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holding that a drug manufacturer "need only warn of complications stemming from the use of the Product—not the subsequent measures medical professionals may employ to treat those complications"
Summary of this case from Blackburn v. Shire U.S. Inc.Opinion
CASE NO. 18-CIV-61485-RAR
2020-06-16
Gregory DYE, Plaintiff, v. COVIDIEN LP, Defendant.
Anthony Maximillien Georges-Pierre, Max Lloyd Horowitz, Remer & Georges-Pierre, PLLC, Miami, FL, for Plaintiff. Ana C. Reyes, Pro Hac Vice, Haley L. Wasserman, Pro Hac Vice, Williams & Connolly, Washington, DC, Elan Abraham Gershoni, DLA Piper LLP, Miami, FL, for Defendant.
Anthony Maximillien Georges-Pierre, Max Lloyd Horowitz, Remer & Georges-Pierre, PLLC, Miami, FL, for Plaintiff.
Ana C. Reyes, Pro Hac Vice, Haley L. Wasserman, Pro Hac Vice, Williams & Connolly, Washington, DC, Elan Abraham Gershoni, DLA Piper LLP, Miami, FL, for Defendant.
ORDER GRANTING IN PART DEFENDANT'S MOTION TO DISMISS
RODOLFO A. RUIZ II, UNITED STATES DISTRICT JUDGE
Plaintiff allegedly underwent an operation to repair an abdominal hernia. During the surgery, the operating physician inserted a Parietex Composite Mesh implant ("Product") into his abdomen. Approximately two years later, Plaintiff began to experience "severe pain" in his abdomen. After several trips to the emergency room, doctors discovered Plaintiff had an infection, requiring an additional surgery to remove the infected portion of his hip. One month later, Plaintiff suffered a second infection and an abscess in his prostate resulting in full hip replacement surgery.
Plaintiff claims his infections and consequential surgeries were caused by design and manufacturing defects in the Product, as well as Defendant's negligence. Plaintiff also alleges that neither he nor his physician were adequately warned of the risks associated with the Product. In response, Defendant asserts that Plaintiff's claims must be dismissed with prejudice because he cannot state a plausible claim for relief.
Having considered Plaintiff's Second Amended Complaint [ECF No. 38] ("SAC"), Defendant's Motion to Dismiss Plaintiff's SAC [ECF No. 39] ("Motion"), Plaintiff's Response in Opposition to the Motion [ECF No. 40] ("Response"), Defendant's Reply in Support of the Motion [ECF No. 41] ("Reply"), and all other pertinent portions of the record, it is hereby
ORDERED AND ADJUDGED that the Motion [ECF No. 39] is GRANTED IN PART AND DENIED IN PART for the reasons stated herein.
Because the Court is considering a motion to dismiss, it must assume all allegations in the SAC are true. Therefore, the facts recited are those set forth in the SAC.
Dr. Samuel Szomstein implanted the Product into the right side of Plaintiff's lower abdomen during a laparoscopic procedure to repair an abdominal hernia. SAC ¶¶ 1, 13. Approximately two years after this procedure, Plaintiff began to experience severe pain on the right side of his abdomen. Id. at ¶ 14. After several trips to the emergency room, doctors discovered a "severe" infection across the front, right section of Plaintiff's abdomen, "near the site of the [Product]." Id. Notably, the size of the infection was "just about the size" of the Product implanted in Plaintiff. Id. However, despite this infection, Plaintiff's doctors did not remove the Product from Plaintiff. Id. at ¶ 30. Instead, Plaintiff's doctors only removed the infected portion of Plaintiff's hip. Id. at ¶ 14.
About a month after Plaintiff's first hip surgery, Plaintiff developed a "second severe infection and abscess in his prostate," which was also near the site of the Product. Id. at ¶ 15. Four months after the second infection was discovered, Plaintiff had full hip replacement surgery. Id. It is unclear whether Plaintiff's doctors then removed or re-implanted the Product after Plaintiff's second hip surgery. Id. at ¶ 64 ("[The Product] ... was implanted in Plaintiff on two separate occasions.") (emphasis added).
Because of these complications, Plaintiff filed suit against Defendant—the designer and manufacturer of the Product—alleging his infections and consequential surgeries were caused by a manufacturing and design defect in the Product. Id. at ¶¶ 5, 15-17, 27-31, 40, 49-66. Plaintiff also claims that had his physician known of the risk of infection and the need for additional surgeries, his physician would not have implanted the Product. Id. at ¶¶ 57, 65, 67-75. Lastly, Plaintiff asserts that Defendant breached its duty of care by, among other things, failing to avoid an unreasonable risk of harm; failing to use reasonable care in testing and studying the Product; and failing to comply with state and federal regulations. This breach of duty, according to Plaintiff, caused his injuries. Id. at ¶ 44.
Notably, this is Plaintiff's Second Amended Complaint. After Defendant filed its First Motion to Dismiss [ECF No. 12], Plaintiff filed his First Amended Complaint [ECF No. 13] as a matter of course pursuant to Rule 15(a)(1)(B) of the Federal Rules of Civil Procedure. Thereafter, Defendant filed its Second Motion to Dismiss [ECF No. 14] and the Court conducted a hearing on the motion on July 2, 2019 ("Hearing"). At the Hearing, the Court expressed concerns about Plaintiff's First Amended Complaint and its lack of factual allegations as to all operative counts. Because of this, Plaintiff requested leave to amend his First Amended Complaint, which was granted by the Court. See Order Granting Defendant's Motion to Dismiss [ECF No. 36]. After Plaintiff filed his SAC, Defendant filed the Motion before the Court.
LEGAL STANDARD
To maintain an action in federal court, a complaint must set forth "a short and plain statement of the claim showing that the pleader is entitled to relief." FED. R. CIV. P. 8(a)(2). If the complaint fails to "state a claim to relief that is plausible on its face[,]" the defendant may seek to dismiss the complaint under Rule 12(b)(6). Ashcroft v. Iqbal , 556 U.S. 662, 678–79, 129 S.Ct. 1937, 173 L.Ed.2d 868 (2009). Once the defendant challenges the complaint, the court assesses whether the complaint's factual allegations, any documents incorporated into the complaint by reference, and any matters of which the court may take judicial notice, if true, would entitle the plaintiff to relief. Tellabs, Inc. v. Makor Issues & Rights, Ltd. , 551 U.S. 308, 322, 127 S.Ct. 2499, 168 L.Ed.2d 179 (2007). While the court must accept as true all properly pleaded factual allegations, the court need not accept the plaintiff's legal conclusions. Id. The court ultimately must determine whether the complaint describes "factual content" that supports "the reasonable inference that the defendant is liable for the misconduct alleged." Iqbal , 556 U.S. at 679, 129 S.Ct. 1937. If the complaint does not contain such factual content, the plaintiff has failed to state a claim upon which relief may be granted, and the court must dismiss the complaint. Id. at 680, 129 S.Ct. 1937 (citing Bell Atlantic Corp. v. Twombly , 550 U.S. 544, 570, 127 S.Ct. 1955, 167 L.Ed.2d 929 (2007) ). And "[f]actual allegations that are merely consistent with a defendant's liability fall short of being facially plausible." Chaparro v. Carnival Corp. , 693 F.3d 1333, 1337 (11th Cir. 2012).
Generally, " ‘a plaintiff must be given at least one chance to amend the complaint before the district court dismisses the action with prejudice.’ " Bryant v. Dupree , 252 F.3d 1161, 1163 (11th Cir. 2001) (quoting Bank v. Pitt , 928 F.2d 1108, 1112 (11th Cir. 1991) ). However, a district court need not permit an amendment in the following three circumstances: "(1) where there has been undue delay, bad faith, dilatory motive, or repeated failure to cure deficiencies by amendments previously allowed; (2) where allowing amendment would cause undue prejudice to the opposing party; or (3) where amendment would be futile." Id. (citation omitted).
ANALYSIS
Defendant maintains that each of Plaintiff's claims fail. First, Defendant asserts that Plaintiff did not allege the Product was the proximate cause of his injuries. Mot. at 6-9. This, according to Defendant, is fatal to all of Plaintiff's claims. In addition, Defendant asserts that Plaintiff's design and manufacturing claims fail because Plaintiff has not alleged a specific defect that caused his injuries or how the Product "departed from its FDA-cleared design." Id. at 6, 10-13. Defendant also alleges that Plaintiff's failure to warn claim must fail because the Product's Instructions For Use clearly warn of the risk of infection. Id. at 6, 13-16. Lastly, Defendant argues that Plaintiff fails to state a cause of action for negligence and in any event, his negligence action "overlaps" with his claims for manufacturing and design defect, thereby warranting dismissal. Id. at 16. The Court will address each issue in turn.
A. Strict Liability—Design Defect
"To state a claim in Florida for strict products liability based on a design or manufacturing defect, a plaintiff must plead three elements: (1) a relationship between the defendant and the product; (2) a defect which caused the product to be unreasonably dangerous; (3) causation between the defect and the harm suffered by the user." Dimieri v. Medicis Pharm. Corp. , No. 14-17638, 2014 WL 3417364, at *4 (M.D. Fla. July 14, 2014) (internal quotations omitted) (quoting Bailey v. Janssen Pharmaceutica, Inc. , 288 F. App'x 597, 607 (11th Cir. 2008) (" Bailey II ")). Here, the parties do not dispute Defendant is the manufacturer and designer of the Product. Defendant also concedes that Plaintiff has alleged four defects with the Product: (1) the absorbable collagen barrier; (2) the polyester textile; (3) the small pore size; and (4) the multifilament construct. Mot. at 10. However, despite identifying these four defects, Defendant argues that Plaintiff's design defect claim fails because the SAC does not allege the Product actually implanted in Defendant suffered from any of these defects. Id. at 11 ("Nowhere in the SAC, however, does Plaintiff allege that his mesh tore, or that the absorbable barrier broke down.") (emphasis in original).
In support of its argument, Defendant relies on Tsavaris v. Pfizer , where the district court dismissed without prejudice plaintiff's design defect claim because the plaintiff "merely declare[d] that the product was ‘unreasonably dangerous,’ that its ‘risks ... exceeded any benefits or utility associated with the design or formulation,’ and that the drug is ‘much more dangerous than other available and safe alternative ... drugs.’ " No. 15-21826, 2016 WL 375008, at *2 (S.D. Fla. Feb. 1, 2016) ; see also Jackson v. St. Jude Med. Neuromodulation Division , No. 14-71738, 2015 WL 1456650, at *7-8 (M.D. Fla. Mar. 30, 2015) (dismissing without prejudice plaintiff's product liability claims in part because plaintiff failed to allege how the product was defective or the type of injuries he experienced); Kaufman v. Pfizer Pharm., Inc. , No. 02-22692, 2010 WL 9438673, at *5 (S.D. Fla. Nov. 23, 2010) ("Plaintiff fails to state a plausible products liability claim[ ] because she does not identify potential defects in each of the drugs that could have caused her cancer ; she merely alleges that the drugs are ‘defective.’ ").
However, the alleged defects in the Complaint are not like the allegations in Tsavaris or Kaufman . Here, the Complaint does not state in a conclusory fashion that the Product is "defective" or "unreasonably dangerous." Rather, it alleges at least four specific defects with the Product, and Plaintiff claims these defects caused either an infection or an inflammatory response. This is sufficient to put Defendant on notice of the alleged defects with the Product. See Bailey II , 288 F. App'x at 605-06 (finding plaintiff sufficiently alleged a defect even though "the complaint alleges in a conclusory fashion that the patch [was] unreasonably dangerous" because it also suggested several possible defects). Additionally, Plaintiff's failure to pinpoint which defect the implanted Product suffered from at this stage in the litigation is not fatal. See Shapiro v. NuVasive, Inc. , No. 19-23163, 2019 WL 5742159, at *2 (S.D. Fla. Nov. 5, 2019) (citation omitted) ("[T]he law only requires [plaintiff] to identify a defect that she contends caused her injury. It does not require [plaintiff] to prove that the screws used in her surgery were in fact defective."); Krywokulski v. Ethicon , No. 09-98030, 2010 WL 326166, at *2 (M.D. Fla. Jan. 21, 2010) (explaining that a plaintiff cannot reasonably be expected "to prove the existence of a product defect at the pleading stage of trial") (emphasis added).
Defendant also claims that even if Plaintiff alleged a defect, the claim still fails because Plaintiff has not adequately alleged causation. Defendant asserts the Complaint is insufficient because "Plaintiff does not explain how the mesh caused his alleged pelvic and hip infections" or that the Product itself was infected. Mot. at 7-8 (emphasis added).
In support of its argument, Defendant relies on Pillitteri v. Merck & Co., Inc., Rincon v. Covidien , and Nowell v. Medtronic, Inc. In Pillitteri , the court dismissed without prejudice plaintiff's strict liability claim because plaintiff simply failed to incorporate his claims regarding proximate cause into his action for strict liability and as a result, the plaintiff only alleged a causal connection between the manufacturers’ breach of duties and his injuries. No. 18-3730, 2018 WL 8244490, at *2 n.3 (M.D. Fla. July 20, 2018) ("Had [p]laintiff incorporated the general allegations into this count, the [c]ourt might have concluded otherwise."). In Rincon , the court, relying on New York law, determined that the complaint was insufficient because plaintiff failed to prove the mesh caused her injuries and failed to eliminate other plausible explanations for her injuries. No. 16-10033, 2017 WL 2242969, at *1 (S.D.N.Y. May 22, 2017). Similarly, the court in Nowell dismissed plaintiff's design defect claim with prejudice, in part, because the injuries alleged were "common injuries caused by hernia surgeries" and the complaint failed to suggest other explanations were less likely. 372 F. Supp. 3d 1166, 1250 (D.N.M. 2019) appeal filed , No. 19-2073 (10th Cir. 2019).
All three cases are distinguishable when compared to the instant case. First, the design defect claim in Pillitteri failed because plaintiff did not incorporate his "general allegations" regarding proximate cause. Here, Plaintiff has specifically alleged that the Product caused a "negative and detrimental bodily reaction[,]" including an infection that spread to Plaintiff's pelvis and hip. See SAC. ¶¶ 27-31. Moreover, Plaintiff has incorporated all factual allegations in each cause of action. Id. at ¶¶ 42, 49, 59, 67. Second, the courts in Rincon and Nowell evidently impose a higher burden on plaintiffs than what Florida law mandates. Under Florida law, plaintiffs are not required to "set forth the precise chemical, biological, or other process" by which the defective product causes the alleged harm in a motion to dismiss. Small v. Amgen , 2 F. Supp. 3d 1292, 1297 (M.D. Fla. 2014) (" Small I "); see also Godelia v. Doe 1 , 881 F.3d 1309, 1318 (11th Cir. 2018) (finding plaintiff "need not state in his complaint the precise defect that caused" the product to malfunction). Instead, plaintiffs need only "place defendants on notice of the type of harm allegedly caused by the design defect." Small I , 2 F. Supp. 3d at 1297. Furthermore, any apparent misuse of the Product by Plaintiff's physicians or any other intervening cause is "relevant only as an affirmative defense and need not be affirmatively pled." Bailey II , 288 F. App'x at 608.
Although Plaintiff's newly added allegations are somewhat bare, they sufficiently notify Defendant of the alleged harm caused by the Product. It would be unreasonable for the Court to require Plaintiff to plead exactly how the implanted Product is defective and how it caused his alleged injuries when Plaintiff has not yet been afforded discovery or the benefit of expert testimony. See Hosler v. Alcon Labs., Inc. , No. 12-60025, 2012 WL 4792983, at *7 (S.D. Fla. Oct. 9, 2012). Therefore, the Court denies Defendant's Motion as to this claim.
B. Strict Liability—Manufacturing Defect
"Courts in the Eleventh Circuit regularly allow plaintiffs to plead multiple theories [of liability] (e.g., both design and manufacturing defect), providing that they adequately allege the defect." Kilmer v. Howmedica Osteonics Corp. , No. 14-45634, 2015 WL 5915950, at *4 (M.D. Fla. Oct. 8, 2015) (citation omitted). Thus, in this circuit and under Florida law, the method by which to state a claim for manufacturing defect is identical to that of a design defect: plaintiff need only allege "three elements: (1) a relationship between the defendant and the product; (2) a defect which caused the product to be unreasonably dangerous; (3) causation between the defect and the harm suffered by the user." Dimieri , 2014 WL 3417364, at *4 (citation and internal quotations omitted); see also Jennings v. BIC Corp. , 181 F.3d 1250, 1255 (11th Cir. 1999) (citation omitted).
Despite this identical standard, Defendant asserts that Plaintiff's manufacturing defect claim must fail because Plaintiff did allege how the Product departs from its intended design or how the Product contains an "aberrational" defect not occurring throughout an entire line of the Product. Mot. at 12. This, according to Defendant, is necessary to distinguish a claim for manufacturing defect from design defect. In support of this proposition, Defendant cites to Bailey v. Janssen Pharmaceutica Inc. , No. 06-80702, 2006 WL 3665417, at *3 (S.D. Fla. Nov. 14, 2006) (" Bailey I ") and Ocasio v. C.R. Bard, Inc. , No. 13-1962, 2015 WL 3496062, at *7 (M.D. Fla. June 3, 2015). However, both cases are distinguishable and/or inapplicable.
In Bailey I , the district court dismissed the operative complaint on both procedural and substantive grounds. 2006 WL 3665417, at *2-3. With respect to the substantive reasons for dismissal, the district court found the complaint did not allege whether the defects "occurred in the assembly line as opposed to an overall design defect." Id. at *3. But in Bailey II , the Eleventh Circuit specifically noted that
[I]t would be difficult at such an early stage in the litigation for a plaintiff to know whether a defect was due to a product's design or manufacture, despite the district court's insistence that appellant specifically plead the source of the defect and not commingle available theories of strict liability recovery. We are not convinced that Florida law applies a rigid distinction among the various theories of recovery available to plaintiffs under strict products liability such that a plaintiff would be required to expressly plead "design defect" versus "manufacturing defect" at the complaint stage. It is difficult for a plaintiff at this stage in the litigation to know the source of the defect that was responsible for the harm caused: whether there was a surprising manufacturing problem, a systemic issue with a product in its design, or a failure on the part of the manufacturer to warn doctors that particular uses might pose an unreasonable risk of harm.
Bailey II , 288 F. App'x at 605-06 (citation omitted). Defendant argues that Bailey II is distinguishable because it merely provided plaintiffs with leniency in pleading a design defect claim with a manufacturing claim. See Mot. Dismiss First Am. Complaint Hearing Transcript [ECF No. 37] ("Hearing Transcript") 23:15-20. And because Plaintiff does not commingle his design defect claim and his manufacturing defect claim, Defendant claims Bailey II is inapplicable. See id. However, despite this minor distinction, the rationale of Bailey II applies. Rule 8(d)(2) of the Federal Rules of Civil Procedure permits pleading in the alternative and it is difficult for a plaintiff to determine, at this stage of the proceedings, whether the defect "occurred in the assembly line as opposed to an overall design defect." Bailey I , 2006 WL 3665417, at *3 ; see also Krywokulski , 2010 WL 326166, at *3 (citing Bailey II , 288 F. App'x at 605 ) ("Plaintiff's allegation of a defect alone is sufficient, as mere knowledge of a defect gives defendant enough notice to produce a proper response which may include discussion of a manufacturing or design based defect.").
In Ocasio , the district court was considering a motion for summary judgment—an entirely different procedural posture where plaintiff was afforded discovery and was required to prove her claim. See Ocasio , 2015 WL 3496062, at *1-2. To prevail on a motion for summary judgment—not a motion to dismiss—plaintiff must prove the product departed from its intended design and failed to perform as safely as the intended design would have performed. Clearly, the procedural posture here differs significantly. Plaintiff does not need to prove his claims, he must only plead enough factual allegations to plausibly state a claim and provide Defendant notice of which claims he intends to pursue.
As stated herein, Plaintiff has sufficiently alleged several defects with the Product and according to the SAC, the Product caused his infection and/or inflammatory reaction. Accordingly, Plaintiff has stated enough facts to support a cause of action for manufacturing defect and the Court must deny Defendant's Motion as to this claim.
C. Strict Liability—Failure to Warn
"Under Florida law, when strict liability is based on a [medical product's] insufficient warnings[,] ... plaintiff must allege all of the following: (1) that the warnings accompanying the item were inadequate; (2) that the inadequacy of the warnings proximately caused Plaintiff's injury; and (3) that Plaintiff in fact suffered an injury by using the product." Dimieri , 2014 WL 3417364, at *4 (quoting Hosler, 2012 WL 4792983, at *9 ) (internal quotations omitted). Plaintiff must also "plead the content of the warning label or otherwise describe the manner in which the warning was inadequate." Tsavaris , 2016 WL 375008, at *3 (citing Bailey II , 288 F. App'x at 609 ); see also Wright v. Howmedica Osteonics Corp. , 741 F. App'x 624, 626 (11th Cir. 2018) (" Wright II ") (same).
In relevant part, Florida has adopted the learned intermediary doctrine. Bailey II , 288 F. App'x at 608 (applying the learned intermediary doctrine when reviewing sufficiency of allegations on motion to dismiss). Consequently, "the duty to warn flows from the [medical product] manufacturer to the physician, not the ultimate consumer[,]" see id. , and plaintiff must "assert [the] warnings given to his physician were inadequate." Dimieri , 2014 WL 3417364, at *4 (emphasis added); see also Small I , 2 F. Supp. 3d at 1297 ("[T]he duty to warn is directed to physicians rather than patients under the ‘learned intermediary’ doctrine."). Thus, if the manufacturer "can show that it provided the medical community with an adequate warning of the risks associated with the product[,]" it will not be held liable. Hosler , 2012 WL 4792983, at *9. This is so because "the prescribing physician, act[s] as a ‘learned intermediary’ between the manufacturer and the consumer, [and] weighs the potential benefits against the dangers in deciding whether to recommend the drug to meet the patient's needs." Pierre v. Intuitive Surgical, Inc. , No. 18-60095, 2020 WL 1240420, at *12 (S.D. Fla. Mar. 6, 2020) (citation omitted); see also Wolicki–Gables v. Arrow International, Inc. , 641 F. Supp. 2d 1270, 1286 (M.D. Fla. 2009), aff'd , 634 F.3d 1296 (11th Cir. 2011) ("It is the physician's duty to inform himself of the qualities and characteristics of the products which he prescribes for his patients, and to exercise an independent judgment, taking into account his knowledge of the patient as well as the product.").
At the Hearing, Defendant argued the Court could take judicial notice of the Product's Instructions For Use [ECF No. 39-1] ("IFU") to contradict Plaintiff's allegations. See Hearing Transcript 6:2-10. Defendant asserted that the IFU specifically warned Plaintiff's physicians of the risks of inflammation and infection. Id. In response, Plaintiff did not dispute the IFU warned of these risks nor did Plaintiff challenge whether the Court may take judicial notice of the IFU. Instead, Plaintiff claimed the IFU was inadequate because it did not warn physicians of the specific risk of hip replacement surgery. Id. at 6:18-25, 7:1-18. In light of this, the Court expressed some concern with Plaintiff's failure to warn claim, stating:
"Federal Rule of Evidence 201 provides that a court may, when requested by a party who supplies ‘the necessary information,’ take judicial notice of an adjudicative fact ‘at any stage of the proceeding’ if it ‘can be accurately and readily determined from sources whose accuracy cannot reasonably be questioned.’ " Leroy v. Medtronic, Inc. , No. 14-284, 2015 WL 4600880, at *5 (N.D. Fla. July 29, 2015) (quoting Fed. R. Evid. 201( b )(2) ). "Courts in this circuit and elsewhere have taken judicial notice of similar FDA public records under similar circumstances, and without transforming a motion to dismiss under Rule 12(b)(6) into a motion for summary judgment." Id. (citation omitted); see also Horne v. Potter , 392 F. App'x 800, 802 (11th Cir. 2010) (finding that a district court may take judicial notice of documents without converting a motion to dismiss into a motion for summary judgment).
The issue here is this could initially cause inflammation, ... which then leads to purportedly—even though it's the general area—infection, which then leads to, ... hip replacement.... [T]he way it's been restated, I think, is troublesome because ... failure to warn would [be] satisf[ied] under any standard.... Just plead something that the FDA hasn't thought of. God forbid there [are] a million things that could manifest, given someone's physical condition.
Id. at 44:2-13.
Despite the Court's concerns and Plaintiff's opportunity to amend, Plaintiff's SAC did not add any allegations regarding his failure to warn claim. Indeed, with the exception of five paragraphs relating to causation, Plaintiff merely re-alleges the exact same information. He claims the IFU fails to adequately warn of numerous side effects relating to the Product, such as "immunologic response, pain, encapsulation, rejection, migration, scarification, contradiction, adhesion, erosion, bowel obstruction, [ ] hernia incarceration and strangulation[,]" increased risk of foreign body response and "long-lasting chronic inflammatory reaction." SAC ¶¶ 70-71. Plaintiff also asserts that the IFU fails to provide warnings regarding the "duration, frequency, or severity" of complications associated with the Product. Id. at ¶ 72. And lastly, Plaintiff maintains that had he and his physician been properly warned of the defects linked to the Product, Plaintiff would not have consented to the implantation of the Product and Plaintiff's treating physician would not have implanted the Product into Plaintiff. Id. at ¶ 73.
Notably, the SAC is devoid of any allegations indicating the IFU was inadequate because it failed to specifically warn of "hip replacement surgery"—an argument raised by Plaintiff at the Hearing. Consequently, the Court will not consider this allegation in addressing the Motion.
In its Motion, Defendant asserts that Plaintiff did not suffer any of the alleged "numerous side effects." Mot. at 14. Defendant claims Plaintiff only alleges he suffered an inflammatory response and/or infection from the Product—a complication clearly warned of in the IFU—and therefore, his claim must be dismissed with prejudice. Id. Further, in light of the learned intermediary doctrine, Defendant maintains that Plaintiff's failure to warn claim fails. Id. at 15. In his Response, Plaintiff does not challenge whether the Court may take judicial notice of the IFU. Instead, Plaintiff merely copies block quotes—without any independent analysis—from two distinguishable cases, Romer v. Stryker Corp. , No. 18-1999, 2018 WL 1496971 (M.D. Fla. Mar. 27, 2018) and Ripple v. Davol, Inc. , No. 16-14455, 2017 WL 2363697 (S.D. Fla. May 31, 2017). The Court will address each in turn.
Given that this issue is uncontested by Plaintiff, the Court will take judicial notice of the IFU provided by Defendant pursuant to Rule 201 of the Federal Rules of Evidence. See Chapman v. Abbott Labs. , 930 F. Supp. 2d 1321, 1323 (M.D. Fla. 2013) (taking judicial notice of FDA-approved label on a motion to dismiss). And to the extent the IFU contradicts the SAC, the Court need not take Plaintiff's allegations as true. See Chapman , 930 F. Supp. 2d at 1323 (citation omitted) ("A court need not accept as true allegations in a complaint that contradict or are inconsistent with judicially-noticed facts.").
In Romer , plaintiff alleged defendants "inadequately warned or failed to warn purchasers of its products or potential users of its products within the general public and foreseeable users of its products, such as [p]laintiff, of the defects in the [product] about which [d]efendants knew or should have known." 2018 WL 1496971, at *4. This, according to the district court, plausibly stated a claim for failure to warn under Florida law. Id. However, this Court respectfully disagrees. Not only is this allegation entirely conclusory and devoid of any factual support, it also improperly focuses on whether the consumer or patient was properly warned by the manufacturer. Under Florida law, the inquiry must be physician-focused pursuant to the learned intermediary doctrine. See, e.g. , Tutwiler v. Sandoz, Inc. , 726 F. App'x 753, 755-56 (11th Cir. 2018) (applying Alabama's identical learned intermediary doctrine; affirming dismissal of failure to warn claim because plaintiff only "claim[ed] that she would not have taken amiodarone had she known of its dangerous effects; noting "Alabama law requires a showing of what [plaintiff's physician] would have done with it") (emphasis in original); Bailey II , 288 F. App'x at 608-09 (affirming the district court's dismissal of failure to warn claim with prejudice in part because the amended complaint failed to state the information available to plaintiff's physician ); Dimieri , 2014 WL 3417364, at *4 (dismissing failure to warn claim because complaint did not allege the warnings given to his physician were inadequate). Therefore, the Court does not find Romer persuasive.
Plaintiff relies on Ripple for two reasons: (1) to establish he has sufficiently pleaded his failure to warn claim; and (2) to assert that Defendant's argument is premature. Resp. at 6. In relevant part, the Ripple Court found the amended complaint sufficiently stated a cause of action for failure to warn because plaintiff asserted that she and her physician were inadequately warned of the alleged defects. However, the inquiry is not whether the manufacturer warned of defects , the question is whether the manufacturer warned of risks. See Pierre , 2020 WL 1240420, at *12 (citation omitted) ("[Defendant] need only reasonably warn physicians of the injury alleged from failure to use the product in the prescribed manner, not the specific way(s) the alleged injury may occur.") (emphasis added); Small I , 2 F. Supp. 3d at 1297 (citation omitted) ("[T]he critical inquiry is whether it was adequate to warn the physician of the possibility that the drug may cause the injury alleged by the plaintiff.") (emphasis added); Brito v. Cty. of Palm Beach , 753 So. 2d 109, 112 (Fla. 4th DCA 1998) ("A warning should contain some wording directed to the significant dangers arising from failure to use the product in the prescribed manner, such as the risk of serious injury or death."). Thus, like Romer , Ripple is similarly unpersuasive.
Notably, the Ripple defendants were parties to a related MDL action which had been litigated for over 10 years. 2017 WL 2363697, at *2. This, at least in part, motivated the district court's decision to deny the motion to dismiss because defendant was sufficiently put on notice of the claims alleged in the amended complaint. Id.
The Ripple Court also determined that defendants’ argument was premature because the warnings defendants may have given plaintiff's physician is a "fact intensive affirmative defense which should not be resolved pursuant to a motion to dismiss." 2017 WL 2363697, at *3 (citation omitted). However, this Court—and several other courts in this circuit—disagree. See, e.g. , Tutwiler , 726 F. App'x at 755-56 ; Bailey II , 288 F. App'x at 608-09 ; Dimieri , 2014 WL 3417364, at *4. To survive a motion to dismiss, Plaintiff must allege facts relating to the learned intermediary doctrine, such as whether plaintiff's physician had "adequate" warning of the resulting injury or whether plaintiff's physician would have prescribed a different course of treatment if given the adequate warning. And although the "adequacy" of these warnings may become a fact-intensive inquiry inappropriate for a motion to dismiss, it may be decided as a matter of law where the warning is "accurate, clear, and unambiguous." Farias v. Mr. Heater Inc. , 684 F.3d 1231, 1233 (11th Cir. 2012) (citation and internal quotations omitted).
Here, the IFU clearly warns of the following complications: "seroma / hematoma / recurrence / adhesions / chronic pains / infection / inflammation / allergic reactions to the components of the product." See IFU-Possible Complications. In relevant part, the SAC alleges the IFU is inadequate because it does not warn of the necessity for invasive surgical intervention in the event of complications; pain; recurrence; chronic inflammatory reactions. Clearly, the IFU contradicts all of Plaintiff's allegations with the exception of one: the necessity for invasive surgical intervention in the event of complications. However, this does not save Plaintiff's claim. As explained above, Defendant need only warn of complications stemming from the use of the Product—not the subsequent measures medical professionals may employ to treat those complications.
The IFU also does not recommend using the Product when undergoing "surgery in an infected or contaminated place." See IFU-Contraindications. It is worth noting—although Defendant did not raise this issue in its Motion—that Plaintiff underwent a surgery for his first infection and the Product was not removed. See SAC ¶ 30. One month later, Plaintiff developed a second infection resulting in full hip replacement surgery, and it is unclear whether Plaintiff's physicians removed or re-implanted the Product. Id. at ¶¶ 15, 64. Thus, it appears that Plaintiff's treating physician continued to use the Product in Plaintiff during surgery in an infected "nearby" area in violation of the IFU recommendations.
Moreover, Plaintiff cannot maintain a cause of action against a manufacturer for failing to warn of injuries he did not experience. See Wright v. Howmedica Osteonics Corp. , No. 17-45930, 2017 WL 4555901, at *3 (M.D. Fla. Oct. 12, 2017), (" Wright I ") ("Of course, a plaintiff must also allege that she was damaged by the failure to warn."); Small I , 2 F. Supp. 3d at 1297 (citation omitted). Nor can Plaintiff state a claim for failure to warn by alleging Defendant failed "to adequately train how to properly treat complications." SAC ¶ 71; see Small v. Amgen , 134 F. Supp. 3d 1358, 1372 (M.D. Fla. 2015) (rejecting plaintiff's theory that defendants failed to provide guidance on resuming treatment after an infection because there is no duty to provide guidance under Florida law). Thus, in light of the Court expressing the aforementioned concerns at the Hearing and Plaintiff's failure to remedy these issues, the Court grants Defendant's Motion as to this claim with prejudice.
D. Negligence
"In order to state a claim for negligence under Florida law, the plaintiff must allege (1) a duty or obligation recognized by the law requiring the defendant to protect others from unreasonable risks; (2) a breach of that duty; (3) a reasonably close causal connection between the conduct and the resulting injury; and (4) actual loss or damages." Small I , 2 F. Supp. 3d at 1299 (citing Williams v. Davis , 974 So. 2d 1052, 1056 (Fla. 2007) ). Here, Plaintiff alleges Defendant breached its duty of care by:
• Failing to design and manufacture the Product to avoid unreasonable risk of harm;
• Withholding adverse information relating to the Product from Plaintiff and Plaintiff's treating physician;
• Failing to adequately inform Plaintiff and his physician of the risks associated with the Product;
• Failing to use reasonable care in testing and studying the Product;
• Failing to comply with state and federal regulations concerning the Product; and
• Failing to adequately instruct, or train treating physicians as to the Product.
Because Plaintiff has plausibly stated a claim for strict liability design defect and manufacturing defect, the Court finds Plaintiff has stated sufficient allegations to support a claim for negligent manufacturing. Additionally, Plaintiff's claim that Defendant withheld adverse information relating to the Product from Plaintiff's treating physician survives because it sufficiently notifies Defendant of its alleged breach of duty.
However, Plaintiff's negligence claim based on inadequate warnings fails for the same reasons his strict products liability failure to warn claim cannot succeed. Tsavaris , 2016 WL 375008, at *4. In addition, Plaintiff's allegation of inadequate testing and "studying" is unsound. "Under Florida law, a manufacturer's duty to test is a subpart of its duty to design a product with reasonable care and, therefore, is subsumed in the plaintiff's claims for defective design and failure to warn." Tsavaris , 2016 WL 375008, at *4 (emphasis added); Small I , 2 F. Supp. 3d at 1299 ("[P]laintiffs’ claim for negligence cannot rest on defendants’ alleged failure to test or inspect."). Accordingly, Plaintiff cannot support his negligence claim on these bases and they must be dismissed.
Likewise, Plaintiff cannot base his negligence claim upon Defendant's alleged failure to comply with state or federal regulations. This allegation is entirely conclusory and does not adequately put Defendant on notice of its alleged wrongdoing. Moreover, the failure to link a violation of purported state or federal regulations to Plaintiff's injury is fatal to his negligence claim on this basis. See Stokes v. I-Flow Corp. , No. 12-99136, 2013 WL 1715427, at *7 (M.D. Fla. Apr. 8, 2013) (finding plaintiff's allegations insufficient because he failed to set forth any problem or failure to comply with a federal regulation that could be linked to the injury alleged).
Lastly, Defendant does not have a duty to provide guidance or training to treating physicians under Florida law. Thus, Plaintiff cannot state a claim for negligence on this basis. See Small II , 134 F. Supp. 3d at 1372 (noting there is no duty to provide guidance under Florida law). Even if such a duty existed, Plaintiff's allegation nonetheless fails because it is conclusory and lacks factual support.
In sum, Plaintiff's negligence claim may only be based on allegations regarding negligent manufacturing and Defendant's failure to notify Plaintiff and his physician of adverse events. The Court grants Defendant's Motion as to all other bases for purported negligence.
CONCLUSION
For the reasons stated herein, it is hereby
ORDERED AND ADJUDGED as follows: 1. Defendant's Motion [ECF No. 39] is GRANTED IN PART AND DENIED IN PART . Except for Plaintiff's negligence claim based on negligent manufacturing and failure to report adverse events to Plaintiff and his physician, Count I of the SAC is DISMISSED with prejudice . Likewise, Count IV of the SAC is DISMISSED with prejudice .
2. On or before June 30, 2020 , Plaintiff shall file a Third Amended Complaint reflecting the changes ordered in Paragraph 1 of this Order.
DONE AND ORDERED in Fort Lauderdale, Florida, this 16th day of June, 2020.