Eleventh Circuit Affirms Exlcusion Of Expert Testimony Relating To Cause of Autism

In Hendrix v. Evenflo Company, Inc. (09-10079), the Eleventh Circuit affirmed the district court's order that "concluded that the methods used by Hendrix’s experts were not sufficiently reliable under Daubert v. Merrell Down Pharmaceuticals, Inc., 509 U.S. 579, 113 S. Ct. 2786 (1993)."   The district court's order under review is found at Hendrix v. Evenflo Co., Inc., 255 F.R.D. 568 (N.D. Fla. 2009). The Eleventh Circuit described the facts as follows:

Appellant Rhonda Hendrix alleges that her son, G.P., sustained traumatic brain injuries when a child restraint system manufactured by Defendant-Appellee Evenflo Company, Inc., (“Evenflo”), malfunctioned during a minor traffic accident. Hendrix further alleges that those brain injuries caused G.P. to develop autism spectrum disorder (“ASD”) and a spinal cord defect known as syringomyelia.

***

On April 17, 2002, Hendrix and her fifteen-day-old son, G.P., were involved in a minor traffic accident (“the accident”) while traveling at a speed of 10-12 mph. Hendrix claims that G.P. was properly strapped into the CRS, and that the CRS was located in the rear center position of her SUV. Hendrix’s theory is that during the accident the seat dislodged from its base because it had been “false-latched.”

***

Nearly eighteen months after the accident, G.P. began to exhibit developmental problems....Approximately three years after the accident, Dr. Suhrbier diagnosed G.P. with an asymptomatic spinal cord cyst....Dr. Suhrbier diagnosed G.P. with ASD in April 2007, when G.P. was five years old.

With regard to the law, the court first rejected the appellant's argument that the district court failed to apply the correct test to the expert testimony.  The court then stated:

Although the standards for finding causation are governed by Florida law, we apply federal law to determine whether the expert testimony proffered to prove causation is sufficiently reliable to submit it to the jury....Therefore, our analysis will focus on whether the district court abused its discretion in excluding the expert testimony of Dr. Hoffman and Dr. Suhrbier upon finding that the testimony was not sufficiently reliable under Daubert....Although experts “commonly extrapolate from existing data . . . nothing in either Daubert or the Federal Rules of Evidence requires a district court to admit opinion evidence that is connected to existing data only by the ipse dixit of the expert.”...Rather, the trial court is free to “conclude that there is simply too great an analytical gap between the data and the opinion proffered.”

Hendrix’s experts rely primarily on the differential etiology method to link G.P.’s traumatic brain injury to his ASD diagnosis. Differential etiology is a medical process of elimination whereby the possible causes of a condition are considered and ruled out one-by-one, leaving only one cause remaining....A reliable differential etiology analysis is performed in two steps. First, the expert must compile a “comprehensive list of hypotheses that might explain the set of salient clinical findings under consideration. . . . The issue at this point in the process is which of the competing causes are generally capable of causing the patient’s symptoms.”....Second, the expert must eliminate all causes but one.

***

Hendrix does not contend that the medical community generally recognizes traumatic brain injury as a cause of autism. Therefore, the district court was correct to apply the Daubert analysis to the question of whether traumatic brain injury can, in general, cause autism.

***

The district court determined that Dr. Hoffman’s testimony regarding ASD causation was insufficiently reliable under Daubert to warrant admission of that testimony at trial. The district court identified errors in Dr. Hoffman’s differential etiology analysis at both the “rule in” and “rule out” steps. Specifically, the district court determined that Dr. Hoffman “fail[ed] to show how, by ‘scientifically valid methodology,’ traumatic brain injury could ever be a possible cause of autism in anyone.”...We agree with the district court that Dr. Hoffman failed to “rule in” traumatic brain injury as a possible cause of ASD.....We hold that the district court reasonably concluded that none of the literature supported the reliability of Dr. Hoffman’s proffered physiological process, and that none of the literature supported Dr. Hoffman’s opinion that a traumatic brain injury like GP’s could have caused or contributed to the development of ASD....We are satisfied that the district court did not abuse its discretion in concluding, based on the literature Dr. Hoffman himself provided, that there is no reliable support for Dr. Hoffman’s assertion that “perinatal and neonatal intensive care follow-up literature does support the association between injury to the developing brain, including traumatic brain injury, and later occurrence of autism spectrum disorder.”

Finally, the court noted that the "Law lags science; it does not lead it."  The court stated:

We emphasize that we express no opinion regarding whether traumatic brain injury sustained in the perinatal or neonatal period can ever cause or contribute to later development of an autism spectrum disorder. Rather, as we have previously stated: “The courtroom is not the place for scientific guesswork, even of the inspired sort. Law lags science; it does not lead it.” Rider, 295 F.3d at 1202 (quoting Rosen, 78 F.3d at 319). We emphasize also that our conclusion, and that of the district court, is based only on the evidence presented in this case. Given the current state of scientific knowledge regarding the causes of autism spectrum disorders (as it has been presented to us by the parties), we are unable to say that the district court abused its discretion in excluding this expert testimony. Because without this testimony there is no genuine dispute of material fact regarding causation of G.P.’s ASD, the district court’s grant of summary judgment on Hendrix’s sole remaining claim was appropriate.

Article About Derespina v. North Broward Hosp. Dist., 19 So. 3d 1128 (Fla. 4th DCA 2009)

Derespina v. North Broward Hosp. Dist., 19 So. 3d 1128 (Fla. 4th DCA 2009), discussed in a prior post HERE, was referenced in the article below:

And the Defense Wins - Feb. 10, 2010 (Derespina)

Florida Supreme Court Accepts Jurisdiction Of Issue Relating To Sufficiency Of Plaintiff's Expert In MedMal Case

The Florida Supreme Court accepted jurisdiction in Cox v. St. Joseph's Hospital (SC09-1771).  The order accepting jurisdiction can be found here.  The Second District's opinion under review was discussed here.  The Petitioner's Brief on Jurisdiction can be found here and the Respondent's Jurisdictional Answer Brief can be found here. 

The Second District's opinion stated:

In moving for a directed verdict, the hospital and ER doctor argued that the Coxes failed to prove that Mr. Cox more likely than not would have benefitted from tPA....In negligence actions, Florida courts follow the "more likely than not" standard of causation, i.e., they require proof that the negligence "probably caused" the plaintiff's injury. Gooding v. Univ. Hosp. Bldg., Inc., 445 So. 2d 1015, 1018 (Fla. 1984). " 'A mere possibility of such causation is not enough; and when the matter remains one of pure speculation or conjecture, or the probabilities are at best evenly balanced, it becomes the duty of the court to direct a verdict for the defendant.' " Id. (quoting Prosser, Law of Torts § 41 (4th Ed.1971) (footnotes omitted)). A medical expert's opinion is not exempt from this rule. The supreme court has explained that "[t]he opinion of an expert is not sufficient to eliminate the necessity of proving the foundation facts necessary to support the opinion."....In the absence of competent evidence to prove that the failure to treat Mr. Cox with tPA more likely than not affected his outcome, the trial court should have granted the defense motion for a directed verdict. Under these circumstances, we must reverse the judgment.

Southern District: When A Wind Expert Is Not Actually An Expert, The Cooperation Clause, And Various Other Insurance Issues

I received an interesting decision by e-mail a month or two ago that covers a broad array of insurance issues.  In Coconut Key Homeowners Ass'n, Inc. v. Lexington Ins. Co., 642 F. Supp.2d 1363 (S.D. Fla. 2009), Judge Seitz resolved a number of motions relating to hurricane damage including (1) breach of the cooperation clause; (2) precluding testimony about causation by an alleged expert with no experience in that area; (3) striking a proposal for settlement; (4) amending affirmative defenses; (5) motion to preclude evidence at trial; (6) motions to exclude various affirmative defenses. 

COOPERATION CLAUSE

With regard to the cooperation clause, the insurer "would first need to show as a matter of law that Coconut Key has materially breached the inspection provision" and then "establish substantial prejudice resulting from the breach...A 'total failure' to comply with a post-loss condition may preclude recovery as a matter of law.  Haiman v. Federal Ins. Co., 798 So.2d 811, 812 (Fla. 4th DCA 2001). 'If, however, the insured cooperates to some degree or provides an explanation for its noncompliance, a fact question is presented for resolution by a jury.' Starling v. Allstate Floridian Ins. Co., 956 So.2d 511 (Fla. 5th DCA 2007). See also Schnagel v. State Farm Mut. Auto. Ins. Co., 843 So.2d 1037 (Fla. 4th DCA 2003)."  The court denied the motion because the insuer had not presented evidence to show prejudice, which it could still do at trial. 

WIND EXPERT

The insuer challenged the testimony of the insured's expert and sought to preclude the expert from presenting testimony regarding:

(1) wind speed and forces in the subject area during Hurricane Wilma, because he is not trained in metereology and has done no scientific determinations about wind pressures; (2) causation of damage, because he has no engineering or meterological background and relied on a TSSA report that did not provide an opinion on the causation of the damages it identified; and (3) damage to any units he has not personally inspected, because it was improper for him to extrapolate based on the findings of his own personal inspection of 8 of the 200 units and the TSSA report.

The court found the witness:

lacks both the expertise and reliable underlying data needed to provide expert testimony about either wind speeds at Coconut Key during Hurricane Wilma or the cause of the damages he has observed there. He admitted at his deposition that he has no scientific background in pressure damage, did not know the wind speed at Coconut Key during Hurricane Wilma and has made no scientific determinations about cyclic loading or wind pressure at Coconut Key during Hurricane Wilma. While he claimed that the damage he observed was consistent with hurricane damage, he also admitted other causes were possible, that he did not undertake any scientific tests to eliminate alternative causes, that he had no background in engineering and that he would defer to an engineer's opinion about the causes of damage at Coconut Key.

On the other hand, Mr. Girard does possess the requisite expertise and data to provide opinion testimony about the condition of windows and doors at Coconut Key and the cost of installing windows and doors that would allow Coconut Key's windows and doors to comply with applicable building codes. He has managed a business specializing in window replacement for over four years. The Court does not find his reliance on the TSSA report to be improper since Defendant has not come forward with any evidence to suggest the methodology underlying the TSSA report was unreliable (even though it has presented evidence that the billing of the work underlying the report is suspect). Finally, Mr. Girard's extrapolation from his own inspections and the TSSA report, which together constitute well over 50% of the damaged units, is not so improper that he cannot provide testimony on his opinions at trial.

As a result, Mr. Girard can provide testimony as to the condition of the windows and doors at Coconut Key and cost of replacing windows and doors at Coconut Key so that they comport with the Florida Building Code and the Miami Dade County Building Code. However, Mr. Girard cannot testify about prevailing wind speeds and forces at Coconut Key during Hurricane Wilma or about the cause of the condition of the windows and doors at Coconut Key.

Therefore, the witness was permitted to testify about the condition of the windows that he saw, however, he was not permitted to testify as to the cause of any damage he saw or the conditions that existed during the hurricane. 

MOTION FOR LEAVE TO AMEND AFFIRMATIVE DEFENSES

The court also allowed the insurer leave to amend its affirmative defenses to add a defense stating the insured had intentionally misrepresented the facts and fraudulently inflated its claim, thereby voiding the entire policy.  This defense was added based upon the newly discovered evidence.

MOTION TO EXCLUDE TESTIMONY AT TRIAL

The court next denied the insured's motion to exclude reference to business dealings between its expert and law firm; exclude one of its own expert reports; and exclude reference to the fact that the insured signed the responses to interrogatories before the total amount claimed was inserted into the responses.  These motions were all denied because they are relevant to the insuers fraud defense. 

It seems the issues the insured did not want put before the jury relate in one way or another to the disputes at issue in the following documents [click to view]: 

Romain v Hunter Contracting, Koltun and Garfinkel;

Garfinkel v. Romain, et al;

Kunkel v. Garfinkel [this link is currently not active];

Deitz v. Garfinkel [this link is currently not active];

Mager v. Garfinkel;

Garfinkel v. Mager.

The documents above are somewhat interesting and appear to be somewhat related.  There may be more related cases, however, those documents are all that I have been forwarded at this time.

The entire opinion is below:

Coconut Key Homeowners Ass'n, Inc. v. Lexington Ins. Co., 642 F. Supp.2d 1363 (S.D. Fla. 2009)

Judgment Against Acutane Manufacturer Relating To Label Reversed For Entry Of Directed Verdict

In Hoffman-La Roche Inc. and Roche Laboratories Inc. (1D08-2032), the First District reversed the trial court's denial of a motion for directed verdict after a judgment was entered faulting the manufacturer for putting "Accutane on the market with an inadequate warning to Appellee’s physicians about the risk of developing inflammatory bowel disease."

The court stated:

As a general rule, drug companies have the duty to warn of a drug’s dangerous side effects; however, the duty to warn is directed to physicians rather than patients under the “learned intermediary” doctrine...Thus, the duty of a drug manufacturer to warn of the dangers involved in the use of a drug is satisfied if it gives an adequate warning to the physician who prescribes the drug.

***

While Appellee presented testimony that the warning label was inadequate to warn physicians that Accutane use could lead to IBD, Dr. Fisher, the prescribing physician, testified that he understood the warning label to mean that there was at least a possibility of a causal relationship between Accutane and IBD. He testified that he would still be willing to prescribe Accutane to his patients even if there was evidence showing that it could cause IBD in rare cases. He also testified that even if the warning label contained all of the information suggested by Appellee’s expert, he would still have prescribed the medication for Appellee. Thus, any inadequacies in Accutane’s warning label could not have been the proximate cause of Appellee’s injury because Dr. Fisher understood that there was a possibility that use of the drug could lead to Appellee developing IBD and he made an informed decision to prescribe the drug for Appellee despite this risk. Because Appellee presented no evidence to establish proximate cause, the trial court erred in denying Appellants’ motion for a directed verdict.

The emphasis is mine.

Presuit Affidavit From Sister In Med-Mal Case Properly Stricken

In Derespina v. North Broward Hospital District d/b/a Coral Springs Medical Center, 19 So. 3d 1128 (Fla. 4th DCA 2009) (4D08-2670), the Fourth District affirmed the trial court's conclusion that a presuit notice in a medical malpractice action cannot be from a relative of the alleged victim.  The court stated:

Derespina alleged that the stocking was too small and caused blistering and eventually scarring. She instituted a medical malpractice action against NBHD.

***

Accompanying Derespina’s notice of intent to initiate litigation was the affidavit of her sister, a nurse with forty-six years of experience, who was also the mother of Derespina’s attorney. The affiant stated she had reviewed Derespina’s medical records and concluded the medical malpractice claim had merit.

***

After completing the pre-suit investigation a n d prior to filing a complaint for medical negligence, the plaintiff must notify the defendant of her intent to initiate litigation. § 766.106(2). Section 766.203(2) requires that the notice be corroborated by a “verified written medical expert opinion” furnished to the defendant. § 766.203(2). If a court finds the plaintiff’s notice of intent to initiate litigation does not comply with the pre-suit investigation requirements of the statute, a court shall dismiss the claim. § 766.206(2).

NBHD relies on the case of Grau v. Wells, in which a patient brought a medical malpractice suit against his doctor after plastic surgery. 795 So.2d 988, 989 (Fla. 4th DCA 2001)...The court concluded that the plaintiff could have easily obtained a nurse without family ties to give an expert opinion in the Fort Lauderdale area, but none was ever sought. Based upon the findings of the trial court after an evidentiary hearing, the trial court’s conclusion that the investigation of malpractice conducted by the plaintiff did not constitute the reasonable investigation contemplated by the statute was not an abuse of its discretion.

Derespina v. North Broward Hospital District DBA Coral Springs Medical Center.op

*Disclaimer: Jeffrey Kuntz and/or GrayRobinson, P.A. were involved in the above-referenced action.

Published Eleventh Circuit Opinion On Medicare Lawsuit Against Tenet Health

In Boca Raton Community Hospital v. Tenet Health Care Corporation (07-14352), the Eleventh Circuit affirmed the district court's denial of class certification, striking of the plaintiff's expert witness and the entry of summary judgment.

Judge Carnes started the opinion by stating:

More than a hundred years ago the mother of modern nursing, Florence Nightingale, observed: “It may be a strange principle to enunciate as the very first requirement in a Hospital that it should do the sick no harm. It is quite necessary, nevertheless, to lay down such a principle . . . .” When Nightingale wrote those words hospitals were not the sanitary sanctuaries they have become, and the harm she meant to shield her patients from was new or worsening illness. Since then the health care situation has become more complicated. Some hospitals are part of profit-driven, multi-billion dollar corporations, and the harm they can do has taken on additional forms. One such corporation is Tenet Health Care, and this case is about the economic harm it did by manipulating part of the Medicare program.

***

Boca believed that in the period before the 2003 changes, Tenet had been gaming the outlier program to get more reimbursements than its extraordinary-cost cases justified. Boca filed a class action complaint to that effect in March 2005 and amended it to include a revised class definition in June 2006. In the amended complaint, Boca alleged that Tenet increased its outlier reimbursements by dramatically raising its charges without reference to any actual cost increases, making average-cost cases look like outlier cases.

The Plaintiff's Expert

The party offering the expert testimony has the burden of demonstrating that the testimony is “relevant to the task at hand” and “logically advances a material aspect” of its case.  The offering party must show that the opinion meets the Daubert criteria, including reliable methodology and helpfulness to the factfinder in understanding the evidence or determining a fact, by a preponderance of the evidence. See Rink, 400 F.3d at 1292.  The district court found Boca’s method inadequate and speculative because it did not attempt to show what amount of Tenet’s charges were unlawful. Instead it focused on approximating Tenet’s actual costs more closely. To do this, Boca’s method swapped the outdated audited ratios (or the artificially high average ratios) the Center used to determine Tenet’s outlier payments for the more current and accurate unaudited ratios.

***

The district court’s conclusion that Boca’s expert opinion on injury and damages did not fit its liability theory was not manifestly erroneous because, like an oversized coat, the expert opinion covered too much. Under Boca’s liability theory, it is not unlawful for hospitals to overcharge (that is, to increase charges out of step with costs) as long as their audited ratios do not fall below the low National Threshold. Because Boca’s expert opinion uses unaudited ratios to approximate Tenet’s actual costs, it includes the outlier payments Tenet got from lawful overcharging, as well as unlawful overcharging, as part of Boca’s injury and damages.

***

Boca drew a line between lawful and unlawful behavior for liability purposes: the low National Threshold. Boca could have walked that line in a way that fit its theory of injury and damages to its liability theory; it could have chosen a method that showed that the behavior Boca claims caused its injuries, Tenet’s unlawful overcharging, actually impacted the loss threshold. All that Boca’s expert opinion purported to show, however, was the amount of most clearly lawful outlier payments Tenet could have gotten—the amount of outlier money Tenet would have received if it had used its actual costs to apply for the payments. What Boca’s expert opinion fails to recognize (which, by contrast, its liability theory does) is the range of behavior between clearly unlawful and perfectly lawful. Having tailored a trim-fitting liability theory for the body of its case against Tenet, Boca cannot hang a baggy injury and damages theory on it. Whatever expert opinion Boca provided had to be suitably proportioned. And because Boca’s injury and damages opinion was not confined to charges that its liability theory would consider unlawful, it was too broad. It was ill-fitting. Thus the district court did not abuse its discretion by excluding Boca’s expert opinion on injury and damages for lack of fit with its liability theory.

The Summary Judgment and Class Certification Order

 

The decision to affirm the district court's conclusion about the expert ended the discussion about the other two issues.  The court stated:

 

Our conclusion that the district court did not abuse its discretion in excluding Boca’s expert opinion on injury and damages compels a second one: that the district court’s grant of summary judgment in favor of Tenet was appropriate. Without its expert opinion, Boca has not offered any evidence of injury—an essential element of its RICO claim.

Additionally:

 

Because summary judgment was appropriate, Boca’s challenge to the district court’s denial of class certification is moot. See Rink, 400 F.3d at 1297 (“Because we have found that summary judgment was properly granted as to the underlying claims of the class representatives, the issue of class certification is moot.”).

Tenet Was Not Blameless

 

The district court made a point to emphasize, as we do now, that while summary judgment for Tenet was appropriate, Tenet was not blameless. The record shows that Tenet hospitals took advantage of a system designed to help pay for the sickest and least fortunate patients to heal. The people hurt the most by Tenet’s manipulation of the Medicare outlier program through excessive charge increases are the uninsured, who are forced to pay hospitals’ “sticker prices” instead of the reduced rates insurance companies negotiate for their clients. This may not be what Florence Nightingale had in mind when she warned about the harm hospitals could do, but it is still a harm against which patients deserve protection. The government has addressed this new strain of harm by recovering almost a billion dollars from Tenet and making changes to the way the outlier program runs. Hopefully those actions will help prevent similar abuse in the future and serve to remind hospitals that their first duty is to do no harm to anyone.

Documents Maintain Privilege Status Even When Disclosed to Testifying Expert

In Mullins, D.M.D. v. Tompkins (1D09-1148), the First District granted certiorari and quashed the trial court's order requiring the production of documents that were provided to a testifying expert.

The documents in question were described by the court as: "Dr. Mullins’ counsel described the materials in controversy as letters from counsel (to Dr. Mullins and her malpractice insurer, whom he also represented) which included counsel’s evaluations of claims and defenses; and as e-mails and other correspondence from Dr. Mullins to him in which she explained in detail and commented on Ms. Tompkins’ care and treatment."

The court held that: "The principle of law at issue here is that a party does not automatically waive any privilege simply by furnishing protected or privileged material to the party’s own expert...Even when the expert is to testify, opposing parties may be unable to discover privileged material that is not being offered as evidence...

Even assuming that work product and privileged communications provided to an expert witness become discoverable if used as a basis for the expert’s opinion, there has been no such showing here.