Judicial notice is a procedure for admitting facts the truth of which are beyond dispute. A special kind of magically thinking occurs when judges take judicial notice of falsehoods, myths, or lies.
In the federal judicial system, Federal Rule of Evidence 201 addresses judicial notice of adjudicative facts, and provides:
(b) Kinds of Facts That May Be Judicially Noticed. The court may judicially notice a fact that is not subject to reasonable dispute because it:
(1) is generally known within the trial court’s territorial jurisdiction; or
(2) can be accurately and readily determined from sources whose accuracy cannot reasonably be questioned.
Procedurally, Rule 201 provides that a court must take judicial upon the request of a party who has supplied any needed basis for the fact to be noticed. A court may take notice sua sponte. Rule 201(c)(1), (2).
In the Chantix litigation, counsel for Pfizer challenged plaintiffs’ expert witness, Curt Furberg, on Rule 702 grounds. According the MDL judge, the Hon. Inge Prytz Johnson, Pfizer asserted that Furberg’s proferred testimony because the FDA approved Chantix as safe and effective. In re Chantix (Varenicline) Prods. Liab. Litig., 889 F. Supp. 2d 1272, 1285 n.8 (N.D. Ala. 2012). Citing no authority or text, Judge Johnson announced that “[a]pproval by the FDA is not evidence of the safety of a medication.” Id.
To be sure, safety issue can sometimes arise after initial approval, but before the FDA or the manufacturer and sponsor of the medication can react to the new safety data. The sweeping statement, however, that the FDA’s approval is not any evidence of safety seems bereft of factual support and common sense.
Judge Johnson went on, however, to invent supporting evidence out of thin air:
“The court takes judicial notice of such things as that at one time, thalidomide was used for morning sickness in pregnant women. Unfortunately, 10,000 children were born with birth defects from it before it was banned. And 50 years elapsed before doctors understood why thalidomide caused limbs to disappear. See e.g. http://www.nytimes.com/2010/03/16/science/16limb.html?pagewanted=all. Similarly, the fact that the FDA at one time approved Vioxx did not prevent the same being removed from the market due to growing concerns that it increased the risk of heart attacks and strokes. http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm103420.htm. Hence, initial approval by the FDA is not proof of the safety of a medication.”
The point about the FDA’s approval not constituting evidence of safety may simply be sloppy writing and reasoning. In the quote above, perhaps Her Honor merely meant to say that initial approval is not evidence that a medication is safe in view of later obtained data that were not available to the FDA on its review of the new drug application. If so, fair enough, but the sweeping statement that the initial approval is no evidence of safety ignores the considerable time, cost, and energy that goes into the FDA’s review of safety before agency approves marketing.
More egregious, however, is Judge Johnson’s taking judicial notice of the marketing of thalidomide as though it had some relevancy and probative value for her claim about the inefficacy of the FDA’s safety reviews.[1] Consider the recent review of the FDA’s handling of thalidomide by Margaret Hamburg, M.D., Commissioner of the U. S. Food and Drug Administration:
“Fifty years ago, the vigilance of FDA medical officer Dr. Frances Kelsey prevented a public health tragedy of enormous proportion by ensuring that the sedative thalidomide was never approved in the United States. As many remember, in the early 1960’s, reports were coming in from around the world of countless women who were giving birth to children with extremely deformed limbs and other severe birth defects. They had taken thalidomide. Although it was being used in many countries, Dr. Kelsey discovered that it hadn’t even been tested on pregnant animals.”
Margaret Hamburg, “50 Years after Thalidomide: Why Regulation Matters” (Feb. 7, 2012).
Judge Johnson took judicial notice of a non-fact. The FDA never approved thalidomide for use in the United States, back in the 1950s or 1960s.[2]
[1] Judge Johnson’s fantastical history of the FDA was recently cited by plaintiffs’ counsel in the Zoloft birth defects litigation. See Plaintiffs’ Opposition to Defendants’ Motion to Exclude the Testimony of Anick Berard, Ph.D., at 13 (Filed Feb. 24, 2014), in In re Zoloft (sertraline hydrochloride) Prods. Liab. Litig., Case 2:12-md-02342-CMR Document 713.
[2] Judge Johnson’s errant history may have resulted from her European perspective of the thalidomide tragedy. Judge Inge Prytz Johnson immigrated from Denmark, where she was born and educated. She became a U.S. citizen in 1978, and a state court judge one year later. In 1998, she was nominated by President Clinton to the Northern District of Alabama. In October 2012, Judge Johnson assumed senior status. See Kent Faulk, “U.S. District Judge Inge Johnson goes into semi-retirement” (Oct. 19, 2012) (quoting Judge Johnson as saying that “One thing I like about my job is I don’t have to take sides.”)
