Tillman v. C.R. Bard, Inc.

• Decision Date: 30 March 2015
• Docket Number: Case No. 3:13–cv–222–J–34JBT.
• Citation: 96 F.Supp.3d 1307
• Parties: Lessie TILLMAN, Plaintiff, v. C.R. BARD, INC., and Bard Peripheral Vascular, Inc., Defendants.
• Court: U.S. District Court — Middle District of Florida

96 F.Supp.3d 1307

Lessie TILLMAN, Plaintiff

v.C.R. BARD, INC., and Bard Peripheral Vascular, Inc., Defendants.

Case No. 3:13–cv–222–J–34JBT.

United States District Court, M.D. Florida, Jacksonville Division.

Signed March 30, 2015.

James P. Cannon, Montee Law Firm, Kansas City, MO, Joseph R. Johnson, Babbitt, Johnson, Osborne & Leclainche, PA, West Palm Beach, FL, Julia Reed–Zaic, Heaviside Reed Zaic, Laguna Beach, CA, for Plaintiff.

Brandee J. Kowalzyk, Elizabeth C. Helm, Matthew B. Lerner, Richard B. North, Jr., Taylor Tapley Daly, Nelson, Mullins, Riley & Scarborough, LLP, Atlanta, GA, David E. Cannella, Carlton Fields Jorden Burt, PA, Orlando, FL, Edward W. Gerecke, David J. Walz, Carlton Fields Jorden Burt, PA, Tampa, FL, James F. Rogers, Nelson, Mullins, Riley & Scarborough, LLP, Columbia, SC, John A. Camp, Carlton Fields Jorden Burt, PA, Miami, FL, for Defendants.

ORDER

MARCIA MORALES HOWARD, District Judge.

THIS CAUSE comes before the Court as a products liability action pertaining to an inferior vena cava filter

, known as the G2®, designed and manufactured by Defendants C.R. Bard, Inc., and Bard Peripheral Vascular, Inc.¹ On February 19, 2008, a physician implanted a G2® Filter (the Filter) in Plaintiff Lessie Tillman (Tillman). Although the physician intended for the Filter to be retrieved later, it changed position within Tillman's body such that it cannot be removed safely. Tillman contends that the Filter is defective and, because it cannot be removed, exposes her to an ongoing risk of serious harm for which she requires medical monitoring. On March 19, 2013, Tillman filed an Amended Complaint for Damages (Doc. 10; Complaint) asserting a state law negligence claim, as well as strict liability claims for failure to warn, design defect, and manufacturing defect. See Complaint at 12–16.² This matter is presently before the Court on several motions.

On August 1, 2014, Bard filed four motions seeking to exclude the testimony of certain of Tillman's expert witnesses. See Defendants C.R. Bard, Inc. and Bard Peripheral Vascular, Inc.'s Motion to Exclude the Opinions of Michael Freeman, Ph.D. and Memorandum of Law in Support (Doc. 95; Motion to Exclude Freeman); Defendants C.R. Bard, Inc. and Bard Peripheral Vascular, Inc.'s Motion and Memorandum of Law to Exclude the Opinions of William A. Hyman (Doc. 96; Motion to Exclude Hyman)³ ; Defendants C.R. Bard, Inc. and Bard Peripheral Vascular, Inc.'s Motion to Exclude the Opinions of Robert McMeeking and Matthew Begley and Incorporated Memorandum of Law in Support Thereof (Doc. 99; Motion to Exclude McMeeking/Begley)⁴ ; Defendants C.R. Bard, Inc. and Bard Peripheral Vascular, Inc.'s Motion to Exclude the Opinions of Robert Ritchie, Ph.D. and Memorandum of Law in Support (Doc. 100; Motion to Exclude Ritchie).⁵ Tillman filed responses in opposition to these Motions on August 22, 2014. See Plaintiffs' Opposition to Defendants' Motion to Exclude the Opinions of William Hyman and Brief in Support Thereof (Doc. 96; Hyman Response); Plaintiff's Opposition to Defendants' Motion to Exclude the Opinions of Michael Freeman, Ph.D. and Brief in Support Thereof (Doc. 120; Freeman Response)⁶ ; Plaintiff's Opposition to Defendants' Motion to Exclude the Opinions of Robert Richie [sic], Ph.D. and Brief in Support Thereof (Doc. 122; Ritchie Response)⁷ ; Plaintiff's Opposition to Defendants' Motion to Exclude the Opinions of Robert McMeeking and Matthew Begley as to Manufacturing and Legal Conclusions and Brief in Support Thereof (Doc. 123; McMeeking/Begley Response). With leave of Court, see Order (Doc. 141), Bard filed reply briefs on October 9, 2014. See Bard's Reply in Support of its Motion to Exclude the Opinions of Michael Freeman, Ph.D. (Doc. 144; Freeman Reply); Bard's Reply in Support of its Motion to Exclude the Opinions of Robert McMeeking and Matthew Begley (Doc. 145; McMeeking/Begley Reply); Bard's Reply in Support of its Motion to Exclude the Opinions of William A. Hyman (Doc. 146; Hyman Reply); Bard's Reply in Support of Its Motion to Exclude the Opinions of Robert Ritchie, Ph.D. (Doc. 147; Ritchie Reply).

In addition, both parties filed motions for summary judgment on August 1, 2014. See Plaintiff's Motion for Partial Summary Judgment Against Defendant C.R. Bard and Bard Peripheral Vascular, Inc. (Doc. 93; Tillman Motion)⁸ ; Defendants' Motion for Summary Judgment (Doc. 98; Bard Motion).⁹ The parties filed their respective responses in opposition to the summary judgment motions on August 22, 2014, and with the Court's permission, the parties filed replies on October 9, 2014. See Defendants' Response in Opposition to Plaintiff's Motion for Partial Summary Judgment (Doc. 116; Bard Response); Plaintiff's Response to Defendants' Motion for Summary Judgment (Doc. 121; Tillman Response)¹⁰ ; Plaintiff's Reply to Defendant's Opposition to Plaintiff's Motion for Partial Summary Judgment Against Defendant C.R. Bard and Bard Peripheral Vascular, Inc. (Doc. 142; Tillman Reply); Bard's Reply in Support of its Motion for Summary Judgment (Doc. 143; Bard Reply). Accordingly, the various pending motions are ripe for review.

I. Background

This case concerns a medical device known as an inferior vena cava (IVC) filter. An IVC filter is a “device that's implanted into the inferior vena cava.... And its responsibility essentially is to capture a clot that may become dislodged from a [deep vein thrombosis

] and potentially be a life-threatening pulmonary embolism to the patient.” See Deposition of Andrew Stockland, M.D. (Doc. 137–7; Stockland Dep.) at 13. These filters originated in the 1960's and 1970's, and were first used as permanently implanted devices. See Bard Motion, Ex. A: Report of Clement J. Grassi, M.D. (Doc. 98–1; Grassi Report) at 2–3. With advances in technology and design, manufacturers began developing “retrievable” or “option” filters. Id. Bard's expert, Clement J. Grassi, M.D., a physician and interventional radiologist, explains that all IVC filters carry the risk of complications. See id. at 4. “Well known” filter complications include “filter migration, filter fracture, component embolization, access site thrombosis, IVC occlusion, filter tilt, penetration or perforation, and others.” Id.; Stockland Dep. at 14–17. According to Grassi, “there is no perfect filter device available in the market today.” Grassi Report at 4. Indeed, Matthew Begley, Ph.D., one of Tillman's engineering experts, concedes that it is not possible to design an IVC filter that never migrates, tilts, perforates, or fractures.

See Bard Motion, Ex. I: June 19, 2014 Deposition of Matthew Begley, Ph.D. (Doc. 98–9; June Begley Dep.) at 43.

Bard originally marketed a permanent IVC filter known as the Simon Nitinol Filter (SNF), and later developed a retrievable filter named the Recovery. See Tillman Response, Ex. EE: Report of Jeffrey Hull, M.D. (Doc. 134–16; Hull Report) at 2. The FDA approved the Recovery filter as a permanent filter in November 2002, and as a retrievable filter in July 2003. See Tillman Response, Exs. F, G. Bard obtained this approval via the “ § 510(k) process,” through which the FDA will clear a device for marketing if it is substantially equivalent to a predicate device.¹¹ Id. The Recovery's predicate device was the SNF. Id., Ex. F. Bard withdrew the Recovery from the market in 2005, and replaced it with the G2 filter. See Hull Report at 2. On August 29, 2005, Bard obtained FDA clearance to market the G2 filter through this same process by identifying the Recovery filter as a substantially equivalent predicate device. See Tillman Response, Ex. H.

In early 2008, Tillman, who was in a rehabilitation center recovering from two knee replacement surgeries, woke up with leg pain. See Bard Motion, Ex. B: Deposition of Lessie Tillman (Doc. 98–2; Tillman Dep.) at 70–71. Testing revealed the pain was caused by a blood clot

in her leg. Id. As a result, on February 19, 2008, Dr. Luis Anez ordered the implantation of an IVC filter. See Tillman Dep. at 71–72; Tillman Response, Ex. Z. According to Tillman, she was informed that the filter was needed to protect her from “the blood clot that was in my left leg to make sure that it didn't go all the way up.” See Tillman Dep. at 80. Andrew Stockland, M.D., an interventional radiologist, performed the placement procedure that same day, implanting a G2 filter manufactured by Bard. See Tillman Response, Ex. Z; Stockland Dep. at 10, 32. Stockland states that the Filter was centered in the IVC when it was placed, and “was very vertical” in his opinion. See Stockland Dep. at 79.

In the Final Report following the implantation, Stockland notes that “[t]his filter may remain as a permanent device, or be potentially retrieved within 12 months. Given the patient's young age, consider retrieval in the very near future when her current medical issues have resolved.” See Tillman Response, Ex. Z. Stockland explains that

[t]he plan was to potentially take it out if possible ... [b]ecause I think the filter served a purpose for [Tillman] in the current situation that she presented with, but when she was done with rehab and done with her getting back on anticoagulation

and we felt it was safe and the risk of a [pulmonary embolism ] was

low, then we should seriously consider removing it.

See Stockland Dep. at 63. Stockland explains that “[t]he preference is to place a retrievable with the hope of getting it out. But unless I ... was convinced that someone needed a permanent filter, I would place a temporary or a retrievable. But there's always an understanding that a retrievable can turn into a permanent device.” Id. at 75.

Tillman saw Dr. Kedra Williams on June 18, 2008, “[t]o have some medications refilled and to follow up some labs that were done.” See Bard Motion, Ex. D: Deposition of Kedra Williams, M.D. (Doc. 98–4; Williams Dep.) at 24. At that time, Tillman was taking Coumadin

to treat her previous deep vein thrombosis (DVT), and Williams ordered a venous Doppler...