Bad news arrives in all sorts of vehicles, not just product liability suits. For example, in a medical malpractice case, the E.D. of Tenn recently issued a ruling that admitted an FDA Alert into evidence. Guthrie v. Ball, 2014 U.S. Dist. LEXIS 148900 (E.D. Tenn. October 17, 2014). That ruling displeased us, but since to be forewarned is to be forearmed, we share it with you in an effort to get all of the week’s nasty rulings behind us before we are halfway through hump day.
In Guthrie, the plaintiff’s counsel sought to use an FDA Alert sent to physicians regarding the risks of fentanyl patches. Specifically, the plaintiff’s counsel used the FDA Alert during depositions of expert witnesses. It appeared that the plaintiff’s counsel was attempting to use the FDA Alert to establish the standard of care. The doctor defendant filed a motion in limine to exclude the FDA Alert on the ground that it was inadmissible hearsay to which no exception applied, including the 803(8) hearsay exception. Among other things, the defendant argued that the FDA Alert did not contain a statement identifying the office responsible for the alert or reflect the FDA’s activities, did not indicate whether it pertained to a matter observed under a legal duty to report, and did not appear to reflect actual findings from a legally authorized investigation. Rule 803(8) creates an exception to the hearsay bar for “[a] record or statement of a public officer if: (A) it sets out: (i) the office’s activities; (ii) a matter observed while under a legal duty to report …; or (iii) in a civil case …. factual findings from a legally authorized investigation; and (B) the opponent does not show that the source of information or other circumstances indicate a lack of truthworthiness.” Fed.R.Evid. 803(8).
The court held that the FDA Alert was relevant because it specifically mentioned the brand of patch used by the plaintiff and it was issued in 2007, years prior to the plaintiff’s treatment by the defendant doctor in 2010. Additionally, unlike some other cases, the FDA Alert in question was not merely a proposed finding and did not invite public comment before final publication. The FDA Alert in Guthrie was based upon adverse event reports submitted to the FDA. Are such adverse events a source of trustworthiness? You know what we think about that, right? As we have said here and here, for example, adverse events are hardly enough to establish a scientific fact or the standard of care. By relying upon such an unreliable source as adverse events reports, that “trustworthiness” concept has been transformed into what the Colbert Report calls “truthiness.”
The Guthrie court acknowledged that “[s]ome courts have found that expert testimony based upon adverse event reports is likely inadmissible as unreliable because such opinion testimony is not based upon sufficient facts and data.” 2014 U.S. Dist. LEXIS 148900 at *13. It is nice that the Guthrie court was aware of the smart, good, fair cases. But, sadly, the Guthrie court was more moved by the dumb, awful, and wretched cases: “Other courts have found that such adverse event reports are reliable and an adequate scientific basis for expert testimony, given that such reports are often the only data available, and they are widely relied upon by both the FDA and experts in the industry.” Id. at *14. Which experts, exactly? How many of them cavort around the country, singing loudly from sheet music placed in front of their snouts by plaintiff lawyers? Anyway, as if purposely to administer injury and insult to this very blog, the Guthrie court cites an opinion from the Gadolimium-Based Contrast Agents litigation, that selfsame litigation that prompted Bexis to erupt into a post on “spherical error.” We’re not entirely certain what spherical error is, but it sounds pretty bad.
The defendant in Guthrie mounted a spirited attack on the reliability of adverse event reports, but the court seemed comfortable with its error, whether such error was spherical, triangular, or trapezoidal. Thus, the court did not believe that reliance upon a peer-reviewed article was a necessary requirement in establishing reliability. Id. at *15. The court held that there is no authority to support the limitation of Rule 803(8)’s public records exception to only epidemiological studies or accident investigations, because “no formal proceedings are necessary to satisfy the prerequisites of the rule.” Id. Further, the form of the record is not determinative of their admissibility, because the “indicia of reliability for the governmental investigative report is the fact that it is prepared pursuant to a duty imposed by law.” Id. It was enough that the FDA Alert “was based on the FDA’s investigation into adverse event reports which had been filed regarding the association between fentanyl patches, including Duragesic branded patches, with fatal respiratory depression from fentanyl overdose.” Id. at *15-16. [Speaking of finding an association, we cannot resist pointing out that there appears to be an association between fentanyl patch cases and dreadful judicial opinions. One such case was selected by us as the single worst case of 2011.] That’s all it took for the court to conclude “that the FDA Alert is admissible as a public records exception to the hearsay bar under Rule 803(8).” Id. at *16.
In the private sector, when someone jokingly admits that they did a less-than-thorough job, they sometimes use the phrase “close enough for government work.” The Guthrie court really took that notion to heart – without understanding the joke.