Source: s3://data.kl3m.ai/documents/govinfo/USCOURTS/USCOURTS-ared-4_05-cv-00567/USCOURTS-ared-4_05-cv-00567-3/pdf.json

Nature of Suit Code: 365
Nature of Suit: Personal Injury - Product Liability
Cause of Action: 28:1332 Diversity-Personal Injury-Product Liability

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IN THE UNITED STATES DISTRICT COURT

EASTERN DISTRICT OF ARKANSAS

WESTERN DIVISION

CHARLES ROBERT PERRY PLAINTIFF

vs. CASE NO. 4:05CV567GH

ETHICON, INC.; ET AL. DEFENDANTS 

ORDER 

Pending before the Court are a number of motions concerning discovery. Plaintiff

has filed a fourth motion to compel, seeking responses to requests for production 38 to 43.

He has filed a motion for sanctions, based on defendants’ failure to provide discovery

within the time ordered and agreed by the parties. He has also filed a motion to enforce

the discovery order of October 27, 2005, asserting that defendants have improperly

redacted the identities of surgeons, nurses and hospitals submitting reports on the

malfunctions of defendants’ surgical staplers.

It appears that the parties have attempted to create a joint plan for providing

outstanding discovery. Defendants agreed to provide plaintiff with copies of certain

requested discovery and to make other documents available for plaintiff to review and copy

at EES’s corporate headquarters in Cincinnati, Ohio during the week of January 9, 2006.

 Plaintiff did not object to holding the motion for sanctions in abeyance until plaintiff has

determined whether all the records are produced for inspection in Cincinnati. The time has

passed and plaintiff has not notified the Court of any outstanding discovery disputes. It

therefore appears that defendants have produced the information requested in requests

for production 38 to 43. Thus, the fourth motion to compel is denied as moot. 

With regard to the motion for sanctions, the Court cannot find, after reviewing the

record, that defendants’ conduct is so egregious as to warrant the imposition of sanctions.

Thus, the motion for sanctions is denied.

Case 4:05-cv-00567-GH Document 39 Filed 01/23/06 Page 1 of 3
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In his motion to enforce the discovery order, plaintiff states that defendants

improperly redacted information on the Product Inquiry Verification Reports (“PIVRs”) and

the Medical Device Reports (“MDRs”). By Order entered on October 27, 2005, the Court

had directed defendants to produce the PIVRs and MDRs but allowed defendants to

redact information pursuant to 21 C.F.R. § 20.63(f). 

The PIVRs are reports made by individuals or hospitals reporting stapler

malfunctions to defendants. Plaintiff argues that they are internal records, not required to

be submitted to the Food and Drug Administration (“FDA). MDRs concerning deaths,

serious injuries or malfunctions involving the staplers are submitted to the FDA. Plaintiff

contends that 21 C. F. R. § 20.63(f) does not apply to required reports, such as the MDRs,

but only to information voluntarily submitted to the FDA. Plaintiff’s arguments are

foreclosed by the Eighth Circuit’s decision in In re Medtronic, Inc., 184 F. 2d 807 (8th Cir.

1999) and the decision of Judge Wilson in Adcox v. Medtronic Inc., 131 F. Supp.2d 1070

(E.D. Ark. 1999)(permitting discovery of voluntary reports only after redaction of identifying

information but prohibiting discovery of mandatory reports in toto). See Contratto v.

Ethicon, Inc., 225 F. R. D. 593, 599 (N.D. Calif 2004) (requiring defendant to produce

MDRs as well as complaint files with the names and other identifying information redacted

from all documents)

It is clear that defendants do not have to provide the identifying information and that

redaction of the information from the documents was proper. Therefore, the motion to

enforce the discovery is denied.

Accordingly, the fourth motion to compel (document no. 28) is denied; the first

motion for sanctions (document no. 31) is denied; the first motion to enforce discovery

order (document no. 32 is denied. 

Case 4:05-cv-00567-GH Document 39 Filed 01/23/06 Page 2 of 3
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IT IS SO ORDERED this 23rd day of January, 2006.

_______________________________

UNITED STATES DISTRICT JUDGE

Case 4:05-cv-00567-GH Document 39 Filed 01/23/06 Page 3 of 3