jury charge - mcdarby v. merck (2008)

Upload: george-conk

Post on 03-Jun-2018

222 views

Category:

Documents


0 download

TRANSCRIPT

  • 8/12/2019 Jury charge - McDarby v. Merck (2008)

    1/84

    THOMAS & JOYCE CONAv.

    MERCK & CO., INC.

    JOHN & IRMA McDARBY

    v.MERCK & CO., INC.

  • 8/12/2019 Jury charge - McDarby v. Merck (2008)

    2/84

    Perez v. Wyeth (1998)

    "for all practical purposes, absent deliberateconcealment or nondisclosure of after-acquired knowledge of harmful effects,compliance with FDA standards should

    be virtually dispositive" of a failure to

    warn claim

  • 8/12/2019 Jury charge - McDarby v. Merck (2008)

    3/84

    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 evidencedemonstrating 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).

  • 8/12/2019 Jury charge - McDarby v. Merck (2008)

    4/84

    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 circumstanceswould have provided with respect to the

    danger and that communicates adequateinformation on the dangers and safe use ofthe product, . . . in the case of prescription

    drugs, taking into account thecharacteristics of, and the ordinaryknowledge common to, the prescribing

    physician."

  • 8/12/2019 Jury charge - McDarby v. Merck (2008)

    5/84

    The presumption N.J.S.A. 2A:58C-4. If the warning or instruction given in

    connection with a drug or device or food orfood additive has been approved or

    prescribed by the federal Food and DrugAdministration 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 warni ng orinstruction is adequate . . . .

  • 8/12/2019 Jury charge - McDarby v. Merck (2008)

    6/84

    A. PURPOSE OF CHARGE

    I am now going to tell you about the principles of lawgoverning this case. You are required to accept myinstructions as the law.

    Any ideas you have of what the law is or what the lawshould be or any statements by the attorneys as towhat the law may be, must be disregarded by you, if

    they are in conflict with my charge.

    6

  • 8/12/2019 Jury charge - McDarby v. Merck (2008)

    7/84

    B. ROLE OF THE COURT

    I am the judge of the law. As part of thisresponsibility, I have made various rulings andstatements throughout this trial. I may have askedquestions. Do not view these rulings, statements or

    questions as clues about how I think this case shouldbe decided. They are not. They are based solely onmy understanding of the law and rules of evidence and

    they do not reflect any opinions of mine about themerits of this case. Even if they did, you shoulddisregard them, because it is your role to decide thiscase, not mine.

    7

  • 8/12/2019 Jury charge - McDarby v. Merck (2008)

    8/84

    C. ROLE OF THE ATTORNEYS

    The lawyers are here as advocates for their clients. Intheir opening statements and in their summations theyhave given you their views of the evidence and theirarguments in favor of their clients positions. While

    you may consider their comments, nothing that theattorneys say is evidence and their comments are notbinding 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 likeone attorneys style more than another. You cannotdecide the case based on the attorneys commentsduring the trial.

    8

  • 8/12/2019 Jury charge - McDarby v. Merck (2008)

    9/84

  • 8/12/2019 Jury charge - McDarby v. Merck (2008)

    10/84

    From time to time during the trial I have been called

    upon to make rulings on objections or motions madeby the lawyers. It is the duty of the attorney on eachside of a case to object when the other side offers

    testimony or other evidence which the attorneybelieves is not properly admissible. You should notshow prejudice against an attorney or his clientbecause the attorney has made objections. You shouldnot infer or conclude from any ruling or othercomment I made that I have any opinions on themerits of the case favoring one side or the other. And

    10

  • 8/12/2019 Jury charge - McDarby v. Merck (2008)

    11/84

    if I sustained any objection to a question that went

    unanswered by the witness, you should not draw anyinferences or conclusions from the question itself.

    11

  • 8/12/2019 Jury charge - McDarby v. Merck (2008)

    12/84

    D. ROLE OF THE JURY

    You sit here as judges of the facts. You alone have theresponsibility of deciding the factual issues in thiscase. It is your recollection and evaluation of the

    evidence that controls. If the attorneys or I sayanything about the facts in this case that disagrees withyour recollection of the evidence, it is your

    recollection that you should rely on.Your decision in this case must be based solely on theevidence presented and my instructions on the law.

    12

  • 8/12/2019 Jury charge - McDarby v. Merck (2008)

    13/84

    E. JURORS NOTES POST TRIAL

    You are to resolve the factual disputes in this case

    based upon the exhibits which you will have in thejury room with you and your recollection of thetestimony of witnesses as bearing on those issues.

    You have been permitted to make notes during thecourse of this trial. These notes are not evidence. Youmay use the notes during your deliberations to helpyou to recall what the testimony was. However, do notoveremphasize the significance of a written note madeby yourself or by a fellow juror. If a note does help torefresh your recollection, it has then been useful,

    13

  • 8/12/2019 Jury charge - McDarby v. Merck (2008)

    14/84

  • 8/12/2019 Jury charge - McDarby v. Merck (2008)

    15/84

    advise the Court now about what news reports youhave seen or heard. It would be unfair for you toconsider such reports, since they are not evidence, andthe parties have no way to demonstrate the accuracy or

    inaccuracy of these reports.

    15

  • 8/12/2019 Jury charge - McDarby v. Merck (2008)

    16/84

    F. EVIDENCE

    You must decide this case solely on the evidence. Theevidence in this case consists of:

    1. the testimony that you heard from the witnesses;2. the exhibits that have been marked into

    evidence; and3. the deposition testimony that was played into

    the record.

    Any testimony that I have stricken from the record isnot evidence and should not be considered by you inyour deliberations. This means that even though you

    16

  • 8/12/2019 Jury charge - McDarby v. Merck (2008)

    17/84

    may remember the testimony you are not to use it inyour discussions or deliberations.

    Further, if I gave a limiting instruction as to how to

    use certain evidence, that evidence must be consideredby you for that purpose only. You cannot use it forany other purpose.

    17

  • 8/12/2019 Jury charge - McDarby v. Merck (2008)

    18/84

    G. JURORS QUESTIONS

    In this trial, I allowed you to submit certain questionsthat you wanted the witnesses to answer. Some were infact asked and answered, and others were not asked.Keep in mind that the rules of evidence or other rulesof court may have prevented me from allowing somequestions. I have applied the same rules to yourquestions that I applied to the questions asked by the

    lawyers. Some questions may have been modified orrephrased. Some may have been asked just as youhave written them, and others may not have been

    asked at all. If a question that you submitted was not

    18

  • 8/12/2019 Jury charge - McDarby v. Merck (2008)

    19/84

    asked, you should not take it personally, nor shouldyou attach any significance to my decision not toallow the question. I caution you not to treat jurorsquestions, or the answers to those questions,

    differently than you would treat any other testimony.You are to carefully consider all of the testimony andother evidence in this case before deciding how much

    weight to give particular testimony.

    19

    20

  • 8/12/2019 Jury charge - McDarby v. Merck (2008)

    20/84

    H. DIRECT AND CIRCUMSTANTIALEVIDENCE

    Evidence may be direct or circumstantial. Directevidence is direct proof of a fact, such as the testimonyof an eyewitness. Circumstantial evidence (sometimescalled inferences) consists of a chain of circumstancespointing to the existence of certain facts.Circumstantial evidence is based upon deductions or

    logical conclusions that you reach from the directevidence.

    20

  • 8/12/2019 Jury charge - McDarby v. Merck (2008)

    21/84

    You may consider both direct and circumstantial

    evidence in deciding this case. The law permits you togive equal weight to both, but it is for you to decidehow much weight to give to any evidence.When deciding this case, you are permitted to drawinferences from the evidence. Inferences aredeductions or logical conclusions drawn from theevidence. Use logic, your collective commonknowledge and your common sense when determiningwhat inferences can be made from the evidence.

    21

  • 8/12/2019 Jury charge - McDarby v. Merck (2008)

    22/84

    I. CREDIBILITY

    You will have to decide which witnesses to believeand which witnesses not to believe. Regardless ofwhether the witness is a lay person or expert, youmay 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;

    22

  • 8/12/2019 Jury charge - McDarby v. Merck (2008)

    23/84

    3. The witness' ability to know what he/she istalking 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 certainquestions);

    6. The witness candor or evasion when being

    questioned;7. The witness willingness or reluctance to answerquestions;

    8. The inherent believability of the testimony;

    23

  • 8/12/2019 Jury charge - McDarby v. Merck (2008)

    24/84

    9. The presence of any inconsistent or contradictorystatements.10. Use your common sense when evaluating the

    testimony of a witness. If a witness told yousomething that did not make sense, you have a right toreject that testimony. On the other hand if what thewitness said seemed reasonable and logical, you havea right to accept that testimony.

    24

  • 8/12/2019 Jury charge - McDarby v. Merck (2008)

    25/84

    J. EXPERT TESTIMONY

    You have heard testimony from witnesses whowere called as experts. Generally, witnesses can testifyonly about the facts and are not permitted to giveopinions. However, an exception to this rule exists inthe case of an expert witness. An expert witness maygive an opinion on a matter in which the witness hassome special knowledge, education, skill, experience

    or training. An expert witness may be able to assistyou in understanding the evidence in this case or inperforming your duties as a fact finder. But I want to

    25

  • 8/12/2019 Jury charge - McDarby v. Merck (2008)

    26/84

    emphasize to you that the determination of the facts inthis case rests solely with you as jurors.

    In this case, Dr. Eric Topol, Dr. Harlan Krumholz,Dr. Nicholas DePace, Dr. Arnold Criscitiello, Dr. AlanWasserman, Dr. Barry Rayburn, were called as experts

    and testified about certain opinions.In examining each expert's opinion(s), you mayconsider the person's reasons for testifying, if any. Youmay also consider the qualifications of theindividual(s) and the believability of the expert,including all the considerations that generally apply

    26

  • 8/12/2019 Jury charge - McDarby v. Merck (2008)

    27/84

    when you are deciding whether or not to believe awitness' testimony.

    The weight of the expert's opinion depends on thefacts on which the expert bases his/her opinion. You asjurors must also decide whether the facts relied upon

    by the expert actually exist.Finally, you are not bound by the testimony of anexpert. You may give it whatever weight you deem isappropriate. You may accept or reject all or part of anexpert's opinion(s).At times an expert witness was asked to assume thatcertain facts were true and to give an opinion based onthat assumption. This is called a hypothetical question.

    27

  • 8/12/2019 Jury charge - McDarby v. Merck (2008)

    28/84

    You must determine if any fact assumed by thewitness has not been proved and the effect of thatomission, if any, upon the weight of the expert'sopinion.

    It is for you the jury to resolve any conflicts in the

    testimony of the experts, using the same guidelines indetermining credibility that I mentioned earlier.

    The amount of the expert witness' fee is a matter

    that you may consider as possibly affecting thebelievability of an expert. However, there is nothingimproper in the expert witness(es) being paid areasonable fee for his/her work and for his/her time inattending court.

    28

  • 8/12/2019 Jury charge - McDarby v. Merck (2008)

    29/84

    You will recall that statements were read inconnection with the direct or cross-examination ofseveral of the experts and other witnesses. Thesestatements were contained in a reference orprofessional publications, or journals.

    However, merely because a publication has beenread to you does not mean that you must accept it asbinding on any of your decisions. You may give the

    statement(s) discussed in the publication whateverweight you believe it deserves using your reason,judgment and common sense.

    29

  • 8/12/2019 Jury charge - McDarby v. Merck (2008)

    30/84

    K. BURDEN OF PROOF

    Plaintiffs each have two separate claims against thedefendant. 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 claimsbecause if a person makes an allegation then thatperson must prove the allegation.

    In this action, the plaintiffs have the burden of proofbut the level of proof required is different for theirclaim of failure to warn from their claims forconsumer fraud.

    30

  • 8/12/2019 Jury charge - McDarby v. Merck (2008)

    31/84

    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 apreponderance of the evidence . This means thatplaintiffs must prove each element of their claim ismore likely true than not. If you picture a scale andput on one side of the scale all the credible evidencethat favors plaintiffs position on a question and all the

    credible evidence that favors the defense on the otherside plaintiffs have to tip the scales ever so slightly inorder to prevail. If the scales tip in favor of the

    31

    32

  • 8/12/2019 Jury charge - McDarby v. Merck (2008)

    32/84

    defense or even if they are absolutely equal then

    plaintiffs hasnt prevailed and you must find for thedefendant.

    When I talk about weighing the evidence, I refer to itscapacity to persuade you. I do not mean that you are tocount the number of witnesses presented by each sideor measure the length of their testimony. The concept

    of weighing the evidence refers to its quality and notits quantity.

    32

    33

  • 8/12/2019 Jury charge - McDarby v. Merck (2008)

    33/84

    The defendant Merck as the manufacturer of aproduct has the duty to make a product that isreasonably safe. To be a reasonably safe product, theremust be adequate warning of risks of the product.

    33

    34

  • 8/12/2019 Jury charge - McDarby v. Merck (2008)

    34/84

    In this case the plaintiffs claim that VIOXX was notreasonably safe because of a failure to adequatelywarn about an increased risk of cardiovascular eventsfor people taking VIOXX.

    Let me now discuss the law governing the plaintiffsclaim of failure to warn.

    If a product fails to contain an adequate warning orinstructions, it is considered defective under the law.

    Plaintiffs say Merck did not provide adequatewarnings when selling VIOXX because it did not

    34

    35

  • 8/12/2019 Jury charge - McDarby v. Merck (2008)

    35/84

    warn of an increased risk of serious cardiovascularevents such as heart attacks. Merck says theyadequately warned doctors about VIOXX based onwhat they knew or should have known up to the timeof 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 ifVIOXX was perfectly designed and manufactured.To decide the plaintiff's failure to warn claim you mustdetermine what warnings the defendant provided andwhether those warnings were adequate.

    35

    36

  • 8/12/2019 Jury charge - McDarby v. Merck (2008)

    36/84

    Let's talk about what a warning is. Warnings mayconsist of statements that a drug should not be used atall under certain circumstances, that it should be usedonly 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 whichwill effectively convey the information. A prescribingphysician has a right to be warned about potentialserious risks of a drug if those risks are known orshould be known by the manufacturer.

    36

    37

  • 8/12/2019 Jury charge - McDarby v. Merck (2008)

    37/84

    To be adequate, the warning or instruction must bethe kind of warning or instruction which a reasonablyprudent manufacturer in the same or similarcircumstances would have provided to the prescribingphysician. In the case of a prescription drug adequate

    warning must be given to the doctors who willprescribe the drug. This is true because it is theprescribing doctor who has to decide whether toprescribe a prescription drug to a patient.

    An adequate warning or instruction willcommunicate sufficient information on the risks of thedrug that are known or should be known by themanufacturer.

    37

    38

  • 8/12/2019 Jury charge - McDarby v. Merck (2008)

    38/84

    When you consider what is known or should be

    known, you should understand that a reasonablyprudent drug manufacturer should be deemed to knowof reasonably obtainable and available reliableinformation.

    When deciding whether the information provided isadequate, you should take into account thecharacteristics and ordinary common knowledge ofprescribing physicians.

    38

    39

  • 8/12/2019 Jury charge - McDarby v. Merck (2008)

    39/84

    Mr. Cona and Mr. McDarby allege an increased risk ofheart attack was known or knowable to the defendant,and the defendant failed to adequately warn physiciansthat patients with risk factors for heart attacks shouldnot be prescribed the drug. Merck contends that theygave adequate warnings of any risks which wereknown or knowable during the time VIOXX wasused by Mr. Cona and Mr. Mc Darby. If the defendant

    proves that there was no risk or the risk was notknown or knowable during those times, then it had noduty to warn of any such risk and cannot be held liable

    for failure to do so. In evaluating this defense of

    39

    40

  • 8/12/2019 Jury charge - McDarby v. Merck (2008)

    40/84

    Merck, you may consider evidence relating to Mercks

    knowledge of potential serious cardiovascular risks ofVIOXX . A duty to warn arises if the manufacturer,in this case Merck, actually knew or should haveknown of the need to issue a particular warning.

    In determining what Merck should have known,you must understand that the law requires amanufacturer to keep reasonably familiar with and toknow reliable information generally available orreasonably obtainable in the scientific community. Inthat regard, Merck is deemed to be an expert in its

    40

    41

  • 8/12/2019 Jury charge - McDarby v. Merck (2008)

    41/84

    field. This information may come from its ownscientists and studies, from outside experts and/orliterature in the field.

    A pharmaceutical manufacturer such as Merck alsohas a responsibility to warn doctors of increased risks

    discovered after the product was placed on the marketwhen subsequently obtained or reasonably obtainableknowledge was available either at the time ofdistribution of the product or in sufficient time beforethe injury so that an adequate warning could have beengiven. In this regard it is the

    41

    42

  • 8/12/2019 Jury charge - McDarby v. Merck (2008)

    42/84

    defendant who must prove that the information aboutthe 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, thetime frame to consider is the time before Mr. Conasand Mr. McDarbys heart attacks.

    42

    43

  • 8/12/2019 Jury charge - McDarby v. Merck (2008)

    43/84

    To establish a claim of failure to warn, plaintiff mustprove all of the following elements by apreponderance (greater weight) of the credibleevidence:

    l. That Merck failed to provide an adequate warning toprescribing doctors based on what Merck knew orshould have known about the risks of VIOXX insufficient time before the plaintiffs heart attacks toallow for an effective warning to be given.

    43

    44

  • 8/12/2019 Jury charge - McDarby v. Merck (2008)

    44/84

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

    44

    45

  • 8/12/2019 Jury charge - McDarby v. Merck (2008)

    45/84

    In the case of a prescription drug, the warning must beone that a reasonably prudent manufacturer would

    have provided to adequately communicate informationon the risks of the product to the prescriber, taking intoaccount the characteristics of, and the ordinary

    knowledge common to, such prescribing physicians.When deciding if an adequate warning was given bythe defendant you should look at the totality of theinformation given to the physicians about the drug andits risks, including information given in the packageinsert, in the published articles, in the promotionalmaterials and the information provided by Mercks

    sales representatives to doctors.

    45

  • 8/12/2019 Jury charge - McDarby v. Merck (2008)

    46/84

    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 aclaim for failure to warn involving a prescription

    drug that there is a rebuttable presumption that a labelapproved by the FDA is adequate.Therefore, we start with the presumption that if the

    FDA approved a drug label, then the warnings on thelabel are adequate.

    However, if plaintiffs produce substantial evidencethat the approved label is not an adequate warning,then the presumption can be overcome.

    46

    47

  • 8/12/2019 Jury charge - McDarby v. Merck (2008)

    47/84

    If the plaintiffs produce such evidence, then you, thejury, must weigh all the evidence produced by both the

    plaintiffs and the defendant on the issue of theadequacy of the warning and decide if plaintiffs havemet its burden of proving that Merck failed to provide

    an adequate warning to physicians.This presumption applies only to the label and onlywhere the FDA has approved the label as adequate.However, if you find that plaintiffs have proven by apreponderance of the evidence that after a label wasapproved there was new information that changed theknown or knowable cardiovascular risks of VIOXX

    then under FDA regulations, Merck had a duty to

    47

    48

  • 8/12/2019 Jury charge - McDarby v. Merck (2008)

    48/84

    warn physicians of any newly discovered risks of thedrug.

    The FDA requires a drug manufacturer to warn themedical community as soon as there is reasonableevidence of an association of a serious hazard with a

    drug. There need not be proof of causation, onlyassociation in other words, if there is reasonableevidence of association between taking the drug and

    certain harm occurring without proof of exactly howthe drug causes the harm, the FDA still requireswarning be given to the physicians of the risk.

    48

    49

  • 8/12/2019 Jury charge - McDarby v. Merck (2008)

    49/84

    Merck could, if it chooses to without prior FDAapproval, send letters to physicians, take out ads,publish in journals, or send out sales representatives inorder to advise physicians of newly known risks ofVIOXX. There is a procedure under the regulations

    where a manufacturer of a drug like Merck can changetheir label to add risk information and submit it to theFDA for approval within 30 days. If the FDA doesnt

    object to the change in that time, the new warning canbe used.

    49

    50

  • 8/12/2019 Jury charge - McDarby v. Merck (2008)

    50/84

    The FDA will not allow this procedure to be used forclaims for a new use of the drug or to claim a new

    safety benefit. Therefore, Merck could not, forexample, amend the VIOXX label with claims ofgastrointestinal safety or that VIOXX dosage could

    be increased or it could be used for new purposes or anew patient population without a formal FDA approvalprocess.

    It is up to you to decide what Merck knew or shouldhave known about whether there were potentialcardiovascular risks of VIOXX based uponreasonable evidence and when. It is up to you to thendetermine whether in light of all the information that

    50

    51

  • 8/12/2019 Jury charge - McDarby v. Merck (2008)

    51/84

    Merck knew or should have known it acted reasonablyand adequately warned physicians of any serious

    cardiovascular risks that they should have beenwarned about based on all the facts you find to be truein the time period where they could have gotten the

    information to the prescribing physician before theplaintiffs heart attacks.

    51

    52

  • 8/12/2019 Jury charge - McDarby v. Merck (2008)

    52/84

    N. PROXIMATE CAUSEIf you find that Merck failed to provide an adequate

    warning, the law requires you presume that plaintiffsdoctors would have heeded adequate warning and nothave prescribed VIOXX to Mr. Cona and Mr.McDarby.

    However, to recover damages for their heart attacksMr. Cona and Mr. McDarby must still prove that theirtaking 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

    52

    53

  • 8/12/2019 Jury charge - McDarby v. Merck (2008)

    53/84

    even the primary cause of their heart attacks. Theymust prove that VIOXX was a substantial

    contributing factor in causing their heart attacks. Bysubstantial, it is meant that it was not a remote, trivialor inconsequential cause, but the mere circumstance

    that there may also be another cause or causes of theirheart attacks does not mean that there cannot be afinding of proximate cause. Even if there were othercauses of the heart attack, if you find VIOXX was asubstantial contributing factor in causing the plaintiffsheart attack, you should find for plaintiffs on this issuebut if you do not find VIOXX was a substantial

    53

    54

  • 8/12/2019 Jury charge - McDarby v. Merck (2008)

    54/84

    contributing factor in causing the plaintiffs heartattacks you should find no proximate causation and

    find for the defendant on this issue.

    54

    55

  • 8/12/2019 Jury charge - McDarby v. Merck (2008)

    55/84

    O. CONSUMER FRAUD CLAIM

    Now we will review specifically what the lawrequires the plaintiffs to prove to prevail on theirconsumer fraud claims.

    As I have told you, there are different burdens of

    proof for different types of actions. For example, theState must prove a criminal guilty beyond areasonable doubt. That is not the burden of proof in a

    civil case.With regard to their consumer fraud claim it is theobligation of the plaintiffs to prove their allegations byclear and convincing evidence. Clear and convincing

    55

    56

  • 8/12/2019 Jury charge - McDarby v. Merck (2008)

    56/84

    evidence is evidence that produces in your minds afirm belief or conviction that the allegations sought to

    be proved by the evidence are true. It is evidence soclear, direct, weighty in terms of quality, andconvincing 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 requiresthat the result shall not be reached by a mere balancingof doubts or probabilities, but rather by clear evidencewhich causes you to be convinced that the allegationssought to be proved are true. This standard of proofapplies to the questions on the verdict sheet relating toconsumer fraud.

    56

    57

  • 8/12/2019 Jury charge - McDarby v. Merck (2008)

    57/84

    I must make it clear that the plaintiffs claim ofpersonal injury from a heart attack is part of their

    failure to warn claim. It is not part of the consumerfraud claim. Whether VIOXX was or was not aproximate cause of plaintiffs heart attacks and what

    injuries they have suffered as a result of their heartattack are not elements of the consumer fraud claim.

    The Consumer Fraud Act in connection with the saleor advertisement of merchandise states:

    57

    58

  • 8/12/2019 Jury charge - McDarby v. Merck (2008)

    58/84

    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 withintent that others rely upon

    such concealment, suppression or omission, inconnection with the sale or advertisement ofany merchandise . . . whether or not any personhas in fact been misled, deceived or damagedthereby, is declared to be an unlawful practice

    58

    59

  • 8/12/2019 Jury charge - McDarby v. Merck (2008)

    59/84

    Advertisement in this case includes the attemptdirectly or indirectly by publication, dissemination,

    solicitation, indorsement or circulation or in any otherway to induce the purchase of the product.

    Under the Consumer Fraud Act it would be aviolation for Merck to engage in unconscionablecommercial practice, to make misrepresentations offact about VIOXX or to knowingly conceal,suppress or omit any material fact while marketingVIOXX to physicians who would then prescribe theproduct to consumers.

    60

  • 8/12/2019 Jury charge - McDarby v. Merck (2008)

    60/84

    An unconscionable commercial practice is anactivity in the public marketplace which is basicallyunfair or unjust, which materially departs fromstandards of good faith, honesty in fact and fairdealing. The plaintiffs allege that Merck did make

    material misrepresentations about the cardiovascularsafety of VIOXX when marketing the drug tophysicians. Merck denies this. If Merck voluntarily

    made a misrepresentation about the cardiovascularsafety of VIOXX to physicians when marketing thedrug, then Merck committed an illegal act under theconsumer fraud statute. If as Merck contends, it made

    61

  • 8/12/2019 Jury charge - McDarby v. Merck (2008)

    61/84

    no misrepresentation about the cardiovascular safetyof VIOXX while marketing the drug to doctors then

    you cannot find violation of the act based on the claimof misrepresentation.Plaintiffs also allege Merck knowingly omitted,

    suppressed or concealed information about thecardiovascular risks of VIOXX when marketing it tophysicians with the intent to mislead them.

    The difference under the law between an affirmativemisrepresentation and the omission or a suppression ofa fact is the former doesnt require knowledge of the

    falsity of the misrepresentation, but with an omission

    62

  • 8/12/2019 Jury charge - McDarby v. Merck (2008)

    62/84

    plaintiffs must show that the defendant omitted orsuppressed the information knowingly with intent tomislead. Merck contends that it appropriatelyrepresented and disclosed the relevant information tophysicians and acted in good faith.

    If plaintiffs prove that Merck knowingly omitted,concealed or suppressed material information aboutthe cardiovascular risks of VIOXX with intent tomislead physicians as plaintiffs allege, then you mustfind Merck committed a violation of the Act whetheror not physicians were actually misled.

    If you find that plaintiffs have not proven thisalle ation, then ou must find there was no violation

    63

  • 8/12/2019 Jury charge - McDarby v. Merck (2008)

    63/84

    of the Consumer Fraud Act for the claim of omission,suppression or concealment.

    Based on that explanation of the law you mustdetermine what the facts are and answer thequestion on the verdict sheet as to whether Merck

    committed consumer fraud in the manner it marketedVIOXX to prescribing doctors before the last dateMr. Cona and Mr. McDarby purchased VIOXX.

    The Consumer Fraud Act allows anyone whosuffered any ascertainable loss of money as a result ofconsumer fraud as I just described to you to bring anaction. Mr. Cona alleges he lost $45 co-pay he paid for

    64

  • 8/12/2019 Jury charge - McDarby v. Merck (2008)

    64/84

    VIOXX because of Mercks consumer fraud. Mr.McDarby alleges that he lost $3,968.36 he paid forVIOXX because of Mercks consumer fraud.

    In order for plaintiffs to be awarded damages, they

    must prove they sustained a loss of money that has acausal nexus to Mercks alleged consumer fraud.

    Plaintiffs loss must be supported by evidence of lossthat it is capable of calculation and not merespeculation but the proof of the amount of loss neednot be precise.

    65

  • 8/12/2019 Jury charge - McDarby v. Merck (2008)

    65/84

    The plaintiffs claim is for what they paid for thepurchase of VIOXX. They claim if the consumer

    fraud had not occurred they wouldn't have purchasedVIOXX. In order to prove a causal nexus plaintiffsmust prove that the consumer fraud had a causal effect

    on their physicians decision to prescribe VIOXXand on Mr. Conas and Mr. McDarbys decision topurchase it, and they sustained an ascertainable loss.

    66

  • 8/12/2019 Jury charge - McDarby v. Merck (2008)

    66/84

    You can award a maximum of $45 to Mr. Cona and amaximus of $3,968.36 to Mr. McDarby for this claim.Any amount you award for this claim will be tripledby the court after the verdict. The defendant will haveto pay reasonable attorney fees and costs for proving

    the consumer fraud in an amount determined by thecourt. This is the penalty for consumer fraud set bythe Legislature. You have to decide the answers to the

    questions based solely on the law and evidence. Youmust accept the law on the penalty for consumer fraudas the law dictates it should be regardless of whetheryou agree with it.

    P DAMAGES 67

  • 8/12/2019 Jury charge - McDarby v. Merck (2008)

    67/84

    P. DAMAGES

    I shall now instruct you on the law governingdamages in the event you decide the liability issue infavor of plaintiffs.

    The fact that I instruct you on damages should not

    be considered as suggesting any view of mine aboutwhich 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 averdict. I am required to provide instructions ondamages in all cases where the trial includes a claimfor damages.

    67

    68

  • 8/12/2019 Jury charge - McDarby v. Merck (2008)

    68/84

    Q. DISABILITY, IMPAIRMENT, LOSS OFTHE ENJOYMENT OF LIFE, PAIN AND

    SUFFERINGIf 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 theharm caused, no more and no less.A plaintiff who is awarded a verdict is entitled to

    fair and reasonable compensation for any permanentor temporary injury resulting in disability to orimpairment of his faculties, health, or ability toparticipate in activities, as a proximate result of the

    defendant's wrongdoing. Disability or impairment

    69

  • 8/12/2019 Jury charge - McDarby v. Merck (2008)

    69/84

    health or ability to participate in activities. It includesthe inability to pursue one's normal pleasure andenjoyment. You must determine how the injury hasdeprived plaintiff of his customary activities as awhole person. This measure of damages is what a

    reasonable person would consider to be adequate andjust under all the circumstances of the case tocompensate plaintiff for his injury and his consequent

    disability, impairment, and the loss of the enjoymentof life.The law also recognizes as proper items for

    recovery, the pain, physical and mental suffering,

    69

  • 8/12/2019 Jury charge - McDarby v. Merck (2008)

    70/84

    71

  • 8/12/2019 Jury charge - McDarby v. Merck (2008)

    71/84

    You are to consider the nature, character andseriousness of any injury or discomfort. You must alsoconsider their duration, as any award you make mustcover the damages suffered by plaintiffs since theheart attacks, to the present time, and even into the

    future if you find that plaintiffs injuries and itsconsequences have continued to the present time orcan 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 andsuffering disability, impairment, loss of enjoyment of

    71

    72

  • 8/12/2019 Jury charge - McDarby v. Merck (2008)

    72/84

    life may be measured in terms of money. The amountis left to your sound discretion. You are to use yourdiscretion to attempt to make the plaintiffs whole, sofar as money can do so, based upon reason and soundjudgment, without any passion, prejudice, bias or

    sympathy. You each know from your commonexperience 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 ofequating the two so as to arrive at a fair and reasonableaward of damages requires a high order of human

    72

    73

  • 8/12/2019 Jury charge - McDarby v. Merck (2008)

    73/84

    judgment. For this reason, the law can provide no

    better yardstick for your guidance than your ownimpartial 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 alump sum of money that will fairly and reasonablycompensate plaintiffs for their pain, suffering,disability, impairment, and loss of enjoyment of life.

    73

  • 8/12/2019 Jury charge - McDarby v. Merck (2008)

    74/84

    T PER QUOD DAMAGES 75

  • 8/12/2019 Jury charge - McDarby v. Merck (2008)

    75/84

    T. PER QUOD DAMAGES

    A wife is entitled to the services of her spouse in

    attending to the household duties, to companionshipand comfort. A plaintiff who is awarded a verdict isentitled to fair and reasonable compensation for any

    loss or impairment of her spouse's services or societybecause of injuries sustained by her husband as aproximate result of the defendant's negligence.Damages may be awarded not only for total loss ofservices but for a worsening of their quality. Thisclaim is for damages from the date of the heart attackto the present and even into the future, if you find

    losses will continue into the future.

  • 8/12/2019 Jury charge - McDarby v. Merck (2008)

    76/84

    77

  • 8/12/2019 Jury charge - McDarby v. Merck (2008)

    77/84

    the eyes of the law, both individuals and corporationsare equal and both are entitled to be judged by thesame standards of fairness and impartiality.

    78

  • 8/12/2019 Jury charge - McDarby v. Merck (2008)

    78/84

    The fact that Merck is a New Jersey corporation orthat the plaintiffs are from New Jersey cannot be afactor in your decision.

    Sympathy for Mr. Cona and/or Mr. McDarby and/ortheir respective wives or family cannot be a factor in

    your decision.The fact that Merck has produced or will produceother drugs that have or will help people cannot be afactor in your decision.

    Wh h di h l ill hi k b79

  • 8/12/2019 Jury charge - McDarby v. Merck (2008)

    79/84

    What the media or other people will think about yourdecision is not something you should consider. The

    fact that there have been other cases or may be othercases in the future involving VIOXX must not affectyour decision.

    You have sworn to decide this case on the evidenceand on the law, and you must focus solely on this andspecifically on each question and then answer eachquestion based on your decision of what the truth isand applying the law as I give it to you.

    V DELIBERATIONS80

  • 8/12/2019 Jury charge - McDarby v. Merck (2008)

    80/84

    V. DELIBERATIONS

    You are not advocates for either party. You are judgesof the facts. Your sole interest is to determine the truthfrom the evidence in the case.

    It is your duty, as jurors, to consult with one anotherand to deliberate with a view to reaching anagreement, if you can do so without compromising

    your individual judgment. Each of you must decide thecase for yourself, but do so only after an impartialconsideration of the evidence with the other jurors.

    W VERDICT 81

  • 8/12/2019 Jury charge - McDarby v. Merck (2008)

    81/84

    W. VERDICT

    Since this is a civil case, any verdict of at least seven

    of the jurors is a legal verdict. Therefore, it is notnecessary 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 eachand every question, and all eight jurors must determineand vote upon each question. It is not necessary thatthe same seven jurors agree upon the answers to allquestions. Whenever at least seven jurors have agreedto any answer, that question has been decided, and youmay move on to consider the remaining questions in

    the case if it is appropriate to do so. All eight jurors

    t ti i t f ll i d lib ti th i i82

  • 8/12/2019 Jury charge - McDarby v. Merck (2008)

    82/84

    must participate fully in deliberating on the remainingquestions. A juror who has been outvoted on any

    question shall continue to deliberate with the otherjurors fairly, impartially, honestly and conscientiouslyto decide the remaining questions. Each juror must

    consider each question with an open mind.

    When at least seven of you have agreed upon averdict, indicate to the attendant that you have reacheda verdict but say nothing more. The attendant willescort you back to the jury box so that the court mayreceive your verdict.

    X COMMUNICATIONS WITH COURT 83

  • 8/12/2019 Jury charge - McDarby v. Merck (2008)

    83/84

    X. COMMUNICATIONS WITH COURT

    If during your deliberations you wish to communicatewith the Court, or you would like me to repeat anypart of the jury instruction, please write your requestor question and give the note to the attendant. I will

    respond as quickly as I can by having you in thecourtroom on the record. However, at no point untilyou reach your final verdict should you indicate to the

    attendant or anyone else what your vote has been onany question before you. That is a matter that onlymembers of the jury should know until you havereached a verdict.

    83

    84

  • 8/12/2019 Jury charge - McDarby v. Merck (2008)

    84/84

    Y. DESIGNATE THE FOREPERSON

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

    84