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`IN THE UNITED STATES COURT OF APPEALS
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`FOR THE ELEVENTH CIRCUIT
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`No. 19-13087
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`D.C. Docket No. 1:18-cv-05648-WMR
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`KAREN LEIGH HUBBARD,
`MICHAEL L. HUBBARD,
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` Plaintiffs - Appellants,
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`versus
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`BAYER HEALTHCARE PHARMACEUTICALS
`INC.,
`BAYER PHARMA AG,
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` Defendants - Appellees,
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`TEVA PHARMACEUTICALS USA INC.,
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` Defendant.
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`________________________
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`Appeal from the United States District Court
`for the Northern District of Georgia
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`(December 22, 2020)
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` [PUBLISH]
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`IN THE UNITED STATES COURT OF APPEALS
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`FOR THE ELEVENTH CIRCUIT
`________________________
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`No. 19-13087
`________________________
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`D.C. Docket No. 1:18-cv-05648-WMR
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`KAREN LEIGH HUBBARD,
`MICHAEL L. HUBBARD,
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` Plaintiffs - Appellants,
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`versus
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`BAYER HEALTHCARE PHARMACEUTICALS
`INC.,
`BAYER PHARMA AG,
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` Defendants - Appellees,
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`TEVA PHARMACEUTICALS USA INC.,
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` Defendant.
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`________________________
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`Appeal from the United States District Court
`for the Northern District of Georgia
`________________________
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`(December 22, 2020)
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`Before GRANT and MARCUS, Circuit Judges, and AXON,* District Judge.
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`MARCUS, Circuit Judge:
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`This tragic case began when Karen Hubbard suffered a catastrophic stroke.
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`The stroke left her paralyzed and her cognitive functions severely impaired. Her
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`oral contraceptive, Beyaz--a drug known to increase the risk of blood clots that can
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`cause strokes--may have been to blame. We must decide whether Karen Hubbard
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`and her husband Michael Hubbard have adduced sufficient evidence to survive
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`summary judgment on their claims against the manufacturers of Beyaz, Bayer
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`Pharma AG and Bayer HealthCare Pharmaceuticals Inc. (together, “Bayer”), for
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`failing to provide an adequate warning of the risk of stroke.
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`We hold they have not. Georgia’s learned intermediary doctrine controls
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`this diversity jurisdiction case. That doctrine imposes on prescription drug
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`manufacturers a duty to adequately warn physicians, rather than patients, of the
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`risks their products pose. But a plaintiff claiming a manufacturer’s warning was
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`inadequate bears the burden of establishing that an improved warning would have
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`caused her doctor not to prescribe her the drug in question. The Hubbards have not
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`met this burden. The prescribing physician testified unambiguously that even with
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`the benefit of the most up-to-date risk information about Beyaz, he considers his
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`* Honorable Annemarie Axon, United States District Judge for the Northern District of Alabama,
`sitting by designation.
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`2
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`decision to prescribe Beyaz to Karen Hubbard to be sound and appropriate. Under
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`our binding precedent interpreting Georgia law, the Hubbards, therefore, cannot
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`recover. Though the Hubbards have suffered greatly, the law plainly entitles Bayer
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`to summary judgment. We affirm the judgment of the district court.
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`On October 30, 2012, Michael Hubbard found his 41-year-old wife, Karen
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`Hubbard, unresponsive. She had suffered a catastrophic stroke caused by a blood
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`clot to her brain--a venous sinus thrombosis, a type of venous thromboembolism
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`(“VTE”). The VTE caused grievous, permanent injury: brain damage, paralysis,
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`and profound loss of cognitive functioning. At the time of her stroke, Karen
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`Hubbard had been taking Beyaz, a birth control pill manufactured by defendant
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`Bayer. While she first received a prescription for Beyaz on December 27, 2011,
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`Karen Hubbard had been taking similar Bayer birth control products since 2001.
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`A birth control pill, also known as a combination oral contraceptive, or
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`“COC,” typically consists of two synthetic hormone components: estrogen and one
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`of several progestins (also referred to as progesterones or progestogens). When
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`first developed, COC pills delivered a high dose of estrogen and one of two
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`progestins: norethindrone or ethynodiol. After studies in the 1980s determined that
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`higher doses of estrogen posed an increased risk of VTE, or blood clots,
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`3
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`pharmaceutical companies generally developed second-generation COCs that
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`featured lower levels of estrogen. To further “decrease the cardiovascular side
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`effect profile,” pharmaceutical companies produced a third generation of COCs
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`which paired a low dose of estrogen with one of three progestins: desogestrel,
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`gestodene, or norgestimate. In the 1990s, when further studies revealed that these
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`progestins carried an elevated risk of VTE, manufacturers revised their product
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`labels for these COCs and focused on developing pills with a new, “fourth
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`generation” progestin: drospirenone, or DRSP.
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`Bayer first sought the FDA’s approval to use DRSP in a birth control pill on
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`November 17, 1993. Today, Bayer markets Yasmin, YAZ, and Beyaz. All are
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`fourth-generation COCs that combine an estrogen, ethinyl estradiol (“EE”), with
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`DRSP. Each pill of Yasmin, which became available in the United States in 2001,
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`contains 30 micrograms of EE and three milligrams of DRSP. In 2006, the FDA
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`approved YAZ, which combines a lower dose of estrogen (20 micrograms) with
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`the same three milligrams of DRSP. Bayer introduced Beyaz in 2010. A Beyaz
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`pill and a YAZ pill share the same hormonal profile--20 micrograms of EE and 3
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`milligrams of DRSP. The sole difference between the two pills is that Beyaz
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`includes a supplement, folate, which “has been shown to be beneficial in [fetal]
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`neuro development.”
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`The medical community has been aware since the 1960s that COCs are
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`associated with an increased risk of blood clots. But the magnitude of that risk
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`varies depending on the make-up of particular types of pills. A higher dose of
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`estrogen is “a clear risk factor”; indeed, “when subsequent COC’s had their
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`estrogen doses reduced, a corresponding decrease in the incidence of VTE disease
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`occurred.” Similarly, different progestins carry different VTE risks. Thus, for
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`example, the third-generation progestins desogestrel and gestodene nearly doubled
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`the risk of VTE from COCs in the second generation. This elevated risk found its
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`way onto third-generation warning labels; these labels “have wording specifying
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`an increased risk associated with their products.”
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`Like third-generation COCs, fourth-generation pills--those containing
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`DRSP--“carry a significantly greater risk of VTE relative to” second-generation
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`COCs. Bayer thus includes information about the nature and extent of the VTE
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`risk on labels for its DRSP-containing products. The 2010 Beyaz warning label,
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`the label in place at the time of Karen Hubbard’s first and final Beyaz prescription
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`5
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`on December 27, 2011, warned that COCs generally pose a risk of VTEs1 and
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`summarized studies on the VTE risks associated with DRSP-containing COCs in
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`particular. The label noted that some studies concluded the risks of DRSP pills are
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`comparable to those of other pills, while other studies showed Yasmin increased
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`the risk of VTE relative to certain non-DRSP COCs.2 The label provided reasons
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`1 In relevant part, the label read:
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` 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
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`users and the other included women of various risk levels.
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`In May 2011, the FDA released a drug safety communication announcing an
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`“ongoing safety review of birth control pills that contain drospirenone.” The FDA
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`explained that its European counterpart, the European Medicines Agency, was
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`“updating the product information on oral contraceptives containing drospirenone
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`and ethinyl estradiol regarding the risk of venous thromboembolism after [its]
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`review of all available data, including the same newly published data [the] FDA is
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`reviewing.” In September 2011, the FDA put out a second announcement,
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`“informing the public that” while it had “not yet reached a conclusion,” it
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`“remain[ed] concerned . . . about the potential increased risk of blood clots with the
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`use of drospirenone-containing birth control pills.” The preliminary results of an
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`FDA-funded study suggested “an approximately 1.5-fold increase in the risk of
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`blood clots for women who use drospirenone-containing birth control pills
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`compared to users of other hormonal contraceptives.” On October 27, 2011--two
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`months before Karen Hubbard received her final Beyaz prescription--the FDA
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`announced that it was “continuing its review of the potential increased risk of
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`blood clots with the use of birth control pills containing drospirenone.”
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`Then, on April 10, 2012, the FDA announced that it had “completed its
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`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
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`“concluded that drospirenone-containing birth control pills may be associated with
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`a higher risk for blood clots than other progestin-containing pills.” As a result of
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`this finding, the FDA added “information about the studies to the labels of
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`drospirenone-containing birth control pills,” including Beyaz, YAZ, and Yasmin.
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`These “revised drug labels” relayed “that some epidemiologic studies reported as
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`high as a three-fold increase in the risk of blood clots for drospirenone-containing
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`products when compared to products containing levonorgestrel or some other
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`progestins, whereas other epidemiological studies found no additional risk of blood
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`clots with drospirenone-containing products.” Thus, in April 2012, Bayer revised
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`its Beyaz warning label to include, among other information, the possibility of up
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`to a three-fold relative increase in blood clot risk (“the risk ranged from no
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`increase to a three-fold increase”).3 The label included graphics demonstrating that
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`3 In relevant part, the label read:
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`studies had reached varying estimates regarding the comparative VTE risk of
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`DRSP-containing COCs.4 The warning noted that VTE risk is highest during
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`4 In relevant part, the label read:
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` . . .
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`the first year of COC use and that the risk of VTE from pregnancy is greater than
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`the risk from using oral contraceptives.5
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`Karen Hubbard began taking Bayer’s COCs in approximately 2001. She
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`took Yasmin from 2001 until May 2006, when she began taking YAZ. Though her
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`prescribing physician, Dr. Lawrence Rowley, didn’t know for sure why she
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`changed her prescription, he thought the change would have been made because
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`YAZ contains a lower dose of estrogen, and his office “always prefer[s] to use the
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`lower-dose pills.” Karen Hubbard remained on YAZ until December 2011, when
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`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
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`explained the change, he thought it was likely due to the folate that Bayer added to
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`Beyaz. Karen Hubbard had been taking Beyaz for a little less than a year when she
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`suffered a stroke in October 2012.
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`On January 17, 2014, Karen and Michael Hubbard sued Bayer in the United
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`States District Court for the Southern District of Illinois as part of a multidistrict
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`litigation proceeding relating to the manufacture, marketing, and sale of certain
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`oral contraceptives. They alleged that, as a direct result of her use of Bayer’s birth
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`control pills, including Yasmin, YAZ, Beyaz, and their generic equivalents, Karen
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`suffered a VTE which caused “an intracerebral hemorrhage” and “life-
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`threatening,” “catastrophic injuries.” The Hubbards sought compensatory and
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`punitive damages for negligence; strict liability based on a design defect; strict
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`liability based on a defective warning; negligence based on a failure to issue a
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`timely post-sale warning; fraud; breach of warranty; and loss of consortium. 6
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`On August 15, 2018, with the matter still pending in the Southern District of
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`Illinois, Bayer moved for summary judgment. According to Bayer, the undisputed
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`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
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`knowledge of the risk that” the Hubbards contend Bayer failed to disclose. Dr.
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`Rowley, Bayer claimed, “provided explicit, uncontroverted testimony that he was
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`aware of the potentially higher risk of VTE [associated with DRSP-containing
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`COCs] long before he wrote” Karen Hubbard’s “final prescription.” Thus, “no
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`failure to disclose any information in the warning label caused Dr. Rowley to
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`prescribe Beyaz to” Karen Hubbard, since “he was already well aware of the
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`alleged risks.” Bayer argued that the failure-to-warn claims therefore failed, and
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`so did the others: the Hubbards had not raised a triable issue of fact on causation.
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`The Hubbards opposed the motion. They said that the warnings available to
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`Dr. Rowley in December 2011 were inadequate, including because they lacked the
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`information made available in the 2012 update to the Beyaz label. The Hubbards
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`further claimed that Dr. Rowley’s testimony on his December 2011 knowledge of
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`the increased VTE risks associated with Beyaz was “equivocal.” And Bayer’s new
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`warning “changed the way he counseled patients.” Without unequivocal testimony
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`from Dr. Rowley that he would have prescribed Beyaz to Karen Hubbard after
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`reading an appropriate warning, the Hubbards offered, summary judgment was not
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`warranted.
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`With Bayer’s summary judgment motion still pending, the case was
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`transferred to the Northern District of Georgia because the parties had completed
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`generic discovery, obviating the need for multidistrict coordination.
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`After further briefing, the district court in the Northern District of Georgia
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`granted Bayer’s motion for summary judgment, reasoning that the Hubbards could
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`not prove Bayer’s inadequate warning caused Karen Hubbard’s injury. “Without
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`evidence that a different warning would have changed the prescribing decision,”
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`the district court wrote, the Hubbards could not show that Karen Hubbard’s injury
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`“would have been avoided but for Bayer’s alleged failure to warn.” The district
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`court agreed with Bayer that Dr. Rowley’s testimony established “that no different
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`warning would have changed the prescribing decision and avoided the injury.”
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`The Hubbards timely appealed the district court’s order.
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`We review a district court’s grant of summary judgment de novo, viewing
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`the evidence and drawing all reasonable inferences in the light most favorable to
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`the nonmoving party. Tesoriero v. Carnival Corp., 965 F.3d 1170, 1177 (11th Cir.
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`2020). Summary judgment is appropriate only when “there is no genuine dispute
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`as to any material fact and the movant is entitled to judgment as a matter of law.”
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`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.”
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`Tesoriero, 965 F.3d at 1177 (quotation marks and citation omitted).
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`The parties agree that all relevant events took place in Georgia and that, in
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`this diversity action, Georgia law applies to the Hubbards’ failure to warn claim.7
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`In the typical failure-to-warn product liability case, “Georgia law insists that a
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`plaintiff show that the defendant had a duty to warn [the plaintiff], that the
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`defendant breached that duty, and that the breach proximately caused the plaintiff’s
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`injury.” Dietz v. Smithkline Beecham Corp., 598 F.3d 812, 815 (11th Cir. 2010).
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`But this general standard applies somewhat differently when the product at issue is
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`a prescription drug. Under Georgia’s learned intermediary doctrine, the drug
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`manufacturer “does not have a duty to warn the patient of the dangers involved
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`with the product, but instead has a duty to warn the patient’s doctor.” Id. (quoting
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`McCombs v. Synthes (U.S.A.), 587 S.E.2d 594, 594 (Ga. 2003)). “The rationale
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`for [this] doctrine is that the treating physician is in a better position to warn the
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`patient than the manufacturer, in that the decision to employ prescription
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`medication involves professional assessment of medical risks in light of the
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`physician’s knowledge of a patient’s particular need and susceptibilities.” Id.
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`(quoting McCombs, 587 S.E.2d at 594) (alteration accepted).
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`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
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`inadequate. But that does not end our analysis. “If the warning is inadequate, or
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`merely presumed to be, the plaintiff must demonstrate that the deficient warning
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`proximately caused the alleged injury.” Id. at 816. To establish proximate cause,
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`the plaintiff must prove a causal link between the inadequate warning and the
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`prescription decision. Thus, “in cases where a learned intermediary has actual
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`knowledge of the substance of the alleged warning and would have taken the same
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`course of action even with the information the plaintiff contends should have been
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`provided, courts typically conclude that the causal link is broken and the plaintiff
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`cannot recover.” Id. (internal quotation marks and citation omitted; alteration
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`accepted).
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`While proximate cause is an issue of fact normally reserved for the jury,
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`Georgia law provides that the court may decide questions of proximate cause as a
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`matter of law when the evidence is “plain and undisputed.” Sanders v. Lull Int’l,
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`Inc., 411 F.3d 1266, 1271 (11th Cir. 2005) (quoting Ont. Sewing Mach. v. Smith,
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`572 S.E.2d 533, 536 (Ga. 2002)).
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`On this record, we hold that even when viewed in the light most favorable to
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`the Hubbards, the evidence does not raise a genuine issue of material fact and that
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`Bayer is entitled to final summary judgment as a matter of law. Dr. Rowley
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`“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
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`found in Bayer’s updated 2012 Beyaz label, he would still have prescribed Beyaz
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`to Karen Hubbard. See Dietz, 598 F.3d at 816. Moreover, Dr. Rowley’s testimony
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`indicates that he already knew in December 2011 what he considered to be
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`substantially the same risk information later included in the 2012 Beyaz label. The
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`causal chain is therefore broken, and the Hubbards cannot establish proximate
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`cause.
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`Most importantly, Dr. Rowley unambiguously testified that he views his
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`December 2011 decision to prescribe Beyaz to Karen Hubbard as an appropriate
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`one, even now that he knows exactly what was included in the 2012 label. At his
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`deposition, after having discussed the risks listed in the 2012 Beyaz label as well as
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`risks discussed in previous studies and FDA warnings, Dr. Rowley was asked “Do
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`you believe today that your decision to prescribe Beyaz for Mrs. Hubbard was
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`appropriate?” He responded, “Yes.”
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`Were this not enough, Dr. Rowley’s response to the 2012 Beyaz label update
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`further indicates that knowledge of that information in December 2011 would not
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`have changed his decision to prescribe Beyaz to Karen Hubbard. Dr. Rowley
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`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
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`Beyaz or similar pills:
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`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
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`control to patients . . . after April of 2012,” and he still prescribes Beyaz, YAZ, and
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`Yasmin (though he more frequently prescribes birth control pills containing
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`progestins other than DRSP).
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`Dr. Rowley’s testimony about his general prescribing practices bolsters still
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`further the ultimate conclusion that he would have prescribed Beyaz to Karen
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`Hubbard in December 2011 even if he had the 2012 Beyaz label in hand. Dr.
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`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
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`same pill or a similar pill, unless the patient has developed a contraindication for
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`the pill. A patient who has tolerated a pill for a long time is “[l]ess likely to
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`suddenly develop problems.” So the “first thing” Dr. Rowley does when deciding
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`which birth control pill to prescribe a patient is to “find out which birth control
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`pills” the patient has taken “in the past and how” she’s “done on them.” If a
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`patient “is doing well on a pill, it makes sense to keep [her] on that pill.” Karen
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`Hubbard had been doing well on Bayer’s line of DRSP-containing birth control
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`pills for many years. Her medical records indicated that she was satisfied with
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`Yasmin in 2005 and requested a refill; that she was satisfied with Yasmin in 2006
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`and requested a refill (though she ended up receiving a prescription for YAZ); and
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`that she was satisfied with YAZ and requested refills in each of 2007, 2008, 2009,
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`and 2010.
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`In short, Karen Hubbard tolerated YAZ “quite well” for several years, and
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`she had tolerated Yasmin well “for several years prior to that.” Thus, in December
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`2011, Dr. Rowley prescribed Karen Hubbard Beyaz, which he regards as “the same
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`medication” as YAZ: the only difference is that Beyaz contains a folate
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`supplement, which provides benefits to women of childbearing age. As we’ve
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`noted, Dr. Rowley agreed that even after the 2012 label change, “the benefits of
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`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
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`taking YAZ, a materially identical drug, for several years without any problem--
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`underscores Dr. Rowley’s testimony that he would have prescribed her Beyaz even
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`if he had the benefit of the 2012 label change at the time.
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`Moreover, Dr. Rowley’s unequivocal testimony that knowledge of the
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`information contained in the 2012 Beyaz label would not have altered his 2011
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`decision to prescribe Beyaz to Karen Hubbard puts this case on all fours with
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`Dietz, 598 F.3d at 814–15. In Dietz, a doctor diagnosed Garrison David Dietz with
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`major depression and prescribed Paxil, an antidepressant the defendant
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`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
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`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
`19
`
`
`
`
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`USCA11 Case: 19-13087 Date Filed: 12/22/2020 Page: 20 of 31
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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
`
`
`
`20
`
`
`
`USCA11 Case: 19-13087 Date Filed: 12/22/2020 Page: 21 of 31
`
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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
`
`
`
`21
`
`
`
`USCA11 Case: 19-13087 Date Filed: 12/22/2020 Page: 22 of 31
`
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`absolute game changer at the time.” In his words, the information in the FDA
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`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.”
`
`
`
`22
`
`
`
`USCA11 Case: 19-13087 Date Filed: 12/22/2020 Page: 23 of 31
`
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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.
`
`
`
`23
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`
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`USCA11 Case: 19-13087 Date Filed: 12/22/2020 Page: 24 of 31
`
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`First, the Hubbards say that Dr. Rowley changed his method of counseling
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`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 s
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