Case: 09-10983 Document: 00511258321 Page: 1 Date Filed: 10/08/2010
IN THE UNITED STATES COURT OF APPEALS
FOR THE FIFTH CIRCUIT United States Court of Appeals
Fifth Circuit
FILED
October 8, 2010
No. 09-10983 Lyle W. Cayce
Clerk
MARTHA PUSTEJOVSKY,
Plaintiff-Appellant, Cross-Appellee,
v.
PLIVA, INC.,
Defendant-Appellee, Cross-Appellant.
Appeal from the United States District Court
for the Northern District of Texas
Before STEWART, PRADO, and ELROD, Circuit Judges.
JENNIFER WALKER ELROD, Circuit Judge:
Martha Pustejovsky appeals the district court’s summary judgment on her
products-liability claims in favor of PLIVA, Inc., a manufacturer of the generic
drug metoclopramide. Specifically, she challenges the district court’s conclusion
that, under the learned-intermediary doctrine, Pustejovsky failed to present
evidence showing that the inadequate warning was the producing cause of her
injuries. Because Pustejovsky offered no summary-judgment evidence that her
doctor’s significant misunderstanding of the risks of metoclopramide resulted
from PLIVA’s defective warnings, we AFFIRM.
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I.
Martha Pustejovsky was hospitalized in January 2002 for an episode of
severe gastric problems and was diagnosed as having gastroesophageal reflux
disease. Upon discharge, she received a thirty-day prescription for
metoclopramide (“MCP”). Pustejovsky underwent her follow-up care with
internist Dr. Wendi Collini. Dr. Collini had her continue on a regimen of
Protonix, Carafate, and MCP, which effectively controlled her symptoms. In
November 2002, Pustejovsky returned to Dr. Collini to refill her prescription for
MCP, and Dr. Collini continued to prescribe that medication for her until
February 2005.
Following that three-year period, Pustejovsky began to experience tardive
dyskinesia (“TD”)—a neurological disorder causing involuntary, spasm-like
movements—in her tongue and mouth. At the time Pustejovsky was taking
MCP, the product label warned that “[b]oth the risk of developing [TD] and the
likelihood that it will become irreversible are believed to increase with the
duration of treatment and the total cumulative dose.” A package insert also
warned that “[e]xtrapyramidal symptoms, manifested primarily as acute
dystonic reactions, occur in approximately 1 in 500 patients treated with the
usual adult dosage of 30 to 40 mg/day of metoclopramide” (the “1/500 Warning”)
and that a duration of therapy “longer than 12 weeks has not been evaluated
and cannot be recommended.”
After being diagnosed with TD, Pustejovsky brought this products-liability
lawsuit in state court, which PLIVA subsequently removed to federal court.
Pustejovsky alleged that PLIVA failed to adequately warn doctors and patients
of the true magnitude of the risks associated with the long-term use of MCP. In
the course of discovery, the parties deposed Dr. Collini. Dr. Collini testified that
she did not recall ever reading the package insert for the drug or consulting the
Physician’s Desk Reference, which reprints the information from the
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manufacturers’ labels. Similarly, she did not recall learning of possible side
effects of MCP use through discussions with other physicians or at continuing-
education seminars she had attended. Nevertheless, from her training and
experience, she understood that TD was a possible, rare side effect of the drug.
“What I mean as rare,” she testified, “would be very infrequent, maybe never see
during your practice. If I had to give you a number, I would say rare would be,
you know, one in a million.” She acknowledged that credible information that
the risk were higher would affect her prescribing practices. Even a one-percent
risk of TD “would be a consideration.”
In June 2007, PLIVA moved for summary judgment, arguing that:
(1) Pustejovsky could not establish any of the statutory exceptions to the
presumption of nonliability under Texas Civil Practice & Remedies Code
§ 82.007; (2) federal law preempts the exception in § 82.007(b)(1), which permits
a plaintiff to rebut the presumption by presenting evidence that the defendant
withheld from or misrepresented to the United States Food and Drug
Administration (“FDA”) material and relevant required information; and (3) the
Drug Price Competition and Patent Term Restoration Act preempted her claims.
The district court denied PLIVA’s motion in November 2007.
In January 2009, PLIVA again moved for summary judgment, reasserting
the grounds raised in its first motion and arguing, for the first time, that
Pustejovsky had failed to produce evidence sufficient to show that the
inadequate warning was the producing cause of her injuries, as required by the
learned-intermediary doctrine. On September 4, 2009, the district court granted
PLIVA’s second motion for summary judgment, reasoning that the learned-
intermediary doctrine barred recovery. According to the court, the unrefuted
evidence demonstrated that Dr. Collini “was aware of the possible risk involved
with MCP use but decided to prescribe it” nevertheless. In making that decision,
the court observed, Dr. Collini did not rely on PLIVA’s warning, but rather on
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“what she learned in medical school, continuing medical education, her own
experience, and the experience of her colleagues.” Thus, the inadequate warning
“had no impact on her decision to prescribe MCP” and was not the producing
cause of Pustejovsky’s injuries.
In February 2009, while PLIVA’s second summary-judgment motion was
still pending, the FDA announced that it would require changes to the warning
on MCP’s label, as well as the addition of a black-box warning that “[c]hronic
treatment with metoclopramide can cause tardive dyskinesia, a serious
movement disorder that is often irreversible. . . . Prolonged treatment (greater
than 12 weeks) with metoclopramide should be avoided in all but rare cases
where the therapeutic benefit is thought to outweigh the risks to the patient of
developing tardive dyskinesia.” The FDA also directed that the “Warning”
section of the label include the following information: “Although the risk of
tardive dyskinesia (TD) with metoclopramide has not been extensively studied,
one published study reported a TD prevalence of 20% among patients treated for
at least 3 months.” Further, the FDA directed Reglan, the manufacturer of the
brand-name drug, to develop a risk-mitigation strategy for MCP. The revised
warnings did not, however, include any change to the 1/500 Warning, which still
appears on the package insert.
Shortly following the FDA’s announcement, Pustejovsky requested and
received permission to file supplemental briefing regarding its effect on PLIVA’s
summary-judgment motion. Pustejovsky did not, however, seek to reopen
discovery or obtain any additional information from Dr. Collini while the motion
was pending. In September 2009—just after the district court decided the
motion and nearly seven months after the FDA’s announcement—Pustejovsky
filed a motion requesting that the district court reconsider its order, vacate the
judgment, and grant her leave to redepose Dr. Collini in light of the FDA’s
intervening imposition of a black-box warning on the MCP label. The district
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court denied her motion for reconsideration and additional discovery. This
appeal followed.
Pustejovsky challenges the district court’s finding that the inadequate
warning was not the producing cause of her injuries. She also contends that the
district court erred in denying her request to redepose Dr. Collini in light of the
black-box warning mandated by the FDA in 2009. PLIVA cross-appeals,
challenging the district court’s rejection of its preemption arguments.
II.
We first address PLIVA’s argument that the Drug Price Competition and
Patent Term Restoration Act—also known as the Hatch-Waxman
Amendments—preempts Pustejovsky’s claim. According to PLIVA, because a
generic manufacturer has no ability to unilaterally change its labeling and
cannot provide different or additional warnings without prior FDA approval, it
could not comply with both the Amendments and its state law duties. Our
precedent squarely forecloses this argument, however. See Demahy v. Actavis,
Inc., 593 F.3d 428, 447-49 (5th Cir. 2010) (holding that the Hatch-Waxman
Amendments do not federally preempt state-law failure-to-warn claims against
a manufacturer of a generic drug). Accordingly, we hold that Pustejovsky’s
claims are not preempted.
Turning to Pustejovsky’s appeal, we review a district court’s summary
judgment de novo. LeMaire v. La. Dep’t of Transp. & Dev., 480 F.3d 383, 386
(5th Cir. 2007). Summary judgment is appropriate when “the pleadings, the
discovery and disclosure materials on file, and any affidavits show that there is
no genuine issue as to any material fact and that the movant is entitled to
judgment as a matter of law.” Fed. R. Civ. P. 56(c); Breaux v. Halliburton Energy
Servs., 562 F.3d 358, 364 (5th Cir. 2009). “A genuine issue of material fact exists
if a reasonable jury could enter a verdict for the non-moving party.” Brumfield
v. Hollins, 551 F.3d 322, 326 (5th Cir. 2008) (citation omitted). We take all the
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facts and evidence in the light most favorable to Pustejovsky, the nonmoving
party. Breaux, 562 F.3d at 364.
Under Texas law, a manufacturer must instruct consumers as to the safe
use of its product and warn consumers of dangers of which it has actual or
constructive knowledge at the time the product is sold. See Pavlides v. Galveston
Yacht Basin, Inc., 727 F.2d 330, 338 (5th Cir. 1984). But where a plaintiff sues
the manufacturer of a prescription drug for failing to adequately warn of the
drug’s effects, Texas courts employ the learned-intermediary doctrine. See Alm
v. Aluminum Co. of Am., 717 S.W.2d 588, 591 (Tex. 1986). Under the doctrine,
the manufacturer may rely on the doctor—the learned intermediary—to pass on
its warnings. Thus, so long as the drug manufacturer “properly warns a
prescribing physician of the dangerous propensities of its product, the
manufacturer is excused from warning each patient who receives the drug.” Id.
If, on the other hand, “the warning to the intermediary is inadequate or
misleading, the manufacturer remains liable for injuries sustained by the
ultimate user.” Id. at 592 (citations omitted).
An inadequate warning alone is not enough, however. The learned-
intermediary doctrine also requires that the inadequate warning was a
“producing cause” of the plaintiff’s injuries. See McNeil v. Wyeth, 462 F.3d 364,
372 (5th Cir. 2006). Therefore, “a plaintiff who complains ‘that a prescription
drug warning is inadequate must also show that the alleged inadequacy caused
her doctor to prescribe the drug for her.’”1 Id. (quoting Porterfield v. Ethicon,
Inc., 183 F.3d 464, 468 (5th Cir. 1999)); accord Stewart v. Janssen
Pharmaceutica, 780 S.W.2d 910, 912 (Tex. App.—El Paso 1989, writ denied).
1
“Where the physician would have adequately informed a plaintiff of the risks of a
disease, had the label been sufficient, but fails to do so on that account, and where the plaintiff
would have rejected the drug if informed, the inadequate labeling could be a ‘producing’ cause
of the injury, because it effectively sabotages the function of the intermediary.” McNeil, 462
F.3d at 373 (footnote omitted).
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Where the evidence demonstrates that “‘the physician was aware of the possible
risks involved in the use of the product but decided to use it anyway,’” the
plaintiff cannot show that the inadequacy of the warning was a producing cause.
Ackermann v. Wyeth Pharms., 526 F.3d 203, 208 (5th Cir. 2008) (quoting
Porterfield, 183 F.3d at 468). But “[e]ven if the physician is not aware of a risk,
the plaintiff must show that a proper warning would have changed the decision
of the treating physician, i.e., that but for the inadequate warning, the treating
physician” would not have prescribed the product. Id. (citation and internal
quotation marks omitted).
Contrary to the district court’s observation, the record evidence refutes the
notion that Dr. Collini was aware of the risks of prescribing MCP for long-term
use. In Dr. Collini’s deposition, she stated that she believed TD to be a
“possible[,] rare side effect” of MCP treatment. When pressed to elaborate on her
definition of rare in this context, she responded with “very infrequent,” or “one
in a million”—so infrequent that a doctor might “never see” the side effect during
her practice. Further, Dr. Collini testified that, had she been aware of even a
one-percent risk of developing TD with use, such information would have
affected her prescribing practices. This testimony indicates that Dr. Collini
significantly underestimated the danger of long-term MCP usage, as reflected
by the new FDA prescription warnings. Her testimony that only “one in a
million” MCP users might acquire TD in no way reflects the twenty-percent
prevalence rate found among patients treated for at least three months.2 Nor
2
PLIVA counters that Dr. Collini’s statements do not reflect any misunderstanding of
the risks, relying on the fact that the MCP product insert still bears the 1/500 Warning, even
after the FDA-mandated changes. It further argues that a study finding a prevalence rate of
twenty percent does not necessarily invalidate the 1/500 Warning, which it claims reflects an
incidence rate. We need not resolve this question, however, as the record contains sufficient
evidence to create a genuine issue of material fact as to whether Dr. Collini was unaware of
the risk. Indeed, three years before the FDA’s action, we held that a “jury could find that the
risk of developing [extrapyramidal symptoms] from long-term use was not just higher, but that
it was ‘significantly’ higher” than the 1/500 Warning suggested. McNeil, 462 F.3d at 370.
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does it reflect an appreciation of the magnitude of the risk of developing TD,
which prompted the FDA to caution against prolonged MCP treatment in “all
but rare cases.”
Because Dr. Collini was not fully aware of the risk of TD, we proceed to
consider whether Pustejovsky has put forth summary-judgment evidence to
show that a proper warning would have changed Dr. Collini’s decision to
prescribe MCP—that is, whether PLIVA’s inadequate warning was the
producing cause of her injuries. Pustejovsky has not carried her burden. As
Pustejovsky admits, Dr. Collini did not recall ever reading the package insert for
the drug or consulting the Physician’s Desk Reference. Her lack of memory, of
course, does not preclude the possibility that she had read these materials, but
neither can it sustain Pustejovsky’s burden.
Lacking any evidence that Dr. Collini was aware of PLIVA’s warnings,
Pustejovsky instead speculates about other ways an adequate warning might
have reached Dr. Collini and altered her decision. She suggests, for example,
that a modification to MCP’s warning label might have come up in conversations
with other physicians or been discussed at a continuing-education seminar.
Certainly, these scenarios are possible. Ultimately, however, without any
summary-judgment evidence to support them, they remain nothing more than
possibilities. Although Dr. Collini did testify that she attended continuing-
education seminars where MCP was discussed as a treatment option, there is no
evidence of the content of these lectures, and Dr. Collini did not recall whether
side effects were ever discussed at any seminar she had attended. Neither did
she recall discussing MCP’s side effects with any of her colleagues. While
Pustejovsky can imagine any number of scenarios to fill the gaps in Dr. Collini’s
memory, she has provided evidentiary support for none of them. Accordingly,
Pustejovsky fails to demonstrate a genuine issue of material fact regarding
causation. See Brown v. City of Houston, 337 F.3d 539, 541 (5th Cir. 2003)
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(“Unsubstantiated assertions . . . and unsupported speculation are not sufficient
to defeat a motion for summary judgment.” (citations omitted)). As Pustejovsky
cannot demonstrate that PLIVA’s inadequate warning was the producing cause
of her injury, the learned-intermediary doctrine bars her recovery.
Pustejovsky also challenges the district court’s refusal to allow her to
redepose Dr. Collini about the effect that the FDA’s action in February 2009
might have had on her prescribing practices. We review a district court’s denial
of a discovery request for abuse of discretion. See Beattie v. Madison Co. Sch.
Dist., 254 F.3d 595, 605 (5th Cir. 2001). While PLIVA’s second summary-
judgment motion was still pending, Pustejovsky sought and received permission
from the court to file supplemental briefing concerning the effect of the FDA’s
new MCP-labeling requirements. During that time, Pustejovsky never sought
additional discovery from Dr. Collini concerning the FDA’s actions. Not until
after the district court granted summary judgment—about seven months after
the FDA’s actions—did Pustejovsky first raise the necessity of a second
deposition with the court. Under the circumstances, we cannot say that the
district court abused its discretion in denying her request.
III.
Although Pustejovsky’s claims are not preempted by the Hatch-Waxman
Amendments, she has failed to produce sufficient evidence that PLIVA’s
inadequate warnings were the producing cause of her injuries. Likewise,
Pustejovsky has not shown that the district court abused its discretion in
refusing to reopen discovery. In light of our disposition of Pustejovsky’s
arguments, we need not reach PLIVA’s remaining preemption argument on
cross-appeal. We therefore AFFIRM the summary judgment in favor of PLIVA.
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