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January 18, 1996


Appeal from the Appellate Court for the Fifth District; heard in that court on appeal from the Circuit Court of St. Clair County, the Hon. Robert L. Craig, Judge, presiding.

Rehearing Denied April 1, 1996.

Chief Justice Bilandic delivered the opinion of the court: Justice Harrison took no part in the consideration or decision of this case, Justice Miller, concurring in part and dissenting in part: Justice Heiple, dissenting:

The opinion of the court was delivered by: Bilandic

CHIEF JUSTICE BILANDIC delivered the opinion of the court:

The plaintiff, Donald Haudrich, brought this action for strict products liability in the circuit court of St. Clair County against defendant Howmedica, Inc., and for negligence against codefendant, Michael Lukens, a Howmedica sales representative. The plaintiff sought damages for injuries allegedly caused by a defective prosthetic device that had been surgically inserted into his knee. The plaintiff alleged that Howmedica designed, manufactured and sold the device that, at the time it left Howmedica's possession and control, was defective and unreasonably dangerous. He further alleged that Lukens negligently and carelessly sold the defective device and negligently and carelessly failed to warn of the device's defective and unreasonably dangerous condition. Following a bench trial, the trial court entered a judgment against the defendants and awarded the plaintiff damages of $1,686,988.70. The appellate court affirmed. (267 Ill. App. 3d 630.) We allowed the defendants' petition for leave to appeal. 145 Ill. 2d R. 315. *fn1

The primary issue presented in this appeal is whether provisions of the United States Food, Drug, and Cosmetic Act of 1938 (Act) (21 U.S.C. § 301 et seq. (1970)) preempt the plaintiff's State-law tort claims. Specifically, the defendants point to the Medical Device Amendments of 1976 (21 U.S.C. §§ 351 through 360 (1994)) as barring the plaintiff's claims. The appellate court rejected this contention, holding instead that the United States Congress did not intend to preempt common law tort actions by passing the Medical Device Amendments. The appellate court declined to address the plaintiff's argument that the defendants waived the issue of preemption by failing to raise it in the trial court.

The defendants also contend that the evidence was insufficient to prove that the plaintiff was injured by an unreasonably dangerous condition of the knee device, that the award of damages was excessive, and that the appellate court erred in finding that they waived the issue of whether Lukens' negligence had been sufficiently proved.


In 1983, the plaintiff sustained a work-related injury to his left knee and subsequently underwent a series of treatments to improve his condition. When these treatments failed, the plaintiff opted for a total knee replacement. The plaintiff's treating physician, Dr. William Simmons, selected the "PCA Total Knee System" manufactured by Howmedica. This device received premarket approval by the Federal Food and Drug Administration in September 1988, three years after the plaintiff's surgery.

The surgery was performed in November 1985. The plaintiff was allowed to return to work one year later. Approximately 2 1/2 years after the surgery, the plaintiff complained to Dr. Simmons of "popping" inside his knee joint. In May 1988, the plaintiff began complaining of pain, swelling and instability in his knee. A few months later, the plaintiff felt something snap inside the back of his knee, and shortly thereafter, the decision was made to replace the prosthetic knee device. At the time the initial surgery was performed, Dr. Simmons had informed the plaintiff that the knee prosthesis would last approximately 10 years, give or take two years, and that it would eventually need to be replaced. Charles Lawyer, Howmedica's director of quality assurance, testified that he was unable to say how long the knee device should last, since its longevity depended on numerous factors. The prosthetic device implanted in the plaintiff's knee failed in less than three years.

The PCA Total Knee System is comprised of three components. The component at issue is comprised in part of a piece of polyethylene plastic which rests inside a metal tray and is situated on top of the shin bone. While performing the "revision" surgery in January 1989, Dr. Simmons discovered that the polyethylene piece attached to the first knee implant had "almost completely worn away," and he found "multiple shavings of this particular plastic" behind the plaintiff's knee joint. Dr. Simmons determined that the plastic piece had slipped from its original position, which explained the plaintiff's statement that something in the knee had "popped." At a deposition, Dr. Simmons testified that when he implanted the first device, he did not expect the plastic failure to occur. He had used the device in the past and had been satisfied with its performance. Based on his findings during the second surgery, Dr. Simmons opined that the first knee prosthesis failed to perform as reasonably intended, based on a reasonable degree of medical and scientific certainty. He could not identify anything in his surgical technique or in the plaintiff's physical makeup that could explain the device's failure. Although the plaintiff had a deformity in his legs which caused bowleggedness, this condition did not contribute to the premature wear of the polyethylene piece. Dr. Simmons found no evidence that the plaintiff had abused the prosthesis.

The second knee replacement differed from the first in that the thickness of the polyethylene piece was nine millimeters as opposed to seven. Bone cement was also used to hold the second device in place whereas a cementless process was used to secure the first one. Dr. Simmons explained that the nine-millimeter model was available at the time of the initial surgery, but he opted for the thinner model because it required less of the plaintiff's bone to be removed, and Howmedica representatives advised that the thinner model be used to preserve bone mass. At that time, Howmedica had not yet recommended that doctors discontinue using the seven-millimeter model. Sometime after the initial surgery, Howmedica began advising doctors to use the thicker model because the other model was "perhaps a little too thin." Dr. Simmons criticized the seven-millimeter polyethylene as being too thin.

After the second surgery, the plaintiff was unable to return to work, and it was not anticipated that he would ever be able to do so. According to Dr. Simmons, the plaintiff continued to complain of pain in his knee even after the second surgery. At the time of trial in July 1992, the plaintiff complained of pain, stiffness, swelling and some instability of the knee. Dr. Simmons stated, however, that the plaintiff was "much better off" having had the second surgery.

Dr. Simmons explained, however, that with every successive knee replacement, the knee becomes more and more unstable. He stated that after a certain number of revisions, it becomes necessary to insert a prosthesis which locks together. After a third or fourth revision, the insertion of that type of prosthesis may have become necessary for the plaintiff. However, it would not have become necessary if the plaintiff had needed only two surgeries in his lifetime, as Dr. Simmons had contemplated, given the plaintiff's age and the anticipated lifespan of the device. Dr. Simmons also noted that subsequent revision surgeries increase the risk of infections, nerve damage, and vessel injury and make rehabilitation more difficult. He added that the expected life of a revision implant tends to decrease as the number of revisions increases. At the time of trial in 1992, the cost of a revision surgery, according to Dr. Simmons, was between $25,000 and $30,000.

The plaintiff's expert witness, Roy D. Bloebaum, Ph.D., testified as to his expertise in the analysis of prosthetic devices. In the course of his research, he investigated a problem with respect to the premature wear of polyethylene in various prosthetic devices and co-authored numerous articles on the subject. Dr. Bloebaum testified that the minimum life expectancy of the PCA Total Knee System was 10 to 12 years, with 18 to 20 years not being unreasonable. Dr. Bloebaum cited one study which reported that 65% of knee devices which predated the PCA device survived 17 years. Dr. Bloebaum agreed that the survivability of a device depended on many factors, including the manner of use and the patient's weight. He saw nothing in the plaintiff's physical makeup that would have adversely affected the lifespan of the knee device. He did not criticize Howmedica's use of the polyethylene material since that was all that was available at the time the device was manufactured, but he did criticize the fact that the polyethylene was processed using heat, which made it susceptible to certain defects like pitting, scratching and "delamination," whereby the polyethylene breaks apart in layers. The specific design errors he noted in addition to the heat processing were concentrated stresses on the femoral component of the device which fits over the polyethylene and the use of a polyethylene plastic piece that had an inadequate thickness. According to Dr. Bloebaum, these design characteristics lead to premature wear and failure of the device. He opined to a reasonable degree of scientific certainty that these characteristics caused the product to be unreasonably dangerous and defective. He eliminated misalignment in the plaintiff's case as a cause of the device's failure.

Defendants' expert, Dr. John Lyons, a specialist in total joint reconstruction, testified that the prosthesis was implanted at an excessive angle, which was the cause of the premature wear of the polyethylene plastic. He based this opinion on a review of post-operative X rays and on an analysis of the knee device that was removed from the plaintiff's body. In Dr. Lyons' opinion, neither the thickness of the polyethylene insert nor the heat processing played any role in the failure of the plastic.

Stephen Hirsch, Howmedica's director of sales and formerly its director of marketing for reconstructive products, testified concerning a Howmedica publication entitled the "Polyethylene Awearness Series." The publication was undertaken because orthopedic surgeons were becoming "quite concerned" about premature wear of the polyethylene piece used in the knee device and about the increasing number of revision surgeries having to be performed. A Howmedica bulletin acknowledged that questions were being asked by orthopedic surgeons about implant design, insert thickness, contact stresses and material composition as they related to polyethylene wear. Through the "Awearness Series," Howmedica sought to determine if premature wear could result from a design which subjected the polyethylene plastic to contact stresses, from an insert that was too thin, or from the heat processing method Howmedica used. Hirsch concluded they were all factors but added that there were other factors which could also explain the premature wear of the polyethylene piece. Howmedica ultimately determined, at some point after the plaintiff's first surgery, that a seven-millimeter plastic piece was too thin and eventually advised doctors to stop using it. Hirsch agreed that if premature failure resulted from contact stresses, the use of heat to process the piece, and inadequate polyethylene thickness, the product would be considered unsafe.

Howmedica's vice president of product development, Peter Van Syckle, testified for the defendants that the design of the PCA Total Knee System was not defective. He acknowledged that the particular device implanted in the plaintiff's knee could have been defective and agreed that the polyethylene plastic failed. However, he stated that other factors besides those claimed by the plaintiff could have caused the failure. Van Syckle defined a defective product as one that does not perform in a "reasonably anticipated way" and acknowledged the testimony of Dr. Simmons, as the user of the device, that the product did not perform as reasonably anticipated.


A. Preemption

The defendants contend that section 360k of the Medical Device Amendments to the Act (21 U.S.C. § 360k (1994)) expressly preempts the plaintiff's State-law tort claims. As previously stated, the appellate court rejected this contention, concluding instead that Congress did not intend to preempt common law tort actions by enacting the Medical Device Amendments. The appellate court declined to address the plaintiff's claim that the defendants waived the issue of preemption by failing to raise it in the trial court. We, however, have decided to address the issue. For the reasons which follow, we hold that the waiver doctrine should apply to the situation presented here.

It is well settled that issues not raised in the trial court are deemed waived and may not be raised for the first time on appeal. (See Daniels v. Anderson (1994), 162 Ill. 2d 47, 58-59, 204 Ill. Dec. 666, 642 N.E.2d 128; Geise v. Phoenix Co. of Chicago, Inc. (1994), 159 Ill. 2d 507, 514-15, 203 Ill. Dec. 454, 639 N.E.2d 1273; Lannom v. Kosco (1994), 158 Ill. 2d 535, 539-40, 199 Ill. Dec. 743, 634 N.E.2d 1097; Mittelman v. Witous (1989), 135 Ill. 2d 220, 230, 142 Ill. Dec. 232, 552 N.E.2d 973.) In Daniels, this court reiterated that "'the theory upon which a case is tried in the lower court cannot be changed on review, and *** an issue not presented to or considered by the trial court cannot be raised for the first time on review.'" ( Daniels, 162 Ill. 2d at 58, quoting Kravis v. Smith Marine, Inc. (1975), 60 Ill. 2d 141, 147, 324 N.E.2d 417.) We concluded that allowing the defendant to change his theory of defense on appeal would "not only weaken the adversarial process and our system of appellate jurisdiction" ( Daniels, 162 Ill. 2d at 59), but would likely prejudice the plaintiff, since he may have been able to present evidence to discredit the theory had it been raised in the evidence presentation stage, that is to say, in the trial court. Daniels, 162 Ill. 2d at 59.

Similarly, in Geise, this court concluded that the theory the defendant attempted to raise for the first time on appeal, which was based on a State statutory provision, was in the nature of an affirmative defense and, as such, was waived by not being presented initially in the trial court. ( Geise, 159 Ill. 2d at 514.) In finding waiver, the court in Geise determined that the situation presented was not one in which "some basic legal impediment existed to a claim or defense on which the judgment [was] based," nor was it "a situation where a party needed to be rescued from some inadvertent blunder it or its attorney made at trial." ( Geise, 159 Ill. 2d at 514.) This court determined, rather, that the defendant had made a purely strategic decision not to raise the statute-based theory at trial in the hope that the plaintiff's common law negligence claim would fail and it would escape liability entirely. The court emphasized that "our responsibilities as a court of review do not extend to protecting a party from its own failed trial strategy." Geise, 159 Ill. 2d at 514-15.

The defendants in this case argue, however, that the claim of preemption is not in the nature of an affirmative defense but is a jurisdictional matter which cannot be waived and which may be raised at any time. Specifically, they argue that section 360k of the Medical Device Amendments deprives State courts of jurisdiction to render judgments for damages based on State tort law for defective or unreasonably dangerous medical devices which have received premarket approval by the Food and Drug Administration. We reject this argument. Initially, we note that on at least one occasion, this court has recognized that a party's failure to invoke the Federal preemption doctrine in the trial court may preclude him from raising it on appeal. (See Beckman v. Freeman United Coal Mining Co. (1988), 123 Ill. 2d 281, 286, 122 Ill. Dec. 805, 527 N.E.2d 303.) Moreover, we find the Supreme Court's decision in International Longshoremen's ...

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