Caouette et al v. Bristol-Myers Squibb Company et al

Filing 41

ORDER by Judge Edward M. Chen in case 3:12-cv-01820-EMC; granting (39) Defendant's Motion for Leave to File Sur-Reply; and requiring supplemental briefing (emclc1, COURT STAFF) (Filed on 6/26/2012)

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UNITED STATES DISTRICT COURT

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NORTHERN DISTRICT OF CALIFORNIA

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JAMES CAOUETTE, et al.,

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For the Northern District of California

United States District Court

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Plaintiffs,
v.
BRISTOL-MYERS SQUIBB COMPANY, et
al.,

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Defendants.
___________________________________/

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No. C-12-1814 EMC
RELATED TO
No. C-12-1815 EMC
No. C-12-1816 EMC
No. C-12-1818 EMC
No. C-12-1819 EMC
No. C-12-1820 EMC
No. C-12-1821 EMC
No. C-12-1822 EMC

AND ALL RELATED ACTIONS.

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ORDER GRANTING DEFENDANT’S
MOTION FOR LEAVE TO FILE SURREPLY; AND REQUIRING
SUPPLEMENTAL BRIEFING

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___________________________________/

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Previously, the Court held a hearing on the motions to remand in the eight related cases. Bristol-

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Myers has now moved for leave to file an omnibus sur-reply. The Court hereby GRANTS Bristol-

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Myers’s motion and further orders supplemental briefing from the parties as follows.

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By July 3, 2012, Plaintiffs in the eight related cases shall file an omnibus supplemental brief
addressing the following issues:
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Do Plaintiffs contend (as articulated at the hearing on the motions to remand) and, if so,

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based on what authority, that distributor liability in a strict products liability case is strictly “derivative”

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of the manufacturer’s liability such that a distributor can do nothing to avoid liability along with the

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manufacturer other than cessation of sales, particularly where the underlying theory is a failure to warn?

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Assuming arguendo that a distributor has an independent duty to warn in a strict products

App. 3d 168, 178 (1990) (noting that company, which “was in the business of renting skis and

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bindings,” “had an independent duty to exercise reasonable care in supplying this equipment and was

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itself subject to strict liability for failure to warn its customers of the dangerous propensities of articles

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it rented”), (a) what should McKesson have done in the instant cases to satisfy that duty and (b) how

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are those actions not inconsistent with or prohibited by federal law, including but not limited to 21

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U.S.C. § 355 and 21 C.F.R. § 314.70(a)? Compare Pliva, Inc. v. Mensing, 131 S. Ct. 2567, 2576 (2011)

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(deferring to the FDA’s position that a Dear Doctor letter qualifies as labeling; stating that “[a] Dear

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Doctor letter [from a generic manufacturer] that contained substantial new warning information would

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For the Northern District of California

liability case (where the underlying theory is a failure to warn), cf. Persons v. Salomon N. Am., 217 Cal.

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United States District Court

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not be consistent with the drug’s approved labeling”).

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3.

What weight should the Court give the FDA’s comments, in conjunction with its

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promulgation of certain labeling and advertising regulations in 1979, see 44 Fed. Reg. 37434, 37447

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(June 26, 1979) (stating that “[t]he addition to labeling and advertising of additional warnings, as well

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as contraindications, adverse reactions, and precautions regarding the drug, or the issuance of letters to

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health care professionals (e.g., ‘Dear Doctor’ letters containing such information) is not prohibited by

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these regulations”), particularly in light of the Supreme Court’s decision in Mensing?

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By July 10, 2012, Bristol-Myers shall file in the eight related cases an omnibus supplemental
brief on the following issues:
1.

For those actions Plaintiffs claim McKesson could have taken to satisfy its duty to warn,

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what specific federal statutes or regulations barred or made it impossible for McKesson from taking

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those actions? The Court seeks more than a general reference to the FDCA’s labeling laws.

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2.

What weight should the Court give the FDA’s comments, in conjunction with its

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promulgation of certain labeling and advertising regulations in 1979, see 44 Fed. Reg. 37434, 37447

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(June 26, 1979) (stating that “[t]he addition to labeling and advertising of additional warnings, as well

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as contraindications, adverse reactions, and precautions regarding the drug, or the issuance of letters to

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health care professionals (e.g., ‘Dear Doctor’ letters containing such information) is not prohibited by

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these regulations”), particularly in light of the Supreme Court’s decision in Mensing?

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Plaintiffs’ brief shall be no longer than twelve (12) pages; Bristol-Myers’s brief shall be no
longer than eight (8) pages.

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IT IS SO ORDERED.

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Dated: June 26, 2012

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EDWARD M. CHEN
United States District Judge

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For the Northern District of California

United States District Court

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