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 Technologist, Laura Price, claims that her former employer, Horizon Diagnostic Center in Orange Park, FL, ignored repeated requests from Ms. Price and other Technologists to repair the coils on the MRI, and that the image quality was so poor as to compromise the clinical value of the scans. She was purportedly fired for insisting that the coils be repaired. She is suing for wrongful termination and has taken her efforts public in an interview with a local television news station.

What is particularly interesting (to me at least) is that there is not currently any claim of injury or misdiagnosis based on the claimed failure to keep the MRI equipment in operational condition. Therefore, this is strictly a claim against the practices of the provider and their adherence to standards of care and best practices.

Though the MRI fatality case has yet to go to trial (having been postponed ad nasuem for years, now), the Technologists are named defendants in that suit, suggesting at least that Techs have a legal obligation for safety and the standard of care.

This Florida suit is intriguing because it puts operations squarely in the legal crosshairs. When legal liability is tied only to injury, it fosters an ‘ends justify the means’ culture of safety. Something akin to, “if we haven’t hurt anybody, it proves that we’re doing things right.”

Many patient safety experts decry this sort of ‘negative proof’ of safety. Getting all the way across the freeway unscathed, on foot, blindfolded, is not proof that walking blindfolded across the freeway is a safe practice, yet this is the logic that prevades MR safety at many locations.

Whatever you may think of this one case, or the Technologist who is bringing it, I am very interested simply because it does put safety practices in the spotlight. I’m also very interested in what you may think of this, so please share your comments, below.

In order for that accident to occur, a few standard procedures had to go awry, and not in ways that you might think. The anesthesiologist’s primary goal was to get his patient oxygen. The Technologists’ primary goal was to figure out why the oxygen (which the anesthesiologist was yelling for) wasn’t working. The nurse passing the MRI unit’s primary goal was to help out when she heard someone calling for help. This accident, like so many others, was the product of well-intended efforts in an environment where the rules are all imperceptibly changed.

There were a number of interventions that could have potentially broken the chain of events that resulted in this fatality. Better access controls, more effective training for the Technologists and anesthesiologist, storage to keep hazardous ferromagnetic materials out of sight, suitable portable cylinders, better QA/QC on the medical gas system… each of these might have been enough to avert this accident.

Add to this list the effective use of ferromagnetic detection, which might have provided the automatic feedback needed to sequester the fatal oxygen cylinder before the MRI exam even began, or remind the anesthesiologist of which materials were dangerous near the magnet, or provide warning feedback to the nurse who let herself into the suite.

As the Colombini accident illustrates, projectile accidents in the MRI suite are most often the result of multiple factors. Effectively interdicting these sorts of accidents requires vigilance on many fronts. While there are no ‘silver bullet’ solutions to MRI risks, no one product or training session that can eliminate the risks, there are products and solutions that help to minimize the risks. Most of the solutions have been around nearly as long as MRI, but only recently has ferromagnetic detection been added to the MR safety armamentarium.

This new ferromagnetic-only detection technology substantially increases the opportunity for Technologists and MR-staff to find and quarantine ferromagnetic threats worn by, or carried by, persons approaching the MRI magnet. In a forthcoming post I’ll describe the flurry of recent ‘best practice’ standards that all now call for the use of ferromagnetic detection to improve MRI safety.

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