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FIRST DIVISION
March 15, 2004

In August 1994 Richard Mele sued Howmedica, Inc., themanufacturer of a medical device a surgeon implanted intoplaintiff. The trial court denied plaintiff's motion forcertification of a class of all patients into whom surgeons inIllinois implanted similar devices. A jury found that plaintiffdid not have notice of wrongful causation for his injury untilSeptember 1992. The jury also found that Howmedica'sunreasonably dangerous medical device caused plaintiff's injury. The court entered judgment on the jury's verdict awardingplaintiff $400,000 in damages. Defendant appeals and plaintiffcross-appeals from denial of the motion to permit the lawsuit toproceed as a class action.

Plaintiff had severe arthritis in his right hip. He went toDr. Mitchell Sheinkop, an orthopedic surgeon, in May 1991. Dr.Sheinkop recommended a total replacement of the hip withartificial components. Plaintiff agreed. Dr. Sheinkop performedthe surgery on May 28, 1991.

To gain access to the hip Dr. Sheinkop needed to cut throughthe femur, the bone that extends from the hip to the knee. Thefemur has a nearly spherical head which fits into the acetabularcup of the hip; near the femur's head lies a large protuberancecalled the trochanter, where several muscles attach to the bone. Dr. Sheinkop performed a trochanteric osteotomy on plaintiff. That is, he cut through the bone and pulled out the top part,including the trochanter.

Dr. Sheinkop then cemented an artificial stem into themarrow canal of the femur. The artificial stem connected to anartificial nearly spherical head of the femur, designed to movesmoothly in an artificial acetabular cup. Dr. Sheinkop implantedan artificial acetabular cup, with a smooth polyethylene lining,into plaintiff's hip, to complete the artificial joint.

After inserting the artificial pieces, Dr. Sheinkopreattached the top part of the femur, including the trochanter,to the portion of the femur that remained in place during thesurgery. For the artificial hip to perform properly, the femurmust heal, with the top part of the femur realigning with thebody of the femur. When Dr. Sheinkop put the top of the femurback in place, he secured it to the body of the femur with aDall-Miles trochanter cable grip system (D-M system) manufacturedby defendant.

On the day of surgery, shortly after the operation, Dr.Sheinkop discovered a dislocation of the hip. About 7% ofpatients experience similar dislocations following hipreplacement surgery. Dr. Sheinkop and his assistants, usingaccepted techniques, manipulated the hip back into place.

At follow-up visits in February and September 1992, plaintiff complained to Dr. Sheinkop of pain in the hip. Dr.Sheinkop took X rays during both visits. According to themedical record for September 18, 1992, Dr. Sheinkop then"introduced the thought of removing the Dall-Miles cable system"to alleviate the pain. In a second surgery performed on January28, 1993, Dr. Sheinkop removed the D-M system.

In September 1997 plaintiff consulted another doctor aboutincreasing pain in his thigh. New X rays showed that plaintiffhad suffered endosteal lysis, which is a form of severe boneloss. The doctor recommended revision surgery to replace severalelements of the artificial hip. Dr. Aaron Rosenberg performedthe revision surgery in November 1997. Plaintiff recovered wellfrom the surgery.

The complaint filed in August 1994 included a class actioncount, in which plaintiff sought to represent all persons intowhom surgeons implanted the D-M system in the course of hipsurgeries performed in Illinois. Plaintiff listed severalquestions allegedly common to claims of all class members,including the question of whether the D-M system had a designdefect rendering defendant strictly liable in tort and whether defendant negligently designed the D-M system. Plaintiff alsorequested class certification with the class action limited to"one or more of the common questions" listed.

Plaintiff supported his motion for class certification withan article reporting on a study of the D-M system. Silverton,"Complications of a Cable Grip System," 11 J. Arthroplasty 400(1996). Dr. Silverton reported that, at the one hospitalstudied, five surgeons used the D-M system in 68 surgeriesperformed between January 1990 and July 1992. Eight of thepatients had large deposits of metal debris near the joint of thefemur with the hip. 11 J. Arthroplasty at 401. "Bonedestruction or osteolysis around the cable in the area of thelesser trochanter was seen in seven patients (10%)." 11 J.Arthroplasty at 401. Five of the patients needed reoperationsdue to painful cables and fragmentation. 11 J. Arthroplasty at401. As a result of the study, the hospital decided not to usethe D-M system for routine trochanteric osteotomies. 11 J.Arthroplasty at 404.

Plaintiff found two other patients who filed lawsuitsagainst defendant alleging defective design of the D-M system.

After argument on the motion for class certification, thecourt said:

"[B]ifurcation, as I understand it, at least dealswith establishing liability first and then going on todamages.

And I don't think that's what we're doing in thisparticular case. I have trouble certifying the classfor a number of reasons.

It's a medical device. And I went through thetranscript, and as I understand it, there's not greatnumerosity here.

[Dr. Silverton] mentions a doctor in Boston who'shad excellent results. And so Silverton says I can'tunderstand why we had these results.

I just can't say I have numerosity because thesepeople have the device implanted in them. ***

It's not a tort liability like an airplane crashwhere *** it arises out of one occurrence.

*** [I]f I would certify the class, it wouldresult in piecemeal litigation with troubling issues ofcausation and damage left unresolved.

It seems to me that too many details would be leftunresolved, and complex individual trials would need tobe adjudicated as well.

*** I don't think that (A) you establishednumerosity.

You talk about predominance, and we talk aboutadequacy of representation. I don't think that he's aproper class representative because these are tortcases, and they are very different than the massdisaster torts ***.

I think they are completely different. I thinkit's a products case. And I think that looking downthe line, I think there are too many individual legalissues that really predominate."

Plaintiff moved for clarification of the basis for denial ofclass certification. The court denied the motion. Plaintiffthen moved for an order pursuant to Supreme Court Rule 308 (155Ill. 2d R. 308) to permit immediate appellate review of thedenial of class certification. At the hearing the courtresponded:

"[T]here are individual issues in this thing thatmake it very difficult for you to have classcertification. ***

I've read the cases. When you have productliability cases that concern medical devices I thinkthat the courts are hesitant to move in that area. ***And for that reason and for a multitude of otherreasons, which have been argued for many many hoursnow, I am going to deny the [Rule] 308 request."

After plaintiff's second deposition, defendant moved for summary judgment, arguing that the deposition testimony showedthat by February 1992 plaintiff had sufficient notice of wrongfulcausation to trigger the statute of limitations period. Thedefendant argued that the filing of the complaint in August 1994came too late. The trial court found material issues of factconcerning the time plaintiff discovered wrongful causation forhis injury. Accordingly the court denied the motion for summaryjudgment.

Before trial plaintiff moved to exclude evidence of

"the expectation of injury by anyone other than [an]implantee patient; *** the comparative superiority ofthe Dall-Miles cable over other fixation devices; ***the fact that there was a need for a cable in view ofproblems with earlier fixation devices; *** the factthat other fixation devices or other cable can abradebone, fray or fragment; *** [and] a risk versus benefittest."

Plaintiff sought to prove that the D-M system was designeddefectively in that it did not perform as safely as an ordinaryimplantee would expect. He argued that the evidence he sought toexclude bore no relevance to the case, because the evidence wouldrebut only a case in which a plaintiff tried to show that anotherdesign could achieve similar benefits with less risk. Defendantargued that surgeons who implanted the system were its consumersfor purposes of determining whether the device met theexpectations of ordinary consumers. In the alternative defendantsought to show that the benefits of the product outweighed itsrisks.

The court held:

"[I]n this case, the plaintiffs have decided tobring their action on strict liability in tort basedonly on the consumer user contemplation test.

So that would for the court set up the parametersof what is relevant. I did not see a case where thatwas the claim and solely that being the consumer userapproach where that was used by the plaintiff that thedefense could then *** rebut that claim or put on adefense of the danger utility or risk benefit when thesole claim was the consumer user expectation test.

So the court is going to judge the relevance ofwhat evidence goes in *** based on the claim of the plaintiff. ***

*** And the risk benefit analysis is out given thepleadings by the plaintiff."

At trial plaintiff testified that when he complained of painnine months after the initial surgery, on February 28, 1992, Dr.Sheinkop told him that such pain was a "very normal" part ofrecovery, and it may persist for 18 months after a successfulsurgery. The pain persisted into September, when plaintiff nextvisited Dr. Sheinkop. Plaintiff testified that Dr. Sheinkop thensuggested that the D-M system might be the cause of the pain andthat plaintiff might want the system removed. Contrary to histrial testimony, plaintiff at his second deposition had testifiedthat he learned in February 1992 that the D-M system caused thepain. At trial plaintiff explained that he confused the dates inhis testimony at the second deposition. Prior to the September1992 visit with Dr. Sheinkop, he had never heard of the D-Msystem, and he had no idea Dr. Sheinkop had placed such a devicein him. Plaintiff testified that he was very surprised to learnabout the system and to learn that it might be the cause of hispain.

According to plaintiff, the first surgery in May 1991relieved the pain from arthritis that led him to choose hipreplacement surgery. But new pains began around February 1992. Plaintiff described the pain and disability he suffered from thattime until spring of 1998, when he completed his recovery fromhis third hip surgery, the revision operation Dr. Rosenbergperformed. The surgical removal of the D-M system in January1993 did not alleviate the pain.

On cross-examination plaintiff admitted that shortly afterFebruary 1992 he telephoned a friend of his neighbor who workedas an attorney. He discussed with the attorney possible legalliability for the pain he continued to suffer. But plaintiff didnot then meet with or retain an attorney.

Dr. Sheinkop testified that as a general practice hediscussed with each patient the benefits and risks associatedwith the surgery proposed for the patient. He usually would notdiscuss the possibility of dislocation with hip replacementpatients. He would not describe the trochanteric osteotomy, aspart of the hip replacement, to his patients. And he usuallywould not mention the device he used to reattach the parts of thefemur following a trochanteric osteotomy. Dr. Sheinkop did notrecall giving any special warnings to plaintiff.

Dr. Sheinkop described the first surgery and his use of theD-M system. He secured the top of the femur, including thetrochanter, to the body of the femur by drilling a hole in thetrochanter and passing the cable of the D-M system through thehole. He cut the end of the cable with a cutter that was alsopart of the D-M system. The cable, attached to the grip, thenheld the two parts of the bone in place.

The cable consisted of a number of wires wound together. The wound wires gave the cable a rougher surface than anindividual monofilament wire. Dr. Sheinkop believed that when plaintiff walked the cable moved very slightly back and forththrough the bone. Dr. Sheinkop characterized this effect asmicromotion that acted like a saw against the bone. The abrasionof the cable separated small particles of the bone near the holefrom the rest of the bone. X rays of plaintiff's femur showedexpansion of the hole for the cable. In September 1992 Dr.Sheinkop noted in plaintiff's medical record that the X rayshowed bone loss in connection with the D-M system.

In general Dr. Sheinkop would discuss the X rays with thepatient the same day he took them. He admitted that the X ray hetook in February 1992 showed expansion of the hole drilled forthe cable, probably due to the sawing effect of the cable againstthe bone. He did not specifically remember when he discussed theD-M system and this possible effect with plaintiff.

Dr. Rosenberg agreed with Dr. Sheinkop that the cable sawingagainst the bone caused bone loss. The particles of bone sawedoff could then migrate into the acetabular cup, coming betweenthe artificial head and the polyethylene lining of the cup. Thebone particles, possibly together with metal debris from thecable, scraped polyethylene particles off the lining of the cupwhen plaintiff moved his leg. This process released polyethyleneparticles into the body. While the body's response to loose boneparticles is relatively benign, the body responds moreaggressively to loose particles of polyethylene or other foreignbodies. Macrophages attack these displaced foreign particles,and these macrophages "[c]an stimulate bone ingestion by othercells."

In Dr. Rosenberg's opinion, this process led to plaintiff'spainful endosteal lysis. The revision surgery provided supportfor Dr. Rosenberg's opinion: when he removed the artificialacetabular cup from plaintiff in 1997, Dr. Rosenberg found thecup badly pitted and scratched, with many abrasions of thepolyethylene surface. Bone particles observed in several X raysfurther supported Dr. Rosenberg's opinion about the causalconnection between the D-M system and plaintiff's endosteallysis.

Plaintiff's attorney asked about the source of the particlesthat tore the lining of the acetabular cup. Dr. Rosenberg said:

"I don't know what the third body wear particleswere in this case other than through the study of thesedevices by pathologists and other experts who havelooked at them.

*** [I]t seems to me that [you are] asking forpotential sources of debris[. I]t's from all the partsthat were implanted.

You can get debris caused by the plastic, by thecables, by the cable grip interaction, by the cablebone interaction, by the head, the neck junctioninteraction where you can get corrosion and corrosionproducts."

On cross-examination Dr. Rosenberg admitted that a studyshowed patients with artificial hips needed replacements onaverage 62 months after the initial implantation. Plaintiff hadhis first artificial hip for about six years. Dr. Rosenberg alsoagreed that bone loss is a common complication of hip replacementsurgery, with or without the D-M system. On redirect Dr.Rosenberg reiterated his opinion that the D-M system was acontributing cause of plaintiff's endosteal lysis and the pain heexperienced from 1992 until recovery from the revision surgery.

Plaintiff's expert, Dr. Alan Litsky, agreed with most of Dr.Rosenberg's opinions. Dr. Litsky testified that the D-M systemwas unreasonably dangerous in that plaintiff, like ordinaryimplantees, had no reason to expect injury from the D-M system. Dr. Litsky agreed that most patients, like plaintiff, "would haveno knowledge base whatsoever to make a judgment as to how thatfixation system should perform." But he said, "Even if[patients] don't know what is going on, they expect the devicesthat their surgeon chooses to use to help, and not injure."

Defendant presented its experts on issues of causation andthe performance of the D-M system. Defendant also made an offerof proof outlining the evidence it would have produced to showthat the benefits of the D-M system outweighed its risks. Dr.Sheinkop would have testified that the cable in the D-M systemdid not break as easily as monofilament wires used in othersystems for fixing femurs. The D-M system made the fracturesmore stable and provided better fixation. All fixation devicesfor repairing the femur after a hip replacement could destroy thebone or fail, and they created other risks as well. A fixationdevice that used a monofilament wire would have a similarabrasive effect in a case like plaintiff's.

Defendant's experts would have echoed much of Dr. Sheinkop'sassessment of the benefits of the D-M system. They would haveexplained the state of medical knowledge in 1988, when defendantfirst manufactured the D-M system, and in 1991 when plaintiffunderwent his first hip surgery. They would have explained thereasons for developing the system and how it solved severalproblems found with other fixation systems for trochantericosteotomies. An expert would specifically testify that thebenefits of the D-M system outweighed its potential risks.

The jury answered a number of special interrogatories defendant requested. The jurors specifically found the cable inthe D-M system unreasonably dangerous, and they found that thedangerous condition of the cable caused plaintiff to sufferinjury. Although the jurors also found the cable cutterunreasonably dangerous, they held that the cutter did not cause plaintiff's injuries. The jurors also found that prior to August1992, plaintiff did not know that he suffered an injury fromenlargement of the drill hole used to attach the cable. Theyfound that plaintiff did not have sufficient notice, prior toAugust 1992, that his injury may have had a wrongful cause. Thejury awarded plaintiff $400,000 in itemized damages. The trialcourt entered judgment on the verdict.

In the posttrial motion defendant repeated the argument thatthe trial court should have tested the danger of the device bythe doctors' expectations instead of the implantee'sexpectations. Defendant also contended that the court erred byexcluding evidence of the benefits and risks of the D-M system. The court denied the posttrial motion. Defendant filed a timelynotice of appeal, and plaintiff filed a separate appeal from thedenial of his motion for class certification. We consolidatedthe appeals and directed the parties to brief the classcertification issue as a cross-appeal.

I. Statute of Limitations

Defendant argues that the trial court should have enteredjudgment in its favor because the evidence overwhelmingly provedthat plaintiff did not file his complaint within two years fromthe date on which the cause of action accrued. See 735 ILCS5/13-202 (West 1994). In the alternative, defendant requests anew trial on the issue because the manifest weight of theevidence opposed the jury's answer to the special interrogatory.

The parties agree that the cause of action accrued when plaintiff knew or should have known that he had suffered aninjury and that wrongful acts caused the injury. Clay v. Kuhl,189 Ill. 2d 603, 608 (2000). Plaintiff admitted that he feltsignificant pain by February 1992, and he spoke to Dr. Sheinkopabout that pain during an office visit that month. According to plaintiff's trial testimony, Dr. Sheinkop then told him the painwas normal during the extended period for recovery from the hipreplacement surgery. Plaintiff first learned that his pain mighthave a wrongful cause in September 1992, when Dr. Sheinkopsuggested he might need to remove the D-M system. Dr. Sheinkop'snotes of the two visits corroborate plaintiff's trial testimony. In one of his depositions plaintiff said he learned in February1992 the D-M system might have caused his pain, but at trial plaintiff explained that questions at the deposition confused himabout the dates of the conversations.

Defendant contends that plaintiff's trial testimony isincredible because plaintiff spoke to an attorney about possiblelegal liability for his pain shortly after the February officevisit. Also, Dr. Sheinkop usually discussed X rays with hispatients the same day he took them, and the February 1992 X rayshowed the expansion of the drill hole in the trochanter due tothe sawing effect of the cable. But Dr. Sheinkop did not saythat he recognized that damage when he first saw the X ray in themeeting with plaintiff.

We cannot say that plaintiff's testimony is so incrediblethat the jury committed manifest error by relying on it. SeeKotvan v. Kirk, 321 Ill. App. 3d 733, 741 (2001). Thus, thejurors could find that Dr. Sheinkop suggested a nonactionablecause for the pain in February 1992. Plaintiff's subsequentconversation with an attorney indicates he may have harbored somedoubts about Dr. Sheinkop's explanation. Plaintiff did notretain an attorney until some time after September 1992, when Dr.Sheinkop first suggested that the D-M system might be the causeof plaintiff's pain. The conversation with an attorney, standingalone, is insufficient to overturn the jury's finding that plaintiff did not have sufficient notice that wrongful acts mayhave caused his pain until September 1992. See Hochbaum v.Casiano, 292 Ill. App. 3d 589, 594-95 (1997); Gara v. Semerad,183 Ill. App. 3d 622, 628-30 (1989).

II. Causation

Next, defendant claims that plaintiff failed to presentsufficient evidence to support the jury's finding that the D-Msystem cause the endosteal lysis. Dr. Rosenberg explained howthe cable chafed the bone particles off the bone and the boneparticles migrated to the artificial hip. There the boneparticles aggravated normal wear on the joint, gouging particlesof polyethylene off the acetabular cup when plaintiff walked. Plaintiff's body attacked the polyethylene particles withmicrophages, which have the unfortunate side effect of destroyinghealthy bone, thereby causing the endosteal lysis.

In the course of this testimony, Dr. Rosenberg admittedthat, apart from the studies of other experts, he did not knowwhat particles interposed themselves between the artificialacetabular cup and the artificial head of the femur. Defendantclaims this admission shows such uncertainty of the cause thatthe jury could not rely on Dr. Rosenberg's testimony as proof ofcausation. Dr. Rosenberg explained his conclusion, from thestudies, that particles of various sorts, including boneparticles chafed off by the cable, all contributed to theextraordinary gouging of the cup lining. The concession that heneeded to rely on other experts does not defeat the evidence ofcausation. See Bong Jin Kim v. Nazarian, 216 Ill. App. 3d 818,827 (1991).

III. Unreasonable danger

To show that a product is unreasonably dangerous due to adefective design, a plaintiff must present evidence that thedesign includes "a defect which subjects those exposed to theproduct to an unreasonable risk of harm." (Emphasis omitted.) Hunt v. Blasius, 74 Ill. 2d 203, 211 (1978). The risk of harmqualifies as unreasonable if it is "'beyond that which would becontemplated by the ordinary consumer who purchases it, with theordinary knowledge common to the community as to itscharacteristics.'" Palmer v. Avco Distributing Corp., 82 Ill.2d 211, 216 (1980), quoting Restatement (Second) of Torts