Court Opinion

ID: 4645459
Source: CourtListenerOpinion
Date Created: 2020-12-22 15:00:38.390071+00
Date Added: 2024-06-11T08:00:52.723051
License: Public Domain

USCA11 Case: 19-13087   Date Filed: 12/22/2020     Page: 1 of 31

                                                                      [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)
          USCA11 Case: 19-13087          Date Filed: 12/22/2020      Page: 2 of 31

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:

                                            8
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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:

                                             10
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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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