Showing posts with label Medical Monitoring Equipment. Show all posts
Showing posts with label Medical Monitoring Equipment. Show all posts

Tuesday, October 30, 2012

More on Graves v. CAS Medical Systems, Inc.

Last week I did a case brief of the South Carolina Supreme Court's decision in Graves v. CAS Medical Systems, Inc. (see the brief here and the full decision here).  This case deserves more blog time because it has some significance to trends in South Carolina's products liability law.  There is also some language I do not care for very much, but this is just my personal opinion.  Set forth below are observations of Graves in order of their significance (to this blogger).

(1) The court backed off of prior decisions suggesting expert testimony is required for a design defect case.  As you may recall from this post, prior South Carolina appellate court decisions suggested a design defect theory requires use of expert testimony to sustain the burden of proof.  In Graves, the court backed off this position.  "In some design defect cases, expert testimony is required to make this showing [of defect] because the claims are to complex to be within the ken of the ordinary lay juror."  (Emphasis added).  The court provided extensive string citation to examples of complex cases requiring expert testimony.  Then, it dropped the bombshell: "Whether expert testimony is required is a question of law."  The court found Plaintiffs' claim to involve complex issues of computer science; accordingly, Plaintiffs' claim required direct evidence of defect in the form of expert testimony.  Be that as it may, this language by the court leaves open the possibility that a design defect claim may not require expert testimony.  This is contrary to the impression given by the appellate courts in Watson v. Ford Motor Co., 389 S.C. 434, 699 S.E.2d 169 (2010) and 5-Star, Inc. v. Ford Motor Co., 395 S.C. 392, 718 S.E.2d 220 (2011).

(2) Use of circumstantial evidence to prove design defect is alive and well.  Defendant argued that without expert testimony (which the court had excluded), Plaintiff had no direct evidence of defect.  Taking it one step further, Defendant argued the court foreclosed use of circumstantial evidence in a design defect case in Branham v. Ford Motor Co., 390 S.C. 203, 701 S.E.2d 5 (2010).  To borrow an expression from Lee Corso, "Not so fast my friend!"  The court said any issue can be proven by circumstantial evidence, and it is just as good as direct evidence if it is equally as convincing to the trier of fact.  The court also pointed out that it allowed the plaintiff in Branham to use other similar incidents, "which is classic circumstantial proof."  However, the court did not have to get into analyzing if there was sufficient circumstantial evidence in Graves because it determined the claim involved complex issues that required expert testimony as a matter of law (see number 1 above).

(3) Okay, I get it...but I don't like it.  So basically, the court is now saying it is going to take a case-by-case approach to the necessity of expert testimony in design defect cases.  Furthermore, if the case is not very complex and does not require expert testimony, then convincing circumstantial evidence may be offered as proof.  I have two problems with this approach. 
  • First, virtually every product's design is beyond the ordinary knowledge of a layperson.  For example, I understand the concept of paint.  You mix some chemicals and pigments, and voila...you have paint.  However, is it really that simple?  I recently had a plaintiff try to use circumstantial evidence that a paint job's allegedly improper appearance supported a design defect claim.  My argument was that although the paint may not appear correctly, he had to prove the design of the paint was defective.  If the painter mixed it incorrectly, that is not a design defect.  If the manufacturer released a manufacturing lot with to much solvent in it, that is not a design defect.  As I sit here, it is difficult for me to come up with an example of a product where its design is within the common knowledge of a layperson.  My coffee cup is pretty simple, but I could not tell you why the manufacturer chose its composition, dimensions, etc.  I also could not tell you how any changes to any aspect of the design of the cup may affect the manufacturer's ability to produce the cup...which brings me to my second point...
  • I could not tell you a reasonable, feasible, alternative way to make my coffee cup.  This is a big problem with leaving the door open to use of layperson testimony or circumstantial evidence in a design defect claim.  In Branham, the court stated a design defect claim requires proof of reasonable alternative design.  Branham, 390 S.C. at 225, 701 S.E.2d at 16-17.  If it is possible for a plaintiff to prove a design defect claim by circumstantial evidence (theoretically), does that mean a plaintiff can also prove alternative design by layperson testimony or circumstantial evidence?  In theory, are we going to allow Joe Sixpack to opine that a tighter fitting coffee lid is a reasonable, feasible design when he has no idea about the manufacturer's ability to produce the cup for a profit with his layperson-approved design?  I do not think so, but the court's case-by-case approach certainly leaves open this possibility.

(4) Introducing the "reasoning to the best inference" methodology for arriving at expert opinion(s).  From my own searches, I cannot see that this methodology has ever been addressed by a South Carolina court, and the court's language in Graves suggests same.  ("Although this is our first opportunity to assess the reliability of an opinion rendered using the reasoning to the best inference methodology . . . .").  As stated by the court, this analysis is "similar to a differential diagnosis in the medical field where potential causes of the harm are identified and then either excluded or included based on their relative probabilities."  The court cites to Bitler v. A.O. Smith Corp., 400 F.3d 1227 (10th Cir. 2004) to provide guidance.  With this approach, experts must provide objective reasons for eliminating alternative causes.  Other possible causes of an accident must be eliminated as "highly improbable," and the cause must be identified as "highly probable."  As stated by the court:
Although the expert need not categorically exclude alternate causes, that does not relieve the expert of his burden to prove the alternate cause is at least highly improbable based on an objective analysis.  We believe this objectivity requirement is consistent with the quality control element of [State v. Council, 335 S.C. 1, 19, 515 S.E.2d 508, 517 (1999)].
(5) The court is going to give some deference to physicians, even when they may not understand the legal significance of being designated as an "expert."  Plaintiffs named a doctor to opine as to whether the infant in Graves could have been revived if someone heard the alarm.  Although the doctor admitted she did not consider herself a Sudden Infant Death Syndrome ("SIDS") expert, the court found her to be qualified based on the fact that she had thirty years experience as a neonatologist, was current on SIDS literature, and encountered SIDS in her practice.  Furthermore, the recognized again that most doctors do not give scientific testimony.  If the doctor is merely applying his/her knowledge to every day experiences, then s/he does not need to satisfy the standard for reliability in State v. Council

(6)  "Res ipsa loquitor...get back in your cell!"  South Carolina still does not accept res ipsa loquitor as a liability theory in products liability claims...period.  Although the court did not use the term, it is pretty clear from its language: "It is well-established that one cannot draw an inference of a defect from the mere fact a product failed."

(7) Finally (and as you have likely realized by now), this decision continues a trend of greater focus on expert testimony by South Carolina's appellate courts.  Beginning with Watson, the appellate courts have really been scrutinizing both whether expert testimony is required for a defect theory and the reliability of any testimony by a proffered expert.  Graves continues this trend.

I welcome any comments.

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Tuesday, October 23, 2012

Case Brief: Graves v. CAS Medical Systems, Inc.


On August 29, 2012, the Supreme Court of South Carolina issued its opinion in Graves v. CAS Medical Systems, Inc.  This case continues the trend of South Carolina’s appellate courts closely scrutinizing expert witness testimony.  I will be blogging more about this case later with regard to its impact on the necessity of expert testimony in a South Carolina products liability case.

FACTUAL BACKGROUND: Plaintiff-parents had a six-month-old girl who was monitored by Defendant-manufacturer’s baby monitor. The monitor was designed to sound an alarm if the patient experienced certain events, and it also included various back-up alarms and logging features to track vital signs and sounding of the alarm.  Plaintiffs awoke one morning and checked the infant only to find she was dead.  Neither Plaintiffs nor another family member heard the monitor sound an alarm.  The logging for the monitor reflected various apneic and bradycardic events, and it also indicated the alarm went off.

PROCEDURE: Plaintiffs filed claims for strict liability (design defect), negligence and breach of warranty against Defendant, claiming the monitor’s software design caused the alarm to fail.  Plaintiffs identified three software experts, none of whom did any real testing.  Instead, they used a “reasoning to the best inference analysis,” which the court likened to a differential diagnosis where other potential causes are excluded.  The experts evaluated three potential causes: complaint error (i.e., that the machine was misused or the alarm sounded but was not heard), hardware error (i.e., whether the machine functioned properly), and software error.  The experts excluded hardware error because the monitor was tested and functioned properly.  Therefore, the issue was whether complaint error or hardware error occurred. 

One of Plaintiff’s experts, Dr. Walter Daugherity, excluded complaint error purely on grounds that he did not believe anyone could sleep through the alarm.  He discounted the monitor’s log that the alarm sounded by pointing to the undisputed testimony of fact witnesses that it did not go off.  Therefore, he opined software error was the only cause.  Plaintiff’s second expert, Dr. William Lively, primarily relied on the conclusions of Dr. Daugherity to arrive at his opinion that software error was the cause.  He did no real analysis himself.  Plaintiff’s third expert, Frank Painter, concluded (similar to Daugherity) that complaint error could be excluded in spite of the monitor’s log.  He also admitted he did not really examine the software code.  Plaintiffs designated an additional expert, Dr. Donna Wilkins, to opine as to whether the infant could be revived.  She admitted she was not an expert in Sudden Infant Death Syndrome (“SIDS”), but she opined the infant likely could have been revived if the alarm sounded.

Defendants moved to exclude all experts based on lack of reliability, and also for summary judgment (on grounds that without expert testimony Plaintiffs had no evidence of design defect).  The circuit court granted both motions.

ISSUES: (1) Whether the circuit court erred in excluding opinions of Plaintiffs’ experts; and (2) whether the circuit court erred in granting summary judgment.

DISPOSITION: Affirmed with modifications (finding the medical expert’s opinions should not have been excluded on reliability grounds, but upholding summary judgment in spite of this modification).

RULES AND OPINION: The opinion is basically divided into two parts, as follows:

Exclusion of Experts

Expert testimony must meet the requirements of South Carolina Rule of Evidence 702 whether it is scientific, technical, or other expert testimony.  Therefore, it must (1) be beyond the ordinary knowledge of the jury, (2) the expert must be qualified, and (2) the substance of the testimony must be reliable.  The reliability prong is the central feature of the inquiry.  Defendants conceded Daugherity, Painter, and Lively satisfied the first two elements.  The only issue was whether the opinions were reliable.   

The court focused on whether these experts had grounds to exclude complaint error based on objective criteria.  For all three experts, the court found they simply assumed the alarm did not sound based on the assertions of the individuals alleging failure of the monitor.  They did not provide objective criteria for eliminating complaint error as a cause.  The court also found the experts improperly relied on reports of other failures to support their conclusions that software error was to blame.  A plaintiff bears the burden of proving that other incidents are “substantially similar to the accident at issue,” and the other incidents relied on by Plaintiffs’ experts did not suggest software error to be a cause.  (Citing Watson v. Ford Motor Co., 389 S.C. 434, 453, 699 S.E.2d 169, 179 (2010)).  The court agreed with the circuit court that the opinions were unreliable and that complaint error was a real possibility. 
Of great concern to us is that each of them began with the assumption that the monitor failed and then discounted evidence to the contrary based on the ipse dixit of the plaintiff who hired them, an analysis we find lacking in the indicia of reliability required for reasoning to the best inference.
Accordingly, there was no abuse of discretion in excluding Daugherity, Painter, and Lively.  (As a side note... BOOM Goes the Dynamite!  I love it when a court drops the “ipse dixit” bomb in review of an expert’s opinions…it is kind of like when someone quotes your brief back to you and drops in “[sic]” to telegraph that you made a grammatical error…but I digress).

With regard to Dr. Donna Wilkins, the court found the circuit abused its discretion in not finding her qualified based on her own testimony that she did not consider herself an expert in SIDS.  She had thirty years of experience and stayed current on SIDS literature.  Furthermore, the circuit court committed an error of law in finding her testimony unreliable.  “[A] doctor who merely applies his knowledge to everyday experiences does not need to satisfy the additional [reliability prong required by South Carolina law in State v. Council, 335 S.C. 1, 19, 515 S.E.2d 508, 517 (1999)].” 

Summary Judgment

Without expert testimony, Plaintiffs had no direct evidence of whether the monitor was unreasonably dangerous because there was no identification of a specific design flaw.  The court then turned to whether there was sufficient circumstantial evidence of defect to survive summary judgment.  The court clarified it had not foreclosed the use of circumstantial evidence for design defect claims.  “[W]e recognized in [Branham v. Ford Motor Co., 390 S.C. 203, 230, 701 S.E.2d 5, 20 (2010)] that other similar incidents can be used to show a design defect, which is classic circumstantial proof.”  It is up to the trier of fact to determine if it is worth as much merit as direct evidence. 

In this context, the court stated that one cannot draw an inference of defect from the mere fact a product failed.  (Citing Sunvillas Homeowners Ass'n v. Square D Co., 301 S.C. 330, 333, 391 S.E.2d 868, 870 (Ct. App. 1990)).  A plaintiff must offer evidence beyond the product’s failure to prove a product is unreasonably dangerous.  Testimony by Plaintiffs and other fact witnesses that the alarm did not sound is not sufficient.  “In some design defect cases, expert testimony is required to make this showing because to make this showing because the claims re too complex to be within the ken of the ordinary lay juror.”  Whether expert testimony is required is a matter of law.  In the instant case, the court found as a matter of law that Plaintiffs’ case required expert testimony; it involved design and structure of software.  Therefore, without it, Defendant was entitled to summary judgment.

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