The opinion
UNITED STATES DISTRICT COURT
NORTHERN DISTRICT OF OKLAHOMA
MISTY DAWN LONG and
DARREN WAYNE LONG,
Plaintiffs,
v. Case No. 20-CV-181-JFH-JFJ
ETHICON, INC., and
JOHNSON & JOHNSON,
Defendants.
OPINION AND ORDER
This matter comes before the Court on the Motion for Partial Summary Judgment
(“Motion”) [Dkt. No. 25], and Memorandum of Law in Support [Dkt. No. 26], filed by Defendant
Ethicon, Inc. (“Ethicon”). The case began as part of multidistrict litigation in the United States
District Court for the Southern District of West Virginia. In re Ethicon, Inc., Pelvic Repair System
Prods. Liability Litig., No. 2:12-MD-02327 (S.D.W. Va.). In April 2020, the West Virginia Court
ordered 51 of the multidistrict litigation’s cases to be transferred to appropriate jurisdictions. Dkt.
No. 34. This case was directed to be transferred to this Court. Id. The transfer was completed on
May 1, 2020. Dkt. No. 46.
Ethicon filed the Motion and supporting brief in the West Virginia Court on October 17,
2018. Dkt. No. 25; Dkt. No. 26. These filings addressed nine (9) claims within the Complaint,
including a failure to warn claim (Count III). Id. Plaintiffs, Misty Dawn Long and Darren Wayne
Long (collectively “Plaintiffs”), filed a Response on October 25, 2018, responding solely to
Ethicon’s products liability failure to warn claim. Dkt. No. 27. Ethicon filed a Reply regarding
the failure to warn claim on October 31, 2018. Dkt. No. 28. The parties stipulated to the dismissal
of the remaining eight (8) counts and confirmed that Plaintiffs’ failure to warn claim is the only
outstanding claim in the Motion. Dkt. No. 73.
For the reasons set forth below, the Court grants the Motion.
STANDARD
“Summary judgment is appropriate if the pleadings, depositions, answers to
interrogatories, and admissions on file, together with the affidavits, if any, show that there is no
genuine issue as to any material fact and that the moving party is entitled to a judgment as a matter
of law.” Jones v. Kodak Med. Assistance Plan, 169 F.3d 1287, 1291 (10th Cir. 1999); Fed. R. Civ.
P. 56(a). “A dispute is genuine when the evidence is such that a reasonable jury could return a
verdict for the nonmoving party, and a fact is material when it might affect the outcome of the suit
under the governing substantive law.” Bird v. W. Valley City, 832 F.3d 1188, 1199 (10th Cir.
2016). Only material factual disputes preclude the entry of summary judgment. Atl. Richfield Co.
v. Farm Credit Bank of Wichita, 226 F.3d 1138, 1148 (10th Cir. 2000).
The movant bears the initial burden to demonstrate the absence of a genuine issue of
material fact and its entitlement to judgment as a matter of law. Adler v. Wal-Mart Stores, Inc.,
144 F.3d 664, 670-71 (10th Cir. 1998). If the movant carries this initial burden, “the burden shifts
to the nonmovant to go beyond the pleadings and set forth specific facts that would be admissible
in evidence in the event of a trial from which a rational trier of fact could find for the nonmovant.”
Id. at 671. If the nonmovant demonstrates a genuine dispute as to material facts, the Court views
the facts in the light most favorable to him. Ricci v. DeStefano, 557 U.S. 557, 586 (2009).
UNDISPUTED MATERIAL FACTS1
Ethicon developed a medical device called the TVT-O: a “mid-urethral sling” made of
polypropylene mesh implanted near a woman’s bladder to reduce or prevent female stress urinary
incontinence. The device provides support to the patient’s bladder and reduces abdominal pressure
on the pelvic area. Board-certified gynecologist Dr. Darla Lofgren performed surgery on Plaintiff
Misty Long in May 2015, including implantation of a TVT-O device. Mrs. Long had numerous
post-surgical complications and eventually had the device removed by a different gynecologist.
ANALYSIS
A manufacturer is liable under Oklahoma product liability law if a plaintiff proves: (1) the
manufacturer’s product was the cause of the plaintiff’s injury; (2) the defect existed in the product
at the time it left the manufacturer’s control; and (3) the defect made the product unreasonably
dangerous. Kirkland v. Gen. Motors Corp., 521 P.2d 1353, 1363 (Okla. 1974). A manufacturer
has a duty to warn consumers of “potential dangers which may occur from the use of [a] product
when it is known or should be known that hazards exist.” McKee v. Moore, 648 P.2d 21, 23 (Okla.
1982). “[E]ven if a product is faultlessly designed . . . it may be considered unreasonably unsafe
or defective if it is placed in the hands of the ultimate consumer without adequate warnings of the
dangers involved in its use.” Id.
Oklahoma recognizes the “learned intermediary” doctrine in product liability cases related
to medical devices or drugs. Edwards v. Basel Pharms., 933 P.2d 298 (Okla. 1997); McKee, 648
P.2d at 24. The doctrine sets out that a medical product “manufacturer's duty is to warn [a
plaintiff’s] physician, who acts as a learned intermediary between the manufacturer and the
1 Both parties’ briefing is quite scant on factual detail, perhaps because the Motion was originally
filed in the multidistrict litigation. The Court has drawn these facts from the record before it,
particularly the deposition of Dr. Darla Lofgren filed as an exhibit to Plaintiffs’ Response.
consumer,” because the physician “is in the best position to evaluate the patient's needs, [to] assess
the benefits and risks of a particular therapy, and to supervise its use.” McKee, 648 P.2d at 24. It
is a physician’s duty “to exercise independent judgment, taking into account [] knowledge of the
patient as well as [of] the product.” Edwards, 933 P.2d at 300 (quoting Wooderson v. Ortho
Pharm. Corp., 681 P.2d 1038, 1052 (Kan. 1984)). “In the absence of FDA regulations to the
contrary, the manufacturer has no obligation to warn a consumer if the prescribing physician has
been adequately warned of any adverse side effects.” McKee, 648 P.2d at 24.
A rebuttable presumption arises in failure to warn cases that an adequate warning would
have been read and heeded. Woulfe v. Eli Lilly & Co., 965 F. Supp. 1478, 1483 (E.D. Okla. 1997).
In a case where the learned intermediary doctrine applies, the defendant “may rebut this
presumption by establishing that although the prescribing physician would have ‘read and heeded’
the warning or additional information, this would not have changed the prescribing physician’s
course of treatment.” Eck v. Parke, Davis & Co., 256 F.3d 1013, 1019 (10th Cir. 2001) (applying
Oklahoma law). If a defendant successfully rebuts the presumption, the burden shifts “rather
heavily” back to the plaintiff. Id. “To submit the case to a jury, [the plaintiff] must either discredit
the physician[’s] testimony or call into question the substance of the testimony, or otherwise
demonstrate that the alleged failure to warn was the proximate cause of their injuries.” Id.
Plaintiffs do not specify—and it is unclear to the Court—what warning Plaintiffs believe
was lacking regarding the TVT-O device. Nevertheless, the Court will apply the rebuttable
presumption that an adequate warning would have been read and heeded. The burden thus falls to
Ethicon to demonstrate that the treating physician, Dr. Lofgren, would not have changed her course
of treatment had she known additional information about the TVT-O device.
The evidence before the Court unequivocally shows Dr. Lofgren was confident in her
treating decision. Dr. Lofgren testified that in May 2015, when she performed surgery on Mrs.
Long, she had done approximately 90 or more TVT-O surgeries. Dkt. No. 27-1 at 22:16-19. She
still used the device at the time of her deposition in 2018 with results she described as “excellent”
and “absolutely” an improvement to patients’ quality of life. Dkt. No. 27-1 at 24-25. Dr. Lofgren
testified she believed use of the TVT-O is within the standard of care for gynecology [Dkt. No.
27-1 at 38:14-17] and explained her reasons for using the device:
One, I'm comfortable with it, and I think it's always important when
you're placing something that it's the surgeon's comfort level and
experience with having good results with it in the past. I use this
device because it goes lateral. I don't have the injury into the bladder
like you do with the retropubic . . . . [So] one, I’m comfortable with
it. Two, I think it has less risk with it . . . .
[I]t changes women's lives. When you have incontinence and it
affects your life with your family and your job and just the way you
live every day, when patients come back and they've had a bladder
sling placed in and they no longer leak urine, their lives have
changed. That's the purpose of what we do is to help people . . . .
With the mid-urethral sling, I’m comfortable with the placement,
and I’m very happy with my results. And so I continue to use it.
Dkt. No. 27-1 at 16:25-17:15, 24:8-14, 22-24.
Dr. Lofgren testified repeatedly that her surgical decision-making process is based on her
education and experience, not manufacturer product warnings. See, e.g., Dkt. No. 27-1 at 27:19-
25, 38:19-21, 69:17-70:9, 158:7-19. She described literature from manufacturers as “just
supportive” [id. at 159:19-24] and said, “I don’t go by the manufacturer. I go by my education
when I go to choosing what patients are candidates” to receive the TVT-O device [id. at 124:8-
10]. Dr. Lofgren said she relies on diagnostic imaging, an exam, and a thorough medical history
to make her decision for each patient, “not [on] what Ethicon said.” Id. at 123:7-10. In sum, Dr.
Lofgren stated: “I don’t choose Ethicon because it’s Ethicon. I choose Ethicon because I’ve had
success with this device, and I’ve had a lot of patient success.” Id. at 104:10-14.
While Dr. Lofgren said she would have wanted to know additional information about the
TVT-O device, she did not testify that she would have changed her treatment decision based on
this knowledge. Dkt. No. 27-1 at 102:8-22. Dr. Lofgren believed that “if there’s a device that has
supported data that says you shouldn’t be placing it,” the information would come through the
medical education updates she received and the device would be taken out of the market. Id. at
124:15-23, 125:5-8. Even after questioning from Plaintiff’s counsel regarding the allegedly
undisclosed issues with the TVT-O device,2 Dr. Lofgren testified that she believed Plaintiff was a
good candidate for the TVT-O [id. at 120:17-19, 122:3-7, 123:11-14] and did not have any risk
factors contraindicating the device [id. at 122:25-123:1]. Dr. Lofgren’s testimony is sufficient to
rebut the presumption that an additional warning from Ethicon would have changed her treating
decision. The burden thus shifts “rather heavily” back to Plaintiffs. Eck, 256 F.3d at 1019.
Plaintiffs do not attempt to discredit Dr. Lofgren’s testimony or call into question the
substance of her testimony. Quite the opposite: they cite to it repeatedly for the proposition that
Dr. Lofgren “reli[ed] on Ethicon to inform her of the risks she was unaware of through Ethicon’s
written materials.” Dkt. No. 27 at 5. The Court finds that the uncontroverted evidence does not
support this characterization. As discussed above, Dr. Lofgren repeatedly testified that it was her
experience and education, not Ethicon’s warnings, that guided her treatment decision. Plaintiffs
2 Although the parties do not specifically brief what information was allegedly omitted from
Ethicon’s warnings, it is the Court’s impression from their arguments and Dr. Lofgren’s deposition
transcript that the TVT-O device implanted in Mrs. Long allegedly had rough, abrasive edges that
put it at risk of fraying, twisting, or moving around within the implantation area.
introduce no other evidence that Ethicon’s alleged failure to warn was the proximate cause of their
injuries. Summary judgment is proper.
IT IS THEREFORE ORDERED that the Motion for Partial Summary Judgment filed by
Defendant Ethicon Inc. [Dkt. No. 25] is GRANTED.
Dated this 1st day of September 2021.
_______________________________
JOHN F. HEIL, III
UNITED STATES DISTRICT JUDGE