               IN THE COURT OF APPEALS OF TENNESSEE
                           AT NASHVILLE
                                 July 24, 2012 Session

      AARON BISSINGER, ET AL. v. NEW COUNTRY BUFFET, ET AL.

                Appeal from the Circuit Court for Davidson County
                 No. 06C2413     Hamilton V. Gayden, Jr., Judge


                 No. M2011-02183-COA-R9-CV - Filed June 6, 2014




A man who suffered a blood infection after eating raw summer oysters at a Nashville
restaurant filed suit against the restaurant, claiming that the oysters were contaminated
because they were kept at an improper temperature. The restaurant owner answered, and
among other things he named three companies in the supply chain that furnished the
oysters to the defendant restaurant as possibly liable under the doctrine of comparative
fault. The plaintiff subsequently died, and his executor was substituted as plaintiff. The
executor filed an amended complaint that added the suppliers as defendants, and
included claims against all the defendants of negligence, negligence per se, product
liability, and breach of warranty. All the parties filed motions for summary judgment.
The trial court denied the defendant restaurant’s motion for summary judgment, but it
granted summary judgment to the defendant suppliers on all issues except failure to
warn. After studying the voluminous record in this case, we affirm all the trial court’s
rulings on the summary motions against the restaurant. We affirm the trial court’s grant
of summary judgment to the suppliers, and reverse the denial of summary judgment to
them for failure to warn.

       Tenn. R. App. P. 3 Appeal as of Right; Judgment of the Circuit Court
                        Affirmed in Part, Reversed in Part

P ATRICIA J. C OTTRELL, P.J., M.S., delivered the opinion of the Court, in which F RANK G.
C LEMENT, J R. and A NDY D. B ENNETT, JJ., joined.

Kathryn Elaine Barnett, Christopher Eric Coleman, Jonathan Lewis Williams, Kenneth
Sherman Byrd, Nashville, Tennessee, for the appellant, Aaron Bissinger, Executor of the
Estate of Randall Bissinger, Deceased.


                                           -1-
Warren Maxey Smith, Harold Richard Donnelly, Jack Paul Brewer, Judith Elizabeth
Lojek, Nashville, Tennessee; David Jackson Sneed, Franklin, Tennessee for the
appellees, New Country Buffet, Shao Chai Chen, individually and d/b/a New Country
Buffet, Gulf Pride Seafood of Franklin, LLC, Leavins Seafood, Inc., Bon Secour
Fisheries, Inc.

                                        OPINION

                                    I. B ACKGROUND

        Randall Bissinger went to New Country Buffet Restaurant on or about May 8,
2006. He ordered an “All You Can Eat” buffet meal and selected and consumed three
raw oysters from the buffet table. Soon after consuming the oysters, Mr. Bissinger
began to experience severe symptoms and illness. His brother took him to the Veterans
Administration Hospital, where he was diagnosed with vibrio vulnificus septicemia, a
serious blood infection. Vibrio vulnificus is a naturally-occurring bacteria that is found
in shellfish that absorb it from their environment.

       On September 18, 2006, Mr. Bissinger filed a Complaint in the Circuit Court of
Davidson County, naming New Country Buffet and its owner, Shao Chai Chen, as
defendants (hereinafter “New Country Buffet” or “the restaurant”). He alleged that the
oysters he consumed were contaminated and that they caused his injuries. He asserted a
number of causes of action.

       It is undisputed that the oysters Mr. Bissinger ate contained vibrio vulnificus,
although there was no proof regarding the level of the bacteria in the oysters. It is also
undisputed that the bacteria caused Mr. Bissinger to become very ill.

       New Country Buffet filed an answer denying that it was guilty of negligence or of
any acts or omissions that caused or contributed to Mr. Bissinger’s injuries. It also
raised the affirmative defense of comparative fault, stating that in the event the proof
showed that it was negligent to some degree, its liability had to be reduced by the fault of
the companies that supplied the oysters consumed by Mr. Bissinger.

       Three suppliers were specifically named as possible third party defendants: Gulf
Pride Seafood of Franklin, Tennessee; Leavins Seafood, Inc., of Apalachicola, Florida;
and Bon Secour Fisheries, Inc., of Bon Secour, Alabama (collectively, “Suppliers”).
Defendant Gulf Pride sold and delivered the oysters in question to New Country Buffet
after obtaining them from “processor/wholesalers” Bon Secour and Leavins. It is
unclear which of the two wholesalers was the source of the oysters Randall Bissinger
consumed.
                                            -2-
      Randall Bissinger remained in the VA hospital for 143 days and died there on
October 20, 2006. Mr. Bissinger’s treating physician testified that the vibrio infection
had become inactive as of July 2006, and that a staph infection had then set it.

        His nephew, Aaron Bissinger (“Bissinger”), was named as his executor, and after
filing a suggestion of death in the trial court, he was substituted as plaintiff in the case.
Bissinger filed an amended complaint on February 22, 2007, in which he named as
additional defendants those parties named in the restaurant’s answer. Bissinger asserted
that his uncle’s death was the result of “vibrio vulnificus primary septicemia caused by
his ingestion of oysters.” Bissinger also stated that his uncle suffered from hepatitis C
and cirrhosis of the liver, was unaware of the dangers of severe injury or death
associated with consuming raw oysters, and was unaware that people with liver disease
or weakened immune systems were at increased risk of those dangers.1

       The three suppliers all filed answers to the amended complaint in which they
denied any liability and asked the court to dismiss all the claims against them. The
defendants also asserted that under the principles of comparative fault, Randall Bissinger
was more than 50% liable for his own injuries, because he knew or should have known
that eating raw oysters could cause serious health risks and even death for individuals
suffering from his medical conditions.

        After taking the depositions Shao Chai Chen, owner of New Country Buffet, and
of his wife and brother-in-law, who were both employees of the restaurant, Bissinger
filed a second amended complaint. Among other things, he added allegations that almost
from its 2005 opening, New Country Buffet was repeatedly cited by the Metro Nashville
Public Health Department for violations related to health and safety. Those violations
included many identified as “critical” and which involved keeping food (including
seafood) at improper temperatures “during storage, preparation, display, service, and
transportation.” Bissinger also added a claim for punitive damages against New County
Buffet and its owners.

       Further discovery followed, and Bissinger filed a third amended complaint. After
the expiration of deadlines established in case management orders, the defendants
attempted to amend their previously-filed answers to name additional parties as partially
responsible for Randall Bissinger’s injuries under the principles of comparative fault.
Their allegations included companies involved in the harvesting and transportation of the
oysters that were sold to New Country Buffet and doctors at the VA hospital who had

        1
          Plaintiff’s amended complaint alleged that his uncle was not diagnosed with cirrhosis of the liver
until after he was admitted to the Veterans Administration Hospital. A later amendment alleged that his
hepatits C had been cured.

                                                   -3-
treated Randall Bissinger. Bissinger filed motions to strike the amendments, which the
trial court granted.

       The causes of action alleged in the final complaint that are relevant to this appeal
included common law negligence, negligence per se, failure to warn, and breach of the
implied warranty that the food Suppliers provided and the restaurant served was
reasonably fit for human consumption. The trial court dismissed Bissinger’s claim based
upon the Tennessee Consumer Protection Act, but that dismissal was not appealed.

                        II. S UMMARY J UDGMENT P ROCEEDINGS

       Bissinger filed a motion for partial summary judgment, asking the court to find,
“as a matter of undisputed fact and law” that the oysters eaten by Randall Bissinger were
“defective and unreasonably dangerous,” and that they were “adulterated” in accordance
with the definition found at Tenn. Code Ann. § 53-1-104 of the Tennessee Food, Drug
and Cosmetic Act. In the same month, the defendants all filed their own motions for
summary judgment on all issues. New Buffet’s motion asserted that there was no
specific evidence that the restaurant improperly handled the raw oysters that Randall
Bissinger ate. For their part, Suppliers argued there was no breach of duty and that, as a
matter of law, Bissinhger could not establish necessary elements of the claims he had
brought.

       The trial court denied Bissinger’s motion for partial summary judgment. The
court noted that no Tennessee Court has addressed the question of what constitutes
“adulterated food,” under Tenn. Code Ann. § 53-1-104, but in reliance on persuasive
authority, it held that oysters containing vibrio vulnificus were not adulterated as a matter
of law. It also held that such oysters were not defective or unreasonably dangerous.

       The trial court granted Suppliers summary judgment on every issue and every
theory of recovery that was raised against them, except for the adequacy of their
warnings about the dangers of ingesting their products. The court allowed all of
Bissinger’s remaining claims against the restaurant to stand.

       All the parties moved the trial court for permission to file applications for
interlocutory appeal of the trial court’s summary judgment order. The trial court granted
the motions, and this court granted all four applications and consolidated them for
appeal.




                                            -4-
                              III. S TANDARD OF R EVIEW

       The standards for decision on a motion for summary judgment are well-known.
The trial court may only grant such a motion if the filings supporting the motion show
that there is no genuine issue of material fact and that the moving party is entitled to
judgment as a matter of law. Tenn. R. Civ. P. 56.04; Martin v. Norfolk S. Ry. Co., 271
S.W.3d 76, 83 (Tenn. 2008); Blair v. West Town Mall, 130 S.W.3d 761, 764 (Tenn.
2004); Byrd v. Hall, 847 S.W.2d 208, 210 (Tenn. 1993). “If there is a dispute as to any
material fact or any doubt as to the conclusions to be drawn from that fact, the motion
must be denied.” Byrd v. Hall, 847 S.W.2d at 211.

        To be entitled to summary judgment, a defendant moving party must either (1)
affirmatively negate an essential element of the non-moving party’s claim or (2) show
that the nonmoving party cannot prove an essential element of the claim at trial. Hannan
v. Alltel Publishing Co., 270 S.W.3d 1, 9 (Tenn. 2008). If the party seeking summary
judgment makes a properly supported motion, the burden shifts to the nonmoving party
to set forth specific facts establishing the existence of a genuine issue of material fact.
Martin v. Norfolk Southern Railway, 271 S.W.3d at 84; Hannan v. Alltel, 270 S.W.3d at
5; Staples v. CBL & Associates, 15 S.W.3d 83, 86 (Tenn. 2000) (citing Byrd v. Hall, 847
S.W.2d at 215)).

       When considering a summary judgment motion, the trial court must view the
evidence in the light most favorable to the non-moving party, draw all reasonable
inferences in the non-moving party's favor, and discard all countervailing evidence.
Bain v. Wells, 936 S.W.2d 618, 622 (Tenn. 1997); Byrd v. Hall, 847 S.W.2d at 210–11.
Accordingly, the court is not to “weigh”the evidence when evaluating a motion for
summary judgment, or substitute its judgment for that of the trier of fact. Martin v.
Norfolk Southern Railway Co., 271 S.W.3d at 87; Byrd v. Hall, 847 S.W.2d at 211.

       A trial court’s decision on a motion for summary judgment enjoys no
presumption of correctness on appeal. Martin v. Norfolk Southern Railway Co., 271
S.W.3d at 84; Blair v. West Town Mall, 130 S.W.3d at 763. We review the summary
judgment decision as a question of law. Id. Accordingly, this court must review the
record de novo and make a fresh determination of whether the requirements of Tenn. R.
Civ. P. 56 have been met. Eadie v. Complete Co., Inc., 142 S.W.3d 288, 291 (Tenn.
2004); Blair v. West Town Mall, 130 S.W.3d at 763.

       In our review, we must also consider the evidence presented at the summary
judgment stage in the light most favorable to the non-moving party, and we must afford
that party all the reasonable inferences to be drawn from that evidence. Green v. Green,
293 S.W.3d 493, 514 (Tenn. 2009); Walker v. Sunrise Pontiac-GMC Truck, Inc., 249
                                           -5-
S.W.3d 301, 307 (Tenn. 2008); Memphis Housing Authority v. Thompson, 38 S.W.3d
504, 507 (Tenn. 2001).

                    IV. E VIDENCE R EGARDING V IBRIO V ULNIFICUS

       The parties presented a tremendous amount of evidence in support of their
respective summary judgment motions, including twenty-two separate depositions. The
deponents included principals and employees of the defendant restaurant and the
defendant suppliers; experts in the harvesting and processing of shellfish; a restaurant
inspector from the Metro Public Health Department; a pathologist, a microbiologist and
several medical doctors.

       The undisputed expert testimony was that vibrio vulnificus is a naturally
occurring, salt-loving bacteria found mainly in warmer marine environments all over the
world. Some level of vibrio is present in almost all oysters. The bacteria has no taste
and no odor, and it cannot be detected by any method that does not also require killing
the oyster.

       There was also undisputed testimony that vibrio vulnificus can be lethal when
large enough quantities are ingested. James Oliver, Ph.D., a microbiologist who has
studied and written about marine bacteria for over forty years, testified that 300
organisms per gram of oyster is sometimes cited as the threshold between safe and
unsafe concentrations of vibrio, but that he himself was unsure of the actual reliability of
that figure. He testified, however, that concentrations of vibrio can vary from
undetectable to over 100,000 organisms per gram of oyster. There was no evidence
regarding the concentration of the bacteria in the oysters consumed by Mr. Bissinger or
those on the buffet.

        Dr. Oliver also testified that vibrio vulnificus has the highest fatality rate of any
food-borne pathogen and estimated that over 95% of the deaths relating to seafood arise
from vibrio infections, and that of those, over 90% are associated with the consumption
of raw oysters from the Gulf of Mexico. However, the proof also showed that the
absolute numbers are relatively small, with less than a hundred deaths a year from all
food-poisoning related illnesses. Dr. Oliver acknowledged that the vast majority of
those who become infected with vibrio also suffer from predisposing conditions such as
liver disease and diabetes.

       In fact, the presence of vibrio vulnificus in oysters is not seriously harmful to the
general public.        While otherwise healthy individuals may suffer temporary
gastrointestinal illness, they do not contract the serious blood infection involved in this


                                            -6-
case. The only danger of serious illness from the bacteria is to those individuals with
immune disorders, liver conditions, or stomach disorders.

        A certified food safety professional testified that vibrio vulnificus proliferates in
warm water, which is the reason for the widespread recognition that it can be dangerous
to eat raw oysters in the summer. That recognition has led to a rule of thumb that one
should not consume raw oysters in months without an “r” in their names (the months
May through August). Because vibrio can continue to multiply in raw oysters after they
are harvested, federal and state regulations govern the manner in which such oysters are
handled, in order to prevent such proliferation by always keeping them at a temperature
below 45 degrees Fahrenheit and preferably between 37 degrees and 40 degrees.

                   IV. N EGLIGENCE C LAIM A GAINST THE S UPPLIERS

       The elements of a cause of action for common-law negligence are duty, breach of
duty, cause in fact, loss or injury and proximate cause. McCarley v. West Quality Food
Service, 948 S.W.2d 477, 479 (Tenn. 1997) (citing Haynes v. Hamilton, 883 S.W.2d 606,
611 (Tenn. 1994)); McClenahan v. Cooley, 806 S.W.2d 767, 774 (Tenn. 1991).
Suppliers asked the trial court to grant them summary judgment on Bissinger’s
negligence claim and presented evidence to negate an essential element of negligence,
breach of the duty of care.

A. Evidence and Burden Shifting

       Suppliers acknowledge that, like all vendors of food, they have a duty to exercise
the highest degree of care in their handling of food intended for consumption by the
public. See Tenn. Code Ann. § 53-1-194; Jones v. Mercer Pie Co., 214 S.W.2d 46, 49
(Tenn. 1948). The proof and relevant regulations indicate that the required degree of
care in the case of raw oysters includes continuously keeping them at a safe temperature
of forty-five degrees Fahrenheit or below while receiving, storing, processing or
transporting them, in order to reduce the potential danger posed by the proliferation of
vibrio vulnificus and other harmful microorganisms.

       Bon Secour, Leavins, and Gulf Pride all presented testimony and documentary
evidence as to the manner in which they handled the oysters they sold. For example,
Chris Nelson, the vice-president of oyster operations at Bon Secour Fisheries testified
that his company does not harvest the oysters it sells, but only buys them from certified
dealers, who are required to adhere to a time limit on how long an oyster can be out of
the water before it is refrigerated. Bon Secour also follows a “Hazard Analysis and
Critical Control Point Program” (HAACP) that governs the safe receiving and storing of
oysters before it ships them out for delivery. When the oysters arrive from the dealer, its
                                            -7-
employees check the temperature in the interior of the trucks delivering them, as well as
the dealer’s tags to make sure the oysters are from an approved water source. The
oysters are then moved to a cooler for storage.

        The oysters are subsequently washed to remove mud, sorted on a conveyor by
appearance and size and then placed in boxes or burlap sacks depending on their size and
anticipated use. The washing and sorting process takes ten to fifteen minutes. The
oysters are then sent back into the cooler or into a refrigerated truck for delivery. Each
burlap sack is sealed, with a USDA-required tag attached that contains safe handling
guidelines and a warning about the risks associated with the consumption of raw oysters.
Mr. Nelson testified that Bon Secour complies with every state and federal regulation
that is applicable to the sale and distribution of oysters.

        Grady Leavins, owner of Leavins Seafood, testified that his company likewise
follows an HAACP plan. He testified that he purchases oysters from Prestige Oyster
Company, which is a certified establishment regulated by the State of Texas, as well as
from fishermen in Apalachicola Bay. He further testified that the oysters sold by
Leavins to Gulf Pride Seafood of Franklin, and then in turn to New Country Buffet, were
purchased by Leavins from Prestige. His testimony about Leavins’ handling of oysters
after they are purchased from Prestige was similar to Mr. Nelson’s testimony about the
practices of Bon Secour, including regular monitoring and recording of temperatures in
trucks and coolers to ensure proper temperature control.

       Each bag of oysters shipped by Leavins is also tagged, in order to provide
traceability of the product back to its source. Like the tags used by Bon Secour,
Leavins’ tags state on their face that, “THIS TAG IS REQUIRED TO BE ATTACHED
UNTIL CONTAINER IS EMPTY AND THEREAFTER KEPT ON FILE FOR 90
DAYS.” The same tags also provide information about the risks of consuming raw
oysters under the heading, “RETAILERS INFORM YOUR CUSTOMERS.”

        James Johnson, owner of Gulf Pride Seafood, testified that his company measures
the temperature in three critical areas when sealed bags of oysters arrive at his business
from Bon Secour or Leavins. The first temperature reading is taken immediately at the
time of arrival. Readings are also taken in the refrigeration units for the storage of
seafood between the time of receipt and the time of delivery. Finally, Gulf Pride
measures the temperature at the time of delivery to the customer’s facility. Temperature
logs for April and May of 2006, submitted as exhibits to Mr. Johnson’s deposition, do
not list any temperatures above 37 degrees Fahrenheit in the company freezer or cooler.
Gulf Pride does not open the sealed bags at any time when they are in its possession.



                                           -8-
       Thus, Suppliers presented evidence as to the standard of care applicable to their
handling of oysters for sale and also evidence that they did not breach that applicable
standard of care.      Accordingly, the burden shifted to Mr. Bissinger to present
countervailing proof that would present a dispute of fact.

       Bissinger did not offer any proof that Suppliers failed to follow the procedures they
described, nor did he offer any other evidence of improper handling of the oysters by
Suppliers. He did not present any evidence of any negligent handling of the oysters from
the time Suppliers received them until they were delivered to New Country Buffet.

B. Duty or Standard of Care

       Instead of presenting evidence to dispute Suppliers’ testimony regarding their
handling of the oysters and their compliance with relevant law and regulation governing
the handling of oysters for sale, Bissinger argues for a different duty or standard of care.
Essentially, he argues that Suppliers had a duty not to deliver these raw, live oysters,
regardless of compliance with all existing safety and handling requirements.

       Relying on testimony of his expert, Bissinger asserts that selling raw oysters from
the Gulf of Mexico in the summer months should be considered an ipso facto violation of
the duty of care. In other words, he asserts that there is no standard of care for selling such
live oysters, because they should not be sold for consumption at all. One expert testified
that “An oyster supplier using reasonable and ordinary care would only sell summer month
Gulf oysters that have been post-harvest processed, and that are, therefore, free of deadly
vibrio bacteria and safe.” The expert acknowledged under cross-examination, however,
that post-harvest processing kills the oyster. Thus, his version of a duty of care does not
apply to the sale of live raw oysters.

       Bissinger presented deposition testimony of his expert witnesses, Clifford Hillman
and Pat Fahey, both long-time veterans of the seafood business, who testified about several
technologies that collectively go by the name of “post-harvest processing,” and which have
been in use since the 1990’s. According to their testimony, post-harvest processing can
reduce vibrio in oysters to non-detectable levels and make them safe (or safer) to consume.
They testified that post-harvest processing is inexpensive and that it does not change the




                                              -9-
appearance, texture or taste of the oyster.2 However, Suppliers note that there is an
appreciable difference between eating a live raw oyster and one that is dead.

       The standard espoused by Bissinger’s experts would preclude the sale of live, raw
oysters harvested from the Gulf in warm weather. The experts’ testimony does not address
a standard, or duty of care, applicable to the handling and processing of live oysters
harvested during the summer in the Gulf. It does not dispute Suppliers’ evidence regarding
the relevant standard of care and their compliance with that standard. The standard
proposed by Mr. Bissinger and his “experts” does not address additional precautions for
handling or processing live Gulf oysters. Instead, they assert that Suppliers have a duty not
to process or sell such oysters at all.

      Bissinger argues that because Suppliers did not offer any evidence to contradict his
expert’s testimony, the trial court should have denied Suppliers’ motion for summary
judgment, in accordance with the rule that all the factual evidence presented at the
summary judgment phase must be considered in the light most favorable to the non-
moving party. Doe v. HCA Health Services, Inc., 46 S.W.3d at 196; Memphis Housing
Authority v. Thompson, 38 S.W.3d at 507.

       The expert’s opinion as to the appropriate standard of care is not, however,
evidence of facts. The question of the applicable standard of care does not involve a
factual issue to which the burden-shifting analysis applies. Instead, duty of care is a
question of law. Whether the defendant owes the plaintiff a duty of care is a question of
law. Bradshaw v. Daniel, 854 S.W.2d 865, 869 (Tenn.1993). Negligence is basically
defined as the failure to exercise reasonable care, and a plaintiff must establish that a duty
of care was owed by defendant to plaintiff and that the defendant’s conduct fell below that
applicable standard of care that amounts to a breach of that duty. Giggers v. Memphis
Housing Auth., 277 S.W.3d 359, 364 (Tenn.2009).

       Duty is a legal obligation to conform to a reasonable person standard of care in
order to protect others against unreasonable risks of harm. Satterfield v. Breeding
Insulation Co., 266 S.W.3d 347, 355 (Tenn.2008) (citing Burroughs v. Magee, 118
S.W.3d 323, 328–29 (Tenn.2003). In any negligence case, the question is whether the
particular defendant owes a particular duty of care to the particular plaintiff. West v. E.

        2
           Mr. Fahey is a founder of Ameripure Processing, a company that developed post-harvest processing
technology using hot water and which sells processed oysters. He holds a patent on the process. Mr. Hillman
is a member of a family that has been in the seafood business for several generations. He owns and operates
a shrimp and oyster company that uses cryogenic freezing for post-harvest processing of oysters. The
defendant suppliers argue that the testimony of these witnesses is suspect, because their post-harvest processed
oysters are in direct competition with the suppliers’ unprocessed oysters.

                                                     -10-
Tenn. Pioneer Oil Co., 172 S.W.3d 545, 550 (Tenn.2005). Whether a defendant owes a
duty of care to a plaintiff is a question of law to be determined by the court. West v. E.
Tennessee Pioneer Oil Co., 172 S.W.3d at 550; Coln v. City of Savannah, 966 S.W.2d 34,
39 (Tenn.1998); see Downs ex rel. Downs v. Bush, 263 S.W.3d 812, 820 (Tenn.2008) (“In
the end, whether a defendant owed . . . a duty of care to a plaintiff is a question of law for
the court to decide.”).

        There is no dispute that Suppliers owe a duty of reasonable care, even heightened
care, to the public who consume the oysters they provide. However, Bissinger would have
this court apply to Suppliers a duty to cease supplying or selling a certain product, not to
impose a duty to handle the product in a way that is different from the methods described
by Suppliers. We decline to do so, especially in the absence of authority for the
proposition that Suppliers must process the oysters in question in a method that kills them.
Adoption of the duty of care espoused by Mr. Bissinger would effectively exclude from
the stream of commerce a product that has never been illegal in Tennessee. We decline to
adopt such a duty.

      In the absence of any evidence that Suppliers violated their duty of care in the
manner that they handled the oysters they sold, we affirm the trial’s dismissal on summary
judgment of Bissinger’s claim of negligence against them.

                  V. P RODUCT L IABILITY C LAIMS A GAINST S UPPLIERS

        Bissinger’s amended complaint included product liability claims against Suppliers,
which the trial court dismissed on summary judgment. Under the Tennessee Products
Liability Act, Tenn. Code Ann. § 29-28-101 et seq., a manufacturer or seller may be held
liable for injuries resulting from the use of a product if the product is found to have been
defective or unreasonably dangerous when it left the control of the manufacturer or seller.
Tenn. Code Ann. § 29-28-102(6).

A. Immunity for Products in Sealed Containers

      The seller of a product produced or manufactured by another may be shielded from
a product liability claim, however, by the “sealed container doctrine,” which is established
at Tenn. Code Ann. § 29-28-106. The version of that statute in effect at the time of
Randall Bissinger’s injury reads in relevant part as follows:

       No “product liability action” as defined in § 29-28-102(6), shall be
       commenced or maintained against any seller when the product is acquired
       and sold by the seller in a sealed container and/or when the product is
       acquired by the seller under circumstances in which the seller is afforded no
                                            -11-
      reasonable opportunity to inspect the product in such a manner which would
      or should, in the exercise of reasonable care, reveal the existence of the
      defective condition. . . .

Tenn. Code Ann. § 29-28-106(a) (1983).3

       In other words, if the seller of a defective or unreasonably dangerous product
receives and sells it in a sealed container and/or is not in a position to discover its
dangerous condition, the Act protects the seller from liability under most circumstances,
and instead places liability solely upon the manufacturer. See Lind v. Beaman Dodge,
Inc., 356 S.W.3d 889, 901 (Tenn. 2011) (dealer not liable because he had no reasonable
opportunity to inspect defective brake system on truck); Ford v. Roddy Mfg. Co., 448
S.W.2d 433, 436 (Tenn. Ct. App. 1969) (bottler liable for insect in bottle of Coca-Cola).

       In the case before us, the trial court declared that it was adopting the sealed
container doctrine, “as far as Bon Secour, Leavins and Gulf Pride are concerned.” The
court reasoned that the doctrine applied to Suppliers because they acquired the oysters
they sold in a sealed condition and did not have a way to inspect each oyster without
destroying it. Suppliers had argued, and argue on appeal, that each oyster is, itself, in a
sealed container. The trial court also found that Suppliers could not be considered the
“manufacturers” of the oysters, and thus that they were entitled to the immunity that the
sealed container doctrine accords to non-manufacturer sellers. See Tenn. Code Ann. § 29-
28-106(b).

       We conclude that Suppliers are not entitled to the immunity granted by the sealed
container doctrine in Tenn. Code Ann. § 29-28-106. First, Suppliers are, according to
applicable statutory definitions, “manufacturers.” Second, we do not believe that a living
oyster’s shell is a “sealed container” as contemplated by the doctrine.

      Since oysters are a natural product, it may seem counterintuitive to consider
Suppliers to be their “manufacturers.” Nonetheless, contrary to the holding of the trial


        3
            The current version of Tenn. Code Ann. § 29-28-106 (2011), reads in relevant part,

                 (a) No product liability action, as defined in § 29-28-102, shall be commenced
        or maintained against any seller, other than the manufacturer, unless:
                 (1) The seller exercised substantial control over that aspect of the design,
        testing, manufacture, packaging or labeling of the product that caused the alleged harm
        for which recovery of damages is sought;
                 (2) Altered or modified the product, and the alteration or modification was a
        substantial factor in causing the harm for which recovery of damages is sought; . . .

                                                  -12-
court, the suppliers do meet the definition of “manufacturers” under the Product Liability
Act. Tennessee Code Annotated § 29-28-102(4) defines a “manufacturer” as “the
designer, fabricator, producer, compounder, processor or assembler of any product or its
component parts.” Bon Secour and Leavins both refer to themselves as processors, and
even if their processing only consists of washing, refrigerating and packing the oysters,
they must be considered manufacturers under the statute. Further, Title 21 of the Code of
Federal Regulations which governs food and drugs includes “handling” and “storing” of
fish or fishery products in its definition of “processing.” 21 CFR 123.3(k) and (l). Under
that definition, therefore, Gulf Pride is also a processor, and is likewise not entitled to the
benefits of the sealed container rule.4

       The evidence shows that improper handling of live oysters can cause proliferation
of vibrio or other dangerous microorganisms. Thus, any suppliers who negligently process
or store live oysters are in a position to cause a dangerous condition or to render an
otherwise safe product unreasonably dangerous. Accordingly, the immunity from liability
through the sealed container doctrine is not applicable to such suppliers, because the
purpose of Tenn. Code Ann. § 29-28-106 is not to shield from liability those in a position
to discover, prevent or cure a dangerous condition.

        Additionally, we cannot find that oysters qualify as a sealed container. The sealed
container immunity is based on the idea of a product made by one entity, sealed by that
entity before it is transferred to a buyer, such as a store, and remaining sealed while in the
store. The seal is eventually broken by the ultimate buyer. A live oyster does not fit this
concept.

       Oysters are not manufactured through human agency. They are not placed in their
containers (shells) and sealed in there by any person or company. Rather, oysters are
natural products, growing in the sea in shells. The shell is part and parcel of their
existence. Oysters are not sealed, for as filter feeders they must open their shells in their
natural environment to take in the sea water that contains the nutrients that sustain their
lives. In so doing, they also take in the microorganisms contained in that water.

      Because live oysters are not sealed, it is possible that they may be handled or
processed in such a way that parties along the supply chain can cause them to become
unreasonably dangerous. The fact that the federal government imposes strict requirements

        4
          Gulf Pride disputes that the oysters themselves are sealed containers, but contends that the burlap
sacks of oysters they receive from Bon Secour and Leavin should be considered sealed containers for the
purposes of the doctrine. But since improper handling of these sacks can cause vibrio to proliferate in the
oysters contained therein, it would be equally inappropriate for them to enjoy the benefits of the sealed
container doctrine.

                                                   -13-
for handling live raw oysters is indicative of that potential. We conclude that Suppliers are
not entitled to immunity under the sealed container doctrine.

B. Unreasonably Dangerous Product

       As set out above, a seller may be liable under our Products Liability statutes for
injuries that result from a product that is in a defective condition or is unreasonably
dangerous. In Tennessee, a defective condition is “a condition of a product that renders it
unsafe for normal or anticipatable handling and consumption.” Tenn. Code Ann. §29-28-
102(2).

      In the case before us, although Suppliers are not entitled to sealed container
immunity, they are entitled to the presumption found at Tenn. Code Ann. § 29-28-104(a),
which provides:

       Compliance by a manufacturer or seller with any federal or state statute or
       administrative regulation existing at the time a product was manufactured
       and prescribing standards for design, inspection, testing, manufacture,
       labeling, warning or instructions for use of a product, shall raise a rebuttable
       presumption that the product is not in an unreasonably dangerous condition
       in regard to matters covered by these standards.

Tenn. Code Ann. § 29-28-104(a).

       The record contains ample proof of compliance by all three suppliers with statutes
and regulations governing the commercial handling of fresh seafood, including very
specific regulations about maintaining proper temperatures at all times. As discussed
more fully below, the proof also shows Supplier complied with regulations regarding
notice or warning of potential dangers with the oysters. Bissinger has not offered any
proof that Suppliers did not adhere to applicable regulation and does not actually dispute
their compliance. Thus, he has failed to raise a material question of fact as to whether the
statutory presumption applies. The presumption that the oysters were not unreasonably
dangerous applied.

      However, Bissinger argues that, despite the presumption, the oysters were in fact in
an unreasonably dangerous condition because, pursuant to Tennessee Code Annotated 53-
1-104(C), Tennessee’s Food, Drug, and Cosmetic Act, food must be free from
contamination and must not be adulterated.

      One of Bissinger’s experts testified that he considered the presence of vibrio to be a
contamination of oysters. The opinion of the witness on the meaning of the word
                                            -14-
“contaminated,” as used in a statute or regulation, is not, however, factual evidence. Since
the question is answered by interpretation of a statute and application of a statutory
standard to a particular set of facts, it is a question of law, not of fact. U.S. Bank v.
Tennessee Farmers Mut. Ins. Co., 227 S.W.3d 381, 386 (Tenn. 2009) (citing Waldschmidt
v. Reassure Am. Life Ins. Co., 271 S.W.3d 173, 175 (Tenn. 2008)).

       The proof showed that vibrio is naturally occurring and that some level of vibrio
can be found in almost all oysters. The proof also showed that vibrio is not dangerous to
most people. Courts in other states have considered the question of whether oysters
containing vibrio can be considered “contaminated” and/or whether they are
“unreasonably dangerous.”

       In Woeste v. Washington Platform Saloon & Restaurant, 836 N.E.2d 52 (Ohio Ct.
App. 2005), the court found that oysters containing vibrio are not “adulterated” and
explained:

       Vibrio is not an added substance. It is a naturally occurring bacteria that is
       taken in as the oysters filter feed. Because it is naturally occurring, vibrio
       cannot adulterate oysters unless the amount of vibrio present in a particular
       oyster would ordinarily render it injurious to health. . . . Vibrio has a
       minimal effect on the general population. At most, it can cause indigestion
       or diarrhea; it is not commonly injurious to health. Vibrio is only deadly to
       those with weakened immune systems or stomach disorders. . . . Because
       the bacteria does not affect the great majority of those who eat raw oysters,
       we conclude that the oysters in this case were not adulterated.

836 N.E.2d at 76-77.

       In other cases, courts have held that oysters containing the naturally-occurring
bacteria vibrio vulnificus are not defective or in a defective condition. See, e.g., Edwards
v. Hop Sin, Inc., 140 S.W.3d 13, 16 (Ky. Ct. App. 2003) ( holding that presence of vibrio
did not make oysters defective because the bacteria occurs naturally under commonly
occurring conditions, screening is not feasible without destroying the oyster, and the
bacteria poses little threat of harm to healthy persons). Another court explained its
holding this way:

       Vibrio vulnificus bacteria in raw oysters poses little, if any, threat to a
       healthy person. The bacteria is only harmful to those persons with specific
       underlying disorders such as liver or kidney disease. Seen in this light, the
       ‘defect’ is really found in the person rather than the product, much in the
       same way that sugar is only harmful when used by someone with diabetes.
                                           -15-
Simeon v. Doe, 618 So2d 848, 851 (La. 1993).

        More recently, another court analyzed previous holdings and concluded that a
defendant was entitled to summary judgment on this question because there was no
genuine issue of material fact as to “whether an oyster with vibrio is dangerous to an
extent beyond that which would be contemplated by the ordinary consumer who purchases
it.” Bergeron v. Pacific Food, Inc., WL 1017872, *4-5 (Conn. Super. 2011). That court,
like others, based its holding that oysters containing vibrio were not unreasonably
dangerous on the evidence that such oysters pose very little threat to healthy individuals.
It also noted the Restatement observation that many products cannot be made absolutely
safe for consumption by all people.

      We agree with the reasoning of these holdings and hold that summary judgment
was appropriate on this issue. We accordingly affirm the trial court’s grant of summary
judgment to Bon Secour, Leavins and Gulf Pride, on Bissinger’s product liability claims.

                         VI. I MPLIED W ARRANTY AND W ARNING

        Bissinger next alleged that Suppliers breached an implied warranty that the oysters
were merchantable. Tennessee Code Annotated § 47-2-314, part of the Sales Chapter of
the Uniform Commercial Code, states that a contract of sale between a merchant and a
customer implies a warranty that the goods sold are “merchantable.” To be merchantable,
goods must, among other things, be “fit for the ordinary purposes for which such goods
are used.” Tenn. Code Ann. § 47-2-314(2)(c). That statute specifically includes the sale
of food and drink for consumption either on the premises or elsewhere as subject to the
implied warranty. To be “fit for ordinary purposes” and thus merchantable, food must be
safe to eat.

       Because a product is “defective” if it is in a condition that renders it unsafe for
normal or anticipated handling and consumption, under the Products Liability Act, Tenn.
Code Ann. §29-28-102(2), and a “merchantable” product must be fit for ordinary
purposes, there may be very little factual difference between a product that is “defective”
under the Tennessee and a product that is not merchantable under Tenn. Code Ann. § 47-
2-314. See Irion v. Sun Lighting, Inc., M2002-00766-COA-R3-CV, 2004 WL 746823
(Tenn. Ct. App. Apr. 7, 2004) (no Tenn. R. App. P. 11 application filed).

       Unlike product liability claims, however, warranty claims sound in contract rather
than in tort, meaning that different elements must be proved to establish such claims and
different defenses may be advanced to defeat them. See Holt v. Stihl, 449 F.Supp. 693,
694 (E.D. Tenn 1977). One significant difference between claims for breach of implied
warranty and other claims that fall under the rubric of product liability is that to prevail on
                                             -16-
a warranty theory, it is not necessary to show negligence, but only breach of the implied
warranty that the product is wholesome and fit for human consumption. See Manzoni v.
Detroit Coca-Cola Bottling Co., 109 N.W.2d 918, 921 (Mich. 1961).

       There are no Tennessee cases that specify the standards a court should apply to
determine whether food is merchantable under Tenn. Code Ann. § 47-2-314. However,
one undisputed principle is that regardless of the type of product involved, to recover for
breach of an implied warranty, the plaintiff must establish that the alleged defect or
unfitness was present when the product left the defendant’s control. Tenn. Code Ann. §
29-28-105(a); Leach v. Wiles, 429 S.W.2d 823, 832 (Tenn. Ct. App. 1968); Meigs
Farmers Co-op. v. Calfee, C.A.90, 1987 WL 5344 at *2 (Tenn. Ct. App. Jan. 16, 1987).

       Suppliers argue that, as a matter of law, the presence of vibrio vulnificus could not
be deemed a breach of the warranty that their oysters were wholesome and fit for human
consumption, because the microorganism is natural to shellfish and is found in almost all
oysters. Bissinger offered no proof of the concentration of vibrio in the oysters consumed
by his uncle or the concentration when the oysters left the control of Suppliers. Thus,
Bissinger would have us hold that any amount of the bacteria would make an oyster
unmerchantable.

       As Suppliers have explained, although Tennessee has not established a standard for
analyzing the merchantability of food, other states have adopted the “foreign natural test”
or the “reasonable expectation test.” Under the foreign natural test, food is unfit for the
purpose for which it is sold if an object found in the food does not naturally occur in that
food. Webster v. Bue Ship Tea Room, 198 N.E.2d 309 (Mass. 1964). Under the
reasonable expectation test, “liability will lie for injuries caused by a substance where the
consumer of the product would not reasonably have expected to find the substance in the
product.” Jackson v. Nestle-Beich, Inc., 589 N.E.2d 547, 548 (Ill. 1992).

        Factors relevant to the reasonable expectation analysis, i.e., what a consumer might
reasonably expect, include the “naturalness” of the substance causing the injury and the
amount of processing the food may have gone through since its harvesting and its sale. As
one court explained, “A consumer, by seeking to eat clams raw, wishes the clams to be
such. Thus a consumer should expect substances that are indigenous to the organism in its
natural state to be present when he or she receives it.” Clime v. Dewey Beach Enterprises,
Inc., 83 F. Supp. 341 (D. Del. 1993).

       Because vibrio vulnificus is naturally occurring, appears in most shellfish and
almost all oysters to some degree, and can reasonably be expected to be found in live raw
oysters, the oysters supplied herein were merchantable under both tests. We find the tests


                                            -17-
used in other states to be a reasonable way to analyze the issue of merchantability of food
products.

       Since the consumption of raw summer oysters can be dangerous to consumers who
suffer from certain medical conditions, it follows that the sale of such oysters without
adequate warning of the dangers of ingesting them could indeed render them
unmerchantable and make their sale a breach of the implied warranty. Suppliers
acknowledge that they have a duty to warn such individuals of the danger of consuming
raw oysters.

       Suppliers contend, however, that, even if there were a question of merchantability
as to certain individuals, they have rendered their product merchantable by furnishing
specific warnings directed towards people whose medical condition places them at risk.
They also insist that they had no reason to believe that such individuals would be so
foolish as to ignore those warnings. See Woeste v. Washington Platform Saloon &
Restaurant, 836 N.E.2d 52 (where proper warning is given, the seller may reasonably
assume that it will be read and heeded).

       The proof in this case showed that in accordance with Federal Regulations, both
Bon Secour and Leavins fastened harvesting tags to each bag of oysters they sold. The
information on the tags included the harvest date, the State where the oysters were
harvested, and the instruction that the product should not be consumed raw after 14 days
from the date of harvest, but should be thoroughly cooked.

     Bon Secour’s tags contained the following warning: Consumer Information:
THERE IS A RISK ASSOCIATED WITH CONSUMING RAW OYSTERS OR ANY
RAW ANIMAL PROTEIN. IF YOU HAVE CHRONIC ILLNESS OF THE LIVER,
STOMACH OR BLOOD OR HAVE IMMUNE DISORDERS, YOU ARE AT
GREATER RISK OF SERIOUS ILLNESS FROM RAW OYSTERS. YOU MAY,
HOWEVER, EAT YOUR OYSTERS FULLY COOKED. IF UNSURE OF YOUR RISK
YOU SHOULD CONSULT YOUR PHYSICIAN. PLEASE SHARE THIS
INFORMATION WITH YOUR CUSTOMERS.

       Leavins’ tags contained a similar (although not identical) warning. The proof
showed that Gulf Pride did not remove the warnings from the bags of oysters it received
from Bon Secour and Leavins, but sold the oysters to the restaurant with the tags intact.
These warnings were adequate to put a susceptible individual on notice and to put a
restaurant on notice that it should pass the warning on to customers. “When the adequacy
of such a warning is to be judged, whether under strict liability, negligence or breach of
warranty, the standard of reasonable care is to be applied.” Whitehead v. Dycho Co., Inc.,
775 S.W.2d 593, 596 (Tenn. 1989).
                                           -18-
       Bissinger argued that the notice was not sufficient because it did not mention death
as a potential risk. It is not entirely clear if Bissinger’s failure to warn claim was brought
as a separate, negligence-based claim or whether it was part of its lack of merchantability
argument. Despite Bissinger’s insistence, we hold that the warnings provided by Supplers
were sufficient to meet the reasonable care standard and to satisfy the implied warranty of
merchantability. Additionally, because Suppliers had no ability to directly warn customers
of restaurants that bought oysters from them, they cannot be held to have breached a duty
to warn the eventual consumer of its products.

        Accordingly, we reverse the trial court as to this issue, and grant summary
judgment to Suppliers on the claims of breach of implied warranty of merchantability and,
to the extent it is a separate cause of action, on the claim of failure to adequately warn.

         V. T HE N EGLIGENCE C LAIMS A GAINST THE D EFENDANT R ESTAURANT

        Bissinger brought the same or similar claims against the restaurant. The trial court
denied New Country’s motion for summary judgment. New Country Buffet argues that
the trial court should have granted it summary judgment on all issues.

      For his part, Bissinger argues that the trial court’s denial of summary judgment in
favor of New Country should be affirmed, presumably as to all causes of action.
However, the only argument made by Bissinger in his brief relates solely to the negligence
claim. Thus, the basis for his argument on appeal as to the other causes of action is not
explicit.

A. Negligence

       Our courts have long acknowledged the importance of food safety. See Jones v.
Mercer Pie Co., 214 S.W.2d 46, 49 (Tenn. 1948) (“. . . it is very important that producers
of food products intended for consumption by the public should be held to the highest
degree of care in the production of that product and in the placing of it upon the market.”).
See, also, State ex rel. Nashville Pure Milk Co. v. Town of Shelbyville, 240 S.W.2d 239,
243 (Tenn. 1951); Boyd v. Coca-Cola Bottling Works, 177 S.W. 80, 81 (Tenn. 1914);
American Chariot v. City of Memphis, 164 S.W.3d 600, 604 (Tenn. Ct. App. 2004).

       There is no dispute that the restaurant had a duty to use reasonable care in handling,
preparing, storing, and serving the food it sold. In the context of the sale of food products
to the public, reasonableness may be measured by a duty to use the greatest care to insure
the safety of those products. As to the common law negligence claim, the restaurant
contends that Bissinger submitted no proof that it breached its duty of care in the way it
handled the oysters that it served.
                                            -19-
       However, in the summary judgment stage, it was incumbent upon the movant, New
Country Buffet, to first provide evidence that its employees did use reasonable care in the
handline of the oysters. The only actual evidence presented by the restaurant on that issue
was summarized by the restaurant in its brief. Essentially, raw oysters are placed on the
buffet after 4:00 p.m.; prior to being put on the buffet, raw oysters are stored in a walk-in
refrigerator; there has never been a finding by an inspection official that the temperature in
the walk-in was improper; and that the refrigerator underwent regular inspections by a
refrigeration company to insure it performed at the correct temperature.

        Additionally, the restaurant provided testimony of a Metro Health Department
official that New Country Buffet has had no issues related to raw oysters; that the
restaurant had properly maintained the labels from oyster suppliers; that there had been no
other complaints of food borne illnesses from food served at the restaurant; specifically
there had been no other complaints of illness caused by raw oysters at the restaurant; and,
finally, that the restaurant had never been cited for any violations regarding the storage,
handling, and display of raw oysters. It even goes so far as to assert that “[t]he fact is that
when raw oysters are involved, New Country Buffet had a spotless record and Plaintiff
submitted no proof to the contrary.”

       Bissinger provided evidence of the restaurant’s failure to comply with Metro Health
Department’s regulations regarding the safe handling of foods, even though the food
involved was not raw oysters. We are not persuaded that proof should be limited to raw
oysters. The restaurant’s handling of other food products, especially those with
requirements similar to oysters, is relevant to the issues.

       The evidence presented by Bissinger relates to failures to observe required
regulations during a time frame near to Mr. Bissinger’s dining there on May 8, 2006.
Metro Health Inspector Danny Ripley testified about reports from restaurant inspections
he conducted both before and after the date that Randall Bissinger patronized the buffet.
For example, on December 20, 2005, New Country Buffet received a Health Inspection
Score of 79 out of 100 because of an array of food safety violations. Among the listed
requirements that the restaurant failed to meet was “[p]otentially hazardous food meets
temperature requirements during storage, preparation, display, service, transportation.”
New Buffet’s score improved to 82 after it was reinspected on May 2, 2006 (about six
days before Randall Bissinger’s fateful restaurant meal). In that inspection, however, the
restaurant once again lost five points for the same failure to meet the temperature
requirements for potentially hazardous food, and it lost an additional two points for failure
to meet the requirement of “potentially hazardous food properly thawed.”

      Another inspection on August 24, 2006 resulted in the same score of 82, with the
same two deficiencies mentioned above. On January 1, 2007, the restaurant’s score
                                             -20-
declined to 71, again with the same two critical deficiencies. The Health Department also
embargoed food that was kept at improper temperatures during every inspection. During
the inspection of December 20, 2005, it embargoed and discarded two pounds of roast
pork. On May 2, 2006, it discarded one pound of roast pork and one pound of chicken.
On August 24, 2006, it discarded four pounds of meat pasta, squid, and crab meat for
“Severe Temperature Abuse.” Danny Ripley’s affidavit states that on that date, he
“observed and inspected cold food on the buffet at hazardous temperatures including
clams at 45.6 degrees, crab/fish at 60 degrees and cold cooked squid at 55 to 60 degrees.”

       Although the manager of New Country Buffet testified that any deficiencies noted
by the Health Department had been corrected by employees, there is certainly evidence
that proper temperature control was a problem on several sequential inspections, and
Bissinger is entitled to the most favorable inferences from that evidence.

       Thus, even though none of the cited reports specifically mention oysters, there is, as
Bissinger asserts, a “mountain of circumstantial evidence” involving a pattern of unsafe
food handling practices, from which a jury could reasonably infer that New Country
Buffet improperly handled the raw oysters it obtained. See Browder v. Pettigrew, 541
S.W.2d 402, 405 (Tenn. 1976) (any material fact in a negligence case “may be proven by
direct evidence, circumstantial evidence, or a combination of direct and circumstantial
evidence.”). Bissinger further contends that the reason oysters were not mentioned in the
inspection reports was that, according to the affidavit of Shao Chai Chen, the restaurant
does not add oysters to the buffet table until after 4:00 p.m., and the inspections were
conducted at an earlier hour.

       As we noted above, when ruling on a summary judgment motion, the trial court
must consider the evidence presented in the light most favorable to the non-moving party,
and must afford that party all the reasonable inferences that can be drawn from that
evidence. Sunrise Pontiac-GMC Truck, Inc., 249 S.W.3d at 307; Draper, 181 S.W.3d at
288; Doe v. HCA Health Servs., Inc., 46 S.W.3d at 196; Memphis Housing Authority v.
Thompson, 38 S.W.3d at 507. “If there is a dispute as to any material fact or any doubt as
to the conclusions to be drawn from that fact, the motion must be denied.” Byrd v. Hall,
847 S.W.2d at 211. In this case, it is reasonable to infer that if New Country Buffet has
been negligent in its handling of every other category of food that it serves, it was also
negligent in the way it handled the oysters that sickened Randall Bissinger.

       Additionally, under the principles first announced in Hannah v. Alltel, supra, a
defendant cannot obtain summary judgment by merely raising doubts about the pertinence
of the plaintiff’s evidence, but must satisfy a more stringent test:



                                            -21-
       To affirmatively negate an essential element of the nonmoving party’s claim,
       [the movant] must point to evidence that tends to disprove a material factual
       allegation made by the nonmoving party. [the movant] cannot satisfy its
       burden of production with a conclusory assertion that the nonmoving party
       has no evidence or with presentation of evidence that raises doubts about the
       nonmoving party’s ability to prove a claim. A trial court must dismiss the
       summary judgment motion if the moving party fails to satisfy this initial
       burden of production.

Mills v. CSX Transportation, Inc., 300 S.W.3d 627, 631 (Tenn. 2009) .

       In this case, New Buffet has, at best, raised a doubt as to whether Bissinger will be
able to prove that the restaurant negligently handled the oysters that were served to his
uncle. That is not sufficient to meet the restaurant’s burden of production on a summary
judgment motion under the standards announced in Hannan v. Alltel, Miller v. CSX, and
other cases. Thus, the trial court did not err in declining to grant New Buffet summary
judgment on Bissinger’s negligence claim.

B. Negligence Per Se

        The distinction between common-law negligence and negligence per se is that
common-law negligence is based on the general duty to act reasonably to avoid harming
others, while negligence per se involves “more specific duties governing particular
situations and relationships [that] may be imposed by the General Assembly.” Rains v.
Bend of the River, 124 S.W.3d 580, 588 (Tenn. Ct. App. 2003) (citing Cook v. Spinnaker’s
of Rivergate, Inc., 878 S.W.2d 934, 937 (Tenn. 1994)).

       When the General Assembly enacts a penal statute, without explicitly creating a
new cause of action for its breach, the courts may nonetheless find that in some situations
a violation of the penal statute is also a violation of a civil legal duty, thereby establishing
a possible cause of action for negligence per se. Mitchell v. Ketner, 393 S.W.2d 755, 757
(Tenn. Ct. App. 1964). However, not every violation of a penal statute triggers the
negligence per se doctrine. Rains v. Bend of the River, 124 S.W.3d at 590.

        Two threshold questions that must be answered before it can be determined whether
the violation of a statute can trigger the negligence per se doctrine: whether the injured
party is within the class of persons intended to benefit from or be protected by the statute,
and whether the plaintiff’s injury is of a type that the statute was designed to prevent.
Rains v. Bend of the River, 124 S.W.3d at 591 (citing Harden v. Danek Medical, Inc., 985
S.W.2d 449, 452 (Tenn. Ct. App. 1998)).


                                             -22-
        There are also several other factors that the court should consider before applying
the doctrine. Those factors include, “(1) whether the statute is the sole source of the
defendant’s duty to the plaintiff, (2) whether the statute clearly defines the prohibited or
required conduct, (3) whether the statute would impose liability without fault, (4) whether
invoking the negligence per se doctrine would result in damage awards disproportionate to
the statutory violation, and (5) whether the plaintiff’s injury is a direct or indirect result of
the violation of the statute.” Rains v. Bend of the River, 124 S.W.3d 580, 591 (Tenn. Ct.
App. 2003).

       Bissinger’s negligence per se claim is based upon allegations that New Country
Buffet violated the Tennessee Food, Drug and Cosmetic Act of 1978, Tenn. Code Ann. §
53-1-101 et seq. The Act prohibits “the manufacture, sale, or delivery, holding or offering
for sale of any food, drug, device or cosmetic that is adulterated or misbranded.” Tenn.
Code Ann. § 53-1-103(a)(1). It is a penal statute, because Tenn. Code Ann. § 53-1-
103(b)(1) declares that violation of any of the provisions of Tenn. Code Ann. § 53-1-
103(a) is a Class C misdemeanor.

       We are unaware of any Tennessee cases upholding a negligence per se claim
specifically based upon a violation of the Food, Drug and Cosmetic Act.5 The courts of
some other jurisdictions have, however, upheld such claims on the basis of similar statutes.
See, for example, Koster v. Scotch Associates, 640 A.2d 1225, 1229 (N.J. Super. 1993);
Brumit v. Cokins, 281 S.W.2d 154, 158 (Tex. Civ. App. 1955); Peters v. Double Cola
Bottling Co. of Columbia, 224 S.C. 437, 443, 79 S.E.2d 710, 713 (S.C. 1954); McKenzie v.
Peoples Baking Co., 31 S.E.2d 154 (S.C. 1944); Yochem v. Gloria, Inc., 17 N.E.2d 731
(Ohio 1938).

        While Bissinger contends that the oysters sold by New Country Buffet meet the
definitions of “adulterated food” found at Tenn. Code Ann. § 53-1-104(1)(C) and (D),
New Country Buffet argues to the contrary that the oysters cannot be considered
adulterated. We have, earlier in this opinion, held that Suppliers could not be held liable
under the Products Liability Statute because the oysters were not “contaminated” under
Tenn. Code Ann. § 53-1-104(1)(C) largely because vibrio vulnificus is present in nearly all
oysters

       There is a difference, however, with the claim against the restaurant. The
difference lies in the relevant statutory definition and the evidence regarding the

        5
           In Jones v. Mercer Pie Co., the court did not use the expression “negligence per se,” but we stated
that the “evidence supports both the common law count of the declaration and the count charging a violation
of the statute prohibiting the existence of unsanitary conditions in [a commercial bakery].” Jones v. Mercer
Pie Co., 214 S.W.2d at 49.

                                                    -23-
restaurants’ practices in handling certain foods.          Tennessee Code Annotated §
53-1-104(1)(C) defines food as adulterated if “it consists in whole or in part of a diseased,
contaminated, filthy, putrid, or decomposed substance, or if it is otherwise unfit for food.”
Tenn. Code Ann. § 53-1-104(1)(D)’s definition of adulterated food includes the following:

       . . . if it is a potentially hazardous food, which would consist of meat,
       poultry, liquid eggs and partially cooked egg products, fish, milk and milk
       products, shellfish, . . . capable of supporting rapid and progressive growth
       of infectious or toxigenic micro-organisms and is transported, stored or
       offered for sale at a product temperature in excess of forty-five degrees
       Fahrenheit (45° F) if a cold food . . .

       Due to the evidence recounted earlier with regard to temperature violations at the
restaurant, Bissinger has clearly raised a question of material fact as to whether the oysters
the restaurant served his uncle were adulterated under the definitions found at Tenn. Code
Ann. § 53-1-104(1)(C) and (D), and thus whether the restaurant violated the statute. There
can also be no doubt that Randall Bissinger was within the class of persons the Act was
enacted to protect, or that the injury he suffered was of a type it was designed to prevent.
We also note that the facts of this case are consistent with the factors set out by the Rains
court for determining whether a claim can be sustained under the negligence per se
doctrine.

       We affirm the trial court’s denial of summary judgment to New Country Buffet on
the negligence per se claim.

C. Failure to Warn

       There is no proof in the record that New Country Buffet passed along to its
customers the suppliers’ warnings about the dangers of eating raw oysters. The trial court
noted that there was “no statutory duty to warn under the Tennessee regulatory scheme,”
and stated the issue is whether there is a common law duty.

       Bissinger’s claims of breach of a duty to warn are argued under various causes of
action. Breach of a duty to warn is not a free-standing claim, but rather an element that
may apply to a number of different types of claims, including simple negligence and
various product liability claims. See Flax v. DaimlerChrysler Corp., 272 S.W.3d 521, 542
(Tenn. 2008) (manufacturer who becomes aware that a product is defective or
unreasonably dangerous must take reasonable steps to warn consumers who purchased the
product); Pittman v. Upjohn Co., 890 S.W.2d 425 (Tenn. 1994) (describing the scope of
the duty to warn borne by the drug manufacturer and the prescribing physician); Estate of
Amos v. Vanderbilt Univ., 62 S.W.3d 133, 135 (Tenn. 2001) (medical center had a duty to
                                            -24-
warn patient of possible exposure to HIV); Trimble v. Irwin, 441 S.W.2d 818, 820 (Tenn.
Ct. App. 1968) (manufacturer of floor finishing chemicals had duty to warn of their
dangerous volatile characteristics).

        Warnings are not always necessary, however. Tennessee Code Annotated §
29–28–105(d) states that “[a] product is not unreasonably dangerous because of a failure
to adequately warn of a danger or hazard that is apparent to the ordinary user.” See, also,
Eaton v. McLain, 891 S.W.2d 587, 595 (Tenn. 1994) (no duty to warn of danger of
unlighted stairs in premises liability case); Shoemake v. Omniquip Int'l, Inc., 152 S.W.3d
567, 574 (Tenn. Ct. App. 2003). Further, the law does not impose a duty to warn of risks
that are widely known. Pemberton v. American Distilled Spirits Co., 664 S.W.2d 690, 692
(Tenn. 1984) (seller of 100% grain alcohol had no duty to warn customer of the effects of
consuming a large quantity of it in undiluted form).

        The proof showed that there is no difference between the appearance, smell or taste
of a raw oyster that is safe to eat and one that contains large quantities of vibrio vulnificus.
Thus, we cannot say that the danger of the product was open and obvious. It could be
argued that the danger of eating raw oysters is well-known to the public. But, it may be
that the extent of that danger is not as well-known. The courts of other jurisdictions have
acknowledged the significance of this distinction.

        For example, in Edwards v. Hop Sin, Inc, 140 S.W.3d at 17, a customer with a bad
liver condition suffered severe septicemia from eating raw oysters. The trial court held
that the defendant restaurant was entitled to summary judgment, because a reasonable
consumer is probably aware that raw seafood poses a certain risk of mild illness. But the
appeals court reversed, holding that most people were probably not aware of the greater
risk of serious illness or death for those with stomach, liver, or blood conditions, or with
compromised immune systems. The court concluded that because of that risk, it was a
question for the jury whether the restaurant could be held liable for failing to pass along to
its customers the warnings that its suppliers furnished with their product. See also Simeon
v. Doe, 618 So.2d at 852 (holding that there was a danger inherent in the normal use of the
product that was not within the knowledge of an ordinary user, and that given the
magnitude of the potential harm to a vulnerable person, a warning was particularly
necessary if the vendor was aware of the risk). The restaurant was on notice here, because
of the warning notices on the bags from Suppliers.

        Ayala v. Bartolome, 940 S.W.2d 727, 732 (Tex. Ct. App. 1997), involved another
man who suffered from cirrhosis of the liver and who died after eating raw oysters. In that
case, the Texas appeals court reversed the summary judgment for the defendant restaurant.
The court acknowledged the defendant’s contention that it was common knowledge to the
public that eating uncooked meat carries an element of danger, but it stated that “it is not
                                             -25-
common knowledge that eating raw oysters could be fatal.” The court accordingly
concluded that it was a question of fact for the jury whether the oysters the defendant
served were defective or unreasonably dangerous.

        The above cases and others of similar import stand as strong persuasive authority
that given the current state of knowledge about the dangers of vibrio vulnificus in oysters,
New Country Buffet had a duty to warn its customers about those dangers. We affirm the
trial court’s determination that the restaurant was not entitled to dismissal on summary
judgment of claims based on failure to warn.

                       VI. O THER C LAIMS A GAINST R ESTAURANT

        Aside from the common-law negligence claims against New Country Buffet, the
trial court declined to grant the restaurant summary judgment on Bissinger’s other claims,
which included product liability and breach of implied warranty of merchantability.

       As we discussed above, a manufacturer or seller may be held liable under the
Tennessee Products Liability Act for injuries resulting from the use of a product if the
product is found to have been defective or unreasonably dangerous when it left the control
of the manufacturer or seller. Tenn. Code Ann. § 29-28-105.

        The restaurant insists that the oysters it served were not defective or unreasonably
dangerous. Its sole argument is based on the rebuttable presumption that a product is not
unreasonably dangerous if the manufacturer or seller can demonstrate compliance with
federal or state statutes or administrative regulations creating relevant standards for a
product’s “design, inspection, testing, manufacturing, labeling, warning or instructions.”
Tenn. Code Ann. § 29-28-104(a). The trial court held that the defendant suppliers were
entitled to that presumption, because the evidentiary material they submitted indicated that
their handling of the oysters satisfied the federal regulations governing seafood safety, and
because Bissinger did not offer any countervailing evidence.

       The restaurant insists that it is entitled to the same presumption, because “there is
no evidence that it broke any federal or state law regarding the maintenance, storage, sale
and distribution/display of the oysters in this case.” However, that insistence misstates the
circumstances in which the presumption applies. The party claiming the presumption has
the burden to show compliance with applicable statutes and regulations; it is not the
burden of the plaintiff to show the opposite. New Country Buffet did not provide evidence
that demonstrated compliance. Thus, the restaurant is not entitled to the presumption that
the oysters it served were not unreasonably dangerous, and its argument is without merit.



                                            -26-
       With or without the presumption, the question is whether the oysters were defective
or unreasonably dangerous when served. As discussed earlier, the same evidence is
relevant to whether the oysters were unfit for consumption and, therefore, not
merchantable.

       Bissinger also claimed that New Country Buffet violated the implied warranty of
merchantability by serving oysters that “were contaminated with vibrio vulnificus and
were therefore unmerchantable and unfit for human consumption.” See Tenn. Code Ann.
§ 47-2-314. New Country Buffet asserts on appeal “that it should have been granted
summary judgment on this claim as the raw oysters in question were merchantable,
wholesome and fit for human consumption.” (emphasis in original statement).

       Based upon the same authorities and standards that we discussed with regard to
Suppliers, the restaurant argues that because vibrio vulnificus is natural to shellfish, their
oysters should be deemed to have passed the two tests that are normally applied to
determine whether food is suitable for sale and consumption.

       Under the foreign-natural test, food is considered unfit for ordinary purposes if an
object is found in the food that does not occur naturally. There are no allegations in the
record that such an object made the oysters unfit. Under the reasonable expectations test,
food is considered unfit for ordinary purposes if it contains substances which cause injury
and which the consumer would not reasonably expect to find in the product, even if those
substances are natural. Such substances might include a chicken bone found in a chicken
enchilada or a walnut shell in walnut ice cream. For an extensive discussion of cases from
many jurisdictions involving both kinds of impurities, see Mexicali Rose v. Superior
Court, 822 P.2d 1292 (Cal. 1992).6

       New Country Buffet argues that because vibrio vulnificus occurs naturally, the
restaurant cannot be found liable under the foreign-natural test, and that since the proof
shows that vibrio is found in virtually all oysters, a consumer cannot reasonably expect to
receive a oyster free from the bacteria.

        For these or similar reasons, we held that Suppliers could not be held liable under
either product liability or implied warranty of merchantability. The same basic legal
principles apply to New Country Buffet. However, if New Country was, in fact, negligent
in its handling of the oysters, its conduct may have allowed the bacteria to proliferate.
Thus, actions of the restaurant may have rendered the oysters unfit for consumption. As

        6
          The cited cases involving discussion of the foreign/natural test and the reasonable expectations test
do not generally involve claims of violation of the warranty of merchantability, but rather other theories of
recovery, such as strict liability, res ipsa loquitur and negligence per se.

                                                    -27-
discussed earlier, Tenn. Code Ann. § 53-1-104(1)(D) defines adulterated food as including
shellfish capable of supporting rapid and progressive growth of infectious or toxigenic
micro-organisms that is stored or offered for sale at a temperature greater that forty-five
degrees Fahrenheit (45° F).

       Because of the testimony of the temperature findings of inspectors, including the
specific temperatures cited therein, it may be possible for Bissinger to establish that the
oysters consumed by his uncle were adulterated and, thus, unfit for consumption and
unreasonably dangerous. At present, there is no proof of the concentration of vibrio when
the oysters were delivered to the restaurant or the concentration when the oysters were
served. However, while it may be difficult for Bissinger to establish an increase, that
question is not before us at this time.

      The trial court did not err in declining to grant New Country Buffet’s summary
judgment on his claims of products liability or breach of the implied warranty of
merchantability.

           VII. A TTEMPTS TO A SSERT F AULT A GAINST A DDITIONAL P ARTIES

        Gulf Pride and New Country Buffet argue on appeal that the trial court erred in
denying their attempts to assert fault against non-parties. The case management and
scheduling orders found in the record show that the motions and pleadings at issue were
filed long after the expiration of deadlines set by the trial court to move the case along in
an expeditious manner.

        The trial court’s order of June 19, 2007 gave the defendants until October 12, 2007,
to fully review the medical records to determine whether to name any additional parties as
at fault for the plaintiff’s injuries, and until November 13, 2007 to amend their answers to
allege any such fault by those additional parties. After the deadline passed, with no
defendant asserting fault against a non-party, the defendants sought a further extension of
the deadline. The court granted the defendants an extension until February 1, 2008 and a
further deadline until April 1, 2008. Those deadlines also passed with no assertions of
fault made against a non-party.

       On June 15, 2009, more than a year after the expiration of the last deadline, Gulf
Pride attempted to assert fault against three out-of-state entities that were involved in the
harvesting of oysters. Bissinger filed a motion to strike those defenses, which Judge
McClendon granted, stating that they were inexcusably untimely and that the plaintiff
“would be significantly and unfairly prejudiced if the Defendants were permitted to assert
fault against non-parties at this point, more than two years into litigation of this case.”


                                            -28-
       Judge McClendon subsequently recused herself, and the case was assigned to Judge
Gayden. On November 29, 2010, after Judge Gayden assumed responsibility for the case,
Gulf Pride attempted to amend its answer to Bissinger’s third amended complaint by
adding as an affirmative defense the comparative fault of the same non-party oyster
harvesters it had designated earlier, as well as unnamed doctors and medical professionals
at the VA hospital whom Gulf Pride alleged were negligent for not advising Randall
Bissinger of the dietary restrictions he should have followed in light of his medical
condition.

       New Country Buffet attempted to raise the same affirmative defense in its own
answer, which was filed on January 10, 2011. The restaurant named as “necessary and
indispensable parties” the same oyster harvesters that had been named by Gulf Pride, and
as well as four specifically-named medical providers who had allegedly “failed to
diagnose and inform Randall Bissinger that he suffered from cirrhosis of the liver and
should therefore restrict his diet to exclude certain foods, including raw oysters.”

        Bissinger filed separate motions to strike the portions of Gulf Pride’s and New
Country Buffet’s answers that asserted affirmative defenses based upon the fault of
previously unnamed non-parties. After hearings on both motions, the trial court granted
the relief Bissinger asked for. Both of the court orders granting Bissinger’s motions to
strike cited four reasons, set out in Hardcastle v. Harris, 170 S.W.3d 67 (Tenn. Ct. App.
2004), why permitting the proposed amendments would be unfairly prejudicial to
Bissinger. The Hardcastle opinion stated that naming additional parties might be
prejudicial if it would likely “(1) cause additional expense and the burden of a more
complicated and lengthy trial, (2) require the opposing party to engage in significant
additional pre-trial preparation, (3) unduly increase discovery, or (4) unduly delay the
trial.” Hardcastle v. Harris, 170 S.W.3d at 81.

        Gulf Pride argues on appeal that several recent decisions of the Tennessee Supreme
Court and of this court have expanded the rights of both plaintiffs and defendants in cases
involving comparative fault to allege that previously unnamed individuals or entities were
at fault for the plaintiff’s injuries. See Mills v. Fulmarque, Inc., 360 S.W.3d 362 (Tenn.
2012); BellSouth Telecommunications, Inc. v. Young, W2010-01825-COA-R3-CV, 2011
WL 2462996 (Tenn. Ct. App. June 21, 2011) (rule 11 perm. app. denied Oct. 24, 2011).

       Gulf Pride’s proposed amendment in this case was filed almost three years after the
expiration of the trial court’s final deadline for asserting fault against additional parties.
There can be no doubt that allowing additional parties to be brought into the case at that
stage of the proceedings would have resulted in Bissinger suffering all four of the
prejudicial effects cited in Hardcastle v. Harris. Therefore, the trial court did not abuse its


                                             -29-
discretion in granting Bissinger’s motion to strike the relevant paragraphs in Gulf Pride’s
amended answer.

       For its part, New Country Buffet argues that the trial court incorrectly struck its
affirmative defense using the Hardcastle v. Harris standard, because its pleading stood in
a different posture than did Gulf Pride’s motion to amend. The restaurant points out that
Gulf Pride’s allegations of fault against additional non-parties were included in its motion
to amend its answer, and that the issue in Hardcastle involved a motion to amend a
complaint. In contrast, New Country Buffet had not previously filed an answer to
Bissinger’s third amended complaint, so the restaurant contends that the decision on
Bissinger’s motion to strike certain paragraphs from its unamended answer should have
been based on the provisions of Tenn. R. Civ. P. 12.06, rather than on the factors set out in
Hardcastle v. Harris.

       It appears to us, however, that under the circumstances of this case, that is a
distinction without a difference. Tenn. R. Civ. P. 12.06 allows a court, upon motion of a
party, or upon its own motion, to “order stricken from any pleading insufficient defense or
any redundant, immaterial, impertinent or scandalous matter.” This court set out the
standards for decision on a motion to strike under Tenn. R. Civ. P. 12.06 in Doe v. Mama
Taori's Premium Pizza, LLC, M1998-00992-COA-R9-CV, 2001 WL 327906 (Tenn. Ct.
App. Apr. 5, 2001). To succeed on such a motion,

       . . . the moving party must show both that the challenged claim or defense
       does not involve a question of fact or law on which the non-moving party
       can succeed and that failure to strike the challenged claim or defense will be
       prejudicial to the moving party. Prejudice for the purpose of a Tenn. R. Civ.
       P. 12.06 motion arises when the challenged claim or defense has the effect
       of confusing the issues or is so lengthy and complex that it places an undue
       burden on the moving party.

Doe v. Mama Taori's Premium Pizza, LLC, 2001 WL 327906 at *3.

        The paragraphs in New Country Buffet’s answer that were the target of Bissinger’s
motion to strike were based on Bissinger’s statement in his third amended complaint that
Randall Bissinger was not diagnosed with cirrhosis until after he contracted vibrio
vulnificus. That information was available to New Country Buffet when it examined the
medical records in 2007. Likewise, the oyster harvesters were, or could have been,
identified during the discovery period.

      We conclude that the trial court did not abuse its discretion in granting Bissinger’s
motion to strike the affirmative defenses in New Country Buffet’s answer.
                                            -30-
                                   VIII. C ONCLUSION

       The judgment of the trial court is affirmed in all respects except for its denial of
Suppliers’ motion for summary judgment on the failure to warn issue, which ruling is
reversed. We remand this case to the Circuit Court of Davidson County for further
proceedings. Divide the costs on appeal equally among Randall Bissinger, New Country
Buffet Restaurant, Gulf Pride Seafood, Bon Secour, and Leavins.




                                                  _________________________________
                                                  PATRICIA J. COTTRELL, JUDGE




                                           -31-
