Haudrich v. Howmedica, Inc.

662 N.E.2d 1248, 169 Ill. 2d 525, 215 Ill. Dec. 108, 1996 Ill. LEXIS 8
CourtIllinois Supreme Court
DecidedJanuary 18, 1996
Docket78319
StatusPublished
Cited by252 cases

This text of 662 N.E.2d 1248 (Haudrich v. Howmedica, Inc.) is published on Counsel Stack Legal Research, covering Illinois Supreme Court primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Haudrich v. Howmedica, Inc., 662 N.E.2d 1248, 169 Ill. 2d 525, 215 Ill. Dec. 108, 1996 Ill. LEXIS 8 (Ill. 1996).

Opinions

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. 315.1

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.

FACTS

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 21h 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 plaintiffs 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.

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Cite This Page — Counsel Stack

Bluebook (online)
662 N.E.2d 1248, 169 Ill. 2d 525, 215 Ill. Dec. 108, 1996 Ill. LEXIS 8, Counsel Stack Legal Research, https://law.counselstack.com/opinion/haudrich-v-howmedica-inc-ill-1996.