United States District Court, W.D. Oklahoma
WALTER HAMILTON and DIANNA HAMILTON, Individually and as Legal Guardians of the Person and Estate of KAITLIN HAMILTON, an Incapacitated Person, Plaintiffs,
BAYER HEALTHCARE PHARMACEUTICALS, INC., BAYER PHARMA AG, BAYER CORPORATION, BAYER HEALTHCARE LLC, BAYER HEALTHCARE AG and BAYER AG Defendants.
MEMORANDUM OPINION AND ORDER
J. CAUTHRON UNITED STATES DISTRICT JUDGE.
have filed a Motion to Exclude Expert Testimony that YAZ Has
a Higher Risk than Levonorgestrel Pills, as Irrelevant Under
Daubert (Dkt. No. 26), and a Motion to Exclude
Expert Testimony that YAZ Has a Higher Risk than Norgestimate
Pills, as Unreliable Under Daubert, and for Summary
Judgment Due to Plaintiffs' Resulting Failure to Prove
Causation (Dkt. No. 28). Plaintiffs object to each Motion,
arguing their expert has satisfied the Daubert
standards. Additionally, Plaintiffs argue the proffered
expert testimony is sufficient to establish causation.
considering the admissibility of Plaintiffs' expert's
opinions, the Court must resolve a dispute among the parties
regarding the level of risk that must be established.
Defendants argue the Plaintiffs must demonstrate that YAZ had
at least double the risk of causing a blood clot when
compared to other combined oral contraceptives
(“COC”). Defendants rely on Twyman v. GHK
Corp., 2004 OK CIV APP 53, 93 P.3d 51, for that
standard. Defendants argue that in that case the Oklahoma
Court of Civil Appeals adopted a requirement of double the
risk. Defendants direct the Court to a number of decisions
from other courts which have held that when considering
epidemiologic evidence, a doubling of the risk is necessary
to move from a possible cause to a probable cause. In
response, Plaintiffs note that no Oklahoma court has held
that a doubling of the risk is required. Rather, Plaintiffs
assert, Oklahoma only requires proof of probability not
possibility. See Kirkland v. General Motors Corp.,
1974 OK 52, ¶ 29, 521 P.2d 1353, 1363 (“Plaintiff
must prove that the product was the cause of the injury; the
mere possibility that it might have caused the injury is not
enough.”); Dutsch v. Sea Ray Boats, Inc., 1992
OK 155, ¶ 15, 845 P.2d 187, 191 (“the mere
possibility that a defect caused the injury is not
Court is persuaded by Plaintiffs' argument. Oklahoma law
requires only proof of probability. Whether that proof occurs
at risk multiples of 1.5, 1.7, or 2.0, or some other factor,
is not a requirement under Oklahoma law. Rather, there must
be proof from which a reasonable juror could determine that
the alleged defect more probably than not caused the injury.
Thus, to the extent Defendants seek a determination that
there must be double the risk, their request will be denied.
Court now turns to Defendants' challenges to
Plaintiffs' expert, Dr. Rinder. Pursuant to Fed.R.Evid.
702 and Daubert v. Merrell Dow Pharm., Inc., 509
U.S. 579 (1993), the Court must conduct a two-part inquiry
prior to permitting an expert witness to testify before a
First, the district court must “determine whether the
expert is qualified ‘by knowledge, skill, experience,
training, or education' to render an opinion.”
[United States v. Nacchio, 555 F.3d 1234, 1241 (10th
Cir. 2009) (en banc) (quoting Fed.R.Evid. 702)]. Second, if
the expert is sufficiently qualified, the district court
“must determine whether the expert's opinion is
reliable by assessing the underlying reasoning and
Schulenberg v. BNSF Ry. Co., 911 F.3d 1276, 1282-83
(10th Cir. 2018). Here, Defendants do not challenge the
qualifications of Plaintiffs' expert, Dr. Rinder. Rather,
the present Motions only attack the reliability of the
expert's opinion. According to Defendants, Dr. Rinder
cannot reach the conclusion that YAZ was more dangerous for
Kaitie because there are no studies comparing the risk of YAZ
to Ortho Tri-Cyclen, as that is the other drug that
Kaitie's dermatologist stated he would have prescribed.
Defendants argue that Ortho Tri-Cyclen contains norgestimate
(“NGM”) and Plaintiffs rely on studies comparing
YAZ to levonorgestrel (“LNG”). Defendants argue
that because the substances are different those studies
cannot be used to demonstrate the warnings in this case were
inadequate. Defendants also complain that the bulk of the
studies on which Plaintiffs rely compared Yasmin, not YAZ, to
other COCs. According to Defendants, because the amount of
estrogen in Yasmin is higher than in YAZ, those studies lack
relevance to the case at bar.
response, Plaintiffs note that it is well known that NGM
metabolizes to LNG. Plaintiffs further note the labels for
COCs containing NGM are identical to the labels on COCs
containing LNG, as the risk of VTE in the two are the same.
Plaintiffs also note that Dr. Rinder's opinion regarding
the risks of COCs containing drospirenone
(“DRSP”) such as YAZ, as compared to COCs
containing LNG, is relevant to understanding the comparative
risks of DSRP vs. NGM. Plaintiffs assert this is so because
both the FDA and researchers derive their opinions on the
safety of NGM COCs based on studies of LNG COCs. Finally, as
Plaintiffs argue, the MDL Court has previously determined the
Yasmin vs. YAZ issue and Defendants offer no reasons for
revisiting that argument.
Court finds that the arguments raised by Defendants fail to
provide any basis for excluding the testimony of Dr. Rinder.
As noted by Plaintiffs, his opinions are based on a
reasonable analysis and extrapolation of the relevant data.
There is not a great analytical gap between the studies
relied on by Dr. Rinder and his opinion. See Gen. Elec.
v. Joiner, 522 U.S. 136 (1997). Nor are Dr. Rinder's
opinions connected to the data only by an ipse
dixit. Id. Dr. Rinder has offered a reasonable
explanation for the manner in which he applied the studies to
reach his opinion that YAZ had a higher risk of VTE. Without
question, Defendants may challenge the methodology and
conclusions reached by Dr. Rinder and the jury may ultimately
determine that his opinions are insufficient to meet
Plaintiffs' burden of proof. However, at this stage, the
Court finds the reasoning and methodology underlying Dr.
Rinder's opinions are sufficient to satisfy the
gatekeeping requirements of Daubert.
reasons set forth herein, Defendants' Motion to Exclude
Expert Testimony that YAZ Has a Higher Risk than
Levonorgestrel Pills, as Irrelevant Under Daubert
(Dkt. No. 26) and Motion to Exclude Expert Testimony that YAZ
Has a Higher Risk than Norgestimate Pills, as Unreliable
Under Daubert, and for Summary Judgment Due to