before the united states judicial panel on multi …€¦ · 02/02/2017 · acetabular hip system...

BEFORE THE UNITED STATES JUDICIAL PANEL ON

MULTI-DISTRICT LITIGATION

)

IN RE: STRYKER ORTHOPAEDICS ) MDL DOCKET NO. 2768

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. §1407

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. §1407. 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.

Case MDL No. 2768 Document 30 Filed 02/02/17 of 11

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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


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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. 2391) (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, 2016. 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 2011. 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


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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 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?ID=149782

2 See http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2016/60268r-eng.php

3 See https://www.tga.gov.au/alert/lfit-anatomic-cocr-v40-femoral-heads-used-hip-replacements


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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. 2441) (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


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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. 2015). 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.


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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. 2015). 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


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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.


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27, 2016). 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. 1726). 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. 2005). The vast


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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. 2013) (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. 2014) (“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


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pending in Stryker I are expected to resolve by the end of 2017. 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 #0120054

Jason P. Johnston, MN #0391206

Jacqueline A. Olson, MN #0391848

1100 IDS Center

80 South 8th Street

Minneapolis, MN 55402

Phone: 612-341-0400

Fax: 612-341-0844

Email: [email protected]



Counsel for the Brown Plaintiffs


BEFORE THE UNITED STATES JUDICIAL

PANEL ON MULTIDISTRICT LITIGATION

In Re:

STRYKER ORTHOPAEDICS LFIT V40

FEMORAL HEAD LIABILITY LITIGATION

)

)

)

)

)

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MDL Docket No. 2768

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-00190 Nancy F. Atlas

Respectfully submitted,

ZIMMERMAN REED LLP

Dated: February 2, 2017 s/ Charles S. Zimmerman

Charles S. Zimmerman, MN Bar No. 120054

Jason P. Johnston, MN Bar No. 0391206

Jacqueline A. Olson, MN Bar No. 0391848

1100 IDS Center

80 South 8th Street


(612) 341-0400 Phone

(612) 341-0844 Facsimile

[email protected]

[email protected]

[email protected]

Attorneys for Plaintiffs Dennis Brown and Debbie

Brown

Case MDL No. 2768 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

)

)

)

)

)

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MDL Docket No. 2768

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 email

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 49002

Stryker Corporation

2825 Airview Boulevard

Kalamazoo, MI 49002

Howmedica Osteonics Corporation,

d/b/a Stryker Orthopaedics

325 Corporate Drive

Mahwah, NJ 07430

Stryker Ireland, Limited

I.D.A. Business & Technology Park

Carrigtohill, County Cork, Ireland


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Respectfully submitted,

ZIMMERMAN REED LLP

Dated: February 2, 2017 s/ Charles S. Zimmerman

Charles S. Zimmerman, MN Bar No. 120054

Jason P. Johnston, MN Bar No. 0391206

Jacqueline A. Olson, MN Bar No. 0391848

1100 IDS Center

80 South 8th Street


(612) 341-0400 Phone

(612) 341-0844 Facsimile

[email protected]

[email protected]

[email protected]

Attorneys for Brown Plaintiffs


before the united states judicial panel on multi …€¦ · 02/02/2017 · acetabular hip system...

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