Tag Archives: Merck Fosamax Bone Density Osteonecrosis Claims Femur and Jaw Jury Trial US Dist Ct NY Bellweather Case Maley April 23 2010

Maley Bellweather Fosamax® Trial: “We Now Join This Program — Already In Progress”

Despite what the Plaintiffs’ MDL site claimed, apparently the Maley v. Merck Fosamax® bellweather trial is already well-underway, in Judge Keenan’s courtroom in Manhattan. Tonight, his clerks have electronically entered a week’s worth of minute notations on the file jackets. The trial has been underway all week.

Here is the full-text of a letter describing a dispute — about whether a 30 second section of a recorded deposition would be replayed to the jury, for context — at the open of this morning’s testimony (after apparently having had Thursday off):

April 23, 2010

. . . .Re: In re Fosamax Products Liability Litigation (MDL-1789) Malev v. Merck & Co. Inc., Case No. 06-cv-04110-JFK

Dear Judge Keenan:

I write on behalf of Merck Sharp & Dohme (“Merck”) to briefly apprise the Court of two issues that the parties require rulings on in advance of the completion of Dr. Goldberg’s testimony being played to the jury this morning.

First, Plaintiffs counsel has informed Merck’s counsel that it desires to have the last thirty seconds or so of audio played before we adjourned Wednesday replayed to the jury.

Plaintiffs’ Position

The deposition was stopped half way through a very short exam regarding Exh. E-2, which is 1.0922B. The deposition should be resumed at the point where the exhibit is first tendered, which is only about 30 seconds before the break point, so that the jury, which has been off for a day is reoriented as to what the witness is looking at and discussing. Otherwise, the jury will be lost as to the context of the questions and answers.

Merck’s Response

The testimony regarding this exhibit was complete. The only question left to be played with respect to this topic is according to Plaintiff the latter question addressed below, to which Merck has objected. As the Court is aware. Plaintiff has made this 1999 exostosis event a focus of her case. Replaying this testimony will only serve to prejudice Merck by reinforcing the purported importance of this portion of the videotaped testimony by having the jury hear it twice.

Second, white examining the transcript from the testimony that did play, Merck’s counsel realized that the last question on the record was something that it believed it had agreement should not be played. Plaintiff believes there was no agreement.

Regardless of the reasons why the parties thought differently with regard to this testimony, Merck’s position and the question that Merck now knows will follow it are inadmissible. As described below, Merck’s position is that the first question and answer should be stricken from the record, and the second not asked when the video resumes.

Disputed Testimony

Goldberg 448:22-449: 5

22 Q. And did you ever, in your expert

23 reports, disclose the ’99 Adverse Event Report, this

24 particular one, as an ONJ report?

1 A. No, I did not.

2 Q. How did you miss it?

3 A. At that point in time we were not

4 searching on the term exostosis, which is how this

5 event was coded. So I missed it.

Merck’s Objection

This reference to Dr. Goldberg’s “expert reports” clearly relates to searches done in conjunction with two regulatory labeling submissions in 2005. Disclosure of exostosis reports in 2005 labeling submissions runs afoul of the March 2004 time bar in place in this case.

Plaintiff’ apparently wishes to have the excerpt included for the sound byte “I missed it.” However, this unquestionably relates to a 2005 search done in connection with March and August 2005 regulatory submissions, and should be excluded for this reason. Equally, it should be excluded because his testimony is colored by the 2006 updates to this particular exostosis report. This issue already been addressed by the Court with respect to the testimony of Dr. Linda Hostelley. (See ruling at Tr. 1 56:7-20, excluding 2006 discussion of updates to this exostosis report.)

Plaintiffs’ Response

The portion re Dr. Goldberg missing the exostosis goes to the very issue of how it was possible for the adverse event system to miss reports like exostosis which describe ONJ-like symptoms. There is nothing in the question which would implicate any post-injury liability. It simply explains, in a timeless fashion, how it was possible for the safety surveillance physician to miss a report such as this. . . .

We’ll let you know if there is an electronic record of a ruling on this, before Monday.

Maley Fosamax® Bellweather Case — In Manhattan — Opens Monday

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. . . .

I’ll keep you posted as Monday’s trial date gets underway in earnest.