UNITED STATES DISTRICT COURT FOR THE NORTHERN DISTRICT OF CALIFORNIA ) )

Transcription

1 Case3:10-cv EMC Document4 Filed09/03/10 Page1 of Dana B. Taschner, Esq., SBN dbt@lanierlawfirm.com Lee A. Cirsch, Esq., SBN lec@lanierlawfirm.com LANIER LAW FIRM 2049 Century Park East, Suite 1940 Los Angeles, CA Ph: (310) Fax: (310) W. Mark Lanier LANIER LAW FIRM, PC 6810 FM 1960 West Houston, Texas Phone: (713) Fax: (713) wml@lanierlawfirm.com Attorneys for Plaintiff MAURICE BRIGHAM, and all others similarly situated UNITED STATES DISTRICT COURT FOR THE NORTHERN DISTRICT OF CALIFORNIA MAURICE BRIGHAM, individually ) ) Case No. 3:10-cv EMC and on behalf of all others similarly ) situated, ) PLAINTIFF S EX PARTE ) APPLICATION FOR: (1) ) TEMPORARY RESTRAINING Plaintiffs, ) ORDER; AND (2) ORDER TO ) SHOW CAUSE RE: PRELIMINARY ) INJUNCTION vs. ) ) [PROPOSED] ORDER ) DEPUY ORTHOPAEDICS, INC., an ) [Declaration of Dana B. Taschner filed Indiana Corporation; JOHNSON & ) concurrently herewith] JOHNSON SERVICES, INC., a New ) ) Jersey Corporation; and DOES 1-100, ) inclusive, ) ) ) Defendants. ) ) Case No. 3:10-cv EMC PLAINTIFF S EX PARTE APPLICATION FOR: (1) TEMPORARY RESTRAINING ORDER; AND (2) ORDER TO SHOW CAUSE RE: PRELIMINARY INJUNCTION

2 Case3:10-cv EMC Document4 Filed09/03/10 Page2 of TABLE OF CONTENTS TABLE OF CONTENTS.. i TABLE OF AUTHORITIES.. iii MEMORANDUM OF POINTS AND AUTHORITIES. 1 I. PRELIMINARY STATEMENT. 1 II. NATURE OF THE RELIEF SOUGHT.. 4 III. STATEMENT OF FACTS. 4 A. Description Of The ASR Hip Implant Devices 4 B. Defendants Have Been On Notice Since At Least 2007/2008 That The ASR Hip Implant Devices Are Faulty But Did Not Issue A Recall Until More Than Two Years Later C. Defendants Attempts To Obtain Patients Confidential Medical Information and Explanted ASR Hip Implant Devices.. 6 IV. ARGUMENT.. 8 A. Standard For Obtaining A TRO And Preliminary Injunction.. 8 B. A TRO And Preliminary Injunction Is Necessary To Prevent The Irreparable Injury That Would Result From Defendants Attempt To Elicit Confidential Medical Information From Class Members Physicians In Exchange For Compensation 8 C. A TRO And Preliminary Injunction Is Necessary To Prevent The Irreparable Injury That Would Result From Spoliation Of Evidence Defendants Have Control Over Crucial Documentary Evidence And Are Also Case No. 3:10-cv EMC PLAINTIFF S EX PARTE APPLICATION FOR: (1) TEMPORARY RESTRAINING ORDER; AND (2) ORDER TO SHOW CAUSE RE: PRELIMINARY INJUNCTION - i -

3 Case3:10-cv EMC Document4 Filed09/03/10 Page3 of Attempting To Gain Control Over Other Crucial Physical Evidence Without a Court Order To Prevent Spoliation, Defendants Control Of This Evidence Makes It Possible For Them To Cause Irreparable Injury To Plaintiffs 11 D. Plaintiff Is Likely To Prevail On The Merits.. 12 E. The Balance Of Hardships Strongly Favors Plaintiff. 12 V. CONCLUSION Case No. 3:10-cv EMC PLAINTIFF S EX PARTE APPLICATION FOR: (1) TEMPORARY RESTRAINING ORDER; AND (2) ORDER TO SHOW CAUSE RE: PRELIMINARY INJUNCTION - ii -

4 Case3:10-cv EMC Document4 Filed09/03/10 Page4 of TABLE OF AUTHORITIES Cases Diamontiney v. Borg, 918 F.2d 793, 795 (9 th Cir. 1990) 8, 12 Oakland Tribune, Inc. v. Chronicle Publishing Co., 762 F.2d 1374, 1376 (9 th Cir. 1985) Dondore v. NGK Metals Corp., 152 F. Supp. 662 (E.D. Pa. 2001). 9 Am. Pipe & Constr. Co. v. Utah, 414 U.S. 538 (1974) 9 Unigard Sec. Ins. Co. v. Lakewood Engineering and Mfg. Corp., 982 F.2d 363, (9 th Cir. 1992)... 11, 13 Leon v. IDX Systems Corp., 464 F.3d 951, (9 th Cir. 2006). 13 State Farm Fire and Cas. Co. v. Broan Mfg. Co., Inc., 523 F.Supp.2d 992 (D. Ariz. 2007) Rules Federal Rule of Civil Procedure 65(b). 8 ABA Model Rule Pennsylvania Rule of Professional Conduct , Case No. 3:10-cv EMC PLAINTIFF S EX PARTE APPLICATION FOR: (1) TEMPORARY RESTRAINING ORDER; AND (2) ORDER TO SHOW CAUSE RE: PRELIMINARY INJUNCTION - iii -

5 Case3:10-cv EMC Document4 Filed09/03/10 Page5 of MEMORANDUM OF POINTS AND AUTHORITIES Plaintiff Maurice Brigham ( Plaintiff ), individually and on behalf of a class of those similarly situated, hereby applies ex parte to this Court for a Temporary Restraining Order ( TRO ) and an order to show cause regarding issuance of a preliminary injunction as follows: I. PRELIMINARY STATEMENT As discussed more fully in Plaintiff s Class Action Complaint (attached as Exhibit A to the concurrently filed Declaration of Dana B. Taschner), for more than two years, Defendants DePuy Orthopaedics, Inc. and Johnson & Johnson Services, Inc. (collectively, Defendants ) have known that their hip replacement devices the ASR XL Acetabular System and ASR Hip Resurfacing Platform (collectively, ASR Hip Implant Devices ) fail early in a high percentage of patients. Such failures have been shown to give rise to symptoms such as severe pain, inflammation and death to surrounding tissue and bone, a partial or complete lack of mobility, and the need for revision surgery to remove and replace the device giving rise to even more debilitation, a prolonged recovery time, and an increased risk of complications and death from further surgery. However, rather than immediately recalling the ASR Hip Implant Devices upon first receiving notice in 2007/2008 of several hundred complaints made to the F.D.A. regarding the device s failures and the harmful effects described above, Defendants continued to aggressively market the ASR Hip Implant Devices, claiming that that they were a safe and effective hip replacement system. Not until late August, 2010, did Defendants finally issue a recall of these faulty devices. In furtherance of the recall, Defendants are taking actions that, if not enjoined, will cause irreparable harm to potential Class Members. Specifically, Defendants are requesting that physicians meet with their patients to discuss the recalled implant, including whether the patient has suffered any symptoms from Case No. 3:10-cv EMC PLAINTIFF S EX PARTE APPLICATION FOR: (1) TEMPORARY RESTRAINING ORDER; AND (2) ORDER TO SHOW CAUSE RE: PRELIMINARY INJUNCTION - 1 -

6 Case3:10-cv EMC Document4 Filed09/03/10 Page6 of the implant, and to obtain the patient s consent to send a complete copy of his or her medical records (including notes of any physician-patient discussions about the recalled implant) to Defendants. Defendants have also requested that they be sent any devices that have been explanted. In exchange, Defendants have offered physicians an incentive of $50.00 in compensation per patient for such information. Defendants plan is to no doubt use such patient information in subsequent litigation to support their defenses to any legal claims brought against them by these patients. However, such conduct by Defendants should be enjoined because it will lead to irreparable injury to potential Class Members who will not have had the benefit of legal counsel regarding their rights with respect to the recall before such time as imparting sensitive information to their physicans which could in turn end up being used against them in this litigation. For this reason, Plaintiff requests that the Court issue an order enjoining Defendants underhanded attempts to obtain such medical information to the potential detriment of Class Members. Plaintiff also seeks an order enjoining Defendants from taking any steps to destroy evidence relating to the recalled devices that may be relevant to this litigation. Plaintiff has good reason to believe that Defendants have in their possession substantial internal documentation and communciations relating to the research and development of the recalled implants, external communications with regulators such as the F.D.A. regarding gaining approval of the devices, and other materials essential to Plaintiff s case. Such evidence is necessary to establish when Defendants learned that the ASR Hip Implant Devices were prone to failure, and how long Defendants concealed this knowledge from regulators, physicians and the public. Marketing materials will also establish whether, and to what extent, Defendants attempted to profit from medical devices they knew or should have known were not safe for use. In addition, the actual ASR Hip Implant Devices that may have been, or will be explanted from patients are also essential evidence to Case No. 3:10-cv EMC PLAINTIFF S EX PARTE APPLICATION FOR: (1) TEMPORARY RESTRAINING ORDER; AND (2) ORDER TO SHOW CAUSE RE: PRELIMINARY INJUNCTION - 2 -

7 Case3:10-cv EMC Document4 Filed09/03/10 Page7 of Plaintiff s claim that the devices were negligently and defectively manufactured and designed. To the extent Defendants are attempting to obtain, or have already obtained these devices through the recall process, those explanted devices are essential evidence that must be preserved for this litigation. Without a TRO and subsequent preliminary injunction to prevent the potential spoliation of documentary and physical evidence, it is possible that Defendants or their agents whether intentionally or inadvertently could destroy or discard the evidence that Plaintiff and the Class Members will need to prove their case. In light of the foregoing, the circumstances of this case easily meet the test for obtaining a TRO and preliminary injunction. Using Class Members trusted physicians as a conduit to obtain sensitive medical information and potential admissions for later use in litigation without such Class Members first having the benefit of legal counsel, and the potential for spoliation of evidence that is no doubt relevant to Plaintiff s and the Class Members claims, would cause irreparable injury to Plaintiff and the Class Members by effectively depriving them of their day in court. Moreover, in light of Defendants recall of the ASR Hip Implant Devices, there can be no doubt that such devices are faulty and defective, and hence the likelihood of Plaintiff and the Class Members success on the merits is extremely high. Finally, given the ease with which Defendants and their agents could stop any efforts to obtain confidential patient information, refrain from communicating with such patient class members, and act to preserve the documentary and physical evidence, the balance of hardships weighs strongly in Plaintiff s and the Class Members favor. For these reasons, Plaintiff respectfully requests that the Court issue a TRO and preliminary injunction as described in Section II, below Case No. 3:10-cv EMC PLAINTIFF S EX PARTE APPLICATION FOR: (1) TEMPORARY RESTRAINING ORDER; AND (2) ORDER TO SHOW CAUSE RE: PRELIMINARY INJUNCTION - 3 -

8 Case3:10-cv EMC Document4 Filed09/03/10 Page8 of II. NATURE OF THE RELIEF SOUGHT Through this ex parte application, Plaintiff seeks an order from this Court compelling Defendants, and their officers, employees, attorneys and agents, to refrain from engaging in any communications with Class Members regarding the subject matter of the recall, and to preserve evidence relevant to this Class Action. Specifically, Plaintiff requests that the Court order that: 1) Defendants refrain from communicating with Class Members regarding the subject matter of the recall and further refrain from requesting that Class Members sign authorization and consent forms for their physicians to release to Defendants their medical records and/or any explanted ASR Hip Implant Devices; 2) Defendants shall physically retain, without altering, all research, study data, internal or external communications, marketing materials, and other evidence relating to the ASR Hip Implant Devices; 3) Defendants shall physically retain, without altering, all ASR Hip Implant Devices that they, their officers, employees, attorneys, or agents have obtained or will obtain from any source after August 24, 2010; and 4) Defendants compliance with this order shall be immediate and free of charge to Plaintiffs. Plaintiffs further apply to this Court for an Order to Show Cause why a Preliminary Injunction identical to the TRO described above shall not issue. III. STATEMENT OF FACTS A. Description Of The ASR Hip Implant Devices The ASR Hip Implant Devices were developed in order to reconstruct human hip joints that are diseased due to conditions such as osteoarthritis, rheumatoid arthritis, avascular necrosis (AVN), or fracture. The hip joint connects the thigh (femur) bone of a patient s leg to the patient s pelvis. Declaration of Dana B. Taschner ( Taschner Decl. ), 12, Exh. K. The hip joint is like a ball that Case No. 3:10-cv EMC PLAINTIFF S EX PARTE APPLICATION FOR: (1) TEMPORARY RESTRAINING ORDER; AND (2) ORDER TO SHOW CAUSE RE: PRELIMINARY INJUNCTION - 4 -

9 Case3:10-cv EMC Document4 Filed09/03/10 Page9 of fits in a socket. Id. The socket portion of the hip is called the acetabulum. Id. The femoral head at the top of the femur bone rotates within the curved surface of the acetabulum. Id. The ASR XL Acetabular System is made up of three components: the metal femoral stem is inserted inside the femur, the metal femoral head (or ball) connects to the stem and then fits inside the metal acetabulum cup (socket). Taschner Decl., 12, Exh. K. The ASR Hip Resurfacing Platform has two components: a metal cap is placed over the natural femoral head (or ball) and the acetabulum is replaced with the metal acetabulum cup (socket). Id. Once implanted, these devices are supposed to last for an average of about 15 or more years before requiring replacement. Taschner Decl., 9, Exh. H. B. Defendants Have Been On Notice Since At Least 2007/2008 That The ASR Hip Implant Devices Are Faulty But Did Not Issue A Recall Until More Than Two Years Later Since 2007/2008, the F.D.A. has received more than 400 complaints involving patients in the United States that received the devices, with a substantial number (i.e. over 90%) of these patients requiring complicated, expensive, and painful revision surgery to replace the failed devices. Taschner Decl., 10, Exh. I. These patients have also endured severe pain, swelling, inflammation, and a complete or partial lack of mobility due to the device s failures. Taschner Decl., 10, 12, Exhs. I, K. Despite these complaints, Defendants did not issue a recall of the devices until more than two years later on August 26, Taschner Decl., 10, Exh. I. The recall was based on data showing that metal-on-metal implants, such as the ASR Hip Implant Devices, are potentially dangerous because they can generate large amounts of metallic debris as they wear over time. Taschner Decl., 9-12, Exhs. H-K. The metallic debris has been shown to cause severe inflammatory responses in some patients that cause pain in the groin, and death of tissue in the Case No. 3:10-cv EMC PLAINTIFF S EX PARTE APPLICATION FOR: (1) TEMPORARY RESTRAINING ORDER; AND (2) ORDER TO SHOW CAUSE RE: PRELIMINARY INJUNCTION - 5 -

10 Case3:10-cv EMC Document4 Filed09/03/10 Page10 of hip joint and loss of surrounding bone, requiring a revision surgery to replace the device soon after implant instead of the 15 or more years artificial hips are supposed to last. Id. The recall was also based on unpublished data from the National Joint Registry (NJR) of England and Wales. The NJR data shows the five year revision rate for the ASR Hip Resurfacing System is approximately 12 percent, and is approximately 13 percent for the ASR XL Acetabular System. Taschner Decl., 9-12, Exhs. H-K. However, Defendants acknowledge that under generally accepted standards, no more than 5 percent of patients should have a revision surgery within five years of implantation. Id. The data released from the NJR shows that the ASR Hip Implant Devices had a revision rate almost three times that of the generally accepted standards. Many experts in the field of orthopaedics, including one of the codevelopers of the ASR Hip Implant Devices, have acknowledged that the culprit for the high number of revision surgeries is due to the design of the acetabulum metal cup which is shallower than other competitor s cups on the market. Taschner Decl., 9-10, Exhs. H-I. It is this shallower design which presents a challenge for properly implanting the device which can lead to problems such as loosening of the device, malalignment of the device, and fracture of the device from the bone, all of which can cause severe infection and inflammation in patients. Taschner Decl., 9-11, Exhs. H-J. C. Defendants Attempts To Obtain Patients Confidential Medical Information and Explanted ASR Hip Implant Devices On August 24, 2010, Defendants issued a letter to physicians attaching the official recall notice. Taschner Decl., 7, 11, Exhs. F, J. The letter also enclosed several other documents for physicians to use to communicate with their patients such as a sample patient cover letter, information for patients, and medical release forms. Taschner Decl., 7, Exh. F. The letter further indicates that Defendants are Case No. 3:10-cv EMC PLAINTIFF S EX PARTE APPLICATION FOR: (1) TEMPORARY RESTRAINING ORDER; AND (2) ORDER TO SHOW CAUSE RE: PRELIMINARY INJUNCTION - 6 -

11 Case3:10-cv EMC Document4 Filed09/03/10 Page11 of amenable to reimbursing patients for the reasonable and customary expenses associated with any monitoring, treatment, or revision surgery arising from the recall. Id. However, such reimbursement is subject to the completion and required documentation to Defendants to confirm eligibility. Id. The letter explains that, [e]ligibility will be determined, in part, by validation that the patient has an ASR component implanted and has consented to provide [Defendants] with x-rays, explants and any other requested medical information after the revision surgery. Id. The letter concludes by stating that, [w]e will provide you with a brief form to be completed for each patient, including date of surgery, components implanted, follow up status and the results of any metal ion testing. We appreciate your assistance with this process, and we will provide compensation at a rate of $50 per patient for each completed form that is submitted to [Defendants]. Id. The Authorization to Use or Disclose Information (Medical Release Form) accompanying the letter to the physicians provides for disclosure of all medical records and x-rays of [the patient] regarding his/her initial implant surgery and subsequent revision surgery and all follow up visits and records. Taschner Decl., 4, Exh. C. The form states that [d]octor office records should include but not be limited to new patient intake form, progress record, telephone message slips, copies of lab work, radiography, consultation reports, physical therapy reports, product code and lot number of components implanted; and all records relating to these surgeries and all follow up visits and records. Id. The Patient Consent Form (for disclosure of records) also provides for disclosure to Defendants of the ex-planted ASR product component(s), if available, in respect of both my original implant surgery and subsequent revision surgery, to enable [Defendants] to carry out tests upon such components. Taschner Decl., 5, Exh. D Case No. 3:10-cv EMC PLAINTIFF S EX PARTE APPLICATION FOR: (1) TEMPORARY RESTRAINING ORDER; AND (2) ORDER TO SHOW CAUSE RE: PRELIMINARY INJUNCTION - 7 -

12 Case3:10-cv EMC Document4 Filed09/03/10 Page12 of IV. ARGUMENT A. Standard For Obtaining A TRO And Preliminary Injunction The purpose of a temporary restraining order (TRO) or a preliminary injunction is to stop conduct that would result in irreparable injury. Under Federal Rule of Civil Procedure 65(b), this Court may grant a TRO without written or oral notice to the adverse party or its attorney if (A) specific facts in an affidavit or a verified complaint clearly show that immediate and irreparable injury, loss, or damage will result to the movant before the adverse party can be heard in opposition; and (B) the movant s attorney certifies in writing any efforts made to give notice and the reasons why it should not be required. Where, as here, the party seeking injunctive relief can show either (1) a likelihood of success on the merits and the possibility of irreparable injury, or (2) the existence of serious questions going to the merits and the balance of hardships tipping in [the movant s] favor, the Court may grant a preliminary injunction. Diamontiney v. Borg, 918 F.2d 793, 795 (9 th Cir. 1990), quoting Oakland Tribune, Inc. v. Chronicle Publishing Co., 762 F.2d 1374, 1376 (9 th Cir. 1985) (alteration in original). B. A TRO And Preliminary Injunction Is Necessary To Prevent The Irreparable Injury That Would Result From Defendants Attempt To Elicit Confidential Medical Information From Class Members Physicians In Exchange For Compensation In conjunction with the event of the legal recall of the ASR Hip Implant Devices, Defendants are asking putative class members to fill out the release forms available below and mail them to the address on the form. This will allow [Defendants] to contact your surgeon or hospital on your behalf and request execution of a downloadable form for release of confidential medical information. Taschner Decl., 3, Exh. B. Defendants are no doubt requesting such confidential Case No. 3:10-cv EMC PLAINTIFF S EX PARTE APPLICATION FOR: (1) TEMPORARY RESTRAINING ORDER; AND (2) ORDER TO SHOW CAUSE RE: PRELIMINARY INJUNCTION - 8 -

13 Case3:10-cv EMC Document4 Filed09/03/10 Page13 of medical information and statements from Class Members and their surgeons for the sole purpose of using such information later in litigation to bolster their defense. However, as a result of the putative class action filed by Plaintiff in this Court, the patients (i.e. Class Members) from whom Defendants are requesting this private information is prohibited. Under the ABA s Model Rule 4.2, a lawyer shall not communicate with a person the lawyer knows to be represented by another lawyer in the matter. This rule, which many (but not all) states have adopted in whole or in part, was clarified in 1995, when the word person was substituted for party so as to ensure that the ex parte bar applied to, inter alia, pre-litigation settings. In the analogous case of Dondore v. NGK Metals Corp., 152 F. Supp. 662 (E.D. Pa. 2001), 2 CLASS 271, 4/27/01, Judge Harvey Bartle III ruled that counsel for a defendant in a class action was barred from any contact with potential members of the class, even in the pre-certification stage of the proceeding. In Dondore, a defendant s lawyer wanted to interview three potential witnesses in a personal injury action; those witnesses were also putative class members in a state court class action alleging the same tortious conduct. When plaintiffs counsel became aware of the defendant s attempt to interview those individuals, they filed an emergency motion for a protective order in state court; in turn, the defendant s attorney interposed a motion before Judge Bartle to confirm his right to talk to the witnesses regarding the asserted federal claims. With Pennsylvania's Rule of Professional Conduct 4.2 (which tracks Model Rule 4.2, except party substitutes for person ) governing, Judge Bartle first looked to principles enunciated in the federal class action context by the U.S. Supreme Court in Am. Pipe & Constr. Co. v. Utah, 414 U.S. 538 (1974). More specifically (as per Judge Bartle), [t]he mere initiation of a class action extends certain protections to potential class members, who have been characterized by the Supreme Court as passive beneficiaries of the action brought in their behalf. Case No. 3:10-cv EMC PLAINTIFF S EX PARTE APPLICATION FOR: (1) TEMPORARY RESTRAINING ORDER; AND (2) ORDER TO SHOW CAUSE RE: PRELIMINARY INJUNCTION - 9 -

14 Case3:10-cv EMC Document4 Filed09/03/10 Page14 of Among the passive benefits identified was the tolling of the statute of limitations. Judge Bartle then looked to Pennsylvania state law, finding that putative class members are properly characterized as parties to the action. Finally, the judge looked to the intersection of a class action (with its truly representative nature) and Rule 4.2, and ruled that the rights and protections afforded putative class members include the protections contained in Rule 4.2. Citing to the policies underlying the no-contact rule (i.e., protecting uncounselled lay persons and preserv[ing] the efficacy and sanctity of the lawyer-client relationship ), Judge Bartle determined that the benefits of class action litigation could be seriously undermined by any ex parte communications in the precertification period. Here, the same rationale applies to Defendants attempts to obtain Class Members confidential medical information from their surgeons in exchange for the physician receiving compensation. These Class Persons are uncounselled lay persons that will have not had the benefit of legal counsel before allowing the release of their confidential medical information or completing questionnaires that could inadvertently contain admissions that Defendants will later use in litigation to the detriment of such Class Members. As a result, an injunction is necessary to prevent Defendants from communicating with Class Members (through their surgeons) so as to obtain confidential medical information and inadvertent admissions to be used later on in the litigation to these individuals detriment. C. A TRO And Preliminary Injunction Is Necessary To Prevent The Irreperable Injury That Would Result From Spoliation Of Evidence 1. Defendants Have Control Over Crucial Documentary Evidence And Are Also Attempting To Gain Control Over Other Crucial Physical Evidence Case No. 3:10-cv EMC PLAINTIFF S EX PARTE APPLICATION FOR: (1) TEMPORARY RESTRAINING ORDER; AND (2) ORDER TO SHOW CAUSE RE: PRELIMINARY INJUNCTION

15 Case3:10-cv EMC Document4 Filed09/03/10 Page15 of In designing and manufacturing the ASR Hip Implant Devices, Defendants no doubt conducted years of research in order to develop these medical devices. Since Defendants legal culpability will depend in part on when they learned of the connection between the ASR Hip Implant Devices and the harmful effects that arise when they fail, these studies are critical evidence. Additional documents, including internal communications, correspondence with regulators, copies of complaints received by the F.D.A. and provided to Defendants, and marketing materials through which Defendants made representations to physicians and the public, are essential in determining the duration and extent of Defendants knowledge and potential cover-up of the dangers of the ASR Hip Implant Device. In addition, the recall process is likely giving Defendants control over crucial physical evidence. In addition to the ASR Hip Implant Devices that were never sold and are presumably still located at Defendants factories, it is likely that Defendants have received or will receive from surgeons those ASR Hip Implant Devices that have been or will be explanted from patients. Since Defendants will likely dispute Plaintiff s claim that the ASR Hip Implant Devices were defectively manufactured and designed, it will be necessary for Plaintiff to retain experts to study the devices in order to render their opinions. 2. Without A Court Order To Prevent Spoliation, Defendants Control Of This Evidence Makes It Possible For Them To Cause Irreparable Injury To Plaintiffs Defendants control of the vast majority of the evidence in this case gives them a dangerous opportunity. If Defendants destroy research data, communications with the F.D.A. and physicians regarding complaints received about the devices, marketing materials, and the actual devices themselves, Defendants will effectively deny Plaintiffs their day in court. Cf. Unigard Sec. Ins. Co. v. Lakewood Engineering and Mfg. Corp., 982 F.2d 363, (9 th Cir. 1992) (explaining that when a defendant spoliates evidence, the spoliation damages a Case No. 3:10-cv EMC PLAINTIFF S EX PARTE APPLICATION FOR: (1) TEMPORARY RESTRAINING ORDER; AND (2) ORDER TO SHOW CAUSE RE: PRELIMINARY INJUNCTION

16 Case3:10-cv EMC Document4 Filed09/03/10 Page16 of right that the other party possesses: the capacity to bring a lawsuit ). Only by granting a TRO and preliminary injunction can the Court be certain that this will not occur. D. Plaintiff Is Likely To Prevail On The Merits Plaintiffs likelihood of success on the merits, Diamontiney, 918 F.2d at 795, is extremely high in light of Defendants recall of the devices. The recall is in and of itself an admission that the devices are faulty and defective. This alone is enough for Plaintiff to prevail on his strict products liability claims. In addition, Plaintiffs likelihood of success is increased by skilled counsel with many years of experience in class actions, complex litigation, and high-profile medical device cases involving hip implants such as the 2001 Sulzer Orthopaedics Inter-Op brand hip replacement implants. In addition to this experience, Plaintiffs counsel has approximately fifty of the nation s leading litigators, in offices ranging from Los Angeles and Palo Alto to Houston and New York. All that Plaintiffs need now is evidence of what Defendants knew, and when they knew it. If the Court issues a TRO and preliminary injunction preventing Defendants from any spoliation of this evidence, Plaintiffs fully expect to prevail. E. The Balance Of Hardships Strongly Favors Plaintiff Even if the Court entertains doubts about Plaintiffs likelihood of prevailing, the question of Defendants responsibility for the harm Plaintiffs have suffered is a serious question going to the merits of the case. Diamontiney, 918 F.2d at 795. And if there is a balance of hardships at all, it certainly tips in Plaintiff s favor. Id. In the absence of a TRO and preliminary injunction, any effort by Defendants to seek Class Members statements and medical records provided without the benefit of consultation with legal counsel, and to destroy evidence, could deprive Plaintiff, and hundreds or thousands of similarly situated Class Members, of the right to seek redress for their injuries. Case No. 3:10-cv EMC PLAINTIFF S EX PARTE APPLICATION FOR: (1) TEMPORARY RESTRAINING ORDER; AND (2) ORDER TO SHOW CAUSE RE: PRELIMINARY INJUNCTION

17 Case3:10-cv EMC Document4 Filed09/03/10 Page17 of If a preliminary injunction were issued, Defendants would suffer at worst the minor inconvenience of retracting and retreating from their previous efforts of communicating with Class Members and their physicians and obtaining those Class Members confidential medical information, and preserving evidence either already in their possession or which will be in their possession in the near future. But a true accounting of the balance of hardships must also reflect the benefit to Defendants of a TRO and preliminary injunction. Willful spoliation of evidence is a serious offense, and if Defendants were to commit this offense, they could face sanctions and even tort liability. Cf. Leon v. IDX Systems Corp., 464 F.3d 951, (9 th Cir. 2006) (reviewing, and affirming, the district court s grant of spoliation sanctions against a party whose behavior amounted to willful spoliation ); see also Unigard Sec. Ins. Co., 982 F.2d at (noting that some states have recognized spoliation of evidence as an independent tort, and explaining that when a defendant spoliates evidence, the spoliation damages a right that the other party possesses: the capacity to bring a lawsuit ); State Farm Fire and Cas. Co. v. Broan Mfg. Co., Inc., 523 F.Supp.2d 992 (D. Ariz. 2007) (imposing sanctions against a party, including dismissal of that party s case, for willful spoliation of evidence). By preventing Defendants from spoliating evidence, the Court s grant of a preliminary injunction would reduce the potential hardships faced by both parties. V. CONCLUSION Based on the foregoing, Plaintiff respectfully requests that the Court issue a TRO as requested herein, and further issue an Order to Show Cause why a Preliminary Injunction identical to the TRO shall not issue. Dated: September 2, 2010 Case No. 3:10-cv EMC PLAINTIFF S EX PARTE APPLICATION FOR: (1) TEMPORARY RESTRAINING ORDER; AND (2) ORDER TO SHOW CAUSE RE: PRELIMINARY INJUNCTION

18 Case3:10-cv EMC Document4 Filed09/03/10 Page18 of Dana B. Taschner, Esq., SBN dbt@lanierlawfirm.com Lee A. Cirsch, Esq., SBN lec@lanierlawfirm.com LANIER LAW FIRM 2049 Century Park East, Suite 1940 Los Angeles, CA Ph: 310/ Fax: 310/ W. Mark Lanier LANIER LAW FIRM, PC 6810 FM 1960 West Houston, Texas Phone: (713) Fax: (713) wml@lanierlawfirm.com Case No. 3:10-cv EMC PLAINTIFF S EX PARTE APPLICATION FOR: (1) TEMPORARY RESTRAINING ORDER; AND (2) ORDER TO SHOW CAUSE RE: PRELIMINARY INJUNCTION

19 Case3:10-cv EMC Document4-1 Filed09/03/10 Page1 of Dana B. Taschner, Esq., SBN dbt@lanierlawfirm.com Lee A. Cirsch, Esq., SBN lec@lanierlawfirm.com LANIER LAW FIRM 2049 Century Park East, Suite 1940 Los Angeles, CA Ph: (310) Fax: (310) W. Mark Lanier LANIER LAW FIRM, PC 6810 FM 1960 West Houston, Texas Phone: (713) Fax: (713) wml@lanierlawfirm.com Attorneys for Plaintiff MAURICE BRIGHAM, and all others similarly situated UNITED STATES DISTRICT COURT FOR THE NORTHERN DISTRICT OF CALIFORNIA MAURICE BRIGHAM, individually ) ) Case No. 3:10-cv EMC and on behalf of all others similarly ) situated, ) DECLARATION OF DANA B. ) TASCHNER IN SUPPORT OF ) PLAINTIFF S EX PARTE Plaintiffs, ) APPLICATION FOR: (1) ) TEMPORARY RESTRAINING ) ORDER; AND (2) ORDER TO vs. ) SHOW CAUSE RE: PRELIMINARY ) INJUNCTION ) DEPUY ORTHOPAEDICS, INC., an ) Indiana Corporation; JOHNSON & ) JOHNSON SERVICES, INC., a New ) ) Jersey Corporation; and DOES 1-100, ) inclusive, ) ) ) Defendants. ) ) Case No. 3:10-cv EMC DECLARATION OF DANA B. TASCHNER IN SUPPORT OF PLAINTIFF S EX PARTE APPLICATION FOR: (1) TEMPORARY RESTRAINING ORDER; AND (2) ORDER TO SHOW CAUSE RE: PRELIMINARY INJUNCTION - 1 -

20 Case3:10-cv EMC Document4-1 Filed09/03/10 Page2 of DECLARATION OF DANA B. TASCHNER I, Dana B. Taschner, declare as follows: 1. I am an attorney licensed to practice in all courts in the State of California, and am admitted to practice before this Court. I am the managing attorney of the Los Angeles office of The Lanier Law Firm, and am one of the attorneys primarily responsible for representing Plaintiff Maurice Brigham in this case. If called as a witness in this matter, I could and would competently testify to all facts set forth in this Declaration from my own personal knowledge. 2. Attached hereto as Exhibit A is a true and correct copy of the Class Action Complaint filed by Plaintiff Maurice Brigham in this action. 3. Attached hereto as Exhibit B is a true and correct copy of the ASR Hip System Recall Guide that I obtained from Defendant DePuy Orthopaedics, Inc. s website on September 1, Attached hereto as Exhibit C is a true and correct copy of the Authorization to Use or Disclose Information (Medical Release Form) that I obtained from Defendant DePuy Orthopaedics, Inc. s website on September 1, Attached hereto as Exhibit D is a true and correct copy of the Patient Consent Form (for disclosure of records) that I obtained from Defendant DePuy Orthopaedics, Inc. s website on September 1, Attached hereto as Exhibit E is a true and correct copy of the ASR Hip Implant Recall Health Care Professional Information publication that I obtained from Defendant DePuy Orthopaedics, Inc. s website on September 1, Attached hereto as Exhibit F is a true and correct copy of the Health Care Professional Letter dated August 24, 2010 that I obtained from Defendant DePuy Orthopaedics, Inc. s website on September 1, Case No. 3:10-cv EMC DECLARATION OF DANA B. TASCHNER IN SUPPORT OF PLAINTIFF S EX PARTE APPLICATION FOR: (1) TEMPORARY RESTRAINING ORDER; AND (2) ORDER TO SHOW CAUSE RE: PRELIMINARY INJUNCTION - 2 -

21 Case3:10-cv EMC Document4-1 Filed09/03/10 Page3 of Attached hereto as Exhibit G is a true and correct copy of the sample Patient Letter that Defendant DePuy Orthopaedics, Inc. made available to physicians to send to their patients and which I obtained from Defendant DePuy Orthopaedics, Inc. s website on September 1, Attached hereto as Exhibit H is a true and correct copy of an article published by the New York Times on March 9, 2010 entitled With Warning, a Hip Device Is Withdrawn, that I retrieved from the New York Times website on September 2, Attached hereto as Exhibit I is a true and correct copy of an article published by the New York Times on August 26, 2010 entitled Johnson & Johnson Recalls Hip Implants, that I retrieved from the New York Times website on September 2, Attached hereto as Exhibit J is a true and correct copy of an August 24, 2010 recall notice sent by Defendant DePuy Orthopaedics, Inc. to physicians regarding the ASR XL Acetabular System/DePuy ASR Hip Resurfacing System. 12. Attached hereto as Exhibit K is a true and correct copy of the ASR Recall Frequently Asked Questions publication that I obtained from Defendant DePuy Orthopaedics, Inc. s website on September 2, I declare under penalty of perjury under the laws of the United States of America that the foregoing is true and correct. Executed on September 2, 2010, at Los Angeles, California Dana B. Taschner Case No. 3:10-cv EMC DECLARATION OF DANA B. TASCHNER IN SUPPORT OF PLAINTIFF S EX PARTE APPLICATION FOR: (1) TEMPORARY RESTRAINING ORDER; AND (2) ORDER TO SHOW CAUSE RE: PRELIMINARY INJUNCTION - 3 -

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