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A couple of issues in Svindland v. The Nemours Hospital, 2009 U.S. Dist. LEXIS 43315, No. 05-417 & 05-441 (E.D. Pa. May 19, 2009), caught our eye — namely: (1) whether to exclude comparative risk evidence and (2) whether to allow plaintiffs to discover the raw clinical data that formed the basis of published medical articles.
Svindland involved two medical malpractice cases brought by the parents of infants who died after heart surgery performed by Dr. Norwood. Plaintiffs claimed that Dr. Norwood did not cool the infants pre-operatively (don’t ask!) for long enough to protect the infants’ organs and that the informed consent process for the surgery was inadequate.
The cases have a long procedural history, with which we won’t bore you.
Ultimately, plaintiffs wanted to introduce expert testimony comparing mortality data from other hospitals to show that Dr. Norwood’s mortality rates were unusually high. That’s of interest because we’ve seen plaintiffs make similar attempts to compare different drugs having the same indication. In Svindland, the court rejected this testimony under Daubert.
The first data set was based on ICD-9 billing codes (for insurance reimbursement), rather than IPCCC treatment codes. The billing codes can be misclassified or fail to describe accurately the specific nature of the surgery being performed. Id. at *15. The other data set did not contain information about patient co-morbidities and reported only 30-day survival rates. Id. at *16-*17. And, even if the underlying data were sufficient, plaintiffs’ expert intended to use the RACHS-1 method of comparing the surgical data, and that method “was designed to compare the whole body of work of a given program to a national standard for each classification group. It was not meant to compare one surgery to another surgery, or to look at the performance of an individual surgeon for a particular operation.” Id. at *18-*19. The court thus excluded the expert testimony.
Plaintiffs also wanted to introduce and compare “evidence of morbidity and mortality by introducing isolated pages of medical records of other patients who had poor outcomes or who died following pediatric open-heart surgery.” Id. at *19. In other words, plaintiffs wanted to create their own anecdotal case studies. The Court found that evidence to be both irrelevant and, if relevant, more prejudicial than probative. “Even if mortality rates might seem relevant to the plaintiffs’ informed consent claims, the plaintiffs have not persuaded the Court that the mortality data that they would seek to introduce have taken into account co-morbidities or have otherwise been risk-adjusted so as to be relevant to the surgeries at issue.” Id. at *22.
The second issue is trickier, but no less interesting. Plaintiffs served subpoenas “to obtain the raw data underlying publications of studies done” at a hospital where Dr. Norwood had previously worked, and which included data about some of Norwood’s earlier surgeries, “to allow their expert to independently evaluate the data and offer an opinion on whether the cooling technique at issue increased the risk of adverse surgical outcomes.” Id. at *24.
This is a delicate issue for practicing lawyers (such as the two of us) to discuss in public, because our clients’ needs vary with the situation. If the published studies support our clients’ position, then we may well resist any effort by our opponents to obtain and reanalyze the underlying raw data. On the other hand, if the published studies do not support our clients’ position, then we may seek to compel disclosure of that data to permit our experts to review and reanalyze it. For a less biased (and more scholarly) approach to this issue, you might look at Bill Childs’ article about discovery into the peer review process, The Overlapping Magisteria of Law And Science: When Litigation and Science Collide, 85 Neb. L. Rev. 643 (2007).
To avoid having our own words quoted back at us some day, we take no position on the propriety of subpoenaing raw data underlying a published study. Instead, we’ll just report on the court’s holding.
In Svindland, the court held that the hospital did not have to disclose data underlying the published studies. The court chose not to address the public policy issues, such as whether permitting litigation-related discovery into the raw data underlying scientific research would chill medical research.
Instead, the court ruled on narrower grounds: “The data are not relevant to show what Dr. Norwood knew when he operated on Ian Svindland or Michael Daddio. Nor will they prove the applicable standard of care [at the times of the surgeries]. They also will not shed further light on the issues of proximate and but-for causation.” Id. at *30. The court also thought the data might unduly confuse the jury, so the court denied plaintiffs’ motion to compel and granted the defendants’ motion for a protective order.
If you’re ever on that side of the issue, you might put Svindland to use.