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«SANDRA HERSHBERGER and DAVID MITCHELL, her husband, Plaintiffs, v. Case No. 2:10-cv-000837 ETHICON ENDO-SURGERY, INC., an Ohio corporation, a ...»

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her husband,


v. Case No. 2:10-cv-000837


an Ohio corporation, a subsidiary of JOHNSON & JOHNSON, a New Jersey corporation, Defendants.


This products liability case presents the issue of whether, pursuant to Rule 26(g), Fed. R. Civ. P., sanctions should be imposed on defendants which failed, in a timely manner, to produce discovery material relating to other similar incidents involving its product. The plaintiffs also raise other issues respecting the defendants’ conduct. The product in this case is a Proximate ILS Curved Intraluminal Stapler (model CDH29) (“the stapler”), used in a colosotomy reversal to fasten the descending colon to the rectum, a procedure called “anastomosis.” The plaintiffs’ complaint alleges that the stapler “malfunctioned and failed to discharge any staples, resulting in perforation of the colon and necessitating further surgical and other medical treatment.” (Complaint, ECF No.

1-1, at 4.) More specifically, the complaint asserts that the stapler was not loaded with staples prior to distribution. Id.

Pending before the Court is the plaintiffs’ Motion for Sanctions (ECF No. 131), supported by exhibits and a memorandum.

The defendants responded in opposition (ECF No. 212), and the plaintiffs filed a reply (ECF No. 231). An evidentiary hearing was conducted on July 28, 2011. The Motion for Sanctions is granted.

Pertinent Facts The proposed pretrial order (ECF NO. 192, at 16-30), sets forth the parties’ respective recitations of the evidence. On February 6, 2009, Sandra Hershberger underwent surgery to reverse a colostomy. The surgeons have testified that the stapler was used properly but that it did not deploy any staples when fired. Id. at 18-20. The stapler is a single-use device. The defendants contend that the stapler was fired prematurely by the surgical resident and that unformed staples can be seen on a CT scan. Id. at 26-30. The stapler was given to the surgical charge nurse.

On February 19, 2009, a meeting was held at the hospital, attended by the lead surgeon, the surgical charge nurse, the defendants’ division sales manager, Peter McNally, and the defendants’ sales representative, Cynthia Hutchings. The stapler was examined and the functioning of the stapler during Ms.

Hershberger’s surgery was discussed.

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This action was filed in the Circuit Court of Kanawha County, West Virginia on April 16, 2010 (Notice of Removal, ECF No. 1, at 1). Process was served through the Secretary of State’s Office on May 25, 2010. It was removed to this Court on June 17, 2010. Rule 26(a)(1) disclosures were due no later than September 10, 2010 (Order and Notice, ECF NO. 4). Discovery began in August, 2010 and continued very actively through early June, 2011.

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In virtually any products liability case, there are two significant questions: What happened to the plaintiff? Has this happened to anybody else? In pursuing the second question, the plaintiffs served their First Set of Requests for Production of Documents on August 24, 2010 (ECF No. 7), which included Request

No. 16, and received a response on October 21, 2010 (ECF No. 15):

REQUEST NO. 16: All lawsuits, warranty claims, field reports, or other claims or reports with respect to the Ethicon Stapler, or substantially similar products as identified in your response to Interrogatory No. 9 of Plaintiffs’ First Interrogatories to All Defendants, whether generated by this Defendant’s quality control personnel, the FDA, patients, physicians, salespersons, distributors, employees of this Defendant, or other persons, and which allege that the stapler had not been loaded with staples at the time it was manufactured and packaged.

RESPONSE: Objection. Ethicon objects to the relevancy of other litigation. Additionally, this request as a whole is vague and overly broad. Additionally, the term “substantially similar” is vague, broad, and subject to different meanings. Notwithstanding said objections, and after a reasonable investigation, there are no documents

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(ECF No. 131-1, at 2.) The response was signed by a lawyer from Guthrie & Thomas.

On November 17, 2010, the plaintiffs tried again with more specific language, and served their Third Set of Requests for Production of Documents (ECF No. 22), which included Request No.

1(a), and received a response on December 20, 2010 (ECF No. 35):

REQUEST NO. 1: To the extent not previously produced in response to Plaintiffs’ First or Second Requests for

Production, produce the following items:

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*** RESPONSE: (a) Objection. This request is overly broad and irrelevant as it is not limited in temporal or geographic scope and does not pertain to the subject stapler at issue in this case. This request also seeks information beyond the scope of this litigation, information protected by the attorney-client and work product privilege, and is not reasonably calculated to lead to the discovery of admissible evidence.

Additionally, there is no predicate that any such PIVR would be substantially similar or admissible in this (or any other case). Notwithstanding these objections, Ethicon will agree to produce other PIVRs from 2002 to February 6, 2009, which emanate from the United States and in which it was alleged that an Ethicon Proximate ILS Intraluminal Circular Stapler, Product Number CDH29 “failed to fire” due to a lack of staples. Please see the Product Inquiry Verification Report, attached as Exhibit A. Please note that the PIVR Report produced in response to this Request has been redacted to protect the privacy interests of non-EES employers and information protected by the attorney-client and work product privilege has also been redacted.

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regarding one similar incident. Again, the response was signed by a lawyer from Guthrie & Thomas.

On January 9, 2011, the plaintiffs’ attorney expressed his dissatisfaction with the response via e-mail, complaining that it was improper to limit the production to the years 2002-2009, and to the United States. (ECF No. 131-5.) The Court has not been provided with a response to this e-mail.

On January 29, 2011, the plaintiffs served their notice of deposition (ECF No. 57) of Carlos Gabaldon, a customer quality engineer for the defendants, located in the El Paso, TX/Juarez, Mexico area. During his deposition on February 23, 2011, Mr.

Gabaldon testified that, using a Siebel database, he had determined that there were seven incidents in which it was reported that a stapler was missing staples. On February 28, 2011, the plaintiffs’ attorney agreed not to file a motion to compel production of the seven incidents while defense counsel tried to “work something out.” (ECF No. 131-6.) On March 6, 2011, the plaintiff’s attorney inquired again about the documents, id., and on March 9, 2011, defense counsel produced them. (ECF No. 131-7.) On February 25, 2011, two days after Mr. Gabaldon’s first deposition and before the defendants produced the records of the seven incidents, the plaintiffs served their Tenth Set of Requests for Production of Documents (ECF No. 67), which included Request

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REQUEST NO. 2: To the extent not previously produced, produce all “Verification Report - Product Issue” documents and “Product Issue Analysis Reports” related to any incident alleging that a CDH stapler was not loaded with staples from January 6, 1999 to January 6, 2009.

(ECF No. 131-8, at 2.) After some motion practice which is not pertinent here, on April 26, 2011, the defendants were directed to respond to the Tenth Set, and the plaintiffs were permitted to serve their Ninth Set (which had not been previously served due to a clerical error) (ECF Nos. 100, 101). The Ninth Set included

Request No. 5:

REQUEST NO. 5: To the extent not previously produced, produce all MedWatch filings, Siebel database entries (including testing, correspondence, notes, memoranda, product analyses, etc.), and other documentation which contains an allegation that a CDH stapler was not loaded with staples.

On May 24, 2011, the plaintiffs again deposed Carlos Gabaldon about the other incidents disclosed on March 9, 2011 (ECF NO. 107).

On June 3, 2011, in response to the Ninth and Tenth Sets, the defendants produced records of an additional 125 other incidents

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defendants.1 1 The plaintiffs’ response in opposition to the defendants’ Motion in Limine No. 10 to Preclude Reference to Other Events and

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ECF No. 132, at 7.) They base their Motion for Sanctions on Federal Rule of Civil Procedure 26(g), 28 U.S.C. § 1927, and the court’s inherent authority to impose sanctions for conduct which

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Rule 37.

The defendants’ Response argues that the plaintiffs’ Motion should not be considered at all because the plaintiffs did not meet and confer in an attempt to resolve the dispute, pursuant to our

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incidents. Id. at 7. They dispute any suggestion of a pattern of improper conduct. Id. at 13-19. In support of their assertions, they provide an affidavit of Kristi Geier, the defendants’ Risk Manager, who was responsible for gathering the information for the discovery responses (ECF No. 212-3).

Occurences Involving Ethicon Staplers (ECF No. 181), states that there are 45 similar incidents, summarized at ECF No. 206-13, filed under seal at ECF No. 207-4.

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the wrong from the start, when they responded to the First Set of requests. (Reply, ECF No. 231, at 1.) They note that Federal Rule of Civil Procedure 37 and Local Rule 37.1 are inapplicable to their Motion. Id. at 11-14. The reply is a particularly compelling document.

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amplification of parties’ and attorneys’ responsibilities while

engaging in pretrial discovery:

Rule 26(g) imposes an affirmative duty to engage in pretrial discovery in a responsible manner that is consistent with the spirit and purposes of Rules 26 through 37. In addition, Rule 26(g) is designed to curb discovery abuse by explicitly encouraging the imposition of sanctions. The subdivision provides a deterrent to both excessive discovery and evasion by imposing a certification requirement that obliges each attorney to stop and think about the legitimacy of a discovery request, a response thereto, or an objection. * * * Although the certification duty requires the lawyer to pause and consider the reasonableness of his request, response, or objection, it is not meant to discourage or restrict necessary and legitimate discovery. The rule simply requires that the attorney make a reasonable inquiry into the factual basis of his response, request, or objection.

The duty to make a “reasonable inquiry” is satisfied if the investigation undertaken by the attorney and the conclusions drawn therefrom are reasonable under the circumstances. It is an objective standard similar to the one imposed by Rule 11. See the Advisory Committee Note to Rule 11. See also Kinee v. Abraham Lincoln Fed.

Sav. & Loan Ass’n,, 365 F. Supp. 975 (E.D. Pa. 1973). In making the inquiry, the attorney may rely on assertions by the client and on communications with other counsel as long as that reliance is appropriate under the circumstances. Ultimately, what is reasonable is a matter for the court to decide on the totality of the circumstances.

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Notes of Advisory Committee on Rules: 1983 Amendment (West 2011).

Two decisions from the District of Maryland discuss Rule 26(g) extensively, Poole v. Textron, Inc., 192 F.R.D. 494 (D. Md. 2000), and Mancia v. Mayflower Textile Servs. Co., 253 F.R.D. 354 (D. Md.

2008), and their analyses have assisted the undersigned in this matter.

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Response to Request No. 16, First Set The discussion of the defendants’ response to Request No. 16 must begin with Kristi Geier, who has received paralegal training and is employed as the defendants’ Risk Manager. (Affidavit, ECF No. 212-3, at 1.) She was responsible for assisting counsel “with the formulation of answers and responses to Plaintiffs’ discovery.” Id. In one of several self-serving statements, she claims, “Each

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interpret Request No. 16 “to include any reports to the FDA or MedWatch reports filed by Ethicon”... or “to apply to ‘Product Inquiry Verification Reports.’” Id. During her testimony at the evidentiary hearing on the Motion for Sanctions, Ms. Geier stated

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potential litigation.” She claimed that during her search, she found no litigation in which it was claimed that a stapler did not have staples in it.

The Court finds Ms. Geier’s interpretation of Request No. 16 to be unreasonable in the extreme and, frankly, nonsensical. There was no justification to single out one word in the request, “lawsuits,” and to limit her search accordingly, thereby ignoring “warranty claims, field reports, or other claims or reports.” Moreover, her interpretation is not reasonable when considered in the context of the rest of the request, which listed many potential

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Defendant, or other persons.” Most of those persons would not be expected to file a lawsuit concerning injuries received as a result of a surgeon using a stapler which had not been loaded with staples. Ms. Geier further stated that she “did not interpret Request No. 16 to include any reports to the FDA or MedWatch

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