Motion 2 - product liability plaintiffs motion for summary judgment - Part 2

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In Hansen -- not that any clarification was needed that it was the plaintiff-victim to whom the law is referring when it speaks of the ordinary person -- the court refers a number of times as to what Andrina Hansen expected or did not expect as to her being injured by the Baxter iv-connection:

-- Based on testimony about the luer slip design the jury could have found it posed an unreasonable risk of harm beyond that contemplated by Andrina as she lied [sic, laid] in her hospital bed. Hansen, [Ex. 10, p. 20, N1, 723 N.E.2d at 313] ;

and, again,

-- In short, the evidence of defective design could be considered by the jury in both of the ways approved in > Palmer v. Avco Distributing Corp., 82 Ill.2d 211, 219-20, 45 Ill.Dec. 377, 412 N.E.2d 959 (1980) : (1) Evidence that Andrina could expect to use the luer slip without risk of harm; and (2) a connector that would prevent foreseeable harm without hindering its function or increasing its price had been designed [Ex. 10, p. 20, N2, 723 N.E.2d at 314].

Hansen notes that the courts have called this Illinois definition of product defect the consumer expectation test.Hansen, [Ex.??p. 21, N2, 723 N.E.2d at 314] (Whethe ?? jury used the ‘consumer expectation test’...). It then noted that it was the patients who were the ultimate consumers:

Baxter also knew the luer slip would be used with central venous catheters, creating a potentially dangerous situation for unsuspecting patients, the ultimate consumers. It should have come as no surprise to Baxter that patients move in bed. They sit up at times. Lines get caught and tangled. Again, * * * objectively reasonable to expect, not merely what might conceivably occur. > Winnett v. Winnett, 57 Ill.2d 7, 12-13, 310 N.E.2d 1 (1974). See C. Chapman & T. Hoffman, Product Liability in Illinois at 11-2 (3d ed.1999).

[Ex. 10, p. 19, N3, 723 N.E.2d at 313]. So, it is clear that in medical device product cases not only does the law look from the patient's viewpoint as to the expectation of safety, but also that the courts find -- as a matter of law -- that patients do not expect to be injured by medical devices that are supposed to help in their healing.

Both of these elements of defect -- intended use and unexpected injury-- are proven as a matter of law with respect to the Dall-Miles cable's defective condition of acting as a Gigli-saw and abrading bone -- as will now be demonstrated.


In every products case, the usually unstated preliminary fact before a defect analysis of intended use and unexpected injury is that the product exhibited some dangerous feature capable of injuring. Here, the dangerous condition was the ability of the cable to destroy the patient's bone by an abrasive action. Plaintiff turns to that condition now.

Uncontested Proof of Abrasive Condition of the Dall-Miles Cable. It is important for the Court to note that for purposes of this motion , the injury is restricted to the destruction of bone by the abrasive action of the Dall-Miles cable. The contention of the plaintiff at trial will be that that initial injury led to the more serious injury called endosteolyis-- ie, the destruction of bone all along the femoral shaft. That degree of injury will be contested and is not a proper subject for summary judgment; but the propensity of the Dall-Miles cable to abrasively destroy bone should be deemed proven as a matter of law.

All the evidence during discovery shows that the Dall-Miles cable has a propensity to destroy bone by a sawing-lik??fect called the Gigli effect 7. This ??des the Silverton papers discussion of the Gigli effect, Mr. Mele's two surgeons, Dr. Mitchell B. Sheinkop and Dr. Aaron G. Rosenberg, testifying to the effect both in the Silverton group of patients and in Mr. Mele's case, admissions by the Defendant's employees, and the affidavit of Plaintiff's expert, Dr. Alan S. Litsky.

The Silverton study has been briefly discussed above and the journal paper based upon it is attached [Ex. 4]. On this specific point the paper reported that 10% of the Dall-Miles cable patients suffered bone destruction from the abrasion of the cable (see Footnote 7).

One of the areas of abrasive osteolysis was the reaming out of the drill hole in the lesser trochanter through which the surgeons passed the Dall-Miles cable. The authors showed this bone destruction in Figure 3 of their paper [Ex. 9 is a reproduction of that micrograph].

Dr. Aaron G. Rosenberg's Testimony. Dr. Aaron G. Rosenberg in his deposition testified to this statistic of 10% abrasive bone destruction and its being caused by the abrasive action of the cable [Ex. 3, 101/13]. He further compared it to the same destruction of bone in Mr. Mele, indicating that the bone destruction in the Silverton cohort was the exact type of bone loss that we saw that we were just looking at of Mr. Mele [by reviewing x-rays of Mr. Mele] in the first year of surgery [Id., 101/18-24]. He pointed out that the type of bone destruction and where it was located was reported in the paper as bone destruction or osteolysis around the cable in the area of the lesser trochanter, where the cable passed through the lesser trochanter [Id., 102/1-8].

Dr. Mitchell B. Sheinkop's Testimony. Dr. Mitchell B. Sheinkop, who implanted the system in 1991 and removed it in 1993 testified extensively to the abrasive destruction of bone [ osteolysis ] by the action of the Dall-Miles cable. He pointed to the Plaintiff's x-ray from 02/28/92 [marked as px10/ca6] [Ex. 12] where there was shown an enlarged hole through which the distal [lower] cable passed [Ex. 11, 91/19]. The diameter had reached 4mm whereas the original diameter was the same as the cable at 2mm [Id., 92/8-11]. As to the cause of the enlargement he testified that the hole was enlarged by the abrasive action of the cable to twice the original diameter [Id., 93/4].

He further testified that the cable also caused a lytic area [bone destruction] where the proximal [upper] cable passed over the bone [Id., 94/17-95/20]. That, he said, was caused by the same mechanism as with the enlarged hole -- an abrasive action on the bone by the cable [Id., 95/23].

In his second deposition (after he disclosed Rule 213(g) opinions), he testified that he had to remove the cable from Rich?? Mele's body because he feared patholog??fracture [Ex. 32, 36/2037/5] by which he meant that if he did not remove it and the cable continue to cut away bone, the abraded bone could fracture.

Dr. Alan S. Litsky's Testimony. The Plaintiff's expert, Dr. Alan S. Litsky has submitted an affidavit [Ex. 15] incorporating his Rule 213(g) opinions, both original and supplemental. In his Opinion I he stated that:

Opinion I -- the original Dall-Miles cable was defective [unreasonably dangerous] when used, as designed and intended, for trochanteric osteotomy since it was in a condition that allowed it to (1) abrade bone by movement of the rough cable surface over adjacent bone...

His bases for this opinion are fully set out in his Rule 213(g) disclosure which is attached [Ex. 15, pp. 3-6]. But to briefly summarize: he personally saw this effect in Richard Mele's x-rays of 02/28/92 and that of 09/18/92; he noted that the Gigli-effect was seen in the Silverton group of patients; the Silverton group of patients and Richard Mele had a number of factors in common including all being Dall-Miles implantees, all having had the same surgical procedure, trochanteric fixation; all having had the Dall-Miles cables implanted during the same period of time with the Silverton cohort getting the Dall-Miles implant between January 1990 and July 1992 and (2) Mr. Mele receiving his implant almost in the middle of that period, May 28, 1991.

In his supplemental Rule 213(g) disclosure [Ex. 16, p. 1] he reported on his testing of the cable model in question here. Part of that testing verified that the Dall-Miles cable was capable of Giglieffect action:

1. Can the cable act as a Gigli-saw and abrade its way through bone? A 2mm hole was drilled through a cadaveric femur... A four inch segment of cable was manually abraded back and forth through the hole for 50 cycles over a period of approximately one minute. The hole expanded to 5.4mm...

Even the Defendant's chief design engineer for the Dall-Miles line, Duane Hoogerhyde, has had to admit that the cable can cause bone abrasion. He stated that during his tenure with the Defendant [since January 1989 as a student] he knew that sometimes cable could act as Gigli saw and abrade bone [Ex. 13, 183/25]; that it could happen if there was motion [Id., 183/25] and that he was definitely aware of cable abrading bone before the Silverton paper reported it [Id., 184/6].

So, as with most products cases, it is uncontested that the Dall-Miles cable can be dangerous, i.e., inflict an injury on a patient. The questions before the court become (1) does that bonedestroying condition manifest itself during intended use and (2) does a patient expect to be so injured? Both questions will be seen to be answerable only in favor of the Plaintiff and as a matter of law.

Element One -- As a Matter of Law, The Gigli-Effect Has Manifested Itself in the Silverton Patients and in Rich?? Mele During Intended Use. Is the firs?? ment satisfied: Did the patients in the Silverton study and Mr. Mele suffer their bone-destruction incidents during intended use? It seems undisputed that they did. The proof is simplicity itself:

1. The Dall-Miles trochanteric cable grip system was intended to be used as a fixation device in re-attaching the greater trochanter after a trochanteric osteotomy. [See drawing and text, px20c2789, here as Ex. 17 wherein the text states that the system provides a method of re-attaching the greater trochanter].

2. But the Silverton study cases and the Mele surgery all involved that precise surgery -- repairing a trochanteric osteotomy. The Plaintiff's case was a primary [first time] hip replacement and some of the Silverton cases were so-called revisions [second or more] replacement but the Dall-Miles Cable Grip System was intended for both primary and revision hip replacements [Defendant's brochure, px20h429, 36, here as Ex. 18 or in revision cases].

The Foreseeability of Non-Union During a Dall-Miles Trochanteric Fixation. It was clear from Defendant's discovery that it sought to make Mr. Mele's fibrous union 8, rather than the preferred boney union, into some kind of unarticulated defense. The attempt to do so would be to argue to the court that the fibrous union caused excess movement and this excess movement caused the Gigli-effect. Then from that factual premise, the Defendant would try to bootstrap fibrous union into some kind of mistaken defense. From discovery, Plaintiff guesses the Defendant's legally faulty defense are as follows: That fibrous union-- instead of the preferred boney union -- is, somehow, an unintended use.

But as will be seen this defense fail as a matter of law.

Fibrous Union is not a Misuse of the Product but Merely One -- A Foreseeable Result in the Intended Use of the Product. It strains logic and the ordinary, plain meaning of words to claim, as Plaintiff suspects the Defendant wishes to do, that although its system was specifically designed for use as a trochanteric repair system and it was so used, that one of two possible results of that use, nonunion, was a misuse. That argument would be akin to Ford Motors arguing in the Pinto gas tank cases that getting rear-ended was not an intended use of its defectively designed Pinto gas tanks. The rebuttal is that being rear-ended is not a use at all-- it is one possible result of using a car as a car. The same is true of the Defendant's suspected claim here. Nonunion is merely one of the only two results (the other being union) that can occur during intended use of its cable system as a cable system.

Moreover, even negligence in the use of a product does not relieve the manufacturer of a defective product of its liabi?? if the negligent use was foreseeable. t is clear from Hansen's rejection of Defendant Baxter's argument that nursing negligence in insecurely fastening its slip iv connectors should have absolved it. Hansen [Ex. 10, p. 19, N2, 723 N.E.2d at 313].

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. Engelke, 76 Ill.2d 154, 165, 28 Ill.Dec. 500, 390 N.E.2d 859 (1979).

So, even if the English language were tortured to the point that a failure to achieve boney union became somehow negligence (which it is not), it would have been objectively reasonable to foresee, as Hansen put it and fall within the ambit of intended or otherwise foreseeable use. In fact the evidence is uncontested that not only should the Defendant have foreseen nonunion but as the Plaintiff will now show the Defendant had actual knowledge of non-union during the intended trochanteric surgeries.

Non-union was well known to the Defendant One witness who so testified was Joe Pizzurro, the former Dall-Miles product manager for the Defendant. He admitted in a company document that there had been reports of fraying and nonunion with the Dall-Miles grip system [Ex. 19, produced as px20/j3335,36,N3]. At his deposition he acknowledged that report [Ex. 20, 174/3]. He further testified that his sources of knowledge for such results included salesmen or other customers of Howmedica [Id., 174/19].

Other of Defendant's documents show that it was well aware of nonunion as a possible result of intended use. For example in one such document its employees are discussing fragment migration [Ex. 21, produced as a Project Initiation Request, px20a3396, pg/nt 400,N4] 9. In another, Chief Dall-Miles Engineer Hoogerhyde is commenting on even Dr. Dall's tests showing more breakage and nonunion with vitallium cables [ the ones in suit here] versus stainless steel [Ex. 22, produced as px20n3651,N1].

In fact, Defendant was so familiar with non-unions that it even had a complaint code for them. In its PER (Product Experience Report system) it assigned non-unions its own code of 54202 [Ex. 24, produced as px20/e2044, p 45nl].

So, to the extent such a misuse defense is what the Defendant had in mind during deposition discovery, it must be rejected under Hansen as being within a foreseeable use. In other words, if Hansen rejected Baxter's argument and held that nursing negligence was a foreseeable use then a nonnegligent surgery achieving fibr?? union is, a fortiori, a foreseeable use. In??, it was actually foreseen by Howmedica.

Element Two of Defectiveness -- As a Matter of Law the Silverton Patients and Richard Mele Could not Reasonably Expect the Dall-Miles Cable to Inflict a Bone-Destroying Iniury Upon Them. Whether the second element -- unexpected injury -- is met is decided in Illinois from the point of view of the ultimate consumer -- the patient-victim. This is true in a medical device product liability case as well. See Haudrich (Ill. 1996), 662 N.E.2d at 1255, [Ex. 8, p. 13, N2] ([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 a ordinary person with ordinary knowledge common to the community as to the product's characteristics); Hansen has specifically held that the ordinary person in a medical device case is the patient. The jury could have found it [the Baxter I.V. product] posed an unreasonable risk of harm beyond that contemplated by Andrina... ( 723 N.E.2d at 313, Ex. 10, p. 20, N1]; Plaintiff's evidence of defect can be based on the fact that Andrina could expect to use the luer slip without risk of harm [Id., at 314, Ex. 10, p. 20, N2].

The Plaintiff here is in precisely the same position as Andrina Hansen was in the First District's case, namely, he had no reasonable expectation that he would be injured by the Dall-Miles cable and its tendency to abrade bone through its so-called Gigli-effect. And, for purposes of this motion , there is no contrary evidence for a jury to consider. The evidence that the injury to Dall-Miles implantees and Mr. Mele is unexpected to them is as follows:

Plaintiff's Testimony. The Plaintiff testimony makes it clear that his subsequent injury by the Dall-Miles cable came as a complete surprise to him. He testified that prior to the implantation surgery, that he was only advised as to the general surgical risks [Ex. 28, 46/13-24]; and, that prior to the implantation surgery he had no knowledge of even the Dall-Miles name nor of any potential injury from that system [Id., 169/12-171/10]. That is the totality of the evidence on this point. There is no evidence to contradict the Plaintiff's testimony.

The Testimony of the Plaintiff's Expert, Dr. Alan S. Litsky. Dr. Litsky is the Plaintiff's expert. His credentials are as follows:

* He is a medical doctor, having graduated from Columbia University College of Physicians and Surgeons in 1979 [Ex. 25, p. 1];

* He is a doctor of engineering as well, having received a doctorate of science from Massachusetts Institute of Technical in Bioengineering in 1988;

* He has been since 1994 both an associate professor of orthopaedics and the director of the orthopaedics biomaterial lab at Ohio State University.

In his Rule 213(g) Opinions [Ex. 15, p. 3], which he has incorporated into his Affidavit [Ex. 14], he opined that:

Opinion I

The original Dall-Miles cable was defective (unreasonably dangerous) when used as designed and intended for trochanteric osteotomy since it was in a condition that allowed it to (1) abraded bone by movement of the rough cable so the surface over adjacent bone...

He based that opinion on the fact that (1) in his experience no patient expects a medical device implanted into him to injure him rather than assist in curing him; (2) the aforesaid testimony of Mr. Mele that he had no knowledge of the name of the Dall-Miles device until he began having post-surgical complaints.

Absence of Gigli-effect Warnings and the Defendant's Literature and Ignorance of it by its Employees. And although the test in Illinois is whether or not the patient expected injury it is of interest and some probative value that the Defendant appeared ignorant of the Gigli-effect, as did some of its key employees.

In its product catalog for 1990 [Ex. 18], it touts the superiority of the system. Nothing is said about the Gigli-effect.

Moreover, key employees of the Defendant have testified during discovery to their ignorance of the Gigli-effect. One of those employees was Charles Lawyer. At his deposition, he indicated that he had joined Howmedica in 1974 and had left the company in March, 1999 [Ex. 26, 19/14]. Mr. Lawyer joined the company in 1974 as a quality assurance engineer at which time his duties included so-called PER (Product Experience Report) evaluations; in the Spring of 1978, he was made manager of quality assurance; in 1983 he was appointed assistant director of quality assurance reporting to vice president; in 1997 he was made director of quality assurance [Ex. 26, 28/7-33]. in Defendant's Answers to Interrogatories, it identified Mr. Lawyer as the senior-most employee in authority for responsibility for identifying and correcting defects in products made by Howmedica [Ex. 27]. As to whether he expected the Gigli-effect, he testified that he did not know of the Gigli-effect until today [Ex. 26, 38/3]. His deposition was taken on October 4, 2000.

The significance of that testimony is obvious. Here is an executive identified in Answers to Interrogatories as the prime person reasonable for identifying defects within the company and he claims he has no knowledge of the Gigli-effect. He would not expect such an injury. If an employee did not expect this type of injury, how could Mr. Mele? The answer is that they could not as a matter of law.

The same testimony was elicited from Keith Merrick, a former engineer for the Defendant. He started with the company in 1984 [Ex. 29, 29/15-19] and left the company in January of 1999. His major in college was metallurgy and material science. He started with the company as an engineer B or lab technician [Id., 29/20-24] and was promoted in 1986 to engineer A or manufacturing engineer [Id., 30/313]. In 1986, he first became i??ved with the Dall-Miles system and was ??lved with the Dall-Miles system the whole time he was employed.

Further, despite that history of 15 years with the company and 13 years of involvement with Dall-Miles, he claimed that he had never heard of the Gigli-effect [Id., 47/16-19].

Again, if even the Defendant's own key employees claim that they did not know of the Giglieffect, how could any implantee? How could Mr. Mele? As a matter of law neither they nor he had any such knowledge and therefore his injuries were unexpected.

Thus, on the key elements of defectiveness as to the Gigli-effect -- the cables bone abrading condition -- there is no issue for the jury.

As a matter of law this dangerous property or condition was manifest during (1) intended use and (2) its patient/victims did not contemplate their being so injured.

Summary judgment should be granted in favor of the Plaintiff as to the defectiveness of the cable with respect to that feature.


Both of Plaintiff's orthopaedic surgeons, Drs. Sheinkop and Rosenberg, have filed Rule 213(g) disclosures. In those disclosures they assert that the Plaintiff's abrasive osteolysis (or Gigli-effect damage) was caused by the motion of the Dall-Miles cable. Their testimony is as follows:

Dr. Sheinkop's Opinion. Dr. Sheinkop was the Plaintiff's surgeon for the implantation of the Dall-Miles Cable Grip System in May, 1991 and for its removal in January, 1993.

Dr. Sheinkop is a prominent orthopaedic surgeon. Among his qualifications are his having been an orthopaedic surgeon since 1968, having been assistant professor of orthopaedic surgery at the University of Chicago, having been a lecturer in orthopaedics at Northwestern University Medical School, since 1999 being a full professor of orthopaedics at Rush University, being a fellow of the American College of Surgeons since 1976, being a fellow of the American Academy of Orthopaedic Surgeons since 1977, being the author of 49 technical journal publications, having made 45 scientific presentations in the field of orthopaedic surgery [Ex. 39, Dr. Sheinkop's CV].

At his deposition in January, 2001, he agreed that the Rule 213(g) Disclosures were his opinions [Ex. 32, 70/7-10]. In those Rule 213(g) disclosures [Ex. 33] his Opinion I reads as follows:

It is Dr. Sheinkop's opinion that Mr. Mele's abrasive osteolysis (Giglieffect damage) was caused by the motion of the Dall-Miles cable [Ex. 33, p. 2].

The bases for that opinion are fully set-out in the Rule 213(g) disclosures but, for convenience, those reasons will be summa?? here and include: (1) numerous x-ra?? showing the lysis (bone destruction); (2) the enlargement of the drill-hole between the September, 1992 and another one nine months later; (3) the present of a lytic area at or near the proximal cable; (4) the roughness of the cable surface; (5) his observation that a pathological fracture might occur from the continued cutting of the cable by the so-called Gigli saw effect; (6) the fact that other of his Dall-Miles patient experienced the same abrasive loss of bone [Ex. 33, pp. 3-4].

At his January, 2001 deposition, he was asked to expand on his fear, in Mr. Mele's case, that if he did not remove the Dall-Miles cable a pathological fracture might result. The colloquy between Mr. Reed and Dr. Sheinkop was as follows:

Reed: To avoid what he [sic, you] thought might become a pathological fracture from this abrasion is that -- again, are simply saying that if the -- what were you saying there?

Sheinkop: Well, if you cut it long enough, it will crack.

Reed: So, you just don't want to keep cutting the hole bigger and bigger?

Sheinkop: The tree will fall if you keep on cutting it.

[Ex. 32, 36/20-37/5]. He continued and testified that the cutting effect was the movement between the cable and non-union [Id., 37/6-9].

Dr. Rosenberg's Opinions. Besides being the co-author of the Silverton study, Dr. Rosenberg is a prominent orthopaedic surgeon. His qualifications include becoming a diplomate of the American Board of Orthopaedic Surgeons in 1986, becoming a Fellow of that Academy in 1988, from 1996 to the present, being a full Professor of Orthopaedic Surgery at Rush Medical College in Chicago, having made a 144 scientific presentations concerning orthopaedic surgery, having delivered 38 lectures such institutions as the Harvard Medical School, various instructional lectures at the American Academy of Orthopaedic Surgeons [Ex. 34, Dr. Rosenberg's CV].

At his January, 2001 deposition, his Rule 213(g) opinions were discussed. He explained how the opinions were drafted and the drafts exchanged with Plaintiff's counsel; how his opinions and bases were arrived at; that the prior draft was similar to the present one, but he had made corrections and those corrections had been incorporated [Ex. 30, 11/1-8].

His Rule 213(g) Disclosures, including his opinion concerning the injury to Mr. Mele by the Gigli-sawing effect of the Dall-Miles cable are expressed in that document and his opinion is stated as follows:

It is Dr. Rosenberg's opinion that Mr. Mele's abrasive osteolysis [or Gigli-effect damage] was caused by the motion of the Dall-Miles cable [Ex. 31, p. 2].

The bases for that opinion were given at a prior deposition of July 19, 2001 [Ex. 3] and citations to that earlier deposition were made p??f his Rule 213(g) Disclosures.

While his Rule 213(g) Disclosures are set-out in full [Ex. 31] his bases, summarized here, were that (1) he saw the lytic areas in the x-rays where the Dall-Miles cable passed through or over Mr. Mele's bone; (2) there was abrasive or Gigli-saw effect bone loss in the Silverton group of patients who were implanted with the same system.

At his second deposition, when asked directly about his opinion on abrasive osteolysis, he affirmed his 213(g) disclosure by indicating that that his Opinion I addressed the Gigli or Gigli-saw effect, that he could see that the hole got bigger, that the hole was caused by the movement of the cable against the bone [Ex. 30, 15/19-16/4]; that a lytic lesion was seen in connection with the inferior Dall-Miles cable when Dr. Sheinkop had drilled the hole through the lesser trochanter or calcar [Id., 16/14-24]. He affirmed that the sawing effect involved movement of the cable against the bone of Mr. Mele [Id., 16/57].

Again, in summary, the evidence is incontrovertible. This evidence of Gigli-saw effect damage is from the two treating orthopaedic surgeons who, moreover, saw the same damage with the other Dall-Miles patients.

Cable As A Proximate Cause. The fact that the abrasive action did not take place in a vacuum and was in conjunction with movement due to the fibrous union of the two fragments of the trochanter, does not constitute a defense. All Plaintiff need show, in any case, including a medical device case, is that the product [the cable here] was a contributing cause. See Hansen, 309 Ill.App.3d at 885, [Ex. 10, p. 21, N1, citing inter alia the 1983 Ill.Sup.Ct. case of Coney] 10 (liability may be found whether the defective design of the defendant's product is the sole or a contributing cause of the plaintiff's injury).

There will be no other evidence upon which a reasonable inference can be based suggesting that a sole proximate cause existed which was unrelated to the Defendant's cable.

Accordingly, partial summary judgment should be granted on this issue.


As the court knows from the motion seeking to amend the complaint by adding punitive damages, the evidence that there was a defect in the Defendant's cable cutter was explicitly made in the so-called Project Initiation Request of July 1993:

The metal ‘tag’ that is left when the excess cable is cut off from the Grip ... causes tissue irritation and allows sma bits of metal to break off from the ‘ta??’ creating metal debris. Either a new des?? cutting instrument or implant is eded to ??ress this design flaw.

[Ex. 35, p. 3396, N1-N2].

The replacement cutter was not released until sometime after November 1993 since another document of the Defendant spoke of a plan to launch the new cutter then. [Ex. 36, p. 3342, N2]. But the plaintiff's implantation was in May 1993 [Ex. 5, p. 35] -- 6 months before even the anticipated introduction date. So Plaintiff was implanted using the flawed cutter.

The Barred Testimony. Moreover, the Court during the hearing on the punitive damage amendment barred any contrary testimony by the Defendant through its putative witnesses, Dall and Kashuba. That was done with respect to Kashuba since the Project Initiation Request was not produced until the day after the Plaintiff's attorney returned from Massachusetts after deposing Mr. Kashuba -- at which deposition neither Mr. Kashuba nor counsel disclosed the design flaw document [Ex. 37, Mr. Trinley's certification]. Dr. Dall was barred since he refused to participate in discovery after being requested to do so by Plaintiff's counsel [Ex. 38, Ms. Cerullo's certification].

Thus the explicit admission of design flaw in the cutter stands uncontradicted and partial summary judgment should be entered thereon since there is no contrary evidence for the jury to consider.


In conclusion partial summary judgment should be entered on the following issues for the reasons stated:

1. Defect in the Cable. There is no genuine issue but that the Dall-Miles cable was defective because of its propensity to abrasively destroy the bone of implantees with a Gigli-saw effect since:

a. it is uncontradicted that such a condition existed in the cable;

b. it is uncontradicted that the condition manifested itself during intended use [trochanteric osteotomy fixation] or otherwise reasonably foreseeable use -- thus satisfying the first element of defectiveness;

c. it is uncontradicted that the abrasive bone destruction was not reasonably expected by any reasonable implantee in Mr. Mele's position -- thus satisfying the second element of defectiveness.

2. Causation of Injury to Mr. Mele by the Gigli-action of the Cable. There is no genuine issue but that Mr. Mele's proximal femur was cut by the Gigli-sawing action of the cable because:

a. Both his surgeons found such damage and attributed it to the cable;

b. Such evidence is uncontradicted;

c. As a matter of law, the combination of trochanteric fibrous union leading to the Gigli-sawing effect into Mr. Mele's bone in his proximal femur makes the cable a contributing cause of the injury.

3. Defect in Cutter. There is no genuine issue but that the Defendant's cable cutter was defective because:

a. By the Defendant's own admission the cutter contained a design flaw at the heart of the Plaintiff's theory-- one causing metal fragmentation from an excess cable tag;

b. Contrary evidence has been barred because of discovery violations by the Defendant.

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