the latest information on MRI safety… both as it relates to specific preventions, such as ferromagnetic detection systems, and broader awareness such as knowledge of the factors in the Colombini fatality.

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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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Now, this time line actually fits nicely within the trial judge’s own disposition deadline of January 4th, 2010. At the moment, however, there still is one unresolved pre-trial motion, and there’s nothing to say that the parties to the trial won’t want to go and file more motions (which may wind up pushing the entire time line back, yet again).

Just over a month ago, I wrote about the resolution of three of the pre-trial motions in this case. I was startled by what appears to me to be a disconnect between the judge’s decisions on some of the questions put to the court in the pre-trial motions, and the real world practice of MRI.

It remains to be seen if, as has been done with an earlier pre-trial decision rendered by this same judge, the attorneys for the Colombini family seek to challenge the judge’s rulings on responsibility and authority of the defendants. If that happens, I imagine that it could easily result in another postponement of the actual start of the trial.

If you are interested in following developments on the trial (and other issues of MRI safety) more closely, you are invited to follow me on Twitter for periodic updates, as they become available.

This case (and the event that precipitated it) are likely to be the most important influences on MR safety (hopefully) for a long time. I invite and encourage you to follow these events as they unfold.

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

The multi-million dollar lawsuit has been grinding through the legal system as a myriad of claims and counter-claims have been ricocheting around among the parties. Those who’ve been watching the pre-trial activities may attest to it sometimes resembling a soap-opera with shifting alliances, but it appears that the parties’ day in court will come in less than 100 days.

While skillful lawyering often has as much to do with the outcome of civil actions as do the merits of the case, the merits fall clearly in favor of the family, and are squarely against the combined defense which includes the Medical Director, hospital, Technologists, and the MRI manufacturer.

The young boy was not the first patient to die in an MR and, given the current MRI accident trajectory, won’t be the last (and already isn’t according to some anecdotal accounts). What makes this incident such a touchstone, however, are the incidental facts surrounding the boy’s death.

First, could there be a more sympathetic victim than a young boy who had just survived the removal of an otherwise fatal brain tumor? Second, this fatality was splashed across CNN and newspapers and was not immediately gagged with non-disclosure agreements and out-of-court settlements which is common of many MRI injuries. Lastly, as the spark that ignited the MRI safety movement, many industry watchers will follow this case if only to observe the epilogue. But odds are that the civil trial will be as central to MRI safety as the original accident was.

Nearly 8 years after-the-fact and there is not a single MRI safety requirement that has been imposed that would short-circuit the sequence of events that caused the accident in the first place. There is an impressive list of recommendations and best-practice calls from a heretofore unrelated collection of professional and accrediting bodies, but no requirements.

Would a multi-million dollar judgment change that? I think that it would. I think that the fear of a high-profile lawsuit and a huge judgment would spur action in ways that the accident which precipitated it hasn’t.

We may all learn, in about 100 days, whether I’m right or not… whether the echo of this incident is as loud as the event itself.

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