[DO NOT PUBLISH]

IN THE UNITED STATES COURT OF APPEALS
FOR THE ELEVENTH CIRCUIT

________________________ No. 17

- 11440 Non

- Argument Calendar

________________________ 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.

________________________ Appeal from the United States District Court for the Middle District of Florida

_________ _______________ ( January 22, 2018 ) Case: 17-11440 Date Filed: 01/22/2018 Page: 1 of 102 Before MARCUS, JORDAN , and FAY , Circuit Judges. PER CURIAM: In this products liability case, Rebecca Small appeals the district court’s grant of summary jud gment 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

summ ary 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 o f 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, M r s. Small was hospitalized and underwent multiple surgeries for a perforated bowel and a diverticulitis infection. M r s. Small and her husband filed suit against the drug manufacturers of Enbrel in August of 2012, alleg ing that Enbre l caused her infection and subsequent surgeries. Mrs. Small’s F ourth Amended Complain t rai sed claims for strict liability for design defect (Count I) , strict liability for failure to warn (Count II) , breach of

Case: 17-11440 Date Filed: 01/22/2018 Page: 2 of 103 express warranty (Count III) , negligence (Count IV) , and l oss of consortium (Count V)

. The district court denied the drug manufacturers’ motion to dismiss , except for any negligent failure

- to

- test , failure

- to

- i nspect, 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 C ount II a s 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 learne d 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 , a rguing that Mrs. Small’s remaining claim s 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, t he district court granted the ir 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.

Case: 17-11440 Date Filed: 01/22/2018 Page: 3 of 104 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
ent ers 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 bear s the burden of proof at trial. See Celotex Corp. v. Catrett , 477 U.S. 317 , 322 (1986)

. A “complete fa ilure of proof regarding an essential element . . . necessarily renders all other fact s 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 ne gligent failure to warn claims in Counts II and IV was im proper because there were factual questions regarding the district court’s treatment of Dr. Kowal as a learned intermediary

. Additionally, s he argues that the district court incorrectly decided tha t that the direct “patient labeling requirement” in the FDA medication guidelines did not preempt Florida’s learned intermediary doctrine. Together, these error s by the district court

Case: 17-11440 Date Filed: 01/22/2018 Page: 4 of 105 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 intermedia ry , ” is in the best position to weigh

“ potential benefits against the dangers in deciding whether to recommend the drug
to meet t he patient’s needs.” Felix v. Hoffmann

- LaRoche, Inc. , 5 40 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 applie s or that the causal link is broken and the

Case: 17-11440 Date Filed: 01/22/2018 Page: 5 of 106 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 m ore reason to know of and discuss possible side

effects 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.
S mall 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 interm ediary, and that the

“ defendants’ purporte d 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 t he proximate cause of a patient’ s injury if the prescribing physician

Case: 17-11440 Date Filed: 01/22/2018 Page: 6 of 107 had independent knowledge of the risk that the adequate warning should have communicated. ”)
B The district court, in discussin g the operation of the learned intermediary doctrine in Florida, examined the FD A 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 “p rovide 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
i mplied preemption, we consider “the promulgating agency’s contemporaneous explanation of its objectives’ as well as the agency’s current views of the

re gulation’s pre

- emptive effect. ” Id. at 941

.

Case: 17-11440 Date Filed: 01/22/2018 Page: 7 of 108 As it set out its final version of this rule, t he FDA responded to concerns that the labeling requirements would change the legal liability of manufacturers, physicians , and dispensers of prescription drug s by abrogating the “ learned intermediary doctrine. ” See 63 F ed R eg. 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 “c ourts have not recognized an exception to the ‘learned intermediary’ defense in situations where FDA has require d 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 94 1

. C Regarding discovery and pro of of causation, i n complex cases where a ju ry is asked to assess complex medical or scientific issues outside the scope of a

Case: 17-11440 Date Filed: 01/22/2018 Page: 8 of 109 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 treatmen t ” ). Without expert testimony, the plaintiff’s claim fail s 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. (T o prove the medical product caused the plaintiff’s injury, the plaintiff was “ requi red 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 direct ly . Instead, it appears she hop es to moot the later order , “akin . .

. to the concept of t he 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

Case: 17-11440 Date Filed: 01/22/2018 Page: 9 of 1010 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

. T he 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 prov e causation , Mrs. Small has waive d 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 order s of 2014 and 2017 by the district court

. V The judgment of the district court is affirmed

. AFFIRMED . Case: 17-11440 Date Filed: 01/22/2018 Page: 10 of 10