Mass Tort Defense : Mass Tort Defense Lawyer & Attorney : Sean P. Wajert : Shook, Hardy & Bacon LLP : Products Liability, Class Actions, Pharmaceutical Litigation

Readers may recall our post about Simmons v. Novartis Pharmaceutical Corp., a case in which the Sixth Circuit affirmed the exclusion of plaintiff's expert testimony seeking to link osteonecrosis of the jaw to plaintiff's use of two cancer medications. The issue was specific causation, and the court helpfully noted that a treating physician’s testimony is subject to Daubert; that an expert's statement that he found “a very close association” between ONJ and the class of drugs is not enough; and that while a treater may be qualified to diagnose a patient, a diagnosis is merely a hypothesis, which does not by itself satisfy Daubert and Rule 702.

The Supreme Court earlier this month denied the plaintiff's cert petition. See Simmons v. Novartis Pharmaceutical Corp., U.S., No. 12-283, cert. denied 11/5/12).

Plaintiff had argued that when a case involves medication that has not been widely studied, and thus published about, a different standard should apply.  She also argued that the opinions would have been admissible under the law of Maryland which, she said, requires only that expert opinions be expressed “to within a reasonable degree of medical/dental probability.”

Novartis has had a number of victories in similar cases, challenging treating physicians who seek to offer expert causation opinions. 

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Follow our train of thought: we have posted about the misuse of the differential diagnosis concept, as plaintiff experts morph it from an accepted tool for deciding what is wrong with a patient to a method for explaining why and how the patient suffered his injury/illness.  Now, three computer experts sought to opine that a software flaw prevented a health monitor alarm from sounding, claiming their methodology was just "like a medical differential diagnosis"!  Fortunately, the South Carolina Supreme Court rejected that attempt last week.  See Graves v. CAS Medical Systems Inc., No. 27168 (S.C., 8/29/12).

Their doctor ordered that the plaintiffs use a monitor manufactured by CAS to track their infant child's breathing and heart rates as a precaution. The monitor was designed to sound an alarm, if the subject were to experience an apneic, bradycardia, or tachycardia event. Once the breathing or heart rate returns to normal, the alarm stops. Each machine also keeps a log of any events, which is the term for when the alarm sounds, and records the pertinent data and vital signs. As an additional safety measure, CAS installed not only a back-up alarm, but also a feature that records whether the alarm sounded. This system operates primarily through an independent and separate microphone specifically designed to listen for the alarm. If it hears the alarm, it then makes a notation in the monitor's internal log. If it does not hear the alarm, then it records "Front alarm not heard," and the monitor will sound the backup alarm. A microphone listens for this back-up alarm as well and records whether it was heard. If the back-up alarm fails, all the lights on the front of the monitor flash.

Tragically, the child died from Sudden Infant Death Syndrome (SIDS), which essentially means that no attributable cause of death exists. Plaintiffs claimed the monitor's alarm never sounded that night. Additionally, they testified that all the lights on the front of the monitor were on, although they were solid and not flashing. Another family member who was asleep downstairs also allegedly could not recall hearing the alarm go off.  Plaintiffs further testified the machine was not turned off until the next day, when the monitor was removed for testing.

Plaintiffs filed a strict liability design defect claim against CAS, contending the monitor's software design caused the alarm to fail.  Their claim revolved around what is known as "spaghetti code," which is when computer code is unstructured and can result from the overuse of "goto" or "unconditional branch" statements, which causes a signal working its way through the code to jump around instead of following a linear path.  This in turn caused the signal to be pushed off course and never reach its destination.

To support this theory, the Graves designated three software experts to testify regarding the alarm's alleged failure. In arriving at their conclusions that a software defect caused the alarm to fail, none of the experts did much actual testing of the software. Instead, they used a "reasoning to the best inference" analysis, which was "similar to a differential diagnosis" in the medical field. In this case, three potential causes were identified: hardware error, complaint error, and software error. Complaint error means that the monitor was misused or the alarm did sound and the Graves failed to hear it.  All the experts were able to dismiss hardware error as a cause because the machine was tested and shown to be functioning properly. Thus, the question became whether complaint error or a software error occurred.

The experts excluded complaint error because the machine was hooked up properly, and they did not believe anyone would sleep through the alarm. In other words, because the Graves claimed the alarm did not wake them, that means it must not have gone off. After being confronted with the fact that the monitor listens for the alarm and separately records whether it was sounded, the experts opined that it must be "certain" the internal logs showing the alarm actually did sound were not reliable "in light of the undisputed testimony that the alarm did not function." That left software error as the most likely cause of the alleged failure, they opined.

Defendant moved to have all these experts excluded, arguing none of them met the reliability factors for scientific testimony set forth in State v. Council, 335 S.C. 1, 515 S.E.2d 508 (1999). CAS also moved for summary judgment, contending that without this expert testimony plaintiffs had no evidence of a design defect. The trial court agreed that their opinions were unreliable both as scientific evidence and as nonscientific evidence and thus were inadmissible. Having excluded the opinions of all the Graves' experts, the lower court granted CAS's motion for summary judgment.

The state Supreme Court noted that this was its first opportunity to assess the reliability of an opinion rendered using the "reasoning to the best inference" methodology, so looked for guidance to the analysis of the United States Court of Appeals for the Tenth Circuit, which had already done so. In Bitler v. A.O. Smith Corp., 400 F.3d 1227 (10th Cir. 2004), the court held that "[e]xperts must provide objective reasons for eliminating alternative causes" when engaging in this analysis. Id. at 1237. Furthermore, "an inference to the best explanation for the cause of an accident must eliminate other possible sources as highly improbable, and must demonstrate that the cause identified is highly probable." Id. at 1238. Although the expert need not categorically exclude all 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. See id. at 1237–38 & n.6. The court found this objectivity requirement consistent with the quality control element of State v. Council.

Here, there was evidence that the alarm worked properly and the plaintiffs failed to hear it. In addition to the monitor's recordation of hearing the alarm sound, the family pediatrician testified he believed plaintiffs slept through it, the court noted. The doctor was aware of just how exhausted the parents were. Although the alarm is loud, if one is tired enough, he testified that it is possible to sleep through it. His opinion was bolstered by the fact that the machine seems to have worked just as it was supposed to and recorded the breathing issues perfectly. The log also seems to show the alarm managed to stimulate the baby into breathing normally at times.

This evidence does not mean that is exactly what happened.  But there was enough that an expert needed to take it into account.. Instead, the experts simply assumed the alarm did not sound and provided no reason for discounting the evidence to the contrary other than the assertion of the persons alleging a failure. Thus, they did not objectively discount the evidence of complaint error as required. See Clark v. Takata Corp., 192 F.3d 750, 757 (7th Cir. 1999) ("Simply put, an expert does not assist the trier of fact in determining whether a product failed if he starts his analysis based upon the assumption that the product failed (the very question that he was called upon to resolve), and thus, the court's refusal to accept and give credence to [the expert's] opinion was proper.").

The trial court did not abuse its discretion in excluding the opinions, and summary judgment was warranted. 

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A tip of the hat to our DRI colleague Mike Weston for alerting us to an interesting 10th Circuit opinion from a couple weeks ago, Hoffman v. Ford Motor Co., 2012 WL 3518997 (10th Cir. Aug. 16, 2012).

Plaintiff was injured in a rollover car accident, and sued the car manufacturer alleging that a defect in the seat belt buckle caused it to release during the accident and allow her to be ejected from the vehicle.  In support of this theory, plaintiff presented the opinion of Dr. Good, a mechanical engineer, who theorized that the buckle most probably inertially unlatched during the accident due to an alleged design defect.  He ran a series of tests on buckles allegedly similar to the one in the accident, but ran into issues when he needed to make a comparison of the data from his lab tests to data from crash rollover tests to determine if the situation measured in the lab could actually occur in the real world.  Specifically, there was an absence of available data from relevant rollover crash tests (which present dynamic, multi-dimensional forces working on the component), and so he compared his results to data from planar crash data -- ones focused on only the horizontal plane (for example, a frontal car crash).

Ford moved to exclude the opinions as unreliable under Daubert, but the district court  (without a hearing) denied the motion, concluding Ford had failed to prove that the differences between the lab test results and the real world rollover accidents were significant.  Defendant appealed. (Note, whether she was even wearing her seat belt at all was hotly contested at trial. For purposes of the Daubert issue, the court assumed she was.) 

The court of appeals concluded that in permitting the testimony, the district court had not been "a sufficiently exacting gatekeeper; Daubert requires more precision."  Plaintiff failed to present a sufficient scientific connection between the accelerations and forces the expert found necessary to unlatch the buckles in the lab, and the acceleration and forces that would have occurred in the actual accident on the street. 

Specifically, the court of appeals held that the trial court should NOT have chastised the defendant for failing to show how the deficiency mattered, the failure to use rollover crash data. And the trial court should not have deemed it "unfair" for Ford to criticize the plaintiff because of the limited amount of rollover crash data available to the expert.  The state of the science is what it is.  And Ford did more than point out a deficiency in the method; it also explained why the deficiency rendered the testing and comparison suspect.  More importantly for our readers, "it was not Ford's burden to show Good's inertial unlatch opinion was unreliable and irrelevant.  Rather, it was plaintiff's burden to show reliability and relevancy."

It was undisputed engineering science that once a component is tested, the results must be applied to the whole vehicle setting; the lab results must be compared to data from the real world. Merely showing that similar buckles can be made to unlatch under certain lab conditions is irrelevant to whether the buckle at issue unlatched in the accident absent proof that the lab conditions were present and can be adequately and accurately related to the actual rollover-type accident.  Plaintiff's expert failed to explain adequately how the acceleration and forces present in the planar crash tests were similar enough to those present in a rollover accident. Nowhere did he show how his comparison was scientifically valid. Thus, his opinion was based on mere speculation, or on the assumption, that the levels of forces he found necessary to unlatch buckles in the lab were substantially similar to those that occurred in the subject accident.

Absent such evidence, plaintiff could not meet her burden.  Since plaintiff had a full and fair opportunity to present the case, and made no attempt to add or substitute other evidence, the court of appeals remanded with instruction for the district court to enter judgment as a matter of law for defendant.

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The Mississippi Supreme Court has vacated a $4.5 million verdict in favor of plaintiffs in a case against defendant Hyundai over a serious car accident. Hyundai Motor America v. Applewhite, No. 2008-CA-01101-SCT (Miss., 2/10/11).

Casino co- workers Dorothy Applewhite, Cecilia Cooper, and Anthony Stewart were traveling in Applewhite's 1993 Hyundai Excel after work.  It is unclear who was driving, but the two women were in the front seats, and Stewart was in the rear seat. A co-worker traveling ahead of them testified that he noticed the car weaving, drifting onto the shoulder, and finally swerving into the northbound lane, where it collided with another vehicle. The Excel separated into two pieces. All three passengers in the Excel died at the scene of the accident. 

Family members of the three decedents sued Hyundai. At trial, the plaintiffs undertook to prove that the Excel was not crashworthy due to alleged defects in both its design and manufacture, including the welds in the vehicle. Plaintiffs offered the testimony of several expert witnesses, including Andrew Webb, an accident reconstructionist.  Webb testified that he had used a computer program to reconstruct the accident and concluded that, had the Excel remained intact, the occupants would have experienced a change in velocity of thirty-five miles per hour. Another expert then testified that at thirty-five miles per hour, it was more likely than not that the occupants would have survived the crash.

The jury awarded the plaintiffs $4.5 million, or $1.5 million for each of three decedents, finding that the automobile at issue was defective in both its design and manufacture.

On appeal, Hyundai argued that it was entitled to a new trial because it was ambushed by changes
to Webb’s opinion. As noted, one of Webb’s main contentions was that, had the Excel remained
intact, the vehicle would have experienced a change in velocity (delta-v) of no more than thirty-five miles per hour. Hyundai deposed Webb before trial, at which time Webb gave a detailed
explanation of his calculations. Months after the deposition, Webb signed an errata sheet concerning his deposition testimony, changing four key variables that he had used to make his calculations. Most notably, Webb changed the angle of the Excel from 22 degrees to 44 degrees and increased the closing speed of the Excel from 68 miles per hour to 78 miles per hour. Despite these dramatic changes, Webb did not alter his ultimate conclusion that the car would have sustained a delta-v of only thirty-five miles per hour had it remained intact.

At trial, Webb testified about the errata sheet, claiming that he had to change several variables because he realized after he had been deposed that he had made some mistakes in his initial analysis. It is undisputed that Webb’s errata sheet was not done to correct errors made by the court reporter or to clarify his testimony. On the sheet itself, Webb listed the reason for the changes simply as “range not asked.”

Hyundai moved to strike Webb’s testimony at trial, alleging that it had never received the errata sheet during discovery and that these changes were a surprise. In response, the plaintiffs argued that the changes were not material because they did not alter Webb’s ultimate conclusion. The plaintiffs also produced a letter trying to demonstrate that they had forwarded Webb’s errata sheet to the defendant. The trial court heard extensive arguments on the issue and denied the defendant’s motion.

The Supreme Court did not agree.  The discovery rules impose a duty on the parties to amend a prior response when the party knows that the response, though correct when made, is no longer
true and the circumstances are such that a failure to amend the response is in substance a
knowing concealment. The failure seasonably to supplement or amend a response is a discovery violation that may warrant sanctions, including exclusion of evidence. Whether the plaintiffs did or did not send the errata sheet was unnecessary and irrelevant to a proper analysis. Even if Hyundai did receive the errata sheet, simply giving the defendant this document did not relieve the plaintiffs of their duties under the rules. The purpose of an errata sheet is to correct scrivener’s errors or provide minor clarification; it is not a means of making material, substantive changes to a witness’s testimony. See e.g., Garcia v. Pueblo Country Club, 399 F.3d 1233, 1242 n.5 (10th Cir. 2002) (“A deposition is not a take home examination.”) If a witness changes his testimony in a manner that conflicts with prior discovery responses, the sponsoring party has a duty under the rules (Rule 26(f) in this state) seasonably and formally to amend or supplement the response -- not try to sneak it through in an errata sheet. This the responsibility of the party sponsoring the witness, not the responsibility of the witness.

The plaintiffs argued that Webb’s changes were not material because they did not alter his opinion that, had the car not separated, the occupants would have experienced a delta-v of only thirty-five miles per hour. The Court did not agree. The changes in Webb’s calculations were material changes because they were essential components of the basis for his opinion. When Hyundai attempted to cross-examine Webb about his calculations, Webb referred to his errata sheet at least seven times to demonstrate that he had corrected his mistakes. It is clear from Webb’s own trial testimony that the figures on the errata sheet were important to his calculations. Moreover, when Hyundai’s experts performed crash testing, they relied on and used the figures given by Webb in his deposition in an attempt to test his opinions and refute his testimony. When Webb changed his calculations, the entire crash test using Webb’s initial calculations lost much of its relevance.  

The Court found that the trial judge abused his discretion by not enforcing the rules, noting "we do
not condone trial by ambush." Hyundai was entitled to full and complete disclosure of the plaintiffs’ expert testimony, and neither these plaintiffs nor any other party litigant may rely on a witness’s notations on a deposition errata sheet as a substitute for formal and timely supplementation. 

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Just about a year ago, we posted about an interesting device case in which the U.S. District Court for the Central District of Illinois, in an opinion by Chief Judge Michael P. McCuskey, found inadmissible plaintiff's expert witness testimony that his knee implant failed due to alleged oxidation caused by the method Zimmer used to sterilize the product. Fuesting v. Zimmer Inc., 2009 WL 174163 (C.D. Ill., 1/26/09).

Last week  the federal appeals court affirmed the judgment for the knee implant maker.  Fuesting v. Zimmer Inc., 2010 WL 271728 (7th Cir. 1/25/10).  Fuesting had alleged he received the Zimmer-made implant in 1994. In 2001, he began experiencing pain in the knee, and his doctor removed the prosthesis in November of that year. Fuesting sued, alleging that Zimmer's sterilization of the prosthesis by gamma irradiation in air (GIA) rendered it defective. At trial, his expert witness, Dr. Pugh, testified that GIA caused the prosthesis to oxidize and delaminate, resulting in premature failure. A jury returned a verdict for plaintiff, but the Seventh Circuit vacated the judgment after finding that Pugh's testimony did not meet the requirements for admissibility of expert testimony under Fed. R. Evid. 702 and the standards set forth in Daubert.

On remand, Fuesting proffered the testimony of a second expert witness, Dr. Rose. But the trial court found that Dr. Rose had not bridged the analytical gap between accepted principles and his complex conclusions. He had not, and could not, show that the prosthesis failed because of the sterilization method used. The expert testimony as to defect also failed.

On appeal, the Seventh Circuit stated that Dr. Rose's testimony did not show that his theory that these knee implants oxidize “in vivo” had sufficient acceptance in the scientific community.  He failed to point to any peer reviewed studies that discuss the oxidation rates of this type of implant in vivo.  Dr. Rose failed to cite any articles or studies that he or any one else conducted regarding how one can discern whether the alleged oxidation occurred before or after implantation.  Dr. Rose also did not rule out possible alternative methods of causation.  Nor did he explain how the device's oxidation caused the device to fail, as the mere presence of oxidation does not prove that the oxidation caused the device to malfunction.

Dr. Rose also failed to “bridge the analytical gap” between the accepted fact that GIA sterilization causes at least some amount of oxidation and his ultimate conclusion that Fuesting's knee implant in particular failed because GIA, rather than another sterilization method, was used. Last, Dr. Rose failed to show that better sterilization alternatives existed in 1991. He concluded, in one sentence of his report, and without any support, that the industry standard was to sterilize implants in an inert gas instead of air. In fact, no manufacturer at that time employed any of  the proffered methods, and Dr. Rose cited no contemporary articles counseling the use of such methods.  For all these reasons, the district court did not abuse its discretion in excluding Dr. Rose's testimony.


 

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