As an anonymous internet post, this cannot automatically be credited as trustworthy, but it is from the commenters on Ed's Blog (a high-quality group), and it certainly has the ring of a genuine juror's view -- from the original Levine trial. [NOTE: Background here.]
. . . .While realizing this case hangs on a point of applicability of law, I thought it might be useful to share a bit of the view as one on the original jury in this case.
My background is healthcare management and I also have worked with a law firm specializing in defense of medical malpractice. [Condor's Q: How did the plaintiffs let this juror get seated?]
When entering the jury room, less than half the jurors, including myself, were ready to return a plaintiff's verdict. We spent an exteneded period of time reading the many documents entered into evidence ranging from actual package insert to many internal Wyeth findings and communications.
A few things became clear:
1. All FDA expert testimony, plaintiff and defense, agreed the package insert could be changed at any time on an expedited basis to add to warnings.
2. The package insert allowed for IV push administration.
3, Tissue death could be induced by interstitial administration not just inter- arterial meaning a needle wandering throuh the wall of the vein or drug leaking around a needle could have this result. This was not clearly explicated on the insert.
4. Wyeth had known about this problem and the consequences for decades and had done nothing, not even a simple “Dear Doctor” letter to communicate the risk to doctors.
5. The insert was the original insert from the introduction of the drug still in use at the time of the incident under a grandfather clause. It was being updated, but the warnings were not being changed at the time.
6. The award contained no punitive element. None was asked for [Condor's Comment: If I remember correctly, there was no legal basis (under applicable state law) for an award of punitive damages in Levine -- thus the lack of demand on that front], and none was given despite the desires of some more extreme jury members. It was based on a life care plan. Due to my previous experience I tended to view such things skeptically but this one was probably optimistic based on medical information revealed at the trial.
7. The head of the clinic involved acknowledged responsibility, both in a settlement, and in testimony, at the trial.
What would have prevented a plaintiff verdict? Almost certainly any act by Wyeth that attempted to communicate with the medical community a need to take a higher degree of care in the administration of this drug. . . .
1 comment:
There's also a comment on this thread on Ed's blog about an FDA reviewer who's being fired for reporting a company hiding deaths during drug development and reporting it to Congress and the FBI.
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