[DO NOT PUBLISH]

IN THE UNITED STATES COURT OF APPEALS

FOR THE ELEVENTH CIRCUIT

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No. 17-11440

Non-Argument Calendar

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D.C. Docket No. 2:12-cv-00476-PAM-MRM

REBECCA A. SMALL, 

LAWRENCE W. SMALL, 

 Plaintiffs - Appellants,

versus

AMGEN, INC., 

PFIZER, INC., 

WYETH, INC., 

 Defendants - Appellees,

DOES 1-20, et al., 

 Defendants.

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Appeal from the United States District Court

for the Middle District of Florida

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(January 22, 2018)

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Before MARCUS, JORDAN, and FAY, Circuit Judges.

PER CURIAM: 

In this products liability case, Rebecca Small appeals the district court’s 

grant of summary judgment in favor of several drug companies, arguing in part 

that the district court mistakenly relied on the learned intermediary doctrine to

dismiss some of her claims. She claims that the district court’s errors damaged her 

discovery efforts on all claims and requests a reversal of the district court’s original 

summary judgment order. After thorough review of the parties’ briefs and the 

record, we affirm.

I

Because we write for the parties, we assume their familiarity with the 

underlying record and recite only what is necessary to resolve this appeal. 

In October of 2002, Mrs. Small began taking a drug called Enbrel to treat 

rheumatoid arthritis at the recommendation of her rheumatologist, Dr. Catherine 

Kowal, M.D.. In August of 2008, Mrs. Small was hospitalized and underwent 

multiple surgeries for a perforated bowel and a diverticulitis infection. Mrs. Small 

and her husband filed suit against the drug manufacturers of Enbrel in August of 

2012, alleging that Enbrel caused her infection and subsequent surgeries.

Mrs. Small’s Fourth Amended Complaint raised claims for strict liability for 

design defect (Count I), strict liability for failure to warn (Count II), breach of 

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express warranty (Count III), negligence (Count IV), and loss of consortium

(Count V). The district court denied the drug manufacturers’ motion to dismiss, 

except for any negligent failure-to-test, failure-to-inspect, or negligence per se 

claim that fell within Count IV. The drug manufacturers then filed a motion for 

summary judgment, which the district court granted in 2014 as to all of Count II as 

well as the negligent failure-to-warn component of Count IV. The district court 

held that the failure-to-warn claims were precluded by Florida’s learned 

intermediary doctrine. The drug manufacturers then filed a motion for judgment 

on the pleadings, which the court denied in January of 2016. 

Discovery on the remaining claims began late in 2015 and eventually 

required an omnibus discovery order in September of 2016. When the drug 

manufacturers learned in February of 2017 that the five treating physicians Mrs. 

Small planned to use as non-retained experts would not testify on either general or

specific causation, they filed a motion to strike Mrs. Small’s disclosures, which the 

magistrate judge granted. The drug manufacturers immediately filed for summary 

judgment, arguing that Mrs. Small’s remaining claims failed as a matter of law 

without an expert to testify as to causation, a prima facie element of all of her 

claims. In 2017, the district court granted their motion for summary judgment, 

concluding that, without an expert to testify as to causation, each of Mrs. Small’s 

remaining claims failed as a matter of law. Mrs. Small now appeals.

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II

We review a district court’s grant of summary judgment de novo, with all 

facts and reasonable inferences construed in favor of the non-moving party. See 

Smith v. Owens, 848 F.3d 975, 978 (11th Cir. 2017). The district court properly 

enters an order of summary judgment against a party who fails to make a showing 

sufficient to establish the existence of an element essential to that party’s case on 

which that party bears the burden of proof at trial. See Celotex Corp. v. Catrett, 

477 U.S. 317, 322 (1986). A “complete failure of proof regarding an essential 

element . . . necessarily renders all other facts immaterial.” Id. at 323.

III

In her brief Mrs. Small does not directly address or dispute the district 

court’s grant of summary judgment in 2017 on all of her remaining counts for 

failure to put forth an expert to testify on causation, which is a prima facie element 

of each of her claims. Rather, she argues that the district court’s grant of summary 

judgment in 2014 on her failure to warn and negligent failure to warn claims in 

Counts II and IV was improper because there were factual questions regarding the 

district court’s treatment of Dr. Kowal as a learned intermediary. Additionally, she 

argues that the district court incorrectly decided that that the direct “patient 

labeling requirement” in the FDA medication guidelines did not preempt Florida’s 

learned intermediary doctrine. Together, these errors by the district court 

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purportedly limited her discovery, which, in turn, made prosecution of her 

remaining claims nearly impossible. She claims she was so prejudiced by these 

errors that we should vacate the initial partial summary judgment order of 2014

and begin the litigation anew from that point. 

IV

A

Florida law provides that a drug manufacturer’s duty to warn is “directed to 

the physician rather than the patient.” Buckner v. Allergan Pharm., Inc., 400 So.2d 

820 (Fla. 5th DCA 1981). The rationale for this doctrine is that the prescribing 

physician, who serves as a “learned intermediary,” is in the best position to weigh

“potential benefits against the dangers in deciding whether to recommend the drug 

to meet the patient’s needs.” Felix v. Hoffmann-LaRoche, Inc., 540 So.2d 102, 104 

(Fla. 1989). Thus, if the warning to the physician is adequate, the manufacturer 

has fulfilled its duty. See Buckner v. Allergan Pharms., Inc., 400 So.2d 820, 822 

(Fla. 5th DCA 1981). Further, regardless of the sufficiency of the warning, 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 

learned intermediary doctrine applies or that the causal link is broken and the 

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plaintiff cannot recover.” Ellis v. C.R. Bard, Inc., 311 F.3d 1272, 1283 n.8 (11th 

Cir. 2002).

Dr. Kowal, Mrs. Small’s rheumatologist, had 22 years of experience. She 

intentionally selected Enbrel for Mrs. Small, despite the risk of possible infections, 

because other forms of rheumatoid arthritis therapy had failed. Because Dr. Kowal 

was involved in clinical trials with Enbrel, and Mrs. Small was a participant in 

those trials, Dr. Kowal even had more reason to know of and discuss possible sideeffects or concerns associated with Enbrel. The record shows that Dr. Kowal knew

that infections were possible from taking Enbrel, but she prescribed it for Mrs. 

Small anyway because the benefits outweighed the risks. When “the prescribing 

physician had ‘substantially the same’ knowledge as an adequate warning from the 

manufacturer should have communicated,” causation on a failure to warn claim 

fails. See Christopher v. Cutter Labs., 53 F.3d 1184, 1192 (11th Cir. 1995). On 

this record, therefore, the district court properly held in 2014 that Mrs. Small’s 

treating physician, Dr. Kowal, qualified as a learned intermediary, and that the 

“defendants’ purported failure to warn of asymptomatic infections could not have 

been the proximate cause of Ms. Small’s injuries.” See id. at 1192 (“The learned 

intermediary rule provides that the failure of the manufacturer to provide the 

physician with an adequate warning of the risks associated with a prescription 

product is not the proximate cause of a patient’s injury if the prescribing physician 

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had independent knowledge of the risk that the adequate warning should have 

communicated.”)

B

The district court, in discussing the operation of the learned intermediary 

doctrine in Florida, examined the FDA medication guide regulations, Congress’ 

intent in passing the regulations, and the FDA’s own comments regarding the 

labeling requirements. See Small v. Amgen, Inc., 134 F. Supp. 3d 1358, 1368-69

(M.D. Fla. 2015). The FDA explained that the purpose of the medication guide 

regulations was to “provide information when the FDA determines in writing that 

it is necessary to patients’ safe and effective use of drug products.” 21 C.F.R.

208.1(b). 

Mrs. Small contends that the FDA medication guide regulations preempt 

Florida’s learned intermediary doctrine. In considering preemption, we must 

remember that “the historic police powers of the States are not superseded unless 

that was the clear and manifest purpose of Congress.” Fresenius Med. Care 

Holdings, Inc. v. Tucker, 704 F.3d 935, 939-940 (11th Cir. 2013). In cases of 

implied preemption, we consider “the promulgating agency’s contemporaneous 

explanation of its objectives’ as well as the agency’s current views of the 

regulation’s pre-emptive effect.” Id. at 941.

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As it set out its final version of this rule, the FDA responded to concerns that 

the labeling requirements would change the legal liability of manufacturers, 

physicians, and dispensers of prescription drugs by abrogating the “learned 

intermediary doctrine.” See 63 Fed Reg. 66378, 66383-84 (Dec. 1, 1998). The 

FDA stated that it “[did] not believe that this rule would adversely affect civil tort 

liability” and that “ the written patient medication information provided [did] not 

alter the duty, or set the standard of care for manufacturers, physicians, 

pharmacists, and other dispensers.” Id. at 63384. In addition, the FDA indicated it 

had no evidence that its current patient labeling had caused “a noticeable change in 

tort rules affecting civil liability.” The FDA concluded that “courts have not 

recognized an exception to the ‘learned intermediary’ defense in situations where 

FDA has required patient labeling, and . . . seem increasingly reluctant to recognize 

new exceptions to this defense.” Id.

Given the FDA’s own explanation of the impact of patient labeling 

requirements, we conclude that the medication guide regulations do not preempt 

Florida’s learned intermediary doctrine. See Fresenius Med. Care Holdings, 704 

F.3d at 941. 

C

Regarding discovery and proof of causation, in complex cases where a jury 

is asked to assess complex medical or scientific issues outside the scope of a 

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layperson’s knowledge, an expert’s testimony is required. See Guinn v. 

AstraZeneca Pharm. LP, 602 F.3d 1245, 1256 (11th Cir. 2010). See also Shepard 

v. Barnard, 949 So.2d 232, 233 (Fla. 5th DCA 2007) (approving trial court’s grant 

of summary judgment against plaintiff after excluding plaintiff’s medical experts’ 

testimony, because the doctors were needed “to provide opinions regarding any 

causal link between the alleged injury and the medical treatment”). Without 

expert testimony, the plaintiff’s claim fails as a matter of law. See Guinn, 602 F.3d 

at 1256. Similarly in Chapman v. Procter & Gamble Distrib., LLC, 766 F.3d 

1296, 1316 (11th Cir. 2014), which applied Florida law, we affirmed the district 

court’s summary judgment where the plaintiff’s only expert failed to meet the 

Daubert standards and the plaintiff had no other expert to testify. (To prove the 

medical product caused the plaintiff’s injury, the plaintiff was “required to have 

Daubert-qualified, general and specific-causation-expert testimony that would be 

admissible at trial to avoid summary judgment.”).

Because Mrs. Small bases her appeal on the 2014 summary judgment order 

rather than on the 2017 summary judgment order, she does not address her lack of 

expert testimony for causation directly. Instead, it appears she hopes to moot the 

later order, “akin . . . to the concept of the fruit of the poisonous tree.” But Mrs. 

Small has not explained why she did not engage an outside expert to testify, or 

confirm with her five treating physicians that they would be willing to testify as to 

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causation on her behalf. Her inability to prove general and specific causation, a 

prima facie element of all the claims on which the district court granted summary 

judgment in 2014 and 2017, is a critical flaw. The district court thus properly 

addressed this shortcoming by granting the drug manufacturers’ second motion for 

summary judgment in 2017. 

By failing to challenge the district court’s grant of summary judgment in 

2017 for lack of expert testimony to prove causation, Mrs. Small has waived that 

argument, and she cannot prevail on appeal. See Sapuppo v. Allstate Floridian Ins. 

Co., 739 F.3d 678, 680 (11th Cir. 2014) (“When an appellant fails to challenge 

properly on appeal one of the grounds on which the district court based its 

judgment, he is deemed to have abandoned any challenge of that ground, and it 

follows that the judgment is due to be affirmed.”)

We therefore affirm the summary judgment orders of 2014 and 2017 by the 

district court.

V

The judgment of the district court is affirmed.

AFFIRMED.

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