anesthesia legal brief

Legal Topic: Documentation

Same Song Different Verse – If It Wasn’t Documented…..

Consider for a moment, that you or a colleague is facing legal action that, on the face of things, appears absurd. How absurd? Well, think for a moment about the first time that you learned how to place an intravenous (IV) line. The first thing that you were taught to do (after determining the correct patient, catheter size, and limb selection) was – clean the site. Traditionally we used alcohol either provided in an IV start kit or provided by our facility. How many of us thought about, or consulted the relevant science, regarding which preparation solution was actually better for patient care?

Now lets take it up notch. Consider what you do as an anesthesia provider when you are preparing to place an epidural catheter or a subarachnoid block. Most of the kits that we used in school and current practice have supplied within them a skin cleansing preparation. According to one manufacturer, B. Braun (bbraunusa.com/images/bbraun_usa/bbrauncatalog.pdf; F3), the supplied cleaning preparation in standard single dose epidural trays is povidone iodine. Again, how many of us question the skin preparation solution provided in a kit by a manufacturer that our facility has chosen to select for us? Relevant science indicates that a better skin preparation solution for neuraxial blocks is chlorhexidine. Furthermore, this solution is optimal when used from a single use package, instead of poured from a multi-use container.

What is the importance of such minutiae? Well, suppose a post-partum patient presented to the ER 4 days after discharge from the mother-baby unit of Smallville Community Hospital with the following symptoms: low grade fever, back ache, intermittent weakness of the right lower extremity. During her ER workup, the on call anesthesiologist, Dr. Nurves, is consulted since the patient had an epidural for labor analgesia. After his physical exam, Dr. Nurves suspects the patient has an epidural abscess. He orders an MRI that confirms his suspicions. Now fast forward 18 months. The patient decides to file a claim against her anesthesia providers for causing the pain and disability from which she now suffers. She suspects her current problems are from the epidural abscess…….

When an attorney is tasked to evaluate this type of claim, the attorney will seek a healthcare professional who is familiar with the standards of care surrounding the activities related the client’s labor epidural for analgesia. Imagine the professional conundrum provided by the following clause on the anesthesia record “Sterile prep and drape” without further elaboration. Would it make any difference if we added another detail: the epidural was placed by a trainee (either physician or nurse) and the use of the trainee was NOT noted on the anesthesia record. Additionally, the patient, and her spouse, recalls multiple attempts at placing the epidural; this is also not noted on the chart. So how does one determine if standards of customary practice were met in such a situation? The use of the trainee, and the multiple attempts at placing the epidural catheter are not documented in the records. These items are not facts in evidence. It is a fact however, that if cultures are obtained from an epidural abscess with bacterium that are not normally found in the epidural space, AND the patient’s physical exam prior to the placement of the epidural does not specifically indicate a bacterial infection in the area where the epidural catheter was to be placed AND (perhaps most importantly to us) the modality for transmission of bacterium into the epidural space is under the exclusive control of the anesthesia provider, then supporting data can be introduced to create a scenario whereby the anesthesia providers who placed the epidural catheter caused the epidural abscess AND the related sequela. What type of supporting data? Standards of care regarding neuraxial blockade; sterile skin preparation; and care documentation. Documents of professional standards, along with several peer- reviewed clinical reports regarding sterile skin preparation are readily available in any medical library (electronic or traditional) or via the world wide web.

A well researched review providing the who, what, when, where, and why of how we are supposed to practice our craft can speak volumes to a trier of fact (a judge or a jury) as to whether or not a patient’s claim has merit. So what is the take home message: Know and adhere to your professional standards of care (review them if necessary) and keep up with the state of your science.

Pamela Chambers, MSN, CRNA, EJD
www.lexterraeconsulting.com

References
Barash, P.G., Cullen, B.F., & Stoelting, R.K. Clinical Anesthesia 3rd Ed. Ch 26 Epidual and Spinal Anesthesia p 651 Lippincott Raven, New York 1997

Birnbach D.J. et al, Povidone Iodine and skin disinfection before initiation of epidural anesthesia. Anesthesiology. 1998; 88:668-672

Nagelhout, J. J., Zaglaniczny, K.L. Nurse Anesthesia 3rd Ed. Ch 44 Obstetric Anesthesia p 1066 Elsevier Saunders, St. Louis 2005

Stoelting, R. K., Miller, R.D. Basics of Anesthesia 3rd Ed., Ch. 12 Spinal and Epidural Anesthesia p 173, Churchill Livingstone, New York. 1994

Pamela Chambers, MSN, CRNA, EJD
www.lexterraeconsulting.com

Clinical Topic: Defenses to Negligence

In earlier articles, I discussed some basics about medical malpractice. Now I want to briefly review some defenses to negligence. Keep in mind that all negligence claims are not credible; and even if a credible claim exists, there are many avenues to resolution. If the required elements of negligence are present and cannot be contested, defenses to negligence may be considered.

One method for mounting a defense to medical malpractice is to assert that the plaintiff caused their own injury, and because of the plaintiff’s action the defendant should not be held liable for the injury. A jurisdiction that recognizes contributory negligence would bar recovery by the plaintiff if the plaintiff is found to have contributed to the cause of his injury. A jurisdiction that recognizes comparative negligence (of the plaintiff) would decrease any award for a plaintiff’s claim based on the amount of fault the court determines the plaintiff contributed to the injury. Additionally, if the defense can establish the plaintiff knew the risks involved in an activity and voluntarily performed the activity, then assumption of the risk might be the appropriate defense to relive the defendant of liability. Adherence to these theories is ascertained by reviewing relevant case law in the applicable jurisdiction, and review of relevant statutes in the applicable jurisdiction.

Consider this example: Priscilla Patient arrives at Sunshine Valley Ambulatory Surgical Center (ASC) for a laproscopic appendectomy. After completing and signing all of the required forms in the admitting office, Priscilla is led to the dressing room to disrobe and to change into her gown for surgery. Priscilla disrobes leaving only her underwear remaining under the gown. As Priscilla gathers her belonging and opens the door to exit the changing room, Priscilla’s right great toe makes contact with the door of the dressing room. The contact doesn’t initially bother her so she doesn’t tell anyone about it. The next day, during the follow-up post-operative call, when asked if she has any questions or concerns about her procedure the prior day, Priscilla states, “My surgery went fine, but my right big toe is really hurting where the door hit it. Now it’s swollen and really hot.”

This example is hypothetical. However, at this point many options can occur. If Priscilla decides to sue the ASC for her injured toe, all of the required steps (such as fact gathering and determining if the claim is credible) will begin to be pursued by her legal team. In a claim of negligence against the Sunshine Valley ASC, if a defense to negligence for a claim like this were considered, it is reasonable to suggest that Priscilla had something to do with the injury that she now has because she didn’t tell anyone about it when it occurred. If a court believed that proposition, any award to which Priscilla may have been entitled to would be either barred in a contributory negligence jurisdiction, or reduced in a comparative negligence jurisdiction. If the defense can establish that Priscilla chose to exit the dressing room without foot coverings, knew she was injured before she had surgery, and before she left the facility, and she chose not to inform medical personnel who were readily able to assess and treat any injury if any were present, then assumption of the risk might be the choice to rebut Priscilla’s claim of injury to her toe. The legal team will evaluate the facts of the case and apply the law as indicated.

Pamela Chambers, MSN, CRNA, EJD

About the author: Pamela Chambers is a staff CRNA a Central Texas regional trauma center and the affiliated Children’s hospital. Ms Chambers received her MSN in 2000 while on active duty in the U.S. Army; then received her Executive Juris Doctor (EJD) in Health Law in 2008 from Concord Law School. Ms. Chambers owns Lex Terrae Consulting a health law research and consulting firm and also teaches Legal Nurse Consulting for Kaplan University. Ms. Chambers is not an attorney. The information provided is legal research and should not replace consultation with an attorney or physician when warranted. Click here to learn more about Lex Terrae Legal consulting services.

The Sticky Situation of Adhesion

Submitted by Pamela Chambers, MSN, CRNA, EJD

Click here for Lex Terrae consulting

Two years ago, Joe Sixpack was admitted to your facility to undergo vasectomy. His clinical course in your fine medical center was uneventful. Today, you are seated in the office of the facility mediator and all relevant parties are present: Joe Sixpack, Mrs. Sixpack, little baby Sixpack who will celebrate his first birthday next week, and everyone involved in the clinical care of Mr. Sixpack on that fateful day 2 years ago.

Before beginning the mediation process, the facility’s attorney presents the admitting forms that Joe signed upon arrival to the facility and prior to receiving any sedation for his procedure. One of the forms, a two sided form, contains an explanation of the procedure that Joe has requested on side one, along with the risks, benefits, and options of the procedure and several blank lines at the bottom of the form in case Joe wanted to add anything to the form. Side two of that same form contains the following statement “I hereby release Smallville Medical Center and it’s employees and contractors, from all liability arising from any injury to me resulting from my requested therapeutic procedure to be performed by Dr. Kuttemup and his staff at Smallville Medical Center.” Immediately after this paragraph is Joe’s signature with the date and time the form was signed.

When a healthcare provider has this type of statement in a contract for services for the express purpose of limiting liability relating to the provision of those services, this is termed an exculpatory clause. When this type of clause is a condition to obtaining the requested service this creates a contract of adhesion. While most courts attempt to enforce contracts by trying figure out what the parties intended when the contract was written; courts often find contracts of adhesion unenforceable as a matter of public policy (Weaver v. American Oil Co., 257 Ind. 458, 276 N.E.2d 144 (1971).

The contract to provide health care services is not usually between 2 similarly situated (i.e. equally knowledgeable) parties. If a contract is deemed grossly unfair to one party it will usually be held unenforceable in court. Consider the following release from Olson v. Molzen (558 S.W. 2d 429, Tenn., 1977) “…I therefore release Dr. Molzen and his staff from responsibility associated with any complications that may come up or be apparent in the next 12 months…” The court in this case found the exculpatory clause particularly distasteful because an individual in such a profession, a physician, should not be permitted to hide behind such a shield as a license to commit professional negligence.

Regarding all contracts, there lies a duty to read. This is small comfort to a plaintiff but a court will evaluate the parties intent to contract by evaluating the terms of the contract. Terms that appears grossly unfair (i.e. unconscionable), violate public policy (i.e. one cannot receive the healthcare service with out agreeing to the term), or lack true assent will likely lead to a ruling that the contract is unenforceable.

Strictly Speaking

Most of us take comfort in the fact that each day that we come to work to serve our patients, we intend to perform at our very highest caliber. We hope that our stellar reputations will shield us from liability if anything unplanned should occur and injury befalls a patient. Well, strictly speaking – this just isn’t the case.

Strict liability is a theory in which fault can be determined regardless of intent or even knowledge of wrongdoing.

Strict liability can apply to crimes or torts. An example of a strict liability crime is the act of serving alcohol to minors. Strict liability in tort is generally focused on objects (not actors) that cause harm (i.e. strict products liability).

To prevail in a cause of action based on strict products liability (SPL), the plaintiff must prove: 1) the product was defective, 2) it was defective when it left the defendants hands, and 3) the defect was the proximate cause of the harm suffered. It is also necessary that the product be expected to and does reach the consumer without substantial change from it’s condition when sold. Liability will attach if a product is sold in a defective condition and the defect causes a foreseeable user of the product to suffer personal injury as a result; any party involved in the commercial supply of that product will be held strictly liable for the injury. Mandatory considerations in a SPL cause of action include: 1) proper plaintiff (any user or consumer), 2) proper defendant (any entity in the marketing chain, not occasional or used dealers), 3) proper context (personal or property harm not harm to the product), 4) defect type (manufacturing, design, or warning), 5) cause in fact (“but for” the defect the plaintiff would not have been injured), 6) proximate cause (the harm was reasonably foreseeable from the defect; no superceding conduct present – like misuse or alteration of the product), and 7) actual harm. A product is considered “defective” if based on it’s design, manufacturing, or lack of adequate warning it constitutes a danger to the average consumer that is greater than the social utility of the product.

So you may be thinking, you are safe from this type of liability because you NEVER intend to harm any of your patients or use any defective equipment. But what if a patient has an injury after surgery that they did not have before surgery, and the injury is such that they could not have contributed to its occurrence and last, but not least, the injury stems from a modality that was under your (the anesthesia provider) exclusive control……Res Ipsa Loquitur – The thing speaks for itself.

Pamela Chambers, MSN, EJD

Evidence Spoilage

Submitted by Pamela Chambers, CRNA, MSN, EJD

As we continually strive to provide the highest level of patient care to the guests in our facility, we cannot help but learn from the mistakes of others. In an article published in the Dallas Morning News regarding the CMS findings at Parkland Hospital, one issue (of many) struck me as something many of us may not think about on a daily basis as we provide patient care. Document preservation, a.k.a. evidence preservation.

As electronic medical records, storage, and retrieval becomes the norm across the nation, all healthcare providers must be vigilant to not only document the care that is provided – but also produce any records about that care that are requested pursuant to any legal action in a timely manner. Unreasonable (re: any) delay in production of records can have harsh adverse consequences.

SPOLIATION: the intentional destruction, mutilation, alteration, or concealment of evidence… If proven, spoliation may be used to establish that the evidence was unfavorable to the party responsible. (Black’s Law Dictionary, 8th Ed.)

While discovery is the process of collecting information to support the allegations and to otherwise build a case; Electronic discovery (E-discovery) is the collection, preparation, review, distribution, and production of electronic documents in litigation discovery. Electronic discovery includes files stored on office CPUs, laptops, network servers, Personal Digital Assistants (PDAs),CDROMs, DVD-ROMs, MP3 players, smart cell phones, backup tapes, flash memory cards and devices, other archive media, and third party storage systems. Also, voice mails become digital evidence, as collectable as e-mail. All of this digital content can become an important part of litigation.

During 2003 and 2004, United States District Court Judge Shira A. Scheindlin issued five groundbreaking opinions in the case of Zubulake vs UBS Warburg LLC. Zubulake involved a typical employee discrimination claim, alleging gender discrimination and retaliation. The defendant produced approximately 100 pages of e-mails pursuant to the plaintiff’s request for production of all relevant documents but failed to search its backup tapes for e-mails that may have been deleted or stored elsewhere. Since the plaintiff had saved more than 400 e-mails herself, she knew the defendant did not produce all relevant information. Zubulake’s attorney was permitted to argue to the jury that the defendant intentionally destroyed incriminating documents. Ultimately, the court found that the defendant had deleted emails, lost backup tapes, and failed to diligently and thoroughly produce all its relevant files.

The court penalized the defendant by allowing an “adverse inference” instruction to the jury, noting that the jury could assume that the missing documents contained information adverse to the defendant’s case. In the end, the plaintiff was awarded more than $29 million in damages.

A party to litigation, or to litigation that is reasonably foreseeable, has a duty to preserve evidence in its possession or control that may be relevant. Adequate preservation of electronic stored information (ESI) requires more than simply refraining from efforts to destroy or dispose of such evidence. The party must immediately intervene to prevent loss due to routine operations or malfeasance. If a party destroys evidence in its custody or control, it can be subject to sanctions that range from an assessment of costs and fees to suppression of evidence, an adverse jury instruction, or even dismissal of the case.

Food for thought…….

Promises, Promises

Submitted by Pamela Chambers, CRNA, MSN, EJD

A guy walks into a bar… he says to the guy next to him, “My laryngoscope is bigger than your laryngoscope”. Unbeknownst to guy #1, guy #2 was a surgeon and was offended to be mistaken for an anesthetist. So guy #2, Dr. Alice, punches guy #1, Dr. Guedel, in the jaw.

Now Dr. Alice has an injured and deformed right hand. He goes to see his friend Dr. Adson – the plastic surgeon. Dr. Adson observes how distraught Dr. Alice is and tells him he can indeed fix his injured hand. Dr Adson tells Dr. Alice that he can give him a good hand so that he can return to surgery.

During the procedure, Dr. Adson realizes he must apply a skin graft to effectively correct Dr. Alice’s injured hand. The operative consent gives Dr. Adson permission to use a skin graft if necessary during the procedure. Dr. Adson obtains skin from Dr. Alices’s chest for use in the skin graft.

Days later, Dr. Alice returns to see Dr. Adson for a follow-up visit and to have his bandages removed. Both doctors observe hair growing from the grafted skin that now is growing on Dr. Alice’s right hand. Dr. Alice is distraught and decides to sue Dr. Adson. But under what theory? If a malpractice suit is filed, Dr. Adson would have to establish negligence and all of the required elements necessary to sustain such a theory. Additionally, expert witness testimony would be needed to establish standard of care and the deviation from it if present.

Dr. Alice sued Dr. Adson for breach of contract. Dr. Adson promised Dr. Alice “a good hand”, presumably that meant a hand free of hair. Does this sound absurd? Well a contract claim can be more advantageous in some circumstances over a malpractice claim. Why? Because, the remedy that is awarded in a contract claim is the difference between what was promised in the contract and what is present. There is no question of wrongdoing, no questions of standards of care, and no pesky expert witness. When there exists a dispute as to the terms of a contract, courts try to interpret contracts based what the parties intended at the time of the agreement. In Guilmet vs. Campbell, 385 Mich.57. 188 N.W.2d 601 (1971), a jury found for the plaintiff under a breach of contract theory. In this case the surgeon promised a particular result. The patient suffered severe postoperative after-effects – which were very different from the promise of “it’s a very simple operation… you’ll be out of work 3-4 weeks at most”.

As with all areas of jurisprudence, the measure of damages in a breach of contract suit can be computed various ways. Expectancy damages would be some amount that would place the plaintiff in the position that he would have had if the contract had been performed as promised. Whereas restitution damages would be an amount equivalent to the benefit conferred upon the defendant by breaching the contract. In Sullivan vs. O’Connor, 363 Mass.579, 296 N.E2d 183 (1973) the court decided to compute damages using an intermediate method – reliance damages. In Sullivan, the plaintiff recovered expenditures and costs that he bore as a result of the defendant’s breach of their contract.

Who said the only contracts in the hospital were the ones in administration??