Strict Liability for Defective Medical Products
This article analyzes the present state of strict liability claims for defective medical products and provides guidance for defense practitioners faced with these cases. Under current Wisconsin law, a plaintiff cannot sue in strict liability for defective medical services; however, it is unresolved whether a plaintiff may sue a hospital under this rule when a defective medical product is at issue. Therefore, a situation may arise where a hospital could be held responsible for selling a defective medication to a patient or implanting a defective device in the absence of any medical negligence. In essence, the plaintiff may seek to hold the hospital strictly liable because it is within the chain of distribution and became the “scene of the crime.”
Strict Products Liability Overview
At first glance, a strict liability claim regarding a defective medical product appears to have merit. Medical supply companies are in the business of manufacturing and selling products to hospitals, who in turn sell these products to patients in the course of treatment. The medical product is typically unchanged when it reaches the consumer, hospitals are within the chain of distribution, and hospitals frequently engage in the sale of medical products. Wisconsin law currently allows a tenuous connection between the defective product and the seller to form the basis of strict liability.[i]
Under this statement of the law, it would be easy for a plaintiff to argue that the hospital should be held liable for the implantation of a defective medical product. Accordingly, defense counsel must advocate for the distinction between the same of defective medications and the implantation of defective medical products in cases involving the sale and use of defective products in the course of rendering medical treatment.
Wisconsin adopted the rule of strict liability in tort, as set forth in Restatement (2d) Torts, § 402A (1965), in Dippel v. Sciano.[ii] Section 402A, titled “Special Liability of Seller of Product for Physical Harm to User or Consumer,” states:
(1) One who sells any product in a defective condition unreasonably dangerous to the user or consumer or to his property is subject to liability for physical harm thereby caused to the ultimate user or consumer, or to his property, if:
(a) the seller is engaged in the business of selling such a product, and
(b) it is expected to and does reach the user or consumer without substantial change in the condition in which it is sold.
(2) The rule stated in Subsection (1) applies although:
(a) the seller has exercised all possible care in the preparation and sale of his product, and
(b) the user or consumer has not bought the product from or entered into any contractual relation with the seller.[iii]
Therefore, in order to succeed on a claim against a chain of distribution defendant, the plaintiff must prove:
(1) that the product was in a defective condition when it left the possession or control of the seller;
(2) that it was unreasonably dangerous to the user or consumer;
(3) that the defect was a cause of the plaintiff’s injuries or damages;
(4) that the seller engaged in the business of selling such product (i.e., that the sale of the product in question was not an isolated or infrequent transaction, unrelated to the principal business of the seller); and
(5) that the product was one which the seller expected to and did reach the user or consumer without substantial change in the condition it was when he sold it.[iv]
It is important to note that an “unreasonably dangerous” defect was later defined as a danger beyond the idiosyncratic response of a particular plaintiff. It is generally recognized that a seller is not strictly liable under § 402A to a consumer who suffers an allergic or toxic reaction to a product without any identifiable defect.[v] Thus, a plaintiff must prove that the medical product was both defective and the cause of the plaintiff’s injuries or damages. Accordingly, if the product was not defective, and hence not unreasonably dangerous to the general population, or if the product was defective, but not the actual cause of the injuries, strict liability does not apply.
In Hoven v. Kelble, Hoven filed a strict liability claim for allegedly defective medical services rendered by the hospital and doctors during a lung biopsy.[vi] The court explicitly refused to extend the Dippel test of strict liability beyond the context of dangerous products into professional medical services:
“There have been many studies of the delivery of health care in this country and of the problems of the malpractice concept of tort liability. Although there may be general dissatisfaction with our present tort medical injury compensation system, moving from the malpractice concept – even with its many problems – to a strict products liability system at the present time appears to be a dubious move.”[vii]
The court noted several commentators’ preference for “no-fault liability” in lieu of negligence or strict-liability concepts in the context of defective medical products.[viii] However, the court did not elaborate on the distinction between dangerous products and negligent professional services for purposes of determining strict liability in a medical setting. This arbitrary distinction is still the present law in Wisconsin.
The Hoven court noted that “[i]t is generally the physician – not the patient – who determines the kind of services to be rendered and how often. It is the physician and not the patient who prescribes other goods and services, e.g., drugs, therapy, and hospitalization, that should supplement the physicians services.”[ix] This reasoning may shed light on the courts’ willingness to define “professional services” expansively to include those products that supplement medical treatment.
In terms of policy considerations, the Hoven court highlighted that while there are some justifications for holding the medical profession strictly liable for the products they use in the course of treatment, those justifications are generally outweighed by other factors. The policy considerations weighing against imposing strict liability for defective products include:
1) A tendency of medical services to be experimental;
2) A dependence on factors beyond the control of the professional; and
3) A lack of certainty or assurance of results.[x]
Moreover, any application of strict liability to medical providers would increase the cost of medical services beyond the means of consumers and hinder the development of new medicines and medical techniques.[xi] In the end, the Hoven court did not specifically indicate whether its ruling applied to strict liability claims involving defective products combined with medical services.
In Hoff v. Zimmer, Inc., the United States District Court, W.D. Wisconsin, applying Wisconsin law, held that a strict liability claim may not be asserted against a hospital based upon injury caused by a defective product supplied by the hospital to a doctor who used the product in rendering medical services.[xii] There, Hoff alleged that she sustained personal injuries following surgical implantation of a defective hip prosthesis.[xiii] After the defendant doctor removed the action to federal court on the basis of diversity, Hoff moved to amend the complaint to add the hospital as a defendant with respect to the strict liability claim only.[xiv] Ultimately, the court did not allow Hoff to submit an amended complaint because any claims made against the hospital in strict liability would be meritless.[xv]
The Hoff court reviewed the applicable Wisconsin law, including Hoven, and determined that any claim made against the hospital on a theory of strict liability would fail as a matter of law.[xvi] The opinion recognized that, “[g]enerally, courts will not apply the doctrine of strict liability to a hospital or medical practitioner for injuries caused by medical instruments, drugs, or other substances used in treatment.”[xvii] Moreover, while the Hoff court acknowledged that Hoven does not specifically preclude a strict liability claim when the injury was caused by a defective product supplied by a hospital, and then used in rendering medical services, it ultimately ruled that this was not permissible: “Whether the injury results from the treatment provided (or omitted) or from the product used in the treatment, the same public policy reasons support the denial of strict liability to a provider of medical services.”[xviii]
Survey of the Law in Other States
The Hoff court recognized that other states, including Texas, Florida, California, New York and New Jersey, have likewise concluded that strict liability should not apply to a hospital when defective products are used in conjunction with providing medical treatment.[xix] These states have adopted the rationale that the essence of the transaction between the retail seller and the consumer relates to the article sold.[xx] For instance, the Florida Court of Appeals refused to impose strict liability against a hospital for the malfunction of an electro-surgical grounding pad because the hospital is not within the product’s distributive chain, but more like a consumer that employs a product in the course of providing a medical service.[xxi] Similarly, the Texas court of appeals refused to apply strict liability against a hospital because it was not a “merchant” dispensing the malfunctioning medical product.[xxii] Ultimately, a hospital offers, and is paid for, professional service and skill -- the sale of the medical product should be considered secondary to the services performed by the hospital.
For example, in Silverhart v. Mt. Zion Hospital, a patient brought a strict liability action against the hospital for damages allegedly sustained when a defective surgical needle broke during an operation and became permanently lodged in the patient’s body.[xxiii] The court denied the claim, holding that the hospital had merely furnished the product in connection with its business of treating the patient.[xxiv] Similarly, in Probst v. Albert Einstein Medical Center, the court ruled that the hospital could not be held strictly liable for selling a defective spinal rod to a patient after it broke following surgical implementation.[xxv] Wisconsin law should similarly distinguish between the true services of the hospital – professional skills and services – and the incidental act of implanting medical products. Wisconsin’s courts should carve out an exception that precludes the application of strict liability when defective medical products are sold by a hospital and used in conjunction with rendering professional services.
This distinction is already in place with respect to the transfer of contaminated blood. The Wisconsin legislature has enacted a statute that specifically precludes application of warranty or strict liability in contaminated blood cases because “. . .all use of blood and blood products is considered a service.”[xxvi] The support for this exception to warranty and strict liability claims arises from the previous scientific inability to screen all carriers for certain viruses, including hepatitis and HIV-AIDS, which made blood unavoidably dangerous despite due care. This consideration, coupled with the fact that blood transfusions are often essential in medical treatment, prompted most states to take legislative action to preclude the application of strict liability in cases involving contaminated blood and blood products.[xxvii] Similarly, the implantation of medical products is often unavoidable and necessary to save a patient’s life. The fact that the medical product later proves defective should not open an avenue to liability for the injured plaintiff because of public policy concerns and because the hospital is not in the “business” of providing such products. Instead, the hospital provides those incident to its true services, and only in cases of extreme need.
In sum, when faced with such an argument, a motion for summary judgment should set forth two argument when faced with this issue:
(1) First, argue that the sale of the defective product was inextricably intertwined and merely incidental to rendering professional medical services, and therefore strict liability should not be permissible under Hoven and Hoff.
(2) Or, argue that the same overriding policy considerations that apply to rendering professional services take priority over applying strict liability to a hospital for the sale of defective medical products – public policy dictates that the strict liability claim should be meritless.
Once the five Dippel factors are met, the tide is turned heavily in favor of the plaintiff in strict products liability cases. It is imperative that defense counsel advocate for the creation of a clear exception to the application of strict liability in situations involving defective medical products under Wisconsin law. Hospitals should not be held strictly liable on the sole basis of being within the chain of distribution and being the “scene of the crime” when defective medical products are at issue.
[i] See Kemp v. Miller, 154 Wis. 2d 538, 453 N.W.2d 872 (1990)(holding that a commercial lessor may be held strictly liable in tort for damages resulting from the lease of a defective and unreasonably dangerous product. Such liability extends not only to design and manufacturing defects, but also to defects which arise after the product leaves the manufacturers’ control).
[ii] 37 Wis. 2d 443, 155 N.W.2d 55 (1967).
[iii] Restatement (2d) Torts, § 402A (1965).
[iv]Dippel, 37 Wis. 2d at 460, 155 N.W. 2d at 63.
[v] See Green v. Smith & Nephew AHP, Inc., 2000 WI App. 192, 238 Wis. 2d 477, 617 N.W.2d 881, 885 (citing Adelman-Treblay v. Jewel Cos., 859 F.2d 517, 522 (7th Cir.)(consumer may not recover in strict liability for injuries she suffered following her idiosyncratic allergic reaction to glue in an artificial-nail kit).
[vi] 79 Wis. 2d 444, 256 N.W.2d 379 (1977).
[vii] Hoven, 79 Wis. 2d at 471.
[viii] Id., at 471.
[ix] Id. at 391.
[x] Id. at 467-472.
[xii] 746 F Supp 872 (1990, WD Wis).
[xiii] Id. at 873.
[xiv] Id. at 874.
[xv] Id. at 876.
[xvi] Id. at 874.
[xvii] Id. citing Hoven v. Kelble, 79 Wis.2d 444, 256 N.W.2d 379 (1977).
[xviii] Id. at 875.
[xix] See Silverhart v. Mt. Zion Hospital, 20 Cal.App.3d 1022, 98 Cal.Rptr. 187 (1971); Magrine v. Krasnica, 94 N.J.Super. 228, 227, A.2d 539 (Law Div. 1967); Cutler v. General Electric Co., 4 U.C.C.Rep.Serv. 300 (N.Y.Sup.Ct. 1967).
[xx] Cutler v. General Electric Co., 4 U.C.C.Rep.Serv. 300 (N.Y.Sup.Ct. 1967); See also Hector v. Cedars-Sinai Medical Center, 180 Cal.App.3d 493, 225 Cal.Rptr. 595 (1986)(hospital not strictly liable for defective pacemaker); Probst v. Albert Einstein Medical Center, 82 A.D.2d 739, 440 N.Y.S2d 2 (1981)(hospital not strictly liable for defective spinal rod broken after surgical implantation).
[xxi] North Miami General Hosp., Inc. v. Goldberg, 520 So. 2d 650 (Fla. Dist. Ct. App. 1988) (overturning jury's verdict of strict liability against hospital for injuries suffered as a result of malfunction of electro-surgical grounding pad; holding that hospital is not a business within product's distributive chain but more like a consumer that employs a product in the course of providing medical services).
[xxii] Nevauex v. Park Place Hosp., Inc., 656 S.W.2d 923 (Tex. Ct. App. 1983) (hospital not liable for misapplication of cobalt radiation, because it is not a "merchant" dispensing radiation treatment).
[xxiii] 20 Cal.App.3d 1022, 98 Cal.Rprt. 187 (1971).
[xxv] 82 A.D.2d 739, 440 N.Y.S2d 2 (1981).
[xxvi] Wis. Stat. § 146.31(2) (emphasis added).
[xxvii] Hoven, 256 N.W.2d 388 n. 10. See also, 100 A.L.R.3d 1205.