Bartlett v. Mutual Pharmaceutical

Bartlett v. Mutual Pharmaceutical      CV-08-358-JL   11/02/09
                   UNITED STATES DISTRICT COURT
                     DISTRICT OF NEW HAMPSHIRE


Karen L. Bartlett
and Gregory S. Bartlett

      v.                             Civil No. 08-cv-358-JL
                                     Opinion No. 

Mutual Pharmaceutical
Company, Inc., et al.


                          MEMORANDUM ORDER

      Plaintiffs have filed a motion for sanctions under Rule 37

of the Federal Rules of Civil Procedure in response to the

defendant Mutual Pharmaceutical Company's belated production of

certain documents.   After reviewing the parties' written

submissions and hearing oral argument,   this court grants the

motion in part and denies it in part.    As explained below. Mutual

lacked a substantial justification for failing to produce the

documents in a timely manner and is therefore subject to

sanctions.   Because Mutual acted in good faith, however,   the

court allows only some of the relief that the plaintiffs have

reguested.



I.   Applicable legal standard

      Rule 37 provides for discovery sanctions in a number of

different situations,   two of which the plaintiffs invoke here.

The first is when a party "fails to obey an order to provide or
permit discovery."         Fed. R. Civ. P. 3 7 (b)(2)(A).   As its plain

language suggests. Rule 37 (b) reguires the moving party to

establish "two things as conditions precedent to engaging the

gears of the rule's sanction machinery: a court order must be in

effect, and then must be violated."          Ortiz-Lopez v. Socieded

Espanola de Auxilio Mutuo & Benefiencia de P.R., 

(1st Cir. 2001)         (guoting R.W. Int'l Corp. v. Welch Foods,    Inc.,

937 F .2d 11, 15        (1st Cir. 1991)).

      The second situation is when a party fails to supplement its

discovery responses,        as reguired by Rule 26(e), upon learning

that its earlier production is materially incomplete or

incorrect.      Fed. R. Civ. P. 37(c) (1).     Unlike the first

situation, no court order needs to be in place for the imposition

of Rule 37(c)     sanctions.      See Ortiz-Lopez, 248 F.2d at 33;

Thibeault v. Sguare D Co., 

          (1st Cir. 1992).

Rather, once the moving party has shown a violation of Rule

26(e), the party facing sanctions for belated disclosure has the

obligation to show that its failure to comply with the rule was

either "substantially justified" or "harmless."             Fed. R. Civ. P.

37(c)(1); Wilson v. Bradlees of New Eng.,         Inc., 

(1st C i r . 2 0 01).




                                        2
II.   Background

      This court recently summarized the plaintiffs'   allegations

as follows:

           In December 2004, Karen Bartlett's physician
      prescribed her Sulindac, a non-steroidal anti­
      inflammatory drug manufactured by the defendants, for
      pain in her right shoulder.  Within weeks of filling
      the prescription, she went to a local emergency room
      complaining of "pimple like bumps, spots or blisters on
      her face, a fever, eye irritation," and other symptoms.
      She was soon diagnosed with Stevens-Johnson syndrome
      progressing to toxic epidermal necrolysis, a serious
      and potentially fatal condition characterized by large
      areas of lesions on and necrosis of the skin and mucous
      membranes.  See Borland's Illustrated Medical
      Dictionary 1872 (31st ed. 2007).  She spent
      approximately three months in the hospital recovering,
      including two months in a medically induced coma, and
      emerged with permanent injuries.
           Sulindac is the generic version of a drug
      originally approved by the FDA in 1978; the generic
      version at issue here was approved in 1991.   The
      Bartletts allege that, following this approval, the
      defendants "had an ongoing duty to conduct
      postmarketing safety surveillance for any reports of
      serious adverse events associated with Sulindac
      including any such report in the medical literature"
      and that, had they done so, they would have uncovered
      information compelling them "to warn physicians about
      the dangers" of the drug, including associations with
      Stevens-Johnson syndrome and toxic epidermal
      necrolysis.

Bartlett v. M u t . Pharm. Co., ___ F. Supp. 2d ___ , 

   (denying defendants' motion for judgment on the pleadings).

      During discovery,   the Bartletts reguested that Mutual

produce "[a]ny and all Annual and Periodic Reports filed by

[defendants]   for any Sulindac products."   Federal regulations

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require companies that hold applications for new drug approval

(known as "ANDAs" and "NDAs")   to file periodic reports with the

Food & Drug Administration    ("FDA") describing any adverse event

information relating to those drugs,      see 

(c)(2), and also to file annual reports that summarize any

"significant new information" that might affect the drug's

"safety, effectiveness,   or labeling."     See i d . § 314.81(b) (2) (i) .

Reports that reflect adverse event information must be retained

by the ANDA holder for at least ten years.       See i d . § 314.80(1).

Since Mutual has held an ANDA for Sulindac since 1991, the

Bartletts expected to receive at least a decade's worth of annual

and periodic reports in discovery.     Mutual, however, produced

only three periodic reports    (from 2001-02 and 2008)      and no annual

reports.

     Shortly after this production,    on January 2, 2009, the

parties held a court-ordered telephone conference to address

unresolved discovery issues.1    During the conference. Mutual's




     1The relevant order stated "the court will likely assess
fees and costs against the parties and/or counsel for any
discovery disputes with respect to which their positions are
deemed unreasonable or not well supported by applicable law."
Document no. 48. About a month later, in advance of a hearing on
plaintiffs' motion to compel discovery, this court again stated
in a margin order that "positions deemed unreasonable by the
court at the hearing will result in commensurate awards of
attorneys' fees and costs."

                                  4
counsel stated that "we already produced" all annual and periodic

reports and that an affidavit to this effect would be

forthcoming.    The affidavit,   signed on January 21, 2009 by

Mutual's Vice President of Regulatory Affairs, Robert Rettery,

stated:   "Following reasonable inguiry. Mutual has produced all

adverse event related documents in its possession regarding

[S]ulindac,    including ... periodic reports."

     On August 14, 2009, one month before the scheduled close of

discovery, plaintiffs'    counsel mentioned to Mutual's counsel that

they had been unable to locate all of the annual and periodic

reports in Mutual's production.     Mutual's counsel replied that

"you have everything there is."     But on August 28, 2009, in

connection with Rettery's deposition. Mutual's counsel learned

that this statement had been incorrect and that additional annual

and periodic reports existed in Mutual's off-site storage,

unknown to Rettery but known to his subordinate Andria Werynski,

Mutual's Manager of Regulatory Affairs, who had helped with the

initial production of the three periodic reports.

     Mutual produced the additional periodic reports on September

1, 2009 and the additional annual reports on September 8, 2009,

one week before the scheduled close of discovery and plaintiffs'

expert disclosure deadline.      The reports totaled 4277 pages --

more than Mutual's entire production up to that point     (3687


                                    5
pages).     As it turned out, none of them reported any adverse

events.     The only three reports with adverse event information

were the ones that Mutual had produced earlier in the case.

Notwithstanding the late production, plaintiffs managed to review

the additional reports,     forward them to their experts to

consider,    and meet their expert disclosure deadline.

       Plaintiffs now reguest discovery sanctions under Rule 37.

Specifically,     the plaintiffs have reguested that the court    (a)

exclude the reports from evidence;      (b) allow plaintiffs to

conduct an on-site inspection for additional responsive documents

in Mutual's possession; and     (c) award attorneys'   fees and costs

caused by the discovery error.2



Ill.   Analysis

       Plaintiffs have invoked two separate grounds for imposing

Rule 37 sanctions on Mutual:      failure to comply with a discovery

order under Rule 3 7 (b) and failure to supplement discovery under

Rule 3 7 (c).   As explained below. Mutual has not violated a



     2In the event that such relief is denied, plaintiffs
alternatively reguest the opportunity to conduct discovery of the
facts underlying Mutual's late production.   In light of the other
relief granted in this order, the court need not reach -- and, in
any event, declines to grant -- this alternative reguest.   The
court sees little value in conducting such discovery at this
point, particularly after the extensive discussion of the
underlying facts at oral argument.

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specific discovery order and thus cannot be sanctioned under Rule

3 7 (b).   Nevertheless, Mutual failed to supplement its document

production, which was neither substantially justified nor

harmless,    and is therefore subject to sanctions under Rule 37(c) .

Because Mutual acted in good faith, however,       the court grants

only some of the relief reguested by plaintiffs.



A.    Rule 37(b)

       Plaintiffs have not established either of the two

prereguisites for discovery sanctions under Rule 37 (b) :      first,

that the court issued an applicable discovery order; and second,

that the defendants violated it.        See Ortiz-Lopez, 

.    Plaintiffs point to two general orders from this court

warning the parties not to take unreasonable positions in

discovery.     See note 1, supra.   But neither order mentions

plaintiffs'    reguest for annual and periodic reports, or even the

completeness of the defendants'     document production.    "The

proposition that an order to answer specific       [discovery reguests]

can be implied from such a blanket directive -- a directive which

does not mention the subject matter inguired into -- is

inconsistent with both the structure and language of Rule 37."




                                    7
R.W. Int'1 Corp., 937 F.2d at 16.      Accordingly,   this court cannot

grant discovery sanctions under Rule 37(b).3



B.   Rule 37(c)

      Rule 3 7 (c) authorizes discovery sanctions when a party fails

to supplement its discovery responses as reguired by Rule 26(e),

"unless the failure was substantially justified or is harmless."

Fed. R. Civ. P. 37(c)(1); see also Ortiz-Lopez, 248 F.2d at 33.

Rule 26(e),   in turn, reguires a party who has responded to a

reguest for production to supplement or correct its response "in

a timely manner if the party learns that in some material respect

the disclosure or response is incomplete or incorrect."        Fed. R.

Civ. P. 26( e ) (1).   The court of appeals has said that Rule 37(c)

"clearly contemplates stricter adherence to discovery

reguirements, and harsher sanctions for breaches."        Gagnon v.

Teledyne Princeton,     Inc., 

   (1st Cir. 2006)

(guotation omitted).

     As an initial matter. Mutual argues that it complied with

Rule 26(e) because it supplemented its production with the

missing reports as soon as possible after learning that its

earlier production had been incomplete -- and still met the



     3At oral argument, plaintiffs'    counsel appeared to concede
this point.
discovery deadline.     The court disagrees.    Mutual has conceded

that its Manager of Regulatory Affairs      (Werynski)   knew all along

about the off-site storage of the reports, even if Mutual's

counsel and its Vice President of Regulatory Affairs        (Rettery)

did not.     Werynski helped with Mutual's earlier production of

three periodic reports and easily could have been, but was not,

asked to retrieve the rest of the reports.       Under basic agency

principles, her knowledge can be imputed to Mutual for purposes

of Rule 26(e).     Moreover,   there is some authority for the

proposition that Rule 26(e)      reguires a party to turn over not

only responsive documents of which it is actually aware, but also

documents of which it reasonably should be aware.         See 7 James

Wm. Moore et al., Moore's Federal Practice § 26.131[3]        (3d ed.

2009)    (citing Arthur v. Atkinson Freight Lines Corp., 

    (S.D.N.Y. 1995)); but see Zubulake v. UBS Warburg LLC, 22 

    (S.D.N.Y. 2004)   (reguiring "actual knowledge")

(guoting F.R.C.P. 26(e), advisory committee notes        (1970)).

Regardless of which standard applies. Mutual both knew and should

have known about the off-site reports and thus had a duty to

supplement its production under Rule 26(e).

        As to the timing of the additional production. Rule 26(e)

reguires supplementation in a "timely manner."       Mutual produced

the additional reports eight months after expressly representing
to the plaintiffs that all such reports had been produced.       This

production, while made just before the discovery deadline, was

not timely.    Mutual objects that the plaintiffs also waited eight

months before raising concerns about the missing reports.       But

the duty to supplement under Rule 26(e) does not depend upon

repeated reguests by an adversary for updated or complete

information.    See AVX Corp. v. Cabot Corp., 

       (D.

Mass. 2008)    (citing Arthur, 

, and Moore,   supra,

at § 26.131[3]).    This court therefore finds that Mutual violated

Rule 2 6(e).

     Mutual has not shown a substantial justification for its

late production of the reports.     Plaintiffs made a very specific

reguest for them, which the parties expressly discussed at a

court-ordered conference.    Unlike a broad reguest for all

documents relating to a given topic, which can present a complex

challenge for document collection and review, this reguest

targeted a discrete and easily identifiable set of formal FDA

filings.   They are standard fare for discovery in pharmaceutical

litigation of this sort.    Given that Mutual made a fairly small

document production    (less than 4000 pages)   that included only

three periodic reports, the absence of the remaining periodic

reports and all of the annual reports    (which together exceed 4000

pages) was glaring and should have caused Mutual and its counsel


                                  10
to take the reasonable steps necessary to locate them.       See

Sheppard v. River Valley Fitness One, L.P., 

         (1st

Cir. 2005)    (stating that the phrase "substantially justified"

under Rule 37 means "justified to a degree that could satisfy a

reasonable person")    (guoting Pierce v. Underwood, 

   (1988) ) .

      Mutual claims that it failed to notice the omission because

the production, which it made electronically,    included a folder

entitled "ANDA & FDA Correspondence."     The ANDA,   it says, is a

living document that ordinarily would include all annual and

periodic reports filed with the FDA to date.     At oral argument.

Mutual conceded that if someone familiar with ANDAs had reviewed

the electronic folder, he or she would have known that parts of

the ANDA were missing.    The only person who reviewed the folder

before production, however,   appears to have been a paralegal

checking for privilege and confidentiality    (not content).       This

court recognizes that today's electronic productions tend to be

larger and less tangible than paper productions in the past,

potentially making it harder to notice omissions.      But in this

case. Mutual's entire production totaled less than 4000 pages,

which -- regardless of format -- would not have taken long to




                                  11
review.4   Mutual was not substantially justified in assuming that

the ANDA folder contained all of the annual and periodic reports,

without making a reasonable effort to verify its contents.        See,

e.g., Gagnon, 

    (finding no substantial

justification where party did not satisfy its "obligation to

investigate" the discovery issue).

     Mutual also emphasizes that its senior regulatory affairs

executive simply made a good-faith mistake, believing that the

reports had been destroyed until he learned from a subordinate

that they were actually being stored off-site.     The court takes

Mutual at its word.    Nevertheless, even good-faith mistakes can

lack a substantial justification and thus be sanctionable under

Rule 3 7 (c).   See, e.g., Thibeault, 

    (mentioning

"laxity" as an example).     This court rejects the notion that a

senior executive's belief that certain documents have been

destroyed -- without personal knowledge and without consulting

the employees most familiar with such documents -- relieves a

company of its obligation to search any further.        Here, Mutual's

failure to produce the additional reports until a week before the

close of discovery, despite the plaintiffs'    straightforward



      4Indeed, after catching the mistake and retrieving the
additional reports. Mutual's counsel apparently took the time to
review them all before production, which occurred in a matter of
days.   See Document no. 64, at 7 n.7.

                                  12
document request and Mutual's express representation that the

reports had already been produced months earlier, was not

substantially justified.       See Primus v. United States, 

    (1st Cir. 2004)   (affirming Rule 37(c)   sanctions where

the district court "considered, but was unimpressed with,        [the

party's]    explanations for her tardiness").

     Nor can Mutual's discovery error be called harmless.          The

Bartletts proceeded for eight months in reliance on Mutual's

false representations that all annual and periodic reports in it

possession had been produced.       Indeed, the Bartletts were

planning to seek a spoliation instruction at trial that would

allow the jury to infer that the missing reports contained

adverse event information.       They prepared to -- and did -- ask

about the reports in multiple depositions of Mutual employees,

hoping to lay the groundwork for such an instruction.         Mutual's

late production negated this trial strategy and the efforts

devoted to it.     Moreover, by the time the reports were finally

produced,    the Bartletts'   expert disclosure deadline was only a

week away.     Thus, whether or not the experts ultimately referred

to or relied on the new information,      it had to be reviewed,

analyzed,    and factored into their expert disclosures on an

expedited basis.     These efforts may not have been devastating to

the Bartletts'    case, but neither were they harmless.      See Primus


    (finding sanctions justified where "real

resources were expended on legal work that was premised on" the

discovery error); Gagnon, 

        (calling harmlessness

"a fairly limited concept" and "the smaller escape valve in Rule

37(c)(1)").     Mutual's discovery error is therefore sanctionable

under Rule 3 7 (c).



C.      Appropriate relief

        This court has broad discretion under Rule 3 7 (c) to "fashion

an appropriate sanction from a wide range of options."

Thibeault, 

; see also LaPlace-Bayard v. Batlle,

     (1st Cir. 2002).    These options include

striking the documents from evidence,       ordering payment of

reasonable attorney's fees and expenses caused by the discovery

error,    informing the jury of the error, or imposing any "other

appropriate sanctions."       Fed. R. Civ. P. 37(c) (1) (A)- (C) .   As the

court of appeals has explained,      "[t]he range of sanctions

provided in Rule 3 7 (c)     ... gives the district court leeway to

best match the degree of non-compliance with the purpose of Rule

2 6 ' s mandatory disclosure reguirements."     Ortiz-Lopez, 

    (citing Poulin v. Greer, 

   (1st Cir. 1994)).

In choosing the appropriate sanction, the court may consider a

variety of factors,    including the reason for the error, whether

                                     14
the party made it in good faith, the history of the litigation,

the significance of the documents,      the prejudice caused by the

error, the other party's ability to overcome it, and the need to

deter other litigants from disregarding procedural rules.            See,

e.g., Santiago-Diaz v. Laboratorio Clinico &; de R e f e r e n d a del

Este, 

    (1st Cir. 2006); Gagnon, 

; Thibeault, 

 & n.4.

     The most common sanction for Rule 3 7 (c) violations,       and the

first one that the Bartletts reguest,      is the exclusion from

evidence of the relevant documents.       See, e.g., Lohnes v. Level 3

Commc'ns, Inc., 

     (1st Cir. 2001).      For more

serious violations,   this sanction is "near automatic."        Wilson,

.    Where appropriate, however,    the rule also

expressly allows a court to impose other relief "instead of this

sanction."    Fed. R. Civ. P. 37(c)     (emphasis added); see also

Santiago-Diaz, 

     (confirming that "district courts

have some discretion in deciding whether or not to impose that

onerous sanction")    (citing Jackson v. Harvard Univ., 

   (1st Cir. 1990)).   In this case, the court considers

exclusion to be an inappropriate remedy for a variety of reasons.

First, Mutual made the discovery error in good faith, without any

intent to disregard the procedural rules.       Second,    it is unclear

which party would benefit more from the inclusion or exclusion of


                                   15
the reports.5   Third, the plaintiffs already managed to review

the documents and factor them into their expert disclosures,

albeit under unnecessary time pressure,    and will not be unfairly

prejudiced by their inclusion in evidence going forward.       In

contrast, excluding the documents could leave an unexplained and

potentially confusing gap in the evidentiary record at trial.

See Jackson, 

   (declining to impose exclusion

sanction where it would "serve[] only further to suppress

evidence" and would not be "appropriate to the truth-finding

process").   For all these reasons, the court declines to exclude

the reports from evidence.

     Next, the Bartletts reguest an opportunity to conduct an on­

site inspection of Mutual's computer systems,    searching for

emails and other documents that reflect adverse event information

relating to Sulindac and four other drugs manufactured by Mutual

(ibuprofen, tolmetin,   indomethacin,   and Bactrim).   The purpose of

this inspection,   they say, would be to provide independent

confirmation that Mutual's production has been comprehensive.



     50n one hand, the reports do not identify any adverse event
information relating to Sulindac, making them potentially
beneficial to Mutual.  On the other hand, the Bartletts (despite
reguesting their exclusion from evidence) go so far as to call
the reports "incriminatory" of Mutual in that they "demonstrate
violations of the code of federal regulations." Exclusion is
less likely to be an effective remedy in these circumstances.
See Fed. R. Civ. P. 37(c), advisory committee notes (1993).

                                 16
Plaintiffs acknowledge that they have not targeted the four

additional drugs in their prior discovery reguests, but claim

that recent depositions have given them reason to believe that

Mutual might have learned about Sulindac's adverse effects in

connection with those other drugs.

     This court agrees that Mutual's late production of the

annual and periodic reports, which exceeded the size of its

entire original production,   raises concerns about whether its

production has been thorough.    At the same time, the court takes

Mutual at its word that it has made the production in good faith.

On balance,   the court finds that some "double-checking" of

Mutual's production is necessary and appropriate, but that it can

be conducted by Mutual and its counsel rather than by plaintiffs

and their counsel, which will help to mitigate any countervailing

concerns raised by Mutual about the handling of privileged

materials.

     As to the four additional drugs, the court considers it fair

and fitting, given how long it took Mutual to produce the

Sulindac reports, to allow some additional discovery at this

stage by the Bartletts.    They bore the burdens of Mutual's late

production,   and so deserve the benefits as well.   Their reguested

discovery seems reasonably calculated to lead to the discovery of

admissible evidence and, moreover,    should help to confirm whether


                                 17
Mutual's production as to Sulindac and its adverse effects has

been comprehensive.       Under the circumstances,      such relief is the

"best match" for Mutual's discovery error.            Ortiz-Lopez, 

; c f . Jackson, 

      (deeming "further discovery"

to be an appropriate "response to the problems created by             [a

party's]    negligence").6

     The court therefore orders Mutual to conduct a reasonable

review and to confirm,       in a writing submitted to this court

within 45 days of this order, that it has produced to the

plaintiffs all documents       (including emails)     in its possession,

custody, or control that relate to Stevens-Johnson syndrome,

toxic epidermal necrolysis, drug rash with eosinophilia and

systemic symptoms, erythema multiforme,        or other serious skin

reactions,    in connection with any of the following five drugs:

Sulindac,    ibuprofen,   tolmetin,   indomethacin,    and Bactrim   (both

branded and generic).




     6The court notes that it could allow such relief even in the
absence of a Rule 3 7 (c) violation, under its inherent authority
to regulate the discovery process, and, in the alternative,
orders the production on that basis.    See, e.g., Vineberg v.
Bissonnette, 

 (1st Cir. 2008); U.S. v. Saver,

 (1st Cir. 2006); Williams v. Monarch Mach.
Tool C o ., 

 (1st Cir. 1994) . Discovery is still
underway at this point, thanks in part to Mutual's successful
push, over the Bartletts' objection, for an extension of the
discovery and trial schedule.

                                      18
      Finally, the Bartletts seek reimbursement from Mutual of

their attorneys'   fees and costs caused by Mutual's discovery

error.   The court of appeals has called this one of the "more

moderate" sanctions available under Rule 37(c).       I d . at 34.   This

court considers such an award necessary and appropriate here,

given the harm that Mutual's error caused, the lack of

substantial justification for the error, and the other

considerations discussed above.      The court therefore orders

Mutual to reimburse the plaintiffs for their reasonable

attorneys'   fees and costs caused by the late production of the

annual and periodic reports,    including fees and costs associated

with litigating the motion for sanctions.      In light of the good-

faith nature of Mutual's error, however,     the court strongly

cautions the plaintiffs to avoid any over-reaching as to the

amount of fees and costs reguested.      All such fees and costs

should be substantiated and clearly attributable to Mutual's late

production.


IV.   Conclusion

      For the foregoing reasons, plaintiffs' motion for sanctions7

is GRANTED as to parts    (b) and   (c), subject to the limitations

set forth in this order, and otherwise DENIED as to parts        (a),



      7Document no. 67.

                                    19
(d) , and    (e) .   Mutual shall submit to this court within 45 days

of this order a written confirmation that it has conducted the

review and document production ordered by Part III.C,        infra.      In

addition,     if the parties cannot agree on a reasonable amount of

attorneys'     fees and costs,   see i d ., plaintiffs shall submit to

the court, within 14 days of this order, an itemized bill, with

the opportunity for Mutual to respond within 14 days of such

filing.

      SO ORDERED.




                                    Joseph N. Laplante
                                    Ur/lted States District Judge

Dated:      November 2, 2009

cc:   Bryan Ballew, Esq.
      Keith M. Jensen, Esq.
      Christine M. Craig, Esq.
      Timothy P. Beaupre, Esq.
      Patrick J. O'Neal, Esq.
      Paul J. Cosgrove, Esq.
      Jeffrey D. Geoppinger, Esq.
      Joseph P. Thomas, Esq.
      Linda E. Maichl, Esq.
      Stephen J. Judge, Esq.




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