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Porche v. Paradigm Med. Indus. Inc.

California Court of Appeals, Fourth District, Third Division
Jun 15, 2007
No. G037071 (Cal. Ct. App. Jun. 15, 2007)

Opinion


LAWRENCE PORCHE, Plaintiff and Appellant, v. PARADIGM MEDICAL INDUSTRIES, INC., Defendant and Respondent. G037071 California Court of Appeal, Fourth District, Third Division June 15, 2007

NOT TO BE PUBLISHED

Appeal from a judgment of the Superior Court of Orange County, Super. Ct. No. 04CC03211, John M. Watson, Judge.

The Law Offices of Robin Vialla, Robin S. Vialla, Paul B. Donzis and Helmut F. Furth for Plaintiff and Appellant.

Snyder Law, Barry Clifford Snyder and Kenneth H. Martin for Defendant and Respondent.

OPINION

IKOLA, J.

Lawrence Porche (Porche) appeals a judgment following a jury trial of his strict product liability claim against Paradigm Medical Industries, Inc., (Paradigm). Porche’s theory of recovery was that a medical cutting instrument, a microkeratome utilized by the ophthalmologist during Lasik surgery, was defectively designed, making it susceptible to injury-producing misassembly by the surgeon or technician, as Porche alleged occurred in his case. Porche sought to introduce into evidence certain corporate documents pertaining to complaints received and investigated by the designer and manufacturer of the device, Paradigm’s predecessor-in-interest, Innovative Optics, Inc., (Innovative). The documents (complaint forms) were compiled prior to and shortly after Porche’s eye surgery. They memorialized reported incidents of user misassembly of the microkeratome resulting in “deep cuts,” i.e., beyond desired limits. The court, noting the complaint forms constituted hearsay evidence, eventually excluded them under Evidence Code section 352 as highly prejudicial and likely to cause undue consumption of time.

All further statutory references are to the Evidence Code.

Porche concedes he offered the out-of-court statements to prove the truth of the matter stated (§ 1200, subd. (a)), i.e., that the microkeratome had been misassembled and caused injury in the past. But he argues the complaint forms were admissible as exceptions to the hearsay rule — business records (§ 1271), party admissions (§§ 1220, 1224), and third-party declarations against interest (§ 1230). He further contends the court abused its discretion by excluding the evidence under section 352 because the documents were so critical to proving his case. Finally, Porche argues he was entitled to a new trial based on the erroneous evidentiary ruling and on the ground the verdict was against the evidence.

We affirm the judgment. The complaint forms were hearsay evidence as to which no exception applied, at least for substantial portions of the documents, and no request was made to introduce redacted versions. Even if the documents had been admissible in their entirety, the court was well within the bounds of its section 352 discretion in excluding them. Moreover, any error did not result in a miscarriage of justice; their exclusion did not deprive Porche of a fair trial. (§ 354.) The record shows the jury had an abundance of evidence that the microkeratome could be misassembled and cause injury. It knew there had been complaints of such incidents. It saw the videotaped deposition of one of plaintiff’s experts who referred not only to his own misassembly and deep cut incident, but to a complaint form reporting the same problem. Another of plaintiff’s experts alluded to the forms and his reliance on them in forming his opinion that the device could be misassembled and cause injury. He further opined it was likely Porche sustained his injury in precisely that manner. A former Innovative employee stated the company had received at least six complaints about injury-producing user misassembly prior to Porche’s surgery, and corporate correspondence admitted into evidence also referred to reported cases of user misassembly and deep cuts. Moreover, the jury actually had for its examination one of the complaint forms, showing both misassembly and cutting injury.

Notwithstanding this body of evidence supporting Porche’s claim, the jury found other evidence more persuasive, i.e., (1) the eyewitness testimony of Porche’s surgeon that he microscopically inspected the microkeratome he used during the procedure, it was not misassembled, he perceived no inappropriate cuts, and he recorded a good result on the patient’s chart; and (2) the testimony of a defense expert who opined, inter alia, that no one could determine what caused Porche’s condition to a reasonable degree of medical certainty, and the subject surgery probably did not cause it. This evidence is sufficient to support the jury’s special verdict finding that the microkeratome used in Porche’s surgery was not misassembled. The jury’s response to that single question ended any issue of Paradigm’s liability. There is no basis for overturning this determination, and our disposition moots Porche’s challenge to the court’s denial of his motion for a new trial.

FACTS

Background

Lasik surgery is a type of refractive eye surgery designed to eliminate the patient’s need for eyeglasses or contact lenses by reshaping the cornea with a pulverizing laser beam. Before using the laser, the eye surgeon employs an instrument called a microkeratome to cut the surface of the cornea to create a thin layer of tissue — a hinged “flap” — which is folded back while the cornea is reshaped. Afterward, the flap is restored to its original position on the cornea and becomes reattached.

Ophthalmologists use a micron scale of measurement. A micron is 1/1,000th of a millimeter. The cornea is typically 525 microns thick. Subject to variation in individual patients, a “good flap” is a thin flap, usually not more than 160 to 180 microns thick, leaving a residual stromal bed — the part of the cornea remaining intact beneath the flap — of more than 300 microns. If the blade on the microkeratome cuts too deeply, it can create an undesirably “thick flap,” leaving an insufficient stromal bed for ensuring the cornea’s structural integrity. A compromised structure can lead, in turn, to a condition known as ectasia, or bulging of the cornea, which can distort the patient’s vision. To avoid the risk of ectasia, the flap cut should leave a stromal bed at least 250 microns thick.

Innovative’s microkeratome utilized a ring placed over the patient’s eye which, by suction, lifted the corneal dome and pressed it against a translucent “sapphire plate” to level the corneal surface. On the underside of the sapphire plate were a blade and applanator. Powered by an electric cable drive, the blade and applanator advanced across the leveled corneal surface: The latter controlled the depth of the blade’s cut; the oscillating blade cut the flap as it advanced.

Before each surgery, the user of the microkeratome loaded a new blade and applanator onto the sapphire plate. The blade and applanator were packaged together on a loader, from which the user could slide them directly onto the sapphire plate. When the blade and applanator were on the loader, they would slide in only one direction, and if the instruction manual were followed, the microkeratome could not be misassembled using the loader. But some users found it cumbersome to try to hold the loader while sliding the blade and applanator onto the sapphire plate, and they would therefore take the blade and applanator off the loader and manually put them on the sapphire plate. In those cases, there was a risk of misassembly in that the blade and/or applanator could be put on backwards. If the blade were installed backwards, it would not cut. However, if the applanator were put on backwards, the blade could make deep cuts, with flaps up to 500 microns thick, the blade’s maximum cutting depth. Innovative’s corporate correspondence indicated that when deep cuts were documented, they occurred “only as the result of improper placement of the moving applanator in an inverted manner, thus not compressing the cornea to a selected depth for blade engagement.”

Porche’s Surgery and Subsequent Course

Porche underwent Lasik surgery on both eyes in November 1999. His ophthalmologist, Charles Fritch, used Innovative’s microkeratome. According to Fritch’s records, the procedure was without incident, and it markedly improved Porche’s uncorrected vision. However, Porche soon began to experience “doubling” of images and increased glare. Over the next two years, Fritch performed various enhancement procedures, including making an additional cut to the right eye with a microkeratome not manufactured by Innovative. Porche’s vision improved temporarily, but over time it declined.

Porche last visited Fritch in February 22, 2003, more than three years after the initial surgery. That was when Fritch informed Porche he was suffering from ectasia, further enhancement procedures would not help him, and eventually he might need a corneal transplant. Thereafter, Porche consulted with other eye specialists who confirmed the ectasia condition and agreed with Fritch’s prognosis.

Porche sued Fritch, his professional company, Lasercare Medical Center, and Paradigm. By the time of trial at the end of 2005, Porche was experiencing serious distortion in his vision and required “exotic” contact lenses to conform to the irregular contours of his corneas. The lenses improved his visual acuity to 20/100 in the right eye and 20/50 in the left eye, but he has been told the bulging is progressing, with anticipated further degradation of his vision and the ultimate need for corneal transplants.

Porche settled with Fritch and Lasercare Medical Center before trial.

Conflicting Evidence Re: Deep Cuts in Porche’s Procedure

Porche presented expert opinion evidence that (1) Fritch made two deep cuts in the right eye and one in the left eye, leaving residual stromal beds of less than 100 microns; (2) the thickness of the stroma was below the recommended 250 microns that should remain; (3) the nasal end of one of the flaps was some 400 microns thick; and (4) Porche’s ectasia was caused by deep “diving” cuts made by the Innovatome microkeratome. We need not summarize in detail the opinions of all four of Porche’s experts, three of whom were subsequent treating or consulting physicians. Suffice to say, they were qualified experts in the field, and one of them had performed a confocal microscopy to digitally scan the layers of Porche’s cornea and determine the precise interface between the flap and the stromal bed. These experts essentially concurred on the conclusions enumerated ante.

On the other side of the issue, Fritch, who agreed that thin stromal beds resulting from deep cuts could be a cause of ectasia, testified it was his custom and practice to inspect the completed assembly of the microkeratome microscopically when performing Lasik surgery, he followed that custom and practice in this instance, and he found the microkeratome to be correctly assembled. Moreover, he did not find Porche’s flaps to be unduly thick at the time of the procedure, when he charted “good flaps” on Porche’s medical record. Nor did he discern any deep cuts in Porche’s eyes at the time.

In addition, Paradigm’s expert, Michael Paveloff, testified, inter alia, that if there had been deep cuts during the procedure performed by Fritch, the thickness of the flaps would have been very obvious, yet Fritch’s reliable documentation stated “good flaps.” Paveloff said that safe residual stromal bed thickness can vary from one patient to another, and the reason why some patients develop ectasia remains a “great mystery”; he also said it was not possible to determine the cause of Porche’s condition to a degree of medical certainty.

Paveloff’s written report to Paradigm was admitted into evidence. In it, the expert stated he had reviewed the confocal microscopy report of Porche’s expert, as well as “other medical records.” He opined, inter alia: “Mr. Porche was still functional without any complaints of glare, starbursting, halo, or shadowing images after his initial procedure. Mr. Porche did notice an improvement in his uncorrected visual acuity after his primary procedure, but apparently still had some residual astigmatism postoperatively contributing to his blurred vision. [¶] The patient . . . had a visual acuity that allowed him to drive up to his first enhancement on January 29, 2000. At that time the patient was still correctable to 20/20 OD [right eye] and 20/25 OS [left eye] with spectacle lenses. . . . [¶] . . . [¶] Concerning Mr. Porche’s enhancements, had Mr. Porche not undergone any further Lasik surgery after his primary treatment it is likely that his corneal keratometry readings could have remained stable and that he would have been able to continue to function just with eyeglass spectacle correction only. [¶] The addition of further and multiple Lasik enhancements to this patient as well as the cutting of a second flap [with a different, non-Innovative microkeratome] on the patient’s second or third enhancement to the right eye with the loss of a wedge of corneal stromal tissue probably played a role in the advancement of corneal ectasia and significant irregularity in the patient’s corneal curvature and now significant distortion of vision all of which likely could have been avoided for the patient if no further laser treatments had been undertaken after the initial procedure. [¶] Thus, I feel a combination of a thicker than expected corneal flap as well as a high level of myopic astigmatism correction and multiple corneal enhancements with a re-cut on the right eye all contributed to the eventual corneal ectasia suffered by [Porche.]”

The Complaint Forms and the Court’s Evidentiary Ruling

The complaint forms Porche sought to introduce into evidence referred to calls taken by various Innovative personnel in the year preceding and the months following Porche’s surgery. In each case, the complaint forms recited that the surgeon had cut thick flaps or made deep cuts. In some instances, the cuts were 300 to 500 microns deep. Some cuts perforated the anterior chamber, causing aqueous flow, or transected the pupil, requiring suturing and hospitalization. In one case, the flap was so thick it would not lie back, but had to be fixed in place during the laser procedure. One patient reported minimal vision after the surgery. In another case, the surgeon did not notice deep cuts and proceeded to laser both eyes of the patient, resulting in perforation of the anterior chambers. One doctor trusted his new technician’s word of assurance that the microkeratome had been assembled properly, but it had not, and the ensuing procedure caused the patient serious injury. In each case, the problem was determined to be the user’s misassembly of the microkeratome, i.e., the applanator had been placed on upside down or backwards.

Taking the calls were Kevin Miller, Innovative’s vice-president of marketing and sales, Alan Hernley, trainer of medical personnel on use of the microkeratome, Bridget Ward, Mike Johnson, Sara Fisher, another vice-president of marketing and sales, and Harry Dietrich, general manager. Dave Davis, who took no calls, but prepared a report for the Food and Drug Administration (FDA), was a quality management representative.

Paradigm moved in limine to exclude the evidence or any reference to it. The court noted it was required to balance “the value of the jury knowing about these other complaints . . . and the possible consumption of time because if the defendants were so inclined . . . they could defend these.” Asking Porche’s counsel to explain the importance of having the jury hear the details of the complaint, and summarizing counsel’s responses, the court stated, “The problem is what you’re suggesting to me . . . is that it is evidence of alleged wrongdoing on other occasions to prove wrongdoing on this occasion,” to which counsel replied, “Yes.” The matter was submitted and revisited later.

Ultimately, Porche’s counsel attempted to use the complaint forms during the direct examination of one of Porche’s experts. After a long discussion with counsel, the court confirmed with the expert witness that he could articulate his conclusions without directly quoting from the complaint forms, and it then ruled the witness could reference his review of the complaint forms as a basis for his opinion, but could not quote directly from them. In particular, the court stated, “I just don’t want these quotes and stuff. You might even [ask the witness] are you aware that there’s a practice in this company to record complaints? Are you aware the FDA has a practice of recording complaints? Did you have the opportunity to review those? Are those [complaint] forms part of the basis of your opinion you’re giving here? [¶] Yes, and then you must move right on and then I don’t feel like [Paradigm’s counsel] is deprived of the right to cross-examine people [who wrote or participated in the complaint forms.]”

At a subsequent hearing on Porche’s posttrial motions, the trial court confirmed its earlier ruling against admission of the documents, stating, “You had moved for them to be received into evidence and to be used in trial and I had ruled against you.” The court explained that allowing into evidence only those reports where something had gone wrong “goes beyond prejudicial. I mean it’s in essence a conviction unless we’ve brought in the how many thousands that went okay, four thousand or something.” The court concluded, “It’s my judgment that if I allowed those [complaint forms, Dr. Fritch] would have no chance of getting a fair trial.” The court misspoke, since Dr. Fritch was no longer a party, but the substance of the court’s ruling is clear enough.

The Jury’s Deliberations

The jury was asked to answer questions set out in a special verdict form, including the following question: “At the time the Innovatome [microkeratome] was used on Mr. Porche: [¶] (a) was the Innovatome misassembled by Dr. Fritch or Dr. Fritch’s employees?” During its deliberations, the jury asked to see the videotaped deposition testimony of an expert “regarding how many complaints were made to Innovative Optics.” They also asked for a re-reading of an Innovative employee’s testimony regarding how many complaints were made. Later, they asked whether they could examine the complaint forms referenced in witness testimony. Finally, they asked if they could draw inferences from or consider evidence that had not been “brought in.” The court instructed the jury it could consider only evidence that had been presented and could not speculate why certain evidence was excluded since “what doesn’t come into evidence is up to me for legal reasons.” The court further advised the jury that one of the complaint forms was, in fact, in evidence as an exhibit and was in the jury room. Shortly thereafter, the jury returned its special verdict, answering question 2(a) in the negative: the Innovative microkeratome used in Porche’s surgery had not been misassembled. On that basis, the court entered judgment for Paradigm.

The exhibit to which the court referred concerned a procedure performed by one of Porche’s experts on January 8, 1999. Innovative’s Alan Hernley was present at the time, “to provide training to the technician.” According to Kevin Miller, who took the phone call, “The first eye cut on one patient present[ed] with a thickness that was too thick. The thickness was estimated by Hernley to be about 300 micron[s] thick, but Dr. Rad[e]r estimated that the flap was around 500 microns thick. The actual thickness was not measured due to a lack of equipment to do so.” The report further stated, “The blade and applanator assembly were returned to Innovative Optics and received on January 12, 1999. Igor Gradov, VP of Engineering for Innovative measured the blade and applanator and confirmed that the product is in spec. In addition, three cadaver eyes were cut with the assembly, and it was verified that the flap thickness for the blade [was] the correct thickness.” The incident was investigated by Innovative’s manager of regulatory affairs, who determined “that the moving applanator was put onto the microkeratome in the backwards position.” Hernley “had been out of the room at the time the blade assembly was placed by the technician, and [he] failed to verify on his return that the blade was correctly placed.” The patient was expected to recover, but required suturing because the flap failed to reattach. The complaint form noted, “Kevin Miller will discuss with all sales representatives the importance of providing intensive training, and the need for additional training to the sales representatives is currently being evaluated by management.”

DISCUSSION

Porche’s liability theory against Paradigm was that the microkeratome, which had to be assembled by the user prior to surgery, was so designed as to make it susceptible to injury-producing misassembly, that is, the applanator or cutting guide could be inserted upside down or backwards, and it was very difficult, if not impossible, for the user to discern whether the assembly was correct. Porche wanted to bolster his product liability/design defect case against Paradigm by introducing the complaint forms reporting such incidents. The court observed the forms contained “multiple [levels] of hearsay.”

The Hearsay Rule

“‘Hearsay evidence’ is evidence of a statement that was made other than by a witness while testifying at the hearing and that is offered to prove the truth of the matter stated.” (Evid. Code, § 1200, subd. (a).) “Except as provided by law, hearsay evidence is inadmissible.” (Evid. Code, § 1200, subd. (b).) Hearsay evidence is excluded because the statements are not made under oath, the adverse party has no opportunity to cross-examine the person who made the statements, the jury cannot observe the person’s demeanor as he or she makes the statements, and (in criminal cases) the defendant is deprived of the constitutional right to confront the witness. (1 Witkin, Cal. Evidence (4th ed. 2000) Hearsay, § 1, p. 679.) The hearsay rule excludes only out-of-court statements offered to prove the truth of the matter stated. When statements are not offered for that purpose, no special exception to the hearsay rule need be invoked for their admission; they are not within the hearsay rule at all. (1 Witkin, Cal. Evidence, supra, Hearsay, § 5, pp. 683-684.)

The complaint forms generally contained a record of three types of statements: (1) Statements by medical professionals and/or their staff members from various locations in the United States and abroad to various persons at Innovative, who took notes of the conversations, to the effect that a patient had been injured while using the Innovative microkeratome to cut the flaps; (2) The conclusions or opinions of, in most cases, unidentified Innovative employees uniformly stating the problem had resulted from user misassembly of the microkeratome; and (3) In some cases, a report of the incident made by Innovative to the FDA pursuant to 21 Code of Federal Regulations part 803.50(a) (1999). The complaint forms followed a format in which the complaint was described, a resolution of the complaint was recorded, and “customer followup” and “internal follow up and corrective action” was recorded.

We grant Porche’s request to take judicial notice of 21 Code of Federal Regulations parts 803.3, 803.10, 803.11 and 803.50 (1999).

Porche’s counsel acknowledged the complaint forms were being offered to prove the truth of the matter stated therein, i.e., that the microkeratome could be misassembled and cause injury, and to strengthen the inference that a misassembled microkeratome was used in Porche’s surgery and caused him injury. Porche nevertheless contends certain statutory exceptions to the hearsay rule rendered the evidence admissible. Because the complaint forms contain multiple levels of hearsay, we will analyze the asserted statutory exceptions as applied to the chronological sequence of the statements contained in the forms.

Phone Calls to Innovative by Medical Professionals and their Staffs

The complaint forms all begin with the report of a phone call received by Innovative personnel from a medical professional, or staff of a medical professional, in which an adverse incident was reported. Most of these calls reported the nature of the injury suffered by the patient, without more. Others acknowledged the applanator had been misassembled when used during a Lasik procedure. As to this initial level of hearsay, Porche contends the evidence should have been admitted as a declaration against interest under section 1230, providing, “Evidence of a statement by a declarant having sufficient knowledge of the subject is not made inadmissible by the hearsay rule if the declarant is unavailable as a witness and the statement, when made, was so far contrary to the declarant’s pecuniary or proprietary interest, or so far subjected him to the risk of civil or criminal liability, or so far tended to render invalid a claim by him against another, or created such a risk of making him an object of hatred, ridicule, or social disgrace in the community, that a reasonable man in his position would not have made the statement unless he believed it to be true.” “One of the requirements for permitting a statement to be admitted as a declaration against interest is that the declarant realizes at the time of making the statement that it is against the declarant’s own interest.” (1 Jefferson, Cal. Evidence Benchbook (Cont.Ed.Bar 3d ed. 2007) Declarations Against Interest, § 6.4, p. 147.) Although the trial court did not address the issue, a reasonable inference may easily be drawn that the statements of the medical professionals contained in the complaint forms were deemed by the declarants to be exculpatory, rather than incriminating, i.e., the reported incident was attributable to Innovative for having defectively designed the instrument. Why else would these medical professionals telephone the instrument manufacturer to “complain” about their own negligence? Not likely. And we must presume the trial court agreed with that analysis. “A ruling by a trial court is presumed correct and ambiguities are resolved in favor of affirmance.” (Winograd v. American Broadcasting Co. (1998) 68 Cal.App.4th 624, 631.) The court did not abuse its discretion by excluding those portions of the complaint forms that reported statements of third parties.

Recordation of the Complaint — The Business Records Exception

With regard to the next level of hearsay, the writing made by an Innovative employee recording the substance of the conversation, Porche contends the complaint forms were admissible under the business records exception set forth in section 1271, which allows admission of “[e]vidence of a writing made as a record of an act, condition, or event” if certain enumerated criteria are met. However, “[t]he business records exception . . . was not devised to allow unreliable hearsay to be introduced merely because it was reduced to writing in a book of records.” (1 Witkin, Cal. Evidence, supra, Hearsay, § 237, p. 954.) As stated in McGowan v. City of Los Angeles (1950) 100 Cal.App.2d 386, 392, “The statute . . . merely provides a method of proof of an admissible ‘act, condition or event.’ It does not make the record admissible when oral testimony of the same facts would be inadmissible.” Police accident reports are an example of inadmissible business records. As Witkin notes, “The requirement of personal knowledge as the basis of a record is the chief barrier to the introduction of a police report of an accident.” (1 Witkin, Cal. Evidence, supra, Hearsay, § 239, p. 956.) The report is usually inadmissible because, although it is a “‘record of an act, condition, or event[,]’ [it] is often made by an officer who did not see the accident and includes both hearsay statements of others and opinions of the officer.” (Ibid.)

Those parts of the complaint forms recording the substance of the complaining telephone call are analogous in all material respects to police accident reports: While they may be said to have recorded an “event,” i.e., the receipt of the complaint, they were made by various employees, none of whom witnessed or had personal knowledge of the reported incident. Porche’s only authority, Arrow Intern., Inc. v. Sparks (Ark.Ct.App. 2003) 98 S.W.3d 48, dealing with evidence of similar occurrences in a product liability lawsuit and the court’s discretion to admit or bar such evidence, is inapt to the issue of the hearsay rule and California’s statutory business records exception.

The Conclusions of Innovative Employees — The Party Admission or Authorized Admission Exception

The conclusions and opinions of Innovative personnel are not admissible as a business record because they are not the record of an “act, condition, or event,” and are not based on the personal knowledge of the Innovative employee making the writing. Instead, these statements are the untested conclusions and opinions of mostly unidentified Innovative employees. Porche nevertheless contends these portions of the complaint forms were admissible as party admissions against Innovative under section 1220. The statute provides, “Evidence of a statement is not made inadmissible by the hearsay rule when offered against the declarant in an action to which he is a party in either his individual or representative capacity, regardless of whether the statement was made in his individual or representative capacity.” But section 1220 applies to party admissions. None of the employees reporting their conclusions or opinions were parties to this lawsuit in either their individual or representative capacities.

The opinions and conclusions of Innovative employees, if admissible at all as admissions, must qualify as authorized admissions under section 1222, a hearsay exception which was not advanced by argument, either in the trial court or here. Section 1222 provides, “Evidence of a statement offered against a party is not made inadmissible by the hearsay rule if: [¶] (a) The statement was made by a person authorized by the party to make a statement or statements for him concerning the subject matter of the statement; and [¶] (b) The evidence is offered either after admission of evidence sufficient to sustain a finding of such authority or, in the court’s discretion as to the order of proof, subject to the admission of such evidence.” Party admissions and authorized admissions may be received in evidence despite the declarant’s lack of personal knowledge or a foundation for the expressed opinions and conclusions. (Levy-Zentner Co. v. Southern Pac. Transportation Co. (1977) 74 Cal.App.3d 762, 787.) But relaxation of the personal knowledge and opinion rules for authorized admissions does not obliterate the foundational requirement that evidence be produced showing “[t]he statement was made by a person authorized by the party to make a statement or statements for him concerning the subject matter of the statement.” (§ 1222, subd. (a).) Paradigm does not point to any evidence, or even any offer of proof, satisfying this requirement. Nor does Paradigm even argue the opinions should have been received under section 1222. “[T]he determination [whether an employee is authorized to speak for the employer on the subject matter] requires an examination of the nature of the employee’s usual and customary authority, the nature of the statement in relation to that authority, and the particular relevance or purpose of the statement.” (O’Mary v. Mitsubishi Electronics America, Inc. (1997) 59 Cal.App.4th 563, 570.) The authorized admission exception to the hearsay rule “has been interpreted in California as only applying to high-ranking organizational agents who have actual authority to speak on behalf of the organization.” (Snider v. Superior Court (2003) 113 Cal.App.4th 1187, 1203.) We see no parallel to precedent here, where the preparers of the complaint forms simply recorded telephone conversations in which others made statements regarding their various experiences with misassembly of the microkeratome, and conclusions of still others, most of whom are not even identified, regarding the cause of the incidents. We have no evidence of the scope of the various employees’ authority to speak on behalf of Innovative.

Three of the excluded complaint forms purport to attach a copy of a report of the incident made to the FDA. But we are not directed to any evidence authenticating these reports as copies of the actual reports submitted to the FDA. Moreover, two of the reports contain no conclusions by Innovative personnel, but merely report statements made by third party medical professionals which are inadmissible as discussed ante. One of the reports is accompanied by a cover letter to the FDA explaining the late filing of the report by offering an excuse that Innovative had concluded operator error had caused the incident, and not a device defect. But here again, there is no evidence the writer of the letter was speaking within the scope of any authority to do so, nor was any argument to that effect advanced in the trial court. The third purported FDA report is simply a typewritten paragraph on a plain piece of paper, bearing no signature, no date, nor any authentication whatsoever.

The court did not err by excluding the complaint forms and their attachments. Although perhaps they could have been admitted in a severely redacted form to show the fact of complaint, rather than its substance, Paradigm did not propose redaction as a potential solution.

Exclusion of References to the Complaint Forms by Expert Witness under Section 352

Porche contends the court wrongly prohibited his expert witness from referring to the substance of the complaint forms as part of the basis for his opinions, and this constituted an abuse of discretion under section 352. We disagree. The rule invoked by the court is familiar: Experts may not under the guise of opinion bring before the jury inadmissible hearsay evidence. We find the court’s analysis of the issue in Grimshaw v. Ford Motor Co. (1981) 119 Cal.App.3d 757, 788-789, most instructive: “While an expert may state on direct examination the matters on which he relied in forming his opinion, he may not testify as to the details of such matters if they are otherwise inadmissible. [Citations.] The rule rests on the rationale that while an expert may give reasons on direct examination for his opinions, including the matters he considered in forming them, he may not under the guise of reasons bring before the jury incompetent hearsay evidence. [Citation.] Ordinarily, the use of a limiting instruction that matters on which an expert based his opinion are admitted only to show the basis of the opinion and not for the truth of the matter cures any hearsay problem involved but in aggravated situations, where hearsay evidence is recited in detail, a limiting instruction may not remedy the problem.”

Section 352 provides, “The court in its discretion may exclude evidence if its probative value is substantially outweighed by the probability that its admission will (a) necessitate undue consumption of time or (b) create substantial danger of undue prejudice, of confusing the issues, or of misleading the jury.” “We review the trial court’s determination as to the admissibility of evidence . . . for an abuse of discretion. [Citations.] Under this standard, the trial court’s ruling will not be disturbed, and reversal of the judgment is not required, unless the trial court exercised its discretion in an arbitrary, capricious, or patently absurd manner that resulted in a manifest miscarriage of justice.” (Thompson v. County of Los Angeles (2006) 142 Cal.App.4th 154, 168.) As stated by the court in Ajaxo, Inc. v. E*Trade Group, Inc. (2005) 135 Cal.App.4th 21, 44-45: “‘“In the absence of a clear showing that its decision was arbitrary or irrational, a trial court should be presumed to have acted to achieve legitimate objectives and, accordingly, its discretionary determinations ought not [to] be set aside on review.”’”

The court had first been asked to consider the issue when Paradigm made its motion in limine to exclude all references to the complaint forms. Although the court did not rule definitively at that time, its analysis provides insight to its later decision regarding detailed recitation of the reports by the expert. The court pointed out that it had to balance the relevance of the evidence against the prejudice to defendant and the potential consumption of time if Paradigm chose to defend against each complaint on its facts. The court asked Porche’s counsel to explain the importance of having the jury hear the facts of the complaints. After listening to counsel’s responses, the court observed Porche simply wanted to show wrongdoing on other occasions to strengthen his case that wrongdoing had occurred in this instance, and counsel concurred with that assessment. Later, the court asked the expert whether he would be able to articulate his opinions without directly quoting from the complaint forms, to which the expert responded he could. The court then advised the expert he could utilize the reports as a basis for his opinion, but could not quote from them. We do not interfere with the exercise of the court’s discretion unless it is exercised in an arbitrary, capricious, or patently unreasonable manner. Here, that is not the case.

No Prejudice Has Been Shown

Additionally, we note it is highly unlikely a more favorable result would have obtained for Porche had the court admitted the evidence, thus Porche has not shown the requisite basis for reversal. At trial, it was virtually conceded the microkeratome was susceptible to misassembly, and, if misassembled, the patient could sustain injury. A videotaped deposition of Dr. Nick Rader, one of plaintiff’s experts, was played to the jury. Rader referenced the complaint forms during his testimony as supportive of his opinion that the microkeratome could be misassembled. He also testified he had used the microkeratome and his staff had misassembled it before a procedure, in the presence of defendant’s employee, Alan Hernley. The result was that his patient suffered deep corneal cuts. Rader further testified that he spoke with at least three employees of the manufacturer and that the engineer in charge of the design stated he thought the blade had been misassembled. Kevin Miller, a former employee of defendant’s predecessor company, testified that prior to the time of Porche’s surgery, there had been six complaints dealing with misassembly of the microkeratome. Those portions of Rader’s and Miller’s testimony concerning the complaints were requested by the jury during its deliberations and re-read to the jury. Counsel also stipulated that the number of complaints referenced in Rader’s testimony was nine. Dr. Robert Maloney, another of plaintiff’s experts, testified the microkeratome could be misassembled, causing a thicker than expected cut in the cornea. He related that he had treated one of Fritch’s patients who experienced deep diving cuts in her cornea with Fritch’s use of the same microkeratome. The jury also received several exhibits, including the complaint form concerning Dr. Rader’s adverse experience with the microkeratome, showing the device had been misassembled, causing a flap to be cut which was “too thick.” It also had an in-house corrective/preventive action request form in which the first sentence states, “Deep cuts have been made due to improper instrument assembly.” It had Innovative’s reporting policy, entitled, “Deep Cuts as a Result of Improper Instrument Assembly,” which referred to injuries resulting from misassembly of the microkeratome. And it had photographs showing the microkeratome as correctly assembled and as misassembled. Yet, it found the testimony of Fritch and of Paradigm’s expert witness, Paveloff, credible on the issue of whether there had been misassembly at the time of Porche’s surgery.

Fritch testified as to the procedure he performed on Porche. He confirmed that after the device was assembled by his technician, he checked it microscopically and determined it was assembled properly. He stated that the flap on the right eye appeared totally normal, and his chart included a notation, “good flaps.” He testified that it is “so easy” to see the difference between a thick and a thin flap. Fritch also offered his conclusion that the microkeratome performed exactly as he expected it to perform, giving good cuts, no deep cuts, and excellent vision to Porche.

Dr. Michael Paveloff, who previously worked with Fritch side-by-side for some time, testified that Fritch’s ability to document accurately what was going on during the surgery was fully appropriate. A board-certified ophthalmologist, Paveloff also opined the development of ectasia has been documented in cases in which good flaps were formed. In Paveloff’s opinion, about 1 in every 2000 cases of uncomplicated LASIK surgery will go on to develop corneal ectasia as did Porche. Why that occurs, he stated, is a “great mystery.” He also testified that when normal thickness flaps are cut and laid back for the laser application, the flaps will lie down without much effort, but if a flap is thick, it is difficult to bend and it tries to “snap back down.” Paveloff saw no indication that there was any difficulty in keeping Porche’s corneal flaps down at the time of Fritch’s surgery. Finally, Paveloff opined that nobody can, within a reasonable degree of medical probability, determine what caused Porche’s ectasia, and the procedure performed by Fritch probably did not cause ectasia in Porche’s eyes. His report to Innovative stated the same.

The totality of the evidence in this case makes our extended excursion into the law of evidence with regard to the complaint forms essentially an academic exercise. Porche nevertheless argues none of the evidence we have recited is substantial evidence. “Substantial evidence means such evidence as a reasonable fact trier might accept as adequate to support a conclusion; evidence which has ponderable legal significance, which is reasonable in nature, credible and of solid value.” (Guntert v. City of Stockton (1976) 55 Cal.App.3d 131, 142.) Porche asserts the evidence was highly “subjective,” i.e., less than trustworthy, and it should not have been allowed to outweigh the “objective” expert evidence he presented. He analyzes Fritch’s and Paveloff’s testimony, sentence by sentence, attempting to point out inconsistencies. But we cannot reject the statements of witnesses whom the jury has believed: There must exist either a physical impossibility that the statements are true, or their falsity must appear without resort to inferences or deductions, and even suspect testimony does not justify reversal because it is for the jury to decide credibility and the truth or falsity of facts. (Daly v. Wallace (1965) 234 Cal.App.2d 689, 692-693.)“‘The trier of fact may believe and accept a portion of the testimony of a witness and disbelieve the remainder. On appeal that portion which supports the judgment must be accepted, not that portion which would defeat, or tend to defeat, the judgment.’” (Id. at p. 693.)

Our finding of no evidentiary error moots Porche’s challenge to the court’s denial of his motion for new trial.

DISPOSITION

The judgment is affirmed. Paradigm shall recover its costs on appeal.

WE CONCUR: RYLAARSDAM, ACTING P. J., O’LEARY, J.

Although the court did not allude to it, the jury also had another exhibit, one of Innovative’s internal documents labeled “Corrective/Preventive Action Request.” It stated, “Deep cuts have been made due to improper instrument assembly. Blade and moving applanator are shipped on a carrier[. I]f loaded with carrier according to the user manual the assembly would be loaded correctly, however, Doctor’s technicians and others may remove the assembly from the Carrier and attempt to re-load causing the assembly to be put on backwards. There have been [r]eported cases of [doctors] going ahead with the laser procedure after making a deep cut, which [h]as then resulted in a perforation of the anterior chamber.” The proposed corrective action plan was to “[e]stablish a reporting policy” and “[r]e-design the blade assembly to make it more ‘fool proof’, not to allow the assembly to be [m]is-loaded, therefore eliminating such deep[] cuts from misloaded applanators.”


Summaries of

Porche v. Paradigm Med. Indus. Inc.

California Court of Appeals, Fourth District, Third Division
Jun 15, 2007
No. G037071 (Cal. Ct. App. Jun. 15, 2007)
Case details for

Porche v. Paradigm Med. Indus. Inc.

Case Details

Full title:LAWRENCE PORCHE, Plaintiff and Appellant, v. PARADIGM MEDICAL INDUSTRIES…

Court:California Court of Appeals, Fourth District, Third Division

Date published: Jun 15, 2007

Citations

No. G037071 (Cal. Ct. App. Jun. 15, 2007)