Motion 2 - product liability plaintiffs motion for summary judgment

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Plaintiff's Memorandum in Support of Partial Summary Judgment Concerning the Dall-Miles Cable and the Dall-Miles Cable Cutter

I. INTRODUCTION AND OVERVIEW

The Plaintiff's Second Amended Complaint is attached [Ex. 2]. It alleges the abrasive effect, constituting a design defect (Id., Count II, „5(a)) and that the tools, including the cable cutter, were defective (Ibid, „5(b)).

The Dall-Miles System and Trochanteric Fixation. Some terminology should help to clarify the technical aspects of the case. A drawing of the surgical area in question and the medical device [the Dall-Miles Trochanteric Grip System] is attached [Ex. 1]. In conjunction with the drawing a small glossary at this point is helpful:

* Trochanters -- There are two trochanters. They are the two boney outgrowths on either side of the top [proximal] end of the femur; the greater [larger] trochanter is on the outer [lateral] side of the bone and the lesser is on the inner [medial] side. In the drawing the metal grip through which the cable is passed in seen imbedded in the greater trochanter. The lesser trochanter is partially obscured on the left;

* Osteotomy -- This is a medical term for the cutting of bone. In a certain percentage of patients who are having hip replacement surgery, besides the basic replacement of the hip socket [acetabulum] and the femur [femoral stem component], the greater trochanter has to be temporarily removed. But the greater trochanter is functionally important as the attachment point for the hip muscles. So at the end of the surgical procedure the fragment that has been surgically severed has to be re-attached. As can be seen in the drawing, the greater trochanter has been osteomized or cut and the purpose of the device is to fix or help re-join the fragment with its base. And that is where the Dall-Mile system comes into play.

* Grip -- This is the curved component through which the cables are passed and when proper te??on is achieved, pressing the two bone fra??ents together, the grip is embed?? into the greater trochanteric fragment b??virtue of the four curved ends of the grip being sharpened teeth.

* The Tag -- The cables come in lengths considerably in excess of what is needed to fix the trochanteric osteotomy. So when the leading edge of the cable has passed around or through the bone of the patient it is led back through holes on the opposite side of the grip and the excess cable is cut off and discarded. [See Ex. 18, p. 430, N1 for pre-cut views].

The Discovery of Complications at Rush Hospital -- The Silverton Cohort of Patients-- and The Suspension of the System by the Rush Orthopedic Surgeons.

The Testimony of Dr. Aaron G. Rosenberg. Dr. Aaron G. Rosenberg has a number of roles in the history of this case. He is one of the co-authors of the so-called Silverton report that reported abrasive bone loss, fraying and metal fragmentation with the Dall-Miles Cable Grip System. He is also a partner in Midwest Orthopedics, the primary orthopedic group servicing Rush Hospital and a treating physician for Mr. Mele who performed corrective surgery on his affected hip in November 1997.

Sometime in about mid-1993 it came to the attention of Dr. Galante [the Chairman of Rush's Orthopedics Department] what appeared to be complications with the use of the Dall-Miles' trochanteric grip system (hereinafter, the cable grip system). The initial findings were becoming bothersome to Dr. Galante [Ex. 3, Rosenberg Dep. #1, 128/20]. Dr. Aaron G. Rosenberg believed that Dr. Galante noted on several radiographs that in follow-ups of these Dall-Miles cable patients that there was fragmentation of the ends of the cable where it had been cut and Dr. Galante recommended that Dr. Craig Silverton review the patients to determine if this was a common or rare phenomenon [Id., 72/20-73/8]. So a retroactive study was begun of the Dall-Miles patients. The study was of a group of about 68 patients who had had their trochanters reattached by using the Dall-Miles Cable Grip System [Id., 72/3]. The surgeries had taken place roughly over about a two year period from 1990 through 1992 [Id., 72/14.] 1

The History of the Silverton Paper. The findings of that study were published in various forms. Dr. Aaron G. Rosenberg became one of the co-authors [Id., 71/15]. The paper was first presented at Thesis Day for the Rush Hospital residents in 1994 [Id., 74/10]. The paper has been re-published a number of times: in 1995 it was presented at annual meeting of the American Academy of Orthopedic Surgeons [Id., 75/17]. The complications paper was also referred to in Chapter 78 of a 1998 text book [Id., 79/10] of which he is a co-editor with Dr. Callaghan from the University of Iowa and Dr. Harry Rubash from Massachusetts General in Boston [Id., 79/21]. It was published in theJournal of Arthroplasty in June 1996 [Ex. 3, 77/10]. He has had discussions about the paper with other orthopaedic surgeons maybe a dozen tim?? [Id., 78/5] including with orthopaedic??rgeons outside Midwest Orthopedics [his own practice group at Rush] [Id., 78/23]. On those occasions he does not recall anybody disagreeing with the findings of the paper [Id., 79/8]. Noone objected to the inclusion of the complications paper in the textbook [Id., 80/2]. He testified that the publication and re-publications of the Silverton complications paper was a fair indication that he affirmed the validity of the Silverton study [Id., 81/2-9].

The Complications Found in the Dall-Miles Cable Grip System and Its Suspension at Rush. 2 The findings in the Silverton paper were these:

-- in 10 % of the cable cases there was bone destruction by the abrasive action of the cable [Id., 101/13]. The bone destruction and its relationship to the cable was that it was the exact type of bone loss that we saw that we were just looking at of Mr. Mele in the first year of surgery [Id., 101/18-24]. The type of bone destruction and where it was located was reported in the paper. The paper says bone destruction or osteolysis around the cable in the area of the lesser trochanter, where the cable passed through the lesser trochanter. It was there that there was an area of bone loss in that region [Id., 102/1-8].

-- in 47% of the cable cases there was fraying of cable [Ex. 3, Dr. Rosenberg's dep. 96/13]. By fraying: he meant the unravelling of the multiple wires [individual filaments] that the surgeon-authors saw after the initial post-op x-rays [Id., 97/2-14]. What they saw was is not the breaking of cable [Id., 97/15] but the multiple strands that make up the cable starting to separate -- at the cut end -- and this was visible on x-rays [Id., 97/18-22].

-- in 44% of the cable patients there was fraying with metal fragmentation [Id., 98/18]. They did a contact roentgenogram that showed metallic filaments [Id., 97/18-98/4]. So that of the 68 patients 30 of them had not only fraying but also had fragmentation [Id., 98/18-99/2]. The fragmentation was pieces of metallic debris that appeared to be broken off from the strands and released into the surrounding tissue [Id., 99/3-6.]. Dr. Aaron G. Rosenberg noted that that finding was different from a mere breaking of the strand -- breaking is the breaking between the two ends that are crimped -- fraying and fragmentation refers to the portions of the cable that are cut to remove extraneous cable [Id., 99/20-100/3].

-- he and his co-investigators analyzed the metal debris with a microprobe analysis and it appeared to confirm that the metal debris found in these patients was the metal from the Dall-Miles cable [Id., 104/10].

-- Dr. Aaron G. Rosenberg and his coauthors at Page 403, Note 3, indicate a high incidence of debris at 17% and call it alarming [Id., 106/18-24]. It was alarming because they were not used to seeing that level of complication with the material they were using before they began using cables [monofilament wire] and it raised an alarm in their heads - - that's why they used the word -- it made them think it was something they should report to see if other people were having similar incidence of problems or was this unique to their institution [Id., 107/2-11]. It was unexpected [Id., 107/12].

The Suspension at Rush. As the Silverton paper itself notes, upon these findings of abrasive osteolysis [bone destruction], fraying and fragmenting, the Dall-Miles Cable Grip System was suspended at Rush for this procedure -- routine trochanteric fixations:

Although there may be an appropriate role for cable use in other settings (fixation of femoral shaft fractures, allograft plates, or extended trochanteric osteotomies, we no longer use this system for routine trochanteric fixation. Considering the potential problems of free-floating metal debris... monofilament wire has become our current choice for trochanteric fixation. If cables are used, their removal...should be considered to decrease the likelihood of fraying and fragmentation.

[Ex. 4, p. 404 at N1, N2].

The suspension is documented in the Defendant's own records as well following a Fall 1993 meeting between the Defendant's product manager, Joseph Pizzurro, and Dr. Mitchell B. Dr. Sheinkop, the surgeon who implanted and removed the device [Ex. 23]. Dr. Mitchell B. Sheinkop is also a partner of Midwest Orthopaedics and Dr. Rosenberg.

According to Dr. Mitchell B. Sheinkop the suspension at Rush of the Dall-Miles system came after his experience with Mr. Mele [Ex. 11, 134/4-14]. Two company representatives [later identified as Pizzurro and Mike Castelaz, the local sales representative] knew that the group had suspended usage of their system and they came to inquire why and they wanted to reassure us that they were making changes [Id., 154/4]. Dr. Mitchell B. Sheinkop explained the problems he was having with the Dall-Miles system to the two company representatives. The Defendant's representatives acknowledged there were problems and the company was making changes. Until those changes were made he stopped using the Dall-Miles system [Id., 134/15-23]. Dr. Mitchell B. Sheinkop's chart for Mr. Mele documented that meeting and indicated:

I have met with representatives of Howmedica, one was even flown in from East Rutherford, New Jersey (the corproate home base). They admit to me that there are problems with the cable grip system and they are revising the entire manufacturing process as well as the maching process.

[Ex. 5, p. 22-23].

Pizzurro's trip report documents that meeting with Dr. Mitchell B. Sheinkop and then the so-called Dall-Miles team a few days later acknowledged that the product had been suspended at Rush [Ex. 23, p. 3337, N1].

The Concern for Metal Fragmentation at the Mayo Clinic and Suspension of the System by the Mayo Orthopedic Surgeons. Not only was the Dall-Miles system suspended at Rush, the orthopaedic surgeons at the Mayo Clinic suspended it as well. The first document that was produced to Plaintiff concerning Mayo was the so-called cadaver memo that was written in August 1997 [Ex. 6]. It was written in connection with a ca??r trial in Los Angeles conducted by Dall??h Duane Hoogerhyde, the chief Dall-Miles engineer, and Kim Hacherl, the then-Dall-Mile's product manager, observing Dall's cadaver surgery. The report lists projects that should be pursued and then equates the Silverton complications with those at Mayo [Id., p. 3190] ([proposing simulator studies between possibly old grip with new cable (to see if new cable will help prevent the Silverton/Mayo Clinic problems]).

This late and significant disclosure to the plaintiff resulted in the court ordering the Defendant to produce further documents and to present for deposition the Defendant's account representative to Mayo, Rod Kams. His deposition was taken in December 2000 and he confirmed that the Mayo surgeons were concerned with metal fragmentation when using the Dall-Miles Cable Grip System and suspended its use at Mayo. His conversations with the Mayo orthopaedic surgeons was probably in May 1996 [Ex. 7, Deposition of Rod Karns, 45/1-9,22]. He testified that he had multiple conversations over a 2-3 day period with the Mayo surgeons and that the concern they expressed was about fragmentation of the system [Ex. 7, 46/1-6].

Initially Karns was told by Dr. Berry's physicians assistant that Dr Berry, one of the orthopaedic surgeons, had curtailed or backed off using the Dall-Miles trochanteric grips but he did not explain why [Id., 37/3]. Then when Karns spoke with the orthopaedic surgeons they told him their concern was for metal fragmentation; that if, on the one hand, monofilament wire broke that would result in large fragments but if, on the other hand, cable is used instead it will break into many small fragments [Id., 40/11-20]. The decision of the Mayo orthopaedic surgeons was that they were going to discontinue their usage of the Dall-Miles Cable Grip System [Id., 40/20-41/1].

The Absence of Any Genuine Issue of Material Facts on Certain Issues in Litigation. With that general background, the Plaintiff will now turn to the specific issues where the evidence adduced during discovery shows, as a matter of law, that it favors the Plaintiff and that there is no genuine issue that can be raised by the Defendant. The Plaintiff will now show that partial summary judgment should be granted on the following three issues:

1. There is no genuine issue of fact as to whether the cable was defective during ordinary use by virtue of its acting like a Gigli-saw and causing abrasive bone loss to the lesser trochanter of patients into whom the device was implanted.

2. There is no genuine issue of fact as to whether the cable in Mr. Mele caused abrasive bone loss of the lesser trochanter from the Gigli-effect action.

3. There is no genuine issue of fact that the cable cutter was defective by virtue of its leaving an overly long cable tag in the body of patients into whom it was implanted.

II. THE LEGAL STANDARDS FOR THE GRANTING OF SUMMARY JUDGMENT--WHETHER COMPLETE OR PARTIAL ONES

Section 5/2-1005 of the Illinois Code of Civil Procedure provides in pertinent part as follows:

Summary judgments. (a) For plaintiff. Any time after the opposite party has appeared or after the time within which he or she is required to appear has expired, a plaintiff may move with or without supporting affidavits for a summary judgment in his or her favor for all or any part of the relief sought... 3

(c)Procedure. The opposite party may prior to or at the time of the hearing on the motion file counteraffidavits. The judgment sought shall be rendered without delay if the pleadings, depositions, and admissions on file, together with the affidavits, if any, show that there is no genuine issue as to any material fact and that the moving party is entitled to a judgment as a matter of law.

735 ILCS 5/2-1005.

As the statute itself makes clear, summary judgment need not be on all the issues of the case and partial summary judgments are permitted as well ([for] all or part of the relief sought...)

The case law has made frequent reference to partial summary judgments. See Ramco Industries, Inc. v. Board of Trustees of University of Illinois, App. 1 Dist.1992, 168 Ill.Dec. 272, 226 Ill.App.3d 173, 589 N.E.2d 672 (such motions should be granted although substantial controversy exists on other issues); Atwood v. Warner Elec. Brake and Clutch Co., Inc., App. 2 Dist.1992, 179 Ill.Dec. 18, 239 Ill.App.3d 81, 605 N.E.2d 1032, appeal denied > 183 Ill.Dec. 858, 149 Ill.2d 647, 612 N.E.2d 510 (granting partial summary judgment in toxic tort case); Gleicher, Friberg & Associates, MD., S.C. v. University of Health Sciences, Chicago Medical School, App. 1 Dist.1991, 166 Ill.Dec. 460, 224 Ill.App.3d 77, 586 N.E.2d 418 (same holding as in Ramco); Brewer v. Daubert Chemical Co., App. 1 Dist.1979, 28 Ill.Dec. 911, 72 Ill.App.3d 718, 391 N.E.2d 110 (fact that there are other claims before court not subject to partial summary judgment upon which plaintiff may obtain relief is immaterial to question whether defendant is entitled to partial summary judgment as to all or any part of relief filed against him).

The standards for the granting of summary judgments, whether they be complete or partial ones are well-established. Our First District has recently re-stated them in Calhoun ex rel. Calhoun v. Belt Ry. Co. of Chicago, (Ill.App. 1 Dist. 2000), 731 N.E.2d 332, 314 Ill.App.3d 513:

The purpose of summary judgment under section 2-1005 of the Code is to determine whether there exist any genuine issues of material fact between the parties. Hubble v. O'Connor, 291 Ill.App.3d 974, 979, 225 Ill.Dec. 825, 684 N.E.2d 816, 820 (1997). Summary judgment is appropriate only where the pleadings, depositions, and admissions on file, together with any affidavits, present no issue of material fact and show that the moving party is entitled to judgment as a matter of law 735 ILCS 5/2-1005 (c) (West 1998); Benamon v. Soo ??ne Railroad Company, 294 Ill.App.3d 85, ?? 228 Ill.Dec. 494, 689 N.E.2d 366, 369 ??97) [246 Ill.Dec. 808]. Our review o??n order granting summary judgment in favor of a party is conducted de novo ( Benamon, 294 Ill.App.3d at 88, 228 Ill.Dec. 494, 689 N.E.2d at 369 (1997) ), and we will construe all pleadings, depositions and affidavits in a light most favorable to the non-moving party. Soderlund Brothers, Inc. v. Carrier Corp., 278 Ill.App.3d 606, 614, 215 Ill.Dec. 251, 663 N.E.2d 1, 7 (1995). Although a plaintiff is not required to prove her case at the summary judgment stage, some evidentiary facts in support of her cause of action must be presented. Helms v. Chicago Park District, 258 Ill.App.3d 675, 679, 196 Ill.Dec. 851, 630 N.E.2d 1016, 1019 (1994).

731 N.E.2d 332, 335-36.

III. THERE IS NO GENUINE ISSUE OF FACT AS TO WHETHER THE CABLE WAS DEFECTIVE DURING ORDINARY USE BY VIRTUE OF ITS ACTING LIKE A GIGLI-SAW AND CAUSING ABRASIVE BONE LOSS TO THE LESSER TROCHANTER OF PATIENTS INTO WHOM THE DEVICE WAS IMPLANTED

A. THE LAW OF DEFECT- A PRODUCT IS DEFECTIVE IN ILLINOIS IF IT IS CAPABLE OF INFLICTING AN UNEXPECTED INJURY ON THE ULTIMATE USER OF THE PRODUCT DURING INTENDED USE OR EVEN DURING UNINTENDED BUT FORESEEABLE MISUSE

Illinois law is clear that there are two elements involved in the definition of whether a product is defective (or, synonymously, unreasonably dangerous): (1) first, whether the product produced the injury complained of during intended or foreseeably unintended usage, and (2) second, whether the injury was unexpected to an ordinarily knowledgeable victim. These elements are made clear in Haudrich (Ill. 1996) and Hansen (First Dist. 1999).

Our Supreme Court once again defined what a legally defective product was in Haudrich v. Howmedica, Inc. 4 :

In an attempt to once again define the term unreasonably dangerous condition, the court in Hunt 5 agreed that ‘those products are defective which are dangerous because they fail to perform in the manner reasonably to be expected in light of their nature and intended function.’ ( Hunt, 74 Ill.2d at 211, 23 Ill.Dec. 574, 384 N.E.2d 368, quoting Dunham v. Vaughan & Bushnell Manufacturing Co. (1969), 42 Ill.2d 339, 342, 247 N.E.2d 401). The court went on to find that a condition or defect in a product is unreasonably dangerous if it subjects those exposed to the product to an unreasonable risk of harm beyond that which would be contemplated by the ordinary person with ordinary knowledge common to the community as to the product's ch??cteristics. Hunt, 74 Ill.2d?? 211-12, 23 Ill.Dec. 574, 384 N.E.2d ??8, citing Restatement (Second) of Torts §402A, Comment i (1965). See also West v. Deere & Co. (1991), 145 Ill.2d 177, 180, 164 Ill.Dec. 122, 582 N.E.2d 685.

Haudrich v. Howmedica, Inc. (Ill. 1996), 662 N.E.2d 1248, 1255, 169 Ill.2d 525. (Emphasis added) [Full text at Ex. 8].

Thus the Supreme Court once again reiterated the strict tort law of Illinois which has been applied over a period of at least the last thirty-two years since Dunham.(Ill. 1969). There are always two elements to defectiveness and they were discussed in Haudrich: [1] that defective performance is to be regarded in the context of intended function, and [2] that its defectiveness is from the point of view of the ultimate user, or ordinary person in the shoes of the plaintiff.

Element One -- Intended Use or Foreseeable Misuse. Actually, the law of intended use has been long been expanded beyond merely intended use to include also a misuse of the product that was foreseen or, even, merely foreseeable by the product manufacturer. This is clear from the very recent medical device case of, Hansen v. Baxter Healthcare Corp., (Ill.App. 1 Dist. 1999), 723 N.E.2d 302, 309 Ill.App.3d 869 6. That was a case tried here in Cook County wherein the patient, Andrina Hansen, suffered a brain injury from an air embolism when post-surgically a Baxter iv connection disconnected. The First District reversed the jury's verdict finding Baxter guilty of failure to warn of the disconnection but affirmed the $18 million verdict that the slip-type iv connector was defective.

As for intended or foreseeable use, Hansen cited to the Illinois Pattern Jury Instructions:

The question presented to the jury was whether the luer slip connector was * * * unsafe when put to a use that is reasonably foreseeable considering the nature and functions of the * * * connector. Illinois Pattern Jury Instructions, Civil, No. 400.06 (3d ed.1995). That is, a product is defective * * * if it is not safe for such a use that can be expected to be made of it * * *. > Dunham v. Vaughan & Bushnell Mfg. Co., 42 Ill.2d 339, 343, 247 N.E.2d 401 (1969).

[Id., Ex. 10, p. 19, N1, 723 N.E.2d at 313]. But foreseeable uses (at least since the Kerns decision in 1979) include misusage as well since the Court held that Baxter should have known about nursing error in improperly securing the iv:

The luer slip could and did come apart inadvertently, even when properly connected, despite compliance with industry standards. Baxter knew that. In addition, nurses at times would, for convenience, loosely connect the luer slip. Baxter should have known that. If the practice can be characterized as abnormal, it also can be anticipated, and, therefore, objectively reasonable to foresee. See > Kerns v. Engel?? 76 Ill.2d 154, 165, 28 ??c. 500, 390 N.E.2d 859 (1979).

[Id., Ex. 10, p. 19, N2, 723 N.E.2d at 313]. As will be seen, the case at bar involves only the intended use of the Dall-Miles system, namely use in a trochanteric osteotomy fixation. So the court will not even have to look to foreseeable uses beyond the one intended by Defendant. The Plaintiff's reference to Hansen's invocation of even a misuse as warranting liability shows how broad Illinois' strict tort law has been [since 1979 in Kerns] and continues to be. The Plaintiff will now address the second element of the definition of defectiveness -- the so-called consumer expectation test.

Element Two -- Unexpected Injury from the Point of View of the Plaintiff-Victim. This element is a common sense one that has been adopted generally throughout the country since the inception of strict tort law. The concept is an easy one. Only injuries that are unexpected to the plaintiff-victim are actionable. So things like butcher knives -- which are dangerous -- are not defective since cutting oneself with a butcher knife is not unexpected. However, if in the process of using the butcher knife properly, the tip of the blade snapped off and flew into the plaintiff's eye, clearly, the knife would be considered defective since that injury was unexpected.

Haudrich addresses this second element of unexpected injury when it holds that [Hunt] went on to find that a condition or defect in a product is unreasonably dangerous if it subjects those exposed to the product to an unreasonable risk of harm beyond that which would be contemplated by the ordinary person with ordinary knowledge common to the community as to the product's characteristics. Hunt, 74 Ill.2d at 211-12. Haudrich at 622 N.E.2d at 1255, Ex. 8, p. 13, N1.

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