Mrs. Graves' lawyers have proposed forms of instructions for Judge Keenan to submit to the jury in this trial, now underway in the federal District Courts in Manhattan. In an effort to be fair to Merck, though, I'll quote from Merck's (less liberal) version of the proposed jury instructions.
However, it is likely that Judge Keenan will include at least some of Mrs. Graves' instructions, indicating that if Merck doesn't overcome the evidence that Merck didn't comply with all FDA rules in the process of obtaining approval of Fosamax®, and if the jury finds Mrs. Graves was injured by Fosamax, then a presumption arises that Merck is responsible for her injuries -- despite the FDA's approval of Fosamax. We shall, of course, see.
From the proposed jury instructions filed by Merck's lawyers yesterday, then:
. . . .DEFENDANT’S PROPOSED INSTRUCTION NO. 7
Contentions of the Parties
This lawsuit arises out of Judith Graves’ use of Fosamax. Merck manufactured Fosamax. The Plaintiff, Judith Graves, contends that she developed osteonecrosis of the jaw (“ONJ”) on or before March 31, 2003 as a result of her use of Fosamax.
The Plaintiff seeks compensatory damages for her injury. She seeks recovery under two separate theories related to Fosamax’s design.
First, Plaintiff alleges that Merck should be held strictly liable for her injury because it placed Fosamax on the market with a defective design, making it unreasonably dangerous to patients, and that this defective design caused her injury.
Second, Plaintiff alleges that Merck negligently designed Fosamax, that this defective design made Fosamax unreasonably dangerous to patients, and that this defective design caused her injury.
Merck contends that Fosamax did not cause Judith Graves’ injuries, that the scientific evidence does not establish that Fosamax causes ONJ, and that there was no defect in the design of Fosamax. Merck contends, rather, that Plaintiff’s injuries were caused by her own independent health risk factors, and not Fosamax. . . .DEFENDANT’S PROPOSED INSTRUCTION NO. 9
Strict Liability and Negligent Design Defect
Plaintiff alleges that Merck is liable because Fosamax was defectively designed. She brings two types of design defect claims: (1) strict liability design defect; and (2) negligent design defect.
For both of these claims, Plaintiff must prove that Fosamax was a defective product due to a defective design. A product is defectively designed if the product is in an unreasonably dangerous condition and the product is expected to and does reach the user without substantial change affecting that condition.
A prescription drug is “unreasonably dangerous” if the foreseeable risks of the drug outweigh its benefits. In determining whether the foreseeable risk of danger outweighed the benefits, you should consider the feasibility of an alternative safer design given the scientific and technical knowledge that existed at the time of manufacture – in this case, prior to March 2003. You should consider not only the benefits to Plaintiff, but also the overall usefulness and benefits to the public as a whole.
For her strict liability design defect claim, Plaintiff must prove each of the following elements by the greater weight of the evidence.(1) Fosamax was a defective product due to a defective design;
(2) Plaintiff was an intended user of Fosamax; and
(3) Fosamax’s defective design was a “legal cause” of Plaintiff’s injury.If the Plaintiff does not prove each of these three elements by the greater weight of the evidence, then you must return a verdict in favor of Merck on Plaintiff’s strict liability design defect claim.
If the greater weight of the evidence does support Plaintiff’s claim, then you must determine if Plaintiff was herself responsible and, if so, whether such responsibility was a contributing legal cause of her injury.
For her negligent design defect claim, Plaintiff has the additional burden of proving that Merck acted negligently in designing Fosamax. Negligence is the failure to use reasonable care. In this case, reasonable care is that degree of care which a reasonably prudent pharmaceutical company would use under like circumstances. Negligence may consist either of doing something that a reasonably prudent pharmaceutical company would not do under like circumstances or in failing to do something that a reasonably prudent pharmaceutical company would do under like circumstances. For her negligent design defect claim, Plaintiff has the burden of proving each of the following elements by the greater weight of the evidence:(1) Merck was negligent in designing Fosamax;
(2) As a result, Fosamax was a defective product due to a defective design; and
(3) Fosamax’s defective design was a “legal cause” of Plaintiff’s injury.
If you find that Plaintiff has not proven each of these three elements by the greater weight of the evidence, then you must return a verdict in favor of Merck on Plaintiff’s negligent design defect claim. If, however, Plaintiff proves each of these elements by the greater weight of the evidence, then you must determine if Plaintiff was herself negligent and, if so, whether such negligence was a contributing legal cause of her injury. . . .
We are probably still two weeks away from the time when this case will be handed to the jury for a decision, but we'll provide any important updates as they occur, right here.
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