Checklist for Risk Analysis of Unapproved Devices

By Anne M. Menke, RN, Ph.D., OMIC Risk Manager

Revised 7/2003

DISCLAIMER:  This information is intended solely to provide risk management recommendations. It is not intended to constitute legal advice and should not be relied upon as a source for legal advice. If legal advice is desired or needed, an attorney should be consulted.

This information is not intended to be a modification of the terms and conditions of your OMIC policy of insurance. Please refer to your OMIC policy for these terms and conditions.

The FDA approves and regulates the production, sale, and clinical research of medical devices.  It does not directly regulate the practice of medicine.  Prior to using an unapproved device, use this checklist to perform a risk analysis to determine the patient safety and professional liability risks associated with its use.

• What is the device?
• What is its FDA status?
  • Unapproved but undergoing clinical trials under an IDE (Investigational Device Exemption)
  • Unapproved but not yet undergoing trials
  • Unapproved and unlikely to undergo trials
• Who is manufacturing the device
  • A manufacturer or compounding pharmacy
    • Is the manufacturer or compounding pharmacy reputable and known to you?
    • Does the manufacturer or compounding pharmacy follow industry guidelines for sterility and quality assurance?
      • Keep material documenting the sterility and quality in your file on the device
• Are you distributing or reselling it?
  • If the device is labeled, promoted, or distributed in US, it is regulated by the FDA and subject to pre-marketing and post-marketing regulatory controls to assure safety and effectiveness
  • Distributing or selling greatly increases risk of FDA action
• How are you using it?
  • Research:
    • Gathering new information on multiple patients for publication purposes, or to obtain approval for a new device or a new use of an approved device, is probably research and requires an IDE
    • Part of an IDE (Investigational Device Exemption) to collect safety and effectiveness data required to support the PMA (pre-market approval) application to the FDA
      • Follow federal and state requirements for
        • obtaining approval of an IRB (Institutional Review Board) for the trials and
        • obtaining informed consent of the patient for research on human subject
        • disclosing any financial interests/incentives
  • “Practice of medicine”
    • Not for research AND
    • Use based on firm scientific rationale and sound medical evidence
    • The “practice of medicine” is theoretically unregulated by FDA but some case law exists limiting the use of unapproved devices as part of the practice of medicine
• What role does the device play in the treatment?
  • Does the treatment consist primarily of using this device?  If so, the risk of using it prior to FDA approval is greater
    • Example:  Restylane, used for lip augmentation and facial contouring
  • Does the device play an ancillary or supportive role in the performance of a procedure or treatment?  If so, there is less risk.
    • Example:  use of the dye, trypan blue, to stain the anterior capsule to facilitate visualization during cataract surgery
• What are the patient safety risks and how do you know about them?
  • Has a federal agency or state regulatory agency specifically banned the use of the device because it was determined to be unsafe?
  • Is there sound medical evidence supporting the use of this device?
  • Have peer reviewed articles been published supporting the use of this device?
    • Keep a file containing these articles and presentations
  • Can its use be expected to bring good results without a higher complication rate?
  • If there is an increased risk, do a reasonable number of physicians in your specialty use the device?
  • Is the use of the device in the best interest of this particular patient?
• Is the procedure “therapeutic” or cosmetic?
  • Therapeutic use of an unapproved device is less risky than cosmetic
  • If cosmetic
    • Does the patient have reasonable expectations?
    • Has the patient had problems with other treating physicians in the past?
    • Is he or she set on a certain procedure because of advertisements and recent popularity?
    • What are the patient’s motivations for having this procedure?
    • Does the patient fully understand what this procedure entails and the possible outcomes?
    • Does the patient understand that he or she will have to pay out-of-pocket not only for the procedure but also for any enhancement or follow-up?
• Informed consent discussion
  • Content of the discussion
    • Nature of the device or technique
    • Scientific basis for its use
    • FDA-unapproved status
      • It is always prudent to respect patient’s right to obtain the information needed to make reasoned decisions about his or her own health care
      • If physician reasonably believes that the approval status of the device will be a factor in the patient’s decision, disclose the information
      • Benefits
      • Risks
      • Alternatives
      • Possible drawbacks or criticisms from other practitioners
      • Especially with cosmetic procedures, other options and possibility of obtaining 2^nd opinion
  • If part of research or IDE
    • Must follow federal and state guidelines for informed consent
  • If not part of IDE
    • Consult legal counsel about whether state law requires physician to disclose the device’s unapproved status to the patient as part of informed consent discussion
  • Document the informed consent discussion of the risks, benefits, and alternatives, and include the fact that the patient was informed of the device’s unapproved status
    • If the treatment consists primarily of using the device, consider developing a specific consent form for the device that outlines the risks, benefits, and alternatives, and the FDA status, and give the patient a copy
• Verify coverage with your professional liability insurance carrier
• Consequences of violating the FDCA (Food, Drug and Cosmetic Act)
  • May be evidence of breach of the standard of care and result in determination that medical malpractice has occurred
  • May constitute negligence per se, due to statutory violation
    • Easier to prove if state law is stricter than FDCA and specifically prohibits the use of unapproved devices
  • Prosecution by FDA
    • Unlikely if only practice of medicine, and no distribution or sales

Close Door On Liability

 By Dean C. Brick, MD

Argus, September, 1995

Increasingly, ophthalmologists are being asked to practice more efficiently to remain competitive in the new health care arena. Many time-saving strategies allow physicians to provide quality care. However, using pre-dictated operative report forms to save time carries potential liability risks.

The importance of complete and accurate medical records cannot be overemphasized. A poor surgical result linked with an incomplete operative note may lead to liability regardless of the standard of care practiced. Because jurors often are evaluating an incident from two to 10 years after it occurred, they must rely heavily on the medical record. A complete and accurate record becomes indispensable for the defense since the ophthalmologist probably has little independent memory of the surgery.

Standard Forms Help Defend and Define Level of Care

Admittedly, using a standard pre-dictated form saves considerable time over dictating a new report for each procedure. For routine procedures such as a cataract operation, it may seem reasonable to use a pre-dictated report because most operations are very similar. The ophthalmologist can take the time to include on the form all the subtle nuances of the procedure employed, establishing a record that may actually help defend and define the appropriate surgical skill and level of care. When dictating individual reports, a surgeon may be too hurried to pay attention to these details.

If the case proceeded exactly as in the pre-dictated report, this is an acceptable and defensible method. However, if it is discovered that the surgery varied in any way, the surgeon may appear sloppy, careless, and rushed when the operative report is later presented in court and found to be exactly the same as all of the physician’s other cataract surgery reports.

Customize Reports for Each Patient

If an ophthalmologist encounters problems during a procedure, the medical record should reflect the clinical complexity of the case and indicate that the physician provided the proper professional attention. The appearance that careful attention was not given can be devastating if a surgery the ophthalmologist thought went well ends up in court because of an unexpected postoperative complication.

Ophthalmologists who use standard operative reports may want to customize each one by adding notes specific to the patient. For example, document that a specific viscoelastic was used to protect the endothelium in a patient with an endothelial dystrophy or that a procedure was changed in a particular manner because of the density of the nucleus. A reviewer may doubt the veracity of the entire report if it does not mention that a peripheral iridectomy was performed when one obviously was present postoperatively. The surgeon’s recognition of and response to any type of complication needs to be included in the report. If the procedure varied in any way, dictate the report individually or add a section to the pre-dictated form noting the change. Any dictation or writing regarding the operation should be done immediately following the procedure. Beware, however, that it can appear self-serving and defensive if the ophthalmologist drafts an excessively detailed report after recognizing a complication, stating that the patient was informed preoperatively of the possibility of that specific complication.

Proceed With Caution

While it may be tempting to use pre-dictated operative notes, the few minutes saved may result in much more time spent in court trying to defend an incomplete record that all too obviously resembles the other patient reports dictated by the ophthalmologist.

If an accepted complication is associated with a poor outcome and a malpractice action results, the surgeon may lose an otherwise defensible case if the plaintiff’s attorney convinces the jury of a “cover-up.” To be safe, pre-dictated reports should provide for a narrative of any problems encountered. Do not depend solely on a “stock” pre-dictated report.

Delay in Performance of Retinal Detachment Surgery and Associated Nonmedical Issues

Digest, Summer, 1993

ALLEGATION  Insured ophthalmologist allegedly delayed retinal detachment (RD) surgery because patient was unable to pay for the surgery in advance. Plaintiff also alleged that the insured improperly performed RD surgery on the first eye and overtreated the second eye.

DISPOSITION  Jury verdict award for the plaintiff for an amount exceeding $500,000.

Background

During a medical malpractice trial, the professional ethics and credibility of the physician are under intense scrutiny by the jurors. Not only does the physician need to possess irreproachable ethics, but any perceived lack of credibility may doom defense of the case.

Case Summary

The patient was a 48-year-old highly myopic female who presented to the insured’s office with complaints of flashing lights, lines and floaters of two days’ duration in the left eye. An examination revealed a rhegmatogenous retinal detachment with a giant tear and multiple other retinal tears OS. The insured performed a minor laser surgery procedure. The next day, the patient was admitted to the hospital for bed rest and bilateral patching prior to surgery scheduled for the following day, which coincided with a holiday. Surgery was postponed a day, at which time the patient underwent scleral buckle with cryopexy, vitrectomy, air/fluid exchange, laser photocoagulation, and C2F6 gas injection OS. According to the insured’s records, the postponement of surgery was due to a shortage of qualified operating room personnel on a holiday. However, the patient later alleged that surgery was delayed because the insured demanded to be paid before he would perform the surgery, and the patient was unable to get the money on a holiday.

The following month, an examination revealed a retinal detachment in the patient’s right eye. When laser treatment proved unsuccessful in repairing the detachment, the insured performed a scleral buckle, pars plana vitrectomy, retinal cryopexy, endolaser photocoagulation, air/fluid exchange and gas injection. The patient was referred postoperatively to a retinal specialist who confirmed that both retinas were attached. When the specialist last saw the patient four months later, both retinas were flat and attached. V.A. was 20/25 OD and 20/60 OS.

Five months later, the patient was examined by another ophthalmologist who found the patient’s visual acuity to be 20/40+3 OD and 20/80+ OS. A 22 to 23 prism diopter deviation was measured, which the ophthalmologist opined could cause significant double vision and make driving difficult, especially at night. Strabismus surgery was recommended.

Outcome

In her suit against the operating ophthalmologist, the plaintiff’s most damaging claim was the insured’s alleged demand for prepayment of the first retinal surgery, an allegation supported by the testimony of the plaintiff’s father and boyfriend. The insured denied that the delay was financially motivated and maintained that he delayed surgery until after the holiday because he could not obtain a surgical team experienced in vitrectomy procedures. However, the nurses who assisted in the patient’s surgery following the holiday testified that they did not have special training in retinal and vitreous surgery either.

During the trial, the plaintiff presented psychiatric evidence of major depression resulting from her fear of losing vision. Plaintiff also presented testimony from a vocational expert that she was unable to return to her previous employment as a computer salesperson following surgery.

Risk Management Principles and Commentary

Typically, “nonmedical” reasons came into play when a jury awards a large verdict against a physician in the absence of convincing evidence of actual injury to the plaintiff. In this case, although the defense was able to argue that the ophthalmologist followed the standard of care in performing the two RD surgeries, plaintiff’s counsel successfully attacked the defendant’s credibility and judgment on two issues:

• The alleged demand for prepayment.
• The reason for the delay in surgery.

This case might have been successfully defended on clinical issues alone; however, the associated nonmedical issues probably were seen by this particular jury as extremely damaging to the defense and most likely contributed to the high jury award.

Task Force Studies OMIC-Insured Surgical Facilities

By Kimberly Wittchow, JD, OMIC Staff Attorney

Digest, Fall 2005

Over the past year, a task force of OMIC Board and staff members, John W. Shore, MD, Anne M. Menke, RN, PhD, and Betsy Kelley, has been examining and revising underwriting requirements and risk management guidelines for coverage of outpatient surgical facilities (OSFs) insured by OMIC. OMIC’s Board of Directors assigned the task force to study scope of practice issues, state laws governing OSFs, and national, state, and local practice standards that establish a standard of care for cases performed in facilities insured by OMIC.

Types of Outpatient Surgical Facilities

First, the task force reviewed the type of facilities that OMIC insures. It found that OMIC insures a wide variety of OSFs with varying goals, scopes of business, and types of surgical procedures and anesthesia provided, including in-office surgical suites, refractive laser centers, and ambulatory surgery centers (ASCs). The types of anesthesia used in facilities insured by OMIC range from topical ocular anesthesia to full general anesthesia with invasive monitoring in high-risk surgical patients.

Some facilities are office-based treatment rooms where major eyelid and facial procedures are performed. Some of these offices permit outside surgeons of different specialties to utilize the in-office surgical suites. These surgeons, many of whom are not insured by OMIC, may perform major facial surgery in an unlicensed and loosely structured practice environment. This increases the vicarious liability shared by owners of the facility who are insured by OMIC.

Other surgical facilities are refractive surgical and laser centers. Surgical services in these facilities are usually limited to those requiring only topical anesthesia. The procedures are short in duration and the patients are relatively healthy. Some, however, are free-standing, licensed ambulatory surgery centers (ASCs), where surgeons of almost every specialty provide surgical services to a full range of pediatric, teenage, adult, and geriatric patients.

Review Process

Then the task force studied all of OMIC’s claims, suits, and settlements involving OSFs. The task force analyzed nursing, anesthesia, pediatric, and surgical standards by national professional groups as well as state and federal laws, regulations, and directives. Information gathered was used to revise existing underwriting requirements and risk management guidelines for OMIC insured OSFs. In addition to being discussed by both the Underwriting and Risk Management Committees, the proposed changes were extensively reviewed by consultants and practicing ophthalmologists with the goal of providing meaningful, clinically relevant, and workable requirements that cover all types of OSFs insured by OMIC. An anesthesiologist was consulted to review the anesthesia, monitoring, and emergency response requirements.

New Requirements

As a result of its work, the task force produced a rewritten and reformatted “Outpatient Surgical Facility Application” (OSFA), which was adopted by the OMIC Board of Directors. All ambulatory surgery centers, laser surgery centers, and in-office surgical suites used by physicians other than the owners and their employees will be required to complete the new OSFA. The OSFA contains detailed information about OMIC’s underwriting requirements pertaining to patient selection, type of anesthesia/sedation, pre- and postoperative assessments and monitoring, and emergency response and equipment. These requirements will be implemented immediately for all new OSF applicants and effective upon renewal in 2006 for facilities currently insured by OMIC.

It is important that insureds abide by all underwriting and notification requirements specified in the OSFA, as failure to do so could result in uninsured risk or termination of coverage. Working with OMIC’s experienced underwriters should enable insureds to complete the application, understand its requirements to avoid any coverage problems, and obtain an extension for those facilities that need additional time to comply with the requirements. While OSFs that are licensed or accredited may already meet or exceed these requirements, we anticipate that some OSFs may need additional assistance to implement them. Most accredited OSFs will receive a 5% premium discount for meeting the accreditation standards.  There are helpful resources listed at the end of the OSFA itself and OMIC’s risk manager is available for confidential consultations.

All OMIC-insured physicians help bear the cost of defending claims and paying indemnity. It is incumbent on the OMIC Board of Directors, therefore, to protect OMIC insureds as a whole by establishing requirements that it believes will best limit the company’s liability and by making certain that insureds abide by these requirements, while at the same time offering physicians the ability to practice in various settings.

Understanding the Basic Rules of Advertising

By Amy B. Angert, JD

[Argus, December, 1993]

Ophthalmologists who advertise their services often face confusing legal and ethical restrictions. Advertising professional services is different from advertising commercial products or services. Puffery or exaggeration, common in advertising nonprofessional services or goods, is prohibited in the medical arena. In fact, such advertising may be considered deceptive and subject the ophthalmologist to fines or licensing investigations. It is essential for the ophthalmologist to understand the basic rules governing medical advertising and to weigh the benefits against the possible risks.

What Is Physician Advertising?

Ophthalmic professional advertising consists of communications to the public, prospective or current patients, professionals or other people for the purpose of soliciting or encouraging the use of the physician’s services. Advertising may be verbal or written and includes magazine or newspaper ads, telephone directory displays, radio and television spots, promotional flyers, leaflets and brochures. The advertising for which an ophthalmologist can be held responsible includes those ads placed directly by the practitioner as well as communication for the ophthalmologist’s services disseminated by other entities such as hospitals or clinics. In other words, the ophthalmologist is liable for any method that promotes the use of the physician’s services which the ophthalmologist is directly or indirectly responsible for placing.

Who Regulates Advertising?

A multitude of federal and state entities monitor and enforce advertising rules and regulations. One premise common to all regulatory entities: physician advertising must be truthful and not misleading. Advertisements may not directly or indirectly make false claims or misrepresent material facts. Likewise, they must not omit essential or material facts, and any claims made in advertisements must be able to be substantiated. Unfortunately, these basic premises are deceptively simple and often are more difficult to implement than they appear.

The goal of all advertising regulation is to prevent the use of undue influence or coercion regarding the need for ophthalmic care. It is believed that medical advertising has greater potential to influence because target groups may be seriously ill, infirm or suffer from impaired judgment, predisposing them to believe exaggerated claims or promises. Or, advertising may target vulnerable groups that are incapable of critically evaluating the advertisement itself. Medical advertising must not be false, deceptive or misleading.

Federal and state antitrust laws protect physicians who want to truthfully advertise their services. The Federal Trade Commission is primarily responsible for enforcing federal antitrust laws; state attorneys general enforce state antitrust laws. Medical associations are prohibited from impeding truthful advertising by physicians.

The basic premise of these laws is the idea that truthful advertising benefits people by making them better informed. The U.S. Supreme Court in a series of opinions has ruled that truthful advertising is protected under the U.S. Constitution’s First Amendment right to free speech.

These protections extend only to truthfuladvertising. Untruthful advertising is not protected by state or federal antitrust laws or by the First Amendment. If an ad is deemed false or deceptive, the physician may be subject to federal or state action, including litigation or substantial fines.

Physician advertising is evaluated from legal as well as ethical perspectives. Laws, in the form of statutes or administrative rules, generally are enforced by state boards of medicine or state attorneys general. Investigations by these entities are confined to determining the legality of the ad and the disciplinary action required.

Ethical scrutiny is often more subjective and less specific than legal scrutiny. Frequently, it is the province of national, state and local medical associations that publish guidelines or opinions to assist practitioners in their advertising practices. Some have panels available to review their members’ ads and to offer guidance in meeting ethical requirements. Inquiry and disciplinary action generally are confined to evaluating whether the practice is ethical and what remedial action is required.

Ophthalmologists with specific questions regarding the legal or ethical sufficiency of an advertisement should consult an attorney experienced in this area. OMIC’s Risk Management Department, the Academy’s Ethics Unit, state boards of medicine, or local ophthalmic medical societies also may be able to provide guidance.

Hidden Pitfalls

In addition to meeting ethical and legal restrictions, the ophthalmologist must consider the impact of advertising on the patient. While advertising generally has produced more informed and better educated patients, the treating ophthalmologist may have to contend with a patient who already has misconceptions or unrealistic expectations as a result of the physician’s or anyone else’s advertising.

If the ophthalmologist does not identify these misconceptions or unrealistic expectations as they relate to the patient’s circumstances, the physician may be hindered in future informed consent discussions. If this patient sustains a poor or less than perfect outcome from a procedure, even if it is well within the range of outcomes accepted for that treatment regimen, the patient will be dissatisfied and may feel deceived. Dashed expectations often are the driving force behind litigation. The patient needs to know at the outset, before care is rendered, what result is reasonable to expect in the face of his or her particular circumstances. If the case is a difficult one, the ophthalmologist should encourage the patient to get a second opinion.

Ophthalmologists who advertise also must consider how their ad will sound to a jury. Any good plaintiff’s attorney will subpoena ads generated from a doctor’s office and exploit their impact at trial. Plaintiffs often will claim they were seduced or influenced by representations made in the doctor’s advertising. Such claims have tremendous jury appeal and can, in fact, be the decisive factor between a defense verdict and a jury award.

Consider the ophthalmologist who advertises that laser surgery for treatment of cataracts or glaucoma is safe, harmless and painless. Not only does the ad violate federal and state truthful advertising rules, but it also runs afoul of ophthalmic ethical guidelines. The ad is false, deceptive and misleading. The promise of painless surgery is a lure to attract patients who fear conventional surgery. To patients, such a statement implies that the entire event is painless and fails to address the possibility of postoperative complications, the pain associated with the anesthetic injection, or normal postoperative discomfort. Claiming that the procedure is safe is misleading or even outright false. The patient may construe the claim to mean that the procedure is entirely without risk or safer than other options. Claims of safety may influence the patient’s choice over another equally viable alternative procedure. This ophthalmologist would have difficulty defending such a claim in a courtroom even if the physician had advised the patient of the inherent risks associated with the procedure because the seductive message generated by the ad probably would outweigh any informed consent the doctor might claim the patient made.

Any ophthalmologist who advertises should consider how the ad text would sound to a jury in the face of claims of alleged negligence or lack of informed consent. If the ad claims cannot be substantiated, if they overreach in their claims or are subject to multiple interpretations, the ad should be revised or rejected.