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Oscar N. Clifton and Darlene N. Clifton v. I-Flow Corporation

October 26, 2011


The opinion of the court was delivered by: Judge Feinerman


Plaintiffs Oscar N. Clifton and Darlene N. Clifton brought this diversity suit against Defendant I-Flow Corporation, alleging that Oscar sustained injuries from a medical device manufactured and marketed by I-Flow and that Darlene suffered loss of consortium as a result. In response to I-Flow's motion to dismiss portions of the initial complaint under Federal Rule of Civil Procedure 12(b)(6), Plaintiffs filed an amended complaint. I-Flow now moves under Rule 12(b)(6) to dismiss the amended complaint's negligent misrepresentation, fraud, and implied warranty claims, as well as what the parties call a punitive damages "count." Plaintiffs have stood on the amended complaint and oppose the motion. I-Flow's motion is granted as to the implied warranty claim and otherwise is denied.


The well-pleaded facts alleged in the complaint are assumed true on a Rule 12(b)(6) motion. See Reger Dev., LLC v. Nat'l City Bank, 592 F.3d 759, 763 (7th Cir. 2010); United States ex rel. Main v. Oakland City Univ., 426 F.3d 914, 916 (7th Cir. 2005). On March 5, 2004, Dr. James Hill performed shoulder surgery on Oscar. To help Oscar manage post-operative pain, Dr. Hill affixed an I-Flow ON-Q pain pump to Oscar's shoulder, which delivered anesthetic via a catheter directly into the glenohumeral (shoulder) joint. In August 2004, during a second operation, abnormalities were discovered in the joint. The shoulder continued to worsen, and in April 2009 a different physician found that Oscar had "degenerative changes of the glenohumeral joint." According to the amended complaint, the delivery of anesthetic directly into Oscar's shoulder joint caused a condition called "chondrolysis," which is the nearly complete loss of cartilage in the joint. Oscar has undergone shoulder joint replacement and will require additional surgeries.

Pain pumps traditionally were used to deliver anesthetic to the muscle but not to the joint. In the 1990s, I-Flow and other pain pump manufacturers sought approval from the Food and Drug Administration ("FDA") to indicate pain pumps for intra-articular use-meaning with the catheter inserted directly into the joint-but the FDA rejected the applications due to insufficient data. Despite the FDA's decision, and despite knowing that intra-articular use was not safe, I-Flow promoted its pain pumps as safe and appropriate for such use. Oscar and Dr. Hill relied upon those false representations in deciding to use the pain pump inter-articularly after Oscar's March 2004 surgery.


The amended complaint has eight counts: negligence, negligent misrepresentation, fraud, strict product liability (design defect), strict product liability (failure to warn), breach of implied warranty, punitive damages, and loss of consortium. I-Flow has moved to dismiss the negligent misrepresentation, fraud, implied warranty, and punitive damages counts.

A. Fraud

As a general rule, Federal Rule of Civil Procedure 9(b) requires a fraud plaintiff to allege "the identity of the person who made the misrepresentation, the time, place and content of the misrepresentation, and the method by which the misrepresentation was communicated to the plaintiff." Vicom, Inc. v. Harbridge Merchant Servs., Inc., 20 F.3d 771, 777 (7th Cir. 1994). "This ordinarily requires describing the 'who, what, when, where, and how' of the fraud, although the exact level of particularity that is required will necessarily differ based on the facts of the case." AnchorBank, FSB v. Hofer, 649 F.3d 610, 615 (7th Cir. 2011). Rule 9(b) recognizes that "[m]alice, intent, knowledge, and other conditions of a person's mind may be alleged generally." Fed. R. Civ. P. 9(b); see also Burks v. Raemisch, 555 F.3d 592, 594 (7th Cir. 2009). Moreover, "[i]n alleging the time period during which the misrepresentations and omissions are alleged to have been made, the plaintiff may allege an approximate time frame." Hernandez v. Childers, 736 F. Supp. 903, 912 (N.D. Ill. 1990).

I-Flow contends that the amended complaint "fails to set forth the circumstances of IFlow's alleged misrepresentations, their contents, or their speakers, and how Plaintiffs or Plaintiff Oscar Clifton's physician heard and relied upon them." Doc. 23 at 2. The contention is incorrect. The amended complaint identifies I-Flow as the speaker, which suffices where the defendant is a corporation and the corporation itself is alleged to have made fraudulent misrepresentations. See Talavera v. Metabolife Int'l, Inc., 2004 WL 2260628, at *2 (N.D. Ill. Sept. 24, 2004); AAR Int'l Inc. v. Vacances Heliades S.A., 202 F. Supp. 2d 788, 799 (N.D. Ill. 2002) (citing cases). The amended complaint also identifies the content and timing of I-Flow's alleged misrepresentations, including: (1) a press release on September 2, 1998, falsely claiming that I-Flow received FDA approval to market its pain pump for orthopedic surgery applications;

(2) a PowerPoint presentation sent to physicians in May 2001 stating that pain pumps were particularly useful in shoulder and other joint surgery; (3) a PowerPoint presentation prepared in November 2001 stating that the catheter may be inserted into the joint; and (4) a guide developed in July 2002 specifying that the pain pump's catheter may be used intra-articularly. Doc. 21 at ¶¶ 66, 74. Finally, the amended complaint alleges that Oscar and Dr. Hill justifiably relied on IFlow's false representations in deciding to insert the catheter into Oscar's joint space after his March 2004 shoulder surgery. Id. at ¶ 72. The evidence may defeat these allegations-in particular, the allegation that Dr. Hill and Oscar were aware of and relied upon I-Flow's alleged misrepresentations-but at the pleading stage they are sufficient under Rules 9(b) and 12(b)(6).

I-Flow also contends that the fraud claim actually is a "fraud-on-the-FDA" claim and therefore is preempted by the Federal Food, Drug, and Cosmetic Act ("FDCA") under Buckman Co. v. Plaintiffs' Legal Committee, 531 U.S. 341 (2000). Doc. 23 at 4-8. In Buckman, the Supreme Court held that the FDCA preempts state law claims alleging that the defendant made fraudulent representations to the FDA to obtain approval for a drug or medical device and that, had the defendant not made those misrepresentations, the FDA would not have approved the drug or device and the plaintiff would not have been injured. 531 U.S. at 343-45. The amended complaint makes no such claim-to the contrary, it alleges that the FDA declined to approve IFlow's pain pumps for intra-articular use and that I-Flow, despite the FDA's (correct) decision, marketed its pain pumps for that use anyway. Because Plaintiffs allege not that I-Flow tricked the FDA into approving pain pumps for a use that would have been rejected had I-Flow told the truth, but rather that I-Flow made misrepresentations to the medical community and the public at large, Buckman does not apply. See Lafaivre v. KV Pharm. Co., 636 F.3d 935, 944 (8th Cir. 2011) (rejecting Buckman preemption and explaining that "[t]he misrepresentation at issue in Buckman was not made to the plaintiff-or consumers at large-but to the FDA itself") (internal quotation marks omitted); Hughes v. Bos. Scientific Corp., 631 F.3d 762, 775 (5th Cir. 2011) (rejecting Buckman preemption where the plaintiff's "claim does not depend on speculation that the FDA would have taken any particular regulatory action in response to violation of the regulations at issue"); Gaeta v. Perrigo Pharm. Co., 630 F.3d 1225, 1234 (9th Cir. 2011) (rejecting Buckman preemption where "[t]he question before us is not whether [the defendant] provided inaccurate or incomplete information to the FDA, but rather whether it complied with its post-marketing obligations to warn consumers and health care professionals about additional risks associated with its product"); Smith v. I-Flow Corp., 753 F. Supp. 2d 744, 750 n.1 (N.D. Ill. 2010).

B. Negligent Misrepresentation

I-Flow seeks dismissal of the negligent misrepresentation claim on the ground that it does not satisfy Rule 9(b). Doc. 23 at 1-4. The contention is meritless, as "a negligent misrepresentation claim . is not governed by the heightened pleading standard of Rule 9(b)." Tricontinental Indus., Ltd. v. PricewaterhouseCoopers, LLP, 475 F.3d 824, 833 (7thCir. 2007). I-Flow does not argue that the negligent misrepresentation claim fails to satisfy the ordinary pleading standards of Rule 8(a)(2), so any such argument is forfeited. The argument would have been rejected in any event; because the fraud claim satisfies Rule 9(b), the negligent misrepresentation claim-which is based on the same alleged misrepresentations as the fraud claim-surely satisfies the less stringent pleading requirements of Rule 8(a)(2). See Proctor v. Metro. Money Store ...

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