United States District Court, S.D. Illinois
J. ROSENSTENGEL UNITED STATES DISTRICT JUDGE.
January 19, 2017, Defendants filed several nearly identical
motions for summary judgment claiming absolute immunity under
the statutory defense established by the Michigan products
liability law. Compare (Case No. 12-CV-163, Doc.
82) with (Case N. 14-CV-1069, Doc. 13). The
applicable Plaintiffs filed uniform responses to the motions
on February 2, 2017. See e.g., (Case No. 14-CV-1069,
Doc. 14); (Case No. 13-CV-414, Doc. 15). On February 9, 2017,
Defendants filed uniform replies to Plaintiffs'
responses. See e.g., (Case No. 14-CV-1069, Doc. 15);
(Case. No. 14-CV-414, Doc. 16).
claim immunity under the statutory defense established by the
Michigan products liability law, which states:
In a product liability action against a manufacturer or
seller, a product that is a drug is not defective or
unreasonably dangerous, and the manufacturer is not liable if
the drug was approved for safety and efficacy by the United
States food and drug administration, and the drug and its
labeling were in compliance with the United States food and
drug administration's approval at the time the drug left
the control of the manufacturer or seller.
Comp. Laws Ann. § 600.2946(5).
Michigan legislature carved out two exceptions, when a drug
manufacturer or seller:
(a) Intentionally withholds from or misrepresents to the
United States food and drug administration information
concerning the drug that is required to be submitted under
the federal food, drug, and cosmetic act, 675, 62 Stat. 1040,
21 U.S.C. 301 to 321, 331 to 343-2, 344 to 346a, 347, 348 to
353, 355 to 360, 360b to 376, and 378 to 395, and the drug
would not have been approved, or the United States food and
drug administration would have withdrawn approval for the
drug if the information were accurately submitted; or (b)
make an illegal payment to an official or employee of the
United States food and drug administration for the purpose of
securing or maintaining approval of the drug.
Comp. Laws Ann. § 600.2946(5).
claim that Depakote and “its prescribing
information” were FDA approved “at all relevant
times.” (Doc. 52, p. 9). Further, they claim that
Depakote does not fall within the immunity exceptions,
because the FDA did not order Depakote be taken off the
market, the FDA did not withdraw its approval of Depakote,
and Abbott did not intentionally withhold or misrepresent
information concerning Depakote from the FDA. (Doc. 52, p.
10). Plaintiffs make a number of assertions concerning the
inapplicability of Defendants' alleged immunity; however,
the assertion relevant to this Order concerns the lack of
evidence provided by Defendants.
under the Michigan statute § 600.2946(5) is an
affirmative defense, which places the burden of proof on the
Defendants. Taylor v. Smithkline Beecham Corp, 658
N.W.2d 127, 131 (Mich. 2003). Plaintiffs assert that:
…if a manufacturer fails to prove that its drug was
FDA approved or that the drug and
its labeling were in compliance with FDA's approval, the
burden does not shift to the claimant to prove a statutory
exception to this affirmative defense….While Abbott
has asserted, and Plaintiffs do not dispute, that Depakote is
FDA approved, Abbott disregards its additional burden to
establish that Depakote and its labeling have been in
compliance with FDA's approval at all relevant times.
(Doc. 53, at p. 9).
support of their motion, Defendants provided the
Physicians' Deck References (“PDRs”) for each
label year. (Doc. 53-2; 53-5). The PDRs (along with a letter
from the FDA approving the initial Depakote application in
the 1980's and a similar letter approving Depakote ER in
1999) form the only evidence supporting the claim of
immunity. While the PDRs demonstrate that Depakote received
FDA approval for each label, they do not show that the
“drug and its labeling were in compliance with the
United States food and drug administration's approval
at the time the drug left the control of the
manufacturer or seller.” Mich. Comp. Laws Ann.
§ 600.2946(5) (emphasis added).
their response, Plaintiffs imply that because Defendants did
not provide the necessary evidence in their primary brief,
the motion must be denied by default. (Doc. 53, at pp. 9-10).
The Court does not agree. Upon finding that a party has
failed to properly support or address a fact, a court may
“give an opportunity to properly support or address the
fact, ” Fed.R.Civ.P. 56(e)(1), or “issue any
other appropriate order.” Fed.R.Civ.P. 56(e)(4).
“Where the reply affidavit merely responds to matters
placed in issue by the opposition brief and does not spring
upon the opposing party new reasons for the entry of summary
judgment reply papers -both briefs and affidavits-may
properly address those issues.” Beck v. Univ. of
Wis. Bd. of Regents,75 F.3d 1130, 1134 (7th Cir. 1996);
Baugh v. City of Milwaukee,823 F.Supp. 1452,