Karen Leigh Hubbard v. Bayer Healthcare Pharmaceuticals Inc.

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[PUBLISH]
IN THE UNITED STATES COURT OF APPEALS
FOR THE ELEVENTH CIRCUIT
________________________
No. 19-13087
________________________
D.C. Docket No. 1:18-cv-05648-WMR
KAREN LEIGH HUBBARD,
MICHAEL L. HUBBARD,
Plaintiffs - Appellants,
versus
BAYER HEALTHCARE PHARMACEUTICALS
INC.,
BAYER PHARMA AG,
Defendants - Appellees,
TEVA PHARMACEUTICALS USA INC.,
Defendant.
________________________
Appeal from the United States District Court
for the Northern District of Georgia
________________________
(December 22, 2020)
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Before GRANT and MARCUS, Circuit Judges, and AXON,* District Judge.
MARCUS, Circuit Judge:
This tragic case began when Karen Hubbard suffered a catastrophic stroke.
The stroke left her paralyzed and her cognitive functions severely impaired. Her
oral contraceptive, Beyaz--a drug known to increase the risk of blood clots that can
cause strokes--may have been to blame. We must decide whether Karen Hubbard
and her husband Michael Hubbard have adduced sufficient evidence to survive
summary judgment on their claims against the manufacturers of Beyaz, Bayer
Pharma AG and Bayer HealthCare Pharmaceuticals Inc. (together, “Bayer”), for
failing to provide an adequate warning of the risk of stroke.
We hold they have not. Georgia’s learned intermediary doctrine controls
this diversity jurisdiction case. That doctrine imposes on prescription drug
manufacturers a duty to adequately warn physicians, rather than patients, of the
risks their products pose. But a plaintiff claiming a manufacturer’s warning was
inadequate bears the burden of establishing that an improved warning would have
caused her doctor not to prescribe her the drug in question. The Hubbards have not
met this burden. The prescribing physician testified unambiguously that even with
the benefit of the most up-to-date risk information about Beyaz, he considers his
*
Honorable Annemarie Axon, United States District Judge for the Northern District of Alabama,
sitting by designation.
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decision to prescribe Beyaz to Karen Hubbard to be sound and appropriate. Under
our binding precedent interpreting Georgia law, the Hubbards, therefore, cannot
recover. Though the Hubbards have suffered greatly, the law plainly entitles Bayer
to summary judgment. We affirm the judgment of the district court.
On October 30, 2012, Michael Hubbard found his 41-year-old wife, Karen
Hubbard, unresponsive. She had suffered a catastrophic stroke caused by a blood
clot to her brain--a venous sinus thrombosis, a type of venous thromboembolism
(“VTE”). The VTE caused grievous, permanent injury: brain damage, paralysis,
and profound loss of cognitive functioning. At the time of her stroke, Karen
Hubbard had been taking Beyaz, a birth control pill manufactured by defendant
Bayer. While she first received a prescription for Beyaz on December 27, 2011,
Karen Hubbard had been taking similar Bayer birth control products since 2001.
A birth control pill, also known as a combination oral contraceptive, or
“COC,” typically consists of two synthetic hormone components: estrogen and one
of several progestins (also referred to as progesterones or progestogens). When
first developed, COC pills delivered a high dose of estrogen and one of two
progestins: norethindrone or ethynodiol. After studies in the 1980s determined that
higher doses of estrogen posed an increased risk of VTE, or blood clots,
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pharmaceutical companies generally developed second-generation COCs that
featured lower levels of estrogen. To further “decrease the cardiovascular side
effect profile,” pharmaceutical companies produced a third generation of COCs
which paired a low dose of estrogen with one of three progestins: desogestrel,
gestodene, or norgestimate. In the 1990s, when further studies revealed that these
progestins carried an elevated risk of VTE, manufacturers revised their product
labels for these COCs and focused on developing pills with a new, “fourth
generation” progestin: drospirenone, or DRSP.
Bayer first sought the FDA’s approval to use DRSP in a birth control pill on
November 17, 1993. Today, Bayer markets Yasmin, YAZ, and Beyaz. All are
fourth-generation COCs that combine an estrogen, ethinyl estradiol (“EE”), with
DRSP. Each pill of Yasmin, which became available in the United States in 2001,
contains 30 micrograms of EE and three milligrams of DRSP. In 2006, the FDA
approved YAZ, which combines a lower dose of estrogen (20 micrograms) with
the same three milligrams of DRSP. Bayer introduced Beyaz in 2010. A Beyaz
pill and a YAZ pill share the same hormonal profile--20 micrograms of EE and 3
milligrams of DRSP. The sole difference between the two pills is that Beyaz
includes a supplement, folate, which “has been shown to be beneficial in [fetal]
neuro development.”
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The medical community has been aware since the 1960s that COCs are
associated with an increased risk of blood clots. But the magnitude of that risk
varies depending on the make-up of particular types of pills. A higher dose of
estrogen is “a clear risk factor”; indeed, “when subsequent COC’s had their
estrogen doses reduced, a corresponding decrease in the incidence of VTE disease
occurred.” Similarly, different progestins carry different VTE risks. Thus, for
example, the third-generation progestins desogestrel and gestodene nearly doubled
the risk of VTE from COCs in the second generation. This elevated risk found its
way onto third-generation warning labels; these labels “have wording specifying
an increased risk associated with their products.”
Like third-generation COCs, fourth-generation pills--those containing
DRSP--“carry a significantly greater risk of VTE relative to” second-generation
COCs. Bayer thus includes information about the nature and extent of the VTE
risk on labels for its DRSP-containing products. The 2010 Beyaz warning label,
the label in place at the time of Karen Hubbard’s first and final Beyaz prescription
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on December 27, 2011, warned that COCs generally pose a risk of VTEs 1 and
summarized studies on the VTE risks associated with DRSP-containing COCs in
particular. The label noted that some studies concluded the risks of DRSP pills are
comparable to those of other pills, while other studies showed Yasmin increased
the risk of VTE relative to certain non-DRSP COCs. 2 The label provided reasons
1
In relevant part, the label read:
2
In relevant part, the label read:
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to doubt the latter studies: one of them included only a small number of Yasmin
users and the other included women of various risk levels.
In May 2011, the FDA released a drug safety communication announcing an
“ongoing safety review of birth control pills that contain drospirenone.” The FDA
explained that its European counterpart, the European Medicines Agency, was
“updating the product information on oral contraceptives containing drospirenone
and ethinyl estradiol regarding the risk of venous thromboembolism after [its]
review of all available data, including the same newly published data [the] FDA is
reviewing.” In September 2011, the FDA put out a second announcement,
“informing the public that” while it had “not yet reached a conclusion,” it
“remain[ed] concerned . . . about the potential increased risk of blood clots with the
use of drospirenone-containing birth control pills.” The preliminary results of an
FDA-funded study suggested “an approximately 1.5-fold increase in the risk of
blood clots for women who use drospirenone-containing birth control pills
compared to users of other hormonal contraceptives.” On October 27, 2011--two
months before Karen Hubbard received her final Beyaz prescription--the FDA
announced that it was “continuing its review of the potential increased risk of
blood clots with the use of birth control pills containing drospirenone.”
Then, on April 10, 2012, the FDA announced that it had “completed its
review of recent observational (epidemiologic) studies regarding the risk of blood
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clots in women taking drospirenone-containing birth control pills.” The FDA
“concluded that drospirenone-containing birth control pills may be associated with
a higher risk for blood clots than other progestin-containing pills.” As a result of
this finding, the FDA added “information about the studies to the labels of
drospirenone-containing birth control pills,” including Beyaz, YAZ, and Yasmin.
These “revised drug labels” relayed “that some epidemiologic studies reported as
high as a three-fold increase in the risk of blood clots for drospirenone-containing
products when compared to products containing levonorgestrel or some other
progestins, whereas other epidemiological studies found no additional risk of blood
clots with drospirenone-containing products.” Thus, in April 2012, Bayer revised
its Beyaz warning label to include, among other information, the possibility of up
to a three-fold relative increase in blood clot risk (“the risk ranged from no
increase to a three-fold increase”). 3 The label included graphics demonstrating that
3
In relevant part, the label read:
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studies had reached varying estimates regarding the comparative VTE risk of
DRSP-containing COCs. 4 The warning noted that VTE risk is highest during
4
In relevant part, the label read:
...
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the first year of COC use and that the risk of VTE from pregnancy is greater than
the risk from using oral contraceptives. 5
Karen Hubbard began taking Bayer’s COCs in approximately 2001. She
took Yasmin from 2001 until May 2006, when she began taking YAZ. Though her
prescribing physician, Dr. Lawrence Rowley, didn’t know for sure why she
changed her prescription, he thought the change would have been made because
YAZ contains a lower dose of estrogen, and his office “always prefer[s] to use the
lower-dose pills.” Karen Hubbard remained on YAZ until December 2011, when
5
In relevant part, the label read:
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she began taking Beyaz. Though Dr. Rowley again did not know for sure what
explained the change, he thought it was likely due to the folate that Bayer added to
Beyaz. Karen Hubbard had been taking Beyaz for a little less than a year when she
suffered a stroke in October 2012.
On January 17, 2014, Karen and Michael Hubbard sued Bayer in the United
States District Court for the Southern District of Illinois as part of a multidistrict
litigation proceeding relating to the manufacture, marketing, and sale of certain
oral contraceptives. They alleged that, as a direct result of her use of Bayer’s birth
control pills, including Yasmin, YAZ, Beyaz, and their generic equivalents, Karen
suffered a VTE which caused “an intracerebral hemorrhage” and “life-
threatening,” “catastrophic injuries.” The Hubbards sought compensatory and
punitive damages for negligence; strict liability based on a design defect; strict
liability based on a defective warning; negligence based on a failure to issue a
timely post-sale warning; fraud; breach of warranty; and loss of consortium. 6
On August 15, 2018, with the matter still pending in the Southern District of
Illinois, Bayer moved for summary judgment. According to Bayer, the undisputed
6
The Hubbards’ complaint also named as a defendant generic manufacturer Teva
Pharmaceuticals USA, Inc. After Teva answered, the Hubbards stipulated to the dismissal of
their claims against Teva with prejudice.
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facts showed that Karen Hubbard’s prescribing physician, Dr. Rowley, “had actual
knowledge of the risk that” the Hubbards contend Bayer failed to disclose. Dr.
Rowley, Bayer claimed, “provided explicit, uncontroverted testimony that he was
aware of the potentially higher risk of VTE [associated with DRSP-containing
COCs] long before he wrote” Karen Hubbard’s “final prescription.” Thus, “no
failure to disclose any information in the warning label caused Dr. Rowley to
prescribe Beyaz to” Karen Hubbard, since “he was already well aware of the
alleged risks.” Bayer argued that the failure-to-warn claims therefore failed, and
so did the others: the Hubbards had not raised a triable issue of fact on causation.
The Hubbards opposed the motion. They said that the warnings available to
Dr. Rowley in December 2011 were inadequate, including because they lacked the
information made available in the 2012 update to the Beyaz label. The Hubbards
further claimed that Dr. Rowley’s testimony on his December 2011 knowledge of
the increased VTE risks associated with Beyaz was “equivocal.” And Bayer’s new
warning “changed the way he counseled patients.” Without unequivocal testimony
from Dr. Rowley that he would have prescribed Beyaz to Karen Hubbard after
reading an appropriate warning, the Hubbards offered, summary judgment was not
warranted.
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With Bayer’s summary judgment motion still pending, the case was
transferred to the Northern District of Georgia because the parties had completed
generic discovery, obviating the need for multidistrict coordination.
After further briefing, the district court in the Northern District of Georgia
granted Bayer’s motion for summary judgment, reasoning that the Hubbards could
not prove Bayer’s inadequate warning caused Karen Hubbard’s injury. “Without
evidence that a different warning would have changed the prescribing decision,”
the district court wrote, the Hubbards could not show that Karen Hubbard’s injury
“would have been avoided but for Bayer’s alleged failure to warn.” The district
court agreed with Bayer that Dr. Rowley’s testimony established “that no different
warning would have changed the prescribing decision and avoided the injury.”
The Hubbards timely appealed the district court’s order.
We review a district court’s grant of summary judgment de novo, viewing
the evidence and drawing all reasonable inferences in the light most favorable to
the nonmoving party. Tesoriero v. Carnival Corp., 965 F.3d 1170, 1177 (11th Cir.
2020). Summary judgment is appropriate only when “there is no genuine dispute
as to any material fact and the movant is entitled to judgment as a matter of law.”
Fed R. Civ. P. 56(a). “Where the record taken as a whole could not lead a rational
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trier of fact to find for the non-moving party, there is no genuine issue for trial.”
Tesoriero, 965 F.3d at 1177 (quotation marks and citation omitted).
The parties agree that all relevant events took place in Georgia and that, in
this diversity action, Georgia law applies to the Hubbards’ failure to warn claim. 7
In the typical failure-to-warn product liability case, “Georgia law insists that a
plaintiff show that the defendant had a duty to warn [the plaintiff], that the
defendant breached that duty, and that the breach proximately caused the plaintiff’s
injury.” Dietz v. Smithkline Beecham Corp., 598 F.3d 812, 815 (11th Cir. 2010).
But this general standard applies somewhat differently when the product at issue is
a prescription drug. Under Georgia’s learned intermediary doctrine, the drug
manufacturer “does not have a duty to warn the patient of the dangers involved
with the product, but instead has a duty to warn the patient’s doctor.” Id. (quoting
McCombs v. Synthes (U.S.A.), 587 S.E.2d 594, 594 (Ga. 2003)). “The rationale
for [this] doctrine is that the treating physician is in a better position to warn the
patient than the manufacturer, in that the decision to employ prescription
medication involves professional assessment of medical risks in light of the
physician’s knowledge of a patient’s particular need and susceptibilities.” Id.(quoting McCombs, 587 S.E.2d at 594) (alteration accepted).
7
At oral argument in district court, the Hubbards agreed that because each of their claims
requires a triable issue of fact on causation, all claims rise or fall with their failure-to-warn
claims. They do not argue otherwise on appeal.
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For purposes of summary judgment, Bayer assumes that its warning was
inadequate. But that does not end our analysis. “If the warning is inadequate, or
merely presumed to be, the plaintiff must demonstrate that the deficient warning
proximately caused the alleged injury.” Id. at 816. To establish proximate cause,
the plaintiff must prove a causal link between the inadequate warning and the
prescription decision. Thus, “in cases where a learned intermediary has actual
knowledge of the substance of the alleged warning and would have taken the same
course of action even with the information the plaintiff contends should have been
provided, courts typically conclude that the causal link is broken and the plaintiff
cannot recover.” Id. (internal quotation marks and citation omitted; alteration
accepted).
While proximate cause is an issue of fact normally reserved for the jury,
Georgia law provides that the court may decide questions of proximate cause as a
matter of law when the evidence is “plain and undisputed.” Sanders v. Lull Int’l,
Inc., 411 F.3d 1266, 1271 (11th Cir. 2005) (quoting Ont. Sewing Mach. v. Smith,
572 S.E.2d 533, 536 (Ga. 2002)).
On this record, we hold that even when viewed in the light most favorable to
the Hubbards, the evidence does not raise a genuine issue of material fact and that
Bayer is entitled to final summary judgment as a matter of law. Dr. Rowley
“provided explicit, uncontroverted testimony that, even when provided with the
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most current research and FDA mandated warnings,” as well as the information
found in Bayer’s updated 2012 Beyaz label, he would still have prescribed Beyaz
to Karen Hubbard. See Dietz, 598 F.3d at 816. Moreover, Dr. Rowley’s testimony
indicates that he already knew in December 2011 what he considered to be
substantially the same risk information later included in the 2012 Beyaz label. The
causal chain is therefore broken, and the Hubbards cannot establish proximate
cause.
Most importantly, Dr. Rowley unambiguously testified that he views his
December 2011 decision to prescribe Beyaz to Karen Hubbard as an appropriate
one, even now that he knows exactly what was included in the 2012 label. At his
deposition, after having discussed the risks listed in the 2012 Beyaz label as well as
risks discussed in previous studies and FDA warnings, Dr. Rowley was asked “Do
you believe today that your decision to prescribe Beyaz for Mrs. Hubbard was
appropriate?” He responded, “Yes.”
Were this not enough, Dr. Rowley’s response to the 2012 Beyaz label update
further indicates that knowledge of that information in December 2011 would not
have changed his decision to prescribe Beyaz to Karen Hubbard. Dr. Rowley
testified that he did not consider the information contained in the 2012 Beyaz label
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to be significant enough to change his prescribing practices for patients already on
Beyaz or similar pills:
Q: Okay. I believe you said you recall that there may have been a new
label issued sometime in 2012.
A: The FDA alert.
Q: When that happened, did you alert your patients?
A: No.
Q: Why not?
A: Once again, the relative risk that was discussed was actually very
small versus the fact that people have been on it for--have taken it,
they’re happy with it, that they have not had any complications with it.
So the relative risk of trying to pull everybody back as soon as you hear
a--an alert was so small that it really just didn’t justify it, in my mind.
Q: Is it fair to conclude that the benefits of Beyaz outweigh the risk in
patients who have already been taking it for some time with no
problems?
...
A: Yes.
Indeed, Dr. Rowley testified that he did not change “the way [he] prescribed birth
control to patients . . . after April of 2012,” and he still prescribes Beyaz, YAZ, and
Yasmin (though he more frequently prescribes birth control pills containing
progestins other than DRSP).
Dr. Rowley’s testimony about his general prescribing practices bolsters still
further the ultimate conclusion that he would have prescribed Beyaz to Karen
Hubbard in December 2011 even if he had the 2012 Beyaz label in hand. Dr.
Rowley explained that his standard practice is to continue a patient who has been
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taking a particular birth control pill for an extended period without problems on the
same pill or a similar pill, unless the patient has developed a contraindication for
the pill. A patient who has tolerated a pill for a long time is “[l]ess likely to
suddenly develop problems.” So the “first thing” Dr. Rowley does when deciding
which birth control pill to prescribe a patient is to “find out which birth control
pills” the patient has taken “in the past and how” she’s “done on them.” If a
patient “is doing well on a pill, it makes sense to keep [her] on that pill.” Karen
Hubbard had been doing well on Bayer’s line of DRSP-containing birth control
pills for many years. Her medical records indicated that she was satisfied with
Yasmin in 2005 and requested a refill; that she was satisfied with Yasmin in 2006
and requested a refill (though she ended up receiving a prescription for YAZ); and
that she was satisfied with YAZ and requested refills in each of 2007, 2008, 2009,
and 2010.
In short, Karen Hubbard tolerated YAZ “quite well” for several years, and
she had tolerated Yasmin well “for several years prior to that.” Thus, in December
2011, Dr. Rowley prescribed Karen Hubbard Beyaz, which he regards as “the same
medication” as YAZ: the only difference is that Beyaz contains a folate
supplement, which provides benefits to women of childbearing age. As we’ve
noted, Dr. Rowley agreed that even after the 2012 label change, “the benefits of
Beyaz outweigh the risk in patients who have already been taking it for some time
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with no problems.” That Karen Hubbard was just such a patient--she had been
taking YAZ, a materially identical drug, for several years without any problem--
underscores Dr. Rowley’s testimony that he would have prescribed her Beyaz even
if he had the benefit of the 2012 label change at the time.
Moreover, Dr. Rowley’s unequivocal testimony that knowledge of the
information contained in the 2012 Beyaz label would not have altered his 2011
decision to prescribe Beyaz to Karen Hubbard puts this case on all fours with
Dietz, 598 F.3d at 814–15. In Dietz, a doctor diagnosed Garrison David Dietz with
major depression and prescribed Paxil, an antidepressant the defendant
manufactured. Id. at 814. Eight days after beginning his Paxil prescription, Dietz
committed suicide. Id. We affirmed the district court’s grant of the
manufacturer’s motion for summary judgment on Dietz’s wife’s failure-to-warn
claims. Id. at 814, 816. When asked at his deposition whether he “still agree[d]
with [his] decision to prescribe Paxil for Mr. Dietz,” the prescribing physician
replied, “Yes.” Id. at 814. After having read the new, updated prescribing
information for Paxil, the physician testified:
Q. [I]s there anything in that [new warning] that makes you believe that
if you had read that same information in April of 2002 you would have
decided not to prescribe Paxil for Gary Dietz?
A. No.
Q. So sitting here today, knowing Gary Dietz ultimately took his own
life, do you still consider your decision to prescribe Paxil for him on
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April 3rd, 2002, to be an appropriate decision?
A. I felt the risk of not treating him was worse. So I would have to
make a decision, and I felt like I needed to prescribe him Paxil.
Id. at 815 (alteration accepted). Just as here, the doctor’s assertion that he still
considered his prescription decision “appropriate” after reviewing the updated
research and warnings “sever[ed] any potential chain of causation through which
[the plaintiff] could seek relief.” Id. at 816.
The facts in this case are even stronger than those presented in Dietz. While
Dietz did not rely on any evidence suggesting that the prescribing doctor already
knew of the additional risks when he wrote the prescription, here, the record
contains just such evidence. And this further supports the conclusion that an
update to the Beyaz label would not have affected Dr. Rowley’s December 2011
decision to prescribe Beyaz to Karen Hubbard. See id. at 816 (noting that the
causal link is typically broken when “a learned intermediary has actual knowledge
of the substance of the alleged warning and would have taken the same course of
action”). The record demonstrates that Dr. Rowley already knew DRSP-
containing COCs like Beyaz pose an increased risk of VTE when he prescribed
Beyaz to Karen Hubbard in 2011, and that he did not consider the additional
information contained in the 2012 Beyaz label to significantly add to his corpus of
knowledge. Bayer’s failure to include this information in the previous Beyaz label
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could not have caused Dr. Rowley’s decision to prescribe Beyaz to Karen
Hubbard.
The 2012 warning label added studies suggesting that DRSP-containing
COCs may pose up to a three-fold increase in VTE risk compared to COCs that use
other progestins. But when Dr. Rowley prescribed Beyaz to Karen Hubbard in
December 2011, he already knew DRSP-containing pills possibly posed a greater
risk of VTE than other COCs. Dr. Rowley testified he was “aware of the
possibility of an increased risk of blood clots from pills like Beyaz in May of
2011.” Indeed, Dr. Rowley has known since 1979 that all birth control pills carry a
risk of blood clots, and has since then continued to “keep up with the literature on
risks associated with birth control pills that contain [DRSP] in particular.” This
included, for example, knowledge in 2009 of two studies suggesting that there
might be a higher risk from Yasmin than from other types of birth control pills.
Dr. Rowley reviewed the 2010 Beyaz label, which referenced two studies finding a
small increased risk of DRSP-containing pills compared to pills containing
levonorgestrel, an alternative progestin. And the three 2011 FDA updates that pre-
dated Karen Hubbard’s prescription suggested a slightly higher blood clot risk
from DRSP-containing pills than from other pills.
Dr. Rowley testified that when measured against his general knowledge of
the relatively greater risk from DRSP pills, these updates were not “like an
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absolute game changer at the time.” In his words, the information in the FDA
updates “was no different to what had come out from previous studies [that said]
there may be a slight increased risk . . . . It was something which the FDA had
come out with, but there had been studies before which had also suggested that
increased risk . . . .” Dr. Rowley knew in December 2011 the essence of the
information that would later be added to the Beyaz label--that DRSP pills like
Beyaz may pose an increased risk of VTE relative to non-DRSP pills--and did not
regard it as a significant change to what he already knew about the DRSP-pill risk
profile.
To be sure, the April 2012 label listed the possibility of a DRSP-related
increase in blood clot risk up to three-fold, while the September and October 2011
FDA updates referred to a study suggesting only a 1.5-fold risk. But Dr. Rowley’s
testimony expressly offered that he did not view this change as significant. Dr.
Rowley did not alert his patients about the 2012 label change, because the change
was “so small that it really just didn’t justify” changing prescriptions for those who
were already on DRSP-containing pills and were happy with them. And the April
2012 update did not cause Dr. Rowley’s practice group to “reach any new
conclusion about whether” Beyaz carried “a higher risk of causing a blood clot
than other birth control pills.” Most significantly, Dr. Rowley did not change the
way he “prescribed birth control to patients . . . after April of 2012.”
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All told, Dr. Rowley testified clearly that the information found in the 2012
label update would not have changed his decision to prescribe Beyaz to Karen
Hubbard; and, indeed, that he already knew of the relevant risks at the time of the
prescription. Under controlling case law, this precludes the Hubbards from
establishing proximate cause.
As the Hubbards correctly observe, the evidence does indicate that the 2012
label change had some general impact on Dr. Rowley. But for the Hubbards to
show a genuine issue of material fact regarding proximate cause, this evidence
must speak to whether the information in the 2012 label change would have
affected in some way Dr. Rowley’s decision to prescribe Beyaz to Karen Hubbard.
See Dietz, 598 F.3d at 816. The evidence the Hubbards rely on, however, does not
bear on Dr. Hubbard’s decisionmaking regarding prescriptions, at least for patients
similar to Karen Hubbard. 8
8
The Hubbards also argue that summary judgment was inappropriate because Dr. Rowley’s
testimony that he still believes his decision to prescribe Beyaz to Karen Hubbard was appropriate
“could be impeached by evidence that the relative risks and benefits to Mrs. Hubbard of other
COCs were such that an informed intermediary would not have prescribed Beyaz to her.” This
argument misses the mark. Under Dietz, the question relevant to proximate cause is not how a
fully informed physician would have reasonably behaved, but rather how Dr. Rowley himself
would have behaved were he fully informed. See 598 F.3d at 816. And as we have outlined, Dr.
Rowley testified plainly that the information in the 2012 Beyaz label update would not have
changed his risk/benefit calculation with respect to Karen Hubbard or similar patients. See supra
Section II.A.
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First, the Hubbards say that Dr. Rowley changed his method of counseling
patients after the 2012 update. Dr. Rowley testified that, beginning at the time of
the 2012 FDA statement, he began to provide his patients additional information
about Beyaz: “that there is some concern that there may be a slightly higher risk of
a DVT, of a clot in the leg associating with using [Beyaz] versus some other types
of birth control pills.” Also in 2012, Dr. Rowley began telling patients “there may
be a slightly higher risk by being on the pill which has drospirenone.” So the 2012
FDA update caused Dr. Rowley to more clearly communicate to his patients the
possibility that DRSP-containing pills pose a slightly increased risk of blood clots
relative to other pills.
But a change in communication practices says nothing about the 2012
label’s impact on Dr. Rowley’s decisionmaking regarding whether to prescribe
Beyaz; indeed, Dr. Rowley continued to prescribe Beyaz, YAZ, and Yasmin after
2012. It says even less about the central question in this case: whether the 2012
label would have impacted Dr. Rowley’s decision to prescribe Beyaz to Karen
Hubbard in December 2011. Dr. Rowley already knew in December 2011 of the
possibility that DRSP-containing pills posed some increased risk of blood clots yet
prescribed one to Karen Hubbard anyway. And Dr. Rowley testified that he did
not view the 2012 update as significant enough to justify the risk of transferring
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women who did well on and were happy with their DRSP pills to another pill--
women like Karen Hubbard.
Thus, whatever the impact of the 2012 label change on Dr. Rowley’s patient
communications practices, the risks discussed in these communications did not
affect his prescribing decisions for women situated similarly to Karen Hubbard.
The Hubbards’ evidence on this score therefore does not create a material issue of
fact in dispute about whether the 2012 label would have changed Dr. Rowley’s
prescription decision in 2011.
Moreover, even if a change in what Dr. Rowley communicated to his
patients could be instructive, it is far from clear that the change in patient
counseling after the 2012 update was a significant one. Dr. Rowley testified that
even at the time of Karen Hubbard’s December 2011 visit, before the 2012 update,
his office would have communicated to Hubbard “safety information about the
possibility of an increased risk of blood clots” from DRSP-containing pills such as
Yasmin and Beyaz.
Second, the Hubbards point out that Dr. Rowley prescribes fewer DRSP-
containing COCs now than he did prior to the 2012 update. By the end of 2012,
Dr. Rowley prescribed 50 percent less YAZ, Yasmin, and Beyaz than he had at the
beginning of 2012. Dr. Rowley further indicated that now, he typically prescribes
Microgestin and Loestrin more than other birth control pills, in part because “the
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progesterone is norethindrone.” Again, however, this evidence does not raise a
triable issue of fact regarding whether the information contained in the 2012 label
would have affected Dr. Rowley’s decision to prescribe Beyaz to Karen Hubbard.
To the extent Dr. Rowley’s post-2012-update prescribing practices express an all-
things-equal preference for prescribing pills that do not contain DRSP, all things
were not equal for Karen Hubbard: she had been tolerating Bayer’s DRSP pills
well for many years. And a patient who has tolerated a pill for a long time, in the
mind of Dr. Rowley, is less likely to develop problems with that pill; thus his
standard practice is to continue the patient on the same or a similar pill.
What’s more, Dr. Rowley testified that the 2012 decrease in YAZ, Yasmin,
and Beyaz prescriptions was not the result of any change in his own prescription
decisionmaking calculus, but rather was “[b]ecause the patients themselves
decided not to be on those prescriptions.” Dr. Rowley explained this was “part of
the discussion that we’re having that there may be this increased risk from other
pills,” and that “the patients therefore themselves made their determination that in
spite of all the benefits that they may be getting from that particular medication,
they elected not to continue it because they didn’t want to take that increased risk.”
Changes in Dr. Rowley’s prescription frequencies after the 2012 label addition
might tell us something about changes in patient preferences that may have
resulted from discussions about the 2012 label. But they do not shed light on
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whether the 2012 label would have altered Dr. Rowley’s decisional calculus
regarding the appropriate prescription for a woman with a long, positive history of
DRSP use like Karen Hubbard. Indeed, Dr. Rowley flatly testified that he did not
change “the way [he] prescribed birth control to patients . . . after April of 2012”;
that even after the 2012 update “the benefits of Beyaz outweigh the risk in patients
who have already been taking it for some time with no problems”; and that even
today he considers his decision to prescribe Beyaz to Karen Hubbard to be
“appropriate.”
Nothing the Hubbards have presented alters the plain testimony that Dr.
Rowley would have prescribed precisely the same drug to Karen Hubbard in 2011
if he had the additional information contained in the 2012 warning.
The Hubbards also claim that when a warning is inadequate, Georgia law
presumes that the inadequate warning was the proximate cause of a failure-to-warn
plaintiff’s injury (i.e., that an adequate warning would have resulted in a different
prescription decision). While the Hubbards acknowledge that any such
presumption might be rebuttable--that is, it would shift the burden of going
forward to Bayer to show that its (presumptively) inadequate warning was not the
proximate cause of Karen Hubbard’s injury--they go even further and ask us to
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hold that the presumption is irrebuttable and conclusively establishes proximate
cause. We remain unpersuaded.
For one thing, Dietz squarely held that Georgia law assigns the burden of
proving proximate causation to the plaintiff where a prescription drug warning is
presumptively inadequate: “If the warning is inadequate, or merely presumed to be,
the plaintiff must demonstrate that the deficient warning proximately caused the
alleged injury to prevail.” 598 F.3d at 816 (emphasis added). Based on the
prescribing physician’s testimony that he would have prescribed the same drug
even with knowledge of the most current research and warnings, Dietz held that
the plaintiff could not meet her burden of proving proximate cause and affirmed
the district court’s grant of summary judgment in favor of the defendant. Id. Dietz
did not mention shifting burdens or in any other way suggest that Georgia law
creates or applies a presumption of proximate cause, rebuttable or irrebuttable. In
the absence of any clear statement of Georgia law to the contrary from the
appellate courts of Georgia, Dietz forecloses a holding that Georgia law provides
for a rebuttable presumption that shifts the burden to the defendant to establish the
absence of proximate cause or an irrebuttable presumption that conclusively
establishes proximate cause when the warning is inadequate. See Ackermann v.
Wyeth Pharm., 526 F.3d 203, 212 (5th Cir. 2008) (explaining that in jurisdictions
that employ a rebuttable presumption of cause in failure-to-warn cases, the effect
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of the presumption is to “shift the burden of producing evidence to the party
against whom it operates”) (internal quotation marks and citation omitted).
We are bound by the Dietz panel’s interpretation of Georgia law unless and
until Georgia’s courts tell us Dietz interpreted Georgia law incorrectly. See
EmbroidMe.com, Inc. v. Travelers Prop. Cas. Co. of Am., 845 F.3d 1099, 1105
(11th Cir. 2017). They have not done so. And we have not found anything in
Georgia law after Dietz that clearly indicates there is a rebuttable or an irrebuttable
presumption.
The Hubbards rely on Porter v. Eli Lilly & Co., No. CIVA 1:06-CV-1297-
JOF, 2008 WL 544739 (N.D. Ga. Feb. 25, 2008). There, based on a survey of
other jurisdictions, a district court “assume[d]” that Georgia would apply a
rebuttable presumption of proximate cause. 2008 WL 544739 at *11 (emphasis
added). The district court held that the defendant had rebutted any such
presumption by offering the prescribing physician’s testimony that updated risk
information in more recent warnings would not have changed his prescription
decision. Id. A panel of this Court affirmed in an unpublished per curiam opinion
that has no precedential effect. But, in any event, the opinion did not so much as
make any mention of a presumption regarding proximate cause. It did hold that
“[u]nder Georgia law, [the plaintiff] was required to prove that, but for the alleged
inadequate warning, [the] decedent’s physician . . . would not have prescribed
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Prozac to decedent.” Porter v. Eli Lilly & Co., 291 F. App’x 963, 964 (11th Cir.
2008). Neither the district court’s assumption nor our unpublished, pre-Dietz
opinion in Porter held that there is a presumption of proximate cause under
Georgia law, nor could either opinion allow us to depart from our holding in Dietz.
Finally, even if Georgia law applies a rebuttable presumption of proximate
cause, this still would not help the Hubbards because Bayer has presented more
than enough evidence to rebut any such presumption. As we have already
explained, the overwhelming body of record evidence indicates both that Dr.
Rowley would have prescribed Beyaz to Karen Hubbard even if he had been aware
of the 2012 label update and that the 2012 label update did not materially augment
Dr. Rowley’s December 2011 understanding of the Beyaz risk profile. In a
jurisdiction that applies a rebuttable presumption in failure-to-warn cases, this
rebuttal would shift the burden back to the Hubbards to demonstrate a genuine
issue of material fact on proximate cause. See Eck v. Parke, Davis & Co., 256
F.3d 1013, 1019 (10th Cir. 2001) (applying Oklahoma law). The Hubbards
identify no evidence from which a reasonable jury could conclude that the
information contained in the 2012 warning would have altered Dr. Rowley’s
prescription decision. Therefore, “the causal link is broken and the [Hubbards]
cannot recover.” Dietz, 598 F.3d at 816 (quotation marks and citation omitted).
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Accordingly, we AFFIRM the district court’s order granting final summary
judgment to Bayer.
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