Trial Magazine

The question is whether reasonable and prudent physicians would follow those guidelines—and your experts can show that they would.

Many health care organizations publish clinical practice guidelines, which “are systematically developed statements to assist practitioner and patient decisions about appropriate health care for specific clinical circumstances.”¹ Great debate arises in the context of medical negligence litigation about whether these guidelines establish the standard of care. Many guidelines say they do not establish the standard of care. However, plaintiff attorneys should argue that the guidelines represent best practices developed by the best and brightest in that specialty field of medicine and demonstrate that there is consensus around them. The question is whether reasonable and prudent physicians would follow those guidelines—and your experts can show that they would. 

When a medical specialty has clear, evidence-based guidelines, use those to demonstrate how health care providers fell short when treating your client. Take pain treatment, for example. In 2016, approximately 50 million Americans reported suffering from chronic pain.² The estimated annual cost of chronic pain is more than $560 billion in medical care and lost worker productivity.³ The specialty of interventional pain management in particular has exploded as a result.⁴ Typical procedures include lumbar and cervical epidural steroid injections, radiofrequency ablation and thermal facet ablations, facet injections, sacroiliac (SI) joint blocks, selective nerve blocks, and diskography. 

Although injuries to patients undergoing interventional pain procedures can occur in various ways,⁵ this article focuses on injuries due to sedating patients, which is against the great weight of medical evidence and clinical practice guidelines. Unlike some medical negligence cases you may pursue, there is a clear national standard of care with respect to sedation for interventional pain procedures: to perform these procedures under local sedation only.⁶

The American Society of Anesthesia (ASA) has stated that “many patients can undergo interventional pain procedures without the need for supplemental sedation in addition to local anesthesia” and “the use of moderate (conscious) sedation and/or anesthesia must be balanced with the potential risk of harm from doing pain procedures in sedated patients.”⁷ The Centers for Medicare & Medicaid Services (CMS) also states that local anesthesia is the standard practice for epidural injection procedures.⁸

Despite the clear guidelines and regulations of various authoritative and credible organizations, including CMS and the ASA, the use of general anesthesia for routine interventional pain procedures is common.⁹ In one study, 54% of physicians performing epidural steroid procedures used sedation, and 36% of those used propofol, which is considered a general anesthetic.¹⁰ Experts likely will testify that there is a perceived need to increase patient satisfaction (have them feel no pain) as one reason for the widespread use of sedation despite the known risks. But studies have shown that patient satisfaction can be achieved without sedation.¹¹

Common injuries during pain procedures include airway obstruction, hypotension or hypoventilation, and cardiovascular collapse. Deep sedation or general anesthesia prevents patients from communicating about injury-related pain, and drug interactions may result in oversedation and complications.¹² When the evidence-based guidelines are not followed, even the simplest procedure can have catastrophic or fatal results. 

Using the Guidelines

In addition to widespread lack of compliance with clinical practice guidelines, you likely will find defense experts lining up to defend this noncompliance. For example, in a recent pain procedure case I handled, two highly qualified defense experts made the following statements in their expert reports: “It is well within the standard of care to provide propofol as the primary agent to sedate or anesthetize patients for interventional pain procedures”; “Nearly 100% of the patients I see and treat on a weekly basis receive propofol as their primary anesthetic agent”; and “Use of propofol for pain procedures is well within the standard of care.” 

So how do you reconcile the clinical practice guidelines with defendants and their experts who argue the guidelines are not the standard of care? Courts are split regarding the use of clinical practice guidelines to establish the standard of care.¹³ Your expert witness should refer to the applicable clinical practice ­guidelines to educate the jury and to support his or her opinions.¹⁴ Reasonable and prudent health care providers should be knowledgeable about the applicable guidelines, and your expert can establish this.¹⁵

However, the standard of care allows providers to assess the individual patient and then use their medical judgment in deciding whether to follow the clinical practice guidelines in each case.¹⁶ Few courts will consider the violation of clinical guidelines alone as conclusive evidence that the defendant’s actions fell below the standard of care.¹⁷

To determine the authority of the guidelines, courts consider whether the guidelines state that they are rules or simply recommendations, the specificity of the guidelines and how applicable they are to the facts of the case, and whether there is a disagreement in the medical community concerning the practice in debate.¹⁸ Generally, a strong argument exists that failing to meet guidelines is also a failure to meet the standard of care, but it is not a presumed violation without additional evidence of the standard of care.¹⁹

Have your expert explain how the guidelines were developed—that they were built on studies and research, that they are reliable, and that members of the organization were polled for their input. Group guidelines from multiple organizations together to show that it’s not just one rogue organization but rather  that all major practice organizations are in consensus. Most important, your expert should explain that following the guidelines is what a reasonable and prudent doctor would do, and it’s the expert’s opinion that not doing so is a violation of the standard of care. 

You can bolster this evidence by cross-examining the defense expert on how thoroughly the guidelines were developed and establishing that they are reliable. Ultimately, it’s for the jury to decide whether there is credible evidence that the guidelines should have been followed in your case. 

It is crucial to educate the jurors on all the work that goes into adopting the guidelines: the use of medical experts, data, and research; and the fact that other reputable organizations also reached the same or similar conclusions through their own process. 

It also is important to develop evidence concerning whether medical decision-making was based on the patient’s unique situation or whether that doctor or hospital has a pattern and practice of ignoring the clinical guidelines. Examining the medical records to determine whether medical decision-making was documented may help establish that the health care provider did not consider the patient’s needs or document why an exception to the clinical guidelines should be made for that patient. Doctors can violate the guidelines for a particular patient if a valid reason exists and they document an exception in their medical decision-making. Explore this in discovery to find out whether an exception was made for the particular patient versus a widespread standard practice of not following the guidelines.

For example, when an interventional pain case comes across your desk, look for certain patterns by comparing your client’s medical records against the clinical practice guidelines, and discuss these with a qualified expert:

• the patient was not a candidate for the procedure due to lack of medical necessity
• the patient was not a candidate for the procedure due to the risks outweighing the benefits because of comorbidities
• improper pre-procedure anesthesia evaluation, particularly with respect to medications the patient may be taking that could have a synergistic effect with sedation drugs²⁰
• improper sedation (oversedating a patient)
• sedating without medical necessity
• lack of proper anesthesia monitoring, particularly end-tidal Co2 monitoring²¹
• inability to promptly and adequately rescue a patient from an unintended level of sedation or a patient who develops complications
• spinal cord injuries due to improper technique, particularly when coupled with a sedated patient who cannot react to a spinal cord puncture.

Introducing the Guidelines

Clinical practice guidelines may not be introduced independently as treatises, but they may be admitted under Federal Rule of Evidence 702 as documents proffered by medical experts to support their opinions regarding the standard of care.²² When admitting evidence of clinical guidelines, courts determine whether they are relevant and reliable.²³ For example, the relevance inquiry may consider whether the guidelines’ objectives are consistent with the provider’s objectives, the guidelines’ recommendations apply to the plaintiff, and the guidelines account for medical and technological developments.²⁴

The strength of the clinical practice guidelines applicable to your case vary by the field of medicine. Some practice areas have robust organizations that publish very clear guidelines. In other instances, you may have a set of facts that do not have uniform, standard ­guidelines or have conflicting guidelines from various organizations. Some guidelines may be vague, outdated, or not specific or comprehensive enough to apply to the facts of your case. 

Through your experts, establish the credibility and reliability of the people who wrote the guidelines and the organizations that adopted them. Also establish that the guidelines are specific, nonambiguous, relevant, and consistent across the organizations that have written them. Then demonstrate how compliance with the clinical practice guidelines would have prevented the harm that resulted from violating them. 

It is a good practice to ask defendants or their experts to concede that they are a member of the organization or are regulated by the organization in question and that it is “the” organization of choice for their specialty. Ask the defendant or their experts to concede that the experts who studied and crafted the ­guidelines are credible experts in their field, that the methods used to arrive at the final guidelines were reliable, and that the guidelines represent the consensus of the medical community. 

In my experience, the defense likely will draw out language from the ­guidelines that specifically states that the guidelines are not the standard of care, presumably placed there to insulate members who violate them from civil liability. But you can use your experts’ testimony and your cross-examination of the defense experts to demonstrate how this is self-serving and at odds with the clear guidelines.

Many patients are being injured by providers who choose not to comply with clinical practice guidelines. When the guidelines are credible, consistent across multiple organizations, relevant, and specific—as they are in the case of interventional pain procedures—you have a strong argument that these guidelines are the standard of care. You undoubtedly will encounter defendants and experts who protest vociferously, but properly using and introducing the guidelines hopefully will persuade the jury of the provider’s negligent care.

Kay Van Wey is the founder of Van Wey, Presby, and Williams in Dallas. She can be reached at kay@vwpwlaw.com.

Notes

1. U.S. Dep’t of Health & Human Servs., Nat’l Inst. of Health, Clinical Practice Guidelines, https://nccih.nih.gov/health/providers/clinicalpractice.htm. For example, Centers for Medicare and Medicaid Services, the Joint Commission, the American Society of Anesthesia, and the American College of Obstetricians and Gynecologists.

2. James Dahlhamer et al., Prevalence of Chronic Pain and High-Impact Chronic Pain Among Adults—United States, 2016, 67 CDC Weekly 1001 (2018). Darrell J. Gaskin & Patrick Richard, The Economic Costs of Pain in the United States, 13 J. Pain 715 (2012).

3. Darrell J. Gaskin & Patrick Richard, The Economic Costs of Pain in the United States, 13 J. Pain 715 (2012). 

4. Roger Chou et al., Pain Management Injection Therapies for Low Back Pain, Agency for Healthcare Research & Quality Technology Assessments (Jul. 10, 2015) (finding that spinal injections offered minimal results that were not sustainable and did not alter the risk of future surgery); Johan N.S. Juch et al., Effect of Radiofrequency Denervation on Pain Intensity Among Patients With Chronic Low Back Pain, 318 JAMA 68 (2017) (finding spinal injections offered no medically significant relief of pain greater than exercise alone after three months).

5. Nancy E. Epstein, The Risks of Epidural and Transforaminal Steroid Injections in the Spine, 4 (Supp. 2) Surgical Neurology Int’l S74 (2013).

6. Int’l Spine Intervention Soc’y, Practice Guidelines for Spinal Diagnostic & Treatment Procedures (Nikolai Bogduk ed., 2d ed. 2004).

7. Am. Soc’y of Anesthesiologists, Statement on Anesthetic Care During Interventional Pain Procedures for Adults (Oct. 26, 2016).

8. Ctrs. for Medicare & Medicaid Servs., Local Coverage Determination L36920: Epidural Injections for Pain Management (May 4, 2017).

9. Lynn Kohan et al., A Review and Survey of Policies Utilized for Interventional Pain Procedures: A Need for Consensus, 10 J. Pain Research 625 (2017).

10. Id. The use of propofol (Diprivan) in and of itself constitutes “general anesthesia” because patients being administered the drug may rapidly progress from a state of moderate sedation to deep sedation or general anesthesia. The manufacturer’s recommendations for the administration of propofol is that it “should be administered only by persons trained in the administration of general anesthesia, who are not simultaneously involved in these surgical or diagnostic procedures.” Am. Soc’y of Anesthesiologists, Statement on Safe Use of Propofol (Oct. 15, 2014), https://www.asahq.org/standards-and-guidelines/statement-on-safe-use-of-propofol.

11. Felix E. Diehn et al., An Audit of Transforaminal Epidural Steroid Injection Without Sedation: Low Patient Dissatisfaction and Low Vasovagal Rates, 14 Pain Med. 994 (2013).

12. Alan D. Kaye et al., ASIPP Guidelines for Sedation and Fasting Status of Patients Undergoing Interventional Pain Management Procedures, 22 Pain Physician 201 (2019).

13. Somerville ex rel. Somerville v. United States, 2010 WL 2643533, at *n.9 (M.D. Fla. June 30, 2010) (disagreeing that the doctor deviated from the standard of care by not following “best practices” guidelines because the standard of care is not equivalent to best practices).

14. Frakes v. Cardiology Consultants, P.C., 1997 WL 536949, at *5–6 (Tenn. Ct. App. Aug. 29, 1997); Gevas v. McCann, 2014 WL 2926201, at *4 (N.D. Ill. June 27, 2014).

15. See United Blood Servs. v. Quintana, 827 P.2d 509 (Colo. 1992).

16. Frakes, 1997 WL 536949; Gevas, 2014 WL 2926201; see United Blood Servs., 827 P.2d 509.

17. Chris Taylor, The Use of Clinical Practice Guidelines in Determining Standard of Care, 35 J. Legal Med. 273, 280–81 (2014).

18. Hinlicky v. Dreyfuss, 848 N.E.2d 1285 (N.Y. Ct. App. 2006); Falcon v. Rice, 2007 WL 2823234, at *5 (N.J. Super. Ct. App. Div. Oct. 1, 2007).

19. See Gevas, 2014 WL 2926201.

20. “[M]ost patients undergoing interventional pain procedures are taking potent medications that possess synergistic sedative-hypnotic properties. Drug-drug interactions may result in over sedation and complications.” Kaye, supra note 12, at 203.

21. Mark Bauman & Cindy Cosgrove, Understanding End-Tidal CO2 Monitoring, Am. Nurse Today (Nov. 2012), www.americannursetoday.com/understanding-end-tidal-co2-monitoring/.

22. Frakes, 1997 WL 536949, at *5 (finding the trial court did not abuse its discretion in admitting a practice guidelines table that was relevant in determining the standard of care); Jodi M. Finder, The Future of Practice Guidelines: Should They Constitute Conclusive Evidence of the Standard of Care?, 10 Health Matrix 67, 96 (2000).

23. Id.

24. Finder, supra note 22, at 82.