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CAUSE NO. 2018-35641
TERRY GRAY, Individually and as IN THE DISTRICT COURT OF
Heir and Representative of the Estate
of STEPHEN WADE GRAY (Deceased),
Plaintiff
Vv. HARRIS COUNTY, TEXAS
ARGON MEDICAL DEVICES, INC.
AND REX MEDICAL, INC. d/b/a
REX MEDICAL, L.P. and
REX MEDICAL, LP.,
Defendants. 189% JUDICIAL DISTRICT
DEFENDANT ARGON MEDICAL DEVICES, INC.’S
MOTION FOR SUMMARY JUDGMENT
TO THE HONORABLE JUDGE OF THIS COURT:
COMES NOW Defendant Argon Medical Devices, Inc. (hereinafter “Argon”) and files
its Motion for Summary Judgment and would respectfully show this Court as follows:
I INTRODUCTION
The medical device at issue in this product liability litigation is the Option™’ ELITE Vena
Cava Filter (hereinafter referred to as “the Option™ ELITE”). The Option™ ELITE is a cone-
shaped filter, which is surgically implanted in the inferior vena cava (IVC), a large vein carrying
blood from the lower body to the heart. The Option™ filters are intended to save lives and prevent
deadly recurrent pulmonary embolism.
Stephen Wade Gray was implanted with an Argon Option™ ELITE on August 15, 2017.
A previous version of the filter was known as the Option™ filter. The Option™ filter and the Option™
ELITE are hereinafter collectively referred to as either “the Option™ filters” or “the subject medical
devices.”
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Plaintiff alleges that shortly after implantation, Mr. Wade suffered complications from the device,
which led to his death. On May 24, 2018, Plaintiff Terry Gray, individually and as heir and
personal representative of the estate of Stephen Wade Gray, filed this civil action against Rex and
Argon. Plaintiff's Petition is attached hereto as Exhibit D. Plaintiff asserts claims against both Rex
and Argon for:
Negligence;
Strict Liability Failure to Warn;
Strict Liability Defective Design;
Strict Liability Manufacturing Defect;
Breach of Express Warranty;
Breach of Implied Warranties of Merchantability and Fitness for a Particular Purpose;
and
Negligent Misrepresentation.
Id. Plaintiff seeks damages pursuant to the Wrongful Death and Survival Statutes of the State of
Texas, as well as punitive damages. Jd. Argon first received notice of the alleged incident via
Plaintiff's lawsuit. A true and correct copy of the Argon Product Experience Report is attached
hereto as Exhibit E.
Argon now seeks summary judgment as to Plaintiff's claims.
IL. STATEMENT OF FACTS
Pursuant to Tex. R. Civ. P. 166a(c), the following facts either are undisputed or the Court
may assume its truth for the purposes of the present motion. Johnson County Sheriff's Posse, Inc.
An Argon Product Experience Report is an internal document that essentially mirrors an Adverse Event
Report. It is created when Argon is notified ofa problem/event with one of its products. The “Reporter
First Aware Date” notes when Argon received notice of the problem/event.
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v. Endsley, 926 S.W.2d 284, 285 (Tex. 1996).
A Background on the Option™ ELITE IVC Filter
Defendants Rex Medical, Inc. d/b/a Rex Medical, L.P. and Rex Medical, L.P. (hereinafter
collectively “Rex”) together are a privately-held medical device company based in Conshohocken,
Pennsylvania. Rex designed and developed the Option™ filter and brought it to market through
the Food and Drug Administration (“FDA”) 510(k) clearance process in June 2009. A true and
correct copy of the FDA 510(k) clearance letter, dated June 4, 2009, is attached hereto as Exhibit
A The Option™ filter was cleared by the FDA for permanent placement and as a retrievable
device. Jd. On December 17, 2013, the Option™ ELITE, the successor device to the original
Option™ IVC filter, was similarly cleared by the FDA through the 510(k) clearance process. A
true and correct copy of the FDA 510(k) clearance letter, dated December 17, 2013, is attached
hereto as Exhibit B.
Rex designed and developed the Option™ filter and, in compliance with applicable FDA
regulations, brought the Option™ filter to market through the 510(k) clearance process in June
2009. See Exhibit A. Rex also designed and developed a similar, successor device, the Option™
ELITE filter. See Exhibit B. In compliance with applicable FDA regulations, Rex brought the
Option™ ELITE filter to market through the 510(k) clearance process in December 2013. Id.
Defendant Argon is a medical device company headquartered in Frisco, Texas. Argon
develops, manufactures, and markets medical devices for interventional radiology, vascular
surgery, interventional cardiology, and oncology. Argon played no role whatsoever with respect
to the Option™ filters until it began distributing the Option™ filter on March 4, 2011. A true and
correct copy of the License, Supply, Marketing and Distribution Agreement dated March 4, 2011
See 21 U.S.C. § 360e(b)(1)(B) (establishing 510(k) clearance process); 21 C.F.R. 807.87 (outlining
process for 510(k) clearance application).
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is attached hereto as Exhibit C. Argon was also the exclusive distributor of the Option™ ELITE
after it was brought to market in 2013. On December 23, 2015, Argon purchased the manufacturing
rights to the Option™ filters and, thereafter, became the sole manufacturer and distributor of both
the Option™ and the Option™ ELITE. Argon manufactured and distributed the specific Option™
ELITE filter at issue in this matter.
B Stephen Wade Gray and Medical Care at Issue
On August 1, 2017, Mr. Stephen Wade Gray presented to M.D. Anderson Cancer Center
for removal of a recently-diagnosed tumor located on his lumbar spine. A true and correct copy of
the relevant medical record from M.D. Anderson, ACC000250-1, is attached hereto as Exhibit F.
Due to post-procedure complications after the removal of the tumor, it was subsequently
determined that Mr. Gray required a second procedure to implant a lumbar spine drain. A true and
correct copy of the relevant medical record from M.D. Anderson, ACC000202-205, is attached
hereto as Exhibit F. Because Mr. Gray would be immobilized for a significant period of time after
this second procedure, and because coagulation was contraindicated, it was determined that
placement of an IVC filter was an appropriate prophylactic treatment. Jd.
Mr. Gray’s implanting physician, Dr. Kuban, discussed the risks and benefits of an IVC
filter (including the risk of migration) with Mr. Gray, and obtained informed consent for the
procedure. A true and correct copy of Dr. Kuban’s deposition transcript is attached hereto as
Exhibit H, see pg. 36, 39-40; a true and correct copy of the Consent Form, ACC002282-5, is
attached hereto as Exhibit I. An Argon-manufactured Option™ ELITE IVC filter was implanted
on August 15, 2017. A true and correct copy of the Procedure Note is attached hereto as Exhibit J.
Six (6) days later, on August 21, 2017, Mr. Gray disobeyed his treating physicians’ orders
when he rose out of his hospital bed without assistance and walked to the bathroom in hospital
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room. A true and correct copy of the relevant medical record from M.D. Anderson, ACC000427-
8, is attached hereto as Exhibit K. While in the bathroom, Mr. Gray fainted, collapsed to the
ground, and may have struck his chest on the bathroom sink in the process. Id.
A short time later, Mr. Gray began complaining of right-sided chest pain and was noted to
be hypoxic. True and correct copies of the relevant medical records from M.D. Anderson,
ACC000248-9 and ACC000432-7, are attached hereto as Exhibits L and M, respectively. He
subsequently was transferred to the ICU for monitoring. Jd. Rib x-rays and a chest CT ultimately
revealed that the subject Option™ ELITE IVC filter had migrated to the tricuspid valve in his
heart. A true and correct copy of the relevant medical record from M.D. Anderson, ACC000233-
36, is attached hereto as Exhibit N.
The imaging also revealed the presence of multiple pulmonary emboli. Jd. Shortly
thereafter, a Code Blue was called and Mr. Gray stopped breathing. A true and correct copy of the
relevant medical record from M.D. Anderson, ACC000425-6, is attached hereto as Exhibit O. Mr.
Gray underwent emergency open heart surgery on August 21, 2017. See Exhibit N. Mr. Gray never
recovered; he remained in the ICU while hospital staff tried to resuscitate him over the next three
(3) days, and was pronounced dead on August 24, 2017, with the immediate cause of death
identified as cardiac arrest leading to cerebral ischemia. A true and correct copy of the Death
Certificate is attached hereto as Exhibit P. The secondary cause of death was noted to be the
migration of the IVC filter into the heart, requiring emergency cardiac surgery. Id.
Cc. Warnings to Mr. Gray’s Implanting Physician
The Option™ ELITE filter at issue, which was designed by Rex, manufactured by Argon,
and implanted by Dr. Kuban on August 15, 2017, was accompanied by detailed FDA-approved
instructions for use, warnings, an exhaustive list of potential complications, and a statistical
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analysis of the filter’s safety, efficacy, and complication rates. A true and correct copy of the
applicable Instruction for Use (“IFU”) is attached hereto as Exhibit Q. The FDA-approved
instructions/warning label stated, inter alia, as follows:
VI. Potential Complications
Procedures requiring percutaneous interventional techniques should not be
attempted by physicians unfamiliar with the possible complications.
Complications may occur at any time during the implantation, indwelling
period, or at the time of or following filter retrieval. Possible complications
may include, but are not limited to, the following:
Vena cava or other vessel injury or damage, including rupture or dissection,
possibly requiring surgical repair or intervention
Injury or damage to organs adjacent to vena cava, possible requiring
surgical repair or intervention
Vena cava stenosis or occlusion
Incorrect positioning or orientation of the filter
Filter migration/movement
Extravasation of contrast media
Vasospasm or decreased/impaired blood flow
Bleeding or hemorrhagic complication that require transfusions or medical
intervention (e.g. IV fluids, medications).
Thromboembolic events, including DVT, acute or recurrent pulmonary
embolism or air embolism, possibly causing end organ
infarction/damage/failure
Infection, possibly requiring medical or surgical intervention (e.g.
antibiotics or incision and drainage)
Respiratory insufficiency or failure
Cardiac arrhythmia
Myocardial infarction or coronary ischemia
Cerebrovascular accident or other neurologic event
Renal insufficiency or failure
Reaction to contrast media/medication
Hematoma, possibly requiring medical intervention or surgical revision
Other vascular access site injury, including bruising, AV fistula, or
pseudoaneurysm
Neurological deficit associated with vascular access, possibly requiring
nerve intervention or neurology consultation
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Device breakage or failure or inability to retrieve implanted device as
described in IFU, possibly requiring another intervention or treatment
modality to complete procedure
Death.
See Exhibit Q.
Plaintiff's implanting physician, Dr. Kuban gave his deposition in this case. He had no
specific recollection of ever reading the IFU, which would include the potential complications
listed above. See Exhibit H; see pg. 101-02. Moreover, he assumed he did not read the IFU prior
to Mr. Gray’s procedure. See id., pg. 102. However, he was familiar with the Option™ ELITE IFU
at the time of this procedure, and Mr. Gray’s surgery fit one of the indicated uses of the filter. See
id., pg. 103.
Through his education and training, Dr. Kuban was aware that migration was a known risk
of IVC filters. See id., pg. 73-4, 127-28. Dr. Kuban did not rely upon sales representatives of any
medical device manufacturer to educate him on the risks of migration. /d., pg. 106. He did not rely
on information received from an Argon sales representations or any Argon literature in his decision
to use the Option™ ELITE. Jd. Instead, Dr. Kuban relied heavily on his own training and prior
experiences, as well as relevant literature and what others in the field are doing. See id., pg. 106.
D. General Knowledge of Risks Within the Medical Community
All IVC filters, including the Option™ ELITE, come with risks of injury inherent in their
use. By the time that Mr. Wade was treated with an Argon filter, the medical literature extensively
and explicitly discussed the risk of filter complications, including perforation of adjacent organs,
migration, filter malpositioning or tilt, the inability to be removed, and surgical removal. Because
of these complications, the FDA issued in 2010 and 2014 general warnings to implanting
physicians and physicians responsible for the ongoing care of patients with retrievable IVC filters.
True and correct copies of the 2010 FDA safety communication and the 2014 FDA safety
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communication are attached hereto as Exhibit R, collectively. The 2010 and 2014 FDA safety
communications, which generally address all retrievable inferior vena cava filters, describe reports
of device migration, filter fracture, embolization, perforation of the IVC, and difficulty removing
the device. See Exhibit R.
il. SUMMARY JUDGMENT EVIDENCE
Argon relies on and incorporates herein the following summary judgment evidence:
Exhibit A: FDA 510(k) clearance letter for Option™, dated June 4, 2009
Exhibit B: FDA 510(k) clearance letter for Option™ ELITE, dated December 17, 2013
Exhibit C: License, Supply, Marketing and Distribution Agreement (unexecuted copy)
Exhibit D: Plaintiff's Petition
Exhibit E: Argon Product Experience Report for Stephen Gray
Exhibit F: Medical record from M.D. Anderson, ACC000250-1
Exhibit G: Medical record from M.D. Anderson, ACC000202-205
Exhibit H: Dr. Kuban deposition transcript
Exhibit I: Consent form, ACC002282-5
Exhibit J: IVC filter placement Procedure Note (marked as “Exhibit 1” from Dr. Kuban’s
deposition)
Exhibit K: Medical record from M.D. Anderson, ACC000427-8
Exhibit L: Medical record from M.D. Anderson, ACC000248-9
Exhibit M: Medical record from M.D. Anderson, ACC000432-7
Exhibit N: Medical record from M.D. Anderson, ACC000233-36
Exhibit O: Medical record from M.D. Anderson, ACC000425-6
Exhibit P: Stephen Gray Death Certificate
Exhibit Q: Option™ ELITE Instructions for Use
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Exhibit R: 2010 and 2014 FDA safety communications re: IVC filters
IV. LEGAL STANDARDS
A Traditional Summary Judgment Standard
A party moving for a traditional summary judgment “must establish that there is no genuine
issue of material fact so that the movant is entitled to judgment as a matter of law.” Tex. R. Civ.
P. 166a(c); Mann Frankfort Stein & Lipp Advisors, Inc. v. Fielding, 289 S.W.3d 844, 848 (Tex.
2009). At the summary judgment stage, a court must determine if a material question of fact exists.
See Huckabee v. Time Warner Entm’t Co., 19 S.W.3d 413, 422 (Tex. 2000). A nonmovant may
not rely on conclusory allegations, improbable inferences, or unsubstantiated speculation to rebut
an otherwise meritorious motion for summary judgment. See, e.g., Am. Tobacco Co., 951 8.W.2d
at 437 (“Speculation cannot create a fact issue.”); Texas Div.-Tranter, Inc. v. Carrozza, 876
3g &,
S.W.2d 312, 314 (Tex. 1994) (per curiam) (holding that a party s subjective beliefs are no more
than conclusions and are not competent summary judgment evidence.
B No Evidence Summary Judgment Standard
A defendant must challenge specific elements of the plaintiff's claim to be entitled to no
evidence summary judgment. See Tex. R. Civ. P. 166a(i); see Cmty. Health Sys. Prof’l Servs. Corp.
v. Hansen, 525 $.W.3d 671, 695 (Tex. 2017). To preclude summary judgment, the plaintiff must
present summary judgment evidence that raises a genuine issue of material fact on the challenged
elements. See Tex. R. Civ. P. 166a(i); SMI Realty Mgmt. Corp. v. Underwriters at Lloyd’s, London,
179 S.W.3d 619, 623 (Tex. App.— Houston [1st Dist.] 2005, pet. denied).
A plaintiff can defeat summary judgment by producing more than a scintilla of admissible
evidence supporting the challenged elements. See Merriman v. XTO Energy, Inc., 407 S.W.3d 244,
248 (Tex. 2013). More than a scintilla means evidence that would enable fair-minded and
reasonable people to differ when drawing conclusions. Burbage v. Burbage, 447 S.W.3d 249, 259
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(Tex. 2014). Evidence does not create an issue of material fact if it is “so weak as to do not more
than create a mere surmise or suspicion.” See Ford Motor Co. v. Ridgway, 135 S.W.3d 598, 601
(Tex. 2004).
Vv. ARGUMENT
Argon is entitled to summary judgment on Plaintiff's claims for Strict Liability and
Negligent Design Defect, Strict Liability and Negligent Failure to Warn, Breach of Express and
Implied Warranties, and Negligent Misrepresentation because no question of material fact exists
as to those claims under Texas law. In addition, Argon is entitled to summary judgment on
Plaintiff's claim for Manufacturing Defect, as well as the damages claim for punitive damages
because there is no evidence to support essential elements of such claims.
A Argon is Entitled to Summary Judgment on Plaintiff’s Strict Liability and
Negligent Design Defect Claims Because Dr. McMeeking Failed to Present a
Safer Alternative Design.
Under Texas law, a design defect is defined as a condition of the product that renders it
unreasonably dangerous as designed, taking into consideration the utility of the product and the
risk involved in its use. See Comm. On Pattern Jury Charges, State Bar of Tex., Texas Pattern Jury
Charges: Malpractice, Premises & Products PJC 71.4 (2016). This is consistent with Section
402A of the Second Restatement of Torts. See Am. Tobacco Co., Inc. v. Grinnell, 951 S.W.2d 420,
432 (Tex. 1997). Texas law also requires evidence of a safer alternative design in support of a
claimed product defect. See Rojas v. Teva Pharms. USA, Inc., 920 F. Supp. 772, 779 (S.D. Tex.
2013) (referencing TEX IV RAC EM ODE_ NN. § 82.005).
Argon submits in its contemporaneously-filed Daubert motion that Plaintiff's expert,
Robert McMeekung, Ph.D., failed to present a safer alternative design that both reduces the risk
of injury and is both economically and technologically feasible. If this Court grants Argon’s
Daubert motion, Plaintiff will be unable to prove the design defect claim, and, therefore, Argon
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will be entitled to summary judgment.
If this Court does not grant the Daubert motion, Argon presents an alternative argument in
Section B.
B Argon is Entitled to Summary Judgment on Plaintiff’s Strict Liability Design
Defect Claim Because, as a Prescription Medical Device, it Cannot Be Made
100% Safe and is Therefore Protected Under Rest. 402A cmt. K.
Prescription drugs and devices present unique issues as to defect. On the one hand, by their
very nature, such products may lead to significant adverse events. On the other hand, they also
provide significant benefits when properly used. It is for this reason many medications (and many
medical devices as well) are available only by prescription from a licensed healthcare provider:
Prescription drugs are likely to be complex medicines, esoteric in formula and
varied in effect. As a medical expert, the prescribing physician can take into account
the propensities of the drug, as well as the susceptibilities of his patient. His is the
task of weighing the benefits of any medication against its potential dangers.
Wyeth-Ayerst Labs. Co. v. Medrano, 28 S.W.3d 87, 91 (Tex. App.—Texarkana 2000, no pet.)
(quoting Reyes v. Wyeth Labs., 498 F.2d 1264, 1276 (Sth Cir. 1974)). See also Restatement
(Second) of Torts § 402A, cmt. k (1965) (noting that some drugs “for this very reason cannot
legally be sold except to physicians, or under the prescription of a physician”).
In that spirit, comment k to section 402A recognizes that:
There are some products which, in the present state of human knowledge, are
quite incapable of being made safe for their intended and ordinary use. These
are especially common in the field of drugs . . . . Such a product, properly
prepared, and accompanied by proper directions and warning, is not
defective, nor is it unreasonably dangerous . . . The seller of such products,
again with the qualification that they are properly prepared and marketed, and
proper warning is given, where the situation calls for it, is not to be held to strict
liability for unfortunate consequences attending their use, merely because he has
undertaken to supply the public with an apparently useful and desirable product,
attended with a known but apparently reasonable risk.
(Emphasis added.)
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Courts throughout the country, including in Texas, have held that comment k—and the
protection it provides to inherently dangerous products— is applicable to prescription medical
devices, especially those devices implanted in the human body. See, e.g., Robles v. C.R. Bard, Inc.,
No. 5:13-CV-250-C, 2015 WL 11120857, at *3 (N.D. Tex. Mar. 23, 2015) (“comment k applies
to medical devices as well as pharmaceutical drugs”); Phelps v. Sherwood, 836 F.2d 296 (7th Cir.
1987) (pacemaker and heart catheter covered under comment k); Brooks v. Medtronic Inc., 750
F.2d 1227 (4th Cir. 1984) (pacemaker and heart catheter covered under comment k); Soufflas v.
Zimmer, Inc., 474 F. Supp. 2d 737, 749-50 (E.D. Pa. 2007) (granting summary judgment with
respect to plaintiff's strict liability design defect claims because comment k excludes imposition
of strict liability for prescription medical devices); Allen v. G.D. Searle, 708 F. Supp. 1142 (D.
Ore. 1989); Creazzo v. Medtronic, Inc., 903 A.2d 24, 31 (Pa. Super. Ct. 2006) (affirming summary
judgment on strict liability design defect claim under comment k, finding “no reason why the same
rational applicable to prescription drugs may not be applied to medical devices”).
As such, the only viable claims against a prescription device maker are for a manufacturing
defect or a marketing defect (which encompasses claims for failure to warn and for providing an
inadequate warning). See Hackett v. G.D. Searle & Co., 246 F. Supp. 2d 591, 595 (W.D. Tex.
2002) (“The Court thus holds that under Texas law and comment k of the Restatement, Defendants
can only be held strictly liable if the drug was not properly prepared or marketed or accompanied
by proper warnings.”); Holland v. Hoffman-La Roche, Inc., 2007 WL 4042757, at *3 (N.D. Tex.
Nov. 15, 2007) (“[p]rescription drugs are not susceptible to a design defect claim where, as here,
the drug is “accompanied by proper directions and warning”); Carter v. Tap Pharms., Inc., 2004
WL 2550593, at *2 (W.D. Tex. Nov. 2, 2004) (“[u]nder Texas law, all FDA-approved prescription
drugs are unavoidably unsafe as a matter of law’).
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It is undisputed that the Option™ ELITE IVC filter implanted in Mr. Gray was a
prescription medical device that was accompanied by detailed, FDA-approved IFU. Accordingly,
Argon is entitled to summary judgment on Plaintiff’s strict liability design defect claims under
comment k to Section 402A, as incorporated into Texas law.
Cc. Argon is Entitled to Summary Judgment on Plaintiff’s Manufacturing Defect
Claims Because there is No Evidence that the Filter Implanted in Mr. Gray
Deviated from other Option™ ELITE Filters
In order to establish a manufacturing defect, the plaintiff must prove that “‘the finished
product deviates, in terms of its construction or quality, from the specifications or planned output
in a manner that renders it unreasonably dangerous.’”” Ford Motor Co. v. Ledesma, 242 S.W.3d
32, 41-42 (Tex. 2007) (citation omitted); Cooper Tire & Rubber Co. v. Mendez, 204 S.W.3d 797,
800 (Tex. 2006); In re Bridgestone/Firestone, Inc., 106 S.W.3d 730, 736 (Tex. 2002); Ford Motor
Co. v. Ridgway, 135 S.W.3d 598, 600 (Tex. 2004); Torrington Co. v. Stutzman, 46 S.W.3d 829,
844 (Tex. 2000). “This requirement is separate from, and in addition to, the requirements that the
product was defective when it left the manufacturer and that the defect was a producing cause of
the plaintiff's injuries.” Ledesma, 242 $.W.3d at 41-42. “The requirement of a deviation from the
manufacturer’s specifications or planned output serves the essential purpose of distinguishing a
manufacturing defect from a design defect.” Jd. at 42. The Texas Supreme Court further explained:
Moreover, requiring a deviation from specifications or planned output permits a
jury to determine whether a specific defect caused the accident, rather than
premising liability on a belief that a product failure, standing alone, is enough to
find a product defect. Texas law does not generally recognize a product failure or
malfunction, standing alone, as sufficient proof of a product defect. Instead, we
have held that a specific defect must be identified by competent evidence and other
possible causes must be ruled out. Our law requires more than finding an
undifferentiated “condition” that renders the product unreasonably dangerous.
Id. (internal citations omitted).
Here, Plaintiff has failed to produce any evidence that the Option™ ELITE filter implanted
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in Mr. Gray varied from the other Option™ ELITE filters in its lot or deviated in any way from its
design specifications. Accordingly, Argon is entitled to summary judgment on Plaintiff's strict
liability and negligent manufacturing defect claims, and both claims should be dismissed as a
matter of law.
D. Argon is Entitled to Summary Judgment on Plaintiff’s Failure to Warn
Claims
1 Pursuant to the “Learned Intermediary” Doctrine, Argon Owed A Duty to
Warn Plaintiffs Physician, Not Plaintiff.
To prevail on a failure to warn claim under Texas law, a plaintiff must prove by a
preponderance of the evidence that the filter at issue was unreasonably dangerous due to the
absence of adequate warnings or instructions. Joseph E. Seagram & Sons, Inc. v. McGuire, 814
S.W.2d 385, 387 (Tex. 1991). Texas has adopted the learned-intermediary doctrine, under which
the duty of a manufacturer to warn of alleged risks of a medical device runs to the treating
physician, not the patient. See Centocor, Inc., v. Hamilton, 372 S.W.3d 140, 153-55 (Tex. 2012)
(“The learned intermediary doctrine has been part of Texas jurisprudence for many years.”);
Wyeth-Ayerst Labs. Co. v. Medrano, 28 S.W.3d 87, 92 (Tex. App.—Texarkana 2000, no pet.) (“In
Texas, even when a physician makes no individualized judgment in prescribing and administering
a prescription drug, this doctrine has been applied as long as a physician-patient relationship is in
existence”).
Under this doctrine, “a product manufacturer is excused from warning each patient who
receives the product when the manufacturer properly warns the prescribing physician of the
product’s dangers.” Porterfield v. Ethicon, Inc., 183 F.3d 464, 467-68 (Sth Cir. 1999). The Texas
Supreme Court has held the learned intermediary doctrine applies to all claims based upon the
failure to warn, including claims for strict liability, negligence, and breach of warranty. Centocor,
372 S.W.3d at 153-54.
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The Option™ ELITE filter is a prescription medical device manufactured and distributed
by Argon directly to a health care provider and/or facility and is not available to the general public.
Therefore, the learned intermediary doctrine controls, and Argon only had a duty to warn
Plaintiff's trained and credentialed implanting physician, Dr. Kuban, of the risks and potential
complications associated with the filter.
2 Plaintiff Has No Evidence that Warnings Were Defective.
The instructions for use and warnings accompanying the filter device more than adequately
informed Dr. Kuban of the specific complications Plaintiff allegedly suffered in this case (i.e.,
migration). See Exhibit Q. It is undisputed that the Option™ ELITE filter implanted by Dr. Kuban
on August 15, 2017 was accompanied by detailed instructions for use, warnings, an exhaustive list
of potential complications, and a statistical analysis of the filter system’s safety, efficacy, and
complication rates. Jd. More specifically, the FDA-approved warning specifically listed, inter alia,
the following potential complications: vena cava or other vessel injury or damage; injury or
damage to organs adjacent to vena cava; incorrect positioning or orientation of the filter; filter
migration/movement; bleeding or hemorrhagic complication; thromboembolic events; renal
insufficiency or failure; hematoma; and “device breakage or failure or inability to retrieve
implanted device as described in [instructions for use], possibly requiring another intervention or
treatment modality to complete procedure.” Jd.
When he implanted the Option™ ELITE IVC filter in August 2017, Dr. Kuban was armed
with his medical professional knowledge, training, and clinical experience with IVC filters. He
was also armed with the legally adequate and detailed warning label readily available to him in the
event he needed any additional information to properly weigh the risks and benefits associated
with Plaintiff's filter implantation. As discussed above, the warning label specifically lists, inter
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alia, the same complications Mr. Gray is alleged to have suffered. For these reasons alone, Argon
fulfilled any duty to warn under the learned intermediary doctrine and Plaintiffs’ failure to warn
claims fail under Texas law.
3 Plaintiff Cannot Show that the Warning (Even if Defective) Impacted the
Prescribing Doctor’s Decision.
A plaintiff must show not only that the warning to the physician was defective, but also
that “the failure to warn was a producing cause of the injury.” Ackermann v. Wyeth Pharms., 526
F.3d 203, 208 (Sth Cir. 2008); accord Robles v. C.R. Bard, Inc., No. 5:13-CV-250-C, 2015 WL
11120857, at *2 (N.D. Tex. Mar. 23, 2015). A producing cause is a substantial cause of the event
in issue and is a but-for cause—a cause without which the event would not have occurred. Ford
Motor Co. v. Ledesma, 242 $.W.3d 32, 46 (Tex. 2007). For example, a plaintiff who complains
that a prescription product warning is inadequate must show that the alleged inadequacy caused
her doctor to prescribe the product, i.e., that the doctor would not have prescribed the product but
for the defective warning. Ackermann, 526 F.3d at 208; Pustejovsky v. Pliva, Inc., 623 F.3d 271,
276 (Sth Cir. 2010).
Courts have repeatedly held that a defendant’s alleged failure to warn is not a producing
cause of an injury where the prescribing physician testified that he did not read the instructions for
use for the product at issue. See, e.g., Pustejovsky v. Pliva, Inc., 623 F.3d 271, 277 (Sth Cir. 2010)
(under Texas law, the prescribing physician’s failure to recall reading the product warnings could
not sustain plaintiff's burden to demonstrate a genuine issue of material fact regarding causation).
Moreover, “when the prescribing physician is aware of the product’s risks and decides to use it
anyway any inadequacy of the product’s warning, as a matter of law, is not the producing cause of
the patient’s injury.” Gonzalez v Bayer Healthcare Pharms., Inc., 930 F. Supp. 2d 808, 813 (S.D.
Tex. 2012) (memorandum opinion). See also Porterfield, 183 F.3d at 468 (If “the physician was
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aware of the possible risks involved in the use of the product but decided to use it anyway, the
adequacy of the warning is not a producing cause of the injury” and the plaintiffs claim must fail);
see also Centocor, 372 §.W.3d at 170; Pustejovsky, 623 F.3d at 276; Ebel v. Eli Lilly & Co., 536
F. Supp. 2d 767, 780 (S.D. Tex. 2008), aff'd, 321 F. App’x 350 (Sth Cir. 2009) (where physician
knew of the product’s dangers, any inadequacy in the product warnings could not have been the
proximate cause of plaintiff's injuries under Texas law.
Here, Dr. Kuban admitted in his deposition that he had no specific recollection regarding
whether he ever read the instructions for use. See Exhibit H, pg. 101-02. Plaintiff cannot
demonstrate that Dr. Kuban would have forgone filter implantation (or done anything differently
with regard to Plaintiff's care) if he had additional warning information. Dr. Kuban did not and
does not rely on information provided by Argon representatives or Argon literature in his decisions
to use the Option™ ELITE. Instead, he relies heavily on his training and personal experience. See
id., pg. 106. Therefore, Plaintiff cannot establish the proximate cause element of the failure to warn
claim under Texas law, and summary judgment is warranted.
4. Argon Owed No Duty to Warn of Risks Within Common Knowledge of the
Medical Community.
The Texas Supreme Court “has recognized that there is no duty to warn when the risks
associated with a particular product are matters within the ordinary knowledge common to the
community.” Caterpillar, Inc. v. Shears, 911 S.W.2d 379, 382 (Tex. 1995) (internal citations and
quotation marks omitted). In the case of medical products, “[t]he learned intermediary is the one
to whom the warning is directed, and is the one who makes the decision whether to use the
product”; thus, “the duty to warn in the learned intermediate context . . . require[s] an adequate
warning of inherent dangers not within the knowledge of or obvious to the average learned
intermedia[ry].” Willett v. Baxter Int’l, Inc., 929 F.2d 1094, 1098 n.16 (Sth Cir. 1991) (applying
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Louisiana law).
For example, in Stahl v. Novartis Pharms. Corp., the Fifth Circuit affirmed summary
judgment on warnings-based claims alleged against the manufacturer of the prescription antifungal
treatment Lamisil. 283 F.3d 254, 268 (5th Cir. 2002). The plaintiff alleged that the product’s
warnings were inadequate because, among other reasons, they failed to warn that liver failure and
death could result from use of the product. /d. at 268. The court held that summary judgment was
appropriate with respect to this claim because Louisiana law, like Texas law, is clear that “there is
no duty to warn of obvious risks.” /d. According to the court, “liver failure and resulting death are
widely recognized to be possible outcomes in a severe case of hepatitis,” and the product warning
specifically mentioned the risk of hepatitis. /d. “[B]ecause any prescribing physician who is
forewarned of a risk of systematic liver dysfunction and cholestatic hepatitis would find it obvious
that there is an attendant possibility of liver failure and death, Novartis fulfilled its duty” to warn
of that outcome. Id.
The same rationale applies here. Plaintiff's failure to warn claim essentially argues that
Defendants failed to warn that the Option™ ELITE IVC filter allegedly posed a significant risk of
tilt, embedment, perforation, fracture, migration, recurrent thrombosis, and resulting serious
injuries. See Exhibit D, para. 5.7. By the time that Mr. Gray was implanted with the Option™
ELITE IVC filter, however, the medical literature extensively discussed the risk of all
complications that Plaintiff claims Defendants failed to warn about, as well as the specific filter
complications Mr. Gray allegedly suffered. Furthermore, in light of increased reports of these
complications, the FDA issued in 2010 and 2014 general warnings to implanting physicians and
physicians responsible for the ongoing care of patients with retrievable IVC filters. See Exhibit R.
The FDA safety communications, which generally address all retrievable inferior vena cava filters,
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describe reports of device migration, filter fracture, embolization, perforation of the IVC, and
difficulty removing the device. Id.
Further, Dr. Kuban was aware of the risks and benefits of an IVC filter based on his
education, training, and experience. See Exhibit H, pg. pg. 73-4, 127-28. He was aware
specifically that migration is a risk associated with all IVC filters on the market. Jd. Dr. Kuban
relied upon his independent knowledge and training to form his opinion about the risks of
recommending the Option™ ELITE to Mr. Gray, and not on anything communicated to him by
Argon. See id., pg. 106.
At a minimum, this evidence establishes that the complications alleged here were well
within the knowledge of the medical community prior to Mr. Gray’s filter placement on August
15, 2017. See Gerber v. Hoffmann-La Roche Inc., 392 F. Supp. 2d 907, 919 (S.D. Tex. 2005)
(citing Stahl with approval, see supra, and finding “that the additional warnings urged by Plaintiff
concern facts doctors should already know as learned intermediaries”). Therefore, Argon did not
have a duty to warn about these risks under Texas law, and Argon is entitled to summary judgment
on all of Plaintiff's warning-based claims.
E. Argon is Entitled to Summary Judgment on Plaintiff's Warranty Claims
Because Plaintiff Failed to Provide Pre-Suit Notice of the Alleged Breach.
Under Texas law, a buyer is required to notify the seller “within a reasonable time” that a
breach of express or implied warranty has occurred. See Tex. Bus. & Com. Code § 2.607(c)(1).
“Failure to notify the seller of the breach, thereby allowing the seller an opportunity to cure, bars
recovery on the basis of breach of warranty.” Lochinvar Corp. v. Meyers, 930 S.W.2d 182, 189
(Tex.App.-Dallas 1996, no pet.).
Although the Texas Supreme Court has acknowledged a split among its courts of appeals
with regard to whether a buyer is required to give notice of an alleged breach of warranty to a
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remote seller under the Texas Business & Commerce Code § 2.607(c)(1), three out of the four
Texas courts of appeals that have addressed the issue (which include the Houston First Court of
Appeals) have held that a buyer is required to give notice of an alleged breach of warranty to a
remote as well as an immediate seller. See Wilcox v. Hillcrest Mem’l Park of Dallas, 696 S.W.2d
423, 424-25 (Tex. App.-Dallas 1985, writ ref’d); see also Bailey v. Smith, No. 13-05-085-CV,
2006 WL 1360846, at *4—5 (Tex. App.-Corpus Christi 2006, no pet.); U.S. Tire-Tech, Inc. v.
Boeran, B.V., 110 S.W.3d 194, 199 (Tex. App.—Houston [1st Dist.] 2003, pet. denied); cf: Vintage
Homes, Inc. v. Coldiron, 585 S.W.2d 886, 888 (Tex. App.-El Paso 1979, no writ) (holding the
notice requirement applies only between buyer and immediate seller). Plaintiff was required to
provide notice to the physician (the immediate seller), and Argon (the remote seller), to sustain a
breach of warranty claim under this majority rule.
In U.S. Tire-Tech, Inc. v. Boeran, B.V., the First Court of Appeals held that notice of
generalized issues by an intermediary to a defendant-manufacturer—without identifying the end
user—does not satisfy a plaintiff's notice requirement to permit her to bring a claim for breach of
express warranty. 110 S.W.3d at 201-202. Consequently, any generic notice that Argon might
have had regarding problems with the Option™ ELITE does not suffice under Texas law. See In
re Ford Co. E-350 Van Products Liab. Litig. (No. II), 2010 WL 2813788, at *53 (citing U.S. Tire—
Tech Inc. 110 S.W.3d at 202 (stating that “[t]he manufacturer must be made aware of a problem
with a particular product purchased by a particular buyer”)). Instead, the notice must have alerted
Argon to a particular end user, namely Mr. Gray, who was having problems with his product.
Plaintiff failed to provide such notice.
In fact, Argon was not made aware of the alleged problems that Mr. Gray had with his filter
until June 6, 2018, when it received notice by way of the civil action Complaint filed by Plaintiff
20
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on May 29, 2018. See Exhibit E. Plaintiff has not offered any evidence to indicate otherwise.
Accordingly, Argon has shown that Plaintiff did not satisfy the Section 2.607(c)(1) notice
requirement before bringing claims for breach of express and implied warranty. Argon is therefore
entitled to summary judgment on Plaintiffs warranty claims.
Argon is also entitled to summary judgment on all of Plaintiff's breach of warranty claims
on alternative grounds.
1 Argon is Entitled to Summary Judgment on Plaintiff's Breach of Express
Warranty Claim Because There is No Evidence of Reliance.
Argon is entitled to summary judgment on Plaintiff's breach of express warranty claim
because there is no evidence of reliance by the learned intermediary, Dr. Kuban, or by Mr. Gray
himself. See Sw. Bell Tel. Co. v. Mktg. on Hold Inc., 308 S.W.3d 909, 921 (Tex. 2010) (“breach
of express warranty requires proof of some form of reliance”).
2. Argon is Entitled to Summary Judgment on Plaintiff's Breach of Implied
Warranty of Merchantability Claim Pursuant to the “Learned Intermediary”
Doctrine.
Plaintiff's breach of implied warranty of merchantability claim is essentially a repackaged
failure to warn claim. In Centocor, the Texas Supreme Court held that the learned intermediary
doctrine applies to all claims based upon failure to warn, including claims for strict liability,
negligence, and breach of warranty. Centocor, 372 S.W.3d at 153-54; see also Rolen v. Burroughs
Wellcome Co., 856 S.W.2d 607, 608 (Tex. App.-Waco 1993, writ denied) (affirming grant of
summary judgment to defendant based on learned intermediary doctrine involving a claim for
breach of implied warranty of merchantability). Therefore, for the reasons set forth above, Argon
is entitled to summary judgment on all claims based upon failure to warn, including Plaintiff's
breach of implied warranty of merchantability claim.
3 Argon is Entitled to Summary Judgment on Plaintiff's Breach of Implied
Warranty of Fitness for a Particular Purpose Claim Because There is No
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5353323v.1
Evidence the Device was Purchased for a Particular Purpose or that Mr.
Gray Relied on Argon’s Skill or Judgment.
To recover for a breach of implied warranty of fitness for a particular purpose, a plaintiff
must demonstrate that: (1) at the time the contract for sale was made, the seller knew or should
have known of the particular purpose for which the goods would be used and that the plaintiff was
relying on the defendant’s skill or judgment to select or furnish suitable goods; (2) the plaintiff
actually relied on the defendant’s skill or judgment; (3) the plaintiff notified the defendant of the
breach; (4) the plaintiff suffered injury; and (5) the defendant’s breach caused the plaintiff's injury.
See TEX. BUS. & COM. CODE § 2.315; ASAI v. Vanco Insulation Abatement, Inc., 932 S.W. 2d
118, 121 (Tex. App. B — El Paso 1996, no writ).
An implied warranty of fitness for a particular purpose “does not arise unless the particular
purpose differs from the usual and ordinary use of the goods. In other words, the particular purpose
must be some unusual, out of the ordinary purpose peculiar to the needs of an individual buyer.”
Coghlan v. Aquasport Marine Corp., 75 F. Supp. 2d 769, 774 (S.D. Tex. Oct. 8, 1999). The implied
warranty of fitness for a particular purpose arises when the seller is aware that the purchaser is
looking for a product suitable for a particularly-described need and is relying on the seller’s
judgment in selecting the best product for that need. This claim often fails as a matter of law in the
prescription medical products field because plaintiffs typically use such products for only their
ordinary purpose, i.e., the labeled indication, and rely on their prescriber rather than the product
manufacturer. See Ackermann v. Wyeth Pharm., 471 F. Supp. 2d 739, 745 (E.D. Tex. 2006);
Johnson v. Medtronic, Inc., C.A. No. H-03-4186, 2005 WL 1515402, at *5 (S.D. Tex. June 23,
2005).
As an initial matter, Plaintiff/Mr. Gray is not a “buyer” as defined by the Act. See TEX
US OMM_ ODE at § 2.103(a)(1) (defining “buyer” as a person who buys or contracts to buy
22
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goods). Moreover, the implied warranty of fitness for a particular purpose has an explicit
causation/reliance requirement. Section 2.315 contemplates that the “seller” has reason to know
any particular purpose for which the goods are required and that the buyer is relying on the seller’s
skill or judgment to select or furnish suitable goods. In Ackermann v. Wyeth Pharmaceuticals, 471
F. Supp.2d 739 (E.D. Tex. 2006), aff'd on other grounds, 526 F.3d 203 (5th Cir. 2008), the court
recognized the reliance requirement when considering the defendant’s motion for summary
judgment to dismiss Plaintiff's implied warranty claim, and held:
[T]here is no showing that [Plaintiff] was relying on [defendant’s] skill or
judgment. To the contrary, he w
Preview
CAUSE NO. 2018-35641 TERRY GRAY, Individually and as IN THE DISTRICT COURT OF Heir and Representative of the Estate of STEPHEN WADE GRAY (Deceased), Plaintiff Vv. HARRIS COUNTY, TEXAS ARGON MEDICAL DEVICES, INC. AND REX MEDICAL, INC. d/b/a REX MEDICAL, L.P. and REX MEDICAL, LP., Defendants. 189% JUDICIAL DISTRICT DEFENDANT ARGON MEDICAL DEVICES, INC.’S MOTION FOR SUMMARY JUDGMENT TO THE HONORABLE JUDGE OF THIS COURT: COMES NOW Defendant Argon Medical Devices, Inc. (hereinafter “Argon”) and files its Motion for Summary Judgment and would respectfully show this Court as follows: I INTRODUCTION The medical device at issue in this product liability litigation is the Option™’ ELITE Vena Cava Filter (hereinafter referred to as “the Option™ ELITE”). The Option™ ELITE is a cone- shaped filter, which is surgically implanted in the inferior vena cava (IVC), a large vein carrying blood from the lower body to the heart. The Option™ filters are intended to save lives and prevent deadly recurrent pulmonary embolism. Stephen Wade Gray was implanted with an Argon Option™ ELITE on August 15, 2017. A previous version of the filter was known as the Option™ filter. The Option™ filter and the Option™ ELITE are hereinafter collectively referred to as either “the Option™ filters” or “the subject medical devices.” 5353323v.1 Plaintiff alleges that shortly after implantation, Mr. Wade suffered complications from the device, which led to his death. On May 24, 2018, Plaintiff Terry Gray, individually and as heir and personal representative of the estate of Stephen Wade Gray, filed this civil action against Rex and Argon. Plaintiff's Petition is attached hereto as Exhibit D. Plaintiff asserts claims against both Rex and Argon for: Negligence; Strict Liability Failure to Warn; Strict Liability Defective Design; Strict Liability Manufacturing Defect; Breach of Express Warranty; Breach of Implied Warranties of Merchantability and Fitness for a Particular Purpose; and Negligent Misrepresentation. Id. Plaintiff seeks damages pursuant to the Wrongful Death and Survival Statutes of the State of Texas, as well as punitive damages. Jd. Argon first received notice of the alleged incident via Plaintiff's lawsuit. A true and correct copy of the Argon Product Experience Report is attached hereto as Exhibit E. Argon now seeks summary judgment as to Plaintiff's claims. IL. STATEMENT OF FACTS Pursuant to Tex. R. Civ. P. 166a(c), the following facts either are undisputed or the Court may assume its truth for the purposes of the present motion. Johnson County Sheriff's Posse, Inc. An Argon Product Experience Report is an internal document that essentially mirrors an Adverse Event Report. It is created when Argon is notified ofa problem/event with one of its products. The “Reporter First Aware Date” notes when Argon received notice of the problem/event. 2 5353323v.1 v. Endsley, 926 S.W.2d 284, 285 (Tex. 1996). A Background on the Option™ ELITE IVC Filter Defendants Rex Medical, Inc. d/b/a Rex Medical, L.P. and Rex Medical, L.P. (hereinafter collectively “Rex”) together are a privately-held medical device company based in Conshohocken, Pennsylvania. Rex designed and developed the Option™ filter and brought it to market through the Food and Drug Administration (“FDA”) 510(k) clearance process in June 2009. A true and correct copy of the FDA 510(k) clearance letter, dated June 4, 2009, is attached hereto as Exhibit A The Option™ filter was cleared by the FDA for permanent placement and as a retrievable device. Jd. On December 17, 2013, the Option™ ELITE, the successor device to the original Option™ IVC filter, was similarly cleared by the FDA through the 510(k) clearance process. A true and correct copy of the FDA 510(k) clearance letter, dated December 17, 2013, is attached hereto as Exhibit B. Rex designed and developed the Option™ filter and, in compliance with applicable FDA regulations, brought the Option™ filter to market through the 510(k) clearance process in June 2009. See Exhibit A. Rex also designed and developed a similar, successor device, the Option™ ELITE filter. See Exhibit B. In compliance with applicable FDA regulations, Rex brought the Option™ ELITE filter to market through the 510(k) clearance process in December 2013. Id. Defendant Argon is a medical device company headquartered in Frisco, Texas. Argon develops, manufactures, and markets medical devices for interventional radiology, vascular surgery, interventional cardiology, and oncology. Argon played no role whatsoever with respect to the Option™ filters until it began distributing the Option™ filter on March 4, 2011. A true and correct copy of the License, Supply, Marketing and Distribution Agreement dated March 4, 2011 See 21 U.S.C. § 360e(b)(1)(B) (establishing 510(k) clearance process); 21 C.F.R. 807.87 (outlining process for 510(k) clearance application). 3 5353323v.1 is attached hereto as Exhibit C. Argon was also the exclusive distributor of the Option™ ELITE after it was brought to market in 2013. On December 23, 2015, Argon purchased the manufacturing rights to the Option™ filters and, thereafter, became the sole manufacturer and distributor of both the Option™ and the Option™ ELITE. Argon manufactured and distributed the specific Option™ ELITE filter at issue in this matter. B Stephen Wade Gray and Medical Care at Issue On August 1, 2017, Mr. Stephen Wade Gray presented to M.D. Anderson Cancer Center for removal of a recently-diagnosed tumor located on his lumbar spine. A true and correct copy of the relevant medical record from M.D. Anderson, ACC000250-1, is attached hereto as Exhibit F. Due to post-procedure complications after the removal of the tumor, it was subsequently determined that Mr. Gray required a second procedure to implant a lumbar spine drain. A true and correct copy of the relevant medical record from M.D. Anderson, ACC000202-205, is attached hereto as Exhibit F. Because Mr. Gray would be immobilized for a significant period of time after this second procedure, and because coagulation was contraindicated, it was determined that placement of an IVC filter was an appropriate prophylactic treatment. Jd. Mr. Gray’s implanting physician, Dr. Kuban, discussed the risks and benefits of an IVC filter (including the risk of migration) with Mr. Gray, and obtained informed consent for the procedure. A true and correct copy of Dr. Kuban’s deposition transcript is attached hereto as Exhibit H, see pg. 36, 39-40; a true and correct copy of the Consent Form, ACC002282-5, is attached hereto as Exhibit I. An Argon-manufactured Option™ ELITE IVC filter was implanted on August 15, 2017. A true and correct copy of the Procedure Note is attached hereto as Exhibit J. Six (6) days later, on August 21, 2017, Mr. Gray disobeyed his treating physicians’ orders when he rose out of his hospital bed without assistance and walked to the bathroom in hospital 5353323v.1 room. A true and correct copy of the relevant medical record from M.D. Anderson, ACC000427- 8, is attached hereto as Exhibit K. While in the bathroom, Mr. Gray fainted, collapsed to the ground, and may have struck his chest on the bathroom sink in the process. Id. A short time later, Mr. Gray began complaining of right-sided chest pain and was noted to be hypoxic. True and correct copies of the relevant medical records from M.D. Anderson, ACC000248-9 and ACC000432-7, are attached hereto as Exhibits L and M, respectively. He subsequently was transferred to the ICU for monitoring. Jd. Rib x-rays and a chest CT ultimately revealed that the subject Option™ ELITE IVC filter had migrated to the tricuspid valve in his heart. A true and correct copy of the relevant medical record from M.D. Anderson, ACC000233- 36, is attached hereto as Exhibit N. The imaging also revealed the presence of multiple pulmonary emboli. Jd. Shortly thereafter, a Code Blue was called and Mr. Gray stopped breathing. A true and correct copy of the relevant medical record from M.D. Anderson, ACC000425-6, is attached hereto as Exhibit O. Mr. Gray underwent emergency open heart surgery on August 21, 2017. See Exhibit N. Mr. Gray never recovered; he remained in the ICU while hospital staff tried to resuscitate him over the next three (3) days, and was pronounced dead on August 24, 2017, with the immediate cause of death identified as cardiac arrest leading to cerebral ischemia. A true and correct copy of the Death Certificate is attached hereto as Exhibit P. The secondary cause of death was noted to be the migration of the IVC filter into the heart, requiring emergency cardiac surgery. Id. Cc. Warnings to Mr. Gray’s Implanting Physician The Option™ ELITE filter at issue, which was designed by Rex, manufactured by Argon, and implanted by Dr. Kuban on August 15, 2017, was accompanied by detailed FDA-approved instructions for use, warnings, an exhaustive list of potential complications, and a statistical 5353323v.1 analysis of the filter’s safety, efficacy, and complication rates. A true and correct copy of the applicable Instruction for Use (“IFU”) is attached hereto as Exhibit Q. The FDA-approved instructions/warning label stated, inter alia, as follows: VI. Potential Complications Procedures requiring percutaneous interventional techniques should not be attempted by physicians unfamiliar with the possible complications. Complications may occur at any time during the implantation, indwelling period, or at the time of or following filter retrieval. Possible complications may include, but are not limited to, the following: Vena cava or other vessel injury or damage, including rupture or dissection, possibly requiring surgical repair or intervention Injury or damage to organs adjacent to vena cava, possible requiring surgical repair or intervention Vena cava stenosis or occlusion Incorrect positioning or orientation of the filter Filter migration/movement Extravasation of contrast media Vasospasm or decreased/impaired blood flow Bleeding or hemorrhagic complication that require transfusions or medical intervention (e.g. IV fluids, medications). Thromboembolic events, including DVT, acute or recurrent pulmonary embolism or air embolism, possibly causing end organ infarction/damage/failure Infection, possibly requiring medical or surgical intervention (e.g. antibiotics or incision and drainage) Respiratory insufficiency or failure Cardiac arrhythmia Myocardial infarction or coronary ischemia Cerebrovascular accident or other neurologic event Renal insufficiency or failure Reaction to contrast media/medication Hematoma, possibly requiring medical intervention or surgical revision Other vascular access site injury, including bruising, AV fistula, or pseudoaneurysm Neurological deficit associated with vascular access, possibly requiring nerve intervention or neurology consultation 6 5353323v.1 Device breakage or failure or inability to retrieve implanted device as described in IFU, possibly requiring another intervention or treatment modality to complete procedure Death. See Exhibit Q. Plaintiff's implanting physician, Dr. Kuban gave his deposition in this case. He had no specific recollection of ever reading the IFU, which would include the potential complications listed above. See Exhibit H; see pg. 101-02. Moreover, he assumed he did not read the IFU prior to Mr. Gray’s procedure. See id., pg. 102. However, he was familiar with the Option™ ELITE IFU at the time of this procedure, and Mr. Gray’s surgery fit one of the indicated uses of the filter. See id., pg. 103. Through his education and training, Dr. Kuban was aware that migration was a known risk of IVC filters. See id., pg. 73-4, 127-28. Dr. Kuban did not rely upon sales representatives of any medical device manufacturer to educate him on the risks of migration. /d., pg. 106. He did not rely on information received from an Argon sales representations or any Argon literature in his decision to use the Option™ ELITE. Jd. Instead, Dr. Kuban relied heavily on his own training and prior experiences, as well as relevant literature and what others in the field are doing. See id., pg. 106. D. General Knowledge of Risks Within the Medical Community All IVC filters, including the Option™ ELITE, come with risks of injury inherent in their use. By the time that Mr. Wade was treated with an Argon filter, the medical literature extensively and explicitly discussed the risk of filter complications, including perforation of adjacent organs, migration, filter malpositioning or tilt, the inability to be removed, and surgical removal. Because of these complications, the FDA issued in 2010 and 2014 general warnings to implanting physicians and physicians responsible for the ongoing care of patients with retrievable IVC filters. True and correct copies of the 2010 FDA safety communication and the 2014 FDA safety 7 5353323v.1 communication are attached hereto as Exhibit R, collectively. The 2010 and 2014 FDA safety communications, which generally address all retrievable inferior vena cava filters, describe reports of device migration, filter fracture, embolization, perforation of the IVC, and difficulty removing the device. See Exhibit R. il. SUMMARY JUDGMENT EVIDENCE Argon relies on and incorporates herein the following summary judgment evidence: Exhibit A: FDA 510(k) clearance letter for Option™, dated June 4, 2009 Exhibit B: FDA 510(k) clearance letter for Option™ ELITE, dated December 17, 2013 Exhibit C: License, Supply, Marketing and Distribution Agreement (unexecuted copy) Exhibit D: Plaintiff's Petition Exhibit E: Argon Product Experience Report for Stephen Gray Exhibit F: Medical record from M.D. Anderson, ACC000250-1 Exhibit G: Medical record from M.D. Anderson, ACC000202-205 Exhibit H: Dr. Kuban deposition transcript Exhibit I: Consent form, ACC002282-5 Exhibit J: IVC filter placement Procedure Note (marked as “Exhibit 1” from Dr. Kuban’s deposition) Exhibit K: Medical record from M.D. Anderson, ACC000427-8 Exhibit L: Medical record from M.D. Anderson, ACC000248-9 Exhibit M: Medical record from M.D. Anderson, ACC000432-7 Exhibit N: Medical record from M.D. Anderson, ACC000233-36 Exhibit O: Medical record from M.D. Anderson, ACC000425-6 Exhibit P: Stephen Gray Death Certificate Exhibit Q: Option™ ELITE Instructions for Use 5353323v.1 Exhibit R: 2010 and 2014 FDA safety communications re: IVC filters IV. LEGAL STANDARDS A Traditional Summary Judgment Standard A party moving for a traditional summary judgment “must establish that there is no genuine issue of material fact so that the movant is entitled to judgment as a matter of law.” Tex. R. Civ. P. 166a(c); Mann Frankfort Stein & Lipp Advisors, Inc. v. Fielding, 289 S.W.3d 844, 848 (Tex. 2009). At the summary judgment stage, a court must determine if a material question of fact exists. See Huckabee v. Time Warner Entm’t Co., 19 S.W.3d 413, 422 (Tex. 2000). A nonmovant may not rely on conclusory allegations, improbable inferences, or unsubstantiated speculation to rebut an otherwise meritorious motion for summary judgment. See, e.g., Am. Tobacco Co., 951 8.W.2d at 437 (“Speculation cannot create a fact issue.”); Texas Div.-Tranter, Inc. v. Carrozza, 876 3g &, S.W.2d 312, 314 (Tex. 1994) (per curiam) (holding that a party s subjective beliefs are no more than conclusions and are not competent summary judgment evidence. B No Evidence Summary Judgment Standard A defendant must challenge specific elements of the plaintiff's claim to be entitled to no evidence summary judgment. See Tex. R. Civ. P. 166a(i); see Cmty. Health Sys. Prof’l Servs. Corp. v. Hansen, 525 $.W.3d 671, 695 (Tex. 2017). To preclude summary judgment, the plaintiff must present summary judgment evidence that raises a genuine issue of material fact on the challenged elements. See Tex. R. Civ. P. 166a(i); SMI Realty Mgmt. Corp. v. Underwriters at Lloyd’s, London, 179 S.W.3d 619, 623 (Tex. App.— Houston [1st Dist.] 2005, pet. denied). A plaintiff can defeat summary judgment by producing more than a scintilla of admissible evidence supporting the challenged elements. See Merriman v. XTO Energy, Inc., 407 S.W.3d 244, 248 (Tex. 2013). More than a scintilla means evidence that would enable fair-minded and reasonable people to differ when drawing conclusions. Burbage v. Burbage, 447 S.W.3d 249, 259 9 5353323v.1 (Tex. 2014). Evidence does not create an issue of material fact if it is “so weak as to do not more than create a mere surmise or suspicion.” See Ford Motor Co. v. Ridgway, 135 S.W.3d 598, 601 (Tex. 2004). Vv. ARGUMENT Argon is entitled to summary judgment on Plaintiff's claims for Strict Liability and Negligent Design Defect, Strict Liability and Negligent Failure to Warn, Breach of Express and Implied Warranties, and Negligent Misrepresentation because no question of material fact exists as to those claims under Texas law. In addition, Argon is entitled to summary judgment on Plaintiff's claim for Manufacturing Defect, as well as the damages claim for punitive damages because there is no evidence to support essential elements of such claims. A Argon is Entitled to Summary Judgment on Plaintiff’s Strict Liability and Negligent Design Defect Claims Because Dr. McMeeking Failed to Present a Safer Alternative Design. Under Texas law, a design defect is defined as a condition of the product that renders it unreasonably dangerous as designed, taking into consideration the utility of the product and the risk involved in its use. See Comm. On Pattern Jury Charges, State Bar of Tex., Texas Pattern Jury Charges: Malpractice, Premises & Products PJC 71.4 (2016). This is consistent with Section 402A of the Second Restatement of Torts. See Am. Tobacco Co., Inc. v. Grinnell, 951 S.W.2d 420, 432 (Tex. 1997). Texas law also requires evidence of a safer alternative design in support of a claimed product defect. See Rojas v. Teva Pharms. USA, Inc., 920 F. Supp. 772, 779 (S.D. Tex. 2013) (referencing TEX IV RAC EM ODE_ NN. § 82.005). Argon submits in its contemporaneously-filed Daubert motion that Plaintiff's expert, Robert McMeekung, Ph.D., failed to present a safer alternative design that both reduces the risk of injury and is both economically and technologically feasible. If this Court grants Argon’s Daubert motion, Plaintiff will be unable to prove the design defect claim, and, therefore, Argon 10 5353323v.1 will be entitled to summary judgment. If this Court does not grant the Daubert motion, Argon presents an alternative argument in Section B. B Argon is Entitled to Summary Judgment on Plaintiff’s Strict Liability Design Defect Claim Because, as a Prescription Medical Device, it Cannot Be Made 100% Safe and is Therefore Protected Under Rest. 402A cmt. K. Prescription drugs and devices present unique issues as to defect. On the one hand, by their very nature, such products may lead to significant adverse events. On the other hand, they also provide significant benefits when properly used. It is for this reason many medications (and many medical devices as well) are available only by prescription from a licensed healthcare provider: Prescription drugs are likely to be complex medicines, esoteric in formula and varied in effect. As a medical expert, the prescribing physician can take into account the propensities of the drug, as well as the susceptibilities of his patient. His is the task of weighing the benefits of any medication against its potential dangers. Wyeth-Ayerst Labs. Co. v. Medrano, 28 S.W.3d 87, 91 (Tex. App.—Texarkana 2000, no pet.) (quoting Reyes v. Wyeth Labs., 498 F.2d 1264, 1276 (Sth Cir. 1974)). See also Restatement (Second) of Torts § 402A, cmt. k (1965) (noting that some drugs “for this very reason cannot legally be sold except to physicians, or under the prescription of a physician”). In that spirit, comment k to section 402A recognizes that: There are some products which, in the present state of human knowledge, are quite incapable of being made safe for their intended and ordinary use. These are especially common in the field of drugs . . . . Such a product, properly prepared, and accompanied by proper directions and warning, is not defective, nor is it unreasonably dangerous . . . The seller of such products, again with the qualification that they are properly prepared and marketed, and proper warning is given, where the situation calls for it, is not to be held to strict liability for unfortunate consequences attending their use, merely because he has undertaken to supply the public with an apparently useful and desirable product, attended with a known but apparently reasonable risk. (Emphasis added.) 11 5353323v.1 Courts throughout the country, including in Texas, have held that comment k—and the protection it provides to inherently dangerous products— is applicable to prescription medical devices, especially those devices implanted in the human body. See, e.g., Robles v. C.R. Bard, Inc., No. 5:13-CV-250-C, 2015 WL 11120857, at *3 (N.D. Tex. Mar. 23, 2015) (“comment k applies to medical devices as well as pharmaceutical drugs”); Phelps v. Sherwood, 836 F.2d 296 (7th Cir. 1987) (pacemaker and heart catheter covered under comment k); Brooks v. Medtronic Inc., 750 F.2d 1227 (4th Cir. 1984) (pacemaker and heart catheter covered under comment k); Soufflas v. Zimmer, Inc., 474 F. Supp. 2d 737, 749-50 (E.D. Pa. 2007) (granting summary judgment with respect to plaintiff's strict liability design defect claims because comment k excludes imposition of strict liability for prescription medical devices); Allen v. G.D. Searle, 708 F. Supp. 1142 (D. Ore. 1989); Creazzo v. Medtronic, Inc., 903 A.2d 24, 31 (Pa. Super. Ct. 2006) (affirming summary judgment on strict liability design defect claim under comment k, finding “no reason why the same rational applicable to prescription drugs may not be applied to medical devices”). As such, the only viable claims against a prescription device maker are for a manufacturing defect or a marketing defect (which encompasses claims for failure to warn and for providing an inadequate warning). See Hackett v. G.D. Searle & Co., 246 F. Supp. 2d 591, 595 (W.D. Tex. 2002) (“The Court thus holds that under Texas law and comment k of the Restatement, Defendants can only be held strictly liable if the drug was not properly prepared or marketed or accompanied by proper warnings.”); Holland v. Hoffman-La Roche, Inc., 2007 WL 4042757, at *3 (N.D. Tex. Nov. 15, 2007) (“[p]rescription drugs are not susceptible to a design defect claim where, as here, the drug is “accompanied by proper directions and warning”); Carter v. Tap Pharms., Inc., 2004 WL 2550593, at *2 (W.D. Tex. Nov. 2, 2004) (“[u]nder Texas law, all FDA-approved prescription drugs are unavoidably unsafe as a matter of law’). 12 5353323v.1 It is undisputed that the Option™ ELITE IVC filter implanted in Mr. Gray was a prescription medical device that was accompanied by detailed, FDA-approved IFU. Accordingly, Argon is entitled to summary judgment on Plaintiff’s strict liability design defect claims under comment k to Section 402A, as incorporated into Texas law. Cc. Argon is Entitled to Summary Judgment on Plaintiff’s Manufacturing Defect Claims Because there is No Evidence that the Filter Implanted in Mr. Gray Deviated from other Option™ ELITE Filters In order to establish a manufacturing defect, the plaintiff must prove that “‘the finished product deviates, in terms of its construction or quality, from the specifications or planned output in a manner that renders it unreasonably dangerous.’”” Ford Motor Co. v. Ledesma, 242 S.W.3d 32, 41-42 (Tex. 2007) (citation omitted); Cooper Tire & Rubber Co. v. Mendez, 204 S.W.3d 797, 800 (Tex. 2006); In re Bridgestone/Firestone, Inc., 106 S.W.3d 730, 736 (Tex. 2002); Ford Motor Co. v. Ridgway, 135 S.W.3d 598, 600 (Tex. 2004); Torrington Co. v. Stutzman, 46 S.W.3d 829, 844 (Tex. 2000). “This requirement is separate from, and in addition to, the requirements that the product was defective when it left the manufacturer and that the defect was a producing cause of the plaintiff's injuries.” Ledesma, 242 $.W.3d at 41-42. “The requirement of a deviation from the manufacturer’s specifications or planned output serves the essential purpose of distinguishing a manufacturing defect from a design defect.” Jd. at 42. The Texas Supreme Court further explained: Moreover, requiring a deviation from specifications or planned output permits a jury to determine whether a specific defect caused the accident, rather than premising liability on a belief that a product failure, standing alone, is enough to find a product defect. Texas law does not generally recognize a product failure or malfunction, standing alone, as sufficient proof of a product defect. Instead, we have held that a specific defect must be identified by competent evidence and other possible causes must be ruled out. Our law requires more than finding an undifferentiated “condition” that renders the product unreasonably dangerous. Id. (internal citations omitted). Here, Plaintiff has failed to produce any evidence that the Option™ ELITE filter implanted 13 5353323v.1 in Mr. Gray varied from the other Option™ ELITE filters in its lot or deviated in any way from its design specifications. Accordingly, Argon is entitled to summary judgment on Plaintiff's strict liability and negligent manufacturing defect claims, and both claims should be dismissed as a matter of law. D. Argon is Entitled to Summary Judgment on Plaintiff’s Failure to Warn Claims 1 Pursuant to the “Learned Intermediary” Doctrine, Argon Owed A Duty to Warn Plaintiffs Physician, Not Plaintiff. To prevail on a failure to warn claim under Texas law, a plaintiff must prove by a preponderance of the evidence that the filter at issue was unreasonably dangerous due to the absence of adequate warnings or instructions. Joseph E. Seagram & Sons, Inc. v. McGuire, 814 S.W.2d 385, 387 (Tex. 1991). Texas has adopted the learned-intermediary doctrine, under which the duty of a manufacturer to warn of alleged risks of a medical device runs to the treating physician, not the patient. See Centocor, Inc., v. Hamilton, 372 S.W.3d 140, 153-55 (Tex. 2012) (“The learned intermediary doctrine has been part of Texas jurisprudence for many years.”); Wyeth-Ayerst Labs. Co. v. Medrano, 28 S.W.3d 87, 92 (Tex. App.—Texarkana 2000, no pet.) (“In Texas, even when a physician makes no individualized judgment in prescribing and administering a prescription drug, this doctrine has been applied as long as a physician-patient relationship is in existence”). Under this doctrine, “a product manufacturer is excused from warning each patient who receives the product when the manufacturer properly warns the prescribing physician of the product’s dangers.” Porterfield v. Ethicon, Inc., 183 F.3d 464, 467-68 (Sth Cir. 1999). The Texas Supreme Court has held the learned intermediary doctrine applies to all claims based upon the failure to warn, including claims for strict liability, negligence, and breach of warranty. Centocor, 372 S.W.3d at 153-54. 14 5353323v.1 The Option™ ELITE filter is a prescription medical device manufactured and distributed by Argon directly to a health care provider and/or facility and is not available to the general public. Therefore, the learned intermediary doctrine controls, and Argon only had a duty to warn Plaintiff's trained and credentialed implanting physician, Dr. Kuban, of the risks and potential complications associated with the filter. 2 Plaintiff Has No Evidence that Warnings Were Defective. The instructions for use and warnings accompanying the filter device more than adequately informed Dr. Kuban of the specific complications Plaintiff allegedly suffered in this case (i.e., migration). See Exhibit Q. It is undisputed that the Option™ ELITE filter implanted by Dr. Kuban on August 15, 2017 was accompanied by detailed instructions for use, warnings, an exhaustive list of potential complications, and a statistical analysis of the filter system’s safety, efficacy, and complication rates. Jd. More specifically, the FDA-approved warning specifically listed, inter alia, the following potential complications: vena cava or other vessel injury or damage; injury or damage to organs adjacent to vena cava; incorrect positioning or orientation of the filter; filter migration/movement; bleeding or hemorrhagic complication; thromboembolic events; renal insufficiency or failure; hematoma; and “device breakage or failure or inability to retrieve implanted device as described in [instructions for use], possibly requiring another intervention or treatment modality to complete procedure.” Jd. When he implanted the Option™ ELITE IVC filter in August 2017, Dr. Kuban was armed with his medical professional knowledge, training, and clinical experience with IVC filters. He was also armed with the legally adequate and detailed warning label readily available to him in the event he needed any additional information to properly weigh the risks and benefits associated with Plaintiff's filter implantation. As discussed above, the warning label specifically lists, inter 15 5353323v.1 alia, the same complications Mr. Gray is alleged to have suffered. For these reasons alone, Argon fulfilled any duty to warn under the learned intermediary doctrine and Plaintiffs’ failure to warn claims fail under Texas law. 3 Plaintiff Cannot Show that the Warning (Even if Defective) Impacted the Prescribing Doctor’s Decision. A plaintiff must show not only that the warning to the physician was defective, but also that “the failure to warn was a producing cause of the injury.” Ackermann v. Wyeth Pharms., 526 F.3d 203, 208 (Sth Cir. 2008); accord Robles v. C.R. Bard, Inc., No. 5:13-CV-250-C, 2015 WL 11120857, at *2 (N.D. Tex. Mar. 23, 2015). A producing cause is a substantial cause of the event in issue and is a but-for cause—a cause without which the event would not have occurred. Ford Motor Co. v. Ledesma, 242 $.W.3d 32, 46 (Tex. 2007). For example, a plaintiff who complains that a prescription product warning is inadequate must show that the alleged inadequacy caused her doctor to prescribe the product, i.e., that the doctor would not have prescribed the product but for the defective warning. Ackermann, 526 F.3d at 208; Pustejovsky v. Pliva, Inc., 623 F.3d 271, 276 (Sth Cir. 2010). Courts have repeatedly held that a defendant’s alleged failure to warn is not a producing cause of an injury where the prescribing physician testified that he did not read the instructions for use for the product at issue. See, e.g., Pustejovsky v. Pliva, Inc., 623 F.3d 271, 277 (Sth Cir. 2010) (under Texas law, the prescribing physician’s failure to recall reading the product warnings could not sustain plaintiff's burden to demonstrate a genuine issue of material fact regarding causation). Moreover, “when the prescribing physician is aware of the product’s risks and decides to use it anyway any inadequacy of the product’s warning, as a matter of law, is not the producing cause of the patient’s injury.” Gonzalez v Bayer Healthcare Pharms., Inc., 930 F. Supp. 2d 808, 813 (S.D. Tex. 2012) (memorandum opinion). See also Porterfield, 183 F.3d at 468 (If “the physician was 16 5353323v.1 aware of the possible risks involved in the use of the product but decided to use it anyway, the adequacy of the warning is not a producing cause of the injury” and the plaintiffs claim must fail); see also Centocor, 372 §.W.3d at 170; Pustejovsky, 623 F.3d at 276; Ebel v. Eli Lilly & Co., 536 F. Supp. 2d 767, 780 (S.D. Tex. 2008), aff'd, 321 F. App’x 350 (Sth Cir. 2009) (where physician knew of the product’s dangers, any inadequacy in the product warnings could not have been the proximate cause of plaintiff's injuries under Texas law. Here, Dr. Kuban admitted in his deposition that he had no specific recollection regarding whether he ever read the instructions for use. See Exhibit H, pg. 101-02. Plaintiff cannot demonstrate that Dr. Kuban would have forgone filter implantation (or done anything differently with regard to Plaintiff's care) if he had additional warning information. Dr. Kuban did not and does not rely on information provided by Argon representatives or Argon literature in his decisions to use the Option™ ELITE. Instead, he relies heavily on his training and personal experience. See id., pg. 106. Therefore, Plaintiff cannot establish the proximate cause element of the failure to warn claim under Texas law, and summary judgment is warranted. 4. Argon Owed No Duty to Warn of Risks Within Common Knowledge of the Medical Community. The Texas Supreme Court “has recognized that there is no duty to warn when the risks associated with a particular product are matters within the ordinary knowledge common to the community.” Caterpillar, Inc. v. Shears, 911 S.W.2d 379, 382 (Tex. 1995) (internal citations and quotation marks omitted). In the case of medical products, “[t]he learned intermediary is the one to whom the warning is directed, and is the one who makes the decision whether to use the product”; thus, “the duty to warn in the learned intermediate context . . . require[s] an adequate warning of inherent dangers not within the knowledge of or obvious to the average learned intermedia[ry].” Willett v. Baxter Int’l, Inc., 929 F.2d 1094, 1098 n.16 (Sth Cir. 1991) (applying 17 5353323v.1 Louisiana law). For example, in Stahl v. Novartis Pharms. Corp., the Fifth Circuit affirmed summary judgment on warnings-based claims alleged against the manufacturer of the prescription antifungal treatment Lamisil. 283 F.3d 254, 268 (5th Cir. 2002). The plaintiff alleged that the product’s warnings were inadequate because, among other reasons, they failed to warn that liver failure and death could result from use of the product. /d. at 268. The court held that summary judgment was appropriate with respect to this claim because Louisiana law, like Texas law, is clear that “there is no duty to warn of obvious risks.” /d. According to the court, “liver failure and resulting death are widely recognized to be possible outcomes in a severe case of hepatitis,” and the product warning specifically mentioned the risk of hepatitis. /d. “[B]ecause any prescribing physician who is forewarned of a risk of systematic liver dysfunction and cholestatic hepatitis would find it obvious that there is an attendant possibility of liver failure and death, Novartis fulfilled its duty” to warn of that outcome. Id. The same rationale applies here. Plaintiff's failure to warn claim essentially argues that Defendants failed to warn that the Option™ ELITE IVC filter allegedly posed a significant risk of tilt, embedment, perforation, fracture, migration, recurrent thrombosis, and resulting serious injuries. See Exhibit D, para. 5.7. By the time that Mr. Gray was implanted with the Option™ ELITE IVC filter, however, the medical literature extensively discussed the risk of all complications that Plaintiff claims Defendants failed to warn about, as well as the specific filter complications Mr. Gray allegedly suffered. Furthermore, in light of increased reports of these complications, the FDA issued in 2010 and 2014 general warnings to implanting physicians and physicians responsible for the ongoing care of patients with retrievable IVC filters. See Exhibit R. The FDA safety communications, which generally address all retrievable inferior vena cava filters, 18 5353323v.1 describe reports of device migration, filter fracture, embolization, perforation of the IVC, and difficulty removing the device. Id. Further, Dr. Kuban was aware of the risks and benefits of an IVC filter based on his education, training, and experience. See Exhibit H, pg. pg. 73-4, 127-28. He was aware specifically that migration is a risk associated with all IVC filters on the market. Jd. Dr. Kuban relied upon his independent knowledge and training to form his opinion about the risks of recommending the Option™ ELITE to Mr. Gray, and not on anything communicated to him by Argon. See id., pg. 106. At a minimum, this evidence establishes that the complications alleged here were well within the knowledge of the medical community prior to Mr. Gray’s filter placement on August 15, 2017. See Gerber v. Hoffmann-La Roche Inc., 392 F. Supp. 2d 907, 919 (S.D. Tex. 2005) (citing Stahl with approval, see supra, and finding “that the additional warnings urged by Plaintiff concern facts doctors should already know as learned intermediaries”). Therefore, Argon did not have a duty to warn about these risks under Texas law, and Argon is entitled to summary judgment on all of Plaintiff's warning-based claims. E. Argon is Entitled to Summary Judgment on Plaintiff's Warranty Claims Because Plaintiff Failed to Provide Pre-Suit Notice of the Alleged Breach. Under Texas law, a buyer is required to notify the seller “within a reasonable time” that a breach of express or implied warranty has occurred. See Tex. Bus. & Com. Code § 2.607(c)(1). “Failure to notify the seller of the breach, thereby allowing the seller an opportunity to cure, bars recovery on the basis of breach of warranty.” Lochinvar Corp. v. Meyers, 930 S.W.2d 182, 189 (Tex.App.-Dallas 1996, no pet.). Although the Texas Supreme Court has acknowledged a split among its courts of appeals with regard to whether a buyer is required to give notice of an alleged breach of warranty to a 19 5353323v.1 remote seller under the Texas Business & Commerce Code § 2.607(c)(1), three out of the four Texas courts of appeals that have addressed the issue (which include the Houston First Court of Appeals) have held that a buyer is required to give notice of an alleged breach of warranty to a remote as well as an immediate seller. See Wilcox v. Hillcrest Mem’l Park of Dallas, 696 S.W.2d 423, 424-25 (Tex. App.-Dallas 1985, writ ref’d); see also Bailey v. Smith, No. 13-05-085-CV, 2006 WL 1360846, at *4—5 (Tex. App.-Corpus Christi 2006, no pet.); U.S. Tire-Tech, Inc. v. Boeran, B.V., 110 S.W.3d 194, 199 (Tex. App.—Houston [1st Dist.] 2003, pet. denied); cf: Vintage Homes, Inc. v. Coldiron, 585 S.W.2d 886, 888 (Tex. App.-El Paso 1979, no writ) (holding the notice requirement applies only between buyer and immediate seller). Plaintiff was required to provide notice to the physician (the immediate seller), and Argon (the remote seller), to sustain a breach of warranty claim under this majority rule. In U.S. Tire-Tech, Inc. v. Boeran, B.V., the First Court of Appeals held that notice of generalized issues by an intermediary to a defendant-manufacturer—without identifying the end user—does not satisfy a plaintiff's notice requirement to permit her to bring a claim for breach of express warranty. 110 S.W.3d at 201-202. Consequently, any generic notice that Argon might have had regarding problems with the Option™ ELITE does not suffice under Texas law. See In re Ford Co. E-350 Van Products Liab. Litig. (No. II), 2010 WL 2813788, at *53 (citing U.S. Tire— Tech Inc. 110 S.W.3d at 202 (stating that “[t]he manufacturer must be made aware of a problem with a particular product purchased by a particular buyer”)). Instead, the notice must have alerted Argon to a particular end user, namely Mr. Gray, who was having problems with his product. Plaintiff failed to provide such notice. In fact, Argon was not made aware of the alleged problems that Mr. Gray had with his filter until June 6, 2018, when it received notice by way of the civil action Complaint filed by Plaintiff 20 5353323v.1 on May 29, 2018. See Exhibit E. Plaintiff has not offered any evidence to indicate otherwise. Accordingly, Argon has shown that Plaintiff did not satisfy the Section 2.607(c)(1) notice requirement before bringing claims for breach of express and implied warranty. Argon is therefore entitled to summary judgment on Plaintiffs warranty claims. Argon is also entitled to summary judgment on all of Plaintiff's breach of warranty claims on alternative grounds. 1 Argon is Entitled to Summary Judgment on Plaintiff's Breach of Express Warranty Claim Because There is No Evidence of Reliance. Argon is entitled to summary judgment on Plaintiff's breach of express warranty claim because there is no evidence of reliance by the learned intermediary, Dr. Kuban, or by Mr. Gray himself. See Sw. Bell Tel. Co. v. Mktg. on Hold Inc., 308 S.W.3d 909, 921 (Tex. 2010) (“breach of express warranty requires proof of some form of reliance”). 2. Argon is Entitled to Summary Judgment on Plaintiff's Breach of Implied Warranty of Merchantability Claim Pursuant to the “Learned Intermediary” Doctrine. Plaintiff's breach of implied warranty of merchantability claim is essentially a repackaged failure to warn claim. In Centocor, the Texas Supreme Court held that the learned intermediary doctrine applies to all claims based upon failure to warn, including claims for strict liability, negligence, and breach of warranty. Centocor, 372 S.W.3d at 153-54; see also Rolen v. Burroughs Wellcome Co., 856 S.W.2d 607, 608 (Tex. App.-Waco 1993, writ denied) (affirming grant of summary judgment to defendant based on learned intermediary doctrine involving a claim for breach of implied warranty of merchantability). Therefore, for the reasons set forth above, Argon is entitled to summary judgment on all claims based upon failure to warn, including Plaintiff's breach of implied warranty of merchantability claim. 3 Argon is Entitled to Summary Judgment on Plaintiff's Breach of Implied Warranty of Fitness for a Particular Purpose Claim Because There is No 21 5353323v.1 Evidence the Device was Purchased for a Particular Purpose or that Mr. Gray Relied on Argon’s Skill or Judgment. To recover for a breach of implied warranty of fitness for a particular purpose, a plaintiff must demonstrate that: (1) at the time the contract for sale was made, the seller knew or should have known of the particular purpose for which the goods would be used and that the plaintiff was relying on the defendant’s skill or judgment to select or furnish suitable goods; (2) the plaintiff actually relied on the defendant’s skill or judgment; (3) the plaintiff notified the defendant of the breach; (4) the plaintiff suffered injury; and (5) the defendant’s breach caused the plaintiff's injury. See TEX. BUS. & COM. CODE § 2.315; ASAI v. Vanco Insulation Abatement, Inc., 932 S.W. 2d 118, 121 (Tex. App. B — El Paso 1996, no writ). An implied warranty of fitness for a particular purpose “does not arise unless the particular purpose differs from the usual and ordinary use of the goods. In other words, the particular purpose must be some unusual, out of the ordinary purpose peculiar to the needs of an individual buyer.” Coghlan v. Aquasport Marine Corp., 75 F. Supp. 2d 769, 774 (S.D. Tex. Oct. 8, 1999). The implied warranty of fitness for a particular purpose arises when the seller is aware that the purchaser is looking for a product suitable for a particularly-described need and is relying on the seller’s judgment in selecting the best product for that need. This claim often fails as a matter of law in the prescription medical products field because plaintiffs typically use such products for only their ordinary purpose, i.e., the labeled indication, and rely on their prescriber rather than the product manufacturer. See Ackermann v. Wyeth Pharm., 471 F. Supp. 2d 739, 745 (E.D. Tex. 2006); Johnson v. Medtronic, Inc., C.A. No. H-03-4186, 2005 WL 1515402, at *5 (S.D. Tex. June 23, 2005). As an initial matter, Plaintiff/Mr. Gray is not a “buyer” as defined by the Act. See TEX US OMM_ ODE at § 2.103(a)(1) (defining “buyer” as a person who buys or contracts to buy 22 5353323v.1 goods). Moreover, the implied warranty of fitness for a particular purpose has an explicit causation/reliance requirement. Section 2.315 contemplates that the “seller” has reason to know any particular purpose for which the goods are required and that the buyer is relying on the seller’s skill or judgment to select or furnish suitable goods. In Ackermann v. Wyeth Pharmaceuticals, 471 F. Supp.2d 739 (E.D. Tex. 2006), aff'd on other grounds, 526 F.3d 203 (5th Cir. 2008), the court recognized the reliance requirement when considering the defendant’s motion for summary judgment to dismiss Plaintiff's implied warranty claim, and held: [T]here is no showing that [Plaintiff] was relying on [defendant’s] skill or judgment. To the contrary, he w