Estes v. Lanx, Inc. et al
MEMORANDUM OPINION re 110 Order on Motion for Summary Judgment. Signed by District Judge Sharion Aycock on 12/23/2015. (psk)
IN THE UNITED STATES DISTRICT COURT
FOR THE NORTHERN DISTRICT OF MISSISSIPPI
CAUSE NO.: 1:14CV052-SA-DAS
LANX, INC., et al.
Plaintiff filed this suit against Lanx, Inc., for negligence, products liability for design
defect, products liability for manufacturing defect, breach of express and implied warranties,
fraudulent concealment, and negligent misrepresentation.
Defendant filed a Motion for
Summary Judgment  that no genuine disputes of material fact exist as to those claims. After
reviewing the record, motion, response, rules, and authorities, the Court finds as follows:
Factual and Procedural Background
In 2011, Rocky Estes underwent spinal fusion surgery wherein the Lanx Telluride Spinal
Fixation System was implanted to fuse his L5-S1 vertebrae. Within five months, two pedicle
screws fractured. A revision surgery was performed on June 28, 2012, to remove the broken
screws and replace the Telluride Spinal Fixation System with new orthopedic hardware.
Estes seeks compensation for injuries, pain and suffering, and his extensive past and
future medical treatment on the basis that the pedicle screw was negligently designed or
manufactured, that Lanx breached warranties as to the pedicle screws, and that Lanx failed to
obtain FDA clearance for the Telluride System.
Lanx filed a Motion for Summary Judgment on those claims.
Summary Judgment Standard
Summary judgment is warranted under Rule 56(a) of the Federal Rules of Civil
Procedure when the evidence reveals no genuine dispute regarding any material fact and the
moving party is entitled to judgment as a matter of law. The rule “mandates the entry of
summary judgment, after adequate time for discovery and upon motion, against a party who fails
to make a showing sufficient to establish the existence of an element essential to that party’s
case, and on which that party will bear the burden of proof at trial.” Celotex Corp. v. Catrett, 477
U.S. 317, 322, 106 S. Ct. 2548, 91 L. Ed. 2d 265 (1986).
The party moving for summary judgment “bears the initial responsibility of informing the
district court of the basis for its motion, and identifying those portions of [the record] which it
believes demonstrate the absence of a genuine issue of material fact.” Id. at 323, 106 S. Ct. 2548.
The nonmoving party must then “go beyond the pleadings” and “set forth ‘specific facts showing
that there is a genuine issue for trial.’” Id. at 324, 106 S. Ct. 2548 (citation omitted). In reviewing
the evidence, factual controversies are to be resolved in favor of the nonmovant, “but only when
. . . both parties have submitted evidence of contradictory facts.” Little v. Liquid Air Corp., 37
F.3d 1069, 1075 (5th Cir. 1994) (en banc). Importantly, conclusory allegations, speculation,
unsubstantiated assertions, and legalistic arguments have never constituted an adequate substitute
for specific facts showing a genuine issue for trial. TIG Ins. Co. v. Sedgwick James of Wash., 276
F.3d 754, 759 (5th Cir. 2002); SEC v. Recile, 10 F.3d 1093, 1097 (5th Cir. 1997); Little, 37 F.3d
Discussion and Analysis
Plaintiff’s causes of action can be summarized into three broader sub-categories: (1)
claims concerning the specific pedicle screw and/or spinal fixation system used in Estes’ 2011
surgery; (2) claims regarding warranties allegedly made by Lanx; and (3) claims that the
Telluride Spinal Fixation System was improperly placed on the market for sale without proper
(1) Mississippi Products Liability Act and Negligence
As for the first category, claims centered around the specific medical device used on
Estes, the Plaintiff pled these causes of action: negligence, defective design, and manufacturing
defect. Lanx contends that Plaintiff cannot sustain a negligence action on the basis that the
Mississippi Products Liability Act precludes common law negligence.
a. Design Defect under the MPLA
Defendant contends Plaintiff’s MPLA design defect claim should be dismissed as no
feasible alternative design has been offered into evidence. Plaintiff failed to respond. The
Mississippi Supreme Court has summarized the design defect elements under the MPLA as
The danger presented by the product’s design was known or should have been
known to the manufacturer [or seller] (i.e., the danger was foreseeable); (2)
the product failed to function as expected (as a result of a design
characteristic); (3) an alternative design existed that would not impair the
product's usefulness or desirability; and (4) the alternative design would have
to a reasonable probability prevented the harm.
Phillips 66 Co., 94 So. 3d at 1060 (quoting Williams v. Bennett, 921 So. 2d 1269, 1274 (Miss.
2006) (internal quotation marks omitted)). Plaintiff put forth no evidence as to an alternative
design. Accordingly, the Court finds that no genuine issue of material fact has been produced as
to Plaintiff’s design defect claim and that claim is dismissed. See Gilley v. Protective Life Ins.
Co., 17 F.3d 775, 781 n.13 (5th Cir. 1994) (“We have held that an argument is waived if the
party fails to make the argument in response to summary judgment.”).
b. Failure to Warn under the MPLA
For a plaintiff to prevail on a failure-to-warn claim in Mississippi, he must prove by a
preponderance of the evidence that at the time the product left the control of the manufacturer,
designer, or seller:
(i) . . . The product was defective because it failed to contain adequate
warnings or instructions . . . ; and
(ii) The defective condition rendered the product unreasonably dangerous to
the user or consumer; and
(iii) The defective and unreasonably dangerous condition of the product
proximately caused the damages for which recovery is sought.
MISS. CODE ANN. § 11-1-63(a)(i)(2), (ii) (iii). On such a claim, a plaintiff must also prove the
(c)(i) . . . [A]t the time the product left the control of the manufacturer,
designer[,] or seller, the manufacturer, designer[,] or seller knew or in
light of reasonably available knowledge should have known about the
danger that caused the damage for which recovery is sought and that
the ordinary user or consumer would not realize its dangerous
(ii) An adequate product warning or instruction is one that a
reasonably prudent person in the same or similar circumstances would
have provided with respect to the danger and that communicates
sufficient information on the dangers and safe use of the product,
taking into account the characteristics of, and the ordinary knowledge
common to an ordinary consumer who purchases the product; or in the
case of a prescription drug, medical device[,] or other product that is
intended to be used only under the supervision of a physician or other
licensed professional person, taking into account the characteristics of,
and the ordinary knowledge common to, a physician or other licensed
professional who prescribes the drug, device[,] or other product.
MISS. CODE ANN. § 11-1-63(c).
Thus, “[a] manufacturer is liable under a failure-to-warn theory if the product ‘failed to
contain adequate warnings,’ the inadequate warnings ‘rendered the product unreasonably
dangerous to the user or consumer,’ and the inadequate warnings ‘proximately caused the
damages for which recovery is sought.’” Union Carbide Corp. v. Nix, Jr., 142 So. 3d 374, 385
(Miss. 2014). The Fifth Circuit in interpreting Mississippi law has stated:
Under the learned intermediary doctrine, which is codified in the Mississippi
Products Liability Act, a manufacturer of a prescription drug has no duty to
warn the end user of the drug’s possible adverse effects. Wyeth Labs., Inc. v.
Fortenberry, 530 So. 2d 688 (Miss. 1988). The manufacturer’s duty to warn
runs only to the prescribing physician, who acts as an intermediary between
the manufacturer and the patient. Id. The learned intermediary doctrine applies
to medical devices as well as prescription drugs. Moore v. Mem. Hosp. of
Gulfport, 825 So. 2d 658, 662 n.6 (Miss. 2002).
Smith v. Johnson & Johnson, Inc., 483 F. App’x 909, 913-14 (5th Cir. 2012) (per curiam). “In
order to make out a case for failure to warn under the learned intermediary doctrine, the plaintiff
must establish that the treating physician, or a reasonable physician in the treating physician’s
position, would not have used the product had he received an adequate warning.” Id. at 914
(citing Thomas v. Hoffman—LaRoche, Inc., 949 F.2d 806, 812 (5th Cir. 1992)).
Plaintiff alleges Lanx had a duty to inform the hospital and the attending physician that
the Lanx Telluride Spinal Fixation System had not been cleared, or that a standalone 510(k) had
not been submitted to the FDA, and that this failure caused his injuries.1 In support of this claim,
Plaintiff states that “Dr. Crosby has confirmed that had he known that Lanx Telluride Spinal
Fixation System had not been cleared or that a standalone 510(k) had not been submitted to the
FDA and the Telluride System had not been cleared by the FDA he would not have used the
Telluride System in the surgical procedure he performed on Estes.” No record citation is
provided by Plaintiff, and no support is found therein, to substantiate this claim. Thus, Plaintiff
Although the Amended Complaint  does not assert a failure to warn theory of liability under the MPLA, and
the Court generally will not consider claims raised only in response to summary judgment, the Court analyzes them
herein because dismissal of these claims is necessary after their consideration. See Roberts v. Lubrizol Corp., 582 F.
App’x 455, 461 (5th Cir. 2014) (quoting Cutrera v. Bd. of Supervisors of La. State Univ., 429 F.3d 108, 113 (5th
Cir. 2005); see also Green v. JP Morgan Chase Bank, N.A., 562 F. App’x. 238, 240 (5th Cir. 2014).
has failed to put forth evidence that the treating physician would not have used this product had
he known of the alleged lack of FDA clearance for the device or components of the product.
Additionally, the treating physician did indicate in his deposition that he was aware of the risks
of spinal fusion surgery and implantation of fusion devices, including the possibility of device
failure. Even knowing those risks, Dr. Crosby testified he still used the Lanx Telluride Spinal
Fixation System. Plaintiff’s failure to warn claim is dismissed.
c. Manufacturing Defect under the MPLA
For a plaintiff to prevail on a manufacturing defect claim in Mississippi, he must prove
by a preponderance of the evidence that at the time the product left the control of the
manufacturer or designer:
(i) The product was defective because it deviated in a material way
from the manufacturer’s or designer’s specifications or from otherwise
identical units manufactured to the same manufacturing specifications,
. . .; and
(ii) The defective condition rendered the product unreasonably
dangerous to the user or consumer; and
(iii) The defective and unreasonably dangerous condition of the
product proximately caused the damages for which recovery is sought.
MISS. CODE ANN. § 11-1-63(a)(1)(i)-(iii).
“[M]anufacturing defect claims involve allegations not that the entire product line in
question was defectively designed, but rather that the specific product purchased by the
consumer was manufactured in a way which deviated from the design specifications.” Hickory
Springs Mfg. Co. v. Star Pipe Prods., Ltd., 991 F. Supp. 2d 778, 782 (N.D. Miss. 2014).
“[A] product is not ‘defective’ under § 11-1-63(a)(i)(1) unless it is shown to be out of
compliance with the manufacturer’s specifications.” Cooper Tire & Rubber Co. v. Tuckier, 826
So. 2d 679, 693 (Miss. 2002) (citing Leverette v. Louisville Ladder Co., 183 F.3d 339, 341 (5th
Cir. 1999) (holding that expert’s testimony that ladder had manufacturing defect was properly
excluded in products liability action under Mississippi law where expert failed to assess whether
ladder met manufacturer’s specifications)).
Plaintiff’s Amended Complaint suggests that the “Lanx Pedicle Screws were not made in
accordance with the Defendants’ [sic] specifications or performance standards.”
Plaintiff never states how the pedicle screws at issue deviated from the manufacturing
specification. In fact, Plaintiff puts forth no manufacturing specifications at all. Plaintiff further
contends that proof of malfunction creates a genuine issue of material fact as to a manufacturing
defect under the MPLA. Moreover, Plaintiff alleges that Defendant spoliated the evidence by
failing to collect or maintain the broken pedicle screws after their removal from the Plaintiff.
The Court finds that Plaintiff’s assertion that proof of malfunction is enough to sustain a
question of fact in manufacturing defect cases under the MPLA is erroneous. Plaintiff’s citations
on this issue indicate the converse of Plaintiff’s contentions. See Shelter Ins. Co. v. MercedesBenz USA, LLC, 236 F. App’x 45, 47-48 (5th Cir. 2007) (holding that evidence that only the
battery malfunctioned, without proof of an actual deviation from manufacturer specifications,
was not enough to prove an essential element of the plaintiff’s claim); Tuckier, 826 So. 2d at 693
(“[A] product is not ‘defective’ under § 11-1-63(a)(i)(1) unless it is shown to be out of
compliance with the manufacturer’s specifications.”). Accordingly, without evidence of any
manufacturer specifications, Plaintiff has failed to put forth evidence as to an element of the
manufacturing defect claim that he would have to prove at trial. Therefore, Lanx’s motion for
summary judgment as to this claim is granted.
Plaintiff’s Amended Complaint additionally alleges that Lanx breached its duty of
reasonable care in that it negligently “designed, developed, manufactured, tested, inspected,
packaged, promoted, marketed, distributed, labeled, and/or sold” the Lanx Telluride System and
its component, the Lanx Pedicle Screw. Despite the allegations not being in his complaint, the
Plaintiff, in response to Defendant’s Motion for Summary Judgment asserts that Lanx was
additionally negligent in releasing the Telluride Spinal Fixation System into commerce without
proper FDA clearance.
The Mississippi Legislature amended the Mississippi Products Liability Act (MPLA) in
2014 to apply to “any action for damages caused by a product, including, but not limited to, any
action based on a theory of strict liability in tort, negligence or breach of implied warranty” and
details the requirements to find “[t]he manufacturer, designer or seller” liable in such actions.
MS LEGIS 383 (2014), 2014 Miss. Laws Ch. 383 (H.B. 680) (amended text emphasized). This
amendment seems to signal the Mississippi Legislature’s intent for all claims brought for damage
caused by a product to be analyzed under the MPLA. See Little v. Smith & Nephew, Inc., No.
1:15-CV-028-GHD, 2015 U.S. Dist. Lexis 75666, *12-13 (N.D. Miss. June 11, 2015). However,
that version of the MPLA went into “force from and after July 1, 2014.” See 2014 Miss. Laws
WL No. 48 (H.B. 680). “[I]f a statute is to apply ‘effective from and after passage’ it is not to
apply to causes of action that have accrued prior to the passage of the statute.” Tie—Reace
Hollingsworth ex rel McDonald v. City of Laurel, 808 So. 2d 950, 954 (Miss. 2002). “A cause of
action accrues only when it comes into existence as an enforceable claim; that is, when the right
to sue becomes vested, and the theory that an injury has to happen before a tort is considered
complete.” Oaks v. Sellers, 953 So. 2d 1077, 1081 (Miss. 2007) (internal quotation marks and
citation omitted). Indisputably, this cause of action accrued prior to the 2014 amendments to the
Under the previous version of the MPLA, a determination of whether a plaintiff’s
negligence claim can exist alongside his other MPLA claims requires this Court to navigate
unsettled Mississippi law. The previous version of the MPLA states that it applies “in any action
for damages caused by a product except for commercial damage to the product itself.” See Laws
2004, 1st Ex. Sess., Ch. 1, § 3, eff. September 1, 2004, amended by Laws 2014, Ch. 383 (H.B.
No. 680), § 1, eff. July 1, 2014. To date, the Mississippi Supreme Court has never clearly
indicated whether negligence claims are abrogated by the MPLA, and as recently as 2012
declined to decide that issue. See Phillips 66 Co. v. Lofton, 94 So. 3d 1051, 1063 (Miss. 2012)
(“[G]iven that we have found that [the plaintiff] met his evidentiary burden under MPLA, it is
unnecessary for this Court to reach the issue of whether [his] negligence claim was subsumed
under MPLA . . . .”). In interpreting Mississippi law that same year, the Fifth Circuit stated that
negligence claims can be brought alongside strict liability claims, but “a party may not disguise a
products liability claim as a negligence claim to avoid dismissal.” Murray v. GM, L.L.C., 478 F.
App’x 175, 181 (5th Cir. 2012) (per curiam) (citing McSwain v. Sunrise Med., Inc., 689 F. Supp.
2d 835, 844 (S.D. Miss. 2010)). See McSwain, 689 F. Supp. 2d at 846 (the plaintiff’s “common
law negligence claims fail because they are mere restatements of the claims brought under the
MPLA, and . . . are not supported by sufficient evidence”); Murray v. GM, LLC, No. 3:10-CV188-HTW-LRA, 2011 U.S. Dist. LEXIS 93845, 2011 WL 3684517, at *3 (S.D. Miss. Aug. 22,
2011) (“[W]hen a plaintiff's negligence claim cannot survive apart from his MPLA claim,
regardless of how the plaintiff labels the claim . . . the claim is governed by the MPLA.”);
McKee v. Bowers Window & Door Co., 64 So. 3d 926, 940 (Miss. 2011) (the plaintiffs’
“negligence claim fail[s] to present any new discussion or claim that does not relate back to the .
. . products liability claim”)).
With regard to specific claims, courts in Mississippi generally held that a negligence
claim arising from defective design or failure to warn could not exist as a stand-alone claim
because MPLA design defect claims and failure-to-warn claims necessarily required a
negligence analysis. See Hill v. Forest Labs., Inc., No. 2:06-CV-244-KS-MTP, 2014 U.S. Dist.
LEXIS 78057, 2014 WL 2558756, at *2 (S.D. Miss. June 6, 2014) (the plaintiff’s claim that
defendant “negligently failed to warn of the alleged association between Lexapro and suicide”
“was plainly a product liability claim within the scope of the MPLA”); Hankins v. Ford Motor
Co., No. 3:08-CV-639-CWR, 2011 U.S. Dist. LEXIS 143269, 2011 WL 6180410, at *4-5 (S.D.
Miss. Dec. 13, 2011) (quoting Palmer v. Volkswagen of America, Inc., 905 So. 2d 564, 599-600
(Miss. Ct. App. 2003) (internal quotation marks omitted) (“[W]hen a plaintiff claims defective
design under the MPLA, a jury instruction on negligence is not necessary . . . because the riskutility test [in the MPLA] requires the jury to reach a conclusion about the manufacturer’s
conduct[;] the test is a version of Judge Learned Hand’s negligence calculus. Therefore, . . . a
jury performing risk-utility analysis necessarily makes a negligence determination.”); McSwain,
689 F. Supp. 2d at 846 (“The claim that [defendant] negligently failed to warn users of the
danger of the chair without anti-tip tubes is a restatement of the failure to warn cause of action
under the MPLA.”); Jowers v. BOC Group, Inc., No. 1:08-CV-036-KMO, 2009 U.S. Dist.
LEXIS 53126, 2009 WL 995613, at *4 (S.D. Miss. Apr. 14, 2009) aff’d in part, vacated in part
on other grounds, and remanded sub nom., Jowers v. Lincoln Elec. Co., 617 F.3d 346 (5th Cir.
2010) (“[T]he greater weight of the somewhat-mixed authority holds that negligence-based
claims of product defect [against a manufacturer] are abrogated by the MPLA.”); Lundy v.
Conoco, Inc., No. 3:05-CV-477-WHB, 2006 U.S. Dist. LEXIS 82423, 2006 WL 3300397, at *2
(S.D. Miss. Nov. 10, 2006) (“The Court finds that the failure to warn/inadequate warnings
claims, regardless of the fact that Plaintiffs labeled one claim ‘products liability’ and the other
‘negligence’, are both governed by the [MPLA].”); Bennett v. Madakasira, 821 So. 2d 794, 804
(Miss. 2002) (“Although a plaintiff in a prescription drug liability case may alternatively rely on
strict liability and negligence principles, these principles merge into one inquiry; the adequacy of
the defendant’s warnings.”); Palmer, 905 So. 2d at 600, aff’d in part, rev’d in part on other
grounds, 904 So. 2d 1077 (Miss. 2005) (“[L]ike a claim of design defect, a claim of inadequate
warnings under the MPLA requires the jury to perform negligence analysis in assessing liability.
. . . [Thus], the court need not present the jury with a separate negligence instruction on
inadequate warnings.”). Therefore, it is clear that under the prior version of the MPLA, purported
negligence claims that merely restate the elements of defective design or failure-to-warn claims
brought under the MPLA are subsumed by the MPLA.
However, Mississippi case law interpreting the previous version of the MPLA is unclear
as to whether a negligence claim arising from a manufacturing defect can exist as a stand-alone
negligence claim. See Little, No. 1:15-CV-028-GHD, 2015 U.S. Dist. Lexis 75666, at *12-13.
The Fifth Circuit has determined under Mississippi law that “[t]he risk-utility analysis [employed
in defect design and failure-to-warn claims] applies to design defect cases, not manufacturing
defect cases,” thus hinting that a negligence claim premised on manufacturing defect might exist
alongside an MPLA manufacturing defect claim. See Leverette v. Louisville Ladder Co., 183
F.3d 339, 342 (5th Cir. 1999); see also Joiner v. Genlyte Thomas Grp., L.L.C., No. 1:09-CV00093-GHD, 2012 U.S. Dist. LEXIS 20966, 2012 WL 567201, at *4 (N.D. Miss. Feb. 21, 2012)
(a negligence claim arising from manufacturing defect might exist alongside a separate MPLA
manufacturing defect claim). But see Deese v. Immunex Corp., No. 3:11-CV-373-DPJ-FKB,
2012 U.S. Dist. LEXIS 17342, 2012 WL 463722, at *5 (S.D. Miss. Feb. 13, 2012) (“It is unclear
whether Mississippi law recognizes such a negligence claim separate and apart from the MPLA
claims for negligent design or failure to warn.”).
In addition to Plaintiff’s manufacturing defect claim under the MPLA, Plaintiff’s
Amended Complaint could be liberally read to include a negligence action on the basis of
manufacturing. Regardless of whether the MPLA subsumes that negligence action or not, the
Court finds there are no genuine disputes of material fact concerning any manufacturing
negligence, so summary judgment is appropriate as to that claim.
Plaintiff claims that the purpose of the Telluride Spinal Fixation System being implanted
was to stabilize the spinal section to allow boney fusion. According to Dr. Crosby, Plaintiff’s
treating physician, achieving boney fusion takes between six and twenty-four months. The
pedicle screws at issue here severed at five months. Plaintiff contends that evidence of the
screws’ malfunction is enough to show a breach of Lanx’s duty. However, Plaintiff fails to
elaborate or put forth expert testimony as to any particular manufacturing negligence on the part
of Lanx. Plaintiff’s expert testified that he had no opinions as to the manufacturing process as it
applied to the particular screws. In follow up at the deposition, however, Lanx’s counsel
acknowledges that because the screws were not available, any opinion as to their defective
construction would be inappropriate. Plaintiff contends that Lanx spoliated the evidence because
it failed to save the broken pedicle screws after their removal.
Spoliation is “[t]he intentional destruction, mutilation, alteration, or concealment of
evidence.” Black’s Law Dictionary 1531 (9th ed. 2009). But “[a] party can only be sanctioned
for destroying evidence that it had a duty to preserve, and such duty arises when ‘the party has
notice that the evidence is relevant to litigation or when a party should have known that the
evidence may be relevant to future litigation.’” Consol. Aluminum Corp. v. Alcoa, Inc., 244
F.R.D. 335, 339 (M.D. La. 2006) (quoting Zubulake v. UBS Warburg, LLC, 220 F.R.D. 212, 216
(S.D.N.Y. 2003)). When spoliation is the result of a litigant’s bad-faith actions, it gives rise to
an adverse inference that the evidence was detrimental to the spoliating party’s case. Vick v. Tex.
Emp’t Comm’n, 514 F.2d 734, 737 (5th Cir. 1975). “The party requesting an adverse inference
must first show that the documents in question exist or existed and were within the control of the
opposing party.” Jobe v. ATR Mktg., Inc., 189 F.3d 466, at *6 n.3 (5th Cir. 1999) (unpublished
table decision) (citation omitted). “Moreover, a party seeking to obtain an adverse inference
based on non-production or destruction of documents must show bad faith.” Id. (citing Vick, 514
F.2d at 737 (“[T]he circumstances of the act must manifest bad faith. Mere negligence is not
enough, for it does not sustain an inference of consciousness of a weak case.”)).
Dr. Fernandez performed the surgical removal of the Lanx Telluride System. Dr. Crosby
and Allen Rasoul, a medical product distributor, were also present during the surgery. Rasoul
distributed Lanx, as well as other medical devices, and was present at Estes’ surgery to deliver
the new system being implanted. Plaintiff contends because complaints regarding broken screws
were most often reported by distributors, and not individual patients, Rasoul should have
collected the broken screws and either returned them to Lanx, had the hospital maintain
possession of them, or retrieve them for himself. It is undisputed, however, the screws were not
recovered after surgery, and the screws were not destroyed by Lanx or Rasoul. Because Plaintiff
has failed to put forth a genuine issue of material fact as to bad faith on the part of Lanx, no
spoliation instruction is warranted. Without evidence or testimony regarding Lanx’s alleged
manufacturing negligence, Plaintiff has not put forth any genuine issues of material fact as to that
Aside from the negligence claims subsumed by the MPLA and the negligence in
manufacturing claim, Plaintiff also makes negligence claims based on the alleged failure of Lanx
to secure the appropriate clearance from the FDA. However, Plaintiff has not adequately shown a
genuine issue of material fact as to causation against Lanx for its alleged releasing the Telluride
System into commerce without FDA approval. It is well established that causation is an essential
element of a negligence claim. See Weathersby Chevrolet Co., Inc. v. Redd Pest Control Co.,
Inc., 778 So. 2d 130, 133 (Miss. 2001). Plaintiff’s own expert testified that connecting the
Plaintiff’s injury with the alleged failure to properly file with the FDA would be improper as it
was too speculative. Accordingly, despite whether there was any duty to Plaintiff to achieve
proper FDA clearance or breach of that duty by Lanx, the negligence claim for allegedly failing
to obtain proper FDA authorization cannot succeed as there is no causative link between that
alleged failure and Plaintiff’s injuries. Accordingly, Defendant’s Motion for Summary Judgment
as to Plaintiff’s negligence claims identified is granted.
The second category of claims covers Plaintiff’s breach of express warranty and breach
of implied warranties. Defendant counters that because Lanx never made representations to
Estes, that these causes of action are due to be dismissed.
a. Breach of Express Warranty
For a plaintiff to prevail on a breach of express warranty claim in an action for damages
caused by a product in Mississippi, he must prove by a preponderance of the evidence that at the
time the product left the control of the manufacturer, designer, or seller:
(i) . . . The product breached an express warranty or failed to conform to other
express factual representations upon which the claimant justifiably relied in
electing to use the product; and
(ii) The defective condition rendered the product unreasonably dangerous to
the user or consumer; and
(iii) The defective and unreasonably dangerous condition of the product
proximately caused the damages for which recovery is sought.
MISS. CODE ANN. § 11-1-63(a)(i)(4), (ii), (iii).
“[A]n express warranty is any affirmation of fact or promise which concerns the product
and becomes part of the basis for the purchase of such a product. Fault does not need to be
shown to establish a breach. The plaintiff need only show that the product did not live up to its
warranty.” Scirocco, 2015 U.S. Dist. LEXIS 66561, 2015 WL 2451225, at *4 (quoting Forbes v.
GMC, 935 So. 2d 869, 876 (Miss. 2006) (quoting Austin v. Will—Burt Co., 232 F. Supp. 2d 682,
687 (N.D. Miss. 2002), aff’d, 361 F.3d 862 (5th Cir. 2004) (internal quotation marks omitted));
see also MISS. CODE ANN. § 75-2-313(1)(a). The plaintiff must ultimately show that he relied on
the alleged representation. See MISS. CODE ANN. § 11-1-63(a)(i)(4).
Plaintiff alleges the existence of an express warranty as follows:
Defendant expressly warranted that the Lanx Telluride System and its
component part of the Lanx Pedicle Screw were safe and fit for use by
consumers and users including Plaintiff Rocky Estes for its intended purpose,
that it was of merchantable quality, that it did not produce any dangerous side
effects, and that it was adequately tested and fit for its intended use.
In response to summary judgment, Plaintiff again spins his claim to reflect Lanx’s alleged failure
to get FDA clearance for the Telluride System or its components. However, Plaintiff has failed
to allege any express warranty that Lanx made to him regarding its 510(k) submission to the
FDA, or even any specific claim made by Lanx to Plaintiff regarding the safety of the Telluride
System or the pedicle screw associated therewith. Moreover, Plaintiff has produced no evidence
or testimony creating a genuine issue of material fact that he relied on any representation by
Lanx as to the safety or federal regulatory clearance. Accordingly, Defendant’s Motion for
Summary Judgment as to the breach of express warranty claim is granted.
b. Breach of Implied Warranty of Merchantability
To recover on a claim for breach of an implied warranty of merchantability, a plaintiff
must demonstrate the following:
(1) That a “merchant” sold “goods,” and he was a merchant with respect to
“goods of the kind” involved in the transaction, (2) which were not
merchantable at the time of sale, and (3) injuries and damages to the plaintiff
or his property, (4) caused proximately and in fact by the defective nature of
the goods, and (5) notice to the seller of the injury.
Watson Quality Ford. Inc. v. Casanova, 999 So. 2d 830, 834 (Miss. 2008) (citing MISS. CODE
ANN. § 75-2-314). With respect to the last element, the Mississippi Supreme Court has noted that
“though there may have been a breach of the warranty of merchantability, the seller has a right to
attempt cure. An opportunity for the seller to cure is a reasonable requisite of a buyer’s right of
recovery.” Id. at 834-35.
Defendant asserts that because Plaintiff never allowed Lanx the chance to cure the
alleged defect that Plaintiff’s implied warranty of merchantability claim fails. Plaintiff failed to
respond to this specific allegation of Lanx. Because opportunity to cure is a “requisite” to the
buyer’s right of recovery, and there is no testimony or proof that Plaintiff attempted to contact or
contacted Lanx when it was discovered that the pedicle screw was broken, Lanx was not given
an opportunity to cure and that claim is dismissed.
c. Breach of Implied Warranty of Fitness for a Particular Purpose
To recover on a claim for breach of an implied warranty of fitness for a particular
purpose under Mississippi law, a plaintiff is required to demonstrate the following;
(1) the seller at the time of the contracting had reason to know the particular
purpose for which the goods were required; (2) the reliance by the plaintiff as
buyer upon the skill or judgment of the seller to select suitable goods, and (3)
the goods were unfit for the particular purpose.
Watson Quality Ford, Inc., 999 So. 2d at 835 (quoting Garner v. S & S Livestock Dealers, Inc.,
248 So. 2d 783, 785 (Miss. 1971) (internal quotation marks omitted) (citing MISS. CODE ANN. §
75-2-315)). “[N]o claim for breach of the implied warranty of fitness for a particular purpose will
lie when a product is to be used for its ordinary purpose.” Id. (citing Ford Motor Co. v. Fairley,
398 So. 2d 216, 219 (Miss. 1981)).
Aside from the fact that there is no allegation that the pedicle screw or Lanx Telluride
Spinal Fixation System was not used for its ordinary purpose, there is no proof or testimony that
Plaintiff relied on Lanx, the seller, in selecting to use that product. In fact, Estes testified that he
relied solely on his treating physician Dr. Crosby to make that decision. Accordingly,
Defendant’s request for summary judgment as to the implied warranty for fitness for a particular
purpose is granted.
d. Negligent Misrepresentation
Numerous Mississippi district courts have held that the MPLA subsumes common law
negligent misrepresentation claims based on a defective product. See Austin, 2013 U.S. Dist.
LEXIS 137480, 2013 WL 5406589, at *8; Gardley—Starks, 917 F. Supp. 2d at 602; McSwain,
689 F. Supp. 2d at 844-45; Lashley v. Pfizer, Inc., 877 F. Supp. 2d 466, 471 (S.D. Miss. 2012);
Murray, No. 3:10-CV-188 HTW-LRA, 2011 U.S. Dist. LEXIS 93845, 2011 WL 3684517, at *3
(S.D. Miss. Aug. 22, 2011), aff’d, 478 F. App’x 175 (5th Cir. 2012); Walker v. George Koch
Sons, Inc., 610 F. Supp. 2d 551, 562-63 (S.D. Miss. 2009). See also Jowers, 2009 U.S. Dist.
LEXIS 53126, 2009 WL 995613, at *9 (discussing R.J. Reynolds Tobacco Co. v. King, 921 So.
2d 268 (Miss. 2005) (negligent misrepresentation claim may not be product liability claim if
affirmative representations were made in addition to and separate from those in connection with
a failure-to-warn claim)). Because Plaintiff in the case sub judice alleges that Defendant made
representations with respect to the screw that mirror his allegations concerning the alleged
representations in his failure-to-warn claim, the Court finds that his negligent misrepresentation
claim is subsumed by the MPLA and must be dismissed.
(3) Claims as to the FDA
Plaintiff’s factual basis for the final category of claims centers on Lanx’s FDA clearance
for either the pedicle screws used in the Telluride Spinal Fixation System, or the Telluride Spinal
Fixation System itself. Plaintiff’s fraudulent concealment cause of action alleges liability for the
fraudulent concealment or misrepresentation that the Lanx Telluride System had been properly
approved by the FDA.
In a factually and legally similar case to this one, the United States Supreme Court in
Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341, 347-49, 121 S. Ct. 1012, 148 L. Ed. 2d
854 (2001), held that federal law preempts state-law causes of action claiming that a medical
device manufacturer made fraudulent representations to the FDA. 531 U.S. at 353, 121 S. Ct.
1012. Buckman involved orthopedic bone screws that the FDA approved in an expedited process
as “substantially equivalent” to devices already on the market. 531 U.S. at 346, 121 S. Ct. 1012.
Plaintiffs who suffered injuries after implantation of the screws brought suit alleging that the
manufacturer misled the FDA. Like here, they further alleged that the misrepresentations were a
“but for” cause of their injuries because, absent the misrepresentations, the product would never
have reached the market. 531 U.S. at 343, 121 S. Ct. 1012.
The Supreme Court rejected the novel cause of action because the state law claim would
conflict with the FDA’s authority to punish fraud on the agency. As noted by the Court:
[T]he § 510(k) process sets forth a comprehensive scheme for determining
whether an applicant has demonstrated that a product is substantially
equivalent to a predicate device. Among other information, the applicant must
submit to the FDA “proposed labels, labeling, and advertisements sufficient to
describe the device, its intended use, and the directions for its use,” 21 CFR §
807.87(e) (2000), and a statement attesting to and explaining the similarities
to and/or differences from similar devices (along with supporting data), see §
807.87(f ). The FDA is also empowered to require additional necessary
information. See § 807.87(l). Admittedly, the § 510(k) process lacks the PMA
review’s rigor: The former requires only a showing of substantial equivalence
to a predicate device, while the latter involves a time-consuming inquiry into
the risks and efficacy of each device. Nevertheless, to achieve its limited
purpose, the § 510(k) process imposes upon applicants a variety of
requirements that are designed to enable the FDA to make its statutorily
required judgment as to whether the device qualifies under this exception.
Accompanying these disclosure requirements are various provisions aimed at
detecting, deterring, and punishing false statements made during this and
related approval processes. The FDA is empowered to investigate suspected
fraud, see 21 U.S.C. § 372; 21 CFR § 5.35 (2000), and citizens may report
wrongdoing and petition the agency to take action, § 10.30. In addition to the
general criminal proscription on making false statements to the Federal
Government, 18 U.S.C. § 1001, (1994 ed., Supp. IV), the FDA may respond
to fraud by seeking injunctive relief, 21 U.S.C. § 332, and civil penalties, 21
U.S.C. § 333(f)(1)(A); seizing the device, § 334(a)(2)(D); and pursuing
criminal prosecutions, § 333(a). The FDA thus has at its disposal a variety of
enforcement options that allow it to make a measured response to suspected
fraud upon the Agency.
Buckman, 531 U.S. at 348-49, 121 S. Ct. 1012.
Indeed, the Court stated “that the federal
statutory scheme amply empowers the FDA to punish and deter fraud against the
Administration.” 531 U.S. at 348, 121 S. Ct. 1012.
Not only does federal law provide
administrative tools to punish and deter fraud, but the agency’s decision to employ those tools
implicates its discretion and special competence.2 Among the factors that make FDA
enforcement “a somewhat delicate balance of statutory objectives,” id., 121 S. Ct. 1012, are the
need for administrative efficiency and the possibility that tort liability based on inadequate
The FDA has authority to investigate fraud, 21 U.S.C. § 372, consider citizen petitions, 21
C.F.R. § 10.30, and seek criminal and civil penalties particular to fraud-on-the-FDA, 21 U.S.C. §
332-33. Buckman, 531 U.S. at 349, 121 S. Ct. 1012.
disclosures would create “an incentive to submit a deluge of information,” 531 U.S. at 351, 121
S. Ct. 1012. The Court concluded that authorizing tort liability for failure to comply with FDA
disclosure requirements “would exert an extraneous pull on the scheme established by Congress,
and it is therefore pre-empted by that scheme.” 531 U.S. at 353, 121 S. Ct. 1012; Lofton v.
McNeil Consumer & Specialty Pharms., 672 F.3d 372, 375-76 (5th Cir. 2012).
The parties have failed to brief whether federal regulatory law impliedly preempts
Plaintiff’s causes of action based on Lanx’s submissions to the FDA. Accordingly, the parties are
ORDERED to SHOW CAUSE as to whether these claims and others are or are not preempted.
Show Cause Responses are due JANUARY 8, 2016.
Accordingly, the Defendant’s Motion for Summary Judgment  is GRANTED IN
Plaintiff has failed to bring forth genuine issues of material fact as to the following
claims: (1) all negligence claims; (2) all claims under the MPLA; and (3) all warranty claims.
The parties shall have until January 8, 2016, to show cause as to why FDA regulations do
or do not impliedly preempt Plaintiff’s claims regarding Lanx’s failure to procure the appropriate
510(k) clearance from the FDA before introducing the Telluride System and/or pedicle screw
SO ORDERED, this the 23rd day of December, 2015.
/s/ Sharion Aycock_________
U.S. DISTRICT JUDGE
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