Case MDL No Document 30 Filed 02/02/17 Page 1 of 11 BEFORE THE UNITED STATES JUDICIAL PANEL ON MULTI-DISTRICT LITIGATION

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1 Case MDL No Document 30 Filed 02/02/17 Page 1 of 11 BEFORE THE UNITED STATES JUDICIAL PANEL ON MULTI-DISTRICT LITIGATION IN RE: STRYKER ORTHOPAEDICS MDL DOCKET NO LFIT V40 FEMORAL HEAD PRODUCT LIABILITY LITIGATION ORAL ARGUMENT REQUESTED INTERESTED PARTY RESPONSE TO PLAINTIFF ROBERT O HARE S MOTION FOR TRANSFER OF ACTIONS PURSUANT TO 28 U.S.C Plaintiffs Dennis and Debbie Brown (the Brown Plaintiffs, through their counsel, Zimmerman Reed LLP, submit this Interested Party Response supporting, in part, Plaintiff Robert O Hare s Motion for Transfer of Actions Pursuant to 28 U.S.C The Brown Plaintiffs support Plaintiff O Hare s request for centralization. However, the Brown Plaintiffs respectfully request that the Judicial Panel on Multidistrict Litigation (the Panel transfer all actions to Judge Donovan Frank in the District of Minnesota. Judge Frank s experience presiding over the In Re Stryker Rejuvenate and ABG II Hip Implant Products Liability Litigation makes him the optimal choice to ensure just and efficient multidistrict ( MDL proceedings. I. Background At least 20 lawsuits involving Stryker LFIT V40 Femoral Heads have been filed in various federal district courts across the country. Each lawsuit alleges the Stryker LFIT V40 Femoral Head design is defective because the device has a propensity for fretting, corrosion, or other failures at the junction between the femoral head and stem. The various lawsuits also allege Defendants knew, or should have known, of the Stryker LFIT V40 Femoral Head s propensity for failure, but failed to warn plaintiffs or their surgeons.

2 Case MDL No Document 30 Filed 02/02/17 Page 2 of 11 For example, Plaintiff Dennis Brown underwent total hip replacement surgery where he was implanted with a Stryker LFIT V40 Femoral Head that connected to a Stryker Accolade TMZF stem. Over time, but without warning, Mr. Brown s Stryker LFIT V40 Femoral Head experienced corrosion and fretting that eventually led to sudden disassociation of the Stryker LFIT V40 Femoral Head from the Accolade TMZF stem. This catastrophic failure forced Mr. Brown to undergo a revision surgery. The Stryker LIFT V40 Femoral Head lawsuits are similar to other hip litigations that the Panel has centralized. The Stryker LFIT V40 Femoral Head lawsuits and the In Re Stryker Rejuvenate and ABG II Hip Implants Products Liability Litigation (MDL 2551 (referred to hereafter as Stryker I lawsuits share several common characteristics. For example, both litigations share common defendants. Furthermore, both litigations allege that the respective devices have a propensity for fretting, corrosion, or metal ion release at the junction between two of the hip components. Both litigations also allege that the failure of the device is caused by, at least in part, the metal alloys used to manufacture the components. Plaintiffs in the Stryker LFIT V40 Femoral Head lawsuits were implanted with a femoral head made of cobalt chrome and a stem made of titanium. Likewise, the Stryker I plaintiffs were implanted with a modular neck made of cobalt chrome and a modular stem made of titanium. Plaintiffs in both litigations allege that the combination of dissimilar metals (i.e., cobalt chrome and titanium causes excessive corrosion, fretting, and metal ion release. Finally, plaintiffs in both litigations were forced to undergo revision hip replacement procedures because of device failure. In addition to Stryker I, the Stryker LFIT V40 Femoral Head litigation shares common facts with other hip litigations previously centralized. For example, the Panel has entered transfer orders pertaining to multiple metal-on-metal hip systems, including the DePuy ASR XL 2

3 Case MDL No Document 30 Filed 02/02/17 Page 3 of 11 Acetabular Hip System (MDL No. 2197, the DePuy Pinnacle Acetabular Cup System (MDL No. 2244, Wright s Conserve line of hip implant products (MDL No. 2329, and the Biomet M2a Magnum System (MDL No (referred to collectively hereafter as the MoM Litigations. Each of the MoM Litigations involved allegations that the systems were defective and caused the release of metal ions at the articular surface between the acetabular cup and femoral head, often requiring the plaintiff to undergo a revision surgery. Like the MoM Litigations, the Stryker LFIT V40 Femoral Head lawsuits also allege that the design of the device causes the release of metal ions which forces plaintiffs to undergo revision surgery. The Stryker LFIT V40 Femoral Heads have also been subject to a recall, as were the hip products in Stryker I and the DePuy ASR XL acetabular cup system. The Stryker LFIT V40 Femoral Head recall started when Defendants sent an Urgent Medical Device Recall Notification letter to surgeons on August 29, The communication warned surgeons that Defendants had received a higher than expected number of device failure reports for certain sizes and lots of Stryker LFIT V40 cobalt chrome heads implanted prior to The letter notifies surgeons of the hazards associated with the recalled devices, including disassociation of the femoral hip stem and excessive metal debris. Defendants further warned that the device failure may lead to revision surgeries, adverse local tissue reaction, dislocations, inflammatory responses, and other injuries. Defendants chose not to include certain sizes and lots of Stryker LFIT V40 Femoral Heads within their recall. Defendants decision to limit the recall is concerning. Some of the pending Stryker LFIT V40 Femoral Head lawsuits involve products Defendants chose to exclude from the recall. Thus, initial review of filed lawsuits indicate the Stryker LFIT V40 Femoral 3

4 Case MDL No Document 30 Filed 02/02/17 Page 4 of 11 Head litigation will not be limited to the specific sizes and lots Defendants unilaterally chose to include in their recall letter. On November 9, 2016, the U.S. Food and Drug Association ( FDA classified Defendants August 29, 2016 letter as a Class II Device Recall. 1 The FDA s recall notice stated that in addition to the August 29, 2016 letter, Defendants also sent an updated recall notification because additional customers and lot numbers were identified. The recall reportedly includes a total of 42,519 units, but that only accounts for the sizes and lots Defendants chose to disclose in their communications to surgeons. Other regulatory agencies outside of the U.S. have also taken action to address the Stryker LFIT V40 Femoral Head problems. On August 24, 2016, Health Canada classified the Stryker LFIT V40 Femoral Head problem as a Type II Hazard Classification. 2 On September 27, 2016, the Australian Therapeutic Goods Administration (TGA issued a Hazard Alert for the LFIT V40 femoral components. 3 The TGA announcement instructed surgeons to follow-up with patients who received one of the recalled devices. The Panel is now presented with another litigation involving a failed hip system. Like Stryker I and the MoM Litigations, Stryker LIFT V40 Femoral Head lawsuits scattered across the country allege that Stryker LFIT V40 Femoral Heads have a propensity for early device failure. Given the number of Stryker LFIT V40 Femoral Heads manufactured and sold, the Stryker LFIT V40 Femoral Head litigation has the potential of becoming one of the largest hip component litigations yet, making centralization just as important now as it has ever been. 1 See 2 See 3 See 4

5 Case MDL No Document 30 Filed 02/02/17 Page 5 of 11 II. ARGUMENT a. The Panel Should Grant the Motion For Centralized Proceedings of the Stryker LFIT V40 Femoral Head Litigations The Brown Plaintiffs agree the Panel should consolidate and transfer the subject actions pursuant to Section 1407, which authorizes the transfer of civil actions pending in various federal district courts involving one or more common questions of fact to a single federal district court for coordinated or consolidated pretrial proceedings when the Panel determines that such transfers serve the convenience of parties and witnesses and will promote the just and efficient conduct of such actions. 28 U.S.C. 1407(a. The Panel has consistently centralized similar cases involving the failure of hip replacement systems, including In Re DePuy Orthopaedics, Inc., ASR Hip Implant Products Liability Litigation (MDL No. 2197, In Re DePuy Orthopaedics, Inc., Pinnacle Hip Implant Products Liability Litigation (MDL No. 2244, In Re Wright Medical Technology, Inc., Conserve Hip Implant Products Liability Litigation (MDL No. 2329, In Re Biomet M2A Magnum Hip Implant Products Liability Litigation (MDL No. 2391, and In Re Stryker Rejuvenate and ABG II Hip Implant Products Liability Litigation (MDL No (referred to collectively hereafter as the Hip Litigations. The Panel found that in each of the Hip Litigations centralization was appropriate because the litigations shared common questions of fact, including whether defendants hip systems were defectively designed or manufactured, and whether defendants failed to provide adequate warnings concerning the devices. The Panel also found that centralization would eliminate duplicative discovery, prevent inconsistent pretrial rulings on discovery issues, and conserve the resources of the parties, their counsel, and the judiciary. Like the Hip Litigations, the Stryker LFIT V40 Femoral Head cases pending in district courts across the nation share common questions of fact, including whether Stryker s LFIT V40 5

6 Case MDL No Document 30 Filed 02/02/17 Page 6 of 11 Femoral Heads were defectively designed or manufactured, and whether defendants failed to provide adequate warnings concerning the devices. Given the current number of lawsuits filed across the country, and the potential number of similar lawsuits that will likely be filed in the future, centralization is the most efficient and effective way to eliminate duplicative discovery and to prevent inconsistent pretrial rulings over discovery issues. Furthermore, centralization will certainly conserve the resources of the parties, their counsel, and the judiciary. Hip litigations have greatly benefited from centralized proceedings. For example, a significant number of the total actions filed in the DePuy ASR, Biomet M2a Magnum, Wright Conserve, and Stryker I MDLs have resolved or are in the process of resolving. Centralization created the efficiencies necessary to allow the parties to properly assess the cases for resolution. Accordingly, the Brown Plaintiffs respectfully request the Panel enter an order granting centralized proceedings. b. The District of Minnesota is the Optimal Court To Ensure Just and Efficient MDL Proceedings The Brown Plaintiffs respectfully request that the Panel transfer the pending and future actions to the District of Minnesota, Judge Donovan Frank presiding. When determining the appropriate transferee forum, the Panel considers multiple factors, including the experience of the bench, convenience of the parties, and capacity of the district court, in an effort to select the forum that will promote the just and efficient conduct of the actions. In re: Fluoroquinolone Prod. Liab. Litig., 122 F. Supp. 3d 1378 (J.P.M.L Judge Frank s experience, Minnesota s central location, and the District of Minnesota s capacity to advance a new MDL support that the Stryker LFIT V40 Femoral Head litigation should be transferred to the District of Minnesota and Judge Frank. 6

7 Case MDL No Document 30 Filed 02/02/17 Page 7 of 11 i. Judge Frank s experience presiding over Stryker I will benefit the parties and the litigation. Judge Frank already has intimate knowledge of the parties, science, discovery issues, and other aspects of the Stryker LFIT V40 Femoral Head litigation because Judge Frank presides over Stryker I. Judge Frank is one of a select group of jurists with such an extensive background and knowledge of the parties and issues that will be the focus of the Stryker LFIT V40 Femoral Head litigation. Accordingly, Judge Frank s experience gives the Panel the rare opportunity to transfer a complex litigation to a federal district court that already has a significant history with many aspects of the proposed MDL. Judge Frank s leadership during Stryker I helped the parties achieve one of the fastest resolutions of a MDL involving a hip prosthesis. Less than 1.5 years after the Panel transferred Stryker I to Judge Frank, the parties created a settlement program for thousands of plaintiffs. Judge Frank s continued leadership has also fostered a second settlement program expected to affect hundreds of additional plaintiffs who were ineligible for the initial settlement program. Judge Frank s experience will greatly benefit the parties involved in this litigation. ii. Transferring the cases to Judge Frank is consistent with the Panel s previous practice. The Panel historically has recognized the benefits of transferring cases to a judge with previous experience in the litigation. In the In Re Fluoroquinolone Products Liability Litigation (MDL No. 2642, the Panel considered a motion to centralize actions alleging that fluoroquinolones including Levaquin cause or contribute to irreversible peripheral neuropathy. 122 F. Supp. 3d 1378 (J.P.M.L The Panel ultimately found that Chief Judge John R. Tunheim was the appropriate judge to preside over the MDL -- he was already familiar with the science and regulatory history of Levaquin as the transferee judge for an earlier 7

8 Case MDL No Document 30 Filed 02/02/17 Page 8 of 11 Levaquin MDL concerning tendon ruptures. The Panel concluded that Chief Judge Tunheim s experience overseeing [the Levaquin tendon rupture MDL] will benefit the parties and facilitate the just and efficient conduct of this litigation. Id. Transferring the Stryker LFIT V40 Femoral Head cases to Judge Frank is consistent with the Panel s decision in the Fluoroquinolones MDL. Judge Frank s familiarity with many of the issues that will arise during the Stryker LFIT V40 Femoral Head litigation is comparable to Chief Judge Tunheim s background and experience regarding the Levaquin and fluoroquinolone litigations. Judge Frank s experience in Stryker I will benefit the parties and facilitate the just and efficient conduct of this litigation. In additional to Judge Frank s leadership, Judge Noel must also be recognized for his contributions and guidance as Magistrate Judge during Stryker I. Judge Noel s timely and decisive rulings regarding complicated discovery disputes undoubtedly played an important role in the parties reaching a fast and fair resolution. Like Judge Frank, few judges possess Judge Noel s present knowledge regarding certain discovery issues that will likely arise during the Stryker LIFT V40 Femoral Head litigation. Transferring the cases to an experienced bench will benefit of all parties while conserving judicial resources. iii. The District of Minnesota is prepared to advance the Stryker LFIT V40 Femoral Head litigation. Three Stryker LFIT V40 Femoral Head lawsuits have already been filed in the District of Minnesota, and each lawsuit was originally assigned to different judges. However, on December 27, 2016, Chief Judge Tunheim entered an Administrative Order reassigning the Stryker LFIT V40 Femoral Head litigations, and any future similar cases, to Judge Frank and Judge Noel. Denne et al. v. Howmedica Osteonics Corp., 16-cv-02073, Dkt. No. 50 (D. Minn., Dec. 27, 2016; Smith et al. v. Howmedica Osteonics Corp., 16-cv-03897, Dkt. No. 13 (D. Minn., Dec. 8

9 Case MDL No Document 30 Filed 02/02/17 Page 9 of 11 27, Chief Judge Tunheim based his decision on Judge Frank and Judge Noel s experience in Stryker I. Specifically, Chief Judge Tunheim said the Stryker LFIT V40 Femoral Head cases have similar facts and issues as the Stryker Rejuvenate MDL, and Judge Frank was best equipped to oversee the cases because of his work in Stryker I. Id. Chief Judge Tunheim also recognized that the reassignment of the cases to Judge Frank and Judge Noel would promote the just, speedy, and inexpensive determination of every civil action. Id. In addition to Judge Frank and Judge Noel s direct experience with Stryker I, the District of Minnesota has a long history of presiding over complex medical device cases: In Re Bair Hugger Forced Air Warming Devices Products Liability Litigation (MDL No. 2666, In Re Guidant Corp. Implantable Defibrillators Prods. Liab. Litig. (MDL No. 1708, In re Medtronic Inc., Sprint Fidelis Leads Prods. Liab. Litig., (MDL No. 1905, In re St. Jude Medical Inc., Silzone Heart Valves Prods. Liab. Litig. (MDL. No. 1396, and In re Medtronic, Inc. Implantable Defibrillators Prods. Liab. Litig. (MDL No Judge Frank and Judge Noel s specific experience, along with the District of Minnesota s extensive history of efficiently handling medical devices cases makes the District of Minnesota the optimal and logical transferee forum for the Stryker LFIT V40 Femoral Head lawsuits. iv. The District of Minnesota provides a convenient location for a litigation that is nationwide in scope. The District of Minnesota provides a convenient forum for the parties and witnesses. See 28 U.S.C. 1407(a (Panel may transfer related actions upon its determination that transfers... will be for the convenience of the parties and witnesses..... When pending actions are geographically dispersed and defendants conduct business nationwide, no particular district or region emerges as the focal point for this litigation. In re Fedex Ground Package Sys., Inc., Employment Practices Litig. (No. II, 381 F. Supp. 2d 1380, 1382 (J.P.M.L The vast 9

10 Case MDL No Document 30 Filed 02/02/17 Page 10 of 11 number of Stryker LFIT V40 Femoral Head devices implanted nationwide confirms there is no focal point for this litigation. Given its central location, the Minneapolis-St. Paul International Airport provides direct flights to multiple destinations across the country throughout the day, making the District of Minnesota a convenient forum when the litigation is nationwide in scope. In addition, Minneapolis-St. Paul also has ample, reasonably-priced hotel accommodations within easy walking distance of the federal courthouses. Accordingly, the Panel should find that the District of Minnesota s geographically central location will benefit all parties in this litigation. In re Stryker Rejuvenate and ABG II Hip Implant Prod. Liab. Litig., 949 F. Supp. 2d at 1380 (U.S. Jud. Pan. Mult. Lit (finding the District of Minnesota appropriate for complex multidistrict litigation because it provides a geographically central forum ; In Re Fluoroquinolone Prod. Liab. Litig., 122 F. Supp. 3d 1378 (U.S. Jud. Pan. Mult. Lit. 2015(Concluding that the District of Minnesota provides a geographically central and convenient forum for this nationwide litigation. ; In Re: Target Corp. Customer Data Sec. Breach Litig., 11 F. Supp. 3d 1338 (U.S. Jud. Pan. Mult. Lit ( Moreover, the District of Minnesota is easily accessible and relatively centrally located for the parties to this litigation, which is nationwide in scope. v. The District of Minnesota has the capacity to efficiently advance the Stryker LFIT V40 Femoral Head litigation The District of Minnesota s current caseload will allow for effective and efficient management of a new MDL. As of January 17, 2017, the District of Minnesota only accounted for 4.1% (10 of 241 of the MDLs pending nationwide. Furthermore, the 10 MDLs pending in the District of Minnesota only account for 2.9% (3,786 of 131,108 of the individual actions pending in all MDLs nationwide. And, as mentioned above, hundreds of lawsuits currently 10

11 Case MDL No Document 30 Filed 02/02/17 Page 11 of 11 pending in Stryker I are expected to resolve by the end of The District of Minnesota has a caseload that can effectively and efficiently preside over a large and complex MDL. III. Conclusion For the aforementioned reasons, the Brown Plaintiffs respectfully request that the Panel centralize this case for pre-trial proceedings and transfer all of the pending and future Stryker LFIT V40 Femoral Head lawsuits to Judge Donovan Frank in the District of Minnesota. Dated: February 2, 2017 Respectfully submitted, ZIMMERMAN REED LLP s/ Charles S. Zimmerman Charles S. Zimmerman, MN # Jason P. Johnston, MN # Jacqueline A. Olson, MN # IDS Center 80 South 8th Street Minneapolis, MN Phone: Fax: charles.zimmerman@zimmreed.com jason.johnston@zimmreed.com jacqueline.olson@zimmreed.com Counsel for the Brown Plaintiffs 11

12 Case MDL No Document 30-1 Filed 02/02/17 Page 1 of 1 BEFORE THE UNITED STATES JUDICIAL PANEL ON MULTIDISTRICT LITIGATION In Re: STRYKER ORTHOPAEDICS LFIT V40 FEMORAL HEAD LIABILITY LITIGATION MDL Docket No SCHEDULE OF ACTIONS CASE CAPTION DISTRICT CIVIL ACTION NO. JUDGE Plaintiff: Dennis Brown and Debbie Brown Defendant: Howmedica Osteonics Corporation, et al. S.D. Texas 4:17-cv Nancy F. Atlas Respectfully submitted, ZIMMERMAN REED LLP Dated: February 2, 2017 s/ Charles S. Zimmerman Charles S. Zimmerman, MN Bar No Jason P. Johnston, MN Bar No Jacqueline A. Olson, MN Bar No IDS Center 80 South 8th Street Minneapolis, MN ( Phone ( Facsimile charles.zimmerman@zimmreed.com jason.johnston@zimmreed.com jacqueline.olson@zimmreed.com Attorneys for Plaintiffs Dennis Brown and Debbie Brown

13 Case MDL No Document 30-2 Filed 02/02/17 Page 1 of 2 BEFORE THE UNITED STATES JUDICIAL PANEL ON MULTIDISTRICT LITIGATION In Re: STRYKER ORTHOPAEDICS LFIT V40 FEMORAL HEAD LIABILITY LITIGATION MDL Docket No PROOF OF SERVICE I hereby certify that on February 2, 2017, I electronically filed the foregoing Interested Party Response and Schedule of Actions with the Clerk of the Panel using the CM/ECF system, and notice was thereby disseminated to all counsel of record registered via the CM/ECF notification system. I further certify that on February 2, 2017, I caused a copy of the same to be served via U.S. Mail upon the following Defendants: Stryker Sales Corporation 2825 Airview Boulevard Kalamazoo, MI Stryker Corporation 2825 Airview Boulevard Kalamazoo, MI Howmedica Osteonics Corporation, d/b/a Stryker Orthopaedics 325 Corporate Drive Mahwah, NJ Stryker Ireland, Limited I.D.A. Business & Technology Park Carrigtohill, County Cork, Ireland

14 Case MDL No Document 30-2 Filed 02/02/17 Page 2 of 2 Respectfully submitted, ZIMMERMAN REED LLP Dated: February 2, 2017 s/ Charles S. Zimmerman Charles S. Zimmerman, MN Bar No Jason P. Johnston, MN Bar No Jacqueline A. Olson, MN Bar No IDS Center 80 South 8th Street Minneapolis, MN ( Phone ( Facsimile charles.zimmerman@zimmreed.com jason.johnston@zimmreed.com jacqueline.olson@zimmreed.com Attorneys for Brown Plaintiffs 2