The opinion
UNITED STATES DISTRICT COURT
EASTERN DISTRICT OF LOUISIANA
CRAIG COUTURIER CIVIL ACTION
VERSUS NO. 19-12497
BARD PERIPHERAL VASCULAR, SECTION: “B”(2)
INC. AND C.R. BARD, INC.
ORDER AND REASONS
Before the Court are defendants’ motion for summary
judgment on all claims (Rec. Docs. 122, 141) and plaintiff’s motion
for partial summary judgment on defendants’ affirmative defenses
(Rec. Docs. 102, 124).
After reviewing the motions, supplemental briefings, and oral
arguments, IT IS ORDERED that the defendants’ motion for summary
judgment on all claims is GRANTED IN PART and DENIED IN PART.
IT IS FURTHER ORDERED that the plaintiff’s motion for partial
summary judgment on defendants’ affirmative defenses is DENIED.
I. FACTS AND PROCEDURAL HISTORY
This is a products liability action that was remanded to
this Court from the multidistrict litigation captioned In re:
Bard IVC Filters Products Liability Litigation, MDL 2641, in the
United States District Court for the District of Arizona. (the
“MDL”). The parties agreed that voluminous and comprehensive
fact and expert discovery was undertaken in the MDL and that
1
general fact and expert discovery has been completed and is
closed, with two narrow exceptions: (1) any new medical
literature published since 2017 may be added to the reliance
lists of general experts, and the general experts may expand
their trial testimony from the MDL to include a discussion of
such new literature1, and (2) defendants shall supplement their
disclosures of adverse event data2. No further general fact or
expert discovery shall be pursued.
Plaintiff brings this action for personal injuries suffered
after being implanted with an Inferior Vena Cava (“IVC”) filter
medical device manufactured by defendants. Rec. Doc. 6-9 at 25.
An IVC filter is a device that is designed to filter or “catch”
blood clots that travel from the lower portions of the body to
the heart and lungs. Id. at 30. IVC filters were originally
designed to be permanently implanted in the IVC.3 Id. The IVC is
a vein that returns blood to the heart from the lower portions
1 Defendants have expressly reserved their right to object to the admissibility
and/or relevance of any post-implant studies or literature for any and all
purposes.
2 The parties acknowledge and agree that defendants’ production and
supplementation of adverse event data in this case will be the same as that
production by defendants in Caldera v. C.R. Bard, Inc. et al., case no. CV19-
4266 PHX DGC pending in the United States District Court of the District of
Arizona before Judge David G. Campbell (who oversaw the MDL). Defendants have
expressly reserved their right to object to the admissibility and/or
relevance of the adverse event date for any all purposes.
3 Defendant’s Simon Nitinol Filter (“SNF”) “had a well-established safety
record and had been sold for years for permanent implantation only.” Rec.
Doc. 141-1 at 52.
2
of the body. Id. In certain people, blood clots travel from the
vessels in the legs and pelvis, through the vena cava and into
the lungs. Deep vein thrombosis (“DVT”) occurs when the blood
clots develop in the deep leg veins and once these clots reach
the lungs, they are considered pulmonary emboli (“PE”)—
presenting risk to human health, including death. Id. IVC
filters have been on the market for decades but were limited to
patients who could not manage their DVT/PE with prescribed
medications. Id. at 31. Defendants were the first medical device
manufacturer to obtain FDA clearance for marketing a
“retrievable” IVC filter in July 2003. Id. at 31.
Plaintiff Craig Couturier presented to the emergency room
on May 6, 2011 with complaints of “headaches, nausea and
vomiting. Rec. Doc. 141-1 at 2. He was diagnosed with severe ear
infections and meningitis and underwent surgery to treat the ear
infections. Id. Following surgery, plaintiff “showed an upper
gastrointestinal bleed from a Mallory-Weiss tear4.” Id. Plaintiff
required multiple transfusions and was anemic. Id. at 3. On May,
2011, a scan of his lungs showed plaintiff had pulmonary emboli
4 A Mallory-Weiss tear is a tear of the tissue of the lower esophagus and is
most often caused by violent coughing or vomiting. Left untreated, it can
lead to anemia, fatigue, shortness of breath, and even shock. Mallory-Weiss
Tear, Johns Hopkins Medicine, CONDITIONS AND DISEASES,
https://www.hopkinsmedicine.org/health/conditions-and-diseases/malloryweiss-
tear (last accessed June 9, 2021).
3
in his left lower lobe. Id. Because of his anemia and
transfusions, plaintiff could not be placed on blood thinners,
but needed to be protected from further PE. Id.
Dr. Jose Mena5, a board-certified vascular and
cardiothoracic surgeon, discussed potentially implanting an IVC
filter with plaintiff as a form of treatment.6 Id. Dr. Mena
explained the risks and benefits to plaintiff and his wife and
they “voiced understanding and wished to proceed.” Id. at 7.
Plaintiff’s wife signed a consent form (that included various
risks associated with IVC implant procedures, including “heart
problems” and “displacement of device requiring retrieval”) on
plaintiff’s behalf following Dr. Mena’s consultation. Id. at 9-
10. Dr. Mena then implanted an Eclipse® IVC filter7 in plaintiff
under what plaintiff’s wife described as “emergent conditions”
because it was the only IVC filter available at the hospital.
Id. at 11-12.
5 Dr. Mena practices at Ochsner Health Center and had experience implanting
IVC filters (including the Eclipse®) dating back to 2005. Rec. Doc. 141-1 at
12.
6 Dr. Mena wanted to prevent another PE from occurring because he could have
had significant problems, including death. Rec. Doc. 141-1 at 5. Dr. Mena
performed a risk-benefit analysis in determining whether an IVC filter was
appropriate for plaintiff and that it was the “best option available.” Id. at
6.
7 The FDA cleared the Eclipse® filter on January 14, 2010. Rec. Doc. 6-9 at 53.
The Eclipse® filter is the fifth subsequent model of defendant’s IVC filters.
Predecessor models included the original Recovery® Vena Cava Filter, followed
by the G2®, G2® Express, and G2® X filters.
4
Medical device manufacturers, like defendant, provide an
“Instructions for Use” document {“IFU”) in the same box with the
device. Rec. Doc. 141-1 at 13. According to the Eclipse®
filter’s IFU, it is a venous interruption device “designed to
prevent pulmonary embolism” and is “designated to act as a
permanent filter,” but “when clinically indicated, … may be
percutaneously removed after implantation according to the
instructions provided under the Optional Removal Procedure.” Id.
13-14. The IFU includes several indications for use, warnings,
and potential complications such as:
Filter fractures are a known complication of vena cava
filters. There have been some reports of serious pulmonary
and cardiac complications with vena cava filters requiring
the retrieval of the fragment utilizing endovascular and/or
surgical techniques.
Movement, migration or tilt of the filter are known
complications of vena cava filters. Migration of filters to
the heart or lungs has been reported. There have also been
reports of caudal migration of the filter. Migration may be
caused by placement in IVCs with diameters exceeding the
appropriate labeled dimensions specified in this IFU.
Migration may also be caused by improper deployment,
deployment into clots and/or dislodgment due to large clot
burdens. Rec. Doc. 141-1 at 15 (emphasis included).
Possible complications include, but are not limited to …
[p]erforation or other acute or chronic damage of the IVC
wall … [d]istal [e]mbolization … and [o]rgan [i]njury. Id.
at 17 (internal quotes omitted).
5
Notably, the parties are contentious about whether Dr. Mena
read the IFU prior to implanting the filter in plaintiff; Dr.
Mena could not recall whether he read it or not because of the
elapsed time between treating plaintiff and his deposition. Rec.
Doc. 141-1 at 19. Moreover, the parties argue whether Dr. Mena
properly deployed the filter and to what extent did plaintiff
follow up with Dr. Mena post-implantation. Id. at 23-25.
In October 2016, plaintiff presented at the emergency room
and a CT showed that a “linear metallic foreign body” was found
in plaintiff’s right ventricle of his heart. One was found in
his lung in November 2016. Rec. Doc. 141 at 5. Plaintiff
consulted with Dr. Mena and a cardiologist, Dr. Ghiath Mikdadi,
and both agreed that at that time the fragment in plaintiff’s
heart was stable and advised plaintiff to “leave it alone.” Rec.
Doc. 122-2 at 7. Subsequent scans have shown that the fragment
is unchanged in position and is stable. Id. However, as of
December 2019, plaintiff’s IVC has been perforated in eight
places and he continues to suffer from shortness of breath,
irregular heartbeat, and hip pain. Id. Because of this,
plaintiff alleges he is at risk of the filter further
penetrating adjacent organs such as his spine, duodenum, and
aorta, which could result in symptomatic or life-threatening
hemorrhage, infection, bowel perforation, bowel obstruction, leg
6
pain, or back pain. Rec. Doc. 141 at 5. Plaintiff further
alleges that he is at risk of deadly cardiac complications and
further penetration may lead to pericardial tamponade8, arrythmia
and infection. Id.
Plaintiff filed his master short complaint for damages in
the United States Court for the District of Arizona on July 13,
2017. Rec. Doc. 1 at 4. His short form complaint asserts
thirteen causes of action against defendants including strict
liability and negligent manufacturing defect (Counts I, V),
design defect (Counts III, IV), and failure to warn (Counts II,
VII), negligent misrepresentation (Count VIII), negligence per
se (Count IX), breach of express and implied warranty (Counts X,
XI), fraudulent misrepresentation and concealment (Counts XII,
XIII), and violation of state consumer laws (Count XIV). Rec.
Doc. 1 at 3. Plaintiff also alleges punitive damages. Id. at 4.
The case was then transferred to this court on September 9,
2019. Rec. Doc. 5.
8 Cardiac tamponade happens when extra fluid builds up in the space around the
heart. This fluid puts pressure on the heart and prevents it from pumping
well. Cardiac Tamponade, HEALTH LIBRARY, https://www.cedars-sinai.org/health-
library/diseases-and-conditions/c/cardiac-tamponade.html (last accessed June
7, 2021).
7
II. LAW AND ANALYSIS
Under Federal Rule of Civil Procedure 56, summary judgment is
appropriate when “the pleadings, depositions, answers to
interrogatories, and admissions on file, together with the
affidavits, if any, show that there is no genuine issue as to any
material fact and that the moving party is entitled to judgment as
a matter of law.” Celotex Corp. v. Catrett, 477 U.S. 317, 322
(1986) (quoting Fed. R. Civ. P. 56(c)). See also TIG Ins. Co. v.
Sedgwick James of Wash., 276 F.3d 754, 759 (5th Cir. 2002). A
genuine issue of material fact exists if the evidence would allow
a reasonable jury to return a verdict for the nonmoving party.
Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248 (1986). The
court should view all facts and evidence in the light most
favorable to the non-moving party. United Fire & Cas. Co. v. Hixson
Bros. Inc., 453 F.3d 283, 285 (5th Cir. 2006). Mere conclusory
allegations are insufficient to defeat summary judgment. Eason v.
Thaler, 73 F.3d 1322, 1325 (5th Cir. 1996).
The movant must point to “portions of ‘the pleadings,
depositions, answers to interrogatories, and admissions on file,
together with the affidavits, if any,’ which it believes
demonstrate the absence of a genuine issue of material fact.”
Celotex, 477 U.S. at 323. If and when the movant carries this
burden, the non-movant must then go beyond the pleadings and
8
present other evidence to establish a genuine issue. Matsushita
Elec. Indus. Co., Ltd. v. Zenith Radio Corp., 475 U.S. 574, 586
(1986). However, “where the non-movant bears the burden of proof
at trial, the movant may merely point to an absence of evidence,
thus shifting to the non-movant the burden of demonstrating by
competent summary judgment proof that there is an issue of material
fact warranting trial.” Lindsey v. Sears Roebuck & Co., 16 F.3d
616, 618 (5th Cir. 1994). “This court will not assume in the
absence of any proof that the nonmoving party could or would prove
the necessary facts, and will grant summary judgment in any case
where critical evidence is so weak or tenuous on an essential fact
that it could not support a judgment in favor of the [non-movant].”
McCarty v. Hillstone Rest. Grp., 864 F.3d 354, 357 (5th Cir. 2017).
A. Defendant’s Motion for Summary Judgment
Defendants seek summary judgment on all claims asserting that
all of plaintiff’s claims fail for lack of causation. Rec. Doc.
122 at 1. Plaintiff cannot survive summary judgment because neither
of his experts, Dr. Darren Hurst and Dr. Derek Muehrcke, can
connect an alleged defect, negligence, or defendant’s conduct to
plaintiff’s injuries. Rec. Doc. 122-2 at 9. Defendants contend
that if the Court grants their motions to exclude or limit opinions
of Dr. Hurst and Dr. Muehrcke in their entirety, then the Court
should grant summary judgment in their favor for that reason alone.
9
Rec. Doc. 122-2 at 3. Defendants assert that without these two
experts, plaintiff will have no expert who can render an opinion
concerning specific causation. Id. Even still, defendant argues,
neither expert offers the opinion of an allegedly defective
condition in the Eclipse® filter that caused plaintiff’s injuries.
Id. A threshold question for the court to answer before considering
whether plaintiff can prove causation is whether the court will
exclude or limit Dr. Hurst and Dr. Muehrcke’s expert opinions.
Defendants argue that Counts IV, VIII, IX, XI, XII, XIII, and
XIV and plaintiff’s claims for punitive damages fail as a matter
of law because these claims are not set forth in the Louisiana
Products Liability Act (“LPLA”) and the LPLA bars claims based on
any theory of liability not set forth within it. Rec. Doc. 122 at
2. Moreover, defendant’s argue that plaintiff’s manufacturing
defect claim must fail because plaintiff has not presented any
evidence that his specific IVC filter deviated in a material way
from the manufacturer’s specifications or performance standards
from otherwise identical filters that defendants manufactured at
the time the device left defendants’ control. Id. And defendants
contend plaintiffs cannot prove that such a deviation was the
proximate cause of his injuries. Id.
10
Louisiana Products Liability Act
The Louisiana Products Liability Act (“LPLA”) sets forth the
exclusive theories of liability that can be brought against a
manufacturer for damage caused by their products. LA. STAT. ANN. §
2800.52 (2020). Circumstances or conduct that will trigger
liability of a manufacturer under LPLA constitute fault under LA.
CIV. CODE. art. 2315, so that the products action against the
manufacturer continues to be in tort. The LPLA provides that a
“manufacturer of a product shall be liable to claimant for damage
proximately caused by a characteristic of the product that renders
the product unreasonably dangerous when such damage arose from a
reasonably anticipated use9 of the product by the claimant or
another person or entity.” LA. STAT. ANN. § 2800.54 (2020). The LPLA
outlines four instances when a product is “unreasonably dangerous”
including: (1) in construction or composition, LA. STAT. ANN. §
2800.55; (2) in design, LA. STAT. ANN. § 2800.56; (3) when the
manufacturer has not provided an adequate warning about the
product, LA. STAT. ANN. § 2800.57; (4) when the product does not
conform to an express warranty of the manufacturer about the
product, LA. STAT. ANN. § 2800.58.
9 “Reasonably anticipated use” means a use or handling of a product that the
product’s manufacturer should reasonably expect of an ordinary person in the
same or similar circumstances. La. Stat. Ann. § 2800.53(7) (2020).
11
To prevail under any theory under the LPLA, plaintiff must
establish four elements: (1) defendant manufactured the product at
issue; (2) plaintiff’s injury was proximately caused by a
characteristic of the product; (3) this characteristic made the
product unreasonably dangerous; and (4) plaintiff’s injury arose
from a reasonably anticipated use of the product by plaintiff or
someone else. Stewart v. Capital Safety USA, 867 F.3d 517, 520
(La. 2017) (citing Stahl v. Novartis Pharm. Corp., 283 F.3d 254,
260-61 (5th Cir. 2002)). A “proximate cause” is generally defined
as any cause which, in natural and continuous sequence, unbroken
by an efficient, intervening cause, produces the result complained
of without which the result would not have occurred. Marable v.
Empire Truck Sales of Louisiana, LLC., 221 So. 3d 880, 901 (La.
Ct. App. 2017). If there is more than one cause of injury, a
defendant’s conduct is a cause-in-fact, or proximate cause, if it
is a substantial factor generating the plaintiff’s harm. Id. Under
Louisiana law, plaintiff bringing products liability action must
prove not only causation-in-fact, but also that product was most
probable cause of injury. Wheat v. Pfizer, Inc., 31 F.3d 340, 342
(5th Cir. 1994) (citing Brown v. Parker-Hannafin Corp., 919 F.2d
308, 311 and n.9, 312 (5th Cir. 1990).
Plaintiff withdrew any of his claims that are not cognizable
under the LPLA and his claims based on manufacturing defects,
12
rendering defendants’ motion moot on these points. Rec. Doc. 141.
At 4. Because plaintiff withdrew10 these claims, he now asserts
only five claims against defendants:
o Count III: Strict Products Liability – Design defect
o Count IV: Negligence – Design
o Count II: Strict Products Liability – Information
Defect (failure to warn)
o COUNT VII: Negligence – Failure to Warn
o COUNT X: Breach of Express Warranty
Defendant contends that because such claims must be analyzed
under the LPLA, plaintiff actually advances only three claims:
design defect, inadequate warning, and breach of express warranty.
Rec. Doc. 159-1 at 2. This court agrees.
1. Design Defect
Defendants argue that plaintiff cannot prevail on his design
defect claims because he has not provided any evidence there was
a defect in the design of plaintiff’s filter, or the design was
unreasonably dangerous, which was the cause of his specific
injuries. Rec. Doc. 122-2 at 4. Moreover, Dr. Mena was
independently aware of the risks associated with the filter at the
time of implant. Id. at 5. Further, defendant argues the comment
K of § 402(A) of the Restatement (Second) of Torts bars plaintiff’s
design defect claim based on a strict liability theory. Id.
10 Plaintiff submits that defendants’ motions with respect to Counts I, V,
VIII, IX, XI, XII, XIII, XIV, and punitive damages are moot.
13
A product is unreasonably dangerous in design, if at the time
the product left its manufacturer’s control: (1) an
alternative design for the product that was capable of
preventing the claimant’s damage existed; and (2) the
likelihood that the product’s design would cause the
claimant’s damage and the gravity of that damage outweighed
the burden of the manufacturer of adopting such alternative
design and the adverse effect, if any, of such alternative
design on the utility of the product. An adequate warning
about a product shall be considered in evaluating the
likelihood of damage when the manufacturer has used
reasonable care to provide the adequate warning to users and
handlers of the product. LA. STAT. ANN. § 2800.56.
A manufacturer of a product shall not be liable for damage
proximately caused by a characteristic of the product’s
design if the manufacturer proves that, at the time the
product left his control: (1) he did not know and, in light
of then-existing reasonably available scientific and
technological knowledge, could not have known of the design
characteristics that caused the damage or the danger of such
characteristic; or (2) he did not know and, in light of then-
existing reasonably available scientific and technological
knowledge, could not have known of the alternative design
identified by the claimant; or (3) the alternative design
identified by the claimant was not feasible, in light of then-
existing reasonably available scientific and technological
knowledge or then-existing economic practicality. LA. STAT.
ANN. § 2800.59(A).
To survive a summary judgment on the claim of defective
design, the plaintiff must present competent evidence that would
enable a trier of fact to conclude at the time the product left
the manufacturer's control 1) there existed an alternative design
for the product that was capable of preventing the claimant's
damage, and 2) the likelihood that the product's design would cause
14
the claimant's damage and the gravity of that damage outweighed
the burden on the manufacturer of adopting the alternative design
and the adverse effect, if any, of the alternative design on the
utility of the product. Louisiana law does not allow a fact finder
to presume an unreasonably dangerous design solely from the fact
that injury occurred. Ashley v. GMC, 666 So. 2d 1320, 1320 (La.
Ct. App. 1996). Known and disclosed risks associated with a
particular medical procedure using a certain product cannot be
considered a product defect. See McMillen v. Danek Medical, Inc.,
No. 95-1796, 1999 WL 1117104, at *2-3 (E.D. La. July 16, 1999).
First, the plaintiff must show that an alternative design
existed for the product at the time it left the manufacturer’s
control, and the alternative design was capable of preventing the
plaintiff’s damage. Bernard v. Ferrellgas, Inc., 689 So. 2d 554,
558 (La. Ct. App. 1997). If there was no alternative way to make
the product safer, the defendant could not have prevented
plaintiff’s injuries and therefore, the defendant is not liable
under a design defect theory.
Louisiana courts have determined whether an alternative
design was capable of preventing plaintiff’s damage through a
cause-in-fact analysis. Courts which have evaluated cause in fact
have applied the “but for” and substantial factors test both
15
alternatively and in combination to determine cause in fact. Quick
v. Murphy Oil Co., 643 So. 2d 1291, 1295 (La. Ct. App. 1994).
“Conduct is a cause in fact of harm to another if it was a
substantial factor in bringing that harm.” Thomas v. Missouri
Pacific R.R. Co., 466 So. 2d 1280, 1285 (La. 1985). The requirement
that an alternative design be capable of preventing the injury
essentially asks whether the defendants’ design decisions were a
substantial factor in bringing about plaintiff’s injuries, i.e.,
whether plaintiff’s injuries would have been prevented “but for”
defendant’s failure to adopt an alternative design.
If an alternative product capable of preventing plaintiff’s
damages existed, the court must then weigh the utility of the
product against the risk of the harm. Bernard v. Ferrellgas, Inc.,
689 So. 2d 554, 558 (La. Ct. App. 1997). The first determination
to be made is what risk, if any, the product in question created.
Id. at 560. The court may consider any effect an adequate warning
may have had on the likelihood of damages in assessing this risk.
Id. Then, the court must determine whether a reasonable person
would conclude that the danger-in-fact, whether foreseeable or
not, outweighs the utility of the product. Id. at 561.
Defendants rely on Dr. Muehrcke and Dr. Mena’s concession
that all IVC filters can fracture, migrate, embolize, and
16
perforate. Rec. Doc. 122-2 at 18. Therefore, none of these
potential complications can be considered a “defect” and no claim
for a design defect can survive summary judgment. Id. Defendants
also assert that plaintiff’s expert evidence is unreliable and
otherwise incompetent because neither Dr. Hurst nor Dr. Muehrcke
are qualified to testify about product design. Id. Regardless,
plaintiff failed to set forth a single defect that proximately
caused any alleged injuries. Rec. Doc. 159-1 at 3.
In response, plaintiff argues that his experts relied on Dr.
McMeeking’s engineering expertise in opining that the filter was
unreasonably dangerous, and the dangers of this filter outweighed
any benefits at the time it was implanted in plaintiff. Rec. Doc.
141 at 19. Further, plaintiff’s experts identified the Simon
Nitinol filter as a safer alternative permanent filter, and the
Gunther Tulip filter as a safe alternative retrievable filter. Id.
at 19-20. Plaintiff argues summary judgment is inappropriate at
this time because there is a genuine question as to a material
fact of whether the Eclipse was defectively designed and whether
a safer alternative design was available.
17
Plaintiff’s arguments are unconvincing. Plaintiff points to
two possible things that could possibly be interpreted as a design
defect. First, plaintiff points to defendants’ design differences
between the Eclipse and previous models of IVC filters and assert
that “because no other attributes of the filter were changed …
design deficiencies represented by tilt, perforation and migration
were left unaffected.” Rec. Doc. 141 at 19. Yet, plaintiff still
does not describe such design deficiencies or provide any evidence
that these deficiencies exist and are the cause of the tilt,
perforation, migration, etc. As explained, supra, just because an
injury has occurred (such as a perforation), does not mean that a
defect exists.
Next, plaintiff appears to contend that because defendants
allegedly did not follow “professional and industry standards in
the engineering activities” there was a design defect in the
Eclipse filters. Rec. Doc. 141 at 19. Plaintiff confuses design
process with a product defect and does not make a causal link that
some misstep in not adhering to these standards lead to a defect
in the filters.
Finally, plaintiff failed to provide evidence that any “safer
alternative” filter like the Simon Nitinol or Gunther Tulip would
have prevented plaintiff’s injuries. Plaintiff’s experts alleged
18
the Eclipse filter has higher complication rates11 but having
higher complication rates does not negate the fact that these
alternative filters still put patients at risk of the same injuries
as the Eclipse filter.
Because plaintiffs fail to provide evidence of a design defect
or of an alternative filter that could have prevented his injuries,
defendants are entitled to summary judgment on plaintiff’s design
defect claims.
2. Failure to Warn
A product is unreasonably dangerous because an adequate
warning about the product has not been provided if, at the
time the product left its manufacturer’s control, the product
possessed a characteristic that may cause damage and the
manufacturer failed to use reasonable care to provide an
adequate warning of such characteristic and its danger to
users and handlers of the product. LA. STAT. ANN. § 2800.57.
A manufacturer of a product shall not be liable for damage
proximately caused by a characteristic of the product if the
manufacturer proves that, at the time the product left his
control, he did not know and, in light of then-existing
reasonably available scientific and technological knowledge,
could not have known of the characteristics that caused the
damage or the danger of such characteristic. LA. STAT. ANN. §
2800.59(B).
A manufacturer has a continuing statutory duty to warn of any
danger inherent in the normal use of its product which is not
11 The MDL court prevented Dr. Hurst from opining, inter alia, that Bard
filters have higher complication rates that other IVC filters. Rec. Doc. 122-
2 at 19.
19
within the knowledge of an ordinary user. American Cent. Ins. Co.
v. Terex Crane, 861 So. 2d 228, 231 (La. Ct. App. 2003). An
“adequate warning” contains two components: “the warning must both
lead the ordinary user or handler to contemplate the danger in
using the product” and “to either use it safely or decline to use
it.” Stahl v. Novartis Pharmaceuticals Corp., 283 F.3d 254, 271
(5th Cir. 2002) (quoting Thomas C. Galligan, Jr., The Louisiana
Products Liability Act: Making Sense of it All, 49 LA. L. REV. 629,
677 (1989)).
Under Louisiana law, a manufacturer of medical drugs and
devices generally has no duty to warn consumers directly of any
risks or contraindications associated with its product. McCarthy
v. Danek Medical, Inc., 65 F.Supp. 2d 410, 413 (E.D. La. 1999)
(citing Mikell v. Hoffman-LaRoche, Inc., 649 So. 2d 75, 80 (La.
Ct. App. 1994)). Under the “learned intermediary doctrine,” the
doctor acts as an informed intermediary between the drug company
and the patient, and thus, a drug manufacturer has a duty to warn
the prescribing doctor, rather than the patient, of potential risks
associated with the use of the drug. Brown v. Glaxo, Inc., 790 So.
2d 35, 38 (La. Ct. App. 2000). The drug manufacturer’s duty to
warn the prescribing doctor under the learned intermediary
doctrine is fulfilled when the prescribing doctor is informed of
the potential risks from the drug’s reasonably anticipated use so
20
that the physician may intelligently decide on its use with the
particular patient, and the doctor must then advise the patient
accordingly. Id. (citing Mikell v. Hoffman-LaRoche, Inc., 649 So.
2d 75, 79-80 (La. Ct. App. 1994)). To recover for a failure to
warn under this doctrine, a plaintiff must show (1) that the
defendant failed to warn the physician of a risk associated with
the use of product, not otherwise known to the physician, and (2)
that the failure to warn the physician was both a cause in fact
and the proximate cause of the plaintiff’s injury. Willett v.
Baxter Intern., Inc., 929 F.2d 1094, 1098 (5th Cir. 1991). Because
the defective aspect of the product must cause the injury, the
plaintiff must show that a proper warning would have changed the
decision of the treating physician, i.e., that “but for” the
inadequate warning, the treating physician would not have used or
prescribed the product. Id. at 1098-99.
A “mere allegation of inadequacy” is insufficient for a
plaintiff to survive summary judgment on a failure-to-warn claim.
Anderson v. McNeilab, Inc., 831 F.2d 92, 93 (5th Cir. 1987).
Plaintiff must go beyond the pleadings and designate specific facts
in the record showing that there is a genuine issue for trial to
defeat summary judgment.
21
The Fifth Circuit has held that a warning is not adequate as
a matter of law simply because the warning contained a clear and
unambiguous reference to the injury plaintiff suffered. Stahl,
283 F.3d at 267. For summary judgment of an inadequate warning
claim to be appropriate, the plaintiff’s physician must also
unequivocally testify that the warning was adequate to inform her
of the risks involved in prescribing the drug. Id. Under
Louisiana’s learned intermediary doctrine, the treating
physician’s knowledge is the focus of the inquiry. “The doctor’s
testimony provides added assurance that the language in the package
insert was worded strongly enough to adequately inform him or her
of the actual level of risk involved.” Id. When a particular
adverse effect is clearly and unambiguously mentioned in a warning
label and the prescribing physician unequivocally states she was
adequately informed of that risk by the warning, the manufacturer
has satisfied its duty to warn under the learned intermediary
doctrine.
Defendants argue that plaintiff’s failure to warn claim fails
because the content of the IFU was not the proximate cause of
plaintiff’s injuries. Rec. Doc. 122-2 at 15. Defendants contend
because Dr. Mena does not recall reading the IFU, the learned
intermediary doctrine requires summary judgment for the
manufacturer. Id. (citing Pustejovsky v. Pliva, Inc., 623, F. 3d
22
271, 277 (5th Cir. 2010) (holding plaintiff failed to produce
sufficient evidence showing manufacturer’s inadequate warning was
the producing cause when the prescribing physician testified she
did not recall reading the label)). Moreover, Dr. Mena would not
have changed his prescribing decision with any other warning. Id.
Defendant points to the life-and-death situation plaintiff faced
as the reason Dr. Mena made the medical decision to implant the
filter and the Eclipse was the only type of filter the hospital
had. Rec. Doc. 122-2 at 16.
In response, plaintiff argues that defendants had multiple
avenues to warn Dr. Mena—aside from the IFU—including the sales
representatives visiting the hospital and the letters Bard wrote
to doctors about their filters. Rec. Doc. 186 at 24. Plaintiff
vigorously argues that the Eclipse filter had significantly higher
rates of fracture, migration, and perforation, than other filters
and these “non-obvious risks” of injury were not disclosed in
defendants’ warnings. Id. 25-26. Moreover, defendants conducted
the studies and analyses themselves and the risk of failure was
statistically significantly higher. Id. at 26. Dr. Mena testified
that had he been provided with this information, he would have
gone to the hospital to get a different filter to use. Id. at 33.
23
Because a manufacturer’s duty to warn is a continuing one, a
genuine issue of material fact exists whether the increased rate
of failure of the Eclipse filter rendered defendants’ warnings
inadequate. Therefore, summary judgment is inappropriate at this
time and this question should be left for the jury to decide.
3. Breach of Express Warranty
A product is unreasonably dangerous when it does not conform
to an express warranty made at any time by the manufacturer
about the product if the express warranty has induced the
claimant or another person or entity to use the product and
the claimant’s damage was proximately caused because the
express warranty was untrue. LA. STAT. ANN. § 2800.58.
To survive summary judgment on an express warranty claim under
LPLA, plaintiff is required to demonstrate or provide evidence to
create genuine issue of material fact regarding whether (1)
manufacturer made an express warranty regarding the product, (2)
plaintiff was induced to use the product because of that warranty,
(3) the product failed to conform to that express warranty, and
(4) plaintiff’s damages were proximately caused because the
express warranty was untrue. Broussard v. Procter & Gamble Co.,
463 F. Supp. 2d 596 (W.D. La. 2006). It is not necessary for a
plaintiff to cite to a specific express warranty in order to state
claim for breach of express warranty under LPLA, but he must make
more than a general reference to them. Baudin v. AstraZeneca
Pharms. LP, 413 F.Supp. 3d 498, 511 (W.D. La. 2017).
24
Plaintiff points to multiple statements within the IFU but
does not provide evidence that such statements ever induced Dr.
Mena, him, or his wife to use the Eclipse filter. In fact, Dr.
Mena testified that the only factor causing him to use the specific
filter was the fact that it was the only IVC filter the hospital
had available. Rec. Doc. 159-1 at 9. Therefore, plaintiff’s breach
of express warranty claim must fail.
B. Plaintiff’s Motion for Partial Summary Judgment
Plaintiff moves this court for partial summary judgment on
six of defendants’ affirmative defenses: (1) sole proximate
cause; (2) assumption of the risk; (3) failure to mitigate; (4)
contributory negligence and/or comparative fault of plaintiff;
(5) comparative fault of non-parties; and (6) superseding and/or
intervening causes. Rec. Doc. 102 at 1. For the following
reasons, this court finds summary judgment inappropriate at this
time.
Under Louisiana law, a tort victim has an affirmative duty
to make every reasonable effort to mitigate his or her damages.
Campbell v. Robinson, 10 So. 3d 346, 349 (La. Ct. App. 2009)
(citing to La. Civ. Code art. 2002); MB Industries, LLC v. CNA
Insurance Co., 74 So. 3d 1173, 1181 (La. 2011). This duty to
mitigate requires that the plaintiff take reasonable steps to
25
minimize the consequences of his injuries. Id. A patient may
breach their duty to mitigate by failing to follow reasonable
orders from their physician. Bacle v. Wade, 607 So. 2d 927, 935
(La. Ct. App. 1992). Plaintiff argues that the record shows he
routinely sought medical care for the medical conditions he
experienced and there is no evidence that anything he did or
failed to do caused his injuries. Rec. Doc. 102-1 at 4. But
plaintiff did not seek medical treatment related to his Filter
for five years following implantation. Even after the fractured
strut was identified through CT imaging, Plaintiff disregarded
his treating physician’s advice to schedule a subsequent CT scan
in three months and did not schedule another imaging study until
three years later. Further, on December 19, 2019, Plaintiff’s
treating physician recommended Plaintiff schedule further
follow-up imaging in six months. To date, Plaintiff still has
not scheduled any follow-up imaging despite his physician’s
recommendation fifteen months ago, and his bringing these
claims.
Under Louisiana law, assumption of risk as an affirmative
defense is subsumed into Louisiana’s comparative negligence
regime. Murray v. Ramada Inns, Inc., 521 So. 2d 1123, 1132- 33
(La. 1988) ; La. Civ. Code art. 2323 (applying comparative
negligence “to any claim for recovery of damages for injury,
26
death, or loss asserted under any law or legal doctrine or
theory of liability, regardless of the basis of liability.”).
Assumption of the risk looks at Plaintiff’s conduct and is “in
reality a form of contributory negligence.” Murray, 521 So. 2d
at 1125. The fact that a plaintiff was aware of the risk(s) is a
factor to be considered in assessing percentages of fault. Id.
at 1134.
Plaintiff, through his wife, provided all appropriate
consent to the implant of an inferior vena cava filter following
a discussion with Dr. Mena about the risks of the procedure. The
consent specifically acknowledged Dr. Mena informed Plaintiff of
“the risks of the proposed treatment/surgery” as well as the
“risks of no treatment.” Plaintiff accepted these risks by
choosing to go forward with the Filter procedure.
Moreover, Plaintiff’s continued failure to abide by his
treating physician’s recommendations to undergo imaging studies,
as well as his failure to seek medical treatment for his alleged
anxiety and heart palpitations—the injuries alleged to be
attributable to the Filter—prevented Plaintiff from discovering
the condition of the Filter earlier in time and from receiving
medical care for the injuries he alleges to have suffered in
this case.
27
In product liability cases, a plaintiff must bring forth
clear and definite proof establishing the cause of his injury.
Todd v. State Through Dep’t of Soc. Servs., 699 So. 2d 35, 43
(La. 1997). Mere possibilities and speculation are insufficient
to prove causation to a reasonable degree of medical
probability. Richard v. Artigue, 87 So. 3d 997, 1005 (La. Ct.
App. 2012). Where there is more than one possible cause to a
plaintiff’s alleged injuries, a defendant is permitted to
present evidence as to any potential alternative and/or
intervening causes. In a product liability case with a failure
to warn claim at issue, the learned intermediary doctrine
applies, and a plaintiff must prove that the defendant failed to
warn (or inadequately warned) the physician of a risk associated
with the product that was not otherwise known to the physician,
and this failure to warn the physician was the proximate cause
of the plaintiff’s injuries. Stahl, 283 F. 3d at 265-266. To
prove a design defect, a plaintiff must show that his injury was
proximately caused by a characteristic of the product that
renders the product unreasonably dangerous in design. Id. at
261. And any alleged alternative intervening causes that break
the chain of causation are relevant and admissible to
Plaintiff’s claims, whether they be for alleged defect or
alleged failure to warn.
28
Bard’s expert Dr. Sarac opines that “it is more likely than
not that the implant procedure was not performed within the
standard of care and in accordance with the IFU for the Eclipse
device and was the cause of any resultant complication.” Dr.
Sarac further explains that “[d]espite Dr. Mena’s incorrect
implantation, the medical records reveal that no efforts were
made at the time of the procedure to rectify this by removing
the Filter and placing another one.” Plaintiff’s own case-
specific experts agree that Dr. Mena improperly placed the
filter, which increased the risk of complications.
Under Louisiana law, a superseding intervening cause
exonerates a defendant in a products liability or negligence
action—whether the action is based on allegations of design
defect or failure to warn. See Guille v. Comprehensive Addiction
Programs, Inc., 735 So. 2d 775, 778 (La. Ct. App. 1999). A
proximate cause is any cause, which in natural and continuous
sequence is unbroken by any intervening cause. Hutto v. McNeil-
PPC, Inc., 79 So. 3d 1199, 1213 (La. Ct. App. 2011). Dr. Sarac
opined to a reasonable degree of medical probability and/or
certainty that the improper placement of the Filter was not
performed within the standard of care and “was the cause of any
resultant complication.”
29
Under Louisiana’s comparative fault regime, a plaintiff’s
recovery is reduced in accordance with the degree of negligence
is attributable to the person suffering the injury. La. Civ.
Code art. 2323(A). “Louisiana state courts and federal courts
have routinely held that pure comparative fault applies to LPLA
cases”. Allen v. C & H Distribs., LLC, 2013 WL 4506233, at *3
(W.D. La. Aug. 22, 2013) (citations omitted).
Dr. Mena conceded he did not follow the IFU in several
material ways. Dr. Mena conceded that he did not measure
Plaintiff’s inferior vena cava prior to implanting the Filter.
SOMF at ¶36. Plaintiff’s expert, Dr. Hurst, opined that the
Filter should not be deployed unless the IVC has been properly
measured. Id. at ¶72. Dr. Mena conceded at his deposition that
he could not remember the amount of pressure that was used when
injecting the contract medium through the dilator and thus could
not confirm if it was more or less than 800 psi. Dr. Mena did
not see Plaintiff for any follow-up after the implantation and
conceded he, therefore, could not have had a discussion with the
Plaintiff about potential removal of the filter.
III. CONCLUSION
IT IS ORDERED that defendants’ motion for summary judgment
is GRANTED IN PART and DENIED IN PART. All claims against
30
defendants, except the claim for failure to warn, are hereby
DISMISSED.
IT IS FURTHER ORDERED that plaintiff’s motion for partial
summary judgment on affirmative defenses is DENIED.
New Orleans, Louisiana this 8th day of July, 2021
___________________________________
SENIOR UNITED STATES DISTRICT JUDGE
31