While I was largely off-grid this summer, Judge Keenan ruled that the third Boles Fosamax ONJ Trial — on damages — should be held over, until one crucial question of law is resolved. He has asked the Court of Appeals to answer a crucual question about which legal principle(s) should apply. [My backgrounders, here and here.]
So now Mrs. Boles must wait for her retrial (and inexorably grows older, and more frail, with each passing day, in the process). She must wait until a higher court decides whether it is enough that (as her lawyers contend) she showed evidence at trial that the drug Fosamax was inappropriate for patients like her — for long term, uninterrupted use (when initially she was not even diagnosed with full-on osteoporosis — see graphic below); or whether (as Merck’s lawyers contend) Merck should be off the hook because the FDA label for Fosamax was accurate when it was issued, without regard to the special risks presented by long term use by patients like Mrs. Boles. Here is the order, signed in July:
OPINION AND ORDER
. . .[T]he Court certifies that the following is a controlling question of law as to which there is substantial ground for difference of opinion:
May a plaintiff [Shirley Boles] establish that a prescription drug is defective [Fosamax] by showing that its risks outweigh its benefits for a subset of the patient population for whom the drug is indicated [patients like Mrs. Boles], regardless of the risk-benefit calculus for the indicated patient population as a whole [provided by Merck, when originally seeking FDA approval for Fosamax]?
Furthermore, the Court finds that an immediate appeal from the Court’s October 4, 2010 Order will materially advance the ultimate termination of this case, as well as the Fosamax MDL.
Therefore, the Court CERTIFIES the above question for review by the U.S. Court of Appeals for the Second Circuit pursuant to 28 U.S.C. § 1292 (b). Proceedings in the case of Boles v. Merck & Co. Inc., No. 06 Civ. 9455 (JFK), are STAYED pending resolution of the appeal or denial of interlocutory appellate review by the Second Circuit.
However, no other proceedings in the Fosamax MDL are stayed by this Opinion and Order. Re: (309 in 1:06-cv-09455-JFK) MOTION for Leave to Appeal Motion to Certify This Matter for Interlocutory Appeal filed by Merck & Co., Inc.
/s/ John F. Keenan,
United States District Court Judge
for the Southern District of New York
We will keep you posted, but Mrs. Boles grows sicker as she waits.