1

UNITED STATES DISTRICT COURT 

EASTERN DISTRICT OF MICHIGAN 

SOUTHERN DIVISION 

HOMER W. McCLARTY, and 

VICKI RIVERA, 

Plaintiff, 

 vs. 

C.R. BARD INC., and BARD 

PERIPHERAL VASCULAR, INC.,

Defendant. 

4:14-CV-13627-TGB-RSW

ORDER DENYING IN PART 

AND GRANTING IN PART 

 DEFENDANTS’ MOTION FOR 

SUMMARY JUDGMENT 

This is a products liability action regarding a medical device 

designed to prevent blood clots from traveling to the heart and lungs. 

Plaintiff Vicki Rivera1 underwent surgery in 2006 to have an inferior 

1 The other named Plaintiff in this case is Homer W. McClarty (the 

“Trustee”), who is the appointed and acting Chapter 7 Trustee of Vicki 

Rivera’s bankruptcy estate. Pl.’s Compl., ECF No. 1, PageID.2. Under 

the Bankruptcy Code, the bankruptcy estate includes “all legal or 

equitable interests of the debtor in property as of the commencement of 

the [bankruptcy] case.” 11 U.S.C. § 541(a)(1). This includes “causes of 

action.” Bauer v. Com. Union Bank, Clarksville, Tenn., 859 F.2d 438, 

441 (6th Cir. 1988) (quoting Gochenour v. Cleveland Terminals Bldg. 

Co., 118 F.2d 89, 93 (6th Cir. 1941)). Further, because the “trustee in 

bankruptcy acts as a representative of the estate,” the trustee is the one 

who has the “capacity to sue and be sued.” Bauer, 859 F.2d at 441 

(quoting 11 U.S.C. § 323(b)). The Trustee is included in the caption of 

this case as a Plaintiff because the injury at the center of this complaint 

occurred prior to the commencement of the bankruptcy case. ECF No. 1, 

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vena cava filter (“IVC filter”) implanted. In 2011, medical professionals 

discovered that the IVC filter had fractured and migrated to her left lung. 

Plaintiff claims that the manufacturer and seller of the filter, C.R. Bard, 

Inc. and its affiliated company Bard Peripheral Vascular, Inc., violated 

products liability law. Plaintiff’s complaint alleges claims of defective 

design, defective manufacture, failure to warn of the device’s harm, 

breach of implied warranty, and negligent misrepresentation. 

Defendants have moved for summary judgment. ECF No. 27. The 

motions have been fully briefed and the Court heard oral argument on 

August 26, 2020. For the reasons stated below, Defendant’s motion for 

summary judgment is DENIED with respect to Plaintiff’s defective 

design and breach of implied warranty claim, and GRANTED with 

regard to Plaintiff’s negligent misrepresentation claim. 

I. Background 

C.R. Bard, Inc. (“Bard”) is a developer, manufacturer, and 

distributor of medical technologies and devices. Bard is one of many 

manufacturers that creates and sells inferior vena cava filters (“IVC 

filters”), which are medical devices that are surgically implanted in the 

inferior vena cava to prevent blood clots from traveling into the lungs and 

heart. Def.’s Mot. Summ. J., ECF No. 27, PageID.3134. The inferior vena 

cava is the central vein that returns blood to the heart from the lower 

PageID.2. Therefore, the cause of action is part of the bankruptcy estate 

which the Trustee may pursue. 

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portions of the body. Id. at PageID.3135. In certain individuals, blood 

clots (“thrombi”) can develop in the deep leg veins, known as deep venous 

thrombi (“DVT”). If these blood clots travel from the legs up into the heart 

or lungs, they can cause blockage in the smaller vessels. This is known 

as a pulmonary embolism. Pulmonary embolisms may cause a variety of 

health problems, the symptoms of which can be chest pain, shortness of 

breath, and brain damage which can result in death. Id. A doctor may 

recommend an IVC filter for individuals who have experienced, or are at 

increased risk for developing, DVT and pulmonary embolisms. 

In 1992, Bard began distributing the Simon Nitinol Filter (“SNF”), 

an IVC filter, under a distribution agreement with Nitinol Medical 

Technologies (“NMT”). Ex. P, ECF No. 33-2, PageID.3434. After 

distributing the SNF for several years, Defendant developed a modified 

design which would allow the filter to be removed called the Recovery 

Filter. Id. In November of 2002, Bard obtained clearance to market the 

Recovery Filter by submitting a 510(k) application to the Food and Drug 

Administration (“FDA”). A 510(k) application is an FDA approval process 

based on the “substantial equivalence” of a device with a “legally 

marketed predicate device.” Ex. E, ECF No. 32-5, PageID.3322. The FDA 

approved the application based on representations by Bard that the 

Recovery Filter was “substantially equivalent” to the predecessor SNF 

device. Id. at PageID.3324. The FDA also approved the Recovery Filter 

for optional removal in 2003. Ex. F, ECF No. 32-6, PageID.3329. 

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Beginning in 2005, Bard manufactured and sold an IVC filter 

design called the G2 Filter System (“G2 Filter”). Pl.’s Resp. Mot. Summ. 

J., ECF No. 32, PageID.3284. Like other IVC filters, the G2 Filter is 

designed to prevent blood clots from traveling from the lower portion of 

the body to the heart and lungs. The G2 Filter is constructed out of nickeltitanium alloy (“Nitinol”) and “consists of two tiers of struts that make 

up its ‘arms’ and ‘legs.’” ECF No. 27, PageID.3135. Using a catheter, the 

collapsed filter is inserted into a patient through the jugular vein or 

femoral vein. When the filter, a photo of which is below, is properly in 

place within the inferior vena cava, the arms and legs of the filter open 

up and anchor onto the walls of the vein. Id. 

2

Once in place, the filter’s struts will catch, or break up, blood clots that 

are traveling up from the legs and prevent them from traveling through 

the inferior vena cava to the heart and lungs. 

As it had done previously with the Recovery Filter, Defendant 

obtained clearance to market the G2 Filter by submitting a 510(k) 

2 Illustration of the Bard G2 Filter. ECF No. 27, PageID.3135. 

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application to the Food and Drug Administration (“FDA”). Ex. G, ECF 

No. 32-7, PageID.3336. Here, the application was based on the assertion 

by Bard that the G2 Filter was identical in its description and indications 

for use to a predicate device that had been manufactured by Bard and 

approved by the FDA, the Recovery Filter System. Id. The primary 

modifications were dimensional. Id. at PageID.3335. The FDA approved 

Bard’s 510(k) application in 2005 for the G2 Filter as a permanent 

placement IVC filter. In 2008, the FDA also approved the G2 Filter as a 

retrievable option IVC filter. ECF No. 33-2, PageID.3525. 

Plaintiff, Vicki Rivera, is a resident of Michigan. ECF No. 27, 

PageID.3135. Prior to undergoing surgery for weight loss on March 17, 

2006, due to her history of DVT, Plaintiff underwent a surgical procedure 

to implant a Bard G2 Filter. Five years later, during a CT scan to 

evaluate gastrointestinal issues on September 19, 2011, medical 

professionals discovered a fractured filter strut from the Bard G2 Filter 

in her abdomen. Id. A second fractured strut was discovered in Plaintiff’s 

right lung in December of 2014 during an x-ray to evaluate broken ribs. 

Id. at PageID.3136. The G2 Filter, and its associated fractured parts, 

remain inside Plaintiff’s body. ECF No. 32, PageID.3183. 

Plaintiff alleges Bard was aware that both the G2 Filter and its 

predicate device, the Recovery Filter, had higher reported failure rates 

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than the SNF or other IVC filters on the market.3 ECF No. 32, 

PageID.3284. To support these allegations Plaintiff relies upon a report 

conducted by an independent consultant hired by Bard which 

states,“[r]eports of death, filter migration (movement), IVC perforation, 

and filter fracture associated with Recovery filter were seen in the 

MAUDE database at reporting rates that were 4.6, 4.4, 4.1, and 5.3 

higher, respectively, than reporting rates for all other filters.” Ex. K, ECF 

No. 32-11, PageID.3350. Plaintiff also highlights various internal Bard 

communications suggesting that Bard was aware and attempted to 

conceal the disproportionate failure rates of the G2 Filter and Recovery 

Filter. See Ex. J, ECF No.32-10, PageID.3347 (“Comparison with other 

filters is problematic in many ways, and we should avoid/downplay this 

as much as possible.”). 

In addition to internal Bard documents, the record includes several 

reports by Plaintiff’s experts. The expert reports primarily describe two 

design defects present in both the G2 Filter and Recovery Filter. First, 

the reports allege that both filters lacked an appropriately rounded 

3 Plaintiff asserts that the G2 Filter and its predicate device, the 

Recovery Filter, are similar in a multitude of ways: the devices look 

alike, share the same filtration design, are made of the same material, 

and are inserted the same way. ECF No. 1, PageID.8-9. Most critically, 

Plaintiff alleges that the G2 Filter also shares some of the same defects 

as the Recovery Filter. Id. at PageID.9. For this reason, while the device 

implanted in Plaintiff was a G2 Filter device, the Recovery Filter and 

its properties are also discussed. 

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“chamfer,” that is, a sloped or angled corner to prevent sharp edges, on 

the rim of the filter from which the arms and legs of the device deploy. 

Ex. R, ECF No. 33-4, PageID.3737. As the arms emerge from the top of 

the cap, they may come into contact with the rough, unpolished edge as 

they try to deploy out. The reports opine that this contact and stress can 

cause fatigue, cracks, and bends in the arms. Id. at PageID.3742. Next, 

the experts point out that Bard did not polish away rough grinding marks 

on the bottom of the wires called the “feet.” Id. at PageID.3746. The rough 

surface condition on the bottom of these struts can increase the stress on 

the wires and result in fracture. A fracture in the arm or leg of the filter 

may result in tilting or migration of the device, or pieces of it, as the feet 

help hold the device in position. Id. at PageID.3758. 

To remedy the fracturing caused by the sharp rim, the expert 

reports recommend adding a rounded chamfer where the wires emerge 

from the device during deployment. ECF No. 33-4, PageID.3745. The 

experts also recommend smoothing the surface of the bottom of the wires 

through electropolishing to prevent abnormal strain on the arms and legs 

of the device. Id. at PageID.3748. Additionally, Plaintiff’s experts refer to 

internal Bard communications to support the view that the SNF is an 

alternative permanent filter because it did not receive the same 

complaints regarding fracture and migration. Ex. M, ECF No. 32-13, 

PageID.3362. Specifically, the expert reports note that the SNF 

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possessed an adequate chamfer to prevent premature failure of the filter 

arms. ECF No. 33-4, PageID.3744-45. 

Plaintiff brings this suit against Bard alleging design defect, 

manufacturing defect, failure to warn, breach of implied warranty, and 

negligent misrepresentation. Bard moves for summary judgment on all 

of Plaintiff’s claims. ECF No. 27. 

II. Standard of Review 

 Summary judgment is appropriate “if the movant shows that there 

is no genuine dispute as to any material fact and the movant is entitled 

to judgment as a matter of law.” Fed. R. Civ. P. 56(a). A fact is material 

only if it might affect the outcome of the case under the governing law. 

Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 249 (1986). 

On a motion for summary judgment, the Court must view the 

evidence and any reasonable inferences drawn from the evidence in the 

light most favorable to the non-moving party. Matsushita Elec. Indus. Co. 

v. Zenith Radio Corp., 475 U.S. 574, 587 (1986); Redding v. St. Edward, 

241 F.3d 530, 531 (6th Cir. 2001). 

The moving party has the initial burden of demonstrating an 

absence of a genuine issue of material fact. Celotex Corp. v. Catrett, 477 

U.S. 317, 325 (1986). If the moving party carries this burden, the party 

opposing the motion “must come forward with specific facts showing that 

there is a genuine issue for trial.” Matsushita, 475 U.S. at 587. “[A] mere 

scintilla of evidence in support of the nonmovant’s position is not 

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sufficient to create a genuine issue of material fact.” Towner v. Grand 

Trunk Western R. Co., 57 Fed.App’x. 232, 235 (2003) (citing Anderson, 

477 U.S. at 251-52). Rather, the non-moving party must present 

sufficient evidence as to each element of the case such that a trier of fact 

could reasonably find for the plaintiff. Davis v. McCourt, 226 F.3d 506, 

511 (6th Cir. 2000). 

Summary judgment is appropriate “against a party who fails to 

make a showing sufficient to establish the existence of an element 

essential to that party's case, and on which that party will bear the 

burden of proof at trial.” Celotex, 477 U.S. at 322. 

III. Discussion 

In the original complaint, Plaintiff brought claims for (1) design 

defect, (2) manufacturing defect, (3) failure to warn, (4) breach of implied 

warranty, and (5) negligent misrepresentation. ECF No. 1, PageID.27-

34. In their response brief, Plaintiff voluntarily withdrew the second and 

third claims for manufacturing defect and failure to warn. ECF No. 32, 

PageID.3295. The Court therefore evaluates the remaining claims of 

design defect, breach of implied warranty, and negligent 

misrepresentation. 

Based on the evidentiary record presented, material issues of fact 

preclude summary judgment on Plaintiff’s claims for design defect and 

breach of implied warranty. However, Defendant C.R. Bard is entitled to 

summary judgment on Plaintiff’s claim for negligent misrepresentation 

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as Plaintiff is unable to present evidence demonstrating reliance. The 

reasoning in support of these conclusions is discussed below. 

a. Design Defect 

According to Defendant, Plaintiff’s claim of design defect is 

insufficient because it failed to (1) demonstrate that a safer alternative 

design was feasible, (2) show causation, or (3) overcome the rebuttable 

presumption of nonliability. ECF No. 27, PageID.3132. Michigan has 

adopted a risk-utility test to evaluate products liability claims based on 

an alleged design defect. Peck v. Bridgeport Mach., Inc., 237 F.3d 614, 

617 (6th Cir. 2001). The test requires a plaintiff to show that (1) the 

product was not “reasonably safe” at the time it left the control of the 

manufacturer or seller, and (2) a “practical and technically feasible 

alternative production practice” exists. M.C.L. § 600.2946(2); Croskey v. 

BMW of N. Am., Inc., 532 F.3d 511, 515-16 (6th Cir. 2008). To survive a 

motion for summary judgment, a plaintiff must provide evidence showing 

that: 

(1) the severity of the injury was foreseeable by the 

manufacturer; 

(2) the likelihood of occurrence of the injury was foreseeable by 

the manufacturer at the time of distribution of the product; 

(3) there was a reasonable alternative design available; 

(4) the available alternative design was practicable; 

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(5) the available and practicable reasonable alternative design 

would have reduced the foreseeable risk of harm posed by 

defendant's product; and 

(6) the defendant’s omission of the available and practicable 

reasonable alternative design rendered its product not reasonably 

safe. 

Peck, 237 F.3d at 617. These elements may be supported by direct or 

circumstantial evidence, including expert testimony or evidence of 

similar incidents. Croskey, 532 F.3d at 516. The Court should grant 

summary judgment when the plaintiff fails to make out a prima facie 

design defect claim based on the six elements in the risk-utility test 

outlined above. 

i. Risk-Utility Test 

Defendant does not dispute that Plaintiff has provided evidence of 

the first and second prongs of the risk-utility test, which demonstrate the 

“magnitude of risks involved.” Peck, 237 F.3d at 618 (quoting Owens v. 

Allis-Chalmers Corp., 326 N.W.2d 372, 378 (Mich. 1982)). As there is no 

dispute that Plaintiff satisfies the first two prongs of the risk-utility 

analysis, the Court need only address whether Plaintiff satisfied the 

remaining prongs, all of which focus on the issue of an alternative design. 

The second part of the risk-utility test requires Plaintiff to present 

a reasonable alternative design. Peck, 237 F.3d at 618. To survive 

summary judgment, a plaintiff must present evidence of a “practical and 

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feasible” alternative that would have reduced the risk of particular injury 

at issue without impairing the product’s usefulness or desirability. 

M.C.L. § 600.2946(2). See Dow v. Rheem Mfg. Co., 2011 WL 4484001, at 

*17 (E.D. Mich. Sept. 26, 2011); Zettle v. Handy Mfg. Co., 998 F.2d 358, 

362 (6th Cir. 1993). 

As to the factors requiring plaintiff to show there was a reasonable 

alternative design that was available, practicable, and would have 

reduced the risk, Defendant asserts that Plaintiff has failed to satisfy 

these elements because it says the proposed alternative, the company’s 

predecessor SNF Filter,4 is a different product and not sufficiently 

similar to the alleged defective G2 Filter to serve as a reasonable 

substitute. Def.’s Reply to Resp. Mot. Summ. J., ECF No. 34, 

PageID.3892. Further, Defendant argues that Plaintiff has not provided 

sufficient evidence of a practicable and feasible alternative design 

because there is no evidence that the designs would improve fracture 

rates without impairing the usefulness of the product. Id. at 

PageID.3893; M.C.L. § 600.2946(2). 

4 As discussed in the Background section, the Recovery Filter was the 

predicate device to the G2 Filter. Prior to that, the SNF was the 

predicate device to the Recovery Filter. Bard obtained clearance to 

market the Recovery Filter based on representations by Bard that the 

Recovery Filter was “substantially equivalent” to the SNF device. ECF 

No. 33-2, PageID.3434. 

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Defendant’s argument fails to address the multitude of design 

alternatives presented by Plaintiff’s experts. In addition to discussing the 

SNF Filter, Plaintiff’s experts propose two design alternatives to prevent 

fracturing and migration: (1) electropolishing the rough grinding marks 

on the bottom of the wires, and (2) adding a rounded chamfer onto the 

rim of the filter from which the arms and legs of the device deploy. ECF 

No. 33-4, PageID.3745. See Davis v. C.R. Bard, Inc., 2012 WL 6082933, 

at *4 (E.D. Mich. Dec. 6, 2012) (denying summary judgment as to the 

design defect claim where experts propose smoothing edges of device to 

reduce chance of fracture). The Plaintiff’s expert opines that there are 

grinding marks on the bottom of the wires, or “feet,” of the device because 

Defendant failed to polish the struts of the G2 Filter. ECF No. 33-4, 

PageID.3746. According to the report, rough surfaces lead to local stress 

concentrations, which can result in fatigue fractures in the arms and legs 

of the filter. Id. at PageID.3778. Local stress concentrations in the “ankle” 

region of the wire, which leads to anchoring hooks that keep the filter in 

place, can result in tilting or migration of the device. Id. at PageID.3789. 

Tilting and migration increase the likelihood of perforation or 

penetration of the filter limbs and may result in strut fractures and 

possible fragment migration. According to the expert report, to remedy 

these rough surfaces, the wires could be electropolished to remove any 

scratches, slip markings, or gouging. Id. at PageID.3778. 

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The expert reports also recommend the addition of an appropriately 

rounded “chamfer.” ECF No. 33-4, PageID.3737. When the G2 Filter is 

initially implanted, the arms and legs are collapsed. Once the device is in 

place, the arms and legs deploy from the cap of the device. Experts opine 

that the cap, or rim, from which the arms and legs deploy had sharp, 

rough edges. Id. When the arms and legs tried to deploy, they could come 

into contact with these unpolished edges, Id. at PageID.3742, potentially 

causing fatigue, cracks, and bends in the arms and legs. Plaintiff’s expert 

proposes adding an appropriately rounded “chamfer” to this rim. Id. at 

PageID.3737. A chamfer is a sloped or angled corner that can reduce the 

sharpness of an edge. The expert claims that an appropriately rounded 

chamfer on the inner surface of the rim would reduce, or eliminate, the 

contact between the rim and arms and legs as they deploy. Id. at 

PageID.3787. This reduction, or elimination, of contact would decrease 

stress and potential failure of the struts of the device. 

As evidence of the feasibility of these alternatives, Plaintiff’s expert 

notes that subsequent IVC filters designed by Bard did in fact polish 

down the sharp edges of the rim to create an appropriately rounded 

chamfer. ECF No. 33-4, PageID.3746. Plaintiff also points to internal 

communications where Bard employees discuss the feasibility and 

advantages of utilizing the SNF Filter as an alternative permanent filter 

because it had not received the same complaints as the G2 Filter. ECF 

No. 32-13, PageID.3362. These communications support Plaintiff’s 

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argument that Bard employees themselves believed there to be feasible 

alternatives to the G2 Filter that were available, practicable and indeed, 

already in use. Both the expert recommendations for specific design 

improvements and the internal communications regarding use of the 

SNF Filter are sufficient to raise a question of fact that the third and 

fourth elements of the risk-utility test are satisfied because they point 

with specificity to practical and available alternative designs. 

In addition to presenting alternative designs, the remaining 

elements of the risk utility test require a plaintiff to articulate how the 

proposed alternative design would have reduced harm without sacrificing 

utility. See Zettle, 998 F.2d at 362. For evidence that the proposed 

alternative designs would reduce the risk of harm posed by the G2 Filter, 

Plaintiff compares fracture rates for the G2 against other filters and 

argues that the lower fracture rates for the SNF Filter demonstrate that 

the alternative design it offered would decrease the risk of a fracture. In 

one report, Plaintiff’s expert asserts that a Bard employee had 

recommended the SNF Filter specifically to address complications in 

patients who were undergoing bariatric surgery, the same medical 

procedure Plaintiff was set to undergo. ECF No.33-2, PageID.3491. 

Another expert report compares the rims and sleeves of the G2 Filter 

with other IVC filters and concludes that the polishing down of the sharp 

edges would reduce the stress that could lead to fracture. ECF No. 33-4, 

PageID.3745. Cf. Dow, 2011 WL 4484001, at *13 (finding alternative 

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designs insufficient where expert failed to conduct comparative testing 

or analysis). Having reviewed this record, the Court concludes that 

Plaintiff has presented sufficient evidence to raise a question of fact 

regarding the fifth and sixth elements of the risk-utility test by 

presenting evidence of comparative evaluation that demonstrate safer 

alternative filters and designs which Plaintiff’s experts claim could 

reduce the risk of fracture without impeding utility. 

Because Plaintiff has presented evidence to demonstrate all six 

elements of the risk-utility test, Plaintiff has successfully made out a 

prima facie case of design defect that is sufficient to avoid summary 

judgment. 

ii. Causation 

Defendant also contends that Plaintiff has not demonstrated 

causation because she has failed to present evidence from a treating 

physician or expert witness expressing the opinion that the fracturing of 

the G2 Filter is the cause of Plaintiff’s specific medical conditions. ECF 

No. 27, PageID.3142. Defendant argues that the medical symptoms 

Plaintiff identifies were not caused by the fractured parts of the device 

being present in her body, but rather because of certain pre-existing 

medical conditions from which she suffered. Id. However, during oral 

argument, Defendant conceded that the migration of a strut within a 

patient to a place where it is not supposed to be is in fact a form of injury. 

While such an admission suggests that Defendant’s arguments about the 

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connection between Plaintiff’s specific conditions and the fractured struts 

relates more to the issue of whether the damages arising from her 

medical conditions can be connected to the injury—rather than whether 

the defect in the device caused an injury—the Court will nevertheless 

examine Defendant’s arguments on causation below. 

Under Michigan’s products liability law, Plaintiff must show a 

causal connection between the defect and injury to prevail. Skinner v. 

Square D Co., 516 N.W.2d 475, 478 (Mich. 1994); Glaser v. Thompson 

Med. Co., Inc., 32 F.3d 969, 971 (6th Cir. 1994). Plaintiff must provide 

sufficient evidence that would allow a jury to determine that it was “more 

likely than not that the defendant’s conduct in fact caused the injury.” 

Glaser, 32 F.3d at 971. It is not enough to present evidence that shows a 

“mere possibility” of causation. Id. (quoting Mulholland v. DEC Int’l 

Corp., 443 N.W.2d 340, 350 n.18 (Mich. 1989)). However, the plaintiff 

does not have to present evidence that “positively eliminates every other 

potential cause” to meet the burden. Skinner, 516 N.W.2d at 478. 

Evidence of causation is adequate if it “establishes a logical sequence of 

cause and effect, notwithstanding the existence of other plausible 

theories, although other plausible theories may also have evidentiary 

support.” Id. (quoting Mulholland, 443 N.W.2d at 415). 

The Court is not persuaded by Bard’s argument that Plaintiff has 

failed to present any evidence to demonstrate that the fractured medical 

device is the proximate cause of her alleged medical problems. It is 

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undisputed that the G2 Filter implanted in Plaintiff fractured and the 

two struts that failed are still inside Plaintiff’s body. ECF No. 32, 

PageID.3282-83. Cf. Skinner, 516 N.W.2d at 484 (finding experts’ 

theories deficient because experts were asked to assume without 

explanation critical facts in the chain of causation). The fractured filter 

was discovered by medical imaging. Ex. B, ECF No. 33, PageID.3391. 

Plaintiff has provided materials which show the range of health 

consequences that can result from an IVC fracture and notes that by 

Bard’s own criteria the migration of a filter in and of itself is considered 

a serious injury. Ex. C, ECF No. 27-4, PageID.3210. While not a treating 

physician, Plaintiff’s expert finds that her medical records are consistent 

with the experience of a fractured G2 Filter. Ex. S, ECF No. 33-5, 

PageID.3865. Plaintiff offers her medical records as circumstantial 

evidence of her physical and emotional injury. In addition to complaints 

of abdominal pain, the medical records state that Plaintiff attributes her 

anxiety and mental anguish to knowledge that a fractured piece of the 

filter had migrated to her lung. Ex. T, ECF No. 33-6, PageID.3869, 3878. 

Finally, Plaintiff claims she will have to undergo continuous medical care 

including imaging studies, clinical visits, and physical examinations in 

order to monitor the effects of the fractured G2 Filter. ECF No. 1, 

PageID.13. 

While Defendant contends that Plaintiff’s health problems could 

have been caused by her pre-existing conditions, this attack is not 

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sufficient to support summary judgment. Plaintiff does not have to 

produce evidence which eliminates every potential cause of injury. 

Skinner, 516 N.W.2d at 480. Plaintiff’s medical records certainly provide 

some evidence that her pre-existing conditions could have caused the 

abdominal pain she has suffered. But that reasonable inference must be 

balanced against the evidence of Plaintiff’s undeniable experience of the 

fractures, the migration of the fragments to her abdomen and lung, as 

well as injuries such as continued costs of monitoring and mental and 

emotional stress. Given this conflict in the proof, Defendant’s arguments 

regarding causation are not sufficient to prevail at the summary 

judgment stage. See Swartz v. Proctor and Gamble Mfg. Co., 2018 WL 

2239558, at *4 (E.D. Mich. May 16, 2018) (denying summary judgment 

even when the defendant offered a study to rebut causation). 

Upon review of the medical records, Plaintiff’s testimony, and the 

expert reports, the Court concludes that Plaintiff has presented enough 

evidence for a reasonable jury to determine that the allegedly defective 

G2 Filter caused Plaintiff’s injuries. Defendant may of course seek to 

persuade the jury that a preponderance of the evidence shows Plaintiff’s 

pre-existing conditions caused her injuries at trial, but the Court is not 

persuaded that Plaintiff’s medical history entitles Bard to summary 

judgment. 

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For these reasons, the Court denies Defendant’s summary 

judgment claim on Plaintiff’s design defect claim on the basis that 

Plaintiff failed to present sufficient evidence of causation. 

iii. Rebuttable Presumption of Non-Liability 

Under Michigan’s products liability law, there is a rebuttable 

presumption of nonliability for manufacturers who develop products that 

comply with safety regulations or standards. M.C.L. § 600.2946(4). The 

statute states: 

In a product liability action brought against a manufacturer 

or seller for harm allegedly caused by a product, there is a 

rebuttable presumption that the manufacturer or seller is not 

liable if, at the time the specific unit of the product was sold 

or delivered to the initial purchaser or user, the aspect of the 

product that allegedly caused the harm was in compliance 

with standards relevant to the event causing the death or 

injury set forth in a federal or state statute or was approved 

by, or was in compliance with regulations or standards 

relevant to the event causing the death or injury promulgated 

by, a federal or state agency responsible for reviewing the 

safety of the product. 

Id. The presumption applies to the four theories of products liability, 

which includes design defect and breach of implied warranty claims. 

Peter v. Stryker Orthopaedics, Inc., 2009 WL 235639, at *3 (E.D. Mich. 

Jan. 29, 2009). 

However, the presumption is not absolute and to survive summary 

judgment the plaintiff must bring forth evidence that rebuts the 

presumption of nonliability. See Makki v. OSI Sealants, Inc., 2009 WL 

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4644688, at *2 (E.D. Mich. Dec. 2, 2009) (“The jury's conclusion meant 

one of two things, either (a) Defendant did not convince the jury that its 

product was in compliance with applicable standards, or (b) even if the 

jury was persuaded that the product was in compliance with applicable 

standards, the jury also concluded that Makki rebutted the presumption 

of non-liability.”); Wendorf v. JLG Indus., Inc., 683 F.Supp.2d 537, 546 

(E.D. Mich. 2010); Peter, 2009 WL 235639, at *3 (E.D. Mich. Jan. 29, 

2009) (finding summary judgment appropriate where the plaintiff failed 

to submit any evidence to rebut the presumption of no liability). 

According to Defendant, because the G2 Filter was in compliance 

with FDA standards of design and manufacturing, the burden must shift 

to Plaintiff to rebut a presumption of non-liability. ECF No. 27, 

PageID.3138. Plaintiff contends that it meets this burden with evidence 

that the G2 Filter suffered a high failure rate compared to other filters, 

and that such evidence successfully rebuts the presumption. ECF No. 32, 

PageID.3289. 

Defendant directs the Court to Peter v. Stryker Orthopaedics, Inc., 

to support their argument that Plaintiff has failed to meet the burden in 

providing evidence to rebut the presumption of nonliability. 2009 WL 

235639, at *3 (E.D. Mich. Jan. 29, 2009). However, in that case, Plaintiff 

failed to submit “any” evidence of defect and did not respond at all to the 

motion for summary judgment. Id. Here, in addition to responding to the 

motion, Plaintiff has provided expert reports and studies that provide 

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evidence of disproportionate fracture rates in the G2 Filter. Plaintiff 

identifies a report from an independent consultant hired by Bard that 

reports the rates of death, filter migration, perforation, and fracture with 

the Recovery Filter to be “4.6, 4.4, 4.1, and 5.3 higher” than reporting 

rates for all other filters. ECF No. 32-11, PageID.3350. Plaintiff further 

points to an expert report which states that animal studies of the G2 

Filter were stopped early as they showed risk for filter migration, 

perforation, hemorrhage, and more. ECF No. 33-2, PageID.3508. Even 

during oral argument, Defendant did not dispute that evidence of 

disproportionate fracture rate is the type of evidence that can allow a 

plaintiff to overcome the presumption of nonliability. The facts here are 

more closely aligned with Davis v. C.R. Bard, where the plaintiff, like 

Rivera, produced expert opinion that the product was defective and 

studies which “appear[ed] to allow the inference that the [product] is 

unsafe compared to its competitors and is unreasonably likely to fracture 

and cause major health issues.” 2012 WL 6082933, at *5-6 (E.D. Mich. 

Dec. 6, 2012). 

At summary judgment, the Court does not have to determine 

whether the presumption has been fully rebutted. Davis, 2012 WL 

6082933 at *6. The Court needs only determine whether a reasonable 

jury could so conclude. Id. Here, Plaintiff has presented enough evidence 

to allow such a conclusion. Accordingly, Defendants are not entitled to 

summary judgment based on a presumption of nonliability. 

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In summary, Plaintiff has presented sufficient evidence to create a 

genuine issue of material fact as to the six elements of the risk-utility 

test, to support causation, and to rebut the presumption of nonliability, 

thereby presenting a question for the jury to resolve. Having met their 

evidentiary burden, the Court finds that Defendant is not entitled to 

summary judgment as to Plaintiff’s design defect claim. 

b. Breach of Implied Warranty 

Defendant contends that Plaintiff is unable to establish a breach of 

implied warranty claim because the learned intermediary doctrine bars 

the claim. ECF No. 27, PageID.3133. Defendant also argues that Plaintiff 

has not shown proximate cause. Id. In particular, Defendant asserts that 

in withdrawing her failure to warn claim, Plaintiff concedes that she 

could not prove causation. ECF. No. 34, PageID.3896. Because the failure 

to warn and breach of implied warranty claims are based on the same 

questions, Defendant argues the implied warranty claim should also fail 

as Plaintiff is unable to demonstrate causation. 

Michigan law recognizes breach of implied warranty as a distinct 

cause of action for product failure. Prentis v. Yale Mfg. Co., 365 N.W.2d 

176, 186 (Mich. 1984). To succeed on a breach of warranty claim, the 

plaintiff must show that the product was defective. Kaminiski v. Libman 

Co., 748 Fed.App’x. 1, 4 (6th Cir. 2018). “To that end, the plaintiff must 

prove either defective manufacture or defective design, which may 

include a failure to warn.” Id. 

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When the defendant is both the seller and manufacturer, the 

elements of proof for a breach of implied warranty claim are the same as 

those required in a negligence claim. Prentis, 365 N.W.2d at 186 (“[I]n an 

action against the manufacturer of a product based upon an alleged 

defect in its design, ‘breach of implied warranty and negligence involve 

identical evidence and require proof of exactly the same elements.’” 

(quoting Squibb v. E.R. Squibb & Sons, Inc., 273 N.W.2d 476, 479 (Mich. 

1979))). See Kaminiski, 748 Fed.App’x. at 5 n.3; Peak v. Kubota Tractor 

Corp., 559 Fed.App’x. 517, 523-24 (6th Cir. 2014). The Sixth Circuit has 

explained the logic behind the appropriate legal standard: 

The reason for this confluence is that a plaintiff alleging 

breach of implied warranty on the part of a seller must show 

that the purchased product was defective. That showing, in 

turn, requires proof that the product's manufacturer acted 

negligently, typically by omitting a safety feature or in failing 

to give warning of a latent danger. A suit for breach of implied 

warranty against a seller who is also the manufacturer will 

therefore require the same showing of negligence on the 

defendant's part as an ordinary products liability suit against 

a manufacturer. 

Hollister v. Dayton Hudson Corp., 201 F.3d 731, 737 (6th Cir. 2000). 

Defendant argues that because Plaintiff has conceded there is 

insufficient evidence of causation for a failure to warn claim, Plaintiff’s 

breach of implied warranty claim must also fail due to the fact that the 

claims are based on the same underlying assertion. ECF No. 34. 

PageID.3896. Plaintiff concedes that breach of implied warranty claims 

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are similar to failure to warn claims, and fails to explain why, without 

the testimony of her implanting physician, her implied warranty claim 

should succeed. ECF No. 32, PageID.3297. Unlike in Davis, Plaintiff has 

not presented evidence that Bard’s failure to update its disclosure 

material provided to surgeons caused her injury. If Plaintiff’s only means 

for proving the G2 Filter was defective, as required for an implied 

warranty claim, was her failure to warn claim, Defendant would succeed. 

However, Plaintiff also attempts to show the G2 Filter was 

defective through a design defect claim, which Defendant fails to address. 

To prevail on a breach of implied warranty claim, Plaintiff may 

demonstrate that a product was defective by proving “either defective 

manufacture or defective design, which may include a failure to warn.” 

Kaminski, 748 Fed.App’x at 5 (emphasis added). As discussed in the 

preceding section, Plaintiff has successfully made out a prima facie case 

of design defect under the risk-utility test. As Defendant C.R. Bard is 

both the manufacturer and seller of the G2 Filter, “it is inconceivable that 

a jury could determine that the manufacturer had not breached its duty 

of reasonable care and at the same time find that the product was not 

reasonably safe for its reasonably foreseeable uses.” Prentis, 365 N.W.2d 

at 187. Plaintiff has presented a prima facie case of design defect and in 

so doing has created a genuine issue of fact as to whether Bard breached 

its duty of reasonable care. 

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Accordingly, Defendant is not entitled to summary judgment on 

Plaintiff’s breach of implied warranty claim. 

c. Negligent Misrepresentation 

Defendant contends that Plaintiff’s negligent misrepresentation 

claim must fail because there is no evidence of any misrepresentations 

that Bard made to Plaintiff’s implanting physician with regard to the G2 

Filter. ECF No. 27, PageID.3147. Defendant further asserts that Plaintiff 

has not, and in fact cannot, offer any evidence that Plaintiff’s implanting 

physician detrimentally relied on any misrepresentation by Bard with 

regard to the G2 Filter when treating Plaintiff. ECF No. 27, PageID.3147. 

In response, Plaintiff contends that Bard had knowledge that the G2 

Filter had higher rates of fracture than other filters, but failed to include 

this information in its warnings to users. ECF No. 32, PageID.3298-3299. 

“Michigan law recognizes the tort of negligent misrepresentation.” 

Gillett v. Sofamor, S.N.C., 2001 WL 1135304, at *6 (E.D. Mich. Sept. 13, 

2001). To support a claim for this cause of action, a plaintiff must present 

“proof that a party justifiably relied to his detriment on information 

provided without reasonable care by one who owed the relying party a 

duty of care.” Law Offices of Lawrence J. Stockler P.C. v. Rose Stockler, 

436 N.W.2d 70, 79 (Mich. Ct. App. 1989). In addition to reliance, under 

Michigan law, the elements of negligent misrepresentation are: 

(1) the defendant made a material misrepresentation; 

(2) the representation was false; 

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(3) the defendant was negligent in making the 

misrepresentation; and 

(4) the plaintiff suffered damages as a result. 

Cleveland Indians Baseball Co., L.P. v. New Hampshire Ins. Co., 727 F.3d 

633, 641 (6th Cir. 2013) (referencing Stockler, 436 N.W.2d at 81). 

A plaintiff may show a misrepresentation of fact where “the 

defendant had a duty to disclose facts but suppressed them instead.” 

Boumelhem v. Bic Corp., 535 N.W.2d 574, 579 (Mich. Ct. App. 1995) 

(referencing In re People v. Jory, 505 N.W.2d 228 (Mich. 1993)). The 

question of whether a manufacturer has a duty is one for the Court. 

Avendt v. Covidien, Inc., 262 F.Supp.3d 493, 520 (E.D. Mich. 2017). 

“Michigan has adopted and follows the learned intermediary doctrine, 

which holds that a manufacturer has no duty to warn the ultimate 

consumer if the product is provided for use by a sophisticated consumer.” 

Id. (referencing Brown v. Drake-Willock, Intern., Ltd., 530 N.W.2d 510 

(Mich. Ct. App. 1995)). Under the learned intermediary doctrine, a 

manufacturer is exempt from its duty to warn ultimate users of 

prescription drugs and medical devices of inherent dangers because 

patients rely on the expertise of a doctor when utilizing a medical device 

or prescribed drug and may not appreciate warnings provided by the 

manufacturer. Knight v. St. Jude Med., 2011 WL 1230819, at *10 (W.D. 

Mich. Jan. 11, 2011). 

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In considering whether Plaintiff has presented sufficient evidence 

on this claim, the Court must first determine whether Bard owes a duty 

to Plaintiff, as well as her health care providers. Avendt, 262 F.Supp.3d 

at 520; ECF No. 1, PageID 33. Because Michigan has adopted the learned 

intermediary doctrine and the G2 Filter is a prescription medical device, 

Bard’s duty to warn runs only to Plaintiff’s physicians—not Plaintiff as 

the patient. See Knight, 2011 WL 1230819 at *11 (dismissing claim that 

the defendant withheld relevant information about a medical device 

because the defendant owed no duty to the patient—only their health 

care providers). 

During oral argument, Plaintiff also asserted that Defendant owed 

a duty to her as a patient because she was a member of the class of 

persons to which Bard had a public duty to provide information. Plaintiff 

contends that Michigan has adopted Section 552 of the Restatement 

(Second) of Torts, which extends liability for negligence to “anyone under 

a public duty to provide information to any class of persons that benefits 

from the public duty.” Stockler, 436 N.W.2d at 36. Plaintiff argues that 

Bard owed her a duty because the Restatement provides protection to 

injured third parties who were recipients of the misrepresentation. 

Plaintiff’s reliance on Stockler fails to take account of the context of 

that case. The Court in Stockler adopted the Restatement in “reviewing 

the scope of an accountant’s potential third-party liability for negligent 

misrepresentation.” 436 N.W.2d at 36 (emphasis added). Subsequent 

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cases have recognized the holding of Stockler as limited to particular 

professions and their associated duty of care. See City of Birmingham 

Employees’ Retirement Sys. v. Comerica, Inc., 2012 WL 13002132, at *3 

(E.D. Mich. Aug. 28, 2012) (finding that Michigan only adopted Section 

552 of the Restatement (Second) of Torts with respect to accountant’s 

duties of care). As Stockler is inapplicable here, the scope of Bard’s 

potential liability does not extend to Plaintiff as part of a class of persons. 

Due to the learned intermediary doctrine and the inapplicability of 

Stockler to the current facts, Defendant did not owe a duty directly to 

Plaintiff to avoid making a negligent misrepresentation. As such, to the 

extent any negligent misrepresentation claim relies on the assertion that 

Bard failed to warn or withheld information from Plaintiff, Bard would 

be entitled to summary judgment on such claims. 

But Plaintiff also alleges that Defendant withheld relevant warning 

information from Plaintiff’s health care providers. ECF No. 1, PageID.33. 

Here, the learned intermediary doctrine does not bar Plaintiff’s negligent 

misrepresentation claims as to Plaintiff’s health care provider because 

the treating doctor is the proper recipient of any warnings and 

information about the G2 Filter. See Avendt, 262 F.Supp.3d at 521 

(discussing Brown, 530 N.W.2d at 516). Defendant had a duty to provide 

adequate warnings to Plaintiff’s implanting physician. 

Accepting then that Bard owed a duty to Plaintiff’s health care 

provider, Defendant contends that Plaintiff has not provided any 

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evidence that Bard misrepresented any information about the G2 Filter 

to her implanting physician. ECF No. 27, PageID.3133. As support for 

this argument, Defendant points to Tice v. Zimmer Holdings, Inc., where 

the Court granted a motion to dismiss because the plaintiffs’ claims did 

not “put Defendants on notice of any specific statements that were 

fraudulent, let alone explain why they were fraudulent, or indicate where 

and when they were made.” 2015 WL 4392985, at *8 (W.D. Mich. July 15, 

2015). But unlike Tice, Plaintiff specifically asserts that the information 

packet misrepresented the risks of the G2 Filter because it failed to 

convey the magnitude of risk for fracture, perforation, and migration 

compared to other filters on the market. Ex. H, ECF No. 32-8; 2012 WL 

6082933, at *10-11. Where Plaintiff has provided the information packet 

as evidence of specific statements that omitted necessary information, 

the facts here are more closely aligned with Davis v. C.R. Bard. 2012 WL 

6082933, at *10-11. In Davis, as here, Plaintiff presented a variety of 

expert reports showing that Bard was aware of the disproportionate rates 

of fracture, migration, and perforation, but Bard failed to update its 

materials to appropriately reflect the risks of the G2 Filter. Ex. Q, ECF 

No.33-3, PageID.3714. The Court views Davis as instructive in finding 

that evidence of disproportionate rates of failure and the lack of 

comparative information in the information materials to disclose this risk 

raises factual issues regarding negligent misrepresentations. As such, 

Plaintiff has submitted sufficient evidence to show there is a genuine 

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issue of material fact as to whether the higher rates of failure for the G2 

Filter compared to other filters was made known to the implanting doctor 

or Plaintiff. 

However, Plaintiff must also provide some evidence of reliance. 

Petfreedom.com, L.L.C. v. Net Generation, Inc., 2009 WL 2382430, at *3 

(Mich. Ct. App. Aug. 4, 2009). On this point, the Court is unable to find 

any evidence in the record to demonstrate that Plaintiff’s health care 

provider relied to his detriment on information provided by Bard that 

failed to adequately reflect the risks posed by the G2 Filter. See Knight, 

2011 WL 1230819 at *13 (holding that negligent misrepresentation 

requires evidence of reliance). Further, the surgeon who implanted the 

G2 Filter, Dr. Talbert, is now deceased and therefore unable to provide 

testimony to support the element of reliance. Ex. K, ECF No. 27-12. In

Davis, the plaintiff presented the implanting doctor’s deposition to 

demonstrate reliance on the inadequate warnings in the information 

packet. 2012 WL 6082933 at *10 (denying summary judgment with 

regard to the plaintiff’s negligent misrepresentation claim). Here 

Plaintiff has no such evidence. 

Plaintiff has not provided any evidence to create a genuine issue of 

material fact as to whether Dr. Talbert, or any other medical 

professional, relied on the alleged misrepresentation in treating Plaintiff 

with the G2 Filter. Because there is no evidence to support the element 

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of reliance, Defendant is entitled to summary judgment on Plaintiff’s 

negligent misrepresentation claim. 

IV. Conclusion 

For the foregoing reasons, Defendant C.R. Bard’s motion for 

summary judgment is DENIED with respect to Plaintiff Vicki Rivera’s 

claims for design defect and breach of implied warranty, and GRANTED

as to Plaintiff’s claim for negligent misrepresentation. 

SO ORDERED. 

Dated: October 15, 2020 s/Terrence G. Berg 

TERRENCE G. BERG 

UNITED STATES DISTRICT JUDGE 

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