After a week’s delay, the retrial of the Boles Fosamax® “bellweather” case is getting underway, before Judge Keenan, in the federal District Courts, in Manhattan, this morning. Mrs. Boles’ lawyers have asked Judge Keenan to rule that at the close of the case, he instruct the jury about alleged non-compliance with FDA rules, as another basis to find liability against Merck.
The argument runs that the jury may presume Fosamax was dangerous and adulterated (in the parlance of the FDA), if Merck failed to comply with FDA rules in securing approval of it, and then later, in the way Merck marketed the drug. With a correction of some typos, I think the plaintiffs’ instructions will work well — see below — and click to enlarge:
The FDA rules compliance issue, in turn, will squarely present the matters implicated by this chart (some background on that):
I will keep you informed as the trial progresses.