Coleman et al v. Boston Scientific Corporation

Filing 27

MEMORANDUM Decision Regarding 9 Motion to Dismiss signed by Judge Oliver W. Wanger on 4/20/2011. (Proposed Order Consistent with Memorandum Decision Deadline: 4/27/2011; Plaintiff's Amended Complaint due by 6/20/2011 ) (Figueroa, O)

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1 2 3 4 UNITED STATES DISTRICT COURT 5 EASTERN DISTRICT OF CALIFORNIA 6 7 8 1:10-cv-01968-OWW-SKO PAMELA COLEMAN, et al., 9 MEMORANDUM DECISION REGARDING MOTION TO DISMISS (Doc. 9) Plaintiffs, 10 11 12 v. BOSTON SCIENTIFIC CORPORATION, et al., 13 Defendants. 14 I. INTRODUCTION. 15 16 Plaintiffs Pamela Coleman (“Coleman”), Mary Bower (“Bower”), 17 and Kathleen Paison (“Paison”) (collectively “Plaintiffs”) proceed 18 with an action for damages against Boston Scientific Corporation 19 (“Defendant”) and various Doe Defendants. 20 Defendant filed a motion to dismiss Plaintiffs’ complaint on 21 February 26, 2011. (Doc. 9). Plaintiffs filed opposition to the 22 motion to dismiss on March 28, 2011. 23 a reply on April 4, 2011. Defendant filed (Doc. 17). II. FACTUAL BACKGROUND. 24 25 (Doc. 13). Plaintiffs are three individuals who underwent medical 26 procedures described as “transvaginal tape, bladder sling, urethral 27 suspension, and cystocele repair” in the United States between 28 August 2005 and December 2006. Coleman, a resident of Bakersfield, 1 1 California, underwent her procedures in December 2006. 2 resident of Grand Rapids, Michigan, underwent her procedure in 3 April 2006. 4 her procedure in August 2005. 5 each Plaintiff had her procedure performed. 6 Bower, a Paison, a resident of Westland, Michigan, underwent Defendant designed, The complaint does not allege where researched, advertised, developed, 7 tested, marketed, 8 synthetic surgical mesh devices purported to correct and restore 9 normal vaginal structure secondary to pelvic organ prolapse. received promoted, manufactured, Plaintiffs’ 11 marketed, and sold by Defendant in connection with their respective 12 transvaginal 13 cystocele repair procedures. 14 devices, Plaintiffs have suffered from erosion, shrinkage, and 15 extrusion of mesh from one or more of the mesh devices, causing 16 urinary retention, severe persistent pain, including dyspareunia, 17 and numerous surgical procedures to remove the mesh devices. bladder of sling, mesh devices and sold 10 tape, implants distributed, urethral manufactured, suspension, and Since implantation of the mesh 18 At all times relevant, the mesh devices were widely advertised 19 and promoted by Defendants as a safe and effective treatment for 20 pelvic organ prolapse, rectocele, enterocele, and stress urinary 21 incontinence. 22 implantation 23 Defendants knew that the devices were not safe because the mesh 24 eroded and otherwise malfunctioned causing injuries from erosion, 25 extrusion, infection, sepsis, chronic foreign body invasion, dense 26 adhesions, 27 representations regarding the consistency, safety, reliability, and 28 performance of the mesh devices in published literature and adverse Defendants minimized the risks posed to patients by of and the mesh worsening devices. dyspareunia. 2 At all times Defendants relevant, made false 1 event reports. Defendants failed to disclose to physicians, 2 patients, or Plaintiffs that their mesh devices were subject to 3 erosion or scar tissue formation causing injuries. 4 Defendants continued to promote the mesh devices as safe and 5 effective even when no clinical trials had been done; in doing so, 6 Defendants concealed the known risks and failed to warn of known or 7 scientifically knowable dangers and risks associated with the mesh 8 devices for pelvic organ prolapse, rectocele, enterocele, and 9 stress urinary incontinence. III. LEGAL STANDARD. 10 11 Dismissal under Rule 12(b)(6) is appropriate where the 12 complaint lacks sufficient facts to support a cognizable legal 13 theory. Balistreri v. Pacifica Police Dep't, 901 F.2d 696, 699 (9th 14 Cir.1990). To sufficiently state a claim to relief and survive a 15 12(b) (6) motion, the pleading "does not need detailed factual 16 allegations" but the "[f]actual allegations must be enough to raise 17 a right to relief above the speculative level." Bell Atl. Corp. v. 18 Twombly, 550 U.S. 544, 555, 127 S.Ct. 1955, 167 L.Ed.2d 929 (2007). 19 Mere "labels and conclusions" or a "formulaic recitation of the 20 elements of a cause of action will not do." Id. Rather, there must 21 be "enough facts to state a claim to relief that is plausible on 22 its face." Id. at 570. In other words, the "complaint must contain 23 sufficient factual matter, accepted as true, to state a claim to 24 relief that is plausible on its face." Ashcroft v. Iqbal, --- U.S. 25 ----, ----, 129 S.Ct. 1937, 1949, 173 L.Ed.2d 868 (2009) (internal 26 quotation marks omitted). 27 The Ninth Circuit has summarized the governing standard, in 28 light of Twombly and Iqbal, as follows: "In sum, for a complaint to 3 1 survive a motion to dismiss, the nonconclusory factual content, and 2 reasonable 3 suggestive of a claim entitling the plaintiff to relief." Moss v. 4 U.S. Secret Serv., 572 F.3d 962, 969 (9th Cir.2009) (internal 5 quotation marks omitted). Apart from factual insufficiency, a 6 complaint is also subject to dismissal under Rule 12(b)(6) where it 7 lacks a cognizable legal theory, Balistreri, 901 F.2d at 699, or 8 where the allegations on their face "show that relief is barred" 9 for some legal reason, Jones v. Bock, 549 U.S. 199, 215, 127 S.Ct. 10 inferences from that content, must be plausibly 910, 166 L.Ed.2d 798 (2007). 11 In deciding whether to grant a motion to dismiss, the court 12 must accept as true all "well-pleaded factual allegations" in the 13 pleading under attack. Iqbal, 129 S.Ct. at 1950. A court is not, 14 however, "required to accept as true allegations that are merely 15 conclusory, 16 inferences." Sprewell v. Golden State Warriors, 266 F.3d 979, 988 17 (9th Cir.2001). "When ruling on a Rule 12(b)(6) motion to dismiss, 18 if a district court considers evidence outside the pleadings, it 19 must normally convert the 12(b)(6) motion into a Rule 56 motion for 20 summary 21 opportunity to respond." United States v. Ritchie, 342 F.3d 903, 22 907 court 23 materials-documents 24 incorporated by reference in the complaint, or matters of judicial 25 notice-without converting the motion to dismiss into a motion for 26 summary judgment." Id. at 908. 27 /// 28 /// (9th unwarranted judgment, and Cir.2003). "A deductions it must attached of give may, to 4 fact, the unreasonable nonmoving however, the or party consider complaint, an certain documents IV. DISCUSSION. 1 2 A. Product Identification 3 As an initial matter, Defendants contend that the complaint 4 does not allege facts sufficient to permit identification of the 5 particular 6 Defendants argue that, absent identification of a specific product, 7 the complaint fails to plead the specific facts required to raise 8 a plausible claim for relief. 9 cite Timmons v. Linvatec Corp., 263 F.R.D. 582, 584-85 (C.D. Cal. “mesh products” underlying Plaintiffs’ claims. (Doc. 9, MTD at 3-4). Defendants 10 2010) and Adams v. I-Flow Corp., 11 1339948 *3 (C.D. Cal. 2010); 2010 U.S. Dist. LEXIS 33066, for the 12 proposition that “if a plaintiff fails to specifically identify the 13 product at issue in their Complaint, they [sic] cannot satisfy the 14 necessary 15 dismissed.” 16 onerous pleading burden Defendants advance. pleading requirements (MTD at 4). Adams v. I-Flow Corp., 2010 WL and their claims Neither Timmons nor Adams must be support the 17 In Adams, the complaint did not allege that any of the named 18 defendants manufactured the allegedly defective device that caused 19 the plaintiffs injuries: 20 21 22 23 24 25 26 27 28 The Complaint does not allege that any particular plaintiff was administered a particular drug through a particular pain pump that was manufactured by a particular defendant. Instead, plaintiffs plead only generally that they were injured by pain pumps and anesthetics of the type made by defendants. By suing fourteen (14) "Defendant Pain Pump Manufacturers" and eight (8) "Defendant Anesthetic Manufacturers," the Complaint at most alleges that the individual defendants theoretically could have been the one who manufactured the pain pump or anesthetic used following each plaintiff's surgery. But, the Complaint never specifies that any one of the defendants, as opposed to the 21 other defendants, caused each plaintiff's claimed injury. As such, plaintiffs plead nothing more than the sheer possibility that any particular defendant might have manufactured the product that allegedly injured each 5 1 plaintiff. This sort of speculative pleading is not permitted under the plain text of Rule 8, which requires a "statement of the claim showing that the pleader is entitled to relief." 2 3 Id. at 7-8. Similarly, the complaint in Timmons: 4 allege[d] Mrs. Timmons sustained a shoulder injury as a result of receiving an unidentified "anesthetic medication." Plaintiffs sue[d] AstraZeneca as one of eight "defendant anesthetic manufacturers," but fail[ed] to allege that AstraZeneca manufactured the particular medication administered to Ms. Timmons after her single surgery. Thus, the Complaint [did] not allege that AstraZeneca, as opposed to one of the other anesthetic manufacturer defendants, caused Plaintiffs' alleged injuries. 5 6 7 8 9 10 263 F.R.D. at 584. Timmons does not support Defendants’ ambitious 11 construction of Rule 8, which would require plaintiffs in any 12 medical product liability case to “specifically identify” the 13 products at issue in order to satisfy federal pleading standards. 14 Rather, Timmons stands for the unremarkable proposition that a 15 plaintiff must allege that a particular defendant caused her 16 injury. 17 AstraZeneca 18 against AstraZeneca, Plaintiffs must allege that AstraZeneca 19 caused their injuries.”). See id. (“The Complaint fails to state a claim against under Rule 8, Twombly, and Iqbal. To state a claim 20 Imposing on plaintiffs the burden of specifically identifying 21 a device by reference to a specific product line or model number, 22 without the benefit of discovery, could create an insurmountable 23 pleading burden in some cases. 24 only reflect general information about the type of device used in 25 a 26 specificity the exact product at issue in the pleading phase of her 27 case. See Butts v. Tyco Healthcare Group LP, 2007 U.S. Dist. LEXIS 28 37847 *4 (N.D. Ga. 2007) (noting difficulty plaintiff faced in given procedure, a For example, where medical records plaintiff 6 may be unable to plead with 1 tailoring 2 report did not identify the specific model of the medical device 3 employed 4 regarding the specific medical device at issue is unavailable 5 during 6 circumstantial 7 facility and a device manufacturer, to establish that the device 8 that harmed her was manufactured by a particular defendant; the 9 district court’s analysis of a discovery dispute in Butts is 10 11 12 13 14 15 16 17 appropriate during the discovery plaintiff’s pleading stage, evidence, where doctor's procedure). a such plaintiff as post-operative Where may contracts have between information to a rely medical instructive on this point: defendants have objected to the plaintiff's discovery requests on the grounds that the plaintiff has failed to establish who manufactured the allegedly defective stapler and, even assuming that it was indeed the defendants who manufactured it, the plaintiff does not identify which of the defendants' products was used during her surgery. Specifically, the defendants assert that because the reference to a single "# 25 EEA stapler" in the post-operative report does not identify any specific stapler, but could describe several different staplers manufactured by the defendants, responding to the plaintiff's interrogatories and requests for production is unduly burdensome and would produce information on unrelated products. 18 19 20 21 22 23 24 ...[P]laintiff asserts that she is not required to specifically identify the allegedly defective product at this juncture and that information on any stapler manufactured by the defendants with similar functions, operations, designation, or nomenclature as the "# 25 EEA stapler" is discoverable. The sole factual basis for the action against the defendants...is the post-operative report by the physician who performed the plaintiff's gastric bypass surgery. That report notes the use and apparent malfunction of a "# 25 EEA stapler," which "was married to the anvil and stapler was closed and fired." 25 26 27 28 ...However, the doctor's post-operative report does not identify the specific model of EEA [] stapler used or its manufacturer. Instead, the report simply refers to a "# 25 EEA stapler." Accordingly, because the plaintiff's complaint uses that report as the basis for her claims against Tyco and United States Surgical, the defendants 7 on 1 assert that two questions must be answered before discovery can proceed: (1) whether the defendants manufactured the stapler used in the plaintiff's surgery, and (2) if so, which of the defendants' staplers is the one referred to as the "# 25 EEA stapler." 2 3 4 ...[Plaintiff] has made no direct showing that Tyco Healthcare or United States Surgical manufactured the stapler used during her surgery. Rather, the plaintiff points to a contract between the defendants and Emory Hospitals that establishes United States Surgical as the exclusive provider of gastric bypass staplers. Ostensibly, this contract shows that although it is unknown whether the defendants actually manufactured the stapler used in the plaintiff's surgery, it at least establishes a good faith basis to proceed with discovery against the defendants. Without any direct evidence, this court concludes that while the plaintiff is on shaky ground in this regard, the existence of an exclusive contract with the defendants is persuasive circumstantial evidence sufficient to proceed with discovery against the defendants as the manufacturers of the allegedly defective stapler. 5 6 7 8 9 10 11 12 13 Id. at 2-5 (citations to the record omitted). 14 Like the defendants in Butts, Defendant contends that 15 Plaintiffs’ failure to identify the specific device subject to 16 their complaint is insufficient. In its reply, Defendant complains 17 that it manufactures “at least nine separate products that involve 18 mesh that could potentially fall within Plaintiffs’ vague 19 definition.” (Doc. 17, Reply at 2). Defendants state that the mesh 20 products it manufactures 21 22 23 24 25 26 include, but are not limited to, Advantage Fit System, Advantage Transvaginal Mid-Urethral Sling System, Lynx Suprapubic Mid-Urethral Sling System, Obtryx Tansobturator Mid-Urethral Sling System, Prefyx PPS System, Solyx Sis System, Pinnacle Posterior Pelvic Floor Repair Kit, Uhold Vagindal Support System, and Polyform Synthetic Mesh. The nine above-referenced mesh products are distinguishable, with each having its own separate design, indications, directions for use, techniques for implantation, and warnings. 27 (Id.). 28 8 1 Rather than suggest more specific pleading is required, 2 Defendant’s discussion of its extensive mesh products line reveals 3 the 4 identification of a precise product during the pleading phase of a 5 case, without discovery. 6 such as Plaintiffs are not always in a position to know whether an 7 Obtryx Tansobturator Mid-Urethral Sling System or an Advantage 8 Transvaginal Mid-Urethral Sling System was placed inside of them 9 while they were anaesthetized. injustice that would result from requiring specific It is axiomatic that medical patients Rather, manufacturers are in a 10 better position to ascertain which of their devices was likely used 11 in a given procedure, because they can compare each of their 12 products’ unique “design[s], indications, directions for use, [and] 13 techniques for implantation” to the allegations of the complaint 14 concerning when, where, and for what medical purpose a plaintiff’s 15 surgical procedure was performed. 16 As the Seventh Circuit Court of Appeal recognized recently, 17 there are no special pleading requirements for product liability 18 claims or medical device claims in particular. 19 Corp., 630 F.3d 546, 558 (7th Cir. 2010). 20 notice pleading applies to defective medical device claims: so long 21 as 22 "plausibility" standard applied in Iqbal and Twombly, dismissal 23 under Rule 12 is inappropriate. 24 device claims is difficult, and discovery is often necessary before 25 a plaintiff can fairly be expected to provide specific details. 26 See id. the complaint alleges facts Id. Bausch v. Stryker The federal standard of sufficient to meet the Pleading defective medical 27 Plaintiffs’ complaint provides information regarding the types 28 of surgical procedures they underwent, as well as a detailed 9 1 technical description of the devices they allege injured them: 2 “mesh devices purported to correct and restore normal vaginal 3 structure secondary to pelvic organ prolapse.” 4 states that Defendants “sought and obtained [FDA] approval to 5 market mess [sic] products and/or its monofilament polypropylene 6 mesh 7 Amendment.” 8 type of product. Nevertheless, the complaint contains ambiguities. 9 First, the complaint does not clearly allege where each component under section 510(k) of The complaint also the Medical Device These allegations provide further description of the 10 Plaintiff underwent their respective procedures. 11 is unable to identify a specific medical device in her complaint, 12 information 13 performed should be pleaded to assist manufacturers in identifying 14 which of its products is implicated. 15 which state they underwent their procedures in, let a alone the 16 names of the medical facilities involved, the complaint does not 17 comply with Rule 8. 18 revealing when, where, and why When a Plaintiff a procedure was As Plaintiffs do not allege Second, the complaint is ambiguous with respect to whether 19 each Plaintiff had the same type of mesh device implanted. The 20 complaint suggests that Plaintiffs seek to assert claims based on 21 the failure of more than one mesh device manufactured by Defendant. 22 Paragraph 11 of the complaint states that the term “mesh devices” 23 refers to Defendant’s products “collectively.” 24 Critically, paragraph 14 alleges that Plaintiffs were injured by 25 “extrusion of mesh from one or more of the Mesh Devices.” (Id. at 26 3) (emphasis added). 27 state clearly whether Plaintiffs’ claims are based on one defective 28 device common to all Plaintiffs, or whether claims are asserted (Compl. at 3). Plaintiffs complaint must be amended to (1) 10 1 based on multiple mesh devices that share a common defect; and (2) 2 state 3 procedure was performed. 4 B. Implied Warranty Claim 5 clearly the location where each Plaintiffs’ respective Defendants correctly assert that Plaintiffs’ claims for breach 6 of implied warranty are not cognizable. 7 privity between parties is required for either claim of implied 8 warranty. 9 App. 4th 779, 857 (Cal. Ct. App. 1994) (noting that California 10 Commercial Code section 2315 requires that a buyer rely on sellers’ 11 skill or judgment in order to have a cognizable implied warranty 12 claim and rejecting implied warranty claim against medical device 13 manufcaturer); Blanco v. Baxter Healthcare Corp., 158 Cal. App. 4th 14 1039, 1058 (2008) (rejecting implied warranty claim against medical 15 device manufacture because of lack of privity with citation to 16 Evraets); accord Clemens v. Daimler Chrysler Corp., 534 F.3d 1017, 17 1023 (9th Cir.2008) (plaintiff asserting breach of implied warranty 18 claims 19 defendant). 20 implied warranty claim is DISMISSED WITH PREJUDICE. 21 C. Express Warranty Claims 22 Under California law, E.g., Evraets v. Intermedics Intraocular, Inc., 29 Cal. must stand in vertical contractual privity Plaintiffs do not contend otherwise. with the Plaintiffs’ Defendants contention that privity is an element of an express 23 warranty claim is incorrect. E.g., Evraets, 29 Cal. App. 4th at 24 857 n.4 (“privity is not a requirement for actions based upon an 25 express warranty”); Fieldstone Co. v. Briggs Plumbing Products, 26 Inc., 54 Cal. App. 4th 357, n.10 (Cal. Ct. App. 1997) (“As a 27 general rule, privity of contract is a required element of an 28 express breach of warranty cause of action. However, there is an 11 1 exception where plaintiff's decision to purchase the product was 2 made in reliance on the manufacturers' written representations in 3 labels or advertising materials.”) (citations omitted). 4 Plaintiffs express warranty claims must be dismissed, as the 5 complaint does not allege facts sufficient to give rise to a 6 plausible 7 representations made by Defendants. 8 conclusory allegations that Defendants advertised their products as 9 safe and effective lack even general information describing such 10 alleged conduct. As one district court has aptly noted, conclusory 11 allegations such as those advanced by Plaintiffs are insufficient 12 to support a plausible basis for an express warranty claim: 13 basis to believe that Plaintiffs relied See, e.g., id. However, on any Plaintiffs’ 17 Evraets stands as clear authority that at least at the pleading stage, California law permits a claim for breach of an express warranty to go forward under circumstances [where reliance is alleged]. That said, the complaint as presently constituted fails to allege any express warranties actually made by Stryker, except in the most general and conclusory terms. Accordingly, the claim for breach of express warranty will be denied, with leave to amend. 18 Quatela v. Stryker Corp., 2010 U.S. Dist. LEXIS 133706 * 4-6 (N.D. 19 Cal. 2010). 20 with leave to amend. 21 D. Fraud Based Claims 14 15 16 Plaintiffs’ express warranty claims are DISMISSED, 22 Federal Rule of Civil Procedure 9(b) imposes an elevated 23 pleading standard with respect to claims that "sound in fraud" or 24 are "grounded in fraud." Kearns v. Ford Motor Co., 567 F.3d 1120, 25 1125 (9th Cir. 2009). 26 fraud must be specific enough to give defendants notice of the 27 particular misconduct which is alleged to constitute the fraud." 28 Swartz v. KPMG LLP, 476 F.3d 756, 764 (9th Cir. 2007) (internal "To comply with Rule 9(b), allegations of 12 1 quotation marks omitted). Allegations of fraud must include the 2 "time, place, and specific content of the false representations as 3 well as the identities of the parties to the misrepresentations." 4 Id. (internal quotation marks omitted). The "[a]verments of fraud 5 must be accompanied by the who, what, when, where, and how of the 6 misconduct charged." Kearns v. Ford Motor Co., 567 F.3d 1120, 1124 7 (9th Cir. 2009) (internal quotation marks omitted). A plaintiff 8 alleging 9 necessary to identify the transaction. The plaintiff must set forth 10 what is false or misleading about a statement, and why it is 11 false." Vess v. Ciba-Geigy Corp. USA, 317 F.3d 1097, 1106 (9th Cir. 12 2003). 13 fraud "must set forth more than the neutral facts Plaintiffs’ general allegations do not comply with Rule 9(b)’s 14 particularity requirements. 15 such as Glen Holly Ent., Inc., v. Tektronix, Inc., 100 F. Supp. 2d 16 1086, 1095 (C.D. Cal. 1999) for the proposition that “Rule 9(b) may 17 be relaxed as to matters peculiarly within the opposing party’s 18 knowlege” is unavailing; the complaint does not allege facts 19 sufficient to support an inference that Defendants knew of the 20 alleged defects of their products at any time relevant to the 21 complaint or that any false representations were made to Plaintiffs 22 on 23 DISMISSED, with leave to amend. 24 E. Negligent Misrepresentation Claims 25 which they relied. Plaintiffs’ attempt to rely on cases Plaintiffs’ fraud based claims are Plaintiffs’ negligent misrepresentation claim is based on 26 Plaintiffs’ conclusory contention 27 specifically related to the Mesh Devices showed the Mesh Devices to 28 be defective and dangerous when used in the intended manner.” 13 that “adverse event reports 1 (Compl. at 11). The complaint does not allege facts sufficient to 2 give rise to an inference that, at the time Defendants made alleged 3 representations 4 Defendants had reason to know of the dangers Plaintiffs complain of 5 or that they made any misrepresentations without a reasonable basis 6 for believing them to be true. 7 allege when such representations were made. 8 misrepresentation 9 F. UCL Claims concerning the safety of their mesh devices, Inter alia, the complaint does not Plaintiffs’ negligent claims are DISMISSED, with leave to amend. 10 As discussed above, Plaintiffs’ complaint is insufficient with 11 respect fraud and misrepresentation based claims. The complaint is 12 fatally vague with respect to which mesh devices are the subject of 13 this action. 14 complaint, Plaintiffs’ UCL claims are DISMISSED, without prejudice. 15 G. Venue and Joinder As there are no predicate claims alleged in the 16 Defendant contends that venue for the claims of Plaintiffs who 17 reside in Michigan is improper in the eastern district, and that 18 such Plaintiffs’ claims are improperly joined in this action. 19 propriety of joinder and venue cannot be ascertained due to the 20 pleading deficiencies discussed above. 21 objections to joinder and venue after Plaintiffs provide an amended 22 complaint. The Defendant may renew its ORDER 23 24 For the reasons stated, IT IS ORDERED: 25 1) Plaintiffs’ implied warranty claims are DISMISSED, with 26 prejudice; 27 2) 28 prejudice; Plaintiff’s remaining claims 14 are DISMISSED, without 1 3) Plaintiff’s shall file an amended complaint within sixty 2 days 3 Defendant shall file responsive pleading within twenty days of 4 service of an amended complaint; and 5 4) Defendant shall submit a form of order consistent with this 6 memorandum decision within five days of receiving electronic 7 notice of this decision. of receiving electronic notice of this 8 9 10 IT IS SO ORDERED. Dated: hkh80h April 20, 2011 /s/ Oliver W. Wanger UNITED STATES DISTRICT JUDGE 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 15 decision.

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