James E. Szalados

Introduction to the Interface of Law and Medicine

Rules, regulations, and laws become necessary whenever there is an interaction between people who potentially have diverging interests. Optimally, the interests of physicians and their patients are aligned in the mutual goal of a successful diagnostic and therapeutic outcome. Honest communication and consensual therapeutic interactions between patients and their physicians form the basis of good medical care. Disagreements may arise when expectations diverge from perceived outcome. When misperceptions or frank disagreements escalate into conflicts, fair and equitable resolution necessitates a system of rules and procedures for dealing with such conflicts. The legal system is such an “adversarial” process—a process that includes the rights to representation, a fair and impartial hearing, and justice, designed to resolve conflict. The legal system is based on arguments submitted in the context of procedure and rules of evidence; the goal of the legal system is justice, and not the determination of truth.

Since medicine is a profession, the practice of medicine is governed by complex implicit and explicit rules and regulations that share their bases both in ethical theory and principles of morality. The principles of good medical care, inherent in the Hippocratic Oath, form the guiding ethical and legal tenets for professionalism. Physicians must both uphold the interests of the patient and endeavor to “do no harm.” Inherent in the professional obligations of physicians is the ethics-based fiduciary duty to act in the best interests of their patients. A fiduciary duty (from the Latin fiduciarius, meaning “to hold in trust,” and from the root fides, meaning “faith”) is a legal or ethical relationship of deep confidence and trust between two or more parties. Fiduciary duties arise whenever there is an imbalance of knowledge, training, or experience that puts one party at a relative disadvantage in an agreement for services. In a fiduciary relationship, a party who is in a position of vulnerability and is therefore seeking aid, advice, or protection justifiably vests confidence, good faith, reliance, and trust in another more learned and experienced party. Thus, a fiduciary duty represents, albeit as an aspiration or ideal, the highest standard of professionalism at either equity or law.

Although modern laws are largely based on ethical and moral principles, the legal system has become more complex and less subjective. The rules of modern law are codified as “black-letter law,” which embodies the Constitution, federal and state statutes (legislation), and case law (precedent). A parallel system of codes and regulations define the legal processes and procedures that must be strictly adhered to in order to access the judicial system and argue one’s point of view. Laws govern all formal interactions between government, institutions, and individuals. Therefore, it is imperative that physicians develop an understanding of basic substantive and procedural law—first, so their practices can be more focused and rewarding, unencumbered by fear of the unknown; second, so they can work proactively to minimize legal risk; third, so they can better communicate with risk managers, attorneys, and insurers; and finally, so physicians can better understand and participate in future legal, legislative, regulatory, and public policy development. ¹

Technology is implicated in medical-legal risk, since no drug or technology is, nor can ever be, completely safe. In addition, early adopters of technology are potentially exposed to unknown product liability risks; late adopters may be criticized for not providing access to state-of-the-art care.

The FDA and Regulation of Medical Devices

The U.S. Food and Drug Administration (FDA) governs all aspects of drugs and medical device regulation in the United States. The FDA has detailed rules and regulations regarding development, approval, marketing, and postmarketing follow-up for medical devices; these largely parallel those for pharmaceuticals. Congressional legislation in the form of the Federal Food, Drug, and Cosmetic Act (FFDCA or FDCA) ² empowers the FDA as a federal agency with statutory regulatory authority. ³ The Medical Device Amendments Act of 1976 (MDA) ⁴ expanded the reach of the FFDCA from agriculture and pharmaceuticals to include medical devices.

Within the FFDCA, a device is defined as:

Thus, medical devices can range from simple tongue depressors to complex computerized imaging equipment and biomedical implants. Under the FFDCA, the distinction between drugs and devices rests in their respective mode of action: drugs effect their intended action through chemical action or via metabolism, whereas devices do not. Devices in turn are classified based upon intended use, potential benefit, approved medical indications for use, and risk. Potential risks associated with devices, in conjunction with potential benefits, are the major factors used in classifying a device on a scale of I to III, where class I devices denote the lowest risk and class III the highest; classification determines the level of FDA controls associated with the manufacture and marketing of the particular device. ⁶ Transesophageal echocardiography (TEE) equipment is a class II device, an intermediate-risk device, wherein General Controls are insufficient, and methods/standards/guidance processes and documents must provide assurances of safety and effectiveness. ⁷

The intent of the MDA is to provide consumers of medical devices with a reasonable assurance of both safety and efficacy, which together represent the dual statutorily mandated standards upon which the FDA bases its approval of both pharmaceuticals and devices. However, in the case of devices, FDA approval more heavily favors safety over efficacy. The safety profile of any drug or device is a complex interplay between product design, use, and potential for operator error. Courts explicitly recognize that no drug or device is completely safe and that such products are “inherently dangerous.” ⁸

Medical professionals and consumers naturally expect medical devices to be well manufactured, have comprehensive and accurate labeling and directions for use, and perform reliably in the manner manufacturers intend and advertise. The potential for user or operator error is not considered a threshold issue by the FDA, and it recognizes that operator errors can result from a large number of variables over which the manufacturer has no control (e.g., training and skill of individual operators, patient variability, ergonomics, and the complex clinical environment). However, manufacturers are expected to consider human factor engineering principles during product design and encourage appropriate user education and training so the risk for user errors can be minimized or mitigated. ⁹

The formal process whereby the FDA approves a drug or device is highly structured and requires manufacturers to submit data before clinical trials to begin testing in humans. Thereafter, data from carefully controlled clinical trials must be submitted to panels of FDA experts. After premarket approval, medical devices are subject to reporting requirements under the MDA. These requirements include an ongoing obligation for manufacturers to inform the FDA of new device-related clinical investigations, scientific studies, or incidents of patient harm the manufacturer becomes aware of, knows, or should reasonably be aware of. The FDA recognizes that malfunctions and other safety concerns must be reliably communicated to manufacturers so they may consider and potentially take corrective actions based on such reports. Postmarketing surveillance and reporting of adverse events is the process that seeks to ensure that rare adverse events not detected during product development and testing can be followed by the FDA, and that such devices can be subsequently withdrawn from market, modified in subsequent models, or relabeled with additional warnings as the FDA might deem necessary. The FDA’s safety-surveillance strategy for medical devices relies on physicians, healthcare institutions, manufacturers, and patients to report medical device failures and complications through the Medical Device Reporting (MDR) system. The process is analogous to the Adverse Event Reporting System (AERS) database, which is the basis for the FDA’s postmarketing safety surveillance program for drugs and biological products. The Standards Management Staff (SMS) of the FDA has the responsibility to ensure that evolving medical device standards are published to provide formal notice to designers and manufacturers and thereby facilitate the incorporation of new regulatory standards into product design and manufacture.

Medical device tracking provisions within the FDCA mandate that manufacturers be able to track class II and class III devices through sales and distribution channels to the specific ultimate device users so they can promptly locate and remove specific devices from the clinical arena in the event of any product recall. In 2009, the FDA launched the Sentinel Initiative, a program that integrates the electronic health records (EHRs) of healthcare institutions with FDA databases in order to perform continuous and online postmarketing safety analyses. Since medical devices, in contrast to pharmaceuticals, lacked unique device identifiers (UDIs), the FDA was authorized through the FDCA Amendments Act of 2007 to develop a comprehensive UDI system for medical devices that is expected to soon be integrated with EHRs, as well as administrative and claims databases to identify patients who have been exposed to specific devices and thereby track rare postexposure risks. The UDI project is now under consideration with the Office of Management and Budget (OMB).

With respect to diagnostic ultrasound equipment, FDA regulations governing the output of ultrasound probes are based upon internationally agreed-upon standards developed by a variety of authorities. These include, for example, the International Electrotechnical Commission (IEC), the American Institute of Ultrasound in Medicine (AIUM), and the National Electrical Manufacturers Association (NEMA). For example, NEMA standards are especially material to the issue of safety, and the NEMA Output Display Standard (ODS) specifically address factors such as the thermal (TI) and mechanical indices (MI) for diagnostic ultrasound equipment. In brief, the MI represents an estimate of the maximum amplitude of the acoustic pressure pulse created by the ultrasound beam in tissue and is thus an indicator of risk associated with any potential mechanical bioeffects. The TI represents the ratio of the total acoustic power to that required raising a maximum temperature increase of 1°C in various tissue types. The ALARA (“As Low as Reasonably Achievable”) principle ¹⁰ would minimize thermal and mechanical output levels from ultrasound devices so as to minimize any potential adverse effects associated with their use. Despite a general consensus that there are no known risks associated with ultrasound imaging per se, there is also a recognition that ultrasound may produce effects on the body such as cavitation, whereby ultrasound waves heat tissues slightly and may produce small pockets of gas in body fluids or tissues. The long-term effects of tissue heating and cavitation, especially in fetal tissue, are not presently known with absolute certainty.

Medical Device Defects and Medical Device Malfunctions

Products are marketed with warranties. A warranty can be express, where it is explicit and in writing, or it may be implicit and implied under the UCC code of commercial law. ¹¹ Strictly speaking, a warranty is defined as a legal assurance or promise by a manufacturer that a product is fit for public use as intended, free of defects, and that it meets specifications; a warranty will usually also delineate the rights and obligations of both parties in the event of a dispute. For example, the warranty of merchantability is one example of an implied warranty where merchantability requires that goods sold through commerce must reasonably conform to the expectations of the ordinary buyer. The warranty of fitness for a particular purpose represents another example of an implied warranty; in this case, a consumer with specific technical requirements reasonably relies on a manufacturer’s claim that the goods fit those specific needs. A warranty can be violated when a product does not conform either to reasonable expectations as promised or has inherent defects.

Despite strict standards, a rigid FDA approval process, manufacturing oversight, and postmarketing surveillance, it is a reality that medical devices will sometimes fail, malfunction, or otherwise cause patient harm. Thus, it is inevitable some product recalls will occur under even optimal circumstances; such recalls may result in removal a product from commerce, either voluntarily by the manufacturer ¹² or by FDA order ¹³ and either permanently or temporarily. ¹⁴ MDR requirements by manufacturers are mandatory, and failure to report malfunctions can result in punitive damages (as well as render a device misbranded) and rescission of FDA approval. Manufacturers must submit reports to the FDA whenever there are data to suggest a device (1) may have caused or contributed to a death or serious injury or (2) has malfunctioned and that the device or a similar device marketed by the manufacturer or importer would be likely to cause or contribute to a death or serious injury if the malfunction were to recur. Adverse event data are logged by both manufacturers and the FDA. Although physicians and institutions have no absolute legal duty to report, reporting of adverse events and malfunctions are important to prevent future injuries and to trend events—documentation and trending that may later become important in the defense of potential future litigation. In response to MDRs, the FDA may also order product recalls by statutory authority. Recalls conducted at the manufacturer’s initiative or at FDA request are both considered voluntary recalls, whereas recalls conducted pursuant to the FDA’s statutory authority are considered mandatory recalls. ¹⁵

Product defects are generally categorized as (1) design defects, (2) manufacturing defects, or (3) marketing defects. In the law of products liability, a design defect is considered to exist when the defect is inherent in the design of the product. In a products liability case, a plaintiff can establish that a design defect exists only if he or she can establish that an alternative design, albeit hypothetical, would be (1) safer, (2) as economically feasible, and (3) as practical as the original design while retaining the primary purpose. ¹⁶ Manufacturing defects, on the other hand, are unintended defects occurring during manufacture or assembly. Marketing defects are defects that typically pertain to inadequate warnings and/or instructions and are typically exemplified by inadequate or faulty instructions and failures to warn consumers of latent dangers that might be associated with normal use of the product.

Products liability is the field of legal analysis that refers to liability incurred by one or more parties along the chain of commerce of any product. A product liability claim might be based in various grounds such as, for example, negligence, strict liability, misrepresentation, or breach of warranty of fitness. Products liability is generally considered to be a strict liability offense, meaning liability is not predicated on the degree of carefulness used in the design, manufacturing, or marketing of a product. Under strict liability, a manufacturer is liable when it is shown that the product is defective. However, product liability claims are increasingly difficult for plaintiffs to bring against manufacturers of medical devices. Since there is no federal products liability law, the laws governing products liability have been codified in state-specific products liability statutes. Paradoxically, through its ruling in Reigel v Medtronic, the U.S. Supreme Court virtually eliminated state product liability claims through its preemption ¹⁷ of state tort law claims. ¹⁸ After Reigel, medical device manufacturers have been able to use federal patient safety legislation as a shield against claims made under existing state tort laws.

Misrepresentation usually refers to an intentional concealment of defects or potential hazards associated with a product. However, if it can be shown that a reasonable manufacturer should have known that a product defect or hazard existed, a case of negligent (rather than intentional) misrepresentation may be found. Litigation against manufacturers and distributors of medical devices may also be based in allegations that the devices are adulterated or misbranded under the FFDCA. A device may be determined adulterated or misbranded if it was marketed without FDA approval, not manufactured in accordance with the required manufacturing standards, found to be of inferior quality, or if advertising or labeling is deemed false or misleading. ¹⁹

The Learned Intermediary Doctrine ²⁰ defense provides that manufacturers of prescription drugs and/or medical devices fulfill their duty of care to patients when they provide warnings to physicians regarding their products. This doctrine is grounded in the doctor-patient relationship whereby it is reasonable to expect that the treating physician would be in a better position to warn a patient about pertinent risks than would the manufacturer, since in any decision to prescribe a drug or medical device, there is a professional assessment of risks as balanced against the patient’s needs, susceptibilities, and projected benefit. The Doctrine does not obviate a manufacturer’s duty to provide adequate warnings, but instead substitutes the medical professional for the patient as the required recipient of the warnings. ²¹ Therefore, the Doctrine has become another shield to protect manufacturers from liability, since manufacturers are deemed to have discharged their duty under the Doctrine, thereby passing the risks for liability under normal use to the medical professional.

Liability claims may also be predicated in a theory of negligence. Negligence is defined as a failure to exercise proper or ordinary care, and a manufacturer might be held liable for negligence if it can be established that a lack of reasonable care in the production, design, or assembly of the manufacturer’s product caused a harm. One specific type of negligence action pertaining to medical devices is the “failure to warn” case. ²² The duty to warn arises whenever a manufacturer knows or reasonably should have known of latent dangers associated with use of its product under normal circumstances. ²³ The manufacturer may be found to have had constructive knowledge of latent risks if by the application of reasonable, developed human skill and foresight it could have or should have known of such risks. Although the injured party still bears the responsibility to prove that a manufacturer had such actual or constructive knowledge, this evidentiary burden can sometimes be satisfied via documented complaints or prior injuries, reports in relevant scientific or trade literature, recognition of the risks by industry experts, or alerts issued by the FDA or other governmental agencies.

Importance of Practice Guidelines and Society Statements

The promulgation of guidelines, protocols, and pathways represent another potential important driver of medical legal risk. Evidence-based medicine (EBM) emphasizes clinical reasoning that is based on cumulative evidence derived from prior clinical research that is then distilled into guidelines by expert consensus. ²⁴ Practice guidelines represent systematically developed consensus statements intended to assist both practitioner and patients in making rational healthcare decisions in specific clinical circumstances. ²⁵ As the volume and rigor of evidentiary support from meta-analyses accumulates, EBM is ever more widely accepted to at least represent persuasive outlines of best practices that should at least be considered during individualized clinical decision making. Nonetheless, even guidelines are fluid and subject to revision with new developments in medical knowledge, technology, and practice.

Proponents of EBM suggest that adherence to guidelines might bolster a practitioner’s medical decision making by demonstrating adherence to an authoritative and widely accepted published statement of standardized care, thereby facilitating administrative review and even potentially reducing legal liability. Although guidelines are colloquially referred to as “standards,” they are not truly in themselves legal standards of care. The legal definition for standard of care is that physicians employ that level of ordinary skill and care consistent with good medical practice. ²⁶ The appropriateness of a physician’s medical care is judged by the testimony of other experts—physicians in the same or a similar field of practice. Despite widespread acceptance of EBM, expert testimony remains the legal basis upon which the appropriateness of medical care is assessed.

EBM standards in the form of guidelines are gradually being successfully admitted into evidence during medical malpractice litigation. In 2006, the New York Court of Appeals decided Hinlicky v Dreyfuss, ²⁷ a ruling that addressed the importance of adhering to accepted standards of care as a legal duty. Briefly, in this case a 71-year-old woman underwent a successful carotid endarterectomy but suffered a postoperative myocardial infarction and died 25 days later. The key issue at trial was whether the defendant physician, an anesthesiologist, was negligent in not obtaining a preoperative cardiac evaluation. The plaintiff’s cardiology expert asserted that as a “mandatory minimum,” the patient should have had a preoperative cardiac stress test. At trial, the defendant anesthesiologist testified at length regarding his deliberate adherence to the American Heart Association (AHA)/American College of Cardiology (ACC) guidelines addressing preoperative testing for patients with cardiac risk factors. ²⁸ The defendant testified that the AHA/ACC guidelines provided him with an algorithm (“a link in the chain of data”) on which his decisions regarding preoperative cardiac testing in that particular case were based. The value of the AHA/ACC exhibit was underscored when all defense experts agreed that the algorithm not only “represented the standard of care” but actually represented state of the art medicine. The court subsequently ruled in favor of the physician. The case was appealed, and the momentum of the Hinlicky case continued through the appellate system and reached New York’s highest court—the Court of Appeals—where the verdict for the defense was upheld. In its decision, the Court of Appeals recognized that clinical practice guidelines represented systematically developed statements to assist practitioners in decisions; as such, guidelines could be reasonably admitted into evidence for the purpose of illustrating the decision-making steps used in the care of a specific patient.

Importance of State Laws

Individual states have authority to regulate the practice of medicine within their state boundaries through police powers conferred upon them in the Constitution. State laws and regulations regarding the practice of medicine vary significantly, and it is imperative that physicians and other healthcare providers familiarize themselves with the regulations specific to the state in which they practice. State enforcement of regulations related to medical practice is usually delegated to the State Board of Medicine, State Department of Health, Office of Professions, or a similar state agency. The primary responsibilities of State Boards of Medicine are (1) the issuance of licenses to practice medicine, (2) investigation of complaints against licensees, and (3) disciplinary actions. In general, state licensure boards discipline physicians for conduct which is either potentially harmful to public health or conduct involving moral turpitude. Physicians convicted of crimes are uniformly subject to loss of licensure.

Physicians commonly under-appreciate the scope of authority and powers vested in State Boards of Medicine. Lawsuits alleging negligence may subject a physician to liability for plaintiffs’ damages both under insurance policy limits and potentially personal financial liability in the case of excess judgment. Medical negligence actions, unless unusually frequent, egregious, or repetitive, are unlikely to result in loss of licensure. On the other hand, State Boards of Medicine can discipline physicians through either licensure sanctions or licensure revocation. Furthermore, although State Boards must adhere to administrative due process, such administrative hearings are typically closed, not bound by legal precedent, limit the introduction of evidence and witnesses, and generally shift the burden of proof to the defendant-physician.

Policies and Procedures Impacting Hospital Practice

Two interrelated administrative processes relating to the practice of medicine by physicians in hospitals as members of the medical staff are (1) peer review and (2) credentialing. Peer review refers to a continual process of monitoring and evaluation of the qualifications and skills of individual physicians by their collective colleagues. Peer review occurs through departmental quality improvement and morbidity and mortality reviews, informal observation, and review of external adverse administrative actions. ²⁹ The intent of peer review is to ascertain that the physicians on the medical staff are of the highest quality and help minimize quality-of-care–related litigation against the hospital. The two peer review–related issues that most commonly rise to legal scrutiny under peer review relate to (1) the confidentiality of peer review and (2) claims of restraint of trade under the guise of peer review.

The Health Care Quality Improvement Act (HCQIA) of 1986 ³⁰ established the National Practitioner Data Bank (NPDB) as a national repository and clearinghouse for peer review data regarding physicians. Data that must be reported to the NPDB include (1) settlements without trial and judicial verdicts against or involving a physician; ³¹ (2) any action by a State Board of Medicine that revokes, suspends, or otherwise restricts a physician’s license or censures, reprimands, or places a physician on probation for reasons relating to the physician’s professional competence or professional conduct; and (3) any review action by a healthcare entity that completes a professional review action that subsequently adversely affects the clinical privileges of a physician for a period longer than 30 days or involves surrender of a physician’s clinical privileges. ³² Since such data are considered material to the due diligence process whereby clinical medical staff privileges are granted or renewed, hospitals are under a duty to query the NPDB both at the time of a physician’s initial application for clinical privileges and then every 2 years thereafter. ³³ Thus, peer review is the process that represents the foundation for both (1) the credentialing of providers to ensure that minimum requirements for education, training, and certification have been met and (2) formal internal reviews of adverse clinical events and outcomes. ³⁴ If a hospital or other entity fails to request information on a physician who is later sued for malpractice, it is nonetheless legally on notice regarding the physician’s prior history and may be both implicated in the lawsuit and/or held independently liable under a claim of negligent credentialing. In addition to its mandate regarding the NPDB, the HCQIA was also enacted as a means of facilitating the process of peer review and protecting those engaged in candid and objective evaluations of physicians’ professional conduct, competence, and abilities. The HCQIA grants limited immunity from liability in suits brought by disciplined physicians for monetary damages to physicians who participate in professional peer review actions. ³⁵ To be granted peer review immunity under the HCQIA, the review action must be (1) in the reasonable belief that the action was in the furtherance of quality health care, (2) after a reasonable effort to obtain the facts of the matter, (3) after notice and hearing procedures are afforded to the physician involved or after such other procedures as are fair to the physician under the circumstances, and (4) in the reasonable belief that the action was warranted by the facts. ³⁶

Two general circumstances under which legal discovery of otherwise confidential peer review information may be sought are (1) cases of criminal conduct, fraud and abuse, or antitrust actions and (2) in medical negligence cases. In the case where prior training, experience, and outcomes have not been verified through a strict credentialing process, hospitals, departments, and individuals may be liable under a claim of “negligent credentialing.” In criminal cases, federal agencies typically have broad reach regarding what they may obtain via their subpoena powers from hospital files; however, in negligence cases, there is significant state-by-state variation regarding the discoverability of confidential peer review materials. Most states have enacted statutory protections whereby the proceedings, minutes, records, and reports of any medical staff committee, utilization review committee, or peer review committee either oral or written, are considered to be privileged communications that may not be disclosed or obtained by legal discovery. However, in New York, for example, the law is explicitly more limited. Although New York law generally immunizes from disclosure all proceedings and records relating to performance of a medical or a quality assurance review function, it nonetheless creates an exception for statements made by any person in attendance at such a medical or quality assurance review meeting who is a party to an action or proceeding the subject matter of which was reviewed at such meeting. Under the New York statute, disclosure may be obtained where the statements were made during a peer review meeting, the peer review meeting concerned the same subject matter as the action, and the statements were made by a defendant in the action. ³⁷ Therefore, physicians must familiarize themselves with the laws regarding the confidentiality of peer review in their own states.

Peer review has also been used to restrain physicians’ practices. Physicians whose entry into an established provider market might pose a financial threat to existing providers or practices may be prevented from obtaining medical staff privileges under the guise of peer review. Since administrative decisions regarding peer review and credentialing may be appealed for judicial review, the courts confer an additional level of safeguard aimed to maintain a fair due process. The term economic credentialing refers to using economic criteria to determine whether a physician will be granted medical staff membership, privileges, or referrals and is a misuse of the credentialing process to displace existing practitioners and groups from a hospital and replace them with more fiscally desirable medical staff.

In the case of TEE, the credentialing for TEE privileges may cut across the lines of multiple medical specialties such as anesthesiology, cardiology, and radiology. Restriction of TEE credentialing by a dominant specialty within a hospital has been used to prevent credentialing of others. Although strict adherence to a defined credentialing process is important to minimize hospital liability under the negligent credentialing doctrine, inappropriate denial of privileges may conversely result in liability for an unlawful restraint of trade.

Informed Consent

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