© Springer Science+Business Media New York 2015
Ninh T. Nguyen, Robin P. Blackstone, John M. Morton, Jaime Ponce and Raul J. Rosenthal (eds.)The ASMBS Textbook of Bariatric Surgery10.1007/978-1-4939-1206-3_4242. Liability Reduction, Patient Safety, and Economic Success in Bariatric Surgery
(1)
Department of Surgery, Einstein Healthcare Network, Einstein Bariatrics, Elkins Park, PA 19027, USA
(2)
Health Care Department, Health Care Litigation and Risk Management Group, Stevens & Lee, 51 South Duke St., Lancaster, PA, USA
Chapter Objectives
1.
To provide an overview of the medicolegal system for the physician
2.
To explain typical proceedings of a bariatric surgery lawsuit
3.
To discuss issues surrounding liability insurance
4.
To discuss strategies for increasing patient safety and reducing risk
Introduction
The medical malpractice system is designed to compensate victims whose injuries are causatively connected to negligence and create a strong incentive for the health-care providers to improve patient safety. From the plaintiff perspective, a medicolegal claim may be the only manner in which to obtain the facts that may have resulted in an adverse event. Defendants served with a claim fear that the case outcomes are arbitrarily decided upon by a lay jury that tends to oversimplify complex decisions and these judgments are based on a paid expert witness. Surgeons who have been served with a claim of malpractice often have terrible feelings of anger, betrayal, guilt, anxiety, and/or frustration, not to mention fear of financial loss. Unfortunately, with an increasing number of years in practice, nearly every bariatric surgeon will eventually have a claim filed against him or her. Sadly, the medical malpractice system is not well designed for one of its potential positive purposes: to improve patient safety. For instance, there is not a reasonable manner to review malpractice claims, suit, or court judgments at any level of the legal system for the analysis of the causes of suits and methods to avoid them.
Physicians are poorly trained in the legal system and do not approach their everyday conversations, documentation, and decision-making by considering the legal implications behind their actions. Furthermore, the medical literature is very complicated, voluminous, sometimes biased, contradictory, incomplete, and often, over time, found to be incorrect. The “standard of care” is a legal, not medical, definition. So how are surgeons managing complex patients supposed to protect themselves against breaching these nebulous “standards?” In addition, nonnegligent claims often occur and may be difficult to prevent. While organized efforts through medical societies should focus on malpractice reform, at an individual level, surgeons can best protect themselves from liability by improving upon their strengths: the delivery of quality care. Efforts to systematize patient safety and the implementation of risk management strategies should decrease the chance of medicolegal claims (and improve patient outcomes).
History of Bariatric Liability
There are no accessible resources, national registries, or databases to analyze specific malpractice claims in the United States. Without the ability to analyze aggregate data, surgeons cannot easily study common causes of medical malpractice ligation and develop patient safety improvements. Nor does there exist a means to measure trends in bariatric surgery litigation. In order for a claim of medical malpractice, the plaintiff must prove that the “standard of care” has been breached. The standard of care can be defined as the care that an ordinary, prudent professional having similar training and experience in good standing in the same or similar community would practice under the same or similar circumstances. For physicians, these standards are difficult to understand. There are no books of standards. “Standards” change quickly and several reasonable care plans may exist for any one patient.
In the early 2000s, spurred by the wide acceptance of laparoscopic bariatric surgery, weight loss surgery volumes surged exponentially. Unfortunately, there was likely a substantial increase in the number of patients experiencing adverse outcomes. Malpractice carriers in some regions began to limit or outright refuse to offer indemnity insurance to bariatric surgeons due to the perceived (or real) claims risk. Health insurance carriers (and even Medicare) were restricting or planning to eliminate coverage from bariatric surgery to their beneficiaries due to the increasing costs—especially costs related to adverse outcomes. An organized and multipronged effort by the bariatric surgery community focused on improved quality and training, outcomes research, and proactive advocacy. This effort averted a potential crisis in bariatric surgery where patients could have been denied access to weight loss surgery both directly by health-care insurers and indirectly by lack of malpractice insurance coverage. Today, there exist some regional difficulties in obtaining malpractice insurance, and costs are still reportedly higher than the average general surgeon. However, most patients have access to surgeries that have been proven to improve quality of life, increase life expectancy, and decrease obesity-related medical conditions.
Overview of Medicolegal System
Types of Claims Asserted
There are several types of claims that can be asserted in bariatric professional liability surgery cases. These include negligence, a lack of informed consent, vicarious liability for your staff, and, in some states, corporate negligence for your corporate entity. Typically, a lawsuit will involve more than one theory and generally includes a claim for negligence in the performance of the procedure or negligence in how one addresses a complication of a procedure, as well as a claim for lack of informed consent. There are also claims available to spouses and family members under loss of consortium theories for the loss of society, comfort, and companionship resulting from the negligent acts. The following is a brief but intense overview of some of the issues relevant to claims of professional liability.
Provider Negligence
To successfully assert a claim for negligence, a plaintiff must prove that the surgeon owed a duty to the patient, that the surgeon breached that duty, that the breach was a cause of the injury, and that there are demonstrable injuries. These four elements are required, except in certain limited circumstances, to be proven at trial through qualified expert testimony. Typically, the first element, existence of a duty, is easily proven and often conceded by the defense. If a patient seeks treatment with the surgeon, a duty to act reasonably has been established.
Standard of Care
The standard of care typically applied is that of a “reasonable man.” This is a legal term of art and often refers to a duty to act consistent with what a reasonably prudent bariatric surgeon would do under the same or similar circumstances. In some areas of the country, there is also a requirement that the standard of care refers to local, rather than national, standards and practices.1
The standard of care almost always needs to be set forth by experts. Experts typically possess the same or similar board certifications and specialty training as the defendant surgeon.2 In some cases, there may be some overlap in specialties that allows a differently credentialed physician to provide testimony against a surgeon for the care the surgeon provides that is not surgery specific (e.g., postoperative pain management, consultation to other service lines). Your counsel should work toward obtaining “true experts,” who not only will have outstanding credentials but also are good communicators and are willing to take the time to help your lawyer prepare the case and take the time to work with your lawyer to be prepared for a deposition or trial. As you will see throughout this chapter, good preparation at all steps and knowledge of the process are a critical success factor.
Causation
Causation refers to a requirement that a plaintiff proves that the alleged breach is the legal cause of the injuries. It is sometimes more difficult to prove direct causation, especially in delay in diagnosis and treatment cases. That is why in many states, there is the “increased risk of harm doctrine” or proportionality standards.3 This means that a plaintiff need not prove that the breach caused in fact the harm but rather can assert that the breach increased the risk of the damage occurring. Once the plaintiff proves this, they have met their burden of proof.
Causation experts take many forms and need not necessarily possess the same or similar board certification and training as the defendant physician. In a case involving an anastomotic leak, causation testimony may be from a gastroenterologist regarding the future prognosis with regard to the loss of bowel due to resection or perhaps from a physiatrist or neurologist with regard to physical status following sepsis/bacteremia. Therefore, even though it is a surgical case, causation opinions are generally tied to the conditions resulting from the alleged negligence.
Damages
The plaintiff must also prove their damages. This can be an emotional part of the case for both sides.
There are two general categories of damages: compensatory and punitive damages. Compensatory damages include economic and noneconomic damages. Economic damages include claims for past and future wage loss and medical expenses. Noneconomic damages include emotional distress and pain and suffering as well as disfigurement. There are claims that can be raised by spouses for loss of consortium, which are typically noneconomic damages for changes to the marital relationship.
Part of the case development of defense on damages may include experts on life expectancy, life care planning (future medical expenses), vocational training, and an economist to evaluate damages and, if appropriate, reduce future damage claims to present value (state dependent). The plaintiff’s attorney will often obtain testimony from the same type of experts and, in addition, may have the plaintiff and family member testify as to how the alleged injury has impacted their lives.
Claims for punitive damages include the allegation that the surgeon acted grossly negligent or recklessly and that harm resulted due to that gross negligence or careless/reckless conduct. It must be conduct beyond regular negligence and so shocking to the jury that the jury finds that there was essentially a willful act. Punitive damages result in discovery of the surgeon’s assets at the appropriate time depending on when the judge orders it to occur. This could be a very intrusive process and one that the surgeon hopes to avoid. Typically assets, depending on state law, that are held jointly by spouses as well as many retirement funds are not subject to attachment to satisfy a judgment. However, practice group accounts receivable and property held by the surgeon individually, or perhaps jointly with a nonspouse (business partnership), are subject to efforts to attach those assets and use them to satisfy a judgment for punitive damages. A claim for punitive damages is alarming and should be taken seriously as in most states it is not an insurable claim.4 Often if there is a claim for punitive damages, the surgeon may want to speak to personal counsel to help him or her guide them on this issue.
Agency Claims
With the increasing use of mid-level providers including nurse practitioners and physicians assistants, bariatric surgeons are now finding themselves liable for the actions or inactions of those mid-level personnel. In states that require direct supervision of mid-levels, there is a direct agency claim, and the bariatric surgeon can be held liable for the negligence of those being supervised. Additionally, even if there is not a direct supervisory responsibility but they operate within the practice, a patient can assert that the surgeon owning the practice is responsible for the actions under an agency theory. In other words, there is liability whether you have to directly supervise them or not. The difference is that a direct supervision claim may expose you to direct liability, whereas employment liability is not a claim for your negligence, but that you are financially responsible for your employees’ negligence.
Corporate Liability
Further, corporate liability continues to be asserted against surgical practice groups around the country. This is typically a claim reserved for hospitals and other entities that control total health care (e.g., surgical centers, specialty hospitals, nursing homes/long-term care), and whether this will be expanded to surgical practices is unclear. As surgical practices grow and develop into centers that care for all aspects of the weight loss journey, there will likely be claims that the center owed a separate duty to the patient to ensure that the providers were properly credentialed and that the medical staff was properly supervised and/or the center failed to adequately supervise or hire staff or even surgeons in the practice. These types of claims may be asserted against a surgeon as an owner of some of the new entities such as an Accountable Care Organization. One goal appears to be to gain discovery of the corporate structures and financial arrangements. This is a new and evolving area of liability but worthy of your consideration.
Informed Consent
A particularly high-risk area for bariatric surgeons remains informed consent. Informed consent is a particularly important process and often is a source of a claim. Informed consent is also an important general risk management tool as it helps to appropriately set expectations at a reasonable level. Typically, patients must be apprised of the material risks, benefits, and alternatives of the procedure being offered.5 Notably, care should be taken to ensure that both a good informed consent form and process is in place. Also, one should identify circumstances in which an interpreter may be required given the large number of patients in certain geographic areas of the country that may not speak English as a first language.6 The hallmark of informed consent is that the information is understood. When the patients understand the risks and alternatives and have had their questions answered, they are now “informed” and can give their consent.
States typically recognize informed consent claims under one of two theories: battery or negligence. In Schloendorff v. N.Y. Hosp., 105 N.E. 92 (N.Y. 1914) (Cardozo, J.), Justice Cardozo recognized that without proper consent, the surgery was an unpermitted touching and therefore constituted battery. More recently, states, including New York, have migrated to a negligence standard, finding that the failure to obtain informed consent constitutes a breach of one of the physician’s duties to the patient.7
Notably, each state has different parameters as to the type of information and the type of procedures that require consent. Typically, an informed consent claim will involve the physician failing to disclose necessary information that a reasonable patient would consider in making his decision to undergo the procedure. There are two tests regularly used regarding the information to be disclosed to the patient:
Once a plaintiff has met the burden regarding the standard of care, they must also show that there is a causal link between the information not provided and the patient’s decision to undergo the procedure. The causation inquiry will be framed either as (1) whether that patient would not have undergone the procedure10 or (2) whether a reasonable patient would not have undergone the procedure?11
From a pragmatic point of view, most often in informed consent cases, a plaintiff at deposition will state that had he or she known a certain risk (always the one at issue!), he or she would not have undergone the procedure. Therefore, it is advisable that the informed consent process utilizes “second-generation informed consent” with procedure-specific forms.12 Additionally, informed consent can be useful in any post-adverse event discussions and/or disclosure with the patient to assist the patient in understanding when a complication occurs, it is just that and not negligence. All surgical procedures have risks, some of which are very serious. The patient needs to be aware of and accept those risks. This is the essence of obtaining an informed consent. A good informed consent form and process can both reduce the potential of a claim in the first place and help to defend one if it was to occur.
Anatomy of a Bariatric Surgery Lawsuit
Pleadings
A claim is started most often by a legal document referred to as a complaint. This is a document that sets forth the allegations against the surgeon as well as the necessary arguments regarding a link between the breach of the standard of care and the harm. There is often a factual section setting forth the facts, as the plaintiff believes they have occurred. There is a trend toward the plaintiff’s attorney almost writing what they think is a compelling story. It is important to remember that this is only the plaintiff’s version of events and is often their best version of the event.
Once this document is received, the surgeon must promptly provide a copy to their professional liability insurer, secure the chart, and await guidance from counsel appointed by the insurer. The surgeon should not discuss the case with anyone—often a difficult task. However, this is important since those conversations would not be protected from discovery, a process discussed later in this chapter. The surgeon will need to review the allegations in a complaint carefully. This can become a very frustrating process. However, it is necessary for the surgeon to review and provide comments to your counsel. You will have knowledge of the facts not available to your counsel. This should be a collaborative process. The response or answer to the complaint is often concise. Rebutting all the factual assertions in detail will occur later in the process. Your lawyer will raise legal defenses, which in some jurisdictions are referred to as affirmative defenses. Many of these must be raised, or they are waived and your counsel will want to be careful and prudent in this regard.
In some cases, your lawyer may file certain legal motions attacking the complaint as being legally deficient. This is a strategic decision better left to your experienced counsel. A few pragmatic comments about counsel: Most professional liability carriers chose counsel carefully. However, if your counsel is not responsive, or appears ill prepared, bring this to the attention of your carrier or your own personal counsel. Your expectations should be high. The experience, talent, and responsiveness of your counsel are other critical success factors. Be demanding!
Discovery
Discovery includes both written discovery and depositions. Written discovery includes interrogatories, request for production of documents, request for expert discovery, and subpoenas to third-party record holders. Interrogatories are often an exhaustive list of questions very detailed in the information sought and require a great deal of effort both on your part and that of your attorney to answer them properly. While well-answered discovery often does not become an issue later at trial, poorly answered discovery can become an issue either at deposition or at trial if certain admissions are inadvertently made. Therefore, it is important that both you and your lawyer review the discovery responses in depth before submitting them to the other side. These are part of the building blocks of the foundation of your defense.
It is also important that you follow your attorney’s direction in terms of what documents you may or may not review prior to your deposition. You may be tempted to conduct medical research to try and refute the claim. However, if you do conduct this medical research, it is likely that you will be asked about it at your deposition, and it becomes something that lengthens your deposition. Again, there may be strategic reasons to do this; however, that will be on a case-by-case basis. Be guided by the instructions of your counsel, which will occur very early in the process.
After written discovery is exchanged by both sides, the parties will engage in depositions. This, together with the selection of experts, is among the most important aspects of the case. This is particularly true as the trial process continues to change from actual jury trials to arbitrations where it may be that your deposition is your only testimony. It is also important in that, to a great extent in many jurisdictions, the experts rely significantly on deposition testimony in formulating their opinions. A deposition is a formal question-and-answer session under oath, and it is imperative that you and your attorney carefully prepare for it. It is recommended that your counsel have an expert evaluation performed prior to your deposition so that you know the broad extent of possible medical issues. You should go through a mock deposition with tough questioning. You should be filmed since most depositions are filmed these days and portions of that film could be shown to the jury. You should be instructed on body language and demeanor and, of course, be very familiar with the facts and medicine. Preparation is the key. Make sure you understand the process, the habits of the particular plaintiff’s lawyer, and the themes. Deposition preparation is an important and worthwhile investment.
Presently, prior to your deposition, the plaintiff’s lawyers may seek social media discovery (e.g., Facebook, MySpace, Twitter) and electronic discovery such as iPhone, iPad, and laptop. In that these are provided, make sure you are prepared for inquiry about the same.
Expert Witnesses
As already mentioned, expert witnesses are extremely important in any medical malpractice lawsuit. A well-qualified expert who can connect well with a jury is your best choice. However, beware that there are some experts who just are expert at being experts. At times, this can be problematic in front of a jury. All counsel will have available to them extensive information about the expert. This could include prior testimony, the volume of testifying they do, and much research into their credentials. If the expert spends more time in reviewing cases than their clinical practice, this will significantly impact their credibility. A well-balanced true expert will have testified typically because of their position and perhaps publications, research, and involvement in professional societies. Further, they often testify for both plaintiff and defendant.
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