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THOMAS & JOYCE CONA v. MERCK & CO., INC. JOHN & IRMA McDARBY v. MERCK & CO.

, INC.

Perez v. Wyeth (1998)


"for all practical purposes, absent deliberate concealment or nondisclosure of afteracquired knowledge of harmful effects, compliance with FDA standards should be virtually dispositive" of a failure to warn claim

Bailey v. Wyeth (2011)


New Jersey courts have recognized that before the FDA warning presumption will be deemed rebutted, the plaintiff must produce a specific type of evidence demonstrating intentional misconduct by the manufacturer. See William A. Dreier, John E. Keefe, Sr., & Eric D. Katz, New Jersey Products Liability & Toxic Torts Law 15:4 at 443 (2008).

The presumption
N.J.S.A. 2A:58C-2 An adequate product warning is "one that a reasonably prudent person in the same or similar circumstances would have provided with respect to the danger and that communicates adequate information on the dangers and safe use of the product, . . . in the case of prescription drugs, taking into account the characteristics of, and the ordinary knowledge common to, the prescribing physician."

The presumption
N.J.S.A. 2A:58C-4. If the warning or instruction given in connection with a drug or device or food or food additive has been approved or prescribed by the federal Food and Drug Administration under the "Federal Food, Drug, and Cosmetic Act," 52 Stat. 1040, 21 U.S.C. 301 et seq., . . . a rebuttable presumption shall arise that the warning or instruction is adequate . . . .

A.

PURPOSE OF CHARGE

I am now going to tell you about the principles of law governing this case. You are required to accept my instructions as the law. Any ideas you have of what the law is or what the law should be or any statements by the attorneys as to what the law may be, must be disregarded by you, if they are in conflict with my charge.

B.

ROLE OF THE COURT

I am the judge of the law. As part of this responsibility, I have made various rulings and statements throughout this trial. I may have asked questions. Do not view these rulings, statements or questions as clues about how I think this case should be decided. They are not. They are based solely on my understanding of the law and rules of evidence and they do not reflect any opinions of mine about the merits of this case. Even if they did, you should disregard them, because it is your role to decide this case, not mine.

C.

8 The lawyers are here as advocates for their clients. In their opening statements and in their summations they have given you their views of the evidence and their arguments in favor of their clients positions. While you may consider their comments, nothing that the attorneys say is evidence and their comments are not binding upon you. In addition, you must not decide this case based on the performance of the attorneys. You cannot decide the case based on whether you like one attorneys style more than another. You cannot decide the case based on the attorneys comments during the trial.

ROLE OF THE ATTORNEYS

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In some cases attorneys asked a question and then withdrew the question. At times, remarks were made by counsel to witnesses. You must not consider these statements of counsel. All counsel in this case are passionate advocates for their client's positions. You must decide the case based on the evidence. The court and counsel had numerous conference at sidebar. You cannot consider any statements or comments you overheard during these discussions.

10 From time to time during the trial I have been called upon to make rulings on objections or motions made by the lawyers. It is the duty of the attorney on each side of a case to object when the other side offers testimony or other evidence which the attorney believes is not properly admissible. You should not show prejudice against an attorney or his client because the attorney has made objections. You should not infer or conclude from any ruling or other comment I made that I have any opinions on the merits of the case favoring one side or the other. And

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if I sustained any objection to a question that went unanswered by the witness, you should not draw any inferences or conclusions from the question itself.

D.

ROLE OF THE JURY

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You sit here as judges of the facts. You alone have the responsibility of deciding the factual issues in this case. It is your recollection and evaluation of the evidence that controls. If the attorneys or I say anything about the facts in this case that disagrees with your recollection of the evidence, it is your recollection that you should rely on. Your decision in this case must be based solely on the evidence presented and my instructions on the law.

E.

JURORS NOTES POST TRIAL

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You are to resolve the factual disputes in this case based upon the exhibits which you will have in the jury room with you and your recollection of the testimony of witnesses as bearing on those issues. You have been permitted to make notes during the course of this trial. These notes are not evidence. You may use the notes during your deliberations to help you to recall what the testimony was. However, do not overemphasize the significance of a written note made by yourself or by a fellow juror. If a note does help to refresh your recollection, it has then been useful,

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but it is your recollection not the note which is important. Your verdict must be based solely on the evidence presented in this courtroom in accordance with my instructions. During the trial, you should not have read any newspaper or internet reports, or watched or listened to any television or radio coverage of the trial, VIOXX, or the parties to this lawsuit. If you have at any point come into contact with any news reports concerning the trial, VIOXX, or the parties to this

15 advise the Court now about what news reports you have seen or heard. It would be unfair for you to consider such reports, since they are not evidence, and the parties have no way to demonstrate the accuracy or inaccuracy of these reports.

F. EVIDENCE 16 You must decide this case solely on the evidence. The evidence in this case consists of:

1. the testimony that you heard from the witnesses; 2. the exhibits that have been marked into evidence; and 3. the deposition testimony that was played into the record. Any testimony that I have stricken from the record is not evidence and should not be considered by you in your deliberations. This means that even though you

17 may remember the testimony you are not to use it in your discussions or deliberations.
Further, if I gave a limiting instruction as to how to use certain evidence, that evidence must be considered by you for that purpose only. You cannot use it for any other purpose.

G.

JURORS QUESTIONS

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In this trial, I allowed you to submit certain questions that you wanted the witnesses to answer. Some were in fact asked and answered, and others were not asked. Keep in mind that the rules of evidence or other rules of court may have prevented me from allowing some questions. I have applied the same rules to your questions that I applied to the questions asked by the lawyers. Some questions may have been modified or rephrased. Some may have been asked just as you have written them, and others may not have been asked at all. If a question that you submitted was not

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asked, you should not take it personally, nor should you attach any significance to my decision not to allow the question. I caution you not to treat jurors questions, or the answers to those questions, differently than you would treat any other testimony. You are to carefully consider all of the testimony and other evidence in this case before deciding how much weight to give particular testimony.

20 H. DIRECT AND CIRCUMSTANTIAL EVIDENCE


Evidence may be direct or circumstantial. Direct evidence is direct proof of a fact, such as the testimony of an eyewitness. Circumstantial evidence (sometimes called inferences) consists of a chain of circumstances pointing to the existence of certain facts. Circumstantial evidence is based upon deductions or logical conclusions that you reach from the direct evidence.

21 You may consider both direct and circumstantial evidence in deciding this case. The law permits you to give equal weight to both, but it is for you to decide how much weight to give to any evidence. When deciding this case, you are permitted to draw inferences from the evidence. Inferences are deductions or logical conclusions drawn from the evidence. Use logic, your collective common knowledge and your common sense when determining what inferences can be made from the evidence.

22 I. CREDIBILITY You will have to decide which witnesses to believe and which witnesses not to believe. Regardless of whether the witness is a lay person or expert, you may believe everything a witness says or only part of it or none of it. In deciding what testimony to believe, you may take into consideration: 1. The witness interest, if any, in the outcome of this case; 2. The accuracy of the witness' recollection;

23 3. The witness' ability to know what he/she is talking about; 4. The reasonableness of the testimony; 5. The witness demeanor on the stand (by which I mean the way the witness acted, the way the witness talked or the way the witness reacted to certain questions); 6. The witness candor or evasion when being questioned; 7. The witness willingness or reluctance to answer questions; 8. The inherent believability of the testimony;

24 9. The presence of any inconsistent or contradictory statements. 10. Use your common sense when evaluating the testimony of a witness. If a witness told you something that did not make sense, you have a right to reject that testimony. On the other hand if what the witness said seemed reasonable and logical, you have a right to accept that testimony.

J.

EXPERT TESTIMONY You have heard testimony from witnesses who were called as experts. Generally, witnesses can testify only about the facts and are not permitted to give opinions. However, an exception to this rule exists in the case of an expert witness. An expert witness may give an opinion on a matter in which the witness has some special knowledge, education, skill, experience or training. An expert witness may be able to assist you in understanding the evidence in this case or in performing your duties as a fact finder. But I want to

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26 emphasize to you that the determination of the facts in this case rests solely with you as jurors. In this case, Dr. Eric Topol, Dr. Harlan Krumholz, Dr. Nicholas DePace, Dr. Arnold Criscitiello, Dr. Alan Wasserman, Dr. Barry Rayburn, were called as experts and testified about certain opinions. In examining each expert's opinion(s), you may consider the person's reasons for testifying, if any. You may also consider the qualifications of the individual(s) and the believability of the expert, including all the considerations that generally apply

27 when you are deciding whether or not to believe a witness' testimony. The weight of the expert's opinion depends on the facts on which the expert bases his/her opinion. You as jurors must also decide whether the facts relied upon by the expert actually exist. Finally, you are not bound by the testimony of an expert. You may give it whatever weight you deem is appropriate. You may accept or reject all or part of an expert's opinion(s). At times an expert witness was asked to assume that certain facts were true and to give an opinion based on that assumption. This is called a hypothetical question.

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You must determine if any fact assumed by the witness has not been proved and the effect of that omission, if any, upon the weight of the expert's opinion. It is for you the jury to resolve any conflicts in the testimony of the experts, using the same guidelines in determining credibility that I mentioned earlier. The amount of the expert witness' fee is a matter that you may consider as possibly affecting the believability of an expert. However, there is nothing improper in the expert witness(es) being paid a reasonable fee for his/her work and for his/her time in attending court.

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You will recall that statements were read in connection with the direct or cross-examination of several of the experts and other witnesses. These statements were contained in a reference or professional publications, or journals. However, merely because a publication has been read to you does not mean that you must accept it as binding on any of your decisions. You may give the statement(s) discussed in the publication whatever weight you believe it deserves using your reason, judgment and common sense.

K.

BURDEN OF PROOF

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Plaintiffs each have two separate claims against the defendant. The first is a claim alleging failure to warn and the second is for consumer fraud. The burden of proof is on the plaintiffs to establish their claims because if a person makes an allegation then that person must prove the allegation. In this action, the plaintiffs have the burden of proof but the level of proof required is different for their claim of failure to warn from their claims for consumer fraud.

31 L. BURDEN OF PROOF-FAILURE TO WARN Now we go to the law on the plaintiffs claim for failure to warn. This claim has to be proven by a preponderance of the evidence. This means that plaintiffs must prove each element of their claim is more likely true than not. If you picture a scale and put on one side of the scale all the credible evidence that favors plaintiffs position on a question and all the credible evidence that favors the defense on the other side plaintiffs have to tip the scales ever so slightly in order to prevail. If the scales tip in favor of the

32 defense or even if they are absolutely equal then plaintiffs hasnt prevailed and you must find for the defendant. When I talk about weighing the evidence, I refer to its capacity to persuade you. I do not mean that you are to count the number of witnesses presented by each side or measure the length of their testimony. The concept of weighing the evidence refers to its quality and not its quantity.

33 The defendant Merck as the manufacturer of a product has the duty to make a product that is reasonably safe. To be a reasonably safe product, there must be adequate warning of risks of the product.

34 In this case the plaintiffs claim that VIOXX was not reasonably safe because of a failure to adequately warn about an increased risk of cardiovascular events for people taking VIOXX. Let me now discuss the law governing the plaintiffs claim of failure to warn. If a product fails to contain an adequate warning or instructions, it is considered defective under the law. Plaintiffs say Merck did not provide adequate warnings when selling VIOXX because it did not

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warn of an increased risk of serious cardiovascular events such as heart attacks. Merck says they adequately warned doctors about VIOXX based on what they knew or should have known up to the time of plaintiffs respective heart attacks. The defendant, as the manufacturer of a product, had a duty to provide adequate warnings about the dangers of its product. Merck had this duty even if VIOXX was perfectly designed and manufactured. To decide the plaintiff's failure to warn claim you must determine what warnings the defendant provided and whether those warnings were adequate.

36 Let's talk about what a warning is. Warnings may consist of statements that a drug should not be used at all under certain circumstances, that it should be used only in a particular way, or that it should be used with particular care because of an increased risk of harm. Warnings or instructions may be in the form of words, symbols or pictures. They must be in a form which will effectively convey the information. A prescribing physician has a right to be warned about potential serious risks of a drug if those risks are known or should be known by the manufacturer.

37 To be adequate, the warning or instruction must be the kind of warning or instruction which a reasonably prudent manufacturer in the same or similar circumstances would have provided to the prescribing physician. In the case of a prescription drug adequate warning must be given to the doctors who will prescribe the drug. This is true because it is the prescribing doctor who has to decide whether to prescribe a prescription drug to a patient. An adequate warning or instruction will communicate sufficient information on the risks of the drug that are known or should be known by the manufacturer.

38 When you consider what is known or should be known, you should understand that a reasonably prudent drug manufacturer should be deemed to know of reasonably obtainable and available reliable information. When deciding whether the information provided is adequate, you should take into account the characteristics and ordinary common knowledge of prescribing physicians.

39 Mr. Cona and Mr. McDarby allege an increased risk of heart attack was known or knowable to the defendant, and the defendant failed to adequately warn physicians that patients with risk factors for heart attacks should not be prescribed the drug. Merck contends that they gave adequate warnings of any risks which were known or knowable during the time VIOXX was used by Mr. Cona and Mr. Mc Darby. If the defendant proves that there was no risk or the risk was not known or knowable during those times, then it had no duty to warn of any such risk and cannot be held liable for failure to do so. In evaluating this defense of

40 Merck, you may consider evidence relating to Mercks knowledge of potential serious cardiovascular risks of VIOXX. A duty to warn arises if the manufacturer, in this case Merck, actually knew or should have known of the need to issue a particular warning. In determining what Merck should have known, you must understand that the law requires a manufacturer to keep reasonably familiar with and to know reliable information generally available or reasonably obtainable in the scientific community. In that regard, Merck is deemed to be an expert in its

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field. This information may come from its own scientists and studies, from outside experts and/or literature in the field. A pharmaceutical manufacturer such as Merck also has a responsibility to warn doctors of increased risks discovered after the product was placed on the market when subsequently obtained or reasonably obtainable knowledge was available either at the time of distribution of the product or in sufficient time before the injury so that an adequate warning could have been given. In this regard it is the

42 defendant who must prove that the information about the risk was not reasonably available or obtainable in sufficient time before the injury. When deciding whether plaintiff has proven Merck failed to warn of potential serious cardiovascular risks of VIOXX, that it knew or should have known, the time frame to consider is the time before Mr. Conas and Mr. McDarbys heart attacks.

43 To establish a claim of failure to warn, plaintiff must prove all of the following elements by a preponderance (greater weight) of the credible evidence:

l. That Merck failed to provide an adequate warning to prescribing doctors based on what Merck knew or should have known about the risks of VIOXX in sufficient time before the plaintiffs heart attacks to allow for an effective warning to be given.

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2. That VIOXX was a proximate cause of Mr. Conas and Mr. McDarbys injury and damages. I will describe what proximate cause is in a moment.

45 In the case of a prescription drug, the warning must be one that a reasonably prudent manufacturer would have provided to adequately communicate information on the risks of the product to the prescriber, taking into account the characteristics of, and the ordinary knowledge common to, such prescribing physicians. When deciding if an adequate warning was given by the defendant you should look at the totality of the information given to the physicians about the drug and its risks, including information given in the package insert, in the published articles, in the promotional materials and the information provided by Mercks sales representatives to doctors.

46 M. FDAs ROLE Under the Product Liability Act of New Jersey which sets forth the law for failure to warn claims, there is a provision that states that in the case of a claim for failure to warn involving a prescription drug that there is a rebuttable presumption that a label approved by the FDA is adequate. Therefore, we start with the presumption that if the FDA approved a drug label, then the warnings on the label are adequate. However, if plaintiffs produce substantial evidence that the approved label is not an adequate warning, then the presumption can be overcome.

47 If the plaintiffs produce such evidence, then you, the jury, must weigh all the evidence produced by both the plaintiffs and the defendant on the issue of the adequacy of the warning and decide if plaintiffs have met its burden of proving that Merck failed to provide an adequate warning to physicians. This presumption applies only to the label and only where the FDA has approved the label as adequate. However, if you find that plaintiffs have proven by a preponderance of the evidence that after a label was approved there was new information that changed the known or knowable cardiovascular risks of VIOXX then under FDA regulations, Merck had a duty to

48 warn physicians of any newly discovered risks of the drug. The FDA requires a drug manufacturer to warn the medical community as soon as there is reasonable evidence of an association of a serious hazard with a drug. There need not be proof of causation, only association in other words, if there is reasonable evidence of association between taking the drug and certain harm occurring without proof of exactly how the drug causes the harm, the FDA still requires warning be given to the physicians of the risk.

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Merck could, if it chooses to without prior FDA approval, send letters to physicians, take out ads, publish in journals, or send out sales representatives in order to advise physicians of newly known risks of VIOXX. There is a procedure under the regulations where a manufacturer of a drug like Merck can change their label to add risk information and submit it to the FDA for approval within 30 days. If the FDA doesnt object to the change in that time, the new warning can be used.

50 The FDA will not allow this procedure to be used for claims for a new use of the drug or to claim a new safety benefit. Therefore, Merck could not, for example, amend the VIOXX label with claims of gastrointestinal safety or that VIOXX dosage could be increased or it could be used for new purposes or a new patient population without a formal FDA approval process. It is up to you to decide what Merck knew or should have known about whether there were potential cardiovascular risks of VIOXX based upon reasonable evidence and when. It is up to you to then determine whether in light of all the information that

51 Merck knew or should have known it acted reasonably and adequately warned physicians of any serious cardiovascular risks that they should have been warned about based on all the facts you find to be true in the time period where they could have gotten the information to the prescribing physician before the plaintiffs heart attacks.

52 N. PROXIMATE CAUSE If you find that Merck failed to provide an adequate warning, the law requires you presume that plaintiffs doctors would have heeded adequate warning and not have prescribed VIOXX to Mr. Cona and Mr. McDarby. However, to recover damages for their heart attacks Mr. Cona and Mr. McDarby must still prove that their taking VIOXX was a proximate cause of their heart attacks. To prove proximate cause plaintiffs must prove that VIOXX was a cause of their heart attacks but they need not prove that VIOXX was the only cause or

53 even the primary cause of their heart attacks. They must prove that VIOXX was a substantial contributing factor in causing their heart attacks. By substantial, it is meant that it was not a remote, trivial or inconsequential cause, but the mere circumstance that there may also be another cause or causes of their heart attacks does not mean that there cannot be a finding of proximate cause. Even if there were other causes of the heart attack, if you find VIOXX was a substantial contributing factor in causing the plaintiffs heart attack, you should find for plaintiffs on this issue but if you do not find VIOXX was a substantial

contributing factor in causing the plaintiffs heart attacks you should find no proximate causation and find for the defendant on this issue.

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O.

CONSUMER FRAUD CLAIM

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Now we will review specifically what the law requires the plaintiffs to prove to prevail on their consumer fraud claims. As I have told you, there are different burdens of proof for different types of actions. For example, the State must prove a criminal guilty beyond a reasonable doubt. That is not the burden of proof in a civil case. With regard to their consumer fraud claim it is the obligation of the plaintiffs to prove their allegations by clear and convincing evidence. Clear and convincing

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evidence is evidence that produces in your minds a firm belief or conviction that the allegations sought to be proved by the evidence are true. It is evidence so clear, direct, weighty in terms of quality, and convincing as to cause you to come to a clear conviction of the truth of the precise facts in issue. The clear and convincing standard of proof requires that the result shall not be reached by a mere balancing of doubts or probabilities, but rather by clear evidence which causes you to be convinced that the allegations sought to be proved are true. This standard of proof applies to the questions on the verdict sheet relating to consumer fraud.

I must make it clear that the plaintiffs claim of personal injury from a heart attack is part of their failure to warn claim. It is not part of the consumer fraud claim. Whether VIOXX was or was not a proximate cause of plaintiffs heart attacks and what injuries they have suffered as a result of their heart attack are not elements of the consumer fraud claim.
The Consumer Fraud Act in connection with the sale or advertisement of merchandise states:

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The act, use or employment by any person of any unconscionable commercial practices . . . misrepresentation, or the knowing, concealment, suppression, or omission of any material fact with intent that others rely upon such concealment, suppression or omission, in connection with the sale or advertisement of any merchandise . . . whether or not any person has in fact been misled, deceived or damaged thereby, is declared to be an unlawful practice

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Advertisement in this case includes the attempt directly or indirectly by publication, dissemination, solicitation, indorsement or circulation or in any other way to induce the purchase of the product.
Under the Consumer Fraud Act it would be a violation for Merck to engage in unconscionable commercial practice, to make misrepresentations of fact about VIOXX or to knowingly conceal, suppress or omit any material fact while marketing VIOXX to physicians who would then prescribe the product to consumers.

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An unconscionable commercial practice is an activity in the public marketplace which is basically unfair or unjust, which materially departs from standards of good faith, honesty in fact and fair dealing. The plaintiffs allege that Merck did make material misrepresentations about the cardiovascular safety of VIOXX when marketing the drug to physicians. Merck denies this. If Merck voluntarily made a misrepresentation about the cardiovascular safety of VIOXX to physicians when marketing the drug, then Merck committed an illegal act under the consumer fraud statute. If as Merck contends, it made

61 no misrepresentation about the cardiovascular safety of VIOXX while marketing the drug to doctors then you cannot find violation of the act based on the claim of misrepresentation. Plaintiffs also allege Merck knowingly omitted, suppressed or concealed information about the cardiovascular risks of VIOXX when marketing it to physicians with the intent to mislead them. The difference under the law between an affirmative misrepresentation and the omission or a suppression of a fact is the former doesnt require knowledge of the falsity of the misrepresentation, but with an omission

62 plaintiffs must show that the defendant omitted or suppressed the information knowingly with intent to mislead. Merck contends that it appropriately represented and disclosed the relevant information to physicians and acted in good faith. If plaintiffs prove that Merck knowingly omitted, concealed or suppressed material information about the cardiovascular risks of VIOXX with intent to mislead physicians as plaintiffs allege, then you must find Merck committed a violation of the Act whether or not physicians were actually misled. If you find that plaintiffs have not proven this allegation, then you must find there was no violation

63 of the Consumer Fraud Act for the claim of omission, suppression or concealment. Based on that explanation of the law you must determine what the facts are and answer the question on the verdict sheet as to whether Merck committed consumer fraud in the manner it marketed VIOXX to prescribing doctors before the last date Mr. Cona and Mr. McDarby purchased VIOXX. The Consumer Fraud Act allows anyone who suffered any ascertainable loss of money as a result of consumer fraud as I just described to you to bring an action. Mr. Cona alleges he lost $45 co-pay he paid for

64 VIOXX because of Mercks consumer fraud. Mr. McDarby alleges that he lost $3,968.36 he paid for VIOXX because of Mercks consumer fraud. In order for plaintiffs to be awarded damages, they must prove they sustained a loss of money that has a causal nexus to Mercks alleged consumer fraud. Plaintiffs loss must be supported by evidence of loss that it is capable of calculation and not mere speculation but the proof of the amount of loss need not be precise.

The plaintiffs claim is for what they paid for the purchase of VIOXX. They claim if the consumer fraud had not occurred they wouldn't have purchased VIOXX. In order to prove a causal nexus plaintiffs must prove that the consumer fraud had a causal effect on their physicians decision to prescribe VIOXX and on Mr. Conas and Mr. McDarbys decision to purchase it, and they sustained an ascertainable loss.

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66 You can award a maximum of $45 to Mr. Cona and a maximus of $3,968.36 to Mr. McDarby for this claim. Any amount you award for this claim will be tripled by the court after the verdict. The defendant will have to pay reasonable attorney fees and costs for proving the consumer fraud in an amount determined by the court. This is the penalty for consumer fraud set by the Legislature. You have to decide the answers to the questions based solely on the law and evidence. You must accept the law on the penalty for consumer fraud as the law dictates it should be regardless of whether you agree with it.

P.

DAMAGES

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I shall now instruct you on the law governing damages in the event you decide the liability issue in favor of plaintiffs. The fact that I instruct you on damages should not be considered as suggesting any view of mine about which party is entitled to prevail in this case. Instructions on damages are given for your guidance in the event you find that the plaintiffs are entitled to a verdict. I am required to provide instructions on damages in all cases where the trial includes a claim for damages.

68 Q. DISABILITY, IMPAIRMENT, LOSS OF THE ENJOYMENT OF LIFE, PAIN AND SUFFERING If you find for plaintiffs, Mr. Cona and/or Mr. McDarby, they are entitled to recover fair and reasonable money damages for the full extent of the harm caused, no more and no less. A plaintiff who is awarded a verdict is entitled to fair and reasonable compensation for any permanent or temporary injury resulting in disability to or impairment of his faculties, health, or ability to participate in activities, as a proximate result of the defendant's wrongdoing. Disability or impairment

69 health or ability to participate in activities. It includes the inability to pursue one's normal pleasure and enjoyment. You must determine how the injury has deprived plaintiff of his customary activities as a whole person. This measure of damages is what a reasonable person would consider to be adequate and just under all the circumstances of the case to compensate plaintiff for his injury and his consequent disability, impairment, and the loss of the enjoyment of life. The law also recognizes as proper items for recovery, the pain, physical and mental suffering,

70 discomfort, and distress that a person may endure as a natural consequence of the injury. The measure of damages is what a reasonable person would consider to be adequate and just under all the circumstances to compensate plaintiff. Here are some factors you may want to take into account when fixing the amount of the award for disability impairment, loss of enjoyment of life, pain and suffering. You may consider plaintiff's age, usual activities, occupation, family responsibilities and similar relevant facts in evaluating the probable consequences of any injuries you find he has suffered.

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You are to consider the nature, character and seriousness of any injury or discomfort. You must also consider their duration, as any award you make must cover the damages suffered by plaintiffs since the heart attacks, to the present time, and even into the future if you find that plaintiffs injuries and its consequences have continued to the present time or can reasonably be expected to continue into the future. The law does not provide you with any table, schedule or formula by which a person's pain and suffering disability, impairment, loss of enjoyment of

72 life may be measured in terms of money. The amount is left to your sound discretion. You are to use your discretion to attempt to make the plaintiffs whole, so far as money can do so, based upon reason and sound judgment, without any passion, prejudice, bias or sympathy. You each know from your common experience the nature of pain and suffering, disability, impairment and loss of enjoyment of life and you also know the nature and function of money. The task of equating the two so as to arrive at a fair and reasonable award of damages requires a high order of human

73 judgment. For this reason, the law can provide no better yardstick for your guidance than your own impartial judgment and experience. You are to exercise sound judgment as to what is fair, just and reasonable under all the circumstances. After considering the evidence, you shall award a lump sum of money that will fairly and reasonably compensate plaintiffs for their pain, suffering, disability, impairment, and loss of enjoyment of life.

S. TAX CONSEQUENCES A personal injury damage award is not subject to federal or state income tax. Therefore, if you decide to award the plaintiffs damages for his/their personal injury, you should not add or subtract any tax in fixing the amount of the award.

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T. PER QUOD DAMAGES A wife is entitled to the services of her spouse in attending to the household duties, to companionship and comfort. A plaintiff who is awarded a verdict is entitled to fair and reasonable compensation for any loss or impairment of her spouse's services or society because of injuries sustained by her husband as a proximate result of the defendant's negligence. Damages may be awarded not only for total loss of services but for a worsening of their quality. This claim is for damages from the date of the heart attack to the present and even into the future, if you find losses will continue into the future.

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U.

NO PREJUDICE, PASSION, BIAS OR 76 SYMPATHY Your oath as jurors requires you to decide this case fairly and impartially, without sympathy, passion, bias or prejudice. You are to decide this case based solely upon the evidence that you find believable and in accordance with the rules of law that I give you. The mere fact that plaintiffs have instituted suit against the defendant and has brought this case to trial does not mean that the plaintiffs are entitled to recover damages or to obtain a verdict against the defendant. The fact that the defendant in this case is a company should have no bearing on your verdict in this case. In

77 the eyes of the law, both individuals and corporations are equal and both are entitled to be judged by the same standards of fairness and impartiality.

78 The fact that Merck is a New Jersey corporation or that the plaintiffs are from New Jersey cannot be a factor in your decision. Sympathy for Mr. Cona and/or Mr. McDarby and/or their respective wives or family cannot be a factor in your decision. The fact that Merck has produced or will produce other drugs that have or will help people cannot be a factor in your decision.

79 What the media or other people will think about your decision is not something you should consider. The fact that there have been other cases or may be other cases in the future involving VIOXX must not affect your decision. You have sworn to decide this case on the evidence and on the law, and you must focus solely on this and specifically on each question and then answer each question based on your decision of what the truth is and applying the law as I give it to you.

V.

DELIBERATIONS

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You are not advocates for either party. You are judges of the facts. Your sole interest is to determine the truth from the evidence in the case. It is your duty, as jurors, to consult with one another and to deliberate with a view to reaching an agreement, if you can do so without compromising your individual judgment. Each of you must decide the case for yourself, but do so only after an impartial consideration of the evidence with the other jurors.

81 W. VERDICT Since this is a civil case, any verdict of at least seven of the jurors is a legal verdict. Therefore, it is not necessary that all eight jurors agree on each question. An agreement of any seven jurors is sufficient. All eight jurors must deliberate fully and fairly on each and every question, and all eight jurors must determine and vote upon each question. It is not necessary that the same seven jurors agree upon the answers to all questions. Whenever at least seven jurors have agreed to any answer, that question has been decided, and you may move on to consider the remaining questions in the case if it is appropriate to do so. All eight jurors

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must participate fully in deliberating on the remaining questions. A juror who has been outvoted on any question shall continue to deliberate with the other jurors fairly, impartially, honestly and conscientiously to decide the remaining questions. Each juror must consider each question with an open mind. When at least seven of you have agreed upon a verdict, indicate to the attendant that you have reached a verdict but say nothing more. The attendant will escort you back to the jury box so that the court may receive your verdict.

X.

COMMUNICATIONS WITH COURT

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If during your deliberations you wish to communicate with the Court, or you would like me to repeat any part of the jury instruction, please write your request or question and give the note to the attendant. I will respond as quickly as I can by having you in the courtroom on the record. However, at no point until you reach your final verdict should you indicate to the attendant or anyone else what your vote has been on any question before you. That is a matter that only members of the jury should know until you have reached a verdict.

Y.

DESIGNATE THE FOREPERSON

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The foreperson insures that each juror deliberates, writes any questions the jury may have for the court and marks the verdict and vote on the jury verdict sheet. The foreperson also signs and submits the verdict sheet. When the jury returns to the court room, the foreperson must report the verdict to the Court by giving the vote and answer to each of the questions on the jury verdict sheet. Juror No. 2 is the foreperson of this jury.

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