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Kendall v. Bausch & Lomb

June 17, 2009


The opinion of the court was delivered by: Karen E. Schreier Chief Judge


Defendant Bausch & Lomb, Incorporated (B&L) moves for summary judgment. Docket 181. B&L also moves to strike. Docket 241. Plaintiff, Craig Kendall, has fully responded to the motions, and the matters are now ripe for disposition. The motion to strike is denied, and the motion for summary judgment is granted in part and denied in part.


Following are the relevant facts construed in the light most favorable to Kendall, the non-moving party:

On December 10, 2002, Kendall underwent LASIK surgery to correct his vision. Dr. John Bormes performed Kendall's surgery at Opthamology Associates in Aberdeen, South Dakota. During LASIK surgery, a device called a microkeratome applies suction to the patient's cornea while a motorized blade cuts a flap of the corneal tissue. The surgeon then uses a laser to remove corneal tissue, after which the flap is replaced. Dr. Bormes contracted with defendant Laser Vision Centers, Inc. (LVCI) to supply LASIK equipment, including AccuGlide blades and personnel to assist during surgeries. For Kendall's surgery, Dr. Bormes used a microkeratome with an AccuGlide blade from manufacturing lot #517984, which was designed, manufactured, packaged, sold, and distributed by B&L.

LVCI technician Elaine Shotwell assisted Dr. Bormes during Kendall's surgery. Neither Dr. Bormes nor Shotwell recall anything about Kendall's procedure, but it is believed that no remarkable complications arose during the surgery. Docket 211, Plaintiff's Statement of Material Facts (PSMF), ¶ 3. It is Shotwell's normal practice to inspect the AccuGlide blade under a microscope to ensure that there are no visible defects and to reject the blade if it appears abnormal or defective. Additionally, Dr. Bormes typically conducts a visual inspection of the blade before using it.

After the surgery, Kendall developed diffuse lamellar keratitis (DLK) in both of his eyes. DLK is a inflammatory condition of the interface of the corneal flap that may be a complication of LASIK surgery. The causes of DLK are not completely understood in the medical community. Incidences of DLK often cannot be traced to one cause, and studies have linked it to many different causes that arise over the course of LASIK and other eye surgeries. This condition is widely-known among individuals who perform LASIK surgery, and it is standard procedure to watch for the development for DLK during postoperative check-ups.

Dr. Bormes performed eleven LASIK surgeries on December 10, 2002. PSMF ¶ 4. All of Dr. Bormes' patients from that day whose surgery involved a blade from lot #517984 developed DLK. Id. ¶ 8. Prior to this date, none of Dr. Bormes' LASIK patients had contracted DLK. Id. ¶ 5.

DLK is often treated effectively by anti-inflammatory drops. But the anti-inflammatory drops prescribed for Kendall did not successfully treat his DLK. As a result of the DLK, Kendall required a further procedure called a flap lift, after which he developed further complications, including striae, epithelial ingrowth, and irregular astigmatism. PSMF ¶ 9. Kendall has undergone additional surgeries to address these complications, and he has sustained permanent injury that he claims stems from the DLK. Id. ¶ 10.

Prior to November 2002, B&L had received complaints of post-operative DLK in less than one percent of procedures which used AccuGlide blades. During the 12 months prior to November 2002, B&L had received 53 reports of DLK and 580,000 blades were shipped over that time. Customer complaints to B&L are typically made by the doctor who used the blade or by a B&L customer service or sales representative.

Between November 2002 and May 2003, B&L received an increased number of reports of DLK occurrences. In particular, reports of DLK occurrence from surgeries involving blades in lot number #517984 were exceptionally high. Each blade lot, including lot #517984, includes 1400 blades. The first complaint of DLK associated with lot #517984 was received by Juli Moore, a Product Surveillance Officer with B&L, on November 18, 2002. On November 25, 2002, Moore notified a B&L Quality Control Engineer that Product Surveillance had received reports of 37 incidences of DLK from three different facilities which had used blades from lot #517984. PSMF ¶ 15. On November 29, 2002, Product Surveillance received a report from a fourth facility of four instances of DLK in surgeries that had involved blades from lot #517984; Moore notified Parker of this fourth report on December 2, 2002. Id. at ¶ 17. Quality Control Manager Tom Brennan was also notified about Product Surveillance's reports on December 2, 2002. By that date, B&L had been informed about 42 cases of DLK occurrences in surgeries associated with blade lot #517984. In response, Brennan called for a containment meeting. That same day, B&L quarantined the remaining blades in lot #517984 which had not yet been shipped. Daniel Newhart did not set up a containment meeting until December 9, 2002, even though it was his regular practice to set up a containment meeting within 24 hours of notification of a potential problem. By December 9, 2002, B&L had received 79 complaints of DLK from seven different surgery sites who used blades from lot #517984.

At the December 9, 2002, containment meeting, those conducting the investigation behind the DLK occurrences were operating under a general assumption that DLK was the result of residue or debris on the blades; however, their testing was inconclusive, and no causal factor was identified. No immediate action was taken after the December 9 containment meeting regarding blades in lot #517984 or in any other lot. On December 10, 2002, however, LVCI initiated its own recall of the blades in lot #517984. That same day, December 10, 2002, Dr. Bormes performed Kendall's LASIK surgery using a blade from lot #517984. B&L held containment meetings on December 11 and 12, and on December 13, B&L voluntarily recalled lots #517984 and #517985. Ultimately, B&L received 281 DLK complaints that involved blades associated with lot #517984 from over fifteen different locations. PSMF ¶ 39.

B&L did not receive customer complaints of DLK regarding all distributed blades from lot #517984. Additionally, the incidences of DLK increased during this time period for several lots of blades, not just lot #517984, with some lots reporting between 41 to 89 cases of DLK. B&L conducted a number of studies to determine whether the blades in lot #517984 were defective and tested for every contaminant suggested by medical literature as a possible cause of DLK. The investigation did not provide a conclusive answer regarding the causation of the DLK. Additionally, the blade used in Kendall's surgery was not tested after his DLK diagnosis, and that blade has since been discarded without testing. No tests were performed on any of the instruments used in Kendall's procedure or on the autoclave, a device which sterilized the equipment.

After the increased reports of DLK occurrence, B&L took a number of steps to improve its blade manufacturing process. The rates of DLK after these measures were taken were comparable to the rates reported prior to November 2002.


I. Motion to Strike

In opposition to B&L's motion for summary judgment, Kendall filed, among other things, a response to B&L's statement of material facts, Docket 210, as well as his own statement of material facts, Docket 211. See also Docket 212, 213 (affidavits in support of statement of material facts). B&L then filed a response to Kendall's statement of material facts as well as objections to exhibits submitted in support of the statement of material facts. Docket 221. In response, Kendall filed a reply to B&L's response and objections, arguing that he properly submitted his statement of material facts and that his exhibits are properly authenticated. Docket 233. It is that final reply that B&L seeks to strike as improper. Docket 241. For the reasons stated below, the motion to strike is denied as moot.

First, the court addresses B&L's opposition to Kendall's statement of material facts. While not a formal motion to strike, B&L argues in its reply that Kendall improperly submitted his own statement of material facts in Docket 211, contending that "the Local Rules do not contemplate the submission of such a lengthy, argumentative submission by a party opposing a motion for summary judgment." See Docket 221. Asserting that the allegations in Kendall's statement of material facts (PSMF) are duplicative, irrelevant, and lengthy, B&L asks that this filing be stricken. Id. at 1-2.

The court disagrees with B&L that Kendall's statement of material facts was an improper filing. While Local Rule 56.1 does not explicitly require a party opposing a summary judgment motion to file its own separate statement of material facts, it does state that a party "shall identify any material facts as to which it is contended that there exists a genuine material issue to be tried." D.S.D. CIV. LR 56.1(B). That is precisely what Kendall did in his statement of material facts. Additionally, such submissions of material facts from parties opposing a motion for summary judgment are not uncommon in the District of South Dakota. See Terrell v. Dooley, 2008 WL 1957847, *1 (D.S.D. May 2, 2008); Statler v. Buffalo-Bodega Complex, Inc., 2007 WL 320959, *1 (D.S.D. Jan. 30, 2007). Finally, "the district court has considerable leeway in the application of its local rules." Silberstein v. I.R.S., 16 F.3d 858, 860 (8th Cir. 1994). Because the court is to consider the facts in the light most favorable to the nonmoving party in its consideration of a motion for summary judgment, it does not believe that it was improper for Kendall to submit his own statement of material facts, especially given that both parties have submitted voluminous filings to the court regarding the disputed facts in this case. For these reasons, the court denies B&L's request to strike Kendall's statement of material facts.

B&L also objects to the exhibits filed by Kendall, presumably in Dockets 212, 213, and 217, in support of his statement of material facts. See Docket 221, page 3. B&L argues that eight of the exhibits should be stricken because they are entire deposition transcripts in violation of Local Rule 7.3, and because the exhibits are not properly authenticated. Id. at 3. B&L also submits numerous specific evidentiary objections to portions of the exhibits. Id. at 3-4. Both parties in this case have filed ample documents in support of their versions of the facts. See Docket 200.

Local Rule 7.3 states: "A party must submit as exhibits or attachments only those excerpts of the referenced document that are directly germane to the matter under consideration by the Court. . . . Highlighting relevant portions is encouraged." D.S.D. CIV. LR 7.3. Local Rule 56.1(C) states that documentary evidence related to a motion for summary judgment "shall be submitted with proper highlighting as encouraged by LR 7.3." As discussed above, the court has significant leeway in enforcing its own rules, and this would seem to be especially true when the rules in question are designed for the convenience of the court. Therefore, the motion to strike the exhibits is denied.

B&L also states that these exhibits should not be considered because they are inadmissible and are not authenticated by an affidavit. Docket 221, page 3. Again, while the court would prefer a pared-down version of the exhibits filed by Kendall in Dockets 212, 213, and 217, it believes that it may properly consider these exhibits under Federal Rule of Civil Procedure 56(c), which provides that the court is to examine the pleadings as well as "discovery and disclosure materials on file" and affidavits to determine the propriety of summary judgment. As the exhibits consist of discovery and disclosure materials, the court believes that it may properly consider such in deciding the motions before it, and B&L has given the court no reason to think otherwise.

Finally, B&L lists many specific evidentiary objections to several exhibits filed in Docket 217. Docket 221, page 3-4. A party opposing a motion for summary judgment must show that there is a genuine factual dispute by setting out facts "that would be admissible in evidence." Fed. R. Civ. P. 56(e)(1). The court declines to rule on each of the objections at this time. Instead, it will broadly consider B&L's objections as discussed in Docket 221 and the general admissibility of the exhibits discussed therein in making its determination regarding summary judgment.

The court finds that Kendall properly submitted his own statement of material facts and properly filed exhibits in Docket 212, 213, and 217. Accordingly, the court need not consider Kendall's sur-reply in Docket 233, and B&L's motion to strike Docket 233 is now moot.

II. Motion for Summary Judgment

Summary judgment is proper "if the pleadings, depositions, answers to interrogatories, 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." Fed. R. Civ. P. 56(c). In determining whether summary judgment should issue, the facts and inferences from those facts are viewed in the light most favorable to the nonmoving party, and the burden is placed on the moving party to establish both the absence of a genuine issue of material fact and that such party is entitled to judgment as a matter of law. Id.; Matsushita Elec. Indus. Co. v. Zenith Radio Corp., 475 U.S. 574, 586, 106 S.Ct. 1348, 89 L.Ed. 2d 538 (1986). Once the moving party has met this burden, the nonmoving party may not rest on the allegations in the pleadings, but by affidavit or other evidence must set forth specific facts showing that a genuine issue of material fact exists. Fed. R. Civ. P. 56(e)(2). In determining whether a genuine issue of material fact exists, the court views the evidence presented based upon which party has the burden of proof under the applicable substantive law. Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 252, 106 S.Ct. 2505, 91 L.Ed. 2d 202 (1986).

A. Preliminary Evidentiary Disputes

In its motion for summary judgment, B&L alleges that much of the evidence that Kendall intends to use to prove the existence of a defective blade is inadmissible. Docket 182, page 5. B&L anticipates four different ways Kendall will attempt to prove the existence of a defect: evidence of customer complaints, evidence of B&L's blade recall, evidence of other subsequent corrective measures, and potential expert testimony of Dr. Hardten. B&L argues that "[s]uch inadmissible and/or unreliable evidence is legally insufficient to support his case." Id. In his response opposing summary judgment, Kendall admits that his case is based on circumstantial evidence, but he maintains that this fact "is no barrier to the maintenance of this action." Docket 218, page 6.

The court notes that, under South Dakota law, a plaintiff in a strict products liability action may prove the presence of a defect through circumstantial evidence. Jahnig v. Coisman, 283 N.W.2d 557, 560 (S.D. 1979). "No specific defect need be shown if the evidence, direct or circumstantial, permits the inference that the accident was caused by a defect." Shaffer v. Honeywell, Inc., 249 N.W.2d 251, 256 (S.D. 1976) (involving both strict liability and negligence claims). Moreover, "causation may be established by circumstantial evidence where that evidence establishes by a preponderance, the probability that the accident was caused by a defect." Id.

The parties appear to disagree over the framing of the disputed evidence. B&L contends that evidence of the customer complaints, evidence of B&L's blade recall and other subsequent corrective measures, and potential expert testimony by Dr. Hardten goes primarily to Kendall's proof of the existence of a defect. See Docket 182, pages 5-18. But Kendall views this evidence instead as admissible to prove causation. Docket 218, pages 5-14.

As discussed below, each of Kendall's strict liability claims requires him to prove causation as well as the existence of a defect. See Brech v. J.C.Penney Co., Inc., 698 F.2d 332, 333-34 (8th Cir. 1983); Restatement (Second) Torts § 402A. Evidence of customer complaints, remedial measures taken by B&L, and expert testimony is relevant to establish both of these essential elements. Based on the facts known to the court, some or all of this disputed evidence must be admissible for Kendall to prove the necessary elements of his strict liability claims and to avoid summary judgment. Accordingly, the court must determine the admissibility of each of these areas of evidence before it draws a conclusion regarding the presence of a genuine dispute of material fact.

1. Customer Complaints Against Blade Lot #517984

As discussed above, B&L received many complaints regarding DLK occurrence in surgeries using blades from lot #517984. B&L argues that evidence of these complaints is inadmissible hearsay. Kendall states that he does not plan "to rely upon the opinions of the reporting physicians that a blade from lot #517984 caused DLK in their patient. Rather, Kendall offers the evidence to show that (1) surgery was performed with a blade from lot #517984 and, (2) the patient was subsequently diagnosed with DLK." Docket 218, page 12. Kendall argues both that B&L's records of customer complaints are admissible under Federal Rule of Evidence 803(6) as business records, and that he intends to present non-hearsay ...

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