Moore et al v. Wright Medical Technology, Inc.

Filing 101

ORDER granting in part and denying in part 49 Motion for Summary Judgment. Plaintiffs design defect, failure-to-warn, negligence, and loss-of-consortium claims shall proceed to trial. Signed by Judge J. Randal Hall on 03/31/2016. (thb)

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IN THE UNITED STATES DISTRICT COURT SOUTHERN FOR THE DISTRICT OF GEORGIA AUGUSTA DIVISION OTIS MOORE and DOROTHY * R. MOORE, * Plaintiffs, * * v. l:14-cv-62 * WRIGHT MEDICAL TECHNOLOGY, INC., * * Defendant. * 0 Plaintiffs Defendant arising Otis Wright out of E R and Dorothy Moore Medical the D R filed this Technology, failure of the Inc. case seeking against damages PROFEMUR® titanium modular long neck component of Otis Moore's hip implant, which Defendant designed and manufactured. Plaintiffs' Complaint advanced numerous legal claims against Defendant, and Defendant now seeks summary judgment in its favor on the following claims theories: • Product Liability based on Design Defect; • Product Liability based on Manufacturing Defect; • Product Liability based on Failure to Warn; • Negligence Per Se; • Loss of Consortium; • Punitive Damages and and (Def.'s Mot. Summ. DENIES IN PART J., 49. )1 Doc. Defendant's motion. I. BACKGROUND Wright Medical Technology, PROFEMUR® Hip System, which PROFEMUR® titanium modular line of modular necks, neck connects to the introduced in 2002 Inc. long neck. which has stem referred to 2002 and sheet as a The Ex. that at 8-9.) reported pre-2002. modular neck model, in April information the a market. PROFEMUR® model Defendant, in Europe advertising the since however, 1985. A was had 2003 PROFEMUR® modular neck the 50,000 modular necks implanted between 1985 and claimed 10 part PROFEMUR® neck is The "[n]one of the necks clinical failure since their inception." 95, component a modular connection where the component. for the U.S. follow-up is the manufacturer of the includes produced modular neck components clinical The Court GRANTS IN PART and and May However, Later, with a (Pis.' dozen respect has to experienced the Br., Doc. fractures neck Opp. a were 2002 PROFEMUR® Defendant received notice of neck fractures 2005. concerning Later significant still, numbers Defendant of received fractures, which Defendant warned surgeons about in subsequent letters. 1 Plaintiffs' Complaint also alleges a negligence claim that is distinct from their negligence per se claim. Defendant has not moved for summary judgment on the negligence claim. Additionally, Defendant filed three Daubert motions to exclude Plaintiffs' which the Court addresses in a separate order. experts' testimony, The 2002 PROFEMUR® Hip System includes Instructions For Use ("IFU") that detail some of the associated with the hip implant. "factors," among others, that considerations and risks The IFU included the following "can be critical to the eventual success of the procedure": Patient's Weight. An overweight or obese patient can produce high loads on the prosthesis which can lead to failure of the prosthesis Patient's occupation or activity. If the patient is involved in an occupation or activity, which includes substantial walking, running, lifting, or muscle strain, the resultant forces the fixation, the can cause device, or failure both. of The prosthesis will not restore function to the level expected with normal healthy bone, and the patient should not have unrealistic functional expectations. (Pis.' Opp. Br., "absolute contraindications," "obesity where weight." In Scott Doc. 95, Ex. obesity is 1 at 1-2.) The IFU also includes which defined as specifically three times mention normal body (Id. at 2-3.) September Corpe, an 2005, Plaintiff orthopedic surgeon the Medical College of Georgia, residency in 1981, modularity hip Dr. replacement Otis and Moore met Associate with Dr. R. Professor at regarding hip pain. Corpe has systems. been He Since his experienced understood that with hip replacement systems and their component parts include the risk of failures, material at each modular interactions, junction. Dr. and corrosion and fretting Corpe also authored surgical guides for Defendant, including one for the PROFEMUR® hip stem that he implanted in Otis Moore. had no information that In 2005, Defendant's however, PROFEMUR® hip Dr. Corpe system had a greater risk of mechanical failure by fracture of its component parts than other hip systems, or that it was not appropriate for heavier patients or those who wanted to engage in high levels of activity. During the course of his consultation with Otis Moore, Dr. Corpe determined that Moore suffered from end-stage degenerative joint disease was so in his great right hip. that he wanted Moore his indicated that the pain hip replaced and further informed Dr. Corpe that he caddied for professional golfers and that golf a full bag can weigh as Corpe cautioned Moore that the much as sixty pounds. Dr. bag's additional weight and the amount of walking associated with his job could adversely affect the success of his a hip replacement. Nevertheless, Dr. Corpe agreed to perform the surgery. In his "muscular week 72.01 initial in his before the inches Defendant's consultation, build" operation, tall. IFU, and which "not Moore Moore did defined Dr. Corpe obese." weighed not described Moore (Doc. 230.8 qualify obesity as 49 as three as at 31.) A lbs. and was obese times under normal body weight. On November 15, 2005, Dr. Corpe performed a right hip total arthroplasty, implanting the PROFEMUR® total hip system, including years the later, relevant on titanium modular March 13, 2012, Otis long neck. six artificial Moore's Over hip failed, causing severe pain. Moore sought a consultation with Dr. Corpe the Dr. Corpe performed a revision surgery to who determined that modular neck had fractured. remove the fractured neck component. At the time of Moore's initial implant surgery on November 15, 2005, only two had fractured. agreed to Dr. implant generally, was Defendant's other late 2008, necks, of Defendant's 2002 PROFEMUR® modular necks Corpe was unaware of these fractures when he the modular unaware of modular neck the in Otis fractures neck models that between after he did learn of fractures Moore 1985 and, more occurred and 2002. in In in PROFEMUR® modular Dr. Corpe switched to using models with smaller heads and non-metal bearings before discontinuing using the PROFEMUR® modular neck entirely around 2010. II. Summary genuine 56(a). the judgment dispute entitled to as is to judgment appropriate any as STANDARD material a matter of only fact if and law." "there the Fed. is no movant is R. Civ. P. Facts are "material" if they could affect the outcome of suit under Liberty Lobby, view SUMMARY JUDGMENT the facts the Inc., in governing 477 U.S. the light substantive 242, 248 most favorable law. (1986). to Anderson v. The Court must the non-moving party, Matsushita U.S. 574, in [its] 1428, 587 Elec. (1986), favor." 1437 Indus. Co. v. Zenith Radio Corp., 475 and must draw "all justifiable inferences U.S. v. (11th Cir. Four Parcels of Real Prop., 1991) (en banc) 941 F.2d (internal punctuation and citations omitted). The Court, moving by motion. How 1115 reference Celotex to proof party carry at this two the initial materials v. Cir. burden 1993) . on Catrett, depends Fitzpatrick v. proof at trial, of to Corp. trial. (11th has When file, 477 on City the burden the U.S. who of showing basis 317, bears of Atlanta, non-movant has for 323 the 2 the (1986). burden F.3d the the of 1112, burden of the movant may carry the initial burden in one ways: by negating an essential element of the non- movant's case or by showing that there is no evidence to prove a fact necessary to the non-movant's case. Clark, (11th Cir. Inc., Adickes 477 v. U.S. response movant 929 S.H. 317). in F.2d Kress opposition, its issues of judgment & 606-08 Co., 398 it must 144 (1970) first consider initial burden of showing that material fact and as a matter of law. F.3d 248, 254 U.S. 1991) Coats & (explaining and Celotex, Before the Court can evaluate the non-movant's has met genuine 604, See Clark v. (11th Cir. 1997) that Jones v. it City (per curiam). is whether there the are no entitled of Columbus, to 120 A mere conclusory statement that the non-movant cannot meet the burden at trial is insufficient. Clark, 929 F.2d at 608. If—and only if—the movant carries its initial burden, non-movant may avoid summary judgment only by that there is indeed a material summary judgment." proof at trial, Id. the issue of the "demonstrat[ing] fact that precludes When the non-movant bears the burden of non-movant must tailor its method by which the movant carried its response to the initial burden. If the movant presents evidence affirmatively negating a material fact, the non-movant withstand fact a "must directed sought to be the movant shows non-movant must respond verdict with evidence motion negated." at trial Fitzpatrick, 2 sufficient on the F.3d at either show that the record material 1116. an absence of evidence on a material fact, contains to If the evidence that was "overlooked or ignored" by the movant or "come forward with additional verdict motion deficiency." burden by evidence at Id. relying sufficient trial at on based 1117. the to on The withstand the alleged non-movant pleadings or by cannot repeating a directed evidentiary carry conclusory allegations contained in the complaint. See Morris v. Ross, F.2d Rather, 1032, 1033-34 (11th Cir. 1981). the its 663 non-movant must respond with affidavits or as otherwise provided by Federal Rule of Civil Procedure In action, notice this of 56. the Clerk Defendant's motion for of the Court gave Plaintiffs summary judgment and informed them of the summary judgment rules, the right to file affidavits or other materials in opposition, and the consequences of default. (Doc. Wainwright, therefore, 52.) The notice 772 F.2d 822, 825 requirements (11th Cir. of Griffith v. 1985) (per curiam), are satisfied and the motion is ripe for review. III. ANALYSIS Plaintiff Otis Moore asserts the followings three causes of action: (1) strict product negligence per se. Otis Moore liability: warn. alleges design (Id. damages (Compl., at liability; Doc. three defect, 39-41.) (2) 1 at 39-43.) different manufacturing Further still, section that requests negligence; (3) In more detail, theories defect, of and product failure to the Complaint includes a Plaintiff Dorothy Moore's loss of consortium damages and punitive damages against Defendant. (Id. at into 44.) Defendant's individual claims motion breaks relief and for Plaintiffs' requests requests summary judgment on each. A. Design Defect Defendant defect theory seeks judgment on the grounds that, [Defendant's] Daubert motions then judgment Otis regarding summary (Def.'s that Mot. on summary Summ. J. is at also 5). proving a design defect expert testimony. 1833-TWT, 2011 WL See Meade 4402539, at "should Court in this Ford *2 (N.D. 8 as to agrees case v. the all claims." with Defendant Co., 2011) grant experts, requires the Motor Ga. design Court Plaintiffs' warranted The Moore's No. use of l:09-cv- ("Because the alleged design defect ... is not one that can be understood by the reasonable quotations Daubert juror, omitted)). motions, favorable Moore's to the testimony is required." Having Court Plaintiffs, design defect therefore, expert denied finds the the that, expert theory of product bulk in of the (internal Defendant's most supports evidence light Otis liability. The Court, DENIES Defendant's motion with respect to the design defect theory. B. Manufacturing Defect Defendant's motion for summary judgment seeks the dismissal of Otis Moore's (Def.'s Mot. manufacturing Summ. J. at 12.) defect theory of liability. Under Georgia law, [t]o establish defendant's strict liability, plaintiffs must prove that defendant is the manufacturer of the property, that the property when sold by the manufacturer was not merchantable and reasonably suited to the use intended (i.e., defective), and that its condition when sold was the proximate cause of the injury sustained. Chicago Hardware & 877-78 (Ga. Ct. App. Fixture 1999) Co. v. Letterman, 510 S.E.2d 875, (footnote omitted). In their response brief, Plaintiffs admit that Defendant's "manufacturing records indicate that at the time of manufacture the subject device surface-finish 15.) defect conformed specifications." Nevertheless, claim to should [Defendant's] (Pis.' Opp. Plaintiffs assert that proceed because Dr. dimensional Br., the Doc. 95 and at manufacturing Corpe supposedly testified that design a manufacturing or that Dr. factual 252 of the device's failure defect. Corpe's testimony is dispute. (Doc. 85 was In caused reply, by either Defendant a argues insufficient to create a material at 3 (citing Anderson, 577 U.S. at (M[t]he mere existence of a scintilla of evidence in support the plaintiff's position will be insufficient" to avoid summary judgment))). The Dr. Court Corpe's manufacturing agrees with off-hand defects Defendant. remark in Plaintiffs' about Defendant's the reliance possibility products cannot on of sustain Otis Moore's manufacturing defect theory of liability because no reasonable juror could conclude based solely on that testimony that Moore's hip implant was defectively manufactured.2 put, Dr. Corpe's testimony is not "evidence Simply sufficient to 2 A review of the testimony in question makes clear that Dr. Corpe is speaking about the possibility of manufacturing defects in hip implants generally and not with respect to Otis Moore's implant. The full exchange in deposition was as follows: Q: With respect to implant challenges, Total Joint Arthroplasty implants realistically guaranteed for five "whether can be years, guaranteed for five years, let alone 20 years, is also questionable. Catastrophic implant failures can mechanically occur in the absence of a design or manufacturing flaw. A: I would have to say that I agree with everything in that until the last statement, because I don't understand that last statement. Q: Okay. A: There has to be some reason that it failed, but to say that it's not a design or a manufacturing flaw, how else does it fail then? 10 withstand a directed verdict fact sought to be negated." Court, GRANTS motion therefore, at trial Fitzpatrick, on the 2 F.3d at summary judgment with material 1116. respect The to Otis Moore's manufacturing defect theory. C. Failure to Warn Under Georgia law, on a failure-to-warn defendant and to prove a product-liability claim based had a the duty to warn, breach injury." theory, was the Ga. 1999) "when the manufacturer (citations S.N.C., ways: by failing or "must the duty of 46 F. Supp. omitted). knows to cause show breached that the defendant danger arising from product use." two plaintiff proximate Wheat v. Sofamor, (N.D. a A duty reasonably Id. the plaintiff's 2d 1351, to 1362-62 warn should arises know of a Breach may be proved in adequately communicate the warning to the ultimate user or by failing to provide an adequate warning of the 1213, product's 1219, doctrine, of the because potential (11th Cir. [Defendant] risks Dr. manufacturer of and 1999). was not the Corpe risks. was "Under the ultimate v. Ford, 190 titanium learned consumer; F.3d learned intermediary required to directly warn [PROFEMUR® a Watkins modular intermediary [Defendant] [Moore] long neck] between could the have adequately communicated the warning by only warning Dr. Corpe." Mims 2012 v. 1681810, Wright at *4 Med. Tech. , Inc., (N.D. Ga. 2012). 11 No. 1: ll-cv-213-TWT, WL Defendant seeks summary judgment two a matter of law because Defendant warned of the risk risks, activity, namely implant, that and Dr. PROFEMUR® Corpe its for adequate as and that claim First, weight contends this reasons. of Defendant on knew modular warnings of necks, the relevant like could fail and that weight and activity, were any hip in particular, is a cause of failure. Second, Defendant argues that Plaintiffs cannot because prove causation PROFEMUR® necks after he Plaintiffs' that failure-to-warn used in IFU PROFEMUR® IFU's only definition (Pis.' "obesity" Br., Ex. definition, Dr. affect the success weight did not and that he initial or meet the neck. Corpe's 1 In three at the a hip Doc. 67 own included body a weight. with Otis contained that Moore's in the IFU population" for the And Dr. 102-05.) indicated he was (Outpatient Note, Elsewhere, be knew weight can implant, at not Defendant's Consistent though he warn Defendant's normal patient evaluation of Moore Ex. 4 at 49.) implant allegation should weight contraindication Depo., an particular, times "appropriate (Corpe to inadequate to begin, 2-3.) of on necks regarding failure in build" and "not obese." J., To Corpe testified that, was modular as rests long lbs. claim. contraindication Opp. continued Corpe was titanium modular Plaintiffs' of theory Dr. someone weighing 230.8 supports Corpe learned of fractures. that the information given to him Dr. "muscular Def.'s Mot. Summ. the IFU mentions that a patient's 12 weight this "can as and to failure of the prosthesis," a "major consideration when the patient small Pis.' lead sized Opp. Br., prosthesis Ex. 1 at must 1.) be Dr. used." Corpe but is (Hip describes small boned System IFU, further testified that Defendant never warned that "heavier weight" or "high levels of activities" produced an or that increased risk of failure in a patient a modular neck possessed an increased risk compared to fixed necks. (Corpe Depo. The inadequacy of Plaintiffs' orthopedic expert surgeon "had any notice at 102-05.) Defendant's warning is reports. expert, of prior Dr. gave the also supported by Sonny Bal, opinion that failures by factures of Plaintiffs' if Defendant any model of these modular necks ... an orthopedic surgeon would reasonably expect" that Defendant would correct the problem or give a clear warning if a correction was not possible. at 25.) And the engineering expert expert, report of Mari states, warning pages supplied by among other (Bal Report, S. Truman, opinions, Doc. 51 Plaintiffs' that [Defendant] for this device "[t]he (in 2003) were insufficient concerning weight and/or activity restrictions to prevent implant (Truman Report, Doc. evidence, including testimony, and overload, 91, Ex. the Plaintiffs' failure 2 at 66.) IFU, Dr. experts, and patient In short, Plaintiffs' Corpe's raises a evaluation factual over whether Defendant adequately warned Dr. Corpe. 13 injury." and dispute With no respect evidence Corpe's to Defendant an that causation, additional warning conduct. testimony that Defendant Dr. Corpe different warnings." argues Defendant, Dr. conduct fractures. after would that there have have acted Summ. J. to "obtained no differently at is changed Dr. Plaintiffs continued Corpe 11.) with Moreover, implant PROFEMUR® after he learned that his own patients (Id.) In of fractures learning would that (Def.'s Mot. modular necks until 2010, suffered notes argues Defendant's view, demonstrates Dr. Corpe's that he would have implanted the PROFEMUR® titanium modular long neck in Moore even with an adequate warning. Defendant's selective reading of Dr. Corpe's does not provide a full picture of his response to fractures Read in PROFEMUR® modular favorable to favor, neck Dr. Plaintiffs, necks. in the testimony learning of light and with all inferences drawn in their Corpe testified that once he learned about PROFEMUR® failures he discontinued his use of the titanium long necks and then all of Defendant's modular necks. counsel asked fractures, 2010, Dr. he and "large experienced Corpe continued Dr. crucially, Dr. with most Corpe whether, to use even after PROFEMUR® confirmed that learning modular was the modular Defense of necks some until case. But, Corpe clarified that he stopped using the models heads any against fractured metal bearings," necks "that were and not he had not articulated against a metal liner ... or a short neck," though he admitted 14 the decision to stop was not fracture in his patients. not aware of immediately any stop legal made (Doc. immediately 67, Ex. all 1 at 69.) that authority implanting requires learned heads of fractures against Moore. metal Even if Dr. he because he adequately not have evidence stopped implanted raises a of the the the the for device's device in Corpe neck to models models "with implanted large in Otis PROFEMUR® modular neck judgment on beck model risks, Moore. disputed material summary model long Defendant's warnings and causation, motion Dr. a jury could draw the inference that implanting apprised using Corpe's cessation of implants was not immediate, first His testimony was that once stopped bearings," the The Court is PROFEMUR® modular for Plaintiffs to prove causation. he after fact he once he therefore Because regarding was would Plaintiffs' adequacy of the Court DENIES Defendant's Otis Moore's failure-to-warn theory. D. Negligence Per Se Claim Defendant's motion also seeks summary judgment in its favor with respect to Mot. Summ. abandon GRANTS favor J. at that Otis Moore's negligence per se claim. 12-13.) claim. summary judgment of In response, (Doc. 95 at on Moore's Defendant. 15 (Def.'s Otis Moore has chosen to 16.) The Court therefore negligence per se claim in E. Dorothy Moore's Loss-of-Consortium Claim Because Moore's the Court claims, derivative 477 F. Court Supp. nature DENIES dismissed Dorothy loss-of-consortium (discussing derivative the not Plaintiff Ports Authority, Thus, has all of Otis may Moore Plaintiff maintain her claim. See 2d 1272, 1276-77 of the Defendant's Pattee v. (S.D. Georgia Ga. 2007) loss-of-consortium claim). motion for summary judgment on Dorothy Moore's loss-of-consortium claim. F. Punitive Damages Claim Under Georgia where "defendant's fraud, wantonness, would raise law, Plaintiffs may recover punitive actions showed oppression, the willful presumption of conscious § 51-12-5.1(b). to by this Further, in typically with conduct a not at *5 435 949 F.Supp. (N.D. Stone 843 evidence Man 206 showing an v. Moseley, "punitive manufacturer No. culpable of has But, Inc. General if punitive then are complied 2012 Motors Corp., present "nothing damages." WL v. Green, Plaintiffs behavior," 447 S.E.2d 302, 311 16 to Id. damages 1: ll-cv-213-TWT, Welch v. 1996)). award evidence. (citing Stone Man, 1993); Ga. indifference convincing the Mims, 2012) (Ga. (N.D. precludes Motors Corp. Ga. malice, Plaintiffs are required case, where standards." S.E.2d 205, "other and product-liability regulatory 1681810, clear appropriate misconduct, or that entire want of care which consequences." O.C.G.A. prove damages in General (Ga. Ct. App. 1994) abrogated on other grounds by Webster v. Boyett, (Ga. 1998). Defendant argues that Plaintiff malice, Plaintiff, and, further, PROFEMUR® modular As should an that matter, ruling because wantonness, the FDA has evidence "willful oppression" cleared the to sale harm of the neck. initial defer judgment fraud, no state of that Defendant acted with the required mental misconduct, 496 S.E.2d 459 on Plaintiffs the whether punitive punitive argue damages damages that claim can be the at Court summary proven is a question "best left for the Court to make when it hears and sees all of the trial." evidence (Pis.' that Opp. will Br. be at submitted 17.) But, in this under case Georgia at law, punitive damages claims may be decided at summary judgment "when a plaintiff fails defendant's to Pizza, No. 765, LLC, Jan. 769 establish conduct indifferent Ga. to 14, the consequences . . any legal the misconduct." (Doc. allegation is that claimed to have 95 at Defendant never . fact or that a consciously ." Puling v. Domino's 2015 WL 3407602, at *5 Powertel, Inc., 551 (N.D. S.E.2d 2001). referencing generally citing of willful 2015) (citing Taylor v. App. question either 1:13-CV-01570-LMM, (Ga. Ct. Without was a authority, Plaintiffs "evidence 16.) published At of materials Plaintiffs' in which fractures it since 1985, even though Defendant knew those statements were false. 17 by [Defendant's] bottom, experienced modular neck respond As discussed Plaintiffs, theory. the above, evidence However, in the light supports Plaintiffs a have most viable failed favorable failure-to-warn to point to evidence that Defendant did so with "willful misconduct, fraud, wantonness, would raise oppression, the consequences." cleared Defendant's 1681810, at *5 § any malice, or that entire want of care which presumption O.C.G.A. to of conscious 51-12-5.1(b) . product for Additionally, sale. (dismissing plaintiffs' indifference See to FDA 2012 Mims, the WL punitive damages claim on similar evidence as presented in this case). Given Defendant's Plaintiffs' failure to misconduct, the Court compliance point to GRANTS with federal evidence of Defendant's regulations willful motion and and wanton for summary and DENIES IN PART judgment on Plaintiffs' punitive damages claim. IV. As discussed, Defendant's defect, motion the CONCLUSION Court for failure-to-warn, GRANTS summary IN PART judgment. negligence, and Plaintiffs design loss-of-consortium claims shall proceed to trial. ORDER ENTERED at Augusta, Georgia, this ^$/ day of March, 2016. HONORABLE J./ RANDAL HALL UNITED STATES DISTRICT JUDGE JTHERN 18 DISTRICT OF GEORGIA

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