First — a little background, here. With each new drug the FDA approves, it also initiates a pharmacovigilance program, to collect so-called adverse event reports, or AERs — to keep track of whether long-acting, or more-subtly emergent effects are occuring, over time — ones that might not have appeared in the clinical trials needed for the original FDA approval.
In general, these adverse event reports are considered hearsay (afterall, they are second hand, and submitted without verification, by members of the public), and thus are generally ruled inadmissable in subsequent litigation about the actual side effects of any given drug, on any individual patient (other than the patient/person who actually submitted the AER to FDA, obviously). In fact, very few of the earlier Fosamax® ONJ (or “jaw bone death“) bellwether trials featured/admitted any evidence of any adverse event report data. In those cases, in general, local state law generally kept them out, as US District Court Judge John Keenan properly ruled.
However, the very capable US District Court Judge Joel Pisano has ruled that New York law will apply to Mrs. Glynn’s case, in this respect. And, on Friday, he ruled that at least some of the complaints made by patients contained in the AERs — the ones that are most akin to the injuries Mrs. Glynn alleges were the result of long-term, uninterrupted Fosamax use — will be admissable, but only for the limited purpose of establishing that Merck could have been aware of the claimed elevated “atypical” femur fracture risks. That is, the AERs cannot be admitted to establish that the injuries were actually caused by Fosamax use — just that Merck could have been aware that there were reports of such claims.
And, in turn, proof that Merck might have been aware of claims of elevated femur fracture risks, in patients on long-term, uniterrupted Fosamax regimens, would suggest — under applicable New York law — that Merck might have had a duty to warn Mrs. Glynn’s treating physician(s).
Had Merck done so, it will be argued by Mrs. Glynn’s lawyers, the physician(s) would have warned Mrs. Glynn. And by permitted inference, the jury will be allowed to consider that Mrs. Glynn would have heeded the warning, once given — and discontinued her Fosamax use.
Recall that in Scheinberg, the plaintiff won $285,000 on her “failure to warn” claim. I would expect that — given the volume of these AERs — the jury may come to a similar conclusion in Glynn, as it did, in Scheinberg. From Frisay’s transcript/order, then:
. . . .The Court has previously ruled that Adverse Event Reports concerning injuries similar to the injury experienced by plaintiff will be admissible for a limited purpose, for whether Merck had notice of a possible connection between Fosamax and that injury.
The jury will also be given a limiting instruction as to the limited admissibility of the Adverse Event Reports, namely, only for purpose of showing that Merck may have had notice. The AERs, as they are described, are themselves hearsay and their reliability is questioned by Merck. Nevertheless, subject to a limiting instruction, the Court finds that some of the AERs in question are admissible for that limited purpose. . . .
Now we wait, as the jury is picked, tomorrow morning, in Trenton — then opening arguments, probably starting Tuesday. We will keep you posted — as Merck is batting .714 (five of seven) — in the ONJ federal cases (avoiding liability), though. We shall see.