FECHO et al v. ELI LILLY AND COMPANY et al
Filing
237
Magistrate Judge Marianne B. Bowler: ORDER entered. MEMORANDUM AND ORDER. (Feeney, Eileen)
UNITED STATES DISTRICT COURT
DISTRICT OF MASSACHUSETTS
MICHELE FECHO, et al.,
Plaintiffs,
v.
CIVIL ACTION NO.
11-10152-MBB
ELI LILLY AND COMPANY, et al.,
Defendants.
MEMORANDUM AND ORDER
January 20, 2012
BOWLER, U.S.M.J.
For the convenience of the parties, this opinion reduces to
writing the oral ruling on the motions in limine (Docket Entry ##
181-184, 185-191, 193-194 and 199) made in open court on January
19, 2012.
The ruling is as follows:
First, I want to thank all counsel for presenting more than
ten days of highly technical and complex testimony and argument
in such a very skilled and professional fashion.
In order to
expedite this matter given the age and health of plaintiffs and
given the delays in concluding the testimony, it is my preference
to give you an oral ruling which allows for a more prompt and
efficient resolution rather than a written opinion, which will
require an additional period of time.
First, I find that the experts plaintiff proposes satisfy
the requirements of providing opinions that will assist the trier
of fact.
I also find and reiterate that they are all qualified
as experts in their fields.
However, I found Ms. Retha Newbold
to be the weakest in terms of qualifications and testimony by a
significant margin.
Federal Rule of Evidence 702 further dictates that a witness
qualified as an expert may offer scientific testimony if “(1) the
testimony is based upon sufficient facts or data, (2) the
testimony is the product of reliable principles and methods, and
(3) the witness has applied the principles and methods reliably
to the facts of the case.”
Rule 702, F.R.E.
Overall, this court
performs “a gate-keeping function” under Rule 702 “to ensure that
an expert’s testimony ‘both rests on a reliable foundation and is
relevant to the task at hand.’”
U.S. v. Mooney, 315 F.3d 54, 62
(1st Cir. 2002) (quoting Daubert v. Merrell Dow Pharm., Inc., 509
U.S. 579, 597 (1993)).
I have considered the reliability as well as the relevance
of the opinions and the testimony of each of plaintiff’s experts.
Recognizing that an observed association between a disease, in
this instance breast cancer, and in utero exposure to DES does
not, without more, create causation, as discussed in Milward v.
Acuity Specialty Products Group, Inc., 639 F.3d 11 (1st Cir.
2011), at pages 17 to 19, I have also considered the Bradford
Hill viewpoints that counsel have so competently brought out
during the testimony.
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Plaintiff presented the following experts:
Dr. Hans-Olov
Adami; Dr. Paul I. Roda; Dr. David Sassoon; Dr. Robin Fischer;
Ms. Retha R. Newbold; and Dr. Leena Hilakivi-Clarke.
I have not
included the specific academic degrees of the aforementioned
experts.
They are set forth in the experts’ CVs which are part
of the record pursuant to a stipulation which appears in the
record at Docket Entry 236.
I find that their methodology in
arriving at their opinions rests on a reliable foundation and, as
previously stated, their testimony will assist the trier of fact.
Defendant Eli Lilly’s motion to exclude plaintiffs’ experts
(Docket Entry # 181) is therefore DENIED except for the
admissibility of the testimony of Dr. Arnold Schwartz, M.D.,
Ph.D., which I find moot at this point in time.
The same ruling
applies to the motions to exclude brought by the other
defendants, including the motion to exclude filed by defendant
Bristol Meyers Squibb Company.
For the record, these motions are
Docket Entries 182 through 191, 193, 194 and 199.
I would simply add that the facts of this case are somewhat
unique.
We have a relatively defined cohort of women inasmuch as
no scientist today is going to give pregnant women DES today
along with a control group and assess the development in their
offspring of breast cancer years later.
It is therefore
difficult, if not impossible, to conduct human studies to test
the consistency of the association between the environmental
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exposure to DES in utero and the subsequent development of breast
cancer.
The temporal relationship between the exposure and the
development of the disease, however, tracks the natural age at
which breast cancer typically appears and breast cancer is not a
rare disease.
Each of plaintiff’s experts, however, considered a range of
plausible explanations in the context of his or her field of
expertise both in their testimony and in rendering their
opinions.
studies.
A number of them testified about relevant published
Dr. Adami in particular plausibility explained the
merits of the Palmer 2006 study along with the confidence
intervals therein and addressed the reliability of her findings
and methodology, including her finding of a statistically
significant increased risk of developing breast cancer in the
subset of women over 40 after she controlled for confounding
factors.
I recognize the dangers and deficiencies in slicing
data into subgroups that could be characterized as too thin.
That said, we now have a second human study in Hoover 2011,
which I note arrived at a slightly smaller hazard ratio than
Palmer 2006.
Recognizing that there were five additional breast
cancer cases in the over 40 subset, only one of which occurred in
the DES exposed group, Dr. Adami explained that Hoover 2011
excluded the Horn cohort, which was present in Palmer 2006, due
to an absence of information about vaginal epithelial changes in
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the Horn cohort.
Dr. Adami also evaluated the data, including
the confidence intervals in Hoover 2011, discounted an excess
risk calculation in preference for a proportionate hazards model
and found that Hoover 2011 further strengthened the causal link.
It is also notable that the Hoover 2011 article was
published in the New England Journal of Medicine which lends
additional support for Dr. Adami’s testimony.
As testified to by
Dr. Adami, the New England Journal of Medicine is a prestigious
and esteemed journal which examines proposed articles in a most
rigorous fashion with internal and external reviewers and
independent statistical experts.
Indeed, publication in this
particular journal is recognition of a development that
clinicians should take into consideration in the daily practice
of medicine.
I am therefore ordering the parties to mediation with all
due dispatch.
Finally, with all that has been said, plaintiffs
still face an uphill battle.
/s/ Marianne B. Bowler
MARIANNE B. BOWLER
United States Magistrate Judge
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