Holland & Hart Healthcare Law Blog

THE “AVIATION” MODEL IN HEALTHCARE AND AIR FRANCE FLIGHT 447

 In the 1980s the Commercial Aviation Safety Team (“CAST”) determined that eighty five percent of aviation accidents and fifty two percent  of all fatal aviation accidents were the result of cognitive error by pilots. CAST pushed for the use of systems, checklists and foolproof communication systems to reduce the human element in aviation. The result was a fifty percent decrease in aviation accidents. The success of the systems method in aviation led healthcare safety advocates to campaign for the application of the systems model to tamp down the impact of human frailty on adverse healthcare outcomes. The systems model is now a fact of life in high risk medical procedure, pharmaceutical administration and other healthcare delivery modalities.

 You can see it in the operating room when a nurse paints a sign “the other leg” on your healthy limb or where two nurses must sign off on a prescribed medication. The interest in the systems application to quality improvement continues unabated. See Kahn, et al. , “To Err Is Human: Building A Safer Healthcare System.” National Academy  Press. Washington, D.C. (2000); Stripe, et al. “Aviation Model Cognitive Risk Factors applied To Medical Malpractice Cases.” (JABFM.org.);Inglehart & Fleming, “New Patient Safety Uses Aviation System Model.” Health Affairs Blog, April 13, 2009.

 Since the 1980s and the onset of the digital age the aviation model morphed into a much more pervasive systems intervention through the surge in computer driven maintenance and operational applications, not unlike parallel developments in healthcare. The crash of Air France Flight 447 A330 Airbus over the Atlantic Ocean on May 31, 2009 thrust to the fore two separate, but related computer systems driving  both airplanes and healthcare, albeit to differing degrees. The Airbus utilized the Aircraft Communication Addressing and Reporting System (“ACARS”). The onboard computers sent ten automatic maintenance messages to Paris indicating failures in the plane’s electrical systems and decompression of air in the plane’s fuselage.

 The current proliferation of medical devices with direct internet monitoring and reporting capacity provide the potential and fact of real time reporting of human body systemic failure to medical record repositories. The healthcare mimicry of aircraft maintenance information technology is upon us and we will likely embrace the use of “wearable” computers with growing fervor in the future.

Despite the apparent differences between healthcare and aviation, the information exchange paradigm used to insure quality in the aviation industry can be implemented to reduce the impact of the aforementioned system errors in health care delivery system (sic).

Martin, Lance, “Reducing Medical Errors Using an Aircraft Maintenance Information Technology (IT) System Model,” Dartmouth undergraduate Journal of Science. Dujs.dartmouth.edu/2004s/healthcareit.pdf.

 Despite Mr. Martin’s optimism and enthusiasm there appears to two principal kinks in both the aviation and healthcare systems that need to be addressed. The first relates to the information systems. There is no question that computer monitoring systems can generate a great deal of useful data. The critical question is how to sort and present the data in a format and application that can realistically serve the needs of pilots and practitioners. There needs to be assurance that the data is correct and not affected by defective “pitot tubes” or other malfunctions and a means to sift and prioritize mountains of data so as to provide real time, meaningful input to those sitting at the controls.

 The second concern relates to the ultimate control of the mission. The Airbus A330 contains the latest in fly-by-wire technology that substantially limits the operational control of the aircraft by the pilots. This is an exclusively electric system, without manual or hydraulic features. There is a debate ensuing in the blogosphere as to the degree of control, if any can be wrested from the computers by Airbus pilots in the event of an emergency. (Think of HAL in 2010:A Space Odyssey. That would be next year.)  The issue is at what point should human beings be able to reassert control from computer systems, particularly where onboard computers are juggling conflicting information from various sensors?

 Did the computers aboard Flight 447 malfunction causing a crash or did a last ditch effort by the pilots to regain control interfere with the failsafe functioning the planes systems? Was it a combination of both or an unremediable "act of God?" We may never know the answer.

Remember, more often than not, an airliner goes down at the end of a long chain of unrelated, seemingly innocuous decisions, malfunctions, mistakes and external factors. Remove any single link (or even change their sequence) and you have an on time arrival. Miles O’Brien Uplinks, June 19, 2009. trueslant.com/milesobrien/2009/06/10the-paradox-of-simplicity/.

 In the future computer systems will have an ever increasing role in healthcare decision making and treatment as the incorporation of artificial intelligence applications into electronic medical records provides a whole new platform and paradigm for healthcare delivery. The healthcare industry will eventually face the conundrum of when and under what circumstances a physician will need to regain control over the treatment process. The crash landing of U.S. Airways Flight 1549 in the Hudson River earlier this year underscores some legitimate concerns to keep in mind. That crash also involved an Airbus with a similar air flight control system, which may have unnecessarily shut down the plane’s engines after the bird strike, causing the plane to lose all thrust. There may come a time when we need a doctor with the nerve, experience and professionalism of a Chesley B. “Sully” Sullenberger, III to seize the controls and manage a life threatening emergency.

Failed Abortion Leads To Viable Claim For Wrongful Birth of Healthy Child.

 In Dotson V. Bernstein, P.C., M.D., (Colo. App. , No. 08CA 0020 2009), the Colorado Court of Appeals reversed a non-suit granted by the District Court, to hold that Dionne Dotson had stated an actionable claim for negligence and damages against Dr. Dell L. Bernstein for the wrongful birth of a healthy child. as the result of a failed abortion. The court, while recognizing that the child would not have a claim for wrongful life, no matter how impaired or imperfect it might be, determined that the parent had a judiciable claim for foreseeable damages including medical expenses, pain and suffering and the medical complications resulting from the delivery.

Colorado Appeals Court finds Physician can be vicariously responsible for negligence of covering physician.

In Hall v. Frankel,, M.D. and Hall v. Robinson, M.D. et al, 05 CA 2696 and O6CA1774, the Colorado Court of Appeals found that a Physician can be vicariously liable for he negligence of a covering physician. Walter G. Robinson, M.D. performed knee replacement surgery on Dennis Hall on June 4, 2002.  Mr. Hall died of blood clots to his heart and lungs on June 12, 2002.  Dr. Fujisaki, another orthopedic surgeon in Dr. Robinson’s professional corporation “covered” Mr. Hall’s past surgical care between June 6 and June 12, 2002.  The jury found Dr. Robinson individually negligent and also responsible for the negligence of Dr. Fujisaki.

FDA Review to “Pre-Empt” State Pharmaceutical Litigation?

The United States Supreme Court will soon decide whether state tort actions against drug companies will be "pre-empted" by the FDA’s pre-market regulation of new drug products. The case, Wyeth v. Levine, arose out of a Vermont action by a musician, Diane Levine, who was injected with Wyeth’s anti-nausea drug, Phenergan during hospital treatment for migraine headaches. The drug was mistakenly injected into Ms. Levine’s artery resulting in the necessary amputation of her right arm. Many observers believe the Supreme Court will follow the logic of its recent decision in Riegel v. Medtronic, to pre-empt state law tort actions against drug companies where the drug has received FDA approval.

The FDA does not itself test new drugs, but rather relies on reported results of pre-market studies performed by the drug companies themselves. It may not surprise anybody to learn that these self-reports are not always complete and candid. Further, an overextended and underfunded FDA is not always on top of its game in investigating weaknesses in the studies presented to it.

NEGLIGENT DISCHARGE?

The  Indiana Court of Appeals, in McSwane v. Bloomington Hospital and Healthcare System, Ind. App. ct.,No 53A04-075-cv-243 (March 12, 2008) reversed a summary judgment granted in favor of Bloomington Hospital in a claim, that the hospital negligently discharged Malia Vandenneede into the custody of her estranged husband, Monty Vandeneede, following her treatment for apparent martial abuse. The hospital treated Mrs. Vandeneede for laceration puncture wounds and arm and wrist pain
which Mrs. Vandneede herself related to falling off of a horse onto a pile of debris. The plaintiff in the case, Mrs. Ava McSwane, was Mrs. Vandeneede's mother,who advise a hospital nurse that Mr. Vandeneede had beaten his wife with a fireplace poker.

TEXAS & UTAH SPLIT ON EXPERT TESTIMONY REQUIREMENT IN HEALTH CASES.

Two recent cases in Texas and Utah dealing with the requirement of expert testimony in health cases underscore the principal that “law is common sense as amended by the legislature. The Utah Supreme Court in Bowman v. Michael A Kalm, M.D., determined that, while an expert witness is generally required to establish breach of the standard of care and causation of damages because most medical malpractice cases depend upon knowledge of scientific effect of medicine, such requirements do not apply to issues where the factual determination rests upon the common knowledge of the lay jury.
In Bowman, the defendant prescribed sleeping pills to a depressed patient who was known to overuse sleeping pills, which made her drowsy and clumsy.

Supreme Court Pre-empts State Medical Device Litigation.

.  The U.S. Supreme Court issued its long awaited opinion in Riegel v. Medtronic, Inc. ____U.S.___  (2008) as to whether the Medical Device Amendments of 1976 passed by Congress to provide federal oversight for medical devices pre-empted state product liability tort actions. It does. The Plaintiff, Charles Riegel suffered a myocardial infarction in 1996 and underwent a coronary angioplasty. His right coronary artery was diffusely diseased and heavily calcified. When his physician inserted the Evergreen Balloon Catheter into the artery it ruptured and Riegel developed a heart block requiring emergency coronary bypass surgery.  The use of the catheter was contraindicated for the artery according to label warnings and the catheter was over inflated during installation.

Stroke, tPA & Statistical Chance

A healthy dose of fatalism should accompany any patient experiencing the symptoms of stroke when presenting at an emergency room for treatment. Assuming the facility is not a stroke center, with enhanced diagnosis resources and treatment options for combating the effects of ischemic stroke, one’s prospects for full or partial recovery could well depend upon the confidence in and willingness of the E.R. physician to administer tissue plasminogen activator or "tPA," a thrombolytic agent, capable of recanalizing a passage through an arterial clot in the brain tissue.

Although the use of tPA is recommended by the American Heart Association as a first line treatment for ischemic stroke the use of the drug is controversial because of significant risk of inducing intracranial hemorrhage and other organic damage in a small but significant number of patients.

LORD OF THE FLEAS: DOCTOR’S BLOG AIDS MALPRACTICE CLAIM

In one of the most curious and self destructing “dares” since Sen. Gary Hart invited the press to follow him, if reporters believed he was “fooling around”, a Massachusetts Pediatrician, Robert P. Lindeman, M.D., who was also a defendant in a medical malpractice case in Suffolk District Court in Boston, blogging anonymously under the nom de guerre, “Flea,” regaled his audience with daily reports of events in his suit, including his meetings with his attorneys, his trial preparation, his deposition, his views of the jury and his opposing counsel, Elizabeth N. Mulvey. Although his blog was anonymous, he went so far to challenge her in his blog, to read about him as he had developed on-line information about her.

If the plaintiff’s lawyer in Flea’s upcoming trial is any good at all, she’s already Googled Flea.  Goodness knows Flea’s Googled her.

FDA DRUG LABELING: A FLOOR OR CEILING ON PHARMACEUTICAL LIABILITY?

In April of 2000, Diane Levine was a professional musician in Vermont when she suffered two amputations, one to her right hand and a second to her right arm, following the IV administration of the Wyeth drug Phenergan at Northeast Washington County Community Health, Inc.  Her doctor administered the drug to treat migraine headaches resulting from nausea.  She received two injections.  The first was by intermuscular injection.  She received the second dose by a direct intravenous injection procedure known as an “IV push.”  This last resulted in the inadvertent injection of Phenergan into an artery.  The artery turned gangrenous and the amputations followed.  Litigation following the amputations resulted in a 6.4 Million Dollar verdict against Wyeth which the Vermont Supreme Court affirmed in 2005. The trial centered on the adequacy of Wyeth’s warnings on the Phenergan label.