Douse v. Bos. Scientific Corp.
Douse v. Bos. Scientific Corp.
Opinion of the Court
This matter comes before the Court on Defendant Boston Scientific Corporation's ("Boston Scientific") Motion to Dismiss (Doc. 29) and Plaintiff Valerie Douse's ("Douse") Response in Opposition (Doc. 31). The matter is ripe for review.
INTRODUCTION
This is a product liability suit centering on Boston Scientific's permanent inferior vena cava filter (the "Greenfield Filter"). The Greenfield Filter was created to prevent pulmonary embolisms (Doc. 27 at ¶¶ 1, 31), which occur when a blood clot travels through blood vessels like the inferior vena cava to block one of the pulmonary arteries in the lungs. (Doc. 27 at ¶ 18). When clots form in deep leg veins, this condition is called deep vein thrombosis. (Doc. 27 at ¶ 18). Patients at risk of pulmonary embolisms or deep vein thrombosis are often treated with permanent or retrievable inferior vena cava filters, such as the Greenfield Filter, which trap and filter blood clots. (Doc. 27 at ¶¶ 20-21, 30).
Douse alleges that concerns about complications associated with permanent inferior vena cava filters led medical device manufacturers to begin making retrievable *1257filters by 2003. (Doc. 27 at ¶ 36). In 2010, the United States Food and Drug Administration warned against implanting inferior vena cava filters for extended periods due to potential adverse health complications. (Doc. 27 at ¶¶ 34, 36). It released another warning in 2014. (Doc. 27 at ¶ 36). Despite these notifications, Douse alleges Boston Scientific continued to market the Greenfield Filter for long-term use. (Doc. 27 at ¶ 40).
BACKGROUND
In September 2003, Douse suffered a pulmonary embolism. (Doc. 27 at 22). Based on the advice of an unnamed entity, she agreed to have the Greenfield Filter implanted to prevent further blood clot-related issues. (Doc. 27 at ¶¶ 22-24). In 2017, Douse was treated for complications associated with the Greenfield Filter, and was informed that it had perforated the walls of the vein in which it had been implanted. (Doc. 27 at ¶ 26). Apparently, such injuries are commonplace among patients who have undergone the implantation of permanent inferior vena cava filters. (Doc. 27 at ¶ 27).
Douse then sued Boston Scientific in state court. (Doc. 2). After the Complaint was removed (Doc. 1), it was dismissed as a shotgun pleading. (Doc. 25). Douse then filed an Amended Complaint, which deleted paragraphs that had previously incorporated every preceding allegation into each succeeding count. (Doc. 27). The Amended Complaint alleges the Greenfield Filter was defectively designed and manufactured. (Doc. 27 at ¶ 53). It further claims the Greenfield Filter was inadequately tested and had inadequate warnings, instructions, and labeling. (Doc. 27 at ¶ 53). Based on these allegations, Douse claims Boston Scientific is liable for: negligence (Count I), strict liability defective design (Count II), strict liability manufacturing defect (Count III), strict liability failure to warn (Count IV), breach of express warranty (Count V), breach of implied warranty of merchantability (Count VI), breach of implied warranty of fitness (Count VII), fraudulent misrepresentation (Count VIII), fraudulent concealment (Count IX), negligent misrepresentation (Count X), and violations of the Florida Deceptive and Unfair Trade Practices Act ("FDUTPA") (Count XI). (Doc. 27 at ¶¶ 67-234). Douse also seeks punitive damages. (Doc. 27 at ¶¶ 235-237). Now, Boston Scientific moves to dismiss. (Doc. 29).
LEGAL STANDARD
Under Federal Rule of Civil Procedure 8(a)(2), a pleading must contain a short and plain statement of a claim showing the pleader is entitled to relief. The Rule's purpose is to "give the defendant fair notice of what the claim is and the grounds upon which it rests." Bell Atl. Corp. v. Twombly ,
Fraud allegations are subject to heightened pleading standards under Federal Rule of Civil Procedure 9(b), which requires a party to "state with particularity the circumstances constituting fraud." This means "a plaintiff must plead facts as to time, place, and substance of the defendant's alleged fraud, specifically the details of the defendant's allegedly fraudulent acts, when they occurred, and who engaged in them." U.S. ex rel. Atkins v. McInteer ,
Under Federal Rule of Civil Procedure 12(b)(6), a court may dismiss a pleading for failure to state a claim upon which relief can be granted. This decision hinges on the Twombly - Iqbal plausibility standard, which requires a plaintiff to allege sufficient facts "to raise a reasonable expectation that discovery will reveal evidence" to support a claim. Twombly ,
DISCUSSION
Boston Scientific's Motion to Dismiss is multifaceted. It argues the Amended Complaint: (1) is an impermissible shotgun pleading; (2) is improvidently or insufficiently pled; and (3) fails to adequately allege punitive damages. Douse opposes. The Court will address each argument in turn.
A. Shotgun Pleading
Boston Scientific argues the Amended Complaint should be dismissed as a shotgun pleading because the grounds for each claim cannot be discerned. This argument fails. The Eleventh Circuit has found only four types of shotgun pleadings:
The most common type-by a long shot-is a complaint containing multiple counts where each count adopts the allegations of all preceding counts, causing each successive count to carry all that came before and the last count to be a combination of the entire complaint. The next most common type, at least as far as our published opinions on the subject reflect, is a complaint that does not commit the mortal sin of re-alleging all preceding counts but is guilty of the venial sin of being replete with conclusory, vague, and immaterial facts not obviously connected to any particular cause of action. The third type of shotgun pleading is one that commits the sin of not separating into a different count each cause of action or claim for relief. Fourth, and finally, there is the relatively rare sin of asserting multiple claims against multiple defendants without specifying which of the defendants are responsible for which acts or omissions, or which of the defendants the claim is brought against. The unifying characteristic of all types of shotgun pleadings is that they fail to one degree or another, and in one way or another, to give the defendants adequate notice of the claims against them and the grounds upon which each claim rests."
Weiland v. Palm Beach Cty. Sheriff's Office ,
Here, the Amended Complaint differs from the original because it no longer incorporates each preceding allegation into each count. Still, Boston Scientific argues *1259that it remains a shotgun pleading because the grounds for each claim are difficult to understand. To the extent this argument is based on the second of the Eleventh Circuit's enumerated shotgun pleading types-where a pleading is rife with conclusory, vague, and immaterial facts not obviously connected to any particular cause of action-it fails. If, however, this argument is simply a half-court attempt to contend Douse has failed to state a claim upon which relief can be granted, Boston Scientific would be better served to focus its energy on higher percentage shots. The Amended Complaint is not a shotgun pleading.
B. Negligence
Count I alleges Boston Scientific is liable for negligence. The elements of a negligence claim are "(1) a legal duty owed by defendant to plaintiff, (2) breach of that duty by defendant, (3) injury to plaintiff legally caused by defendant's breach, and (4) damages as a result of that injury." Estate of Rotell ex rel. Rotell v. Kuehnle ,
Here, Douse alleges Boston Scientific had a duty to exercise reasonable care in the design, research, manufacture, marketing, testing, advertisement, supply, promotion, packaging, sale, and distribution of the Greenfield Filter. (Doc. 27 at ¶ 68). She claims Boston Scientific breached this duty because it knew or should have known the Greenfield Filter was unsafe when used on a long-term basis, and because it failed to exercise reasonable care in the product's design, manufacture, and marketing, and failed to accompany the product with adequate warnings. (Doc. 27 at ¶¶ 75-76). Moreover, as a result of Boston Scientific's negligence, Douse alleges she suffered injuries including post-implantation deep vein thrombosis and the perforation of her inferior vena cava by the Greenfield Filter. (Doc. 27 at ¶ 81). Accepted as true, these allegations establish a plausible claim for negligence and Count I survives.
C. Strict Liability
"Strict liability is defined as negligence as a matter of law or negligence per se; it relieves the plaintiff of the burden of proving specific acts of negligence." Barrow v. Bristol-Myers Squibb Co., No. 96-689-CIV-ORL-19B,
1. Design and Manufacturing Defects
Counts II and III are strict liability design and manufacturing defect claims. In Florida, a strict liability products liability claim must establish "(1) the manufacturer's relationship to the product in question, (2) the unreasonably dangerous condition of the product, and (3) the existence of a proximate causal connection between the condition of the product and the plaintiff's injury." Cintron v. Osmose Wood Preserving, Inc. ,
Florida has embraced two tests for whether a product is unreasonably dangerous. Aubin v. Union Carbide Corp. ,
Here, the Amended Complaint alleges that long-term inferior vena cava filter implantation positively correlates with inferior vena cava perforation. (Doc. 27 at ¶ 27). Similarly, it alleges the entire Greenfield Filter was "subject to breakage, collapse, migration, perforation, [and] causing thrombus." (Doc. 27 at ¶ 48). Taken as true, these allegations plausibly support the contention that the Greenfield Filter was unreasonably dangerous because it was more hazardous than the ordinary consumer would expect, (Doc. 27 at ¶¶ 94, 115), and its foreseeable risks of harm exceeded its claimed benefits. (Doc. 27 at ¶ 92). As such, Boston Scientific's arguments fail and Counts II and III survive.
2. Failure to Warn
Count IV alleges Boston Scientific is strictly liable for failing to adequately warn of the Greenfield Filter's dangerous complications. To establish a viable claim for strict liability failure to warn, a pleading must state the defendant (1) manufactured or distributed the product, (2) failed to "adequately warn of a particular risk that was known or knowable in light of the generally recognized and prevailing best scientific and medical knowledge available at the time of manufacture and distribution," and (3) that the failure proximately caused the plaintiff's injury. Griffin v. Kia Motors Corp. ,
Here, to establish a failure to warn, Douse begins by alleging Boston Scientific manufactured the Greenfield Filter, which was subject to a range of dangerous complications. (Doc. 27 at ¶¶ 116, 118, 121). She then claims Boston Scientific knew or should have known about the Greenfield Filter's propensity to cause such complications. (Doc. 27 at ¶ 121). Despite that knowledge, Douse alleges Boston Scientific failed to adequately warn consumers, the medical community, Douse, or Douse's doctors about the Greenfield Filter's dangerous propensities. (Doc. 27 at ¶¶ 123). Instead, Douse alleges Boston Scientific affirmatively downplayed the possibility that the Greenfield Filter would cause unsafe complications. (Doc. 27 at ¶ 124). These allegations sufficiently establish a failure to warn.
But Boston Scientific argues that even if the inadequacy of the warning was plausibly pled, Count IV must still fail because it does not establish proximate causation through the learned intermediary doctrine. The Court disagrees. For medical products like the Greenfield Filter, doctors act as an intermediary "between *1261the manufacturer and the consumer, [and] [weigh] the potential benefits against the dangers in deciding whether to recommend the [product] to meet the patient's needs." Felix v. Hoffmann-LaRoche, Inc. ,
D. Breach of Warranties
Counts V, VI, and VII allege Boston Scientific is liable for breach of express warranty, breach of implied warranty of merchantability, and breach of the implied warranty of fitness because Douse relied to her detriment on representations in the Greenfield Filter's product brochure, website, and advertisements. Boston Scientific responds that these counts should be dismissed because they do not sufficiently allege it was in privity with Douse. The Court agrees.
In Florida, "[p]rivity is required in order to recover damages from the seller of a product for breach of express or implied warranties." Intergraph Corp. v. Stearman ,
Cedars and Smith exhibit opposing interpretations of the outer boundaries of privity in Florida. In Cedars , a hospital sued an x-ray manufacturer in state court for breaches of express and implied warranty after it was contacted by the manufacturer's representatives and induced to buy a defective x-ray machine through a third-party seller.
By contrast, the plaintiff in Smith sued a chewing gum manufacturer in federal court for breach of express warranty based on a claim that the chewing gum's label contained misleading statements.
The central issue then is whether the outer boundaries of privity require substantial direct contacts, as in Cedars , or mere product labeling, as in Smith . Other courts have embraced the Cedars standard. See *1262New Nautical Coatings, Inc. v. Scoggin,
With that in mind, the Court finds Counts V, VI, and VII do not allege sufficient contacts for viable breach of warranty claims. Whereas Cedars involved substantial direct contact between the hospital and the manufacturer, the only contacts alleged between Boston Scientific and Douse or her doctor took place through its product brochure, website and advertisements. Such untargeted marketing cannot surmount Florida's privity requirement. Accordingly, Counts V-VII will be dismissed.
E. Fraud
1. Fraudulent Misrepresentation
Count VIII alleges that Boston Scientific fraudulently misrepresented the Greenfield Filter's safety and efficacy to Douse, her doctors, and the public. The elements of a fraudulent misrepresentation claim in Florida are "(1) a false statement concerning a material fact; (2) the representor's knowledge that the representation is false; (3) an intention that the representation induce another to act on it; and (4) consequent injury by the party acting in reliance on the representation." Butler v. Yusem ,
Count VIII generally alleges Boston Scientific falsely portrayed the Greenfield Filter as safe and effective for the prevention of pulmonary embolisms and deep vein thrombosis through its website, product brochures, and instructions for use. Specifically, it alleges Boston Scientific's website claimed the Greenfield Filter had "[t]rusted performance, [and] [t]imeless design," that it had "[p]roven [s]tability," "[e]stablished [f]ilter [p]erformance," and that "[f]ilter [d]esign [p]romotes [c]lot [l]ysis." (Doc. 27 at ¶¶ 185, 187). Meanwhile, the product brochure claimed the Greenfield Filter's"[r]ecurved hooks are designed to provide protection against penetration." (Doc. 27 at ¶ 189). This is not enough.
For starters, the only statement capable of being interpreted as a factual assertion is that the Greenfield Filter's design "[p]romotes [c]lot [l]ysis." (Doc. 27 at ¶¶ 237-238). But the Amended Complaint does not detail why this statement is false, or what relevance it has to the Greenfield Filter's safety and efficacy. Instead, it merely states Boston Scientific knew its representations were false. (Doc. 27 at ¶¶ 184, 193, 195). Rule 9(b) demands more.
*1263The other selections were statements of opinion. This is most readily indicated because they are introduced by subjective adjectives like "trusted," "timeless," "proven," and "established." (Doc. 27 at ¶¶ 185, 187). In Florida, "[a]n action for fraud generally may not be predicated on statements of opinion ... but rather must be based on a statement concerning a past or existing fact." Mejia v. Jurich ,
2. Fraudulent Concealment
Count IX alleges Boston Scientific fraudulently concealed material information about the Greenfield Filter's known risks. Fraudulent concealment is similar to actual fraud except that the defendant conceals facts instead of misrepresents them. Kish v. A.W. Chesterton Co. ,
The Amended Complaint alleges Boston Scientific "had sole access to material facts concerning the defective nature of the [Greenfield Filter], and its propensity to cause serious and dangerous side effects." (Doc. 27 at ¶ 212). It continues that Boston Scientific deliberately concealed and omitted a swath of information including "that the Greenfield Filter was not safe," "that the Greenfield Filter was manufactured negligently," and "that the Greenfield Filter was designed defectively." (Doc. 27 at ¶ 210(a)-(f) ). These claims are problematic because the allegedly concealed information consists of legal conclusions rather than empirically provable facts. Even if that were not the case, Count IV also fails to cite any specific concealed information that would support the alleged conclusions. For instance, it does not cite any specifically concealed materials that would indicate the Greenfield Filter was not safe, or that would show it was manufactured negligently, or that it was not fit for the purpose for which it was used. Because Count IX fails to allege specific facts concealed by Boston Scientific, it will be dismissed.
3. Negligent Misrepresentation
Count X alleges Boston Scientific negligently misrepresented to Douse and her doctors that the Greenfield Filter had been tested and found to be a safe and effective form of therapy. In Florida, a plaintiff seeking to establish negligent misrepresentation must plead
(1) [a] misrepresentation of material fact; (2) the representor ... ma[d]e the representation without knowledge as to its truth or falsity, or ... under circumstances in which he ought to have known of its falsity; (3) the representor ... intend[ed] that the misrepresentation induce another to act on it; (4) injury must result to the party acting in justifiable reliance on the misrepresentation.
*1264Souran v. Travelers Ins. Co. ,
Negligent misrepresentation allegations are subject to Rule 9(b)'s heightened particularity standard. Lamm v. State St. Bank & Tr. ,
F. The Florida Deceptive and Unfair Trade Practices Act
Next, Count XI alleges Boston Scientific violated FDUTPA by engaging in "continuous and pointed marketing activity" that "evaded divulging the known serious risks and warnings to consumers." (Doc. 27 at ¶¶ 233-234). "A consumer claim for damages under FDUTPA has three elements: (1) a deceptive act or unfair practice; (2) causation; and (3) actual damages." City First Mortg. Corp. v. Barton ,
Though FDUTPA prohibits "unfair or deceptive acts or practices in the conduct of any trade or commerce," it does not apply to claims for personal injury or death.
G. Punitive Damages
Lastly, the Amended Complaint asks the Court to award punitive damages. In Florida, punitive damages can only be awarded where a pleading provides a "reasonable basis" for an allegation that a party acted with "intentional misconduct or gross negligence."
Against this backdrop, Counts I-IV remain. Douse alleges Boston Scientific knew or should have known that its actions in relation to remaining Counts were dangerous but still failed to remedy them. (Doc. 27 at ¶¶ 78, 95, 121, 236). She further alleges Boston Scientific acted willfully or with reckless indifference. (Doc. 27 at ¶¶ 60, 80, 135, 236-237). Taken as true, these allegations support a punitive damages claim at this stage.
Accordingly, it is now
ORDERED:
1. The Motion is GRANTED as to Counts V-XI, and those Counts are DISMISSED . The Motion is DENIED in all other respects.
2. Davis must file a Second Amended Complaint on or before May 21, 2018 that is consistent with this Opinion and Order. Boston Scientific has fourteen days thereafter to file an Answer.
DONE and ORDERED in Fort Myers, Florida this 14th day of May, 2018.
Boston Scientific also argues that Count V should be dismissed because Douse did not provide it with notice of a breach of any alleged express warranty it had provided to her. But because the Court dismisses the claim on privity grounds, it need not entertain that argument.
Boston Scientific also argues Count XI should be dismissed because it is not plausibly alleged and because the FDUTPA safe harbor bars the claim. Because Count XI is dismissed on statutory grounds, these arguments need not be confronted.
Reference
- Full Case Name
- Valerie DOUSE v. BOSTON SCIENTIFIC CORPORATION
- Cited By
- 19 cases
- Status
- Published