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finding medical device warnings adequate as a matter of law and dismissing fraud claims as "mere repacking" of the failure to warn claim
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Case No. 19-cv-24000-SINGHAL/Louis
2020-05-20
Maricel NUNEZ, Plaintiff, v. COLOPLAST CORP., Defendant.
Adam Daniel Peavy, Pro Hac Vice, Kathryn Grace Hooten, Pro Hac Vice, Clayton A. Clark, Lauren Schultz, Lezzlie Elizabeth Hornsby, Scott A. Love, Pro Hac Vice, Shelley Van Natter Hutson, Pro Hac Vice, William Michael Moreland, Pro Hac Vice, Clark, Love & Hutson, PLLC, Houston, TX, Joseph Anthony Osborne, Osborne & Francis, Boca Raton, FL, for Plaintiff. Amy E. Furness, Carlton Fields Jorden Burt, P.A., Miami, FL, Caycee Danielle Hampton, Edward Walter Gerecke, David J. Walz, Carlton Fields Jorden Burt, P.A., Tampa, FL, Valentin Leppert, Pro Hac Vice, King & Spalding LLP, Atlanta, GA, William E. Steimle, Pro Hac Vice, King & Spalding LLP, San Francisco, CA, Lana K. Varney, Pro Hac Vice, King & Spalding, Austin, TX, for Defendant.
Adam Daniel Peavy, Pro Hac Vice, Kathryn Grace Hooten, Pro Hac Vice, Clayton A. Clark, Lauren Schultz, Lezzlie Elizabeth Hornsby, Scott A. Love, Pro Hac Vice, Shelley Van Natter Hutson, Pro Hac Vice, William Michael Moreland, Pro Hac Vice, Clark, Love & Hutson, PLLC, Houston, TX, Joseph Anthony Osborne, Osborne & Francis, Boca Raton, FL, for Plaintiff.
Amy E. Furness, Carlton Fields Jorden Burt, P.A., Miami, FL, Caycee Danielle Hampton, Edward Walter Gerecke, David J. Walz, Carlton Fields Jorden Burt, P.A., Tampa, FL, Valentin Leppert, Pro Hac Vice, King & Spalding LLP, Atlanta, GA, William E. Steimle, Pro Hac Vice, King & Spalding LLP, San Francisco, CA, Lana K. Varney, Pro Hac Vice, King & Spalding, Austin, TX, for Defendant.
ORDER ON DEFENDANT'S MOTION FOR SUMMARY JUDGMENT
RAAG SINGHAL, UNITED STATES DISTRICT JUDGE
THIS CAUSE is before the Court on Defendant Coloplast Corp.'s Motion for Summary Judgment and Incorporated Memorandum of Law (DE [101] ). In addition to the following filings—Defendant Coloplast's Statement of Material Facts in Support of its Motion for Summary Judgment (DE [102] ), Plaintiff's Response in Opposition to Defendant Coloplast Corp.'s Motion for Summary Judgment (DE [118] ), Plaintiff's Response to Coloplast Corp.'s Statement of Material Facts in Support of its Motion for Summary Judgment (DE [119] ), and Defendant Coloplast Corp.'s Reply Memorandum of Law in Further Support of its Motion for Summary Judgment (DE [135] )—and record evidence, the Court had the benefit of looking to dozens of district court and circuit court opinions on nearly identical issues raised in the myriad related multidistrict-litigation actions ("MDLs") across the nation emanating from mesh-sling implants. Taking all of the foregoing into consideration and being fully advised in the premises, after careful consideration, this order follows.
I. LEGAL STANDARD ON A MOTION FOR SUMMARY JUDGMENT
Summary judgment is appropriate "if the movant 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). "A district court must grant a motion for summary judgment only if the pleadings, depositions, answers to interrogatories, and admissions on file, together with the affidavits, if any, show that there is no genuine issue as to any material fact and that the moving party is entitled to a judgment as a matter of law." Essex Ins. Co. v. Barrett Moving & Storage, Inc. , 885 F.3d 1292, 1299 (11th Cir. 2018). An issue is "genuine" if a reasonable trier of fact, viewing all of the record evidence, could rationally find in favor of the nonmoving party in light of his burden of proof. Harrison v. Culliver , 746 F.3d 1288, 1298 (11th Cir. 2014). And a fact is "material" if, "under the applicable substantive law, it might affect the outcome of the case." Hickson Corp. v. N. Crossarm Co. , 357 F.3d 1256, 1259–60 (11th Cir. 2004). "[W]here the material facts are undisputed and do not support a reasonable inference in favor of the non-movant, summary judgment may properly be granted as a matter of law." DA Realty Holdings, LLC v. Tenn. Land Consultants , 631 F. App'x 817, 820 (11th Cir. 2015).
The moving party's burden on a motion for summary judgment "depend[s] on whether the legal issues ... are ones on which the movant or the non-movant would bear the burden of proof at trial." Fitzpatrick v. City of Atlanta , 2 F.3d 1112, 1115 (11th Cir. 1993). "[F]or issues on which the movant would bear the burden of proof at trial, ‘that party must show affirmatively the absence of a genuine issue of material fact: it must support its motion with credible evidence ... that would entitle it to a directed verdict if not controverted at trial.’ " Id. (emphasis in original) (quoting United States v. Four Parcels of Real Prop. in Greene & Tuscaloosa Ctys. In State of Ala. , 941 F.2d 1428, 1437 (11th Cir. 1991) ). "For issues, however, on which the non-movant would bear the burden of proof at trial, ‘the moving party is not required to support its motion with affidavits or other similar material negating the opponent's claim in order to discharge this initial responsibility.’ " Id. (emphasis in original) (quoting Four Parcels , 941 F.2d at 1437–38 ).
Coloplast bases this motion for summary judgment on six statements of material fact. See Statement of Material Facts (DE [102] ). Plaintiff "admits" to each of the six statements. See Pl.'s Resp. to Coloplast Corp.'s Statement of Material Facts (DE [119] ).
This action began as an MDL and has since been transferred from the Southern District of West Virginia ("MDL Court"). According to Plaintiff, this action is one of more than 120,000 products liability cases consolidated into seven related pelvic mesh cases as a multidistrict litigation in 2010. Plaintiff brings claims against Coloplast, manufacturer of the Altis Single Incision Sling System ("Altis").
In 2009, Plaintiff elected to undergo pelvic floor reconstructive surgery to treat her symptoms of stress urinary incontinence. In 2013 and 2015, she had a second and third follow-up surgery. All three surgeries were performed by the same surgeon. In the first, she received a mesh sling manufactured by the company Ethicon; in the latter two, she received an Altis manufactured by Coloplast. Following complications from these surgeries, she brought claims for products liability, alleging that her Altis implants were defective and that Coloplast failed to warn of any risks associated with its Altis implants.
Plaintiff has settled her claims with Ethicon.
III. DISCUSSION
Of Plaintiff's sixteen claims, Coloplast first moves for summary judgment on all sixteen, arguing Plaintiff has not proven specific causation. The Court will address this argument first, as it would be dispositive of all other arguments raised by Coloplast, if the Court agrees. The Court will then address Coloplast's arguments as to individual counts.
Based on the Short Form Complaint (DE [1] ), Plaintiff is not seeking relief for the MDL's Count XIII (Violation for Consumer Protections Laws) or Count XVI (Loss of Consortium). Further, as discussed in footnote 4, Count I is effectively three counts.
First, some housekeeping. Coloplast does not move for summary judgment on Count I (Negligence, as to Negligent Testing, Design, or Formulation) or Count V (Strict Liability—Design Defect). Those specific claims shall proceed to trial. As for the following counts, Plaintiff does not oppose summary judgment in Coloplast's favor or has agreed not to pursue them at trial: Count I (Negligence, as to Negligent Manufacturing); Count II (Strict Liability—Manufacturing Defect); Count IV (Strict Liability—Defective Product); Count XV (Unjust Enrichment); and Count XVII (Discovery Rule and Tolling). Thus, for these five counts, summary judgment is GRANTED as unopposed in favor of Coloplast. The remaining arguments and counts are addressed below.
Some clarity on Count I is necessary. Plaintiff's first count is negligence. However, both she and Coloplast parse this into numerous sub-counts:
• Negligent Testing, Negligent Design, and Negligent Form;
• Negligent Manufacturing; and
• Negligent Failure to Warn.
See Joint Status Report (DE [74] ).
A. Specific Causation (All Counts)
Coloplast contends specific causation must be proven by medical-expert testimony; and that summary judgment is required where a plaintiff fails to provide such expert testimony. However, the Court is not entirely convinced the rule is as rigid as Coloplast represents. The cases to which it cites seem to find that expert testimony was necessary there as a matter of fact, not necessarily as a per se matter of law. See Kilpatrick v. Breg, Inc. , 613 F.3d 1329, 1334 n.4 (11th Cir. 2010) ; McClain v. Metabolife Int'l, Inc. , 401 F.3d 1233, 1237 (11th Cir. 2005) ; Guinn v. AstraZeneca Pharm. LP , 598 F. Supp. 2d 1239, 1242 (M.D. Fla. 2009) ; Haller v. AstraZeneca Pharm. LP , 598 F. Supp. 2d 1271, 1275, 1303 n.190 (M.D. Fla. 2009) ; Drury v. Cardiac Pacemakers, Inc. , 2003 WL 23319650, at *4 (M.D. Fla. June 3, 2003) ; Marking v. Novartis Pharm., Corp. , 2002 WL 32255405, at *3 (S.D. Fla. Feb. 12, 2002).
Nevertheless, this argument fails also because it is premised solely on the Court excluding Plaintiff's expert Bruce Rosenzweig, M.D. Coloplast argues: "Because the testimony of Plaintiff's lone expert on specific causation is inadmissible, she lacks the expert testimony necessary to meet her burden of proving causation." Because the Court denied Coloplast's Daubert challenge to Dr. Rosenzweig, see Nunez v. Coloplast Corp. , 2020 WL 2315077, at *7–8 (S.D. Fla. May 11, 2020), this argument is unavailing. Coloplast's motion for summary judgment on all counts for Plaintiff's failure to prove specific causation is DENIED .
B. Failure-to-Warn Claims (Counts I and III)
Next, Coloplast moves for summary judgment on Count I (Negligent Failure to Warn) and Count III (Strict Liability Failure to Warn). The warnings that came with the Altis implants—the "instructions for use" ("IFU")—at the time of Plaintiff's surgeries provided the following:
Adverse Reactions
Potential adverse reactions are those associated with surgery using implantable mesh materials. As with all foreign bodies, the Altis sling is likely to exacerbate any existing infection. Transitory local irritation at the wound site and a foreign body response may occur. There is also the risk of complete failure of the procedure resulting in incontinence and continued mild to moderate incontinence due to incomplete support or overactive bladder.
Known risks of incontinence [related to] surgical procedures with synthetic slings include the following:
• Vaginal extrusion • Scarring • Erosion (e.g., vaginal urethral) • Transient or permanent urinary • Dyspareunia (i.e., painful intercourse) retention/obstruction • Sling migration • Urethral obstruction • Infection • Voiding dysfunction • Pain • Nerve injury • Hematoma • Vascular injury • Bladder, bowel, urethra, vessel and/or nerve perforation
The IFU also provided results of a clinical study of the Altis implants, which included data on the frequency of a dozen adverse events. These included: mesh extrusion, pelvic/urogenital pain, urinary retention, urinary tract infection, de novo urgency, dyspareunia, inflammation, delayed wound healing, non-pelvic pain, worsening overactive bladder, bleeding, and decreased urine stream.
1. The Adequacy of the Warnings
Coloplast argues it is entitled to summary judgment because these IFU were adequate as a matter of law. Coloplast also argues that Plaintiff has not proffered any expert testimony that the IFU were inadequate, and that it has proven its affirmative defense of the "learned intermediary doctrine."
"Under Florida law, to succeed on a failure to warn claim a plaintiff must show (1) that the product warning was inadequate; (2) that the inadequacy proximately caused her injury; and (3) that she in fact suffered an injury from using the product." Eghnayem v. Bos. Sci. Corp. , 873 F.3d 1304, 1321 (11th Cir. 2017). To support a failure-to-warn claim involving a prescription medical product, a plaintiff must present sufficient expert testimony as to how manufacturer's warnings were inadequate. Haggerty v. Upjohn Co. , 950 F. Supp. 1160, 1168 (S.D. Fla. 1996). Failure to present expert testimony warrants summary judgment in favor of the defendant. Paparo v. Ortho McNeil Pharm. , 2007 WL 121149, at *4 (S.D. Fla. Jan. 11, 2007). Should a plaintiff meet this initial burden of production, the adequacy of the warnings typically becomes a question of fact for the jury. Adams v. G.D. Searle & Co. , 576 So. 2d 728, 731 (Fla. 2d DCA 1991). However, the question on the adequacy of the warnings can be resolved as a matter of law if they are "accurate, clear, and unambiguous." Farias v. Mr. Heater, Inc. , 757 F. Supp. 2d 1284, 1293 (S.D. Fla. 2010), aff'd , 684 F.3d 1231 (11th Cir. 2012). This is "determined by a ‘reasonable person’ standard, rather than on each particular plaintiff's subjective appreciation of the danger." Byrnes v. Honda Motor Co., Ltd. , 887 F. Supp. 279, 281 (S.D. Fla. 1994).
Here, the Court has reviewed the IFU extensively and finds them to be adequate as a matter of law. "[M]anufacturers are only required to warn the prescribing physician of the possibility that the drug may cause the injury alleged by the plaintiff." Small v. Amgen, Inc. , 134 F. Supp. 3d 1358, 1367 (M.D. Fla. 2015). The IFU satisfy this. There is no argument that the IFU did not warn of the injury alleged by Plaintiff; they clearly and unambiguously state that "urinary tract infection," "pelvic/urogenital pain," and "dyspareunia" are all possible. In fact, not only do the IFU warn of these risks, they provide the data from clinical studies of these adverse effects.
Recently, in Pierre v. Intuitive Surgical, Inc. , 2020 WL 1240420, at *12–13 (S.D. Fla. Mar. 6, 2020), another court from this district found similar warnings adequate. Further, Pierre forecloses Plaintiff's argument that the IFU fail as a matter of law because they list "potential" adverse effects. Judge Ruiz, in Pierre , rejected a similar argument, relying on Eleventh Circuit case law in ruling: "To warn adequately, the product label must make apparent the potential harmful consequences. The warning must be of such intensity as to cause a reasonable man to exercise for his own safety caution commensurate with the potential danger." 2020 WL 120420, at *13 (emphasis added) (quoting Farias , 684 F.3d at 1233 ).
2. The Learned Intermediary Doctrine
In the alternative, Coloplast also argues it is entitled to summary judgment under the so-called "learned intermediary doctrine." This affirmative defense, MacMorris v. Wyeth, Inc. , 2005 WL 1528626, at *3 (M.D. Fla. June 27, 2005), directs a medical-products manufacturer's duty to warn of potentially dangerous side effects "to the physician rather than the patient," Felix v. Hoffmann-LaRoche, Inc. , 540 So. 2d 102, 104 (Fla. 1989). "The rationale behind the doctrine is that patients do not have access to prescription medicines without the intervention of the learned intermediary; the manufacturer therefore has no duty to warn the patient him or herself." Beale v. Biomet, Inc. , 492 F. Supp. 2d 1360, 1368 (S.D. Fla. 2007). When proved by a defendant, the learned intermediary—the doctor, in this case—breaks the causal link between the patient's injury and the manufacturer's alleged failure to warn. Christopher v. Cutter Labs. , 53 F.3d 1184, 1192 (11th Cir. 1995). In other words, "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 had independent knowledge of the risk that the adequate warning should have communicated." Id.
As explained above in the legal standard portion of this order, when the party moving for summary judgment bears the burden of proof on an issue, "that party must show affirmatively the absence of a genuine issue of material fact." Fitzpatrick , 2 F.3d at 1115. "In other words, the moving party must show that, on all the essential elements of its case on which it bears the burden of proof at trial, no reasonable jury could find for the non-moving party." Id.
It is not necessary to reach this issue because the Court finds the IFU were adequate warnings as a matter of law. As a matter of law, the IFU provided "accurate, clear, and unambiguous" warnings. Consequently, Coloplast's motion for summary judgment on Plaintiff's failure-to-warn claims is GRANTED .
C. Fraud-Based Claims and Warranty Claims (Counts VI, VII, VIII, IX, XI, and XII)
Next, Coloplast moves for summary judgment on Count VI (Common Law Fraud), Count VII (Fraudulent Concealment), Count VIII (Constructive Fraud), Count IX (Negligent Misrepresentation), Count XI (Breach of Express Warranty), and Count XII (Breach of Implied Warranty). It argues several points, but the Court finds one argument dispositive: All of these claims are mere "repackaging" of the failure-to-warn claims in Counts I and III. The MDL Court reached this conclusion on the same claims in Huskey v. Ethicon, Inc. , 29 F. Supp. 3d 736, 741–43 (S.D.W. Va. 2014), and Bellew v. Ethicon, Inc. , 2014 WL 6886129, at *3–4 (S.D. W. Va. Nov. 24, 2014). Because Plaintiff's "fraud-based claims and warranty claims are simply repackaged failure-to-warn claims," Huskey , 29 F. Supp. 3d at 744, Coloplast's motion for summary judgment on Counts VI, VII, VIII, IX, XI, and XII is GRANTED . D. Negligent Infliction of Emotional Distress Claim ("NIED") (Count X)
Coloplast next moves for summary judgment on Count X (Negligent Infliction of Emotional Distress). "Generally, Florida follows the ‘impact rule,’ which provides that before a plaintiff can recover damages for emotional distress caused by the negligence of another, the emotional distress suffered must flow from physical injuries the plaintiff sustained in an impact.’ " Watters v. Walgreen Co. , 967 So. 2d 930, 932 (Fla. 1st DCA 2007) (quoting R.J. v. Humana of Fla., Inc. , 652 So. 2d 360, 362 (Fla. 1995) ). To prevail, "the physical injury must be caused by the psychological trauma." Kendron v. SCI Funeral Servs. of Fla., LLC , 230 So. 3d 636, 637 (Fla. 5th DCA 2017) (quoting LeGrande v. Emmanuel , 889 So.2d 991, 995 (Fla. 3d DCA 2004) ).
Coloplast cites to Salinero v. Johnson & Johnson , 400 F. Supp. 3d 1334, 1353 (S.D. Fla. 2019), where the court granted the defendant-manufacturer summary judgment on the plaintiffs' NIED claim because, while the patient "may have suffered various physical injuries ..., her physical injuries allegedly were caused by defective [mesh], not by psychological trauma." Id.
The Salinero court also granted the defendant-manufacturer summary judgment "by default," as the plaintiffs made "no effort" to respond to the arguments raised by the defendant-manufacturer.
The Court agrees with the Salinero analysis and finds it applies here, as well. Plaintiff's physical injuries stem directly from the allegedly defective product—the Altis implants. This is the entire basis of Plaintiff's claims. In fact, Plaintiff's emotional distress from this ordeal was caused by the trauma from any physical injuries related to the allegedly defective product. This, of course, is the opposite of an NIED claim. Simply, there is no proof, nor any allegation much less, that her alleged emotional distress caused the physical injuries. Coloplast's motion for summary judgment on Count X is GRANTED .
E. Gross Negligence Claim (Count XIV) and Punitive Damages Claim (Count XVII)
Finally, Coloplast moves for summary judgment on Count XIV (Gross Negligence) and Count XVII (Punitive Damages). Under Florida law, a "defendant may be held liable for punitive damages only if the trier of fact, based on clear and convincing evidence, finds that the defendant was personally guilty of intentional misconduct or gross negligence." Fla. Stat. § 768.72. Gross negligence has been defined accordingly:
(1) the existence of a composite of circumstances which, together, constitute an imminent or clear and present danger amounting to more than the normal and usual peril; (2) a showing of chargeable knowledge or awareness of the imminent danger; and (3) an act or omission occurring in a manner which evinces a conscious disregard of the consequences.
Wilder v. JP Morgan Chase Bank, N.A. , 2018 WL 5629922, at *6 (S.D. Fla. Oct. 30, 2018).
Coloplast argues Plaintiff has failed to offer sufficient evidence to meet the heightened standard of clear and convincing evidence. "Clear and convincing evidence is an ‘intermediate level of proof [that] entails both a qualitative and quantitative standard. The evidence must be credible; the memories of the witnesses must be clear and without confusion; and the sum total of the evidence must be of sufficient weight to convince the trier of fact without hesitancy.’ " B.F. v. State, Dep't of Children & Families , 237 So. 3d 390, 392 (Fla. 4th DCA 2018).
Defeating a motion for summary judgment on a claim for punitive damages is an extraordinarily high bar. Plaintiff, bearing the burden of proof on her claim, must meet the heightened standard of clear and convincing evidence in proving a heightened level of culpability in gross negligence. And, because Plaintiff bears the burden of proof in her claim for punitive damages, Coloplast's burden in its motion for summary judgment is relatively low. Coloplast is "not required to support its motion with affidavits or other similar material negating the opponent's claim in order to discharge this initial responsibility." Fitzpatrick , 2 F.3d at 1115. It can simply "point out" that Plaintiff has failed to present sufficient evidence to supports its claim at trial. Id. at 1116.
Looking to other MDLs on this issue is not particularly instructive. Despite the thousands of mesh-sling MDLs, the Court has found few cases involving motions for summary judgment on punitive damages. In fact, the Middle District of Florida, as recently as last month, wrote that it was the first court to do so in the State of Florida. In Katsiafas v. C. R. Bard, Inc. , 2020 WL 1904015, at *4 (M.D. Fla. 2020), the court surveyed the bellweather cases and noted that the MDL Court denied the defendant-manufacturer's summary judgment on punitive damages under Georgia, Mississippi, North Carolina, and Wisconsin law. See also In re C. R. Bard, Inc. , 2013 WL 2432871, at *10 (S.D. W. Va. June 4, 2013). The Katsiafas court relied on this ruling in being the first federal court applying Florida law to rule on a motion for summary judgment on punitive damages. Katsiafas , 2020 WL 1904015, at *4. Specifically, the court relied on the comparison between Florida's punitive-damages statute and Georgia's, finding the similarities sufficient to deny the motion. Id. Finding some evidence of the defendant's want of care and deliberate indifference, the court determined there was an issue of material fact precluding summary judgment. Id.
The Court finds Katsiafas helpful, but not dispositive. The opinion, as summary judgment orders are, is fact specific but does not detail sufficient facts for this Court to make a meaningful comparison. We only know first, the defendant in Katsiafas was a different manufacturer—C. R. Bard, not Coloplast. And second, perhaps more importantly, the product was not the Altis implant; it was an Avaulta Solo Anterior Synthetic Support System ("Avaulta"). There is no indication whatsoever in the record, or in the C. R. Bard line of MDL orders, that the Altis implants have any meaningful similarities to the Avaulta. Obviously, every case presents a different record; the facts and circumstances are necessarily different. Katsiafas simply does not provide a thorough enough recitation of the conduct of C. R. Bard, or the nature of the Avaulta.
On the record before the Court in this case, the Court does not find sufficient evidence to meet the clear-and-convincing standard of Coloplast's "actual knowledge" or "conscious disregard or indifference" to Plaintiff's health and safety. Her reliance on some internal documents from Coloplast is misplaced because none of them actually addresses the Altis implant; rather, they discuss the Aris, a different medical device. The Court fails to see the connection between Coloplast's handling of the Aris and her injuries from the Altis.
Plaintiff's argument that the jury must decide this issue is unavailing. She cites to Florida cases where the courts have held that punitive damages are generally a fact-intensive inquiry that is best suited for a jury. See Melford v. Kahane & Assocs. , 371 F. Supp. 3d 1116, 1129 (S.D. Fla. 2019). True, but punitive-damages claims are no different than any other claim in regard to a motion for summary judgment. Melford and other cases denying summary judgment found issues of disputed fact precluding summary judgment. Plaintiff cannot simply rely on a jury-should-decide argument. To survive summary judgment on punitive damages, a plaintiff cannot simply rely on evidence that might generate an issue of fact on liability. Tiller v. Ford Motor Co. , 2006 WL 166530, at *3 (M.D. Fla. Jan. 21, 2006).
Plaintiff's response brief largely argues what Coloplast should have done or should have known. This is inadequate to meet the heightened standard of clear and convincing evidence. This, also, is not close to the heightened standard of gross negligence. See IBP, Inc. v. Hady Enters., Inc. , 267 F. Supp. 2d 1148, 1170 (N.D. Fla. 2002) (requiring defendant's conduct as "recklessly and consciously disregard[ing] the health and safety" of the plaintiff).
Based on all the foregoing, the record before the Court does not show clear and convincing evidence of intentional misconduct or gross negligence by Coloplast. Plaintiff has not met the necessary factual predicate in defeating summary judgment. Coloplast's motion for summary judgment on Count XIV (Gross Negligence) and Count XVII (Punitive Damages) is GRANTED .
IV. CONCLUSION
Based on the foregoing, it is ORDERED AND ADJUDGED that Coloplast's Motion for Summary Judgment (DE [101] ) is GRANTED accordingly. For the convenience of the parties, the following is a list of all of Plaintiff's counts and their current state:
Count I (Negligent Testing, Negligent Design, and Negligent Form) will proceed to trial .
Count I (Negligent Manufacturing) summary judgment for Coloplast is GRANTED as unopposed .
Count I (Negligent Failure to Warn) summary judgment for Coloplast is GRANTED .
Count II (Strict Liability—Manufacturing Defect) summary judgment for Coloplast is GRANTED as unopposed .
Count III (Strict Liability Failure to Warn) summary judgment for Coloplast is GRANTED .
Count IV (Strict Liability—Defective Product) summary judgment for Coloplast is GRANTED as unopposed .
Count V (Strict Liability—Design Defect) will proceed to trial .
Count VI (Common Law Fraud) summary judgment for Coloplast is GRANTED .
Count VII (Fraudulent Concealment) summary judgment for Coloplast is GRANTED .
Count VIII (Constructive Fraud) summary judgment for Coloplast is GRANTED .
Count IX (Negligent Misrepresentation) summary judgment for Coloplast is GRANTED .
Count X (Negligent Infliction of Emotional Distress) summary judgment for Coloplast is GRANTED .
Count XI (Breach of Express Warranty) summary judgment for Coloplast is GRANTED .
Count XII (Breach of Implied Warranty) summary judgment for Coloplast is GRANTED .
Count XIV (Gross Negligence) summary judgment for Coloplast is GRANTED .
Count XV (Unjust Enrichment) summary judgment for Coloplast is GRANTED as unopposed .
Count XVII (Punitive Damages) summary judgment for Coloplast is GRANTED .
Count XVIII (Discovery Rule and Tolling) summary judgment for Coloplast is GRANTED as unopposed .
DONE AND ORDERED in Chambers, Fort Lauderdale, Florida, this 20th day of May 2020.