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Ebert v. C.R. Bard, Inc.

United States District Court, E.D. Pennsylvania

April 24, 2014

C.R. BARD, INC., ET AL., Defendants.



In this products liability case, the parties disagree about whether a report written by Dr. John Lehmann for the defendants in late 2004 should be produced in discovery. This report was inadvertently disclosed in other cases involving the same or similar product. The plaintiff in this case is represented by the same law firm as the plaintiffs in the cases in which the report was inadvertently disclosed. The plaintiffs in those cases were court-ordered to "immediately and diligently" return or destroy any copies of the report they had received inadvertently. The plaintiff in this case now wants to use Dr. Lehmann's report, though it was never produced to her counsel in discovery.


a. Factual Background

Melissa Ebert alleges that she suffered an injury from the implantation of the defendants' G2 inferior vena cava (IVC) filter.[1] An IVC is a venous interruption device designed to prevent pulmonary embolism by filtering blood to prevent material like blood clots from blocking the main artery of the lung or one of its branches. The defendants obtained FDA clearance for the Recovery IVC filter through the 510(k) pre-market notification process based upon an already approved predicate device called the Simon Nitinol Filter (SNF).[2] The pre-market approval process required Bard to demonstrate that the Recovery IVC Filter device was the "substantial equivalent" to and has the same or better safety profile than the SNF-the device that was currently on the market. The defendants then obtained FDA clearance for the G2 IVC filter through the 510(k) process based upon the Recovery IVC Filter.[3]

The plaintiff claims that, unlike the safety profile for the SNF, the next two generation of filters-the Recovery and G2 IVC filters-were substantially less safe. She argues that the report shows that the defendants had actual knowledge that the subsequent devices were not the substantial equivalent, yet they still continued to market and sell these devices to members of the public, including the plaintiff.[4]

Other products liability cases against Bard related to its IVC filters have been filed throughout the United States. The first was filed in February 2004.[5] In November 2004, Bard retained Dr. John Lehmann, a former Bard medical affairs consultant, to prepare a litigation consultant report.[6] Dr. Lehmann signed a contract to perform work for Bard's law department, which was intended to serve both as legal advice concerning the IVC filters and to assist the law department with anticipated and ongoing litigation.[7] Dr. Lehmann was also instructed by counsel for Bard to convey the results of his investigation to the law department and to those whom the law department may direct.[8]

Dr. Lehmann conducted his investigation in November and December of 2004 and submitted his final report in December 2004.[9] In preparing his report, Dr. Lehmann spoke with a small, limited number of Bard employees in accordance with specific tasks he was required to carry out under his contract.[10] The law department subsequently distributed the report to a small select number of employees outside of the law department but within the company.[11] These employees were instructed that the report was confidential and that further distribution of the report was limited only to those who needed the report to perform their job functions.[12]

Subsequently, the defendants used the Lehmann Report to create a Remedial Action Plan and Health Hazard Evaluation.[13]

b. Relevant Procedural History The plaintiff in this case is represented by lawyers from the Philadelphia office of Lopez McHugh. Lopez McHugh's California office represents plaintiffs in other cases against Bard related to the IVC filters in several other jurisdictions.[14] In other cases, Lopez McHugh and Bard agreed to a protective order that enabled Lopez McHugh to use any documents produced in those cases in all of the cases in which Lopez McHugh was involved.[15] The purpose of that order was to allow for effective and efficient use of judicial resources.[16]

On December 14, 2012, Bard inadvertently disclosed to plaintiff's counsel twelve privileged documents including the litigation consultant's report in those other cases.[17] On December 21, 2012, Bard requested a "clawback" of those inadvertently produced, privileged documents in accord with the protective orders in those other cases.[18] On January 23, 2013, Bard's attorney sent the Lopez attorneys a letter with redacted images of the clawed-back documents, to replace the clawed-back documents. The letter also reminded the attorneys of their obligation to destroy or return the clawed back documents.[19]

Subsequently, the parties litigated the issue of whether the report was privileged or protected in those other cases. A California state court denied the clawback request in an unpublished order with no explanation or analysis.[20] The United States District Court for the District of Nevada, on the other hand, determined that Dr. Lehmann's litigation consultant report was protected from discovery by the work-product doctrine and attorney-client privilege in a nearly 70-page opinion.[21]

On April 30, 2013, following Bard's clawback of these privileged documents in the other cases and the Nevada district court's decision, Bard produced over two million pages of documents and electronically stored information in this case pursuant to the terms of the Agreed Protective Order.[22] Having learned its lesson from the previous productions, Bard did not produce the twelve protected documents that had been inadvertently produced before. Bard claimed the litigation report, along with other documents, was protected and listed the report on its ...

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