“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.

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.

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.