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Date: 01-05-2023
Case Style:
Courtney Kunysz v. Merck & Co., Inc.
Case Number: 3:22-cv-00689
Judge: Robert J. Conrad, Jr.
Court: United States District Court for the Western District of North Carolina (Mecklenburg County)
Plaintiff's Attorney: Tracy Lynn Turner
Defendant's Attorney: Dino S. Sangiamo and Sally Wiest Bryan
Description: Charlotte, North Carolina personal injury lawyer represented Plaintiff, who sued Defendant on a product liability theory claiming to have suffered more than $75,000 in damages and/or injuries as a direct result of a defective and unreasonably dangerous product designed, manufactured and/or sold by Defendant. This case apparently related to Gardasil which is an HPV caccine for use in the prevention of certain strains of human apilomavirus which is the most common sexually transmitted infection among wormen.
There is no strict liability in tort in product liability actions in North Carolina.
Nothing North Carolina law shall preclude a product liability action that otherwise exists against a
manufacturer or seller for breach of warranty. The defenses provided for in this Chapter shall apply
to claims for breach of warranty unless expressly excluded under this Chapter. (1995, c. 522, s. 1.)(a) No product liability action, except an action for breach of express warranty, shall be
commenced or maintained against any seller when the product was acquired and sold by the seller
in a sealed container or when the product was acquired and sold by the seller under circumstances
in which the seller was afforded no reasonable opportunity to inspect the product in such a manner
that would have or should have, in the exercise of reasonable care, revealed the existence of the
condition complained of, unless the seller damaged or mishandled the product while in his
possession; provided, that the provisions of this section shall not apply if the manufacturer of the
product is not subject to the jurisdiction of the courts of this State or if such manufacturer has been
judicially declared insolvent.
(b) A claimant who is a buyer, as defined in the Uniform Commercial Code, of the product
involved, or who is a member or a guest of a member of the family of the buyer, a guest of the NC General Statutes - Chapter 99B 2
buyer, or an employee of the buyer may bring a product liability action directly against the
manufacturer of the product involved for breach of implied warranty; and the lack of privity of
contract shall not be grounds for the dismissal of such action. (
(a) No manufacturer or seller of a product shall be held liable in any product liability action
where a proximate cause of the personal injury, death, or damage to property was either an
alteration or modification of the product by a party other than the manufacturer or seller, which
alteration or modification occurred after the product left the control of such manufacturer or such
seller unless:
(1) The alteration or modification was in accordance with the instructions or
specifications of such manufacturer or such seller; or
(2) The alteration or modification was made with the express consent of such
manufacturer or such seller.
(b) For the purposes of this section, alteration or modification includes changes in the
design, formula, function, or use of the product from that originally designed, tested, or intended
by the manufacturer. It includes failure to observe routine care and maintenance, but does not
include ordinary wear and tear.
No manufacturer or seller shall be held liable in any product liability action if:
(1) The use of the product giving rise to the product liability action was contrary to
any express and adequate instructions or warnings delivered with, appearing
on, or attached to the product or on its original container or wrapping, if the
user knew or with the exercise of reasonable and diligent care should have
known of such instructions or warnings; or
(2) The user knew of or discovered a defect or dangerous condition of the product
that was inconsistent with the safe use of the product, and then unreasonably
and voluntarily exposed himself or herself to the danger, and was injured by or
caused injury with that product; or
(3) The claimant failed to exercise reasonable care under the circumstances in the
use of the product, and such failure was a proximate cause of the occurrence
that caused the injury or damage complained of. (1979, c. 654, s. 1; 1995, c.
522, s. 1.)
(a) No manufacturer or seller of a product shall be held liable in any product liability action
for a claim based upon inadequate warning or instruction unless the claimant proves that the
manufacturer or seller acted unreasonably in failing to provide such warning or instruction, that
the failure to provide adequate warning or instruction was a proximate cause of the harm for which
damages are sought, and also proves one of the following:
(1) At the time the product left the control of the manufacturer or seller, the product,
without an adequate warning or instruction, created an unreasonably dangerous
condition that the manufacturer or seller knew, or in the exercise of ordinary
care should have known, posed a substantial risk of harm to a reasonably
foreseeable claimant.
(2) After the product left the control of the manufacturer or seller, the manufacturer
or seller became aware of or in the exercise of ordinary care should have known
that the product posed a substantial risk of harm to a reasonably foreseeable
user or consumer and failed to take reasonable steps to give adequate warning
or instruction or to take other reasonable action under the circumstances.
(b) Notwithstanding subsection (a) of this section, no manufacturer or seller of a product
shall be held liable in any product liability action for failing to warn about an open and obvious
risk or a risk that is a matter of common knowledge.
(c) Notwithstanding subsection (a) of this section, no manufacturer or seller of a
prescription drug shall be liable in a products liability action for failing to provide a warning or
instruction directly to a consumer if an adequate warning or instruction has been provided to the
physician or other legally authorized person who prescribes or dispenses that prescription drug for
the claimant unless the United States Food and Drug Administration requires such direct consumer
warning or instruction to accompany the product.
(a) No manufacturer of a product shall be held liable in any product liability action for the
inadequate design or formulation of the product unless the claimant proves that at the time of its
manufacture the manufacturer acted unreasonably in designing or formulating the product, that
this conduct was a proximate cause of the harm for which damages are sought, and also proves
one of the following:
(1) At the time the product left the control of the manufacturer, the manufacturer
unreasonably failed to adopt a safer, practical, feasible, and otherwise
reasonable alternative design or formulation that could then have been
reasonably adopted and that would have prevented or substantially reduced the
risk of harm without substantially impairing the usefulness, practicality, or
desirability of the product.
(2) At the time the product left the control of the manufacturer, the design or
formulation of the product was so unreasonable that a reasonable person, aware
of the relevant facts, would not use or consume a product of this design.
(b) In determining whether the manufacturer acted unreasonably under subsection (a) of
this section, the factors to be considered shall include, but are not limited to, the following:
(1) The nature and magnitude of the risks of harm associated with the design or
formulation in light of the intended and reasonably foreseeable uses,
modifications, or alterations of the product.
(2) The likely awareness of product users, whether based on warnings, general
knowledge, or otherwise, of those risks of harm.
(3) The extent to which the design or formulation conformed to any applicable
government standard that was in effect when the product left the control of its
manufacturer.
(4) The extent to which the labeling for a prescription or nonprescription drug
approved by the United States Food and Drug Administration conformed to any
applicable government or private standard that was in effect when the product
left the control of its manufacturer.
NC General Statutes - Chapter 99B 4
(5) The utility of the product, including the performance, safety, and other
advantages associated with that design or formulation.
(6) The technical, economic, and practical feasibility of using an alternative design
or formulation at the time of manufacture.
(7) The nature and magnitude of any foreseeable risks associated with the
alternative design or formulation.
(c) No manufacturer of a product shall be held liable in any product liability action for a
claim under this section to the extent that it is based upon an inherent characteristic of the product
that cannot be eliminated without substantially compromising the product's usefulness or
desirability and that is recognized by the ordinary person with the ordinary knowledge common to
the community.
(d) No manufacturer of a prescription drug shall be liable in a product liability action on
account of some aspect of the prescription drug that is unavoidably unsafe, if an adequate warning
and instruction has been provided pursuant to G.S. 99B-5(c). As used in this subsection,
"unavoidably unsafe" means that, in the state of technical, scientific, and medical knowledge
generally prevailing at the time the product left the control of its manufacturer, an aspect of that
product that caused the claimant's harm was not reasonably capable of being made safe.
(e) Nothing in this section precludes an action against a manufacturer in accordance with
the provisions of G.S. 99B-5.
Outcome: 12/28/2022 4 CONDITIONAL TRANSFER ORDER (CTO-11): This order does not become effective until it is filed in the Office of the Clerk of the United States District Court for the Western District of North Carolina. Signed by the Clerk of the Panel on 12/28/2022. (er) [Transferred from Ohio Southern on 12/28/2022.] (Entered: 12/28/2022)
12/28/2022 5 CONDITIONAL TRANSFER ORDER (CTO-11): Pursuant to Rule 7.1 of the Rules of Procedure of the United States Judicial Panel on MDL, this action is transferred to the Western District of North Carolina. Signed by the Clerk of the Panel on 12/28/2022; certified by the Clerk's Office from WDNC on 12/28/2022. (er) [Transferred from Ohio Southern on 12/28/2022.] (Entered: 12/28/2022)
12/28/2022 Case transferred to District of Western North Carolina. Case file and docket sheet sent Electronically. (er) [Transferred from Ohio Southern on 12/28/2022.] (Entered: 12/28/2022)
12/28/2022 6 Case transferred in from District of Ohio Southern; Case Number 1:22-cv-00734. Original electronic file and docket sheet received. (Entered: 12/28/2022)
12/28/2022 Case assigned to District Judge Robert J. Conrad, Jr. Notice: You must click this link to retrieve the Case Assignment Packet. This is your only notice - you will not receive a separate document.(rth) (Entered: 12/28/2022)
12/28/2022 7 ORDER of Administrative Close Out of Member Cases. Signed by District Judge Robert J. Conrad, Jr on 9/12/22. (rth) (Entered: 12/28/2022)
12/28/2022 8 NOTICE of Appearance by Dino S. Sangiamo on behalf of Merck & Co, Inc., Merck Sharp & Dohme LLC (Sangiamo, Dino) (Entered: 12/28/2022)
12/28/2022 9 NOTICE of Appearance by Sally Wiest Bryan on behalf of Merck & Co, Inc., Merck Sharp & Dohme LLC (Bryan, Sally) (Entered: 12/28/2022)
Plaintiff's Experts:
Defendant's Experts:
Comments: