Rebooted. Postponed for one week (to April 26, 2010), in Manhattan's federal district court, the next Fosamax® bellweather case is about to get underway. Jury selection could begin this afternoon, so here (once again) is Merck's version of the jury instructions, and the below excerpt -- at its essence -- is what Merck requests Judge Keenan instruct the jury to decide, when all the evidence is in:
. . . .This lawsuit arises out of Plaintiff Louise Maley’s use of Fosamax. Merck manufactures Fosamax. Plaintiff contends that she developed osteonecrosis of the jaw, or “ONJ,” prior to March 31, 2004 as a result of her use of Fosamax.
The Plaintiff seeks compensatory damages for her injury. She alleges that Merck negligently failed to warn her prescribing physician, Dr. Lawton, that Fosamax created a risk of ONJ, and that such negligence was the proximate cause of her injury.
Merck contends that the scientific evidence does not establish that Fosamax causes ONJ. Merck also contends that Plaintiff never had ONJ, and that any complaints Plaintiff had about facial pain were the result of other factors having nothing to do with Fosamax.
Further, Merck contends that there would have been no basis to warn physicians about ONJ before Plaintiff’s injury in March 2004 because at that time there was no evidence that Fosamax caused ONJ. . . .
Plaintiff’s lawsuit against Merck is based on a single claim known as negligent failure to warn.
Negligence is the failure to use reasonable care. Reasonable care is the care a reasonably careful and ordinarily prudent pharmaceutical company would use under the same or similar circumstances.
Plaintiff alleges that Merck negligently failed to warn her prescribing physician, Dr. Lawton, that Fosamax presents a risk of ONJ; that Dr. Lawton would not have prescribed Fosamax to Plaintiff if Merck had warned Dr. Lawton that Fosamax presents a risk of ONJ; and that Merck’s failure to warn Dr. Lawton about that risk resulted in Plaintiff developing ONJ.
A manufacturer of prescription medication owes a duty to adequately warn physicians about the medication’s risks. This duty runs to the prescribing physician, not the patient, because the physician is the one who weighs a medication’s risks and benefits to decide whether to prescribe it to the patient.
A manufacturer’s duty to warn does not arise until the manufacturer knows or should know of the risk. When determining what a manufacturer should know, it is held to the knowledge of an expert in the field. Because a manufacturer cannot be required to warn of an unknown risk, the knowledge chargeable to it must be limited to the period prior to the date on which the plaintiff incurred her injury, in this case, March 31, 2004.For her negligent failure to warn claim, Plaintiff has the burden of proving each of the following elements:
(1) By March 31, 2004, Merck knew, or by the exercise of reasonable care should have known, that Fosamax created a risk of ONJ;
(2) Merck should have warned Dr. Lawton of this risk before March 31, 2004;
(3) Dr. Lawton would not have prescribed Fosamax to Plaintiff if Merck had warned Dr. Lawton about this risk;
(4) Plaintiff developed ONJ on or before March 31, 2004; and
(5) Fosamax was the “proximate cause” of Plaintiff’s ONJ.
If the Plaintiff does not prove each of these elements by the greater weight of the evidence, then you must return a verdict in favor of Merck on Plaintiff’s negligent failure to warn claim.
If you determine that Merck should have warned Dr. Lawton about a risk of ONJ, you may presume that Dr. Lawton would have incorporated the risk of ONJ into his decision on whether or not to prescribe Fosamax to Plaintiff. However, Plaintiff bears the burden of proving by the greater weight of the evidence that the risk of ONJ was sufficiently high that it would have changed Dr. Lawton’s decision to prescribe Fosamax to Plaintiff. If Plaintiff does not prove by the greater weight of the evidence that the addition of risk information about ONJ to the Fosamax label would have changed Dr. Lawton’s decision to prescribe Fosamax to her, then you must return a verdict in favor of Merck. . . .
Respectfully submitted,
/s/ William J. Beausoleil
I'll keep you posted as Monday's trial date gets underway in earnest.
4 comments:
Question ... if Merck clearly knew that there was significant differences between "saline" solution placebo drug and (in another situation) "aluminum" solution placebo, couldn't they be held liable for misrepresentation on all accounts?
I am no products liability litigator, but I think the question would boil down to whether Merck misled the FDA into approving the vaccine.
[I assume you are talking about a vaccine, given the reference to aluminum, in a saline solution.]
Vaccines are given an additional layer of protections and immunities from suits, once approved by FDA, compared to other drugs.
I think in a vaccine setting, the best bet -- for establishing liabilty by the maker -- would be to show that the vaccine-maker misled the FDA with "bad" placebo comparisions, and that deception caused FDA to approve the vaccine. Otherwise, it's a pretty tall order, once the vaccine has been approved.
In the case of ordinary (pill) drugs, the hurdle isn't nearly as high.
I hope this is helpful.
Namaste
Gracias! I appreciate your help. Have a good weekend.
The trial has been underway -- in stealth mode -- all week. See the top of the blog, for an update.
Namaste
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