NO. 2014-1012
______________
IN THE
SUPREME COURT OF OHIOWA
SPRING TERM 2014
______________
VOLCK MEDICAL DEVICES, INC.,
Defendant-Petitioner,
v.
GEOFFREY LEVINE
and
KRISTIN LEVINE,
Plaintiffs-Respondents.
______________
On Writ of Certiorari to the
First Appellate Circuit
Court of Ohiowa
______________
BRIEF FOR PETITIONER
______________
TEAM 05
Attorneys for Petitioner
QUESTIONS PRESENTED
I.
Whether Plaintiffs‘ claims are preempted, expressly or impliedly, by the Medical Device
Amendments of 1976 (―MDA‖) of the Food, Drug, and Cosmetic Act (―FDCA‖).
II. Whether summary judgment for Plaintiffs is appropriate as to their state-law failure-to-warn
claims.
i
TABLE OF CONTENTS
Page
QUESTIONS PRESENTED............................................................................................................ i
TABLE OF AUTHORITIES ......................................................................................................... iii
STATEMENT OF THE CASE........................................................................................................1
SUMMARY OF THE ARGUMENT ..............................................................................................3
ARGUMENT AND AUTHORITIES ..............................................................................................4
I.
PLAINTIFFS‘ CLAIMS ARE PREEMPTED BY THE MEDICAL DEVICE AMENDMENT
OF 1976 TO THE FOOD, DRUG, AND COSMETIC ACT ...........................................................4
A. Plaintiffs‘ Claims Are Expressly Preempted Because Fluo-Vas Is Subject
to Specific FDA Requirements and State-Law Advocated by Plaintiffs
Would Impose Requirements ―Different from, or in Addition to‖ Those
Requirements ..............................................................................................................6
B. Plaintiffs‘ Claims Are Impliedly Preempted Because They Conflict with
Federal Law, Which Equips the FDA to Police Its Own Regulations and
Provides That Such Suits Be Brought ―by and in the Name of the United
States‖ .........................................................................................................................9
II. PLAINTIFFS ARE NOT ENTITLED TO SUMMARY JUDGMENT ON THEIR STATELAW FAILURE-TO-WARN CLAIM ..................................................................................... 11
A. Summary Judgment Is Improper Because the Negligence Per Se Standard
of the Restatement Has Not and Should Not Be Adopted by the State of
Ohiowa ...................................................................................................................... 11
B. Summary Judgment Is Improper, Because There Is a Genuine Issue of
Material Fact Concerning Causation ........................................................................14
CONCLUSION ..............................................................................................................................15
ii
TABLE OF AUTHORITIES
Page(s)
UNITED STATES SUPREME COURT CASES:
Anderson v. Liberty Lobby, Inc.,
477 U.S. 242 (1986) ...........................................................................................................11
Buckman Co. v. Plaintiffs’ Legal Comm.,
531 U.S. 341 (2001) .......................................................................................................9, 10
Matsushita Elec. Indus. Co. v. Zenith Radio Corp.,
475 U.S. 574 (1986) ...........................................................................................................11
Medtronic, Inc. v. Lohr,
518 U.S. 470 (1996) .................................................................................................4, 5, 7, 8
Riegel v. Medtronic, Inc.,
552 U.S. 312 (2008) .....................................................................................................5, 6, 7
UNITED STATES CIRCUIT COURT CASES:
Cupek v. Medtronic, Inc.,
405 F.3d 421 (5th Cir. 2005) .........................................................................................6, 10
Reeves v. Acromed Corp.,
44 F.3d 300 (5th Cir. 1995) ...............................................................................................10
UNITED STATES DISTRICT COURT CASES:
Riley v. Cordis Corp.,
625 F. Supp. 2d 769 (D. Minn. 2009) ................................................................................10
Sadler v. Advanced Bionics, Inc.,
929 F. Supp. 2d 670 (W.D. Ky. 2013) ...............................................................................10
iii
STATE COURT CASES:
Carignan v. N.H. Int’l Speedway, Inc.,
858 A.2d 536 (N.H. 2004) .................................................................................................14
Zeni v. Anderson,
243 N.W.2d 270 (Mich. 1976) ...........................................................................................13
STATUTES:
21 U.S.C. § 337(a) (2006)..........................................................................................................6, 10
21 U.S.C. § 360c (2006) ..................................................................................................................5
21 U.S.C. § 360e(d)(1)(A) (2006) ...................................................................................................5
21 U.S.C. § 360h(e) (2006)..............................................................................................................5
21 U.S.C. § 360k(a) (2006)..............................................................................................................6
Fed. R. Civ. P. 56(c) ......................................................................................................................11
REGULATIONS:
21 C.F.R. § 803.50 (2014) ...............................................................................................................5
21 C.F.R. § 808.1(d) (2014) .....................................................................................................5, 6, 7
RESTATEMENT:
Restatement (Third) of Torts: Prod. Liability (1998) ..............................................................12, 14
iv
BOOKS:
5 Louis R. Frumer & Melvin I. Friedman,
Products Liability (2010) ...................................................................................................14
W. Page Keeton et al.,
Prosser and Keeton on Torts (5th ed. 1984) ......................................................................14
ELECTRONIC SOURCE:
Antisperm Antibody Test,
WebMD.com,
http://www.webmd.com/infertility-and-reproduction/
antisperm-antibody-test (last visited Mar. 3, 2014) ...........................................................15
v
STATEMENT OF THE CASE
I.
SUMMARY OF FACTS
Plaintiffs, Geoffrey Levine and his wife, Kristin Levine, bring suit against Volck Medical
Devices, Inc. (―Volck‖) alleging that Fluo-Vas—a medical device manufactured by Volck—was
used by Geoffrey and subsequently rendered him infertile. R. at 2. More specifically, Plaintiffs
claim that Volck violated a state-law duty of care by failing to report known risks of the medical
device to the Food and Drug Administration (―FDA‖) as required by Medical Device
Amendments (―MDA‖) to the Food, Drug, and Cosmetic Act (―FDCA‖). Id.
Plaintiffs are residents of Awesome County, Ohiowa. R. at 3. There, Geoffrey works as a
professional rodeo clown and has done so for the past 12 years. Id. In May of 2007, Geoffrey
fathered a child with his ex-girlfriend. R. at 4. Because Geoffrey wanted to wait to have more
children ―until he was ready,‖ in November of 2008, he had a contraception device called FluoVas surgically implanted in his vas deferens. R. at 4.
Fluo-Vas is a contraceptive device that blocks sperm and is 99.999% effective. R. at 3. It is
manufactured by Volck and marketed to 18- to 28-year-old men as a safe and easily reversible
alternative to a vasectomy. Id. Implanting the device is an outpatient procedure which takes an
hour to complete and requires only a topical anesthetic. Id. Reversing the procedure takes about
30 minutes, putting 75% of men back to pre-treatment sperm counts within three days, 95% of
men back to pre-treatment counts in three months, and 99% of men back to pre-treatment counts
within one year. R. at 4. The length of device implantation roughly correlates to sperm count
recovery time. Id.
The pre-market approval process is rigorous; it allows the FDA to undertake a risk-benefit
analysis of the device and determine the adequacy of the manufacturer‘s proposed label. R. at 6.
1
Volck obtained pre-market approval from the FDA to sell Fluo-Vas in 2002. R. at 3. In its
representations to the FDA for gaining approval, Volck reported the side effects of Fluo-Vas
implementation and reversal as similar to that of a vasectomy and vasectomy reversal. R. at 4.
Before being implanted with the device, Geoffrey received a pamphlet produced by Volck
from his primary care physician. Id. In addition, he discussed the procedure at length with his
urologist. Id. Though the pamphlet did not specifically warn against infertility problems caused
by sperm anti-bodies, Geoffrey‘s urologist did explain to him that, like a vasectomy reversal,
there was a slight chance of anti-sperm antibodies causing infertility. R. at 4–5.
In January of 2010, Geoffrey married Kristen; one month later, he had the Fluo-Vas device
removed so they could begin trying to conceive. R. at 5. After a year of trying, both Geoffrey and
Kirsten went through fertility testing. Id. Testing revealed that, though Geoffrey had a sperm
count similar to his pre-procedure count, 99% of his sperm had antibodies attached, making him
infertile. Id.
At the pre-approval stage in 2002, Volck was not aware of any significant risk of infertility
due to anti-sperm antibodies. Id. However, since 2006, Volck received some reports from
physicians stating that certain patients showed signs of infertility due to anti-sperm antibodies.
Id. Though the MDA required Volck to report these findings to the FDA, it did not do so. Id.
After inspection of Volck‘s facilities by the FDA in late 2010 and early 2011, the FDA sent a
warning letter in July of 2011 to Volck. Id. The letter stated that Volck had ―misbranded‖ its
device by not reporting the known risk, violating 21 C.F.R. § 803.50(a)(1). Id. Volck sent a
correction letter to physicians in January of 2012, stating that Fluo-Vas‘ ―side effects are
comparable to vasovasostomy [vasectomy reversal]. These side effects may include patient
2
producing anti-sperm antibodies. These antibodies can lead to infertility problems in less than
1% of patients.‖ R. at 6.
II.
SUMMARY OF PROCEEDINGS
Volck moved for summary judgment in the Awesome County Court of Common Pleas,
contending that Plaintiffs‘ claims were preempted by the MDA and, alternatively, that the claims
should fail as a matter of law because Volck‘s warnings reasonably apprised Plaintiffs of the
risks associated with the device. R. at 2. Plaintiffs also moved for summary judgment, citing
strict liability failure to warn when coupled with noncompliance with a product safety statute or
regulation. Id. The court of common pleas held that the MDA did not preempt Plaintiffs‘ statelaw failure-to-warn claims, and granted summary judgment on those claims. Id.
On appeal, the trial court‘s finding that Plaintiffs‘ state-law claims are not preempted was
affirmed. Id. However, the court reversed the grant of summary judgment, stating that strict
liability has not been adopted by the State of Ohiowa and that a rebuttable presumption of
negligence is more equitable. R. at 14.
This Court granted certiorari to determine (1) whether Plaintiffs‘ claims are preempted by
the MDA and (2) if summary judgment in favor of Plaintiffs was appropriate.
SUMMARY OF THE ARGUMENT
This Court should reverse the judgments of the lower courts, finding that Plaintiffs‘ failureto-warn claim is expressly preempted. Fluo-Vas was approved by the FDA via the premarket
approval process, making it subject to specific federal requirements. Because the state-law
plaintiffs stake their claim on would impose a requirement on Fluo-Vas that is ―different from, or
in addition to‖ federal labeling requirements, Plaintiffs‘ claim is expressly preempted.
3
Alternatively, if this Court finds that Plaintiffs‘ claim is not expressly preempted, the Court
should find that the claims are impliedly preempted. Plaintiffs‘ claims are impliedly preempted
because they conflict with federal law, which equips both the FDA to police its own regulations
and provides that suits to enforce or restrain violations be brought ―by and in the name of the
United States.‖
This Court should affirm the appellate court‘s reversal of summary judgment. Summary
judgment is improper in this case partly because the negligence per se standard applied by the
trial court is not and should not be the law of Ohiowa. This Court should, instead, utilize a
rebuttable presumption of negligence. Using a rebuttable presumption of negligence, a genuine
issue of material fact would be presented concerning whether or not Fluo-Vas was indeed a
defective product, making summary judgment inappropriate.
Additionally, even if this Court adopts a negligence per se standard for violations of safety
regulations, summary judgment is improper in this case because there is a genuine issue of
material fact concerning whether Volck‘s violation of FDA reporting requirements was the
actual and proximate cause of Plaintiff‘s injury.
ARGUMENT AND AUTHORITIES
I.
PLAINTIFFS’ CLAIMS ARE PREEMPTED BY THE MEDICAL DEVICE AMENDMENT OF 1976
TO THE FOOD, DRUG, AND COSMETIC ACT.
Though the Constitution grants States the power to regulate for the health and safety of
their citizens, the federal government has played an increasingly significant role in regulating
citizens‘ health by means of the Food Drug and Cosmetic Act (―FDCA‖). Medtronic, Inc. v.
Lohr, 518 U.S. 470, 474–75 (1996). While the FDCA authorized the regulation and approval of
new drugs, it did not provide for the regulation of medical devices; this omission resulted in
many injuries caused by unregulated devices and ultimately led Congress to enact to the Medical
4
Device Amendments (―MDA‖) to the FDCA. Id. at 475–76. The MDA categorizes devices into
three classes—I, II, and III—based on the amount of risk associated with the device. Id. at 476.
The device at issue in this case is a class III device, which by definition ―presents a potential
unreasonable risk of illness or injury, [and] is . . . subject . . . to premarket approval to provide
reasonable assurance of its safety and effectiveness.‖ 21 U.S.C. § 360c (2006).
Premarket approval for class III devices is a ―rigorous‖ process, requiring manufacturers to
―submit detailed information regarding the safety and efficacy of their devices, which the FDA
then reviews, spending an average of 1,200 hours on each submission.‖ Lohr, 518 U.S. at 477.
Premarket approval is granted only when the FDA finds ―reasonable assurance‖ of the device‘s
―safety and effectiveness,‖ in accordance with the statutory requirements of a class III device.
Riegel v. Medtronic, Inc., 552 U.S. 312, 318 (2008). In addition to review of the device itself, the
FDA also determines the adequacy of the device‘s proposed labeling. Id. The FDA evaluates a
label‘s adequacy by reviewing ―all material facts pertinent to the proposed label‖ and, if the label
is found to be neither false nor misleading, it is approved. 21 U.S.C. § 360e(d)(1)(A) (2006).
After completing a review of a manufacturer‘s application, the FDA will either grant or deny
premarket approval to the device. Riegel, 552 U.S. at 319. Once a device receives premarket
approval, the manufacturer is required to report incidents of the device causing or contributing to
death or serious injury. 21 C.F.R. § 803.50 (2014). The FDA may withdraw premarket approval
at any time based on newly reported information, and must withdraw premarket approval if it
determines that a device is unsafe or ineffective under the conditions in its labeling. Riegel, 552
U.S. at 319–20; 21 U.S.C. § 360h(e) (2006).
Included in the MDA is an express preemption provision which states:
[N]o State or political subdivision of a state may establish or continue in effect with
respect to a device intended for human use any requirement—
5
(1) which is different from, or in addition to, any requirement applicable under this
chapter to the device, and
(2) which relates to the safety or effectiveness of the device or to any other matter
included in a requirement applicable to the device under this chapter.
21 U.S.C. § 360k(a) (2006).
Supplementing the express preemption provision, state-law claims can also be preempted
impliedly. When private litigants bring suit to enforce FDA regulations or restrain violations
thereof, implied preemption bars those claims, as these types of proceedings are statutorily
required to be brought ―by and in the name of the United States.‖ Cupek v. Medtronic, Inc., 405
F.3d 421, 424 (5th Cir. 2005); 21 U.S.C. § 337(a) (2006).
A. Plaintiffs’ Claims Are Expressly Preempted Because Fluo-Vas Is Subject to
Specific FDA Requirements and State-Law Advocated by Plaintiffs Would
Impose Requirements “Different from, or in Addition to” Those
Requirements.
In Riegel v. Medtronic, Inc., the Supreme Court fashioned a two-part test to determine
whether a state-law claim under the MDA is expressly preempted under § 360k(a) of the MDA.
552 U.S. at 321–22. First, it must be determined whether the federal government has established
―specific requirements‖ applicable to the device in question. Id. at 321. This step is derived from
a federal regulation accompanying MDA enactment, which clarifies that State requirements are
only preempted when either the FDA has established specific regulations or there are other
specific requirements applicable to that particular device. 21 C.F.R. § 808.1(d) (2014).
The second step of the Riegel test requires a determination of whether the state-law claims
at issue are (1) based on state requirements relating to device safety and effectiveness and (2) are
―different from, or in addition to‖ federal requirements. 552 U.S. at 322. This second step is also
derived from a federal regulation, stating that when there are federal regulations for a specific
device, ―any existing divergent State or local requirements applicable to the device [are
6
considered] different from, or in addition to,‖ FDA requirements and, thereby, expressly
preempted. 21 C.F.R. § 801(d) (2014). The regulation also explains that State requirements
which are ―equal to‖ or ―substantially identical to‖ federal requirements are not considered
―different from, or in addition to,‖ and are not expressly preempted. Id. The Supreme Court
interpreted this regulation to mean that a State may provide a damage remedy for claims based
on violations of FDA regulation without being expressly preempted, as state duties in such a
situation would merely ―parallel‖—not add to or differ from—federal requirements. Riegel, 552
U.S. at 330; see also Lohr, 518 U.S. at 495.
In Riegel v. Medtronic, Inc., a meshing of statutes and regulations gave rise to the advent
and inaugural application of the so-called Riegel test. 552 U.S. at 322. In that case, the plaintiff
brought suit against the device manufacturer after an overinflated catheter ruptured inside of him.
Id. at 312. One of the plaintiff‘s many allegations against the manufacturer was negligence in
labeling, or ―misbranding,‖ of the catheter. Id. at 312, 329. The catheter in question was a class
III device and received premarket approval from the FDA. Id. at 312. First, the Court held that
premarket approval, an individualized federal review of a device‘s safety and efficacy, satisfies
the ―specific requirements‖ portion of the test. Id. at 322. Next, the Court found that enforcing
the state-common law claim of negligent labeling would allow a jury to decide if a label already
determined to be adequate by the FDA was, in fact, adequate under state law—in effect, adding a
labeling requirement which was ―different from, or in addition to‖ federal requirements. Id. at
329. Because the catheter was both subject to specific requirements by way of premarket
approval and state law sought to impose a requirement that was ―different from or in addition to‖
federal requirements, the Court held that the plaintiff‘s claim was preempted by the MDA. Id. at
330.
7
In contrast, the Supreme Court found in Medtronic, Inc. v. Lohr that the plaintiff‘s
defective labeling claims were not expressly preempted. 518 U.S. at 502. The plaintiff‘s claims
concerned a class III device approved via the premarket notification process, an abbreviated
FDA approval process in which devices gain approval by demonstrating substantial equivalence
to a device already on the market. Id. at 481. In determining whether the claim was expressly
preempted, the Court focused on the ―generic‖ nature of the applicable premarket notification
process regulation, which merely required manufacturers ―to include with the device a label
containing ‗information for use . . . relevant hazards, contraindications, side effects, and
precautions.‘‖ Id. at 497. The Court also took issue with the generality of the state-law failure-towarn claim, which imposed a ―general duty to inform users and purchasers of potentially
dangerous items of the risks involved in their use.‖ Id. at 501. Because both the state and federal
regulations were too generic to threaten each other and ―impede the ability of federal regulators
to implement and enforce specific federal requirements,‖ the Court held that express preemption
did not bar the plaintiff‘s claims. Id. at 500–02.
Like the plaintiff in Riegel, Plaintiffs in this case bring suit against a manufacturer of a
class III device that received premarket approval from the FDA. Fluo-Vas‘ label, like the
catheter‘s label in Riegel, was individually reviewed and approved by the FDA, making it subject
to ―specific requirements,‖ satisfying the first step of the Riegel test.
The state-law failure-to-warn claim pursued by plaintiffs is predicated on a general duty of
reasonable care imposed on manufacturers. At first blush, this State regulation may seem
somewhat ―generic.‖ However, this is not a situation comparable to Lohr, where a general statelaw duty and a general federal regulation avoid express preemption by being too vague to
impede each other. Rather, this is a situation where applying a generic state-law duty in
8
conjunction with specific FDA labeling requirements results in two different determinations of
adequacy. Plaintiffs‘ claims are not ―parallel‖ seeking only damages for FDA violations, rather,
the duty plaintiffs advocate undermines individualized FDA approval by suggesting that Ohiowa
tort law would impose labeling requirements other than the requirements already deemed
adequate by the FDA. Because Ohiowa tort law would have the effect of imposing labeling
requirements ―different from, or in addition to‖ federal requirements, the second part of the
Riegel test is satisfied.
In accordance with Supreme Court precedent, because Fluo-Vas is both subject to specific
federal requirements and state law would impose requirements ―different from, or in addition to‖
those federal requirements, plaintiffs‘ claims are expressly preempted.
B. Plaintiffs’ Claims Are Impliedly Preempted Because They Conflict with
Federal Law, Which Equips the FDA to Police Its Own Regulations and
Provides That Such Suits Be Brought “by and in the Name of the United
States.”
Alternatively, implied preemption can also serve to bar to a plaintiff‘s MDA claims. The
Supreme Court addressed implied preemption under the MDA in hearing Buckman Co. v.
Plaintiffs’ Legal Committee. 531 U.S. 341, 348 (2001). In Buckman, plaintiffs claimed that bone
screws which caused them injury, were given FDA approval pursuant to fraudulent
misrepresentations made during the premarket notification process. Id. at 343. Plaintiffs asserted
that the fraudulent misrepresentations occurred when the bone screws—which had twice been
denied approval—were approved upon filing of a third application which knowingly omitted the
spine as an area of intended use for the device. Id. at 346. The Court determined that plaintiffs‘
fraud-on-the-FDA claims conflicted with federal law and were, therefore, impliedly preempted.
Id. at 348. The conflict, the Court held, stemmed from the fact that the FDA was amply equipped
to punish and deter fraud itself, as well as Congress‘ clear intent for the MDA be enforced
9
exclusively by the federal government. Id. at 352; 21 U.S.C. § 337(a) (2006) (―[A]ll such
proceedings for the enforcement, or to restrain violations [of the MDA] . . . shall be by and in the
name of the United States.‖). Further, the Court stated that, because plaintiffs‘ claims existed
―solely by virtue of FDCA disclosure requirements,‖ and did not actually rely on state tort law,
the claims could not escape implied preemption by claiming to ―parallel‖ federal requirements.
Buckman, 531 U.S. at 353.
In addition to actual fraud-on-the-FDA claims, courts have also held that claims which are
merely ―disguised‖ fraud-on-the-FDA claims are also impliedly preempted. Cupek, Inc., 405
F.3d at 424; Riley v. Cordis Corp., 625 F. Supp. 2d 769, 777 (D. Minn. 2009); Sadler v.
Advanced Bionics, Inc., 929 F. Supp. 2d 670, 688 (W.D. Ky. 2013). Expanding on this notion,
one court stated: ―a private litigant cannot bring a state-law claim against a defendant when the
state-law claim is in substance (even if not in form) a claim for violating the [MDA]—that is,
when the state claim would not exist if the [MDA] did not exist.‖ Riley, 625 F. Supp. at 776–77.
In a case exemplifying this concept and involving the same bone screws at issue in
Buckman, an injured plaintiff asserted a failure-to-warn claim against the device manufacturer,
due to the omission of information concerning the back as an intended area of use. Reeves v.
Acromed Corp., 44 F.3d 300, 302–03 (5th Cir. 1995). The plaintiff alleged that the
manufacturer‘s suppression of information in violation of FDA regulations requiring disclosure
should allow her claims to survive preemption. Id. at 306. The court, however, found no
exception to preemption for failure-to-warn claims premised on fraud, stating ―the FDA is in the
best position to decide whether [the defendant] withheld material information from the agency
and, if so, the appropriate sanction. Allowing a jury to second-guess the FDA‘s enforcement of
its own regulations contravenes Congress‘ . . . intent . . . .‖ Id. at 307.
10
Like the manufacturer in Buckman, Volck is faced with allegations of misrepresentation to
the FDA. Though the present suit is technically based on failure to warn rather than fraud-on-theFDA, it nonetheless invokes the principles set forth in Buckman as a disguised fraud-on-the-FDA
claim. Plaintiffs‘ failure-to-warn claim exists solely by virtue of MDA reporting violations; if the
MDA did not exist, the state-law failure-to-warn claim, substantiated only on the reporting
violation, would also not exist. For that reason, plaintiffs‘ failure-to-warn claim is simply a
veiled attempt to enforce or restrain MDA violations. The FDA has many enforcement
mechanisms in its arsenal and is in the best position to enforce or restrain MDA violations. If the
FDA finds it necessary, it may bring suit ―by and in the name of the United States‖ to enforce or
restrain the violation.
II.
PLAINTIFFS ARE NOT ENTITLED
FAILURE-TO-WARN CLAIM.
TO
SUMMARY JUDGMENT
ON
THEIR STATE-LAW
Summary judgment is appropriate when the moving party shows that there is no genuine
issue of material fact, making the moving party entitled to judgment as a matter of law. Fed. R.
Civ. P. 56(c). A genuine dispute of material fact is present when a reasonable jury could return a
verdict in favor of the nonmoving party. Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248
(1986). In determining whether summary judgment is proper, a court must view the facts in the
light most favorable to the nonmoving party. Matsushita Elec. Indus. Co. v. Zenith Radio Corp.,
475 U.S. 574, 587–88 (1986).
A. Summary Judgment Is Improper Because the Negligence Per Se Standard of
the Restatement Has Not and Should Not Be Adopted by the State of
Ohiowa.
Plaintiffs argue that Volck‘s violation of reporting requirements resulted in a negligence per
se offense under the Restatement of Torts. However, the Ohiowa Parliament explicitly declined
to adopt the Restatement, making this authority merely persuasive. This Court is in a unique
11
position to champion fairness, both in this case and those to come, by deciding which standard
will apply to Plaintiffs‘ claim. In the interest of equity, this Court should decline the Restatement
position in favor of a rebuttable presumption of negligence for product violations of safety
regulations.
In a typical products liability failure-to-warn case, a defendant who sells or distributes the
product and is in the business of selling or distributing the product is liable for harm to a person
caused by a defective product. Restatement (Third) of Torts: Prod. Liability § 1 (1998). A
product is deemed ―defective‖ in a failure-to-warn case when instructions or warnings regarding
foreseeable risks would have reduced or avoided the risk of harm and
instructions or warnings regarding foreseeable risks of harm are not provided to:
(1) the prescribing and other health-care providers who are in a position to reduce
the risks of harm in accordance with the instructions or warnings; or
(2) the patient when the manufacturer knows or has reason to know that healthcare providers will not be in a position to reduce the risks of harm in accordance
with the instructions or warnings.
Id. § 6(d).
The Restatement provision which Plaintiffs advocate, substitutes the previous definition of
―defective,‖ for another wherein simple noncompliance with a safety regulation renders the
product defective if the regulation was meant to protect the person injured against the injury
suffered. Id. § 4. Application of this provision results in a negligence per se standard, which
disallows product manufacturers—even those who can show that the section 6 definition of
defective product has not been met—from producing evidence concerning a product‘s
defectiveness.
Though many jurisdictions apply a negligence per se standard for noncompliance with a
safety regulation, others afford it less probative value by imposing a rebuttable presumption of
negligence for noncompliance. Id. § 4 cmt. d. The Supreme Court of Michigan explained, ―[t]he
12
approach is just logical,‖ stating that imposing a rebuttable presumption, rather than negligence
per se, gives appropriate deference to legislature and its regulations while retaining flexibility to
judge the unique facts of each case. Zeni v. Anderson, 243 N.W.2d 270, 279 (Mich. 1976). The
court asserted that applying negligence per se can have ―unfortunate effects on the administration
of justice,‖ as it ―improperly takes from the jury its function of setting the duty of care.‖ Id. at
281.
Volck can produce evidence of Fluo-Vas‘ warnings to show that the device was not
defective under the section 6 ―defective‖ definition. Specifically, Volck can produce evidence of
the pamphlet given to Plaintiff by his physician stating that the side effects of the device are
similar to a vasectomy and advising him to consult a physician regarding those specific side
effects. In addition, Volck can show and Plaintiff concedes that the urologist who implanted the
device explicitly discussed with him the possibility of anti-sperm antibodies causing infertility. A
reasonable jury could conclude that warnings regarding foreseeable risks of Fluo-Vas were given
to both Plaintiff and his health-care provider, placing Fluo-Vas outside the section 6 failure-towarn ―defective‖ definition.
On the other hand, application of the negligence per se standard would render Fluo-Vas
defective pursuant to Volck‘s reporting violation alone and without regard to the actual product
warnings which were given. Utilizing negligence per se for a violation of a safety regulation
would, in effect, wrongfully remove a question of fact from the hands of the fact-finder,
needlessly bind courts to an inflexible doctrine, and deny Volck the right to defend itself in this
litigation. A rebuttable presumption of negligence would permit Volck to present evidence
concerning the adequacy of its warnings and ultimately allow the fact finder, not a rigid doctrine,
to determine whether the Fluo-Vas warning is defective. For these reasons, a rebuttable
13
presumption of negligence is a more equitable standard and should be adopted by this Court. If,
in fact, the Court does adopt this standard, Volck‘s evidence concerning the adequacy of the
warnings involved constitute a genuine issue of material fact, making summary judgment in this
case inappropriate.
B. Summary Judgment Is Improper, Because There Is a Genuine Issue of
Material Fact Concerning Causation.
Under Ohiowa law the plaintiff carries the burden of establishing that a defendant‘s
negligent conduct was the actual and proximate cause of the plaintiff‘s injury. Restatement
(Third) of Torts: Product Liab. § 2 cmt. q. ―But for‖ cause means that, but for the defendant‘s
negligent conduct, the injury would not have occurred. Carignan v. N.H. Int’l Speedway, Inc.,
858 A.2d 536, 540 (N.H. 2004). Proximate cause is a more indefinite concept which ultimately is
a ―boundary [which] must be set to liability for the consequences of any act, upon the basis of
some social idea of justice or policy.‖ W. Page Keeton et al., Prosser and Keeton on Torts § 41,
at 264 (5th ed. 1984). Proximate cause ―requires the plaintiff to establish that the negligent
conduct was a substantial factor in bringing about the harm.‖ 5 Louis R. Frumer & Melvin I.
Friedman, Products Liability § 50.05[4], at 50–84 (2010).
Plaintiffs in this case have not produced evidence showing that, but for Volck‘s reporting
violation, Plaintiff would not have had Fluo-Vas implanted and would have avoided injury. On
the contrary, Plaintiff received an explicit warning from his health-care provider about the
specific injury which afflicted him, in spite of Volck‘s failure to report specific occurrences of
that injury to the FDA. Plaintiff cannot sincerely contend that Volck‘s compliance with FDA
reporting requirements would have better warned him of Fluo-Vas‘ dangers when he was already
warned about the particular danger which injured him and the frequency of its occurrence.
Moreover, Plaintiffs have yet to produce evidence showing that the Fluo-Vas device was even
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the but-for cause of injury, rather than the many injuries Plaintiff likely sustains during the
course of his work as a rodeo clown. Antisperm Antibody Test, WebMD.com, http://www.web
md.com/infertility-and-reproduction/antisperm-antibody-test (last visited Mar. 3, 2014) (stating
that any testicle injury can cause the production of anti-sperm antibodies).
In addition, Plaintiffs have also failed to establish any connection between Volck‘s
reporting violation and Plaintiff‘s infertility, let alone that the reporting violation was a
substantial factor in causing his infertility. Because Plaintiffs have the burden under Ohiowa law
to establish both ―but for‖ and proximate cause, causation has not been established. Even if this
Court adopts a standard of negligence per se for violation of safety regulations, a genuine issue
of material fact exists with respect to causation, making summary judgment inappropriate.
CONCLUSION
We respectfully request that the Court REVERSE the holdings of the lower courts and find
that Plaintiffs‘ claims are preempted by the MDA and AFFIRM the court of appeals‘ holding
that summary judgment is not appropriate in this case.
Respectfully submitted,
______________________________
ATTORNEYS FOR PETITIONER
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