Davis v. Actavis, Inc. (In re Testosterone Replacement Therapy Prods. Liab. Litig.)
| Decision Date | 04 November 2020 |
| Docket Number | MDL No. 2545,Case No. 14 C 1748 |
| Parties | In re Testosterone Replacement Therapy Products Liability Litigation Coordinated Pretrial Proceedings (This document applies to Davis v. Actavis, Inc., Case No. 17 C 3775) |
| Court | U.S. District Court — Northern District of Illinois |
(Memorandum Opinion and Order on Actavis, Inc.'s motion for summary judgment in Davis v. Actavis, Inc., Case No. 17 C 3775
)
Plaintiffs in this multidistrict litigation (MDL) proceeding allege that they suffered either arterial cardiovascular injuries or injuries related to blood clots in the veins as a result of taking prescription testosterone replacement therapy (TRT) drugs. Defendants Actavis, Inc., Actavis Pharma, Inc., and Actavis Laboratories UT, Inc. (collectively, Actavis) manufacture or sell Androderm, one of the TRT products at issue in this litigation. Plaintiff Douglas L. Davis alleges that his use of Androderm in July and August 2015 caused him to suffer a stroke in August 2015. He asserts claims against Actavis under Florida law for design defect; failure to warn; negligence; negligent misrepresentation; breach of implied warranty of merchantability; breach of express warranty; fraud; redhibition; consumer protection; unjust enrichment; and punitive damages. Plaintiff Laura C. Davis asserts a claim against Actavis under Florida law for loss of consortium.1
In July 2018, a Master Settlement Agreement was executed covering cases involving Actavis. In August 2019, Davis informed the Court that he elected not to settle his claims. Actavis now moves for summary judgment on a single legal issue: whether a duty exists under Florida law for a prescription drug manufacturer to provide warnings in some manner apart from the product's FDA-approved package insert. According to Actavis, there is no such duty, leaving Davis without any viable claim. For the following reasons, the Court denies Actavis's motion for summary judgment.
Androderm is a testosterone transdermal system, meaning a patch that delivers testosterone to the body through the skin. The Food and Drug Administration (FDA) approved Androderm in September 1995. The uses for which the FDA approved the drug are not relevant for present purposes. In 2015, the FDA ordered Actavis to include the following language in the Warning and Precautions section of the Androderm label:
Actavis Mot. for Summ J., Ex. 4 (Androderm Label Rev. 5/2015) [35-4] § 5.4; Actavis L.R. 56.1 Resp. [52] ¶ 6. The FDA ordered other TRT manufacturers to include the same language in the Warning and Precautions section of their TRT product labels. InMay 2015, the FDA approved a new Androderm label that incorporated the required language.
Dr. J. Frank Avey prescribed Androderm for Davis on July 22, 2015. Davis filled the prescription that same day. Davis contends (and Actavis disputes) that he used one Androderm patch per day for the next 23 days. On August 14, 2015, Davis had a stroke and was transported to a hospital.
Davis states that when he received his Androderm prescription, it came with prescribing information last updated in 2013. In other words, Davis contends he received an outdated version of the Androderm label that did not include the FDA-mandated cardiovascular risk language. In support, Davis offers a photograph of the label he contends he received. See Davis Opp. to Mot. for Summ. J., Ex. 22 (Androderm Label Rev. 11/2013) [47-8].
Actavis admits only that the photograph depicts "a copy of the Androderm Full Prescribing Information and Patient Information, revised in 2013", which did not contain the FDA-mandated cardiovascular risk language. Actavis L.R. 56.1 Resp. ¶¶ 37-38. Actavis maintains that there is no admissible evidence that the photograph portrays the copy of the Androderm label Davis received. According to Davis, Dr. Avey testified that it is unlikely he saw the May 2015 cardiovascular risk language before he made his prescribing decision. Actavis disputes Davis's characterization of the testimony.
This Court has ruled on motions for summary judgment in several cases that were selected as bellwether trial cases in this MDL. See In re TestosteroneReplacement Therapy Prods. Liab. Litig. Coordinated Pretrial Proceedings, 430 F. Supp. 3d 516, 523 (N.D. Ill. 2019) (CMO 166) (collecting cases). The plaintiffs in those cases argued (among other things) that before 2015—when the defendants added the FDA-mandated cardiovascular risk language to their TRT product labels—the labels failed to adequately warn that TRT use increases the risk of cardiovascular injury. The plaintiffs also argued that the defendants knew or should have known about the increased risk well before 2015. Davis's case is different. As noted above, Dr. Avey prescribed Androderm for Davis about two months after Actavis updated the label to include the FDA-mandated cardiovascular risk language. Davis contends that the Androderm he received did not include the new label and that Dr. Avey did not see the new label before prescribing Androderm for him. Davis seeks to hold Actavis liable for failing to adequately communicate the label change to physicians.
Davis first gave notice of this theory in a joint status report filed in November 2019. The Court has permitted Actavis to file a motion for summary judgment limited to one issue: whether a drug manufacturer has a duty under Florida law to provide warnings in some manner apart from the product's FDA-approved package insert. See Actavis Mem. in Supp. of Mot. for Summ. J. (Actavis Br.) [34] at 1; Actavis Reply in Supp. of Mot. for Summ. J. (Actavis Reply) [51] at 3. Actavis maintains that Florida law imposes no such duty.
Summary judgment is appropriate if the moving party "shows that 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). There is a genuine issue of material fact, andsummary judgment is precluded, "if the evidence is such that a reasonable jury could return a verdict for the nonmoving party." Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248 (1986). When ruling on a motion for summary judgment, a court views the record in the light most favorable to the non-moving party and draws all reasonable inferences in that party's favor. Id. at 255; see also, e.g., Driveline Sys., LLC v. Arctic Cat, Inc., 936 F.3d 576, 579 (7th Cir. 2019).
Addressing the legal question presented here requires an understanding of Florida tort law and the learned intermediary doctrine. Under Florida law, the manufacturer of a defective product may be held liable under theories of negligence and strict liability. See Small v. Amgen, Inc., 134 F. Supp. 3d 1358, 1366 (M.D. Fla. 2015), aff'd, 723 F. App'x 722 (11th Cir. 2018). "[A] product may be defective by virtue of . . . an inadequate warning." Ferayorni v. Hyundai Motor Co., 711 So. 2d 1167, 1170 (Fla. Dist. Ct. App. 1998). To prevail on a claim of failure to warn based on either negligence or strict liability, a plaintiff must show that "the warning label was inadequate," "the inadequacy of the warning proximately caused his injury," and "he suffered an injury from using" the defendant's product. Hoffmann-La Roche Inc. v. Mason, 27 So. 3d 75, 77 (Fla. Dist. Ct. App. 2009).
Florida has adopted the doctrine of strict liability set forth in the Restatement (Second) of Torts § 402A. See West v. Caterpillar Tractor Co., 336 So. 2d 80, 87 (Fla. 1976). Section 402A provides that a manufacturer who "sells any product in a defective condition unreasonably dangerous to the user . . . is subject to liability for physical harm thereby caused to the ultimate user" if (1) "the seller is engaged in the business ofselling such a product" and (2) "it is expected to and does reach the user . . . without substantial change in the condition in which it is sold." Restatement (Second) of Torts § 402A. The rule applies even if "the seller has exercised all possible care in the preparation and sale of his product." Id.
Comment k to Section 402A addresses "[u]navoidably unsafe products", including prescription drugs. Restatement (Second) of Torts § 402A, cmt. k. In relevant part, it provides that "[s]uch a product, properly prepared, and accompanied by proper directions and warning, is not defective, nor is it unreasonably dangerous." Id. Accordingly, the manufacturer of an unavoidably unsafe product that was properly prepared and accompanied by adequate directions and warnings will not be strictly liable "for unfortunate consequences attending [its] use . . . ." Id. Florida courts have rejected a "blanket approach" that applies comment k to all prescription drugs and instead have held "that comment k is an affirmative defense to a strict liability claim." Adams v. G.D. Searle & Co., 576 So. 2d 728, 733 (Fla. Dist. Ct. App. 1991). To be protected under comment k, a manufacturer must show that the product "is as safe as current testing and research permits" and that its benefits "outweigh its known risks as of the date the product is distributed." Id. at 732-33.
Where, as here, the...
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