UNITED STATES DISTRICT COURT

DISTRICT OF NEW HAMPSHIRE

Karen S. Bartlett

v. Civil No. 08-cv-00358-JL

Mutual Pharmaceutical

Company, Inc.

SUMMARY ORDER

Bartlett’s motion to exclude or limit testimony by three

former FDA officials as fact witnesses (document no. 168) is

granted in part. 

1. FDA regulations, policy, or procedure

Insofar as Mutual intends for those witnesses to testify

about FDA regulations, policy, or procedure on the issue of

whether a generic drug manufacturer has the ability or

responsibility to strengthen a generic drug’s safety warning,

they are expert witnesses for whom Mutual failed to make the

disclosures required by Fed. R. Civ. P. 26(a)(2). Moreover, such

testimony is unfairly prejudicial for the reasons discussed in

this court’s recent ruling on the parties’ expert motions. See

Bartlett v. Mut. Pharm. Co., 2010 DNH 123, at 5-9; Fed. R. Evid.

403. Bartlett’s request to exclude such testimony is therefore

granted.

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2. Hypothetical FDA action

Insofar as Mutual intends for the witnesses to testify about

what the FDA hypothetically would have done in response to a

generic drug manufacturer’s attempt to strengthen a generic

drug’s safety warning, such testimony is speculative and

therefore also inadmissible. See Bartlett, 2010 DNH 123, at 7,

34 (prohibiting both parties from offering expert testimony to

that effect).

3. Personal beliefs and opinions

Insofar as Mutual intends for the witnesses to offer their

personal beliefs or opinions about generic drug labeling, such

testimony is not relevant, see Fed. R. Evid. 401, 402, and would

not be “helpful to a clear understanding of the witness’

testimony or the determination of a fact in issue,” see Fed. R.

Evid. 701. The same is true of any testimony about the beliefs

or statements of other FDA officials. Moreover, testimony about

others’ beliefs is speculative, see Bartlett, 2010 DNH 123, at 7,

and testimony about others’ statements is hearsay, see Fed. R.

Evid. 801(c). Bartlett’s request to exclude such testimony is

also granted.

4. Industry practice

To the extent that they have personal knowledge, however,

the witnesses may testify about the FDA’s actual practice in past

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cases (if any) where a generic drug manufacturer has attempted to

strengthen a generic drug’s label, or they may testify that they

have no personal knowledge of any such attempts being made during

their time at the FDA (which is what their deposition testimony

suggests). Such testimony is relevant and admissible as evidence

of industry practice. See Bartlett, 2010 DNH 123, at 8; Fed. R.

Evid. 401, 402.

5. Robert Pollock

Mutual intends to call former FDA official Robert Pollock on

the issue of FDA policies and practices, primarily pertaining to

drug labeling. Bartlett seeks to exclude Pollock from testifying

because he failed to produce a citizen’s petition that he

recently prepared for Mutual seeking the FDA’s permission to

manufacture and sell Sulindac in capsule form (as opposed to

tablets). Bartlett argues that the petition should have been

produced pursuant to this court’s order, dated September 25,

2009, that “the witnesses produce all expert designations,

reports, depositions, and trial transcripts” at least 7 days

before their depositions. But the petition is not, as Bartlett

suggests, a “report” within the meaning of Fed. R. Civ. P.

26(a)(2)(B), which is clearly what this court’s ruling meant. 

Bartlett’s request to exclude Pollack from testifying on this

basis is denied.

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Any other objections to these witnesses’ testimony will be

considered at trial, if Mutual calls them to testify.

SO ORDERED.

/s/Joseph N. Laplante

Joseph N. Laplante

United States District Judge

Dated: July 22, 2010

cc: Keith M. Jensen, Esq.

Bryan Ballew, Esq.

Patrick J. O’Neal, Esq.

Christine M. Craig, Esq.

Eric Roberson, Esq.

Timothy P. Beaupre, Esq.

Jeffrey D. Geoppinger, Esq.

Joseph P. Thomas, Esq.

Linda E. Maichl, Esq.

Paul J. Cosgrove, Esq.

Stephen J. Judge, Esq.

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