Denise Budding, Plaintiff/Appellant, v. SSM Healthcare System, et al., Defendants/Respondents.

This slip opinion is subject to revision and may not reflect the final opinion adopted by the Court. Opinion Missouri Court of Appeals Eastern District Case Style: Denise Budding, Plaintiff/Appellant, v. SSM Healthcare System, et al., Defendants/Respondents. Case Number: 74455 Handdown Date: 09/14/1999 Appeal From: Circuit Court of the City of St. Louis, Hon. David C. Mason Counsel for Appellant: Jeffrey J. Lowe and Nancy R. Richards Counsel for Respondent: Kenneth W. Bean, Thomas J. Smith and Carl J. Geraci Opinion Summary: Plaintiff Denise Budding appeals the judgment entered on the jury's verdict in favor of the hospital. Budding alleged the Hospital was liable for injuries attributable to defectively designed teflon implants for her jaw that were inserted at the hospital's St. Mary's Health Center in 1984. REVERSED AND REMANDED. Division Two holds: The trial court erred in refusing Budding's proffered verdict directing instruction. Substitution of the word "transferred" for the word "sold" as permitted in the notes on use for MAI 25.04 would have properly instructed the jury as to the first element of her claim based on strict liability in tort. She was not required to prove that the hospital made a separate charge for the implants. By transferring the implants in the ordinary course of its business, the hospital could properly be held to have placed the defective products in the stream of commerce. Citation: Opinion Author: PER CURIAM Opinion Vote: REVERSED AND REMANDED. Crahan, P.J., filed separate concurring opinion. Teitelman, J., filed separate concurring opinion. Mooney, J., concurs in separate concurring opinion of Teitelman, J. Opinion:

Denise Budding ("Plaintiff") appeals the judgment entered in accordance with the jury's verdict in favor of SSM Healthcare System ("Hospital").(FN1) Plaintiff alleged Hospital was liable for injuries attributable to defectively designed Vitek(FN2) proplast teflon temporomandibular joint (TMJ) implants which were inserted at Hospital's St. Mary's Health Center in 1984. We reverse and remand for a new trial due to instructional error. When Plaintiff was a teenager, she began to experience pain in her jaws, which gradually worsened to the point that she experienced headaches and loss of appetite. In 1983, Dr. Kenneth Rotskoff diagnosed TMJ disease. In 1984, due to the severity of the disease, Dr. Rotskoff scheduled Plaintiff for surgery. Dr. Rotskoff intended to either rebuild the temporomandibular joint or place an implant. When he surgically opened her jaw, he determined that he could not rebuild the existing joint due to the extent of the disease. At that point, he made the decision to insert the Vitek teflon implants, which he obtained from an inventory of implants ordered and stocked by Hospital at his request. Dr. Rotskoff decided which implants to use, sized and fitted the implants, and then surgically inserted them. Following the operation, Plaintiff's symptoms significantly improved. She returned to work and remained virtually asymptomatic for six years. In 1990, Plaintiff again began experiencing pain in her jaw. She returned to Dr. Rotskoff, who ordered x-rays. During this visit, Dr. Rotskoff told Plaintiff that he had learned that teflon implants could cause a giant cell foreign body reaction which could lead to formation of a tumor and destruction of adjacent bone. Dr. Rotskoff recommended that the implants be surgically removed. Plaintiff declined. In March 1991, Dr. Rotskoff sent Plaintiff a letter concerning the Vitek implants as well as an FDA safety alert warning about potential problems with the implants and recommending repeat x-ray examinations and possible removal of the implants if problems developed. In early 1993, Plaintiff obtained a second opinion which agreed with Dr. Rotskoff's recommendation that the implants be removed. Plaintiff decided to undergo surgery to remove the implants in April 1993. During the surgery, Dr. Rotskoff found a giant cell tumor as he was dissecting off the right implant, which had become affixed to part of the floor of the skull. During removal of the implant, part of the base of the skull came off, leaving a hole in the floor of the temporomandibular joint going into the base of the skull. A neurosurgeon was called to assist in closing the hole in the cranial cavity. Dr. Rotskoff testified that the hole was caused by a giant cell foreign body reaction. After the surgery, Plaintiff complained of facial nerve weakness and numbness, severe pain, pain in her bite joint, and seizure-type activity. Plaintiff also complained of pain in the side of her head, heat on the side of her face and decreased hearing. Due to the complications of the first surgery, Dr. Rotskoff was unable to remove both implants during one surgery as planned. Three weeks later, Dr. Rotskoff performed a second surgery and removed the left implant without any

additional complications. Plaintiff filed suit against Hospital in October 1995 seeking to hold Hospital strictly liable for what she alleged were defects in the teflon implants. Plaintiff's theory at trial was that the teflon implants were defectively designed because teflon is an unsuitable material for use in a joint. Specifically, Plaintiff's expert, Dr. Eppley, testified that teflon, when subjected to the force and frequency of normal biting activity, tends to wear and fragment in three years or less. According to Dr. Eppley, once teflon is broken up and fragmented, it is one of the most bioreactive materials in the world. This, in turn, triggers the giant cell foreign body reaction that can, in turn, destroy surrounding tissue and bone. In Dr. Eppley's opinion, this is what occurred in Plaintiff's case. As indicated at the outset, the jury rendered a verdict in favor of Hospital and the trial court entered judgment accordingly. On appeal, Plaintiff raises six points of error, two complain of instructional error and four pertain to various evidentiary rulings. We find Plaintiff's first point to be dispositive. In her first point, Plaintiff claims the trial court erred in refusing her proffered jury Instructions "A" and "B" and requiring Plaintiff to use MAI 25.04 unmodified, thereby requiring the jury to find that Hospital "sold" the implants to Plaintiff. The verdict director given by the Court was as follows: Instruction Number 6 Your verdict must be for plaintiff Denise Budding if you believe: First, defendant St. Mary's Health Center sold the Vitek proplast teflon implants in the course of defendant's business, and Second, the Vitek proplast teflon implants were then in a defective condition unreasonably dangerous when put to a reasonably anticipated use, and Third, the Vitek proplast teflon implants were used in a manner reasonably anticipated, and Fourth, plaintiff was damaged as a direct result of such defective condition as existed when the Vitek proplast teflon implants were sold. Plaintiff proffered to the court two alternatives to Instruction number six. Instruction "A" was identical to Instruction number six except that it omitted the first paragraph requiring a finding that Hospital "sold" the implants in the course of its business. Plaintiff pointed out to the court that the notes on use to MAI 25.04, which was the source for Instruction number six, specifically provide that the term "sold" should be modified to cover other situations such as a commercial lease where strict liability is applicable. Plaintiff urged that under Mulligan v. Truman Medical Center, 950 S.W.2d 576,

582 (Mo. App. 1997), she was not required to prove a sale, only that Hospital had placed the defective product in the stream of commerce. Plaintiff argued that use of the term "sold" would be misleading to the jury because, although Dr. Rotskoff testified that he obtained the implant from Hospital's inventory and Hospital conceded that it maintained such an inventory and customarily charged patients for implants, Hospital was unable to produce a bill containing a specific charge for these implants. Thus, Plaintiff urged, use of the term "sold" in Instruction number six could lead the jury to believe it should return a verdict for Hospital if it did not believe Hospital rendered a separately stated charge for the implants. Inasmuch as it was undisputed that Hospital did render a bill for the surgical services it provided, Plaintiff proposed that the first paragraph could properly be omitted. Alternatively, Plaintiff proposed Instruction "B," which was identical to Instruction number six except it substituted the term "transferred" for the term "sold." Although the trial court agreed with Plaintiff that use of the term "sold" could be misleading, it refused Plaintiff's proposed Instructions "A" and "B." Instead, relying on language from Bailey v. Innovative Management Inv., Inc., 916 S.W. 2d 805, 807-08 (Mo. App. 1995), the trial court proposed that the first paragraph of the instruction be modified to require a finding that Hospital "sold the Vitek proplast implant for the personal profit or other benefit of Defendant's business." Plaintiff declined this proposal on the ground that the language of Instruction number six as ultimately given would be less confusing to the jury. On appeal, Plaintiff again urges the trial court erred in refusing her proffered Instructions "A" and "B" because strict liability attaches not only based on a "sale" of the product but also by reason of a transfer of the product in the ordinary course of business. We find no error in the trial court's refusal of Instruction "A." Hospital did not concede that it provided these specific implants although the evidence tended to show that Hospital was the likely source. We agree, however, that the trial court erred in refusing Instruction "B." In Bell v. Poplar Bluff Physicians Group, Inc., 879 S.W. 2d 618, 619 (Mo. App. 1994), a case which also involved the issue of a hospital's strict liability for TMJ implants, the court observed, "a sale of a product is not required to bring an action for strict liability. Liability is imposed on those placing a product in the stream of commerce. The product need not be sold if it has been placed in the stream of commerce by other means." Id. The fact that the supplier of the product is primarily a provider of services rather than a seller of goods is irrelevant. Mulligan, supra, 950 S.W.2d at 582. (also involving a hospital's strict liability for TMJ implants). See also Gabbard v. Stephenson's Orchard Inc., 565 S.W. 2d 753, 757 (Mo. App. 1978) (lease or bailment for mutual benefit of the parties supports imposition of strict liability irrespective of a sale); Restatement (second) of Torts, section 402 A, comment f. (1965) (seller need not be engaged solely in the business of selling such products).

Bailey v. Innovative Management Inv., Inc., supra, the case relied upon by the trial court and by Hospital on appeal, is not to the contrary. The issue in Bailey was whether a construction company, which loaned a nail gun to its employee, could be held strictly liable for injuries accidentally inflicted on a third party while employee was using the nail gun. 916 S.W.2d at 807. The construction company was not in the business of selling or leasing nail guns or other tools, did not charge employee for use of the nail gun, and had no connection with the building project where the third party was injured. Id. Summary judgment for the construction company was affirmed based on the evidence that the company's loan of the nail gun was an isolated non-commercial transaction, for which it received no compensation. Id. at 808. Thus, the plaintiff could not show that the company had placed the item in the stream of commerce, a required element for the imposition of strict liability. Id. In essence, the company was an end user, not a supplier of the nail gun. Bailey does contain a somewhat confusing passage which it describes as a quotation from Gunderson v. Sani- Kem Corp., 674 S.W.2d 665, 668 (Mo. App. 1984) but is actually the Gunderson court's quotation from 72 C.J.S. Supp., Products Liability, Sec. 40, p. 60: The word "sells" within the Restatement rule [Rest.2d Torts, Section 402A] of strict liability is merely descriptive, and the test for determining the applicability of the rule is not the sale of the product, but rather the placing thereof in commerce. Thus, liability is imposed on all those in the chain of placing a defective product in the stream of commerce, and the product need not be actually sold if it has been injected in the stream of commerce by other means. Under the stream-of-commerce approach to strict liability no precise legal relationship to the member of the enterprise causing the defect to be manufactured or to the member most closely connected with the customer is required before the courts will impose strict liability; it is the defendant's participatory connection, for his personal profit or other benefit, with the injury-producing product and with the enterprise that created consumer demand for and reliance upon the product which calls for the imposition of strict liability. * * *. [Brackets and italics added.] We do not interpret this passage to require a showing that a supplier made a "profit" in the sense of a net profit on the individual product in question or that the plaintiff must show that the defendant's overall business was profitable. Under the stream of commerce approach to strict liability, the focus is not on profit in that sense; the focus is on the acceptance of remuneration or some other benefit in the ordinary course of a business which involves some sort of transfer of the product to another. This is how Missouri Courts have consistently applied the stream of commerce requirement. See, e.g., Bailey, supra; Gunderson, supra; Menschik v. Mid-America Pipeline Co., 812 S.W. 2d 861, 863-64 (Mo. App. 1991). Plaintiff's proffered Instruction "B," that Hospital "transferred" the implants in the ordinary course of its business, would have correctly instructed the jury as to the elements of the stream of commerce requirement that were in dispute. Although Dr. Rotskoff testified that he obtained the implants from Hospital and Hospital conceded that it had maintained an inventory of implants and had a practice of charging patients for them, Hospital had no records which confirmed that it

provided the implants in this instance. On the other hand, it was undisputed that Hospital was involved in the business of providing health care services, which included surgical emplacement of implants, and that it charged remuneration for such services. Whether Hospital made a specific, separate charge for the implants was irrelevant. If, in fact, Hospital provided these particular implants, it placed them in the stream of commerce and was subject to strict liability. If a challenged instruction places a greater burden on the party submitting the case than a correct instruction and the verdict is against the party bearing the burden, prejudicial error has occurred. Gaffney v. Community Federal Savings and Loan Ass'n., 706 S.W. 2d 530, 536 (Mo. App. 1986). Under the challenged instruction, there was a very real possibility that the jury might believe that Hospital did supply the implants but could not be held liable unless it made a separate charge for them. Indeed, Hospital expressly argued to the jury that Plaintiff had failed to prove Hospital made a separate charge for the implants. Plaintiff was not required to prove Hospital made a separate charge for the implants. Accordingly, the instructional error was prejudicial to Plaintiff and the case must be reversed and remanded for a new trial. Hospital alternatively argues that Plaintiff was not prejudiced because imposition of strict liability on hospitals is contrary to public policy and inconsistent with Chapter 538 RSMo 1994 governing tort actions based on improper health care. These contentions were specifically considered and rejected in Mulligan, supra. These arguments are better addressed to the Missouri Supreme Court. Rule 83.02. Hospital further argues that Plaintiff's action is barred by the two year statute of limitation found in section 516.105 RSMo 1994. This contention was likewise considered and rejected in Bell, supra; Brandon v. Southeast Missouri Hosp. Inc., 926 S.W.2d 113 (Mo. App. 1996); and Pinkerton v. Southeast Missouri Hosp. Ass'n., 926 S.W.2d 137 (Mo. App. 1996). Plaintiff's second point pertaining to instructional error is rendered moot by our decision. Plaintiff's remaining points pertain to evidentiary issues that may not arise on retrial. Accordingly, we decline to address them. The judgment is reversed and the cause is remanded for a new trial consistent with this opinion. All Concur. Footnotesn : FN1. There were two defendants, SSM Healthcare System and SSM Healthcare System II, which owned St. Mary's Health Center at different times. During trial and in the instructions both defendants were referred to in the singular. We continue to do so in this opinion. FN2. Vitek is not a party to this suit. Plaintiff's claim against Vitek was discharged in bankruptcy. Separate Opinion:

Plaintiff's proffered Instruction "B." I write separately to encourage the Missouri Supreme Court to use this case to reexamine the law in this area and to explain why I believe Bell v. Poplar Bluff Physicians Group, Inc., 879 S.W.2d 618 (Mo. App. 1994) and Mulligan v. Truman Medical Center, 950 S.W.2d 576 (Mo. App. 1997) were incorrectly decided and are inconsistent with the legislature's intent as expressed in Chapter 538 RSMo 1994. At the outset, I note that according to my limited research, Missouri apparently stands alone in recognizing a cause of action for strict liability against health care providers. Most states considering the issue have rejected liability on the ground that hospitals and physicians are not engaged in the business of selling implantable devices; they are engaged in the business of providing medical services. See, e.g. Hector v. Cedar-Sinai Medical Center, 180 Cal. App. 3d 493, 225 Cal Rptr. 595 (1986) (pacemaker); Cafazzo v. Central Medical Health Services, Inc., 542 Pa. 526, 668 A. 2d 521 (1995) (TMJ implants); Ayyash v. Henry Ford Health Systems, 210 Mich. App. 142, 533 N.W.2d 353 (1995) (TMJ implants); St. Mary Medical Center, Inc. v. Casko, 639 N.E.2d 312 (Ind. App. 1994) (pacemaker). A better reasoned approach, rejecting strict liability for health care providers based on examination of each of the five public policy rationales traditionally advanced in support of strict liability can be found in Parker v. St. Vincent Hosp., 122 N.M. 39, 919 P.2d 1104 (N.M. App. 1996) (TMJ implants). The first Missouri case to consider whether a strict liability action could be maintained against a health care provider was Hershley v. Brown, 655 S.W.2d 671 (Mo. App. 1983). In Hershley, the plaintiffs sued a physician alleging strict liability, negligent installation of a foreign object and fraudulent misrepresentation and concealment of a battery. The strict liability count alleged the physician had implanted a defective tubal ring. Id. at 674. After reviewing cases from other jurisdictions, the Court held that strict liability should not be applied to physicians and that the count alleging strict liability was properly dismissed. Id. at 675. This was the state of the law in Missouri until Bell was decided in 1994. Bell acknowledged the holding in Hershley but declined to follow it, observing that, even if the sale of an implant is incidental to a hospital's purpose, that should not relieve it of liability any more than if a hospital sells a defective toy in its gift shop or a hairdresser sells a defective hairspray incidental to her other services. 879 S.W.2d at 619. There is, of course, a fundamental difference between a hospital's sale of an item in its gift shop and its "sale" of an implant. Selection of the implant is made by a physician in the exercise of his or her professional judgment. Hospitals do not maintain bins of TMJ implants with price tags on them for consumers to make their selections. Even if they did, the

implants would present no danger to anyone because the danger they present can occur only if they are surgically implanted by a physician who must necessarily make a medical judgment that the implants are the best option available to alleviate the patient's problem. In that sense, the physician's medical judgment may properly be viewed as an intervening cause of the patient's damage. "But for" the medical judgment that surgical placement of the implant is the best treatment alternative, the patient could not have been harmed by the implant. Although Bell and Mulligan(FN1) reach the same conclusion, they conflict on one important point. Bell reviewed the product liability statute, sec. 537.760 to 537.765 RSMo 1994 and found it significant that it contained no exception for health care providers. 879 S.W.2d at 620. Thus, the Bell court reasoned, to create an exception for health care providers would be contrary to the legislature's expressed intent. Id. at 620-21. As the Mulligan court recognized, however, the legislature did exempt health care providers from the provisions of the new product liability statute in section 538.300, which was adopted simultaneously with sections 537.760 to 537.765 in

1. Mulligan, 950 S.W.2d at 581. According to the Mulligan court, however, because strict product liability had been

recognized at common law prior to the enactment of sections 537.760 to 537.765, and because those sections do not actually create a cause of action for strict liability but merely modify the common law in certain respects, the enactment of section 538.300 did not evidence a legislative intent to preclude products liability actions against health care providers. Id. Rather, according to Mulligan, the meaning of section 538.300 is simply that the provisions of the tort reform act are inapplicable in actions against health care providers. Id. Thus, one may maintain a traditional common law strict liability action against a health care provider but a health care provider cannot be dismissed from a suit based solely on its status as a seller even if the manufacturer is also a party, it cannot assert a "state of the art" defense, and contributory fault is not abolished as a complete bar to recovery. Id. This somewhat circular reasoning overlooks a number of salient points. Although it is true that strict liability actions were permitted by common law prior to the enactment of sections 537.760 to 537.765, the state of the common law at the time the statute was enacted was that strict liability was not applicable to physicians and thus, by implication, to health care providers. Hershley was decided in 1983, approximately four years prior to the enactment of sections 537.760 to 537.765. The legislature is presumed to be aware of the state of the law at the time it enacts a statute. In the matter of Nocita, 914 S.W.2d 358, 359 (Mo. banc 1996). Both Mulligan and Bell also overlook other provisions of Chapter 538 which are fundamentally irreconcilable with the concept of maintaining strict liability actions against health care providers. Specifically, section 538.205 expressly defines "health care services" to include "transfer to a patient of goods or services incidental or pursuant to the practice of

the health care provider's profession or in furtherance of the purposes for which an institutional health care provider is organized." (emphasis added). Hospital's provision of TMJ implants in the manner that occurred in this case falls squarely within this definition. Section 538.225(FN2) further provides that in "any action" against a health care provider for damages on account of the rendering or failure to render health care services (which, applying the definition of health care services squarely encompasses the claims in this case) the plaintiff or his attorney "shall file" an affidavit stating he has obtained the written opinion of a qualified health care provider which would support a finding of negligence and causation. (emphasis added). Ordinarily, a plaintiff asserting a true strict liability claim would be unable to satisfy this requirement because strict liability claims are not based on fault. Any plaintiff who could satisfy this requirement doesn't need strict liability because he can make a submissible case of negligence. With its enactment of section 538.225, the legislature essentially codified the law established in Hershley, - i.e., a claim against a health care provider based on defective devices implanted during treatment must be based on negligence, not strict liability.(FN3) It is also worth noting that allowing strict liability actions against health care providers potentially places them in a no-win situation. Health care providers are obliged by the canons of their profession and the law to abide by the requisite medical standard of care. At the time Dr. Rotskoff made the decision to use the teflon implants in this case, the very same authoritative medical journal relied upon by Plaintiff's experts to support their opinion of defect were carrying articles touting the use of teflon implants as superior to other treatment options. Although teflon was ultimately proven unsuitable with the passage of time, until that day arrived Dr. Rotskoff conceivably could have been found negligent if he used something else. Finally, the acknowledged purpose of Chapter 538 is that it was an effort to control costs and assure the continued integrity of the health care system. Mahoney v. Doerhoff Surgical Services, 807 S.W.2d 503, 507 (Mo. banc 1991). It is difficult to conceive how that purpose would be advanced by prohibiting health care providers, but not their suppliers, from being dismissed from a case if a solvent manufacturer has been joined. Or how it would serve that purpose to allow manufacturers, but not health care providers, to assert a "state of the art" defense in a failure to warn case, which Mulligan holds was the legislature's intent. 950 S.W.2d at 581. Although not raised by Hospital in this case, it is questionable whether such provisions would satisfy due process, let alone advance the legislature's acknowledged objective. The better view, and one that gives meaning to all of the provisions of Chapter 538, is that section 538.300 was enacted by the legislature to make it clear that in enacting sections 537.760 to 537.765, it had no intention of disturbing the existing state of the law established in Hershley.

To date, the Missouri Supreme Court has declined to address this issue, denying transfer in all four previous TMJ implant cases. Those cases, however, were all reversed and remanded after the trial courts granted dispositive motions. In this case, we now have a complete record upon which to decide the issue. If, as suggested herein, Bell and Mulligan do not correctly interpret the legislature's intent, the legislature may well be awaiting definitive word from the Missouri Supreme Court. Even if Bell and Mulligan's ultimate conclusions are correct, definitive guidance as to the doctrinal basis underpinning a strict liability action would greatly assist the development of the law. For the foregoing reasons, I urge the Missouri Supreme court to accept transfer of this case. Footnotes: FN1. This Court's decisions in Brandon v. Southeast Missouri Hosp., Inc., 926 S.W.2d 113 (Mo. App. 1996) and Pinkerton v. Southeast Missouri Hosp. Ass'n., 926 S.W.2d 137 (Mo. App. 1996) simply follow Bell without any extended discussion of its rationale. FN2. Section 538.225 RSMo 1994 provides: 538.225. Affidavit by a health care provider certifying merit of case-content filed, when-failure to file, effect. -1. In any action against a health care provider for damages for personal injury or death on account of the rendering of or failure to render health care services, the plaintiff or his attorney shall file an affidavit with the court stating that he has obtained the written opinion of a legally qualified health care provider which states that the defendant health care provider failed to use such care as a reasonably prudent and careful health care provider would have under similar circumstances and that such failure to use such reasonable care directly caused or directly contributed to cause the damages claimed in the petition.

1. The affidavit shall state the qualifications of such health care providers to offer such opinion.
2. A separate affidavit shall be filed for each defendant named in the petition.
3. Such affidavit shall be filed no later than ninety days after the filing of the petition unless the court, for good

cause shown, orders that such time be extended.

1. If the plaintiff or his attorney fails to file such affidavit the court may, upon motion of any party, dismiss the

action against such moving party without prejudice. FN3. Judge Teitelman cites Judge Maus's dissent in State ex rel American Medical International v. Sweeney, 845 S.W.2d 648, 652 (Mo. App. 1993), for the proposition that the affidavit requirement of section 538.225 is not inconsistent with allowing common law strict liability claims. Judge Maus agreed that section 538.225 clearly and unambiguously applied to implant cases. Id. Judge Maus would have reconciled the affidavit requirement of section 583.225.1 by simply ignoring or excusing the unambiguous requirement that the affidavit establish a failure to satisfy the applicable standard of care. Instead, Judge Maus would have required an affidavit to the effect that the defective product caused the harm. Id. Thus, Judge Maus's approach would simply disregard one clear requirement of the statute and substitute a new requirement that doesn't appear anywhere in the statute. This would be judicial legislation, not reconciliation. Separate concurring opinion by Richard B. Teitelman, Judge:

Center, 950 S.W.2d 576, 65 A.L.R. 5th 731 (Mo. App. W.D. 1997), was correctly decided, and that Bell v. Poplar Bluff Physicians Group, Inc., 879 S.W.2d 618 (Mo. App. S.D. 1996), was correct in the result reached. Since Mulligan was

correctly decided and there is no conflict among the three Districts of the Court of Appeals I see no need for the Missouri Supreme Court to accept transfer of this case; but if it does, I believe it should find that allowing common law strict product liability claims against hospitals in cases such as this one is neither inconsistent with our legislature's intent nor with sound public policy. It is true, as pointed out in Judge Crahan's well-written concurring opinion, that at present nearly all other jurisdictions that have considered this question have chosen not to allow strict product liability claims against hospitals, even in cases where the hospital has supplied a defective device or implant for surgical insertion into a patient's body. It is also true, however, that at present courts in only a limited number of other state court jurisdictions have been called upon to consider this question. See generally, Linda A. Sharp, Liability Of Hospital Or Medical Practitioner Under Doctrine Of Strict Liability In Tort, Or Breach Of Warranty, For Harm Caused By Drug, Medical Instrument, Or Device Used In Treating Patient, 65 A.L.R. 5th 357, section 7 (1999). As Judge Crahan also notes, many of the decisions from other states rejecting such strict liability claims have done so based in part on the rationale that medical care providers are not engaged in the business of selling medical products, but rather are engaged in the practice of providing medical services. But this "sales/service" distinction is largely one of artificial semantics and does not hold up well under close scrutiny, particularly in "hybrid" transactions such as the one at issue here, in which the medical care provider both provides medical services and transfers to the consumer a product such as an implant. See James W. Poppell, When Is A Sale A Sale, And A Product A Product? Missouri Health Care Providers And Strict Product Liability Claims, 63 UMKC L. Rev. 283, 290-96 (1994) [hereinafter, "Poppell"]. See also Greenberg v. Michael Reese Hospital, 415 N.E.2d 390, 393 (Ill. 1980), where the Illinois Supreme Court, although denying a strict liability claim in connection with the use of an x-ray machine, stated that the sales/service distinction cited by other jurisdictions as a basis for denying strict liability claims against hospitals was a "distortion" used to achieve desired results. Even some courts and commentators who have concluded such strict liability claims ought to be disallowed on policy grounds have nonetheless recognized that the "sales/service" distinction is an empty shibboleth. See, e.g., Parker v. St. Vincent Hospital, 919 P.2d 1104, 1107 (N.M. App. 1996) (normal rule is that one distributes a product when one provides a combination of products and services and the product component is sold; to depart from this characterization in the special case of hospitals would be to obscure the underlying policy issues with "artificial semantic distinctions"). (FN1) See also Melissa Moore, Strict Liability Claims Against Hospitals Under section 402A, 29 Duquesne L Rev. 109 (1990). Judge Crahan's concurrence speaks of Hershley v. Brown, 655 S.W.2d 671 (Mo. App. W.D. 1983), as being part

of the Missouri common law in this area prior to Bell.(FN2) So it was. But Hershley is both distinguishable from the type of case now before us and not compelling. First, the holding in Hershley applied only to an individual physician, not a hospital or other institutional health care provider. The fact that a hospital may be subject to a strict products liability claim in certain instances does not necessarily mean the same would be true of an individual physician. See Johnson v. Sears, Roebuck & Co., 355 F. Supp. 1065, 1066-67 (E.D. Wis. 1973). Second, Hershley makes it clear that its holding was grounded entirely on public policy considerations cited in similar cases by courts from other jurisdictions like Hoven v. Kelble, 256 N.W.2d 379 (Wis. 1977), such as a concern that allowing strict liability claims "will inevitably increase the cost of medical services, which might make them beyond the means of many consumers...and...might hamper progress in developing new medicines and medical techniques." Hershley, 655 S.W.2d at 675, citing Hoven. But even in 1977, when the Wisconsin Supreme Court decided Hoven, it expressed some doubt about the persuasiveness of its policy rationale for denying strict liability. Hoven v. Kelbe, 256 N.W.2d at 391, and n. 17. I believe that these stated policy arguments are even less persuasive today than they may have once seemed so long ago. The general policy underlying the Restatement (Second) of Torts doctrine of strict liability is that it ensures that the costs arising from injuries caused by defective products fall on manufacturers and sellers rather than injured consumers who are powerless to protect themselves. Keener v. Dayton Electric Manufacturing Company, 445 S.W.2d 362, 364 (Mo. 1969). In today's world, there are no longer compelling policy reasons for granting hospitals a blanket exemption from this general rule. See Poppell, at 300-306. Mulligan v. Truman Medical Center, supra, was correctly decided. I further believe the Bell court also reached the proper conclusion. Section 538.300 RSMo(FN3) was first enacted in 1987, and provided, inter alia, that the statutory products liability provisions under sections 537.760 to 537.765 RSMo (which were enacted in 1987 at the same time as section 538.300) were inapplicable to actions under sections 538.205 to 538.230 RSMo. As Judge Crahan's concurring opinion notes, Bell failed to recognize that section 538.300 explicitly made the statutory products liability provisions inapplicable to actions covered by sections 538.205 to 538.230. However, as the Mulligan court indicated, Missouri has long recognized common law strict liability actions under Section 402A of the Restatement (Second) of Torts, and the plain language of section 538.300 does not evidence a clear legislative intent to preclude such common law claims against health care providers, but instead evidences only an intent to preclude statutory strict products liability claims against health care providers. This statutory interpretation is also supported by Judge Maus's dissenting opinion in State ex rel. Anderson Medical International v. Sweeney, (FN4) 845 S.W.2d 648 (Mo. App. S.D. 1992). As Judge Maus explained, had the

legislature not understood and intended Chapter 538 to still include and allow common law strict product liability claims against hospitals, then it would not have been necessary to declare in section 538.300 that the statutory modifications to such claims---sections 537.760 to 537.765 RSMo---do not apply to actions covered by Chapter 538. Sweeney, 845 S.W.2d at 652. Judge Crahan's concurring opinion also criticizes the Mulligan court's statutory interpretation on, among other grounds: (1) the fact that section 538.205 (5) RSMo expressly defines "health care services" to include "transfer to a patient of goods or services incidental... to the practice of the health care provider's profession or in furtherance of the purposes for which an institutional health care provider is organized," (emphasis added); and (2) that it seems anomalous for the affidavit requirement of section 538.225 RSMo to apply to strict product liability claims against a hospital, when ordinarily a plaintiff asserting such a strict liability claim would be unable to produce an expert opinion affidavit alleging fault and causation on the part of the health care provider, since strict liability claims are not based on fault. Judge Crahan argues that these aspects of Chapter 538, as well, support his position that the legislature intended Chapter 538 to preclude any and all strict product liability claims against health care providers. But neither of those two factors is invariably at odds with the Mulligan court's statutory interpretation of section 538.300 RSMo. As was stated by Judge Maus in Sweeney, the mere fact that "goods" as used in the section 538.205 (5) definition of "health care services" presumably is broad enough to include TMJ implants, does not mean that a strict product liability claim cannot be brought against a hospital that provides such a defective implant. See Sweeney, 845 S.W.2d at 651. Similarly, and assuming arguendo that the affidavit requirement of section 538.225 even applies at all to a strict products liability claim (a proposition which is debatable), Judge Maus also explained in Sweeney why such an affidavit requirement is not inconsistent with the view that Chapter 538 does indeed allow such common law strict liability claims to be maintained against health care providers.(FN5) See Sweeney, 845 S.W.2d at 652. The primary rule of statutory construction is to ascertain the intent of the legislature from the language used in the statute and to give effect to that intent, if possible, considering the plain and ordinary meaning of the words used in the statute. Wolff Shoe Co. v. Director of Revenue, 762 S.W.2d 29, 31 (Mo. banc 1988). All statutory sections in a chapter must be read together and harmonized, if possible. Staley v. Missouri Director of Revenue, 623 S.W.2d 246, 250 (Mo. banc 1981). The Mulligan court's statutory interpretation of section 538.300, which is also consistent with Judge Maus's statutory interpretation as expressed in Sweeney, is the correct interpretation, and the one that most faithfully comports with these rules of construction. Further, I strongly agree with the Mulligan court's assertion that if the legislature had intended and believed it to be

necessary for the protection and preservation of health care in Missouri to totally abrogate all causes of action for strict products liability against health care providers, then it could have expressed such an intent in plain, ordinary, unambiguously clear language---which it did not do in section 538.300. Mulligan, 950 S.W.2d at 583. Ordinarily, if a state legislature wished to shield hospitals completely from any and all strict liability claims, it could be expected to clearly say so. See Flynn v. Langfitt, 710 F. Supp. 150, 151 (E.D. Pa. 1989). Other states have found no difficulty in doing so when that was their intention. See Rogers v. Synthes, Ltd., 626 So.2d 775, 777 (La. App. 2Cir. 1993). The fact is that in enacting section 538.300 our legislature referred only to statutory strict liability claims, not common law claims. The question as to whether hospitals should be subject to strict products liability claims in this type of case must be decided primarily on the basis of policy considerations. I fully recognize that, at least in the past, some strong policy arguments have been offered against allowing strict products liability claims to be brought against hospitals. On the other hand, times and situations, social and economic realities, can change. As discussed by Poppell, supra at 300-308, in today's social and economic environment, where hospitals have now generally become big business, there are strong arguments to be made in favor of allowing such claims to be brought against hospitals in appropriate cases. But just as was suggested by the court in Mulligan, these thorny questions of policy---and the resolution of any underlying conflict between the public's interest in protecting innocent persons injured by defective products placed in the stream of commerce by manufacturers and health care providers, as compared to the public's concern over increased costs of health care and the continued integrity of the health care system---may perhaps, at this juncture, best be left to the legislature and not the courts. In the hurly-burly arena of our democratic political process, all of these questions can be ironed out. Since I believe the legislature has not precluded a common law cause of action for strict products liability by section 538.300, and since all three Districts of the Court of Appeals have now agreed in holding that such a cause of action is allowed under currently existing Missouri law, there is no need for the Missouri Supreme Court to address this issue, as Judge Crahan urges.(FN6) If, however, the Supreme Court should agree with Judge Crahan's suggestion and decide to accept transfer of this case in order to re-examine the law in this area, I would urge that the Court uphold the Mulligan court's ultimate conclusions, as to both (a) the legislature's intent and (b) the policy reasons in favor of allowing common law strict liability claims to be brought against hospitals in this type of case. Given the policy considerations discussed in Poppell, supra, strict liability should apply. Footnotes: FN1. By citing Parker I do not in any way wish to imply that I agree with that court's policy analysis of this issue; I strongly disagree with it.

FN2. See also Welkener v. Kirkwood Drug Store Co., 734 S.W.2d 233 (Mo. App. E.D. 1987), in which this court held that a pharmacy could be held strictly liable for transferring a pair of defective crutches to an individual with a leg injury. FN3. This and all further statutory references are to RSMo 1994 unless otherwise noted. FN4. Sweeney was a TMJ implant case much like the instant one, Bell and Mulligan. In Sweeney, where the hospital sought a writ of prohibition, the majority decided the case on narrow procedural grounds but did not discuss the substantive products liability issue. In his dissenting opinion Judge Maus did discuss that issue, concluding after an extended analysis that a strict products liability action under section 402A of the Restatement (Second) of Torts was available in Missouri against a hospital providing defective implants, but that the affidavit requirement of section 538.225 RSMo also applied in such an action. In deciding Bell, the Southern District adopted the part of Judge Maus's dissent in Sweeney which concluded that a strict products liability claim would lie against a hospital that sells a defective TMJ implant, finding Judge Maus's analysis on that issue to be "well reasoned and relevant." Bell v. Poplar Bluff Physicians Group, Inc., 879 S.W.2d at 619. FN5. Too, section 538.225 only requires an affidavit. If I understand Judge Crahan's interpretation of section 538.225 correctly, even under his interpretation a strict products liability claim might survive in those cases where a patient, harmed by a defective implant, could legitimately obtain an affidavit stating that his injury was also caused, at least in part, by the health care provider's negligence. In other words, under his reading of section 538.225, the legislature required an affidavit attesting to fault before it would allow liability without fault to attach. This is an unconvincing interpretation of section 538.225. FN6. If Judge Crahan is correct that the holdings of this court, and the Southern District in Bell, and the Western District in Mulligan, in regard to the legislature's intent on this matter are all wrong, then the legislature is certainly free to act at any time to clarify the law and rectify our mistake. This slip opinion is subject to revision and may not reflect the final opinion adopted by the Court.