Complex Litigation

Interviewing Jurors After Trial

By Michael Hoenig - New York Law Journal - March 8, 2010

This article surveys three recent developments. In the Mason v. Smithklinebeecham Corp. case, the U.S. Court of Appeals for the Seventh Circuit wrestles with the question whether a warnings claim regarding the prescription antidepressant drug Paxil is preempted. Although much of the preemption citadel was broken by a U.S. Supreme Court decision last year, a portion was left standing. Mason examines what's left of the preemption defense.

In the Appellate Division's Thompson v. Mather decision, the court confronts the interesting question whether a nonparty deponent's counsel can object or participate at the deposition. The answer may surprise you. And, in the Appellate Division's Shectman v. Wilson decision we see that there may be limits to the common notion that a "doctor is a doctor" when a physician testifies on medical subjects outside of his or her specialty.

Preemption Rejected

Federal preemption of state law claims may occur in three basic ways: (1) when Congress clearly declares its intention to preempt state law, so called "express preemption"; (2) when the structure and purpose of federal law shows Congress' intent to preempt state law, so-called "implied preemption"; and (3) when there is an actual conflict between state and federal law such that it is impossible to obey both, so-called "conflict preemption."

Our March 2009 column, "Drug Warnings Claims Not Preempted,"1 reported about Wyeth v. Levine,2 where the U.S. Supreme Court rejected a preemption defense to a claim that failure to warn adequately about risks involved with various methods of administering the antinausea drug Phenergan caused amputation of the plaintiff's forearm. The high Court rejected the defense of conflict preemption, i.e., that it was impossible for the manufacturer to comply with both state law duties and federal labeling obligations.

The Court also rejected the defense that state lawsuits would undermine Congress' intent to trust labeling decisions to the expertise of the Food and Drug Administration (FDA). The Court observed that state law claims are an important complement to the FDA's task of regulating the safety and effectiveness of all prescription drugs.

However, the Court left an "opening" in Wyeth v. Levine that there could be preemption of a warning claim if the manufacturer met the stringent standard of proving, by "clear evidence," that the FDA would have rejected the change in the warnings label that a plaintiff has proposed. Exactly what constitutes "clear evidence" was not clarified by the Court. As the Seventh Circuit said in a Paxil decision only weeks ago, "[T]he only thing we know for sure is that the evidence presented in Levine did not meet this exacting standard."

The Paxil case, Mason v. Smithklinebeecham Corp.3 is one of the first from federal circuit courts deciding on prescription drug preemption post-Wyeth v. Levine. The Seventh Circuit's opinion says that Levine represented "a sea change in the way courts are to consider issues of federal preemption." The court called it a "changed landscape."

In Mason, a 23-year-old female student pursuing a Masters degree committed suicide two days after she started taking Paxil, a popular antidepressant. Her parents sued the drug manufacturer claiming negligence, among other things, for not warning that taking Paxil increases the risk of suicide, especially among young adults. The trial court granted the manufacturer summary judgment concluding the claims were preempted under federal law because the warnings plaintiff said should have been included about Paxil conflicted with the FDA-approved warning labeling for the drug.

Plaintiff's Suicide

Defendant attributed the suicide to a family history marked by depression and suicide attempts. The student had struggled with depression long before her suicide. She began experiencing depression during winter months. This worsened over time. After a New Year's Eve party, her boyfriend again told her their relationship had no future. Upon hearing that, she told the boyfriend she had prepared a mix of lethal chemicals intending to kill herself. The boyfriend made her promise she would not commit suicide. The depression continued and she then told another boyfriend she intended to kill herself.

Complaining later of cold symptoms, she told her nurse practitioner about her depression and expressed interest in seeing a counselor. She denied having suicidal thoughts. The nurse provided her with samples of Paxil and a prescription. Two days later she instant messaged her first boyfriend who responded that her behavior made it impossible to continue their relationship. She responded, "Farewell, my love" and signed off her computer. Hours later she ingested cyanide and died.

The Seventh Circuit said that, if this case ever gets to a jury, the jurors will consider all the facts and circumstances surrounding decedent's life and suicide. The court, at this point, however, was not concerned with how she or her history should be viewed. Although a jury might well conclude that she committed suicide "without any help from Paxil," the court's focus was on a legal issue—federal preemption.

The appellate court looked to deciphering the "clear evidence" standard the Wyeth v. Levine decision posited might still result in a holding of federal preemption, i.e., whether it could be shown clearly that the FDA would have rejected plaintiff's proposed change in the drug's label. This "journey," said the court, began with understanding how drug manufacturers receive approval to market new prescription drugs and to change a label once it has been approved.

After the FDA approval process is completed and the label's verbiage is fixed, there are regulations governing how and for what reasons a label can later be modified. While it is important for the manufacturer to warn of potential side effects, it is "equally important that it not over warn because over warning can deter potentially beneficial uses of the drug by making it seem riskier than warranted and can dilute the effectiveness of valid warnings." Therefore, warnings may only be added when there is "reasonable evidence of an association of a serious hazard with the drug."4

The court intensively scrutinized the administrative history of Phenergan, the drug involved in the Wyeth v. Levine case where the Supreme Court found no preemption, and compared it to the administrative history of Paxil. The court's objective was to see if there was "clear evidence" that the FDA would have rejected the change in warnings that the plaintiff in Mason urged should have been sought by Paxil's manufacturer. The regulatory history addressed by the court is quite detailed and involves experience with the class of prescription antidepressants, of which Paxil is one, known as "selective serotonin re-uptake inhibitors" or "SSRIs." These drugs operate by controlling the manner in which serotonin is processed by brain cells and thereby improves the mood of patients.

The first SSRI, Prozac, is well-known. Viewers of the popular show, "The Sopranos," will recall that Prozac was the drug the psychiatrist, Dr. Melfi, prescribed for Tony Soprano after telling him "no one needs to suffer from depression with the wonders of modern pharmacology." The court in Mason gave little weight to the Prozac administrative history. Rather it was more concerned with the Paxil regulatory history and the "clear evidence" exception by which preemption could be viable.

Following its review, the court concluded that Paxil's manufacturer "did not meet its burden of demonstrating by clear evidence that the FDA would have rejected a label change warning about the risk of suicide by young adults before Tricia's life came to an end at 23." Consequently, plaintiffs' claims were not preempted and could be litigated. The Mason decision is important because it attempts to fathom the meaning of the "clear evidence" standard the U.S. Supreme Court let stand even as most of the preemption citadel was knocked down.

Nonparty Depositions

Does counsel for a nonparty witness whose videotaped deposition is being taken have a right to object or otherwise participate in the pretrial deposition? According to a recent Appellate Division, Fourth Department, decision, Thompson v. Mather,5 the answer is a resounding "No." What if the nonparty deponent is a treating physician who might yet be sued in the pending action and his counsel is being provided by the doctor's medical malpractice carrier? Can the nonparty physician's counsel object or participate then? The answer is still "No."

In Thompson, plaintiff sued defendant doctors for malpractice in prescribing oral contraceptives which allegedly caused an acute myocardial infarction. In preparation for trial, plaintiff's counsel arranged for two nonparty treating cardiologists to provide videotaped pretrial testimony that, in accordance with 22 NYCRR 202.15, would be presented at trial. During the videotaped deposition, counsel retained by the cardiologists' malpractice insurer interposed objections to the form and relevance of certain questions. Plaintiff's counsel objected to such participation, but the dispute was unresolved. The videotaping was suspended, and plaintiff's counsel moved for an order precluding nonparty counsel's objections except as to privileged matters or abusive questioning.

The trial court directed that plaintiff and defendants consider providing general releases to the nonparty physicians and, if so provided, the videotaped nonparty depositions would proceed with the nonparties' lawyer not permitted to speak. In the event such releases were not provided, then the attorneys for the parties and nonparty witnesses would work out ground rules for the deposition. If the attorneys could not work out such ground rules, plaintiff would not be entitled to take the videotaped depositions and the nonparties would, instead, be subpoenaed to testify at trial. Plaintiff appealed.

The Appellate Division held that "counsel for a nonparty witness does not have a right to object during or otherwise participate in a pre-trial deposition." CPLR 3113(c) provides that examination and cross of deposition witnesses "shall proceed as permitted in the trial of actions in open court." The court discerned "no distinction" between trial testimony and pretrial videotaped deposition testimony to be presented at trial.

The court noted that 22 NYCRR 202.15, which concerns videotaped recordings of civil depositions, refers only to objections by the parties during the course of the deposition.6 Thus, the videotaped testimony could proceed with counsel for the nonparty doctors "precluded from objecting during or otherwise participating in the videotaped depositions." The court ended by sharply criticizing the practice of conditioning videotaping of nonparty depositions to be presented at trials upon the provision of general releases to the nonparties. This practice was considered "repugnant to the fundamental obligation of every citizen to participate in our civil trial courts and to provide truthful trial testimony when called to the witness stand."

Physician Experts

One of the enduring general notions in New York trial courts has been the premise that duly licensed physicians in the state can opine as experts regarding medical conditions and sequelae even if the condition or mode of treatment is not within the testifier's specialty. The common notion is that "a doctor is a doctor" and, since he or she had a medical education, training and the ability to keep abreast of developments in the medical field is sufficient qualification to testify as an expert. Being somewhat of a fish out of water, so to speak, such as an internal medicine practitioner testifying about surgery, is not a disqualifier. It may be grounds for cross-examination but does not bar the evidentiary gate. So goes the popular notion.

Recently, in Shectman v. Wilson,7 the Appellate Division, Second Department, seems to have injected some doubt into the sanctity of the "doctor is a doctor" talismanic concept. This was a medical malpractice action for causing an infant's developmental disabilities. The defendant physicians moved for summary judgment.

Plaintiff responded with the affidavit of a physician specializing in obstetrics and gynecology who contested causation. However, the affidavit of plaintiff's expert did not mention whether the physician had any specific training or expertise in pediatrics, psychiatry, or particularized knowledge as to the relevant disabilities of the infant plaintiff. The affidavit did not indicate that the doctor had familiarized himself with the relevant literature or otherwise declare how he was, or became, familiar with the applicable standards of care in the specialized area of practice involved.

The Appellate Division, quoting prior case law, said: "While it is true that a medical expert need not be a specialist in a particular field in order to testify regarding accepted practices in that field…the witness nonetheless should be possessed of the requisite skill, training, education, knowledge or experience from which it can be assumed that the opinion rendered is reliable." Thus, when a physician opines "outside his or her area of specialization, a foundation must be laid tending to support the reliability of the opinion rendered." Here the plaintiff's expert failed to lay the requisite foundation for his asserted familiarity with pediatric developmental disabilities and, thus, his affidavit was deemed of no probative value.

The court appears to be saying that "reliability," a foundational requirement for allowing all expert opinions, trumps any automatic "doctor is a doctor" premise. Thus, especially where a physician becomes a testifying "fish out of water," i.e., opining outside his area of specialization, foundational reliability must be shown. This clarification could be a springboard for all sorts of challenges to "fish out of water" doctors who testify.

With this toughening stance on the need for a showing of physician reliability, the recent Appellate Division decision in Howard v. Espinosa8—that a physical therapist could not opine about an accident's aggravation of plaintiff's preexisting spinal stenosis and arthritis—seems almost superfluous. By now, it should be well known that a physical therapist "cannot by definition diagnose or make prognos[e]s and is incompetent to determine the permanency or duration of a physical limitation."

Michael Hoenig is a member of Herzfeld & Rubin.

Endnotes

1. NYLJ, March 9, 2009, p. 3.
2. 555 U.S.—, 129 S. Ct. 1187, 173 L. Ed. 2d 51 (2009).
3. 2010 WL 605922 (7th Cir. Feb. 23, 2010).
4. Mason, Id. at *3.
5. 2010 NY Slip Op 01239 (App. Div. 4th Dept., Feb. 11, 2010).
6. See 22 NYCRR 202.15[g][1], [2], titled "Filing and Objections."
7. 2009 NY Slip Op 09208 (2d Dept. Dec. 8, 2009).
8. 2010 NY Slip Op 00759 (3d Dept. Feb. 4, 2010).

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