Babies' deaths spotlight safety risks linked to computerized systems

Two new tragic cases. (A third, earlier case of infant death was posted in March 2011 here).

Case #1. See Baby's death spotlights safety risks linked to computerized systems by Judith Graham and Cynthia Dizikes in the Chicago Tribune.

A baby died at Advocate Lutheran General Hospital due to an intravenous solution containing a massive overdose of sodium chloride — more than 60 times the amount ordered by the physician. The authors write:

Although a series of other errors contributed to the tragedy, its origin — a piece of data entered inaccurately into a computer program — throws a spotlight on safety risks associated with medicine's advance into the information age, a trend being pushed aggressively under health reform.

One wonders - what happened to the alerting features, for the tens or hundreds of millions of dollars the hospital spent on health IT?

I've also left a number of comments to the Chicago Tribune story in its comments section, in response to the usual pro-health IT-at-all-costs posts.

Case #2. There's also been a baby death locally to me that is allegedly due to HIT (PACS) interference in otherwise simple care processes.

See "Blake vs. Abington Memorial Hospital" at this link. The Complaint in the latter case, a public document, is available as a .tif image at this link (1 MB; you may need to use IE to download beyond the first page).

(July 8 addendum: since this blog post was published, I've noted multiple "hits" on it from the IP of the hospital involved, 65.216.195.x , at different times of the day, as well as on my Drexel website on HIT failure. Clearly they are aware of the issues noted herein.)

A critical x-ray of a PICC (peripherally inserted central catheter) line placement allegedly was never read due to misdating. See for example counts 17 - 25, and 39 - 45. It was dated several days earlier than it was taken.

Counts 39-49 (emphases mine):

39. Defendants also described that the February 27, 2010, x-ray was digitally transmitted to radiology, and the technician attempted to match the image to doctors’ orders, and then put all the identifying information on the film, including the patient’s name, date of birth and date of study.

40. Defendants told Plaintiffs that the radiology technician picked the wrong name and put it on the x-ray, and then later realized it was the wrong name and then somehow changed the information on the image.

41. Defendants told Plaintiffs when the technician changed the information on the image, she typed the date of birth where she should have typed the date of study. [Puzzling; my $99 Canon camera embeds date information in the image itself, as do PACS systems - ed.]

42. Defendants told Plaintiffs that the incorrect date on the image caused the x-ray not to be read by a radiologist in the night the image was taken, and that if the image had been correctly dated February 27, 2010, it would have been reviewed by a radiologist immediately, who would have alerted Defendants that the PICC line was improperly positioned and had to be moved back to a safe position. However, since the film was incorrectly dated February 23, 2010, the film was classified as “old” and was not put in line for immediate review, and was not reviewed in time to prevent injury to Plaintiffs Decedent.

43. The Defendants told Plaintiffs that an older x-ray has less significance than a newer image and is, therefore, not as critical to review. [This is exactly the reverse of good radiological practice. 'Old' - but never officially read - means 'potential danger' - ed.]

44. The Defendants told Plaintiffs that the x-ray was reviewed by Dr. Griffith on the morning of February 28, 2010. At that time, Dr. Griffith, thinking that the image was from the 23rd, compared it to the next most recent image, which was from the 25th In reviewing these x-rays, Dr. Griffith reportedly concluded that the PICC line shown in the image she believed was from the 23rd had been removed by the 25th. [Gevalt - what a tragic error. In healthcare, critical attention to detail at all times is required, or your patient's dead. There is no room for computer fritter. - ed.]

45. Defendants told Plaintiff that the x-ray from the 27th, which was mislabeled as being from the 23rd, would have been reviewed by the neonatologist on duty on the morning of the 28th, but this did not happen because the computer which places films in line to be reviewed would have ignored such an “old” film.

[Note the accusation of the computer acting as cybernetic 'governor' or 'conductor' of care, deciding what the humans should or should not look at. This is not uncommon in HIT. Yet, who qualified these machines to play this role? More on this critical issue at this link. - ed.]

46. The Defendants told Plaintiffs that the next 24 hours were uneventful, but late in the day on Monday May 1, 2010, Destinee’s condition began to deteriorate rapidly.

47. The Defendants told the Plaintiffs that the during the efforts to reverse Destinee’s deterioration, they discovered that the PICC line was in the wrong position, and that they confirmed this by sampling the fluid from around the heart, which was found to be full of hyperalimentation fluid, and then pulled the line back from its incorrect and dangerous position in the heart.

48. The Defendants told Plaintiffs that they did not know if the PICC line caused a hole in the heart, but that just having the line in the heart was enough for it to push the hyperalimentation fluid into the pericardium.

49. As a direct and proximate result of Defendants’ negligence, Plaintiff’s Decedent’s suffered injuries, including but not limited to: [numerous catastrophic complications followed by death - ed.]

If these counts are accurate, I ask the same question as in case #1: if an x-ray was accidentally dated five days or so before it was taken (how can that even happen?), why was an alert not triggered that an "old" (and unread) x-ray needed an official radiologist reading ASAP?

What are hospitals getting for their tens to hundreds of millions of dollars they are throwing at clinical IT?

This latter story really disappoints me if true. I was a Resident in Internal Medicine in this hospital in the mid 1980's and used my knowledge of radiology, in which I spent a year of formal postdoctoral education, and of computing to fix a CT scanner in the middle of the night and save a young man's life (as documented in a letter from my former Residency Director, now the Chief of Staff here and here , pgs. 1 and 2 respectively).

Ironically, even after all these years, I probably could have read that PICC line placement x-ray.

Technology can be a great blessing in medicine. I am alive and healthy in 2011 thanks to it. The medical condition referred to in the aforementioned letter was in fact cured as a result of advances in cardiac electrophysiology science, as here and here, pgs. 1 and 2).

However, technology cannot be applied cavalierly, lawlessly (per Sharona Hoffman), experimentally, without regulation, and without informed patient consent as is often done in the world of HIT.

-- SS

June 27, 2011 addendum:

In further review of the dockets in case #2, I find there seems to be a wee problem getting the hospital's Chief of Staff Jack Kelly to a deposition.

In a motion filed June 10, 2011 by the plaintiffs, "BY ADMINISTRATOR ERICA L ALLEN-BLAKE; RICARDO BLAKE; ESTATE OF DESTINEE LOTOYA BLAKE DECEASED MOTION TO COMPEL DEPOSITION OF DR. JACK KELLY" (.tif file at this link), in Exhibit "J" the plaintiff's attorney writes to the defendants' attorney (emphases mine):

I received your faxed letter of May 2, 2011. I don’t agree with any of your sophistry, and want to depose [Chief of Staff] Dr. Kelly. I remind you that you objected to the Complaint, claiming the meeting with the Plaintiffs had a specific purpose under MCARE (which never made any sense, but you wrote it, not me). Your objection raised issues of fact. If you don’t want to back them up, or can’t, then withdraw the objections.

If you’d like to ask the Plaintiffs one question at a deposition taken pursuant to your pending objections - i.e., whether they were told by your clients that MCARE written notice was purpose of the meeting or not - I’d agree to let you do that. I can represent to you that their answer will be "no.”

Be advised that I am tired of Abington’s dilatory tactics in this clear liability case in which an infant was killed by, among other things, some of the most egregious professional malpractice imaginable. On top of that, Abington refused to provide the name of the radiology technician until suit was filed. Now, you’re playing ticky-tack games about depositions, and my clients are understandably not impressed.

Under cover of separate letter you will find a Notice of Deposition for Dr. Kelly for this Friday, May 6, at 2 pm in my offices.

Wow.

A motion to compel was filed on 6/22/2011 so apparently the May 6 deposition did not take place.

I add the the MCARE Act of 2002 ("MEDICAL CARE AVAILABILITY AND REDUCTION OF ERROR ACT") in Pennsylvania (PDF at this link) states:

MCARE Section 308. Reporting and notification.

... B. Duty to notify patient.--A medical facility through an appropriate designee shall provide written notification ['written' - this word would appear to mean "in writing" - ed.] to a patient affected by a serious event or, with the consent of the patient, to an available family member or designee within seven days of the occurrence or discovery of a serious event. If the patient is unable to give consent, the notification shall be given to an adult member of the immediate family. If an adult member of the immediate family cannot be identified or located, notification shall be given to the closest adult family member.

Allegedly from the June 10 Plaintiff's Motion, as it appears to me, the hospital seems to be trying to claim a verbal meeting with the family satisfied the MCARE Act's notification requirements even though nothing in writing was apparently given, but that the information exchanged in that family meeting is not admissible in court.

It seems hospitals (perhaps pushed by their insurers) attempt to play legal games to try to avoid culpability for their "computer-anecdote" patients, some who end up as roadkill on the experimental racetrack of health IT.

Again, this is doubly disappointing if accurate, as I knew some of the principals on the defendants' side two and a half decades ago.

Also see another case at my aforementioned March 2011 post "Thanks to the wonders of EHR, this premature baby went to the grave, prematurely" at this link, from an Oct. 2010 story in Virginia Lawyers Weekly ("Failures in care alleged after premature birth - $1,000,000 Settlement"). A PICC line was also involved.

-- SS

EMRUpdate's thoughts on health IT

I had posted about my mother's demise at the EMRupdate.com site here where I have written or cross-posted a number of essays over the years. The site's proprietor Nick Harrington of the U.K. replied. In his bio:

Managing Director of UK based document management software vendor Ambay Software providing hosting and support to emrupdate.com

I recognized a number of familiar themes in his reply.

In turn, I replied to his reply as follows:

Nick Harrington replied on Mon, Jun 20 2011 10:12 AM

Dr. Silverstein,

We're sorry for your loss. Genuinely.

However, I don't think this is the right place for you to start a campaign against EMR. The Healthcare industry is making big progress in the quality of patient care directly as a result of using Information Technology. The single act of providing computerized Electronic Health Record for a patient - whatever shape or form from many vendors - makes available important medical information to the whole team involved in patient care. It allows information to be readily available, to be carried with the patient as they move within the health system, it allows Doctors to be more aware of previous treatments, drug regimes and how best to care for this patient now in this consultation or emergency.

Unfortunately laying blame at the door of IT and Electronic Medical Records isn't at all reaslistic and is unlikely to win your anything more than genuine sympathy. Certinaly no support for your premise that EHR is a direct cause of death, however unfortunate its circumstances.

I do wish you peace and strength in your sad bereavement.

Nick

My reply:

Nick Harrington wrote:

Dr. Silverstein,

We're sorry for your loss. Genuinely.

However, I don't think this is the right place for you to start a campaign against EMR.

Thanks for the expression of sympathy. It is appreciated.

A few clarifications though:

I have never maintained a "campaign" against EMR. I merely hold views that experimentation on patients with problematic, poorly engineered, unregulated medical devices (that are deliberately given special accommodation with regard to the federal FD&C act per Jeff Shuren at CDRH, see FDA Decides Regulating Implantable Defibrillator Medical Devices a "Political Hot Potato"; Demurs), and without informed consent, is unethical. As per Hoffman & Podgurski at Case Western School of Law, what I am against is the lawlessness of the industry today.

Nick Harrington wrote:

the Healthcare industry is making big progress in the quality of patient care directly as a result of using Information Technology

Much current and emerging literature refutes that (such as the sampling at this link). In consideration of this literature, today's commercial health IT is not yet ready for large scale rollout from an ethical perspective. Doing so is experimentation by definition. Doing s, especially without patient awareness or consent, is in violation of decades of policy on human experimentation (e.g., see HHS "Human Research Protections Frequent Questions.")

These are first principles, not open to debate. Even modest NIH research grant proposals involving health IT undergo strict review for human subjects (and researcher) protections. I know first hand, as a sat on a Study Section on health of the population and provided Medical Informatics expertise to such proposals.

Nick Harrington wrote:

"The single act of providing computerized Electronic Health Record for a patient - whatever shape or form from many vendors - makes available important medical information to the whole team involved in patient care. It allows information to be readily available, to be carried with the patient as they move within the health system, it allows Doctors to be more aware of previous treatments, drug regimes and how best to care for this patient now in this consultation or emergency."

Ideally, yes. However, we're still quite far from the ideal. At present, what we have is an unknown level of "health IT roadkill" on the way to perfecting the technology. As predicted by the field of Social Informatics, there are also other unanticipated and likely adverse side effects (such as at link), outcome unknown.

Nick Harrington wrote:

Unfortunately laying blame at the door of IT and Electronic Medical Records isn't at all reaslistic

That depends in what setting, and to whom, the blame is laid.

In any case, per my previous post on my mother:

"May she rest in peace, and may my efforts [i.e., at whistleblowing on health IT problems] result in others not having to suffer similar mistakes at the hands of IT."

Nick Harrington wrote:

I do wish you peace and strength in your sad bereavement.

Nick

Thanking you kindly.

-- SS

How to Fix EMRs: Shoreline Pools, Electronic Medical Records and Criminally Negligent Homicide

There are many parallels between the health IT sector (with known injuries and deaths [1]; deliberate lack of regulatory enforcement in part due to regulatory capture [2]; willfull blindness and special pleadings by vendors and purchasers regarding the dangers of the devices [3]; 'certification' standards that ignore safety [4], and other cavalier practices), and this tragic story below:

Swimming pool maker pleads guilty to criminally negligent homicide

Source: Claims Journal "Pool Company Admits Guilt in Connecticut Boy's Drowning" John Christoffersen, April 15, 2011

After the tragic drowning of a 6-year-old Connecticut boy in 2007, his parents have brought a lawsuit against the swimming pool company. The lawsuit against Shoreline Pools detailed statistics of pool entrapment deaths and injuries caused by unsafe drains. It presented nationwide evidence that more than 150 adults and children have been seriously hurt or killed in fatal accidents from the lack of automatic pool pump shutdown devices since 1985.

[FDA is well aware of deaths and injuries caused by health IT products, and they admit their data is likely just the 'tip of the iceberg.' See Internal FDA memorandum on HIT risks to Jeffrey Shuren MD JD, Director, Center for Devices and Radiological Health - ed.]

In a court case involving product liability, a designer or manufacturer is held accountable for product safety [except in the deliberately-unregulated health IT sector, that may employ Joint Commission Safety Standard-violating 'gag' and 'hold harmless' contract clauses as well - ed.] and may be separately liable for civil damages when a product is linked to wrongful deaths.

One industry expert speculated that some swimming pool companies may not have been installing the drain safety device on purpose, hoping that the requirements of the state code would be overturned by industry pressure. [That is, regulatory influence and capture - ed.]

Criminal Consequences

The swimming pool company and its president have pleaded guilty to charges relating to the wrongful death of a Connecticut boy who drowned when his arm became trapped in a pool drain. Shoreline Pools and its president admitted guilt for failing to install a required safety device that would have detected a blockage and shut down the drain pump, preventing the boy's death.

Shoreline Pools will pay $150,000 to purchase swimming pool safety ads as part of its court agreement and guilty plea to second-degree manslaughter. A manslaughter charge against the company president was plea-bargained down to criminally negligent homicide [in effect, it probably was second degree manslaughter, but got reduced as a result of court process - ed.], a misdemeanor carrying less consequential weight. The pool company executive, escaping jail time, has been ordered to perform 500 hours of community service and bring 100 swimming pools up to legal safety standards.

At trial, the swimming pool company president said he was not aware of a 2004 state law that mandated the drain safety device [he and the company knew, should have known, or should have made it their business to know, just as health IT companies know, should have known, or should make it their business to know about the toxic effects of their products - ed.] but prosecutors were able to show that the law and the device were both well promoted at trade shows and in safety awareness campaigns among pool manufacturers, even as soon as two full years before the boy's drowning. [Admonitions about heath IT safety risks have been available for far longer - ed.]

Judgments of criminally negligent homicide or manslaughter against the designers and purchasers of clinical IT, and health IT and hospital executives, would go a long way to improving health IT safety.

Such judgments would likely go far further than the typical "community building workshops" and other selective-attendance, "consensus" government committee meetings now underway.

This seems an area wide open for tort actions.

-- SS

[1] Internal FDA memorandum on HIT risks to Jeffrey Shuren MD JD (Director, Center for Devices and Radiological Health). "Not Intended for Public Use." Feb. 23, 2010. (My description/commentary on the memorandum is at this link).

[2] Statements of Jeffrey Shuren, Director, CRDH, Feb. 25, 2010, HHS - Health Information Technology (HIT) Policy Committee Adoption/Certification Workgroup, http://www.emrupdate.com/forums/t/27502.aspx

[3] Statements of Barry Chaiken, MD, MPH, FHIMSS, former Chairman of the Board of health IT trade group HIMSS, see http://hcrenewal.blogspot.com/2010/07/barry-chaiken-md-mph-lets-be-patient.html

[4] Hoffman, Sharona and Podgurski, Andy, Meaningful Use and Certification of Health Information Technology: What About Safety? (October 25, 2010). Journal of Law, Medicine and Ethics; Case Legal Studies Research Paper No. 2010-34. Available at SSRN: http://ssrn.com/abstract=1697587

-- Originally posted at Healthcare Renewal http://hcrenewal.blogspot.com by S. Silverstein, MD

Making a Stat Less Significant: Common Sense on "Side Effects" Lacking in Healthcare IT Sector

At my Mar. 27, 2011 post "Those Who Dismiss Healthcare (and Healthcare IT) Adverse Events Reports as Mere "Anecdotes" Have Lost - Supreme Court-Style" I wrote that the SCOTUS decided in MATRIXX INITIATIVES, INC., ET AL. v. SIRACUSANO ET AL. (link to PDF) that:

... We conclude that the materiality of adverse event reports cannot be reduced to a bright-line rule ... Because adverse reports can take many forms, assessing their materiality is a fact-specific inquiry, requiring consideration of their source, content, and context.

Wall Street Journal author and "Numbers Guy" Carl Bialik adds to that point in an article today "Making a Stat Less Significant" where he writes:

To determine whether a medical side effect is significant in an experiment requires knowing that every incidence of that side effect is being reported. Researchers can feel confident that is happening in a controlled clinical trial of a drug, but they can't be sure when a drug is being sold to the general public, as was the case with Zicam.

In other words, when one is not sure that every incident of a side effect is being reported, one should not cavalierly dismiss "anecdotal" reports of side effects, especially from reliable reporters.

The practictioners of Medical Informatics, along with the HIT Industry and its customers, appear to have failed in that regard with respect to clinical IT (electronic medical records, CPOE etc.) For years they have argued that these medical devices should not be regulated because that would "stifle innovation" and that reports of device adverse events were "anecdotal." Many in the field still make these arguments.

This view extends all the way up to the Director of the Office of the National Coordinator for Health IT, who glibly stated per the Aug. 2010 Huffington Post Investigative Fund article FDA, Obama Digital Medical Records Team at Odds over Safety Oversight that FDA's own reports of health IT related injuries and deaths were “anecdotal":

ONC director Blumenthal, the point man for the administration, has called the FDA’s injury findings “anecdotal and fragmentary.” He told the Investigative Fund that he believed nothing in the report indicated a need for regulation.

Those "injury findings" appear in an FDA Internal Memo made available by the aforementioned Huffington Post Investigative Fund and archived at the following link:

Internal FDA memorandum on HIT risks (PDF) to Jeffrey Shuren MD JD (Director, Center for Devices and Radiological Health). Health Information Technology (H-IT) Safety Issues. "This is an Internal Document Not Intended for Public Use." Feb. 23, 2010.

(My description/summary of the memorandum is at my Aug. 2010 post "Internal FDA memorandum of Feb. 23, 2010 to Jeffrey Shuren on HIT risks. Smoking gun?")

That memorandum itself emphasizes how FDA's own knowledge of these events is partial due to reporting impediments and lack of knowledge of resources such as FDA's MAUDE database.

The known reports were likely "the tip of the iceberg" according to the Director of FDA’s Center for Devices and Radiological Health (CDRH) Jeffrey Shuren, MD, who also happens to be a lawyer.

As at the aforementioned "tip of the iceberg" link, at an HHS meeting of the HIT Policy Committee's Adoption/Certification Workgroup on February 25, 2010, Shuren testified:

... In the past two years, we have received 260 reports of HIT-related malfunctions with the potential for patient harm – including 44 reported injuries and 6 reported deaths. Because these reports are purely voluntary, they may represent only the tip of the iceberg in terms of the HIT-related problems that exist.

Even within this limited sample, several serious safety concerns have come to light. The reported adverse events have largely fallen into four major categories: (1) errors of commission, such as accessing the wrong patient’s record or overwriting one patient’s information with another’s; (2) errors of omission or transmission, such as the loss or corruption of vital patient data; (3) errors in data analysis, including medication dosing errors of several orders of magnitude; and (4) incompatibility between multi-vendor software applications and systems, which can lead to any of the above.

The problem with ignoring testimony and reports of health IT-related difficulties and dismissing them as "anecdotal" goes back to the issue of "knowing that every incidence of that side effect is being reported."

While FDA itself admits significant doubt about completeness of reporting in its memo, what's worse is that Koppel and Kreda at University of Pennsylvania wrote a paper from which one might conclude that the healthcare and health IT industries are themselves aligned to conceal health IT adverse events reports.

In their remarkable article Health Care Information Technology Vendors' "Hold Harmless" Clause - Implications for Patients and Clinicians, Journal of the American Medical Association, 2009;301(12):1276-1278, we learn that there is little motivation for device safety in the health IT industry:

Healthcare information technology (HIT) vendors enjoy a contractual and legal structure that renders them virtually liability-free—“held harmless” is the term-of-art—even when their proprietary products may be implicated in adverse events involving patients. This contractual and legal device shifts liability and remedial burdens to physicians, nurses, hospitals, and clinics, even when these HIT users are strictly following vendor instructions...HIT vendors are not responsible for errors their systems introduce in patient treatment because physicians, nurses, pharmacists, and healthcare technicians should be able to identify—and correct—any errors generated by software faults. [In other words, they are expected to be clairvoyant when presented with erroneous or missing data - ed.]

We additionally learn that:

The significant disparity between buyers and sellers in knowledge and resources [about healthcare IT problems] is profound and consequential. Vendors retain company confidential knowledge about designs, faults, software-operations, and glitches. Their counsel have crafted contractual terms that absolve them of liability and other punitive strictures while compelling users’ non-disclosure of their systems’ problematic, or even disastrous, software faults.

In other words, health IT customers and users have a gag order imposed on them regarding software faults and defects.

I think any reasonable person would conclude there is great doubt as to whether "every incidence of [HIT side effects] is being reported."

I also pointed out in JAMA (link) and on my Drexel website (link) how agreeing to these terms caused hospital executives to violate both their fiduciary duties to their organization's workers as well as Joint Commission safety standards obligations.

(I've personally reported health IT defects I'd observed in hospitals where my relatives were patients to FDA's MAUDE database, discovering that the institution itself, whose officials I alerted to the problems, did not. An example is here.)

The above is all common sense.

Thus, the dismissal of reports of health IT-related patient injury, deaths, and "near misses" represents a failure of common sense, as well as a massive abrogation of fiduciary responsibilities and legal and ethical obligations among the Medical Informatics, health IT vendor, healthcare delivery, and healthcare regulatory sectors.

One end result is that it permits software like this to be mandated by state governments on hundreds of hospitals. One can only imagine the public, press and legal reactions if mission-critical software issues of this magnitude were brought forth after an aviation or nuclear power plant disaster.

The cavalier dismissals of HIT mishap reports clearly fall into the "knew, or should have known" category of negligence.

Plaintiff attorneys for patients injured or killed via HIT-related mishaps should take note.

-- SS

Note: my WSJ comment on this issue appears here.

Thanks to the wonders of EHR, this premature baby went to the grave, prematurely

Thanks to the distractions of EHR and the wonders of EHR auto entry, cut and paste etc., this premature baby went to the grave, prematurely:

Failures in care alleged after premature birth - $1,000,000 Settlement

By Virginia Lawyers Weekly
Published: October 18, 2010

Tags: Fairfax County Circuit Court, Medical Malpractice, Million-Dollar Settlements

Decedent and his twin sister were born healthy at 27 weeks gestation. Decedent was placed in the neonatal intensive care unit. Six days after birth, a peripherally inserted central catheter (PICC) was inserted into the right axilla and used to infuse nutrition, medication, blood products and lipids.

Within 48 hours, the PICC insertion site began to show evidence of compromise. The attending physician gave a verbal order to monitor the arm, but the order was never reduced to writing and no monitoring of the site was thereafter documented in the chart. Indeed, a comparison of the IV site care notes with the nursing notes revealed the use of an automated entry feature, confirmed by the defendants in discovery, which permitted the nursing staff to simply re-enter prior descriptions of a patient’s condition.

[Transforming medicine, one thunderous mouse click at a time, as expressed by the former HHS secretary. As at this link on EHR risks re: copy and paste, "Another pitfall seen in litigation is the situation of an incorrect history or physical finding that is documented repeatedly in the medical record. This frequently occurs in the in-patient setting but can occur in the outpatient setting as well." - ed.]

As a result, the nursing notes continued to describe the condition of the affected arm as normal when in fact it was continuing to visibly deteriorate. Thereafter, despite swelling and seepage at the PICC insertion site and discoloration of the hand, the PICC was not removed for an additional 48 hours. The decedent was flown to another facility where the right arm was amputated after becoming necrotic and gangrenous. The infant died after 36 days of life. Plaintiffs sued the nurses, hospital and neonatal specialists charged with the decedent’s care.

Plaintiffs’ experts were prepared to testify that it was a departure from the standard of care for the physicians and nurses to fail to monitor the PICC insertion site and promptly remove the line when evidence of compromise and vascular damage developed.

[That's a no-brainer. Were these clinicians distracted by EHR clerical data entry duties, I wonder? - ed.]

They would have further testified that these departures caused a cascade of events leading to necrosis of the arm, the onset of gangrene and eventually staph sepsis, which killed the decedent.

The plaintiffs’ wrongful death claim was primarily for loss of solace. The decedent was survived by his parents and three siblings, including his fraternal twin. The decedent’s twin is now a healthy 2-year old who is meeting all normal developmental milestones.

[10-T-153]

Type of Action: Medical malpractice
Injuries Alleged:
Name of case:
Court: Fairfax County Circuit Court
Tried before:
Name of judge/mediator:
Special Damages:
Verdict or Settlement:
Amount: $1,000,000
Date: Sept. 17, 2010

Plaintiffs’ attorneys: Infant death Confidential Mediation Johanna L. Fitzpatrick $584,000 in medical expenses (contested by defendants) Settlement H. Jan Roltsch-Anoll, Woodbridge; Tracy C. Hudson, Manassas

What a tragedy.

-- SS