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:
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
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
