Brooke Chiasson v. B Braun Medical Inc et al

MOTION for Summary Judgment

W.D. La.January 23, 2017

9551v.1 UNITED STATES DISTRICT COURT WESTERN DISTRICT OF LOUISIANA LAFAYETTE DIVISION BROOKE CHIASSON ) CIVIL ACTION NO. 6:16-cv-01337 ) Plaintiff, ) ) v. ) JUDGE REBECCA F. DOHERTY ) B. BRAUN MEDICAL INC. ) ) MAG. JUDGE PATRICK J. HANNA Defendant ) MOTION FOR SUMMARY JUDGMENT OF DEFENDANT B. BRAUN MEDICAL INC. NOW INTO COURT, through undersigned counsel, comes Defendant, B. Braun Medical Inc. (“B. Braun”) who moves this Honorable Court for summary judgment finding that B. Braun and any alleged “John Doe” employee of B. Braun, are entitled to judgment as a matter of law and dismissing Plaintiff’s claims against them with prejudice. For the reasons set forth more fully in the attached supporting memorandum, hereby incorporated as if copied in extenso, there is no basis for any claim of liability against B. Braun under the Louisiana Products Liability Act (La. R.S. § 9:2800.51 et seq), because the product at issue was not put to a “reasonably anticipated use” and the product warnings provided by B. Braun in the product label were adequate as a matter of law. WHEREFORE, B. Braun respectfully moves for summary judgment as a matter of law in favor of B. Braun and against Plaintiff, Brooke Chiasson, dismissing Plaintiff’s claims in full and with prejudice. Case 6:16-cv-01337-RFD-PJH Document 17 Filed 01/23/17 Page 1 of 2 PageID #: 100 9551v.1 Respectfully submitted, WILSON ELSER MOSKOWITZ EDELMAN & DICKER LLP /s/ Lisa M. Africk Lisa M. Africk (La. Bar No. 26724) Rachal D. Chance (La. Bar No. 31358) 650 Poydras Street, Suite 2200 New Orleans, LA 70130 504-702-1710 (Main) 504-702-1715 (Fax) lisa.africk@wilsonelser.com rachal.chance@wilsonelser.com Attorneys for B. Braun Medical Inc. CERTIFICATE OF SERVICE The undersigned, an attorney, hereby certifies that on January 23, 2017, counsel of record was served via the Court ECF system and/or by placing a true and correct copy of the above and foregoing pleading in the U.S. Mail, properly addressed and pre-paid to: Attorneys for Plaintiff Aaron W. Guidry (21632) Thomas F. Porter, IV (14573) Porter & Guidry, LLC 100 Rue Iberville, Suite 100 Lafayette, LA 70508 ___/s/Lisa M. Africk Lisa M. Africk Case 6:16-cv-01337-RFD-PJH Document 17 Filed 01/23/17 Page 2 of 2 PageID #: 101 9543v.1 UNITED STATES DISTRICT COURT WESTERN DISTRICT OF LOUISIANA LAFAYETTE DIVISION BROOKE CHIASSON ) CIVIL ACTION NO. 6:16-cv-01337 ) Plaintiff, ) ) v. ) JUDGE REBECCA F. DOHERTY ) B. BRAUN MEDICAL INC. ) ) MAG. JUDGE PATRICK J. HANNA Defendant ) DEFENDANT B. BRAUN MEDICAL INC.’S MEMORANDUM OF LAW IN SUPPORT OF ITS MOTION FOR SUMMARY JUDGMENT MAY IT PLEASE THE COURT: This memorandum is submitted on behalf of Defendant, B. BRAUN MEDICAL INC. (“B. Braun”) and any “John Doe” employee of B. Braun, in support of a Motion for Summary Judgment regarding Plaintiff, Brooke Chiasson’s (“Plaintiff’s”) erroneous claim that B. Braun (or its agents) are liable for the injury suffered following a medical procedure wherein she was anesthetized using B. Braun’s product. As will be demonstrated in the memorandum below and supporting competent summary judgment evidence, there is no basis for any claim of liability against B. Braun herein, because the product at issue was not put to a “reasonably anticipated use” and the product warnings provided by B. Braun in the product label were adequate as a matter of law. For the reasons expounded upon more fully below, Defendants are entitled to judgment as a matter of law wherein Plaintiff’s claims against them are dismissed with prejudice. Case 6:16-cv-01337-RFD-PJH Document 17-1 Filed 01/23/17 Page 1 of 17 PageID #: 102 i 9543v.1 TABLE OF CONTENTS Page TABLE OF CONTENTS………………………………………………………………………i TABLE OF AUTHORITIES………………………………………………………………….ii I. INTRODUCTION……………………………………………………………………1 II. MATERIAL FACTS OF WHICH THERE IS NO GENUINE DISPUTE……….2 III. ARGUMENTS AND AUTHORITIES………………………………………………3 A. Summary Judgment Standard……………………………..………………...3 B. The Louisiana Products Liability Act…………………………..……………4 C. The Product was not put to a Reasonably anticipated Use……..……….….4 D. B. Braun, Including its Agents, had no Duty to Directly Warn Plaintiff or to Instruct Plaintiff’s Doctor further regarding the Use of the Product…...…………………………………………………………………….8 1. Dr. Heard was a “Learned Intermediary” and therefore the product warning was sufficient as a matter of law……………..……………...9 2. Alternatively, because Dr. Heard was a Sophisticated User of the Product, B. Braun Owed him no Duty to Warn……………….……10 3. Alternatively, because Lafayette General Medical Center was a Sophisticated Purchaser of the Product, it had the Duty to Instruct or Warn Dr. Heard – not Defendants……………………………….11 IV. CONCLUSION……………………………………………………………………13 Case 6:16-cv-01337-RFD-PJH Document 17-1 Filed 01/23/17 Page 2 of 17 PageID #: 103 ii 9543v.1 TABLE OF AUTHORITIES Cases Anderson v. Liberty Lobby, Inc., 106 S.Ct. 2505 (1986)………………………………………….3 Bealer v. Hoffman-La Roche, Inc., 729 F.Supp. 43 (E.D. La. 1990)……………………………..9 Brousard v. Procter & Gamble Co., 463 F.Supp.2d 596 (W.D.La. 2006)…………….....4, 5, 6, 7 Butz v. Lynch, 762 So.2d 1214 (La.App. 2000)……………………………………………...4, 5, 6 Calhoun v. Hoffman-La Roche, Inc., 768 So.2d 57 (La.App. 2000)……………………………...9 Cobb v. Syntex Laboratories, 444 So.2d 203 (La.App. 1983)…………………………………….9 Davis v. Avondale, 975 F.2d 169 (5 th Cir. 1992)………………………………………………...11 Ducote v. Liberty Mut. Ins. Co., 451 So.2d 1211 (La.App. 1984)…………………….…………11 Fernandez v. Tamko Building Products, Inc., 2 F.Supp.3d 854 (M.D.La. 2014)…………....10, 12 Johnson v. Transwood, Inc., 2015 WL 5690369 *7 (M.D.La. September 25, 2015)……………12 Johnston v. Hartford Ins. Co., 623 So.3d 35 (La.App. 1993)……………………….…………...11 Jones v. Flowserve FCD Corp., 73 Fed.Appx. 706 (5 th Cir. 2003)………………….…………..10 Kampen v. American Isuzu Motors, Inc., 157 F.3d 306 (5 th Cir. 1998)…………….……………..5 Little v. Liquid Air Corp., 37 F.3d 1069 (5 th Cir. 1994)…………………………………………..3 Lockart v. Kobe Steel Ltd. Const. Machinery Div., 989 F.2d 864 (5 th Cir. 1993)………...5, 6, 7, 8 Matthews v. Remington Arms Co., Inc., 641 F.3d 635 (5 th Cir. 2011)…………………………….4 Ortolano v. BDI Marketing, 930 So.2d 192 (La.App. 2006)……………………………………...5 Peterson v. G.H. Bass and Co., Inc., 713 So.2d 806 (La.App. 1998)…………………………….5 Wallace v. Texas Tech Univ., 80 F.3d 1042 (5 th Cir. 1996)……………………………………….3 White v. Slidell Memorial Hospital and Medical Center,1990 WL 111447 *2 (E.D.La. July 26, 1990)………………………………………………………………………………………………9 Zachary v. Dow Corning Corp., 884 F.Supp. 1061 (M.D. La. 1995)…………………………….9 Case 6:16-cv-01337-RFD-PJH Document 17-1 Filed 01/23/17 Page 3 of 17 PageID #: 104 1 9543v.1 I. INTRODUCTION Plaintiff Brooke Chiasson (“Plaintiff”) alleges injury following a medical procedure in which her doctor, Michael Heard, Jr. (“Dr. Heard”) utilized a B. Braun manufactured Perifix FX Springwound Epidural Catheter (“the Catheter”) to anesthetize Plaintiff during child birth. She claims that the Catheter was unreasonably dangerous pursuant to R.S. 9:2800.51 et seq. in construction or composition, in design, because Defendants failed to provide an adequate warning, and because the Catheter failed to conform to the manufacturer’s express warranty. In particular, Plaintiff asserts that Dr. Heard “attempted to withdraw [the Catheter]… through the Touhy [sic] needle at which time the tip of the catheter sheered [sic], leaving a portion of the non-MRI compatible catheter fragment within… plaintiff’s spine.” However, what Plaintiff describes in her Petition is in fact a “misuse” of the Catheter as the conduct taken by Dr. Heard was in direct contravention of the product warning accompanying the Catheter. Additionally, the injurious outcome, that the Catheter tip could shear, was also forewarned. Therefore, the use for which the Catheter was admittedly employed by Dr. Heard is not a “reasonably anticipated use,” and Plaintiff cannot successfully prosecute her claims against B. Braun under the Louisiana Product Liability Act. Moreover, because the product warning clearly and unambiguously cautioned the user, a medical doctor, anesthesiologist, learned intermediary and sophisticated user of this product, as well as Lafayette General Medical Center, a sophisticated purchaser, not to withdraw the Catheter through the epidural needle, Plaintiff cannot prevail on a claim for failure to warn against B. Braun or its agents (such as the alleged “John Doe” sales representative referenced in Plaintiff’s Petition). As a matter of law, B. Braun and its agents did not owe a duty to directly warn the Plaintiff-patient or to instruct Dr. Heard, a sophisticated user and learned intermediary, further, beyond the clear warning noted above, about the Catheter. Accordingly, as Plaintiff cannot carry her burden of Case 6:16-cv-01337-RFD-PJH Document 17-1 Filed 01/23/17 Page 4 of 17 PageID #: 105 2 9543v.1 proof against B. Braun or its agents, Defendants are thus entitled to a dismissal of all of her claims as a matter of law. II. MATERIAL FACTS OF WHICH THERE IS NO GENUINE DISPUTE B. Braun is a Pennsylvania corporation which is registered to do and does business in Louisiana. Doc. 1, Exhibit A, “Petition” at ¶ 1.A. B. Braun manufactured and distributed the Catheter to Lafayette General Medical Center (“Medical Center”), where Plaintiff received medical treatment. Id., ¶¶ 2 and 4. There, Dr. Heard conducted an anesthesia epidural procedure upon Plaintiff in preparation for the delivery of her child. Petition, ¶ 4. During this procedure Dr. Heard, who Plaintiff asserts holds himself out to be qualified physician in the field of anesthesiology, attempted to withdraw the Catheter from 5 cm to 4cm through the epidural needle. Id; Doc 9, attachment 2, “Med Mal Complaint”, ¶¶ 2, 5 and 7. While withdrawing the Catheter through the needle, the tip of the Catheter “sheered” off [sic], leaving a portion of the catheter within the epidural space in Plaintiff’s spine. Petition, ¶ 4. Plaintiff judicially admits that the failure of the Catheter and the alleged injuries resulting therefrom were caused by Dr. Heard partially withdrawing the Catheter through the epidural needle, which is contrary to the specific instructions for use issued with the Catheter by B. Braun. Med Mal Complaint, ¶ 11. The Catheter label specifically warned against using the product in the manner alleged by Plaintiff due to the potential risk of the very injury Plaintiff claims to have suffered. It provides: CAUTION: DO NOT WITHDRAW THE CATHETER THROUGH THE NEEDLE DUE TO THE POSSIBILITY OF SHEARING OR KINKING Id.; see also Exhibit A to the Affidavit of Antonia Roth (“Roth Aff”), attached to Defendant’s Memorandum as Exhibit 1 (emphasis in the original); Roth Aff, ¶¶ 6-8 The Catheter is manufactured solely for use by licensed physicians. Roth Aff, ¶ 5. B. Case 6:16-cv-01337-RFD-PJH Document 17-1 Filed 01/23/17 Page 5 of 17 PageID #: 106 3 9543v.1 Braun did not sell the Catheter directly to Dr. Heard and can demonstrate that it did sell the Catheter to Lafayette General Medical Center with the packaged product warning, where Plaintiff claims to have received treatment from Dr. Heard. Id., ¶¶ 9-11. B. Braun’s records demonstrate that it did not provide any instruction Dr. Heard regarding the use of the Catheter, beyond including the aforementioned warning in the Catheter label and enclosing it with the Catheter. Id., ¶¶ 6, 12-13. III. ARGUMENT AND AUTHORITIES A. Summary Judgment Standard Summary judgment should be granted if the record, taken as a whole, together with any affidavits, show that there is no genuine issue of material fact and that the moving party is entitled to judgment as a matter of law. F.R.Civ.P. 56(c). The moving party must demonstrate the absence of a material fact, but need not negate the non-moving party’s prima facie case. Little v. Liquid Air Corp., 37 F.3d 1069, 1075 (5 th Cir. 1994) (en banc). When a proper motion is made pursuant to Rule 56, the non-movant must go beyond the pleadings and show by affidavits or other admissible evidence that specific facts exist over which there is a genuine issue for trial. Wallace v. Texas Tech Univ., 80 F.3d 1042, 1046-47 (5 th Cir. 1996). Neither conclusory allegations, unsubstantiated assertions, metaphysical doubts as to facts, nor a scintilla of evidence will satisfy the non-movant’s burden. Wallace, 80 F.3d at 1047. A judge’s task is not to weigh evidence, but to examine the substantive law and determine if a genuine issue of fact exists for a trial. Anderson v. Liberty Lobby, Inc., 106 S.Ct. 2505, 2507 (1986). A genuine issue of fact exists “if the evidence is such that a reasonable jury could return a verdict for the nonmoving party.” Id., at 2510. “If no issue of fact is presented and if the mover is entitled to judgment as a matter of law, the court is required to render the judgment prayed for.” Brousard v. Procter & Gamble Co., 463 F.Supp.2d 596, 603 (W.D.La. Case 6:16-cv-01337-RFD-PJH Document 17-1 Filed 01/23/17 Page 6 of 17 PageID #: 107 4 9543v.1 2006) (granting summary judgment to the defendant on circumstances similar to the present case). B. The Louisiana Products Liability Act Under the Louisiana Products Liability Act (“LPLA”), the manufacturer of a product is liable to a claimant for damage proximately caused by a characteristic of the product that renders the product unreasonably dangerous when such damage arose from a reasonably anticipated use of the product by the claimant or another person or entity. La. Rev.Stat. § 9:2800.55(A). The Claimant has the burden of proving the elements of her claim under the LPLA. La. Rev.Stat. § 9:2800.55(D). The LPLA provides the exclusive theories of liability against product manufacturers for damage allegedly caused by their products. Butz v. Lynch, 762 So.2d 1214, 1217 (La.App. 2000) (emphasis added). Because the LPLA is the exclusive source for Plaintiff’s remedies against B. Braun arising out of damage allegedly caused by the Catheter, and because Plaintiff’s judicial admissions foreclose her ability to establish that her injuries arose from a reasonably anticipated use of the product, B. Braun is entitled to judgment as a matter of law regarding all of the claims asserted against it herein. C. The Product was not put to a Reasonably Anticipated Use “Reasonably anticipated use” is a threshold LPLA element. Matthews v. Remington Arms Co., Inc., 641 F.3d 635 (5 th Cir. 2011). “[U]nless that threshold element is satisfied, a manufacturer does not have a legal duty to design its product to prevent such use.” Butz v. Lynch, 1999-1070 (La. App. 1 Cir. 6/23/00), 762 So. 2d 1214, 1218, writ denied, 2000-2660 (La. 11/17/00), 774 So. 2d 980. The LPLA defines the term “reasonably anticipated use” as “a use or handling of a product that the product’s manufacturer should reasonably expect of an ordinary person in the same or similar circumstances.” La. Rev.Stat. § 9:2800.53(7). This is an objective Case 6:16-cv-01337-RFD-PJH Document 17-1 Filed 01/23/17 Page 7 of 17 PageID #: 108 5 9543v.1 standard which asks the Court to determine whether the particular use was reasonably anticipated from the perspective of the manufacturer. Butz, 762 So.2d at 1218. “Under the LPLA, a manufacturer is liable only for those uses it should reasonably expect from an ordinary consumer.” Id. If a manufacturer does not reasonably anticipate a plaintiff's use then he owes no duty to that consumer, and is not responsible for any damages caused by misuse. Kampen v. American Isuzu Motors, Inc., 157 F.3d 306, 316 (5 th Cir. 1998); see also Brousard v. Procter & Gamble Co., 463 F.2d 596 (W.D.La. 2006) (“The manufacturer is not responsible for every conceivable, foreseeable use of its product, and reasonably anticipated use does not encompass misuses in direct contravention of a warning or where the danger should have been obvious to the experienced, as well as the ordinary, consumer”). Louisiana courts have consistently granted summary judgment to manufacturers based upon the determination that the use of a product against the instructions or warnings supplied with the product is not a “reasonably anticipated use.” See e.g. Butz, supra at 1218 (holding that the intentional inhalation of an aerosol, contrary to the warnings, was not a reasonably anticipated use as a matter of law in affirming summary judgment to the manufacturer); Ortolano v. BDI Marketing, 930 So.2d 192, 196 (La.App. 2006) (affirming summary judgment in part on the finding that the failure of the patient to comply with dosage instructions or use the product as otherwise indicated, was not a reasonably anticipated use of the medication); Peterson v. G.H. Bass and Co., Inc., 713 So.2d 806, 809 (La.App. 1998) (affirming summary judgment where it was undisputed that the use of the product was contrary to the product label); see also Kampen v. American Isuzu Motors, Inc., 157 F.3d 306, 318 (5 th Cir. 1998) (affirming judgment to the manufacturer because plaintiffs acted in contravention to a clear warning and failed to come forward with any evidence to establish that their damages arose from a reasonably anticipated use of the product); Lockart v. Kobe Steel Ltd. Const. Machinery Div., 989 F.2d 864 (5 th Cir. Case 6:16-cv-01337-RFD-PJH Document 17-1 Filed 01/23/17 Page 8 of 17 PageID #: 109 6 9543v.1 1993) (affirming summary judgment to the manufacturer); Brousard v. Procter & Gamble Co., 463 F.2d 596 (W.D.La. 2006) (granting summary judgment to the manufacturer). The federal cases are particularly instructive. In Lockart, the plaintiffs were injured (one was killed) when they suspended a steel pontoon from the teeth of the bucket of a hydraulic excavator and the pontoon fell on them as they worked beneath it. The manufacturer was sued under the LPLA, and the manufacturer moved for summary judgment. Summary judgment was granted, and the plaintiffs appealed. The Fifth Circuit Court of Appeals affirmed summary judgment, because the excavator product was not put to a reasonably anticipated use. The court noted that the product’s operator manual specifically stated “never lift a load from the bucket teeth.” Id. at 866. The court found this warning to be “unequivocal.” Id. The plaintiffs countered that the use must be anticipated because it was specifically warned against. Id. The Fifth Circuit rejected this argument holding that when a manufacturer expressly warns against using the product in a certain way in clear and direct language, “it is expected that an ordinary consumer would not use the product in contravention of the express warning.” Id. at 867. The Fifth Circuit further noted that even if the warning never actually reached these workers (because maybe they did not read the operator’s manual), the obvious danger of the act, particularly based upon the experience and training of the users “in same or similar circumstances” was further evidence that such a use would not be reasonably anticipated by the manufacturer. Id. at 868 (emphasis added). In Broussard, this Court granted summary judgment to the manufacturer based upon the failure of the plaintiff to use the product in a reasonably anticipated fashion. Plaintiff used that product – a thermacare “heatwrap” – while she was sleeping, and it moved from her back to her buttocks, causing severe burns. The plaintiff sued the manufacturer under the LPLA, and the manufacturer moved for summary judgment. In its motion, the manufacturer described the many Case 6:16-cv-01337-RFD-PJH Document 17-1 Filed 01/23/17 Page 9 of 17 PageID #: 110 7 9543v.1 warnings on the product label and noted that its warnings were not heeded by the plaintiff, which caused her injury. The court agreed. It held that “by disregarding the express warnings and instructions, [plaintiff’s] actions increased the risk of injury associated with the product and moved her use outside the realm of reasonably anticipated.” Id. at 608. The same circumstances exist here. In the present case, the Catheter about which Plaintiff complains was accompanied by instructions for use which contained a specific warning against withdrawing the Catheter through the epidural needle, noting that the potential consequence was that the Catheter could shear in that process. Med Mal Complaint, ¶ 11; Exhibit A to the Roth Aff. As in Lockart, this warning is direct, clear, and unambiguously describes how the Catheter is not to be withdrawn; it is unequivocal. Moreover, as in Broussard, a user’s decision to disregard this warning clearly created the risk of the injury specifically complained of in the Petition. Plaintiff has judicially admitted in the Petition and in her Medical Malpractice Complaint against Dr. Heard, and therefore it is undisputed 1 that Dr. Heard failed to follow the explicit warning against withdrawing the Catheter through the epidural needle during Plaintiff’s medical procedure. See Med Mal Complaint, ¶¶ 7 and 11; Petition ¶ 4. Plaintiff judicially admits a clear and undeniable misuse of the Catheter, or at the very least, a use that was not reasonably anticipated by B. Braun. It is also undisputed that the admitted misuse of the Catheter, when Dr. Heard withdrew the Catheter through the needle, is what caused the Catheter to shear, and this is what led to the specific injury about which Plaintiff complains in her Petition before this Court. See Petition; Med Mal Complaint, passim. 1 See e.g. In Re Professional Liability Claim of Snavely, 178 So.3d 614, 622 (La.App. 2015) (finding that admissions in medical review panel request were sufficient to demonstrate that the subsequent civil claim was time-barred); see also McCreary v. Richardson, 738 F.3d 651, 659 n. 5 (5 th Cir. 2013) (The Fifth Circuit “has long noted that factual statements in pleadings constitute binding judicial admissions.”) Case 6:16-cv-01337-RFD-PJH Document 17-1 Filed 01/23/17 Page 10 of 17 PageID #: 111 8 9543v.1 Because Plaintiff’s injury admittedly flows from the contra-indicated use of the Catheter by Dr. Heard, this Court must find as a matter of law that Plaintiff cannot meet her burden of proving that Dr. Heard’s use of the Catheter in Plaintiff’s medical care was “reasonably anticipated” by B. Braun. Indeed, as in Lockart, it is not relevant to inquire whether Dr. Heard read the product warning or whether he had ever heard of this type of warning regarding the use of epidural catheters. It would not be reasonable for B. Braun to anticipate that a medical doctor using its product would fail to heed its explicit warning about not withdrawing the Catheter through the epidural needle. Based upon this objective standard, no further discovery and no testimony of Dr. Heard or Plaintiff could alter this fact so as to avoid summary judgment in favor of B. Braun. As a result, the Court should grant B. Braun’s motion, and find as a matter of law that Plaintiff cannot meet a threshold element in the exclusive remedy that she has against Defendant B. Braun Medical Inc. D. B. Braun, Including its Agents, had no Duty to Directly Warn Plaintiff or to Instruct Plaintiff’s Doctor further regarding the Use of the Product In addition to seeking damages against B. Braun under the LPLA, Plaintiff has also asserted a claim against B. Braun’s purported, and as of yet, unidentified “sales representative” regarding his or her alleged failure to warn or instruct end-users or physicians like Dr. Heard regarding the risks associated with Dr. Heard’s actual (alleged) misuse of the Catheter. Under any theory of liability, Plaintiff must prove that she is owed a duty by B. Braun, including its agents, in order to state a claim and survive summary judgment. The law is clear that, because Dr. Heard was a “learned intermediary” and a “sophisticated user” of the Catheter, neither B. Braun nor its agents owed a duty to directly warn Plaintiff, the patient/end-user of the Catheter, or to directly instruct Dr. Heard regarding the risk of shearing the Catheter if it is withdrawn through the epidural needle, beyond the explicit warning that accompanied the Catheter. Case 6:16-cv-01337-RFD-PJH Document 17-1 Filed 01/23/17 Page 11 of 17 PageID #: 112 9 9543v.1 1. Dr. Heard was a “Learned Intermediary” and therefore the product warning was sufficient as a matter of law “The jurisprudence [in Louisiana] has treated the adequacy of a warning as a legal issue and thus, determined whether a particular warning was adequate as a matter of law.” Calhoun v. Hoffman-La Roche, Inc., 768 So.2d 57 (La.App. 2000). Under the “Learned Intermediary” doctrine, a manufacturer fulfills its obligation to the plaintiff/patient once the physician has been adequately informed about the risks of the medical product, because the physician acts as the learned intermediary. Cobb v. Syntex Laboratories, 444 So.2d 203, 205 (La.App. 1983). The manufacturer is under no duty to warn consumers directly. Id. In this way, the decision and corresponding duties about when and how a medical product is used “rests with the doctor and the patient, not with the manufacturer.” Id.; Zachary v. Dow Corning Corp., 884 F.Supp. 1061, 1065 (M.D. La. 1995) (“The learned intermediary is the one to whom the warning is directed and is the one who makes the decision whether to use the product”). A manufacturer that clearly and adequately warns about potential risks of the product “cannot be held responsible for a physician’s treatment decisions.” White v. Slidell Memorial Hospital and Medical Center, Civ. A. No. 89-2691; 1990 WL 111447 *2 (E.D.La. July 26, 1990) (“A drug manufacturer is entitled to summary judgment if reasonable men could not differ to a finding that the warnings supplied by the drug manufacturer adequately informed the physician.”) Louisiana courts have consistently granted summary judgment in favor of medical product manufacturers under the learned intermediary doctrine, where the warning accompanying the product is clear and adequately warns of the dangers associated with the product which are at issue in the case. White, supra (granting summary judgment); Calhoun, supra (affirming summary judgment); Zachary, supra (granting summary judgment); Bealer v. Case 6:16-cv-01337-RFD-PJH Document 17-1 Filed 01/23/17 Page 12 of 17 PageID #: 113 10 9543v.1 Hoffman-La Roche, Inc., 729 F.Supp. 43 (E.D. La. 1990) (granting summary judgment and noting that the warnings provided to the physician were adequate as a matter of law). Here, under the learned intermediary doctrine, B. Braun satisfied the manufacturer’s duty to warn by including written information advising against withdrawing the Catheter through the epidural needle with that product. Dr. Heard is the party responsible for her treatment because of his knowledge, education and training. Therefore, he is assumed to be aware of the risks attendant to the treatment he undertakes for each of his patients. If Dr. Heard decides to use the Product in a way that is not reasonably anticipated by the manufacturer, neither the manufacturer, nor agents, can be responsible for that decision – which rests between a doctor and patient. Under the law, Dr. Heard is treated as having been specifically warned not to do precisely what Plaintiff admits happened here because, as her anesthesiologist, he is the one who made the decision about how to withdraw the catheter. He is also the one against whom Plaintiff currently seeks to convene a medical review panel. See Med Mal Complaint, passim. For these same reasons, this Honorable Court should find that B. Braun and the John Doe Defendant did not owe Plaintiff a duty beyond that which it satisfied by providing the product warning, demonstrated by the Catheter label attached hereto. Exhibit A to the Roth Aff. 2. Alternatively, because Dr. Heard was a Sophisticated User of the Product, B. Braun Owed him no Duty to Warn A product manufacturer has no duty to warn “sophisticated users” of the product who are expected to know of the characteristic of the product that may cause damage. Jones v. Flowserve FCD Corp., 73 Fed.Appx. 706, 711 (5 th Cir. 2003). This defense applies when the product is not one that is intended for the ordinary use of the public, but instead, its use is for a professional user. Fernandez v. Tamko Building Products, Inc., 2 F.Supp.3d 854, 863 (M.D.La. 2014); Case 6:16-cv-01337-RFD-PJH Document 17-1 Filed 01/23/17 Page 13 of 17 PageID #: 114 11 9543v.1 Johnston v. Hartford Ins. Co., 623 So.3d 35, 37 (La.App. 1993) (finding no duty to warn mechanics about the danger of running an automobile engine because they are presumed to know and understand that danger); Ducote v. Liberty Mut. Ins. Co., 451 So.2d 1211, 1213 (La.App. 1984) (“The manufacturer is under no duty to warn a ‘sophisticated user’ of those dangers which he may be presumed to know through his familiarity with the product.”) The Catheter is a medical device, which is manufactured by B. Braun for use by physicians in the care of their patients. Roth Aff, ¶ 5. There can be no dispute that Dr. Heard, the user of the Catheter, is a licensed physician, more specifically, an anesthesiologist. See Med Mal Complaint, passim. As such, it is indisputable that Dr. Heard is a “sophisticated user” of the Catheter. As a sophisticated user, the law is clear that B. Braun and its agents had no duty to instruct Dr. Heard regarding the dangers associated with the use of the Catheter. Specifically in this case, B. Braun had no duty to provide instruction to a sophisticated user in addition to the label warning, which itself adequately warned of the risks of shearing the catheter upon withdrawing the catheter through the epidural needle. Because Dr. Heard was a sophisticated user of the Catheter, based upon the foregoing legal authority, and, as a matter of law, there is no duty to warn or instruct sophisticated users of a product, Defendants are entitled to judgment as a matter of law. 3. Alternatively, because Lafayette General Medical Center was a Sophisticated Purchaser of the Product, it had the Duty to Instruct or Warn Dr. Heard - not Defendants If a product manufacturer provides an adequate warning to the product purchaser, then there is no duty by the manufacturer to warn the employee of that purchaser or further end-user regarding the dangers of the product. Davis v. Avondale, 975 F.2d 169, 173 (5 th Cir. 1992). Therefore, if a sophisticated purchaser buys a product to be used by someone else, that Case 6:16-cv-01337-RFD-PJH Document 17-1 Filed 01/23/17 Page 14 of 17 PageID #: 115 12 9543v.1 purchaser, not the manufacturer, then has the duty to provide any warnings to the employee or end user of the product. See Fernandez, supra; see also Johnson v. Transwood, Inc., 14 CV-102- SDD-SCR; 2015 WL 5690369 *7 (M.D.La. September 25, 2015) (“Manufacturers have no duty to warn an end-user of the product’s dangers when the product is initially purchased by a sophisticated user who then has the duty to warn the end-user.”) Here, Dr. Heard was not the purchaser of the Catheter. The Catheter was purchased by Lafayette General Medical Center, a hospital, and therefore a sophisticated purchaser of medical products, including catheters. Roth Aff, ¶¶ 9-11. Thus, the duty to “instruct” users employing those catheters purchased by Lafayette General Medical Center at Lafayette General Medical Center regarding the dangers of withdrawing the Catheter through the epidural needle would be the sophisticated purchaser - Lafayette General Medical Center, not B. Braun or its agents. Accordingly, because B. Braun had no duty to warn Dr. Heard (or Plaintiff) beyond providing the clear warnings it included with the product about the risks associated with the Catheter, and because there is no evidence that its agents or sales representatives instructed Dr. Heard about the product or the subject warning (see Roth Aff, ¶¶ 12-13), 2 Plaintiff cannot maintain a claim against B. Braun or its sales representatives for negligent failure to instruct or warn users of the Catheter. Because B. Braun’s sales representatives had no duty to warn or instruct Dr. Heard, an end-user, regarding the dangers of a product sold to a sophisticated purchaser, in this case - the hospital, for this alternative reason as well, Defendants are entitled to judgment dismissing Plaintiff’s claims against it in its entirety, as a matter of law. 2 It should be noted that Plaintiff does not plead that anyone from B. Braun (any John Doe sales representative) actually instructed Dr. Heard on the use of the Product. Instead, the pleading vaguely suggests that a “John Doe” failed to “properly instruct and warn users such as [Dr. Heard]” regarding the risks of the use of the product. Accordingly, on its face, the Petition does not adequately plead a claim against this “John Doe” defendant for negligence. On summary judgment, Plaintiff must move beyond the pleadings and establish some evidence that Dr. Heard was actually instructed on the use of the Product by a B. Braun representative for this claim to survive. Case 6:16-cv-01337-RFD-PJH Document 17-1 Filed 01/23/17 Page 15 of 17 PageID #: 116 13 9543v.1 IV. CONCLUSION Each of Plaintiff’s claims against B. Braun or its sales representatives must fail for the simple reason that the precise harmful act admitted by Plaintiff to have caused her harm was expressly warned against in B. Braun’s product instructions that accompanied this product. Therefore the alleged misuse, as a matter of law, is not a reasonably anticipated use, and the claims are meritless under the LPLA. Moreover, because Dr. Heard was a learned intermediary and the product warning sufficiently described the risk of withdrawing the catheter through the needle, specifically warning against doing that specific act, the treatment decision to do so (and the corresponding liability, if any) belongs to Dr. Heard, as neither B. Braun nor its sales representatives owed Plaintiff any duty to warn beyond the duty satisfied by the aforementioned product label. Finally, as Dr. Heard was a sophisticated user and the product was purchased by a hospital, a sophisticated purchaser, there is no basis for holding B. Braun or its agents liable for the misuse of the product, that Plaintiff clearly admits in her Petition for Damages, as Defendants had no duty to Plaintiff or Dr. Heard to instruct or warn Dr. Heard beyond incorporating the explicit warning in the product instructions, as demonstrated by the product warning identified herein. For all of the foregoing reasons, Defendant B. Braun Medical Inc. respectfully requests that this Honorable Court GRANT its Motion for Summary Judgment, on behalf of itself and any alleged agent or sales representative that Plaintiff might identify, and that all of Plaintiff’s claims in the Petition for Damages be dismissed in their entirety, with prejudice. Case 6:16-cv-01337-RFD-PJH Document 17-1 Filed 01/23/17 Page 16 of 17 PageID #: 117 14 9543v.1 Respectfully submitted, WILSON ELSER MOSKOWITZ EDELMAN & DICKER LLP /s/ Lisa M. Africk Lisa M. Africk (La. Bar No. 26724) Rachal D. Chance (La. Bar No. 31358) 650 Poydras Street, Suite 2200 New Orleans, LA 70130 504-702-1710 (Main) 504-702-1715 (Fax) lisa.africk@wilsonelser.com rachal.chance@wilsonelser.com Attorneys for B. Braun Medical Inc. CERTIFICATE OF SERVICE The undersigned, an attorney, hereby certifies that on January 23, 2017, counsel of record was served via the Court ECF system and/or by placing a true and correct copy of the above and foregoing pleading in the U.S. Mail, properly addressed and pre-paid to: Attorneys for Plaintiff Aaron W. Guidry (21632) Thomas F. Porter, IV (14573) Porter & Guidry, LLC 100 Rue Iberville, Suite 100 Lafayette, LA 70508 ___/s/Lisa M. Africk Lisa M. Africk Case 6:16-cv-01337-RFD-PJH Document 17-1 Filed 01/23/17 Page 17 of 17 PageID #: 118 UNITED STATES DISTRICT COURT lryESTERN DISTRICT OF' LOUISIANA LAFAYETTE DIVISION BROOKE CHIASSON CIVIL ACTION NO. 6:16-cv-01337 Plaintiff, v JUDGE REBECCA F. DOHERTY B. BRAUN MEDICAL INC. MAG. JUDGE PATRICK J. HANNA Defendant ArrrpAvrr oF ANTpNIA. BQTH Antonia Roth, a person of the full age of majorit¡ appeared before me, the undersigned Notary Public, and being duly sworn, deposed and stated as follows: 1. My name is Antonia Roth, and I am a resident of the Commonwealth of Pennsylvania. 2. I have not been convicted of any crime. 3. I am an employee of B. Braun Medical Inc. ('8. Braun"). My job title is Product Manager Pain Control, Marketing. Based upon by employment with B. Braun and review of B. Braun corporate documents, I have knowledge of the facts containedherein. 4. B. Braun manufactures the Perifix FX Springwound Epidural Catheter ("the Catheter"). 5. The Catheter is manufactured solely for the use of licensed physicians. 6. When B. Braun sells the Catheter, it includes with the Catheter a set of instructions for use. 7. A true and correct copy of the instructions for use for the Catheter is attached to this Affidavit as Exhibit A. 8. One of the wamings contained within the instructions for use for the Catheter states: CAUTION: DO NOT WITHDRAW THE CATHETER THROUGH THE NEEDLE DUE TO THE POSSIBILITY OF ) ) ) ) ) ) ) ) ) 7917357v.1 Case 6:16-cv-01337-RFD-PJH Document 17-2 Filed 01/23/17 Page 1 of 4 PageID #: 119 SHEARING OR KINKING 9. B. Braun began selling the Catheter to Lafayette General Medical Center in20t3. 10. B. Braun maintains records regarding the dishibution of its products as part of its regular business practices. I l. B. Braun has searched its sales records back to 2008 through present and there are no records of B.Braun selling a Catheter directly to Dr. Michael Heard. 12.8. Braun maintains records regarding meetings between its sales representatives and physicians regarding the use of its products as part of its regular business practices on its Sales Force database. 13. B. Braun has searched its Sales Force database for calendar years 2013,2014 and 2015 and there are no records of any sales representative meeting Dr. Michael Heard or giving Dr. Michael Heard instruction regarding the use of the Catheter. COMMONWEALTH OF PENNSYLVANIA CoI.INTY oF L h' r]N suBscRIBED AND SwoRN to me tr,ir'äðf4 ¿uv >øt1 20t7. NOTARY Printed Name: hV t, ' [40"u ,]j}, ]ü]0, 7917357v.1 My Commission Expires 2 Case 6:16-cv-01337-RFD-PJH Document 17-2 Filed 01/23/17 Page 2 of 4 PageID #: 120 PERIFIX@ FX Sprí ngwound Epidural Catheter @5';;lll.:mu: Not made with Rx only naturel rubber latex. See immediate conta¡ner labeling for sterility and pyrogen claim. A4802s73-2 REV.12114 Description: The PERIFIX tY. Springwound Epidural Catheter is comprised of a flexible spring wire core enclosed within a soft copolymerjacket, The tip of the catheter is marked with a 2 - 3 mm mark. The catheter has a single mark at 5.5 cm fÍom the tip, with additional marks in I cm increments up to 20.5 cm. The 10.5 cm point is indicated by two marks, 1 5.5 cm by three marks, and 20.5 cm by four marks. Marking on the proximal end of the catheter ind¡cates proper catheter ¡nsertion depth ¡nto the câtheter connector, lndications for Use: The PERIFIX FX Springwound Epidwal Catheter is intended for administration of local anesthetic agents into the epidural space to prov¡de continuous epidural or caudal anesthesia. The catheter should be removed or replaced every 72 hours. Contraindications: . Not for use w¡th tunneling techniques . Consult stândard textbooks for contraindications associated with c0ntinuous epidural anesthesia procedures WARNINGS: . N0T INIENDED FoR INTRAVENoUS 0R SPINAL INJECTIoN. . INADVERTENT INTRAVENoUS INJECTI0N MAY BE FOLLOWED BY SYSTEMIC TOXIC EFFECTS FROM THE LOCAL ANESTHETIC AGENT WITH CONVULSIONS AND POSSIBLE CARDIOVASCULAR COLLAPSE, . INADVERTENT lNJECllON |NTO THE SUBARACHNOID 0R SUBDURAL SPACE MAY BE FOLLOWED BY RAPID AND TOTAL SPINAL ANESTHESIA, VASCULAR HYPOTENSION, UNCONSCIOUSNESS. AND/OR APNEA. . INADVERTENT DURAL PUNCTURE MAY RESULT IN HEADACHE AND OTHER NEUROLOGICAL SYMPÏOMS. . INJECTION OF EXCESSIVE DOSES OR CONCENTRATION OF LOCAL ANESTHETIC AGENTS CAN CAUSE NERVE DAMAGE. EXHIBIT k ô Ê Case 6:16-cv-01337-RFD-PJH Document 17-2 Filed 01/23/17 Page 3 of 4 PageID #: 121 NOTE: All components required for epidural câtheter placement may not be included wlth kit. lnstructions for Use: Use aseptic technique. 1. Perform epidural puncture according to standard techn¡ques. 2. PRECAUTION: Advãncing the catheter more then 5 cm past the needle top may increâse the likelihood of kinking or knottlng, Following puncture and verification of the epidural space, introduce the catheter tip through the epidural needle using the Thread Assist Guide, The guide is designed to provide stâbility of the catheter during insertion. CAUTION: DO NOT WITHDRAW THE CATHEÏER THROUGH THE NEEDLE DUE TO THE POSSIBILITY OF SHEARING OR KINKING. 3. 0bserve the flash-back windows for potential spinal fluid or blood. This mây indicate penetration ofvascular structures or dura, and the procedure should be discontinued or âttempted at another inteßpace, 4. Remove needle and thread Assist Guide ovcr catheter while holding catheter tightly ¡n place. 5. Fully insert catheter into catheter connector, (Refer to Cath€t€r Conn€ctor lnstructions for Use,) 6. A primed epidural bacterial filter (0.2 Fm) may be attached to the catheter connector. 7, Aspirate and infuse anesthetic of cho¡ce, Consult drug Package lnsert 8. CAUTIONS: . WHEN REMOVING CATHETER, EXCESSIVE FORCE SHOULD NEVER BE APPLIED, IF CATHETER BECOMES DIFFICULT TO WITHDRAW, CONSULT STANDARD TEXTBOOKS FOR SPECIFIC TECHNIOUES. . FOLLOWING REMOVAL, INSPECT DISTAI- TIP FOR CONTINUITY, THE BLUE MARK ON THE TIP WILLVERIFY THAT THE ENTIRE CATHETER HAs BEEN RETRIEVED. At completion of procedure, remove the epidural catheter per standard technique, B. Braun Medical lnc. Bethlehem, PA 1 801 8-3524 usA www'bbraun.comBIBRAUN Case 6:16-cv-01337-RFD-PJH Document 17-2 Filed 01/23/17 Page 4 of 4 PageID #: 122 9553v.1 UNITED STATES DISTRICT COURT WESTERN DISTRICT OF LOUISIANA LAFAYETTE DIVISION BROOKE CHIASSON ) CIVIL ACTION NO. 6:16-cv-01337 ) Plaintiff, ) ) v. ) JUDGE REBECCA F. DOHERTY ) B. BRAUN MEDICAL INC. ) ) MAG. JUDGE PATRICK J. HANNA Defendant ) RULE 56.1 STATEMENT OF MATERIAL FACTS Pursuant to Local Civil Rule 56.1 and in support of its Motion for Summary Judgment, Defendant, B. Braun Medical Inc. (“B.Braun”), respectfully submits this statement of material facts about which there is no genuine issue for trial. 1. B. Braun is a Pennsylvania corporation which is registered to do and does business in Louisiana. Doc. 1, Exhibit A, “Petition” at ¶ 1.A. 2. B. Braun manufactured and distributed a Perifix FX Springwound Epidural Catheter to Lafayette General Medical Center (“Medical Center”), where Plaintiff, Brooke Chiasson (“Plaintiff”), received medical treatment. Id., ¶¶ 2 and 4. 3. The Catheter label provides: CAUTION: DO NOT WITHDRAW THE CATHETER THROUGH THE NEEDLE DUE TO THE POSSIBILITY OF SHEARING OR KINKING. See Exhibit A to the Affidavit of Antonia Roth (“Roth Aff”), attached to Defendant’s Memorandum as Exhibit 1 (emphasis in the original); Roth Aff, ¶¶ 6-8. Case 6:16-cv-01337-RFD-PJH Document 17-3 Filed 01/23/17 Page 1 of 4 PageID #: 123 9553v.1 4. The Catheter is manufactured solely for use by licensed physicians. Roth Aff, ¶ 5. 5. At the Medical Center, Dr. Michael Heard, Jr. conducted an anesthesia epidural procedure upon Plaintiff using a B. Braun manufactured Perifix FX Springwound Epidural Catheter (“the Catheter”) in preparation for the delivery of her child. Petition, ¶ 4. 6. During this procedure Dr. Heard, who Plaintiff asserts holds himself out to be qualified physician in the field of anesthesiology, attempted to withdraw the Catheter from 5 cm to 4cm through the epidural needle. Id; Doc 9, attachment 2, “Med Mal Complaint”, ¶¶ 2, 5 and 7. 7. While withdrawing the Catheter through the needle, the tip of the Catheter “sheered” off [sic], leaving a portion of the Catheter within the epidural space in Plaintiff’s spine. Petition, ¶ 4. 8. The failure of the Catheter and the alleged injuries resulting therefrom were caused by Dr. Heard partially withdrawing the Catheter through the epidural needle, which is contrary to the specific instructions for use issued with the Catheter by B. Braun. Med Mal Complaint, ¶ 11. 9. B. Braun specifically warned against using the product in the manner alleged by Plaintiff due to the potential risk of the very injury Plaintiff claims to have suffered. Ex. A to Roth Aff. 10. Although B. Braun sold the Catheter to Lafayette General Medical Center with the packaged product warning, where Plaintiff claims to have received treatment from Dr. Heard, it has no record of selling the Catheter directly to Dr. Heard. Roth Aff, ¶¶ 9-11. 11. Likewise, B. Braun has no record of any interactions with Dr. Heard in which it or its Case 6:16-cv-01337-RFD-PJH Document 17-3 Filed 01/23/17 Page 2 of 4 PageID #: 124 9553v.1 agents “instructed” Dr. Heard (beyond supplying the warning label with the Catheter) regarding the use of the Catheter. Id., ¶¶ 12-13. 12. Plaintiff has filed a Medical Malpractice Complaint against Dr. Heard, and therein she judicially admits that the failure of the Catheter, and the alleged injuries resulting therefrom, were caused by Dr. Heard partially withdrawing the Catheter through the epidural needle. Med Mal Complaint, ¶ 11. 13. The conduct by Dr. Heard was in direct contravention of the product warning accompanying the Catheter. See Exhibit A to Roth Aff. Respectfully submitted, WILSON ELSER MOSKOWITZ EDELMAN & DICKER LLP /s/ Lisa M. Africk Lisa M. Africk (La. Bar No. 26724) Rachal D. Chance (La. Bar No. 31358) 650 Poydras Street, Suite 2200 New Orleans, LA 70130 504-702-1710 (Main) 504-702-1715 (Fax) lisa.africk@wilsonelser.com rachal.chance@wilsonelser.com Attorneys for B. Braun Medical Inc. Case 6:16-cv-01337-RFD-PJH Document 17-3 Filed 01/23/17 Page 3 of 4 PageID #: 125 9553v.1 CERTIFICATE OF SERVICE The undersigned, an attorney, hereby certifies that on January 23, 2017, counsel of record was served via the Court ECF system and/or by placing a true and correct copy of the above and foregoing pleading in the U.S. Mail, properly addressed and pre-paid to: Attorneys for Plaintiff Aaron W. Guidry (21632) Thomas F. Porter, IV (14573) Porter & Guidry, LLC 100 Rue Iberville, Suite 100 Lafayette, LA 70508 ___/s/Lisa M. Africk Lisa M. Africk Case 6:16-cv-01337-RFD-PJH Document 17-3 Filed 01/23/17 Page 4 of 4 PageID #: 126 9552v.1 UNITED STATES DISTRICT COURT WESTERN DISTRICT OF LOUISIANA LAFAYETTE DIVISION BROOKE CHIASSON ) CIVIL ACTION NO. 6:16-cv-01337 ) Plaintiff, ) ) v. ) JUDGE REBECCA F. DOHERTY ) B. BRAUN MEDICAL INC. ) ) MAG. JUDGE PATRICK J. HANNA Defendant ) JUDGMENT This matter came before the Court on Motion for Summary Judgment of B. Braun Medical Inc. (“B. Braun”). Considering the motion, memorandum, affidavit filed therewith, and the applicable standards of law; IT IS HEREBY ORDERED, ADJUDGED AND DECREED that the motion of B. Braun Medical Inc. be and is hereby GRANTED, because there is no basis to sustain a claim of liability against B. Braun, or any of its alleged employee representatives, under the Louisiana Product Liability Act; and IT IS FURTHER ORDERED, ADJUDGED AND DECREED that all claims of Plaintiff, Brooke Chiasson, against B. Braun Medical Inc. and against the “John Doe” employee of B. Braun, named in the Petition but not joined, be and are hereby DISMISSED with prejudice. THUS DONE AND SIGNED this _____ day of ____________________, 2017. _______________________________________________ HON. REBECCA F. DOHERTY UNITED STATES DISTRICT COURT JUDGE Case 6:16-cv-01337-RFD-PJH Document 17-4 Filed 01/23/17 Page 1 of 1 PageID #: 127