Health care provider liability related to defective products

New and presumably better orthopedic implants are introduced to surgeons on a reasonably frequent basis. Often, well-known pioneer surgeons will partner with manufacturers to develop new products; the same surgeons then champion the merits of such products at professional meetings and in the peer-reviewed literature and the product becomes accepted into mainstream clinical practice. But what happens when a new, improved, and higher-priced implant turns out to be a defective product?

As an example, metal-on-metal hip joints were promoted as the choice for younger and active patients. Now some surgeons are facing premature revision surgery in angry and confused patients who were led to believe otherwise, and a legal community that is energized by major, deep-pocketed corporate defendants, and multiple claimants who claim to have suffered from a defective product. This article explores the subject of legal liability of health care providers, such as surgeons and hospitals, in the setting of product liability claims.

Liability law

Product liability law dates back to English common law; however the convergence of new product introduction, aggressive promotion by industry and surgeons, direct-to-consumer marketing by industry and surgeons, as well as public awareness of lucrative financial relationships between surgeons and industry is a relatively novel phenomenon; one that may prove to be the proverbial perfect storm, in which protracted litigation.

Historically, recovery was difficult for plaintiffs injured by defective products. Courts maintained that absent a direct legal relationship between parties, no lawsuit could be maintained. This so-called privity limitation was illustrated in the 1842 English case of Winterbottom v. Wright, in which a coach owned by the postmaster general was repaired, and then used by a contractor whose driver was seriously injured when the coach broke. Even though the repairman’s suboptimal work had led to injury, the court said that the injured driver was in privity only with his employer. The employer could not be sued because he had done nothing wrong, and the repairman, who had erred, could not be sued absent a direct connection between him and the injured driver.

Lawrence Brenner

B. Sonny Bal

Criticism of the above decision led to developments in product liability law over the next 100 years; barriers to plaintiff recovery in product liability suits were broken down progressively. The 1944 decision in Escola v. Coca-Cola Bottling Co., for example, invoked the public interest and held that actions for defective products should be governed by a strict liability standard (ie, no fault would be required to attach liability). This doctrine of strict liability still stands, and is one basis under which product liability suits are filed against manufacturers of defective products.

The other doctrine is that of breach of warranty; a warranty being an express or implied representation to the user of a product. The policy reasoning behind these doctrines is to discourage reckless conduct and ensure product safety.

After the 1960 legal case of Henningsen v. Bloomfield, courts have consistently held that all efforts to waive or disclaim liability related to products are against public policy.

Surgeon liability

Almost all U.S. courts have been reluctant to extend product liability claims to health care providers — physicians and hospitals. Courts have viewed physicians and hospitals as providing a service, and any relationship with a defective product is viewed as incidental to that service mission. But, exceptions exist. A few jurisdictions, such as Missouri, have extended product liability claims to health care providers. Also, there are ways in which liability related to a defective product can arise.

One basis of surgeon liability can occur if any aspect of the care falls below professional standards. Medical records related to injury from a defective product are scrutinized by plaintiffs’ attorneys, and any deviation in the standard of care can come to light; if so, it is advantageous for the plaintiff to add a medical malpractice claim to the product liability complaint.

In product liability actions however, medical negligence is not the issue. Rather, the inquiry focuses on whether the physician or hospital made representation about the quality of the defective product to the patient and whether or not a sale existed, independent of the medical services provided. In order to reach the health care provider, the plaintiff must argue that use of the defective product constituted a sale, in addition to the provision of a professional service. Second, the plaintiff must make a case that the policy behind strict liability and breach of warranty, namely, to ensure product safety, should also extend to the health care provider.

What constitutes sale of a product?

In recent years, surgeons and industry have adopted direct to consumer marketing strategies, citing product advantages, promoting specific products using celebrity endorsements, and advertising themselves to be the first to implant innovative products. Supporting these strategies, in some cases, are consulting arrangements with the manufacturer; recent reports have alleged that such agreements can range from legitimate contracts whereby surgeons are properly compensated for professional activity, to sham arrangements designed to push product sales. Dr. Carl Elliott, a bioethicist, has written a book titled White Coat Dark Hat –Adventures on the Dark Side of Medicine, painting a disturbing picture of an unhealthy alliance between physicians and the pharmaceutical industry, marked by bribery, greed, and a lack of concern for the well-being and health of the public.

The risk for surgeons, especially highly compensated consultants to industry, is that information obtained in discovery may allow counsel to portray the surgeon as a well-compensated accomplice in product failure sales, an accomplice whose conduct went well beyond providing medical services. This scenario could give rise to punitive damages, and the prospect of the manufacturer contending that the sole cause of patient injury was improper implantation, rather than a defective product; such blame-shifting tactics are not uncommon in product liability actions. Furthermore, injured patients may claim a lack of proper qualifications, competency, proficiency, and the failure to communicate the uncertainty in the informed consent process.

Specific sources of liability

Informed Consent: Often with new technologies the informed consent process consists solely of identifying the risks of the surgical procedure. However, to make an informed decision the patient may need to know more, such as:

• The additional risks associated with a new surgical procedure (or some information that such risks cannot yet be determined). This is particularly true in orthopedic surgery, where new products may become popular before their long-term durability and safety is known. Two examples were the prosthetic ACL devices of the middle 1970s, all of which ultimately failed, and the silastic toe joint implants of the 1980s, which had problems of durability.
• The experience and qualifications of the surgeon. Qualifications for a new technique or a technologically advanced implant are difficult to assess. In certain instances, the skill required might be an extension of existing skills that are applied in a different way, whereas in other situations the technology may involve a completely new set of skills. Remember, the more novel the surgery or product, the more detailed the explanation of its nature, risks, and benefits should be.

Professional liability claims involving new technologies might include allegations concerning the capabilities of the surgeon to perform the novel surgery or traditional surgery involving technological advances that require a higher degree of surgical precision. These claims fall into three categories: competence, proficiency, and qualifications.

• Competence: New technologies may involve a new set of surgical skills and aptitudes as well as a higher level of surgical ability. Allegations of incompetence are based on the claim that the surgeon did not acquire these skills prior to performing surgery utilizing new technology.
• Proficiency: The surgeon was competent (possessed the capacity to perform the surgery) but lacked proficiency, the acquired skill obtained through experience with the surgery. Familiarity alone will not suffice. By definition a surgeon will not be proficient in early cases of a novel procedure or implantation of new technology. This is an unavoidable consequence of advancement of surgery. A surgeon is not excused from liability simply because a surgical error occurred during the learning curve. Nor can a surgeon expect to justify an inadequate understanding of the surgery, unless there are highly unusual extenuating circumstances.
• Qualifications: A surgeon may be competent and proficient but subject to a professional liability claim because he/she lacked the qualifications to perform the procedure, ie, lacked an appropriate foundation in the conventional principles of safe surgery as evidenced by his/her training.

Qualifications for performing a new procedure are difficult to define. Formal specialty governing and credential bodies typically avoid participating in the credentialing of new procedures. This role often falls to industry-sponsored courses that may lack objectivity and quality control. Device manufacturers’ education of orthopedic surgeons on new products may be inadequate if the instructors are not experienced orthopedic surgeons or if there is a rush to introduce the new surgical product to avoid market impact by competitors.

In summary, an orthopedic surgeon wishing to avoid claims resulting from new surgical technologies or implantation of new prostheses must assure that he/she is competent, proficient, and qualified in performing the surgery.

Hospital corporate liability

A long line of legal cases from Darling v. Charleston Memorial Hospital onwards have held that a hospital has a direct duty for patient safety notwithstanding the fact that its medical staff are not employees of the hospital. This duty is fulfilled (or not fulfilled) mainly by the credentialing and privileging process. With the introduction of a new technology, preceptoring and proctoring may be required by the hospital to assure competence in the procedure before a surgeon performs a novel or technologically advanced technique.

One of the most important concepts in the law of negligence is “foreseeability.” It is foreseeable that certain new procedures may not be safely performed by surgeons whose only background and education in the new technology is a short industry-sponsored course. A related issue is whether or not an orthopedic surgeon should have been allowed to perform a new procedure or implant a new product without first applying for privileges to do so.

Traditionally most surgeons have assumed that their privileges to perform arthroplasty encompassed any new technology without the requirement of notifying the hospital of their intentions to deviate from the standard procedure. However, the liability of a surgeon performing a new technique or implementing new technology may extend to the hospital where he or she performs the procedure.

Risk management principles

The orthopedic surgeon should be mindful of the following five risk-management principles in dealing with any new implant or technology:

• Assure yourself that there is a reasonable basis to conclude that the patient will likely benefit from what the device manufacturer claims is improved technology.
• Recognize that the informed consent process for new technologies must, by its very nature, be more expansive than with conventional surgeries. This includes communicating uncertainty and risk.
• Even though you are using new technology, always adhere to convectional principles of safe surgery and recognize the potential need for enhanced diligence when implanting a new device.
• Assure yourself that you are not promoting or persuading a patient to undergo a new procedure for inappropriate reasons. Be thoughtful and objective in discussing the relative merits of old versus new technology.
• Realistically assess your expertise and competence to perform the new technology with relative safety. If in doubt, work with a colleague or undergo a preceptorship until you are certain that you have the necessary skills.

• B. Sonny Bal, MD, JD, MBA, is associate professor of hip and knee replacement in the department of orthopedic surgery, University of Missouri School of Medicine.
• Lawrence H. Brenner, JD, is on the faculties of orthopedics at Yale University and the University of Southern California and practices in Chapel Hill, N.C. Address all correspondence to Brenner at lb@lawrencebrennerlaw.com