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
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.
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
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
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.
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
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
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
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.
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
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
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
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.
1. NYLJ, March 9, 2009,
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], , 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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