AGENDA What is an IVC filter/what does it do/where implanted? Who are the defendants? What are the injuries Problems? Intake Bard The bad guy story Efficiency/Efficacy Articles/Research FDA Warnings/Advisories Causes of Action Current Status PRODUCT OVERVIEW Intended Use Prevention of PEs When Blood Thinners are Not an Option BARD IVC FILTERS (Nitinol Nickel Titanium Alloy) FDA Approval 510k C. R. Bard Recovery (2003); G2 (2005); G2X (2008); Eclipse (2010) Meridian (2011) Denali (2013); Cook Medical Gunther Tulip (2003); Celect (2007) Simon Nitinol Filter FDA Perm 4/20/1990 Recovery Filter FDA Perm 11/27/2002 Retrievable 7/25/2003 G2 Filter FDA Perm 8/29/2005 Retrievable 1/15/2008 1
COOK IVC FILTERS (Conichrome - cobaltchromium-nickel-molybdenum-iron alloy) PLACED BENEATH RENAL BRANCHES Celect FDA - Permanent 4/20/2007 Retrievable 3/7/2008 Tulip FDA Permanent 10/18/2000 Retrievable 10/31/2003 DIRECT ROUTE TO HEART MANUFACTURERS C.R. Bard and Bard Peripheral Vascular (Recovery, G2, G2X, Eclipse) Cook Medical (Tulip and Celect) Johnson & Johnson (Cordis OptEase, TrapEase) Boston Scientific (Greenfield SS and Ti - Permanent) B. Braun Medical (Convertible, Vena Tech and LP) ALN (ALN) Rex Medical (Option) Rafael Medical (SafeFlo) 2
MARKET SHARE (2009) BARD DEFENDANTS Other 7% Braun 8% Cordis 24% Other 2% Cordis 13% C.R. Bard, Inc., Murray Hill, NJ Bard Peripheral Vascular, Inc., Tempe, AZ TOTAL UNITS DISTRIBUTED Cook 30% Total Filter Market BPV 31% Cook 43% Optional Filter Market BPV 42% Recovery (RNF) 32,810 G2/G2X 162,109 Eclipse 96,087 291,006 units sold Meridian Denali COOK DEFENDANTS Cook Group, Inc., Bloomington, IN Cook Medical Incorporated, Bloomington, IN Cook Medical, LLC, Bloomington, IN Cook Incorporated, Bloomington, IN Medical Engineering and Development Institute, Inc. ( MED Institute, Inc. ) a/k/a Cook MED Institute, Inc., W. Lafayette, IN Cook Medical Technologies, Bloomington, IN Cook Denmark International APS, Bjaeverskov, Denmark Cook Denmark Holding APS, Bjaeverskov, Denmark Cook Group Europe APS, Bjaeverskov, Denmark Cook Nederland BV, Amsterdam, Netherlands William Cook Europe APS, Bjaeverskov, Denmark EXPAND MARKET SHARE Expand Market Share from $100M to $300M Bariatric Patients Trauma Patients Orthopedic Surgery Succeeded: Annual Implants Grew from 49k in 2004 to 260k in 2012 3
PROBLEM Migration Caudal (downward) & Cephalad (upward) Tilts / Shifts (unable to remove, leads to fracture and perforation, loss of efficiency) Device Fracture Embolize to Heart, Lung, Liver and Kidney Perforation Difficult/Impossible to Remove Increase Stress and Strain on Struts leading to Fracture Perforation of Adjacent Organs and Vessels SIZE OF THE PROBLEM 40% of Recovery Filters fracture after 5.5 years Tam, et al, Fracture and Distant Migration of the Bard Recovery Filter: A Retrospective Review of 363 Implantations for Potentially Life-Threatening Complications, J. Vasc. Interv. Radiol. 21:2 (2011) 37.5% of G2 Filters fracture after 5 years An, et al, Prevalence and Clinical Consequences of Fracture and Fragment Migration of the Bard G2 Filter: Imaging and Clinical Follow-up in 684 Implantations, J. Vasc. Interv. Radiol. 2014; 25:941-948 100% of Cook Tulip and Celect Filters Perforated after 71 days 40% of Cook Filters Tilted Durack, et al, Perforation of the IVC: Rule Rather Than Exception After Longer Indwelling Times for the Günther Tulip and Celect Retrievable Filters, Cardiovasc lntervent Radiol; DOI 10.1007/s00270-011-0151-9 INTAKE Date of Implant Purpose for Implant Name of Device if Known Complications with the filter (Inability to remove, Migration, Tilt, Fracture, Perforation) How discovered (i.e. CT Scan, Abdominal Pain) Date when the client learned of issue Symptomatic/Asymptomatic Date of Removal/Surgery Type of surgery (Percutaneous or Open Procedure) If no Surgery, what was the client told about removal If client calls and is not sure what the status of his/her filter, advise them to see their doctor for a follow up RECORDS INTAKE Implant records to identify filter Verify caval measurement if possible Most devices intended for a caval size of less than 28mm All imaging related to filter Explant records Device Preservation Immediately contact pathology before destruction Manufacturing rep may have beat you to it 4
BARD: WHAT THEY KNEW AND WHEN 4/25/2000 Nitinol Medical Technologies (NMT) hired Dr. Murray Asch to conduct compassionate use trial at Mt Sinai Hospital in Toronto 9/1/2000 11 filters implanted and 5 removed, 1 out of the 5 filters migrated cephalad by a filter length. Bard concludes that it was a result of a large clot burden 4/16/2002 Dr. Asch removed a fractured RNF from a patient who was in her third trimester of pregnancy at Mt Sinai Hospital. The upper limb fractured and lower leg hook remained embedded. BARD: WHAT THEY KNEW AND WHEN January 2010 Electropolished Eclipse Filter cleared by FDA Bard keeps selling G2/G2X filter until it runs out of stock MEDICAL LITERATURE: LACK OF EFFICACY Editorial, The Inferior Vena Cava Filter, How Could a Medical Device Be So Well Accepted Without Any Evidence of Efficacy?, JAMA Intern Med. V. 173 (No. 7) 493 (April 8, 2013) Decousis, et al, A Clinical Trial of Vena Cava Filters In The Prevention Of Pulmonary Embolism In Patients With Deep-Vein Thrombosis, N. Eng. J Med. V. 338 No. 7 409 (1998) PREPIC, Eight-Year Follow-Up of Patients With Permanent Vena cava Filters In Prevention of Pulmonary Embolism, Circulation v. 112 No. 3 416(March 3, 2005). Billet, et al, Efficacy of Inferior Vena Cava Filters In Anticoagoaltion Patients, J. Thrombosis and Hemostasis 5: 1848-1853 (June 18, 2007) MEDICAL LITERATURE: TRAUMA EFFICACY Antevil, et al, Retrievable Vena Cava Filters For Preventing Pulmonary Embolism in Trauma Patients: A Cautionary Tale, J. Trauma 60:35-40 (2006) Sarosiek, et al, Indications, Complications and Mangement of Inferior Vena Cava Filters, JAMA Intern Med. V. 173 (No. 7) 513 (April 8, 2013) 5
MEDICAL LITERATURE: GBP EFFICACY Birkmeyer, et al, Preoperative Placement of Inferior Vena Cava Filters and Outcomes After Gastric Bypass Surgery, Ann of Surg v. 252 No. 2 313 (August 2010) Finks, et al, Predicting Risk for Venous Thromboembolism With Bariatric Surgery, Ann. Of Surg. V. 255 No. 6 1100 (June 2012). FDA COMMUNICATIONS & WARNINGS August 9, 2010 FDA Advisory Recommends that implanting physicians and clinicians responsible for the ongoing care of patients with retrievable IVC filters consider removing the filter as soon as protection from PE is no longer needed. May 6,2014 FDA Advisory Update Recommends removal of IVC filter within 29 to 54 days JULY 13, 2015 FDA WARNING LETTER TO C.R. BARD. INC. Recovery Cone Removal System NEVER Approved or Cleared by FDA Methods used to manufacture, store and package did not conform to GMP Denali Misbranded for failing or refusing to provide material and information Failing to properly establish and maintain procedures for reviewing and evaluating complaints relating to G2, G2X and Eclipse Filters BPV failed to report information that reasonably suggests that its device has malfunctioned and likely to cause death or serious injury CAUSES OF ACTION Failure to Warn Design Defect Manufacturing Defect Consumer Fraud/Misrepresentation Strict Liability Breach of Implied/Express Warranty Wrongful Death Consortium 6
CURRENT STATUS OF LITIGATION COOK MDL NO. 2570 (Indianapolis) 102 cases filed as of July 8, 2015 ESI Document Production Underway 30(b)(6) Depositions Corporate for Structure and ESI BARD MDL NO. 2641 (Pending Hearing on July 30, 2015 in San Francisco) 400 plus cases 3,000,000 documents reviewed and in searchable database More than 100 depositions taken to date Experts Retained, Prepared, Deposed and Testified Pre-trial Motions and Oppositions Completed Steve Nober President & CEO Consumer Attorney Marketing Group 21051 Warner Center Lane, Suite 250 Woodland Hills, CA 91367 Office (800) 200-CAMG Steve@camginc.com www.camginc.com Contact us For Additional Information John Dalimonte Founding Partner Karon & Dalimonte LLP 85 Devonshire Street, Suite 1000 Boston, MA 02109 Office (617) 367-3311 johndalimonte@kdlaw.net www.kdlaw.net 7