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Dangerous Drugs & Medical Devices News & Commentary on Prescription Drug & Medical Device Lawsuits

Discovery Battle in Fentanyl Lawsuit Against Mylan Pharmaceuticals

Posted in Duragesic / Fentanyl

Several fentanyl attorneys who have sued Mylan Pharmaceuticals and Mylan Technologies have asked the court to order the production of many documents related to the design, manufacture, and distribution of Mylan fentanyl pain patches:

Plaintiff Monica Cunningham, as personal representative of the estate of John E. Edmonson, and on behalf of the Wrongful Death Beneficiaries of John E. Edmonson (“Plaintiff”), by and through her undersigned attorneys files this Motion to Compel Production of Documents Related to (1) Communications with Governmental Agencies, (2) Inspections of Facilities, (3) Recalls, (4) Batch Records, (5) Operating Procedures, (6) Product Returns, (7) Plaintiff, and (8) Intended Fentanyl Concentrations. Pursuant to Local Rule 3.01(j), Plaintiff requests oral argument on this motion and estimates the Court will need thirty minutes to hear the Motion.

I’m not surprised at all that the fentanyl attorneys representing Mylan are refusing to hand these documents over without a protective order.  Similar documents produced in Duragesic lawsuits have shown fentanyl manufacturers to have shoddy manufacturing plants and lackluster quality control.  At this point, I haven’t seen any documents produced from a Mylan fentanyl patch lawsuit.  I can’t wait for some to be made available, and when they are, I’ll post them here.

PLAINTIFF'S MOTION TO COMPEL PRODUCTION OF DOCUMENTS RELATED TO (1) COMMUNICATIONS WITH GOVERNMENTAL AGENCIES, (2) INSPECTIONS OF FACILITIES, (3) RECALLS, (4) BATCH RECORDS, (5) OPERATING PROCEDURES, (6) PRODUCT RETURNS, (7) PLAINTIFF, AND (8) INTENDED FENTANYL CONCENTRATIONS

Plaintiff Monica Cunningham, as personal representative of the estate of John E. Edmonson, and on behalf of the Wrongful Death Beneficiaries of John E. Edmonson (“Plaintiff”), by and through her undersigned attorneys files this Motion to Compel Production of Documents Related to (1) Communications with Governmental Agencies, (2) Inspections of Facilities, (3) Recalls, (4) Batch Records, (5) Operating Procedures, (6) Product Returns, (7) Plaintiff, and (8) Intended Fentanyl Concentrations. Pursuant to Local Rule 3.01(j), Plaintiff requests oral argument on this motion and estimates the Court will need thirty minutes to hear the Motion.

I. PROCEDURAL BACKGROUND

On November 11, 2008, Plaintiff served Defendants Mylan Inc., Mylan Pharmaceuticals, Inc., and Mylan Technologies, Inc. (collectively the “Mylan Defendants”) with Plaintiff's First Request for Production of Documents.[FN1] On December 31, 2008, the Mylan Defendants served their Responses to Plaintiff's First Request for Production of Documents (“Mylan's Response”).

    FN1. Plaintiff's First Request for Production of Documents is attached hereto as Exhibit A.

In Mylan's Response, the Mylan Defendants lodge general objections to all of Plaintiff's requests. The Mylan Defendants further specifically object to almost all of Plaintiff's requests contending that most of the requests are overly broad, unduly burdensome, vague and ambiguous, and confidential. In addition, the Mylan Defendants refuse to provide documents without a stipulation of confidentiality and protective order, and they have yet to produce a single document.

Plaintiff's counsel conferred with counsel for the Mylan Defendants in a good-faith effort to resolve the dispute without court action, as required by Federal Rule of Civil Procedure 37(a)(1) and as shown in the attached certificate of conference. However, the parties were unable to resolve the dispute. Therefore, Plaintiff seeks the help of the Court.

As set forth more fully in the attached Memorandum of Legal Authority, Plaintiff requests that this court compel production of documents responsive to the requests at issue because they are reasonably calculated to lead to the discovery of admissible evidence. FED. R. Cv. P. 26(b)(1).

II. FACTUAL BACKGROUND

Plaintiff alleges that John E. Edmonson (“Decedent”) filled his prescription for a transdermal fentanyl system patch with a 75 mcg Mylan patch (the “Patch”). (Pl's Original Compl. ¶6.) Decedent was wearing one of these patches at the time of his death and it was the cause of his death. ( Id.) Plaintiff asserts that the Patch worn by Decedent at the time of his death was designed, manufactured, marketed, and distributed by the Mylan Defendants. ( Id.) Plaintiff asserts the Patch was unreasonably dangerous because it gave Decedent a much higher dose of fentanyl than a properly functioning patch should have given him. Plaintiff has brought strict liability claims against the Mylan Defendants for manufacturing, marketing, and design defects. ( Id. ¶¶10-14.) Plaintiff alleges that the Mylan Defendants knew or had reason to know that the Patch was or was likely to be unreasonably dangerous in the use for which it was made and that the Mylan Defendants were aware or had reason to know that the design of the Patch was defective and that another design was feasible. ( Id. at ¶¶12-13.)

Plaintiff further alleges that the Mylan Defendants were negligent in the design, manufacture, marketing, testing and sale of the Patch ( Id. ¶15.) The alleged negligence includes, without limitation:

a. Inadequate and/or insufficient warnings regarding the product;

b. Failure to use due care in designing and manufacturing the Patch;

c. Failure to use proper materials reasonably suited to the manufacture of the Patch;

d. Failure to use due care to test and inspect the Patch to determine its durability and functionality for the purpose for which it was intended;

e. Failure to conduct adequate testing and post-marketing surveillance to determine the safety of the Patch;

f. Inadequate or insufficient inspection for defects;

g. Inadequate and/or insufficient research into the safety of the product prior to sale;

h. Inadequate and/or insufficient monitoring or research regarding adverse events;

i. Failure to provide adequate training, knowledge or information to physicians, distributors, or sellers of the product;

j. Failure to adequately warn individuals of the dangerous and lethal side effects of the product;

k. Formulating and designing the product;

l. Making the product;

m. Inspecting and testing the product; and

n. Packaging the product.

( Id. ¶16.)

Plaintiffs also allege that the Mylan Defendants made negligent misrepresentations to Decedent, physicians, distributors, pharmacists, and the general public by failing to communicate that proper use of the Patch could cause serious injury or death. ( Id. ¶18.)

III. MEMORANDUM OF LEGAL AUTHORITY

Pursuant to Local Rule 3.04, following a brief description of the broad category and argument as to why such category is discoverable, Plaintiff includes quotation in full of each request for production to which the motion is addressed. Each request is followed immediately by quotation in full of the Mylan Defendants' response. Immediately following, to the extent necessary, is additional argument directed to such specific request.

Plaintiff respectfully asks this Court to overrule the Mylan Defendants' objection to forty five different requests for production. These requests fall into eight broad categories of documents related to this litigation: (1) Communications with Governmental Agencies, (2) Inspections of Facilities, (3) Product Recalls, (4) Batch Records, (5) Operating Procedures, (6) Product Returns, (7) Plaintiff, and (8) Alternative Designs.
A. REQUESTS CONCERNING COMMUNICATIONS WITH GOVERNMENTAL ENTITIES RELATED TO THE MYLAN PRODUCTS

Federal Rule of Civil Procedure 26(b)(1) allows parties to obtain discovery regarding any matter, not privileged, which is relevant to the subject matter involved in the pending action. The information sought need not be admissible at trial if the information sought appears reasonably calculated to lead to the discovery of admissible evidence. FED. R. CIV. P. 26(b). In this case, Plaintiff's discovery is relevant and narrowly tailored to the claims made in Plaintiff's Original Complaint.

These ten requests relate to interactions between governmental agencies and the Mylan Defendants concerning the “Mylan Products.” Plaintiff defines “Mylan Products” as “any of the transdermal fentanyl patch system products designed, manufactured or distributed by Defendants.” Documents provided to or by these agencies will likely to lead to admissible evidence relating to Plaintiff's negligence and product liability claims. Specifically, Plaintiff alleges that the Mylan Defendants knew or had reason to know that the Patch was or was likely to be unreasonably dangerous in the use for which it was made and that the Mylan Defendants were aware or had reason to know that the design of the Patch was defective and that another design was feasible. ( Id. at ¶¶12-13.) Documents between the Mylan Defendants and governmental agencies will reveal any concerns the agencies have regarding the Mylan Products and Mylan's knowledge of those concerns. Furthermore, they will probably contain descriptions of the design, or proposed design, of the Mylan Products. What the Mylan Defendant told these agencies regarding the safety of the Mylan Products will also be critical to this litigation. Thus, all of these requests are reasonable likely to lead to the discovery of admissible evidence.

Plaintiff has limited these requests to the transdermal fentanyl patch system at issue in this case, and thus the requests are not overly broad or unduly burdensome. Moreover, due to the nature of the case, these requests are limited in time to a reasonable period. Mylan Inc. announced final FDA approval for its fentanyl transdermal system on January 28, 2005. Thus, obtaining documents relating to communications with governmental agencies will not require Mylan to comb through decades of documents. Most of the documents will have been created within the last five years. Accordingly, these requests are narrowly tailored to lead to evidence directly related to Plaintiff's claims, and production should be ordered. See FED. R. Civ. P. 26(b).

The Mylan Defendants assert that no documents can be produced without a protective order. Plaintiff disagrees. Plaintiff believes the vast majority of the documents sought by Plaintiff are not “trade secret[s] or other confidential research, development, or commercial information” subject to protection under Federal Rule of Civil Procedure 26(c)(1)(G). Certainly, the Mylan Defendants have the burden of justifying the confidentiality of each and every document sought to be covered by a protective order, which they have not done. See Cipollone v. Liggett Group, Inc., 785 F.2d 1108, 1122 (3rd Cir. 1986.) Accordingly, the Mylan Defendants should be required to produce documents responsive to these requests, and seek protection only for “trade secret or confidential research, development, or commercial information” protected by Rule 26(c)(1)(G).[FN2]

    FN2. Plaintiff has provided to Defense counsel an appropriate protective order and offered to have such order entered in this case. However, the Defendants refused such offer. Attached hereto as Exhibit “B” is a copy of the protective order entered by Judge Dan Polster (District Judge for the Northern District of Ohio) in a separate fentanyl case involving these same Defendants.

REQUEST NO. 22: Any and all documents submitted to the FDA in connection with efforts to obtain FDA approval of any Mylan Products or the labeling for same.

RESPONSE: Mylan objects that this Request is overly broad, repetitive, unduly burdensome, vague, ambiguous and seeks production of privileged, confidential and/or proprietary information. Subject to, and without waiving its foregoing General Objections and specific objections, Mylan refers Plaintiff to the Abbreviated New Drug Application (ANDA) for FTS submitted to the FDA for approval pursuant to 21 U.S.C. § 355(j), the correspondence to and from the FDA concerning the ANDA, and the packaging and labeling for FTS which Mylan will produce once a Stipulation of Confidentiality and Protective Order has been executed between the parties and subject to the terms thereof. Mylan will further review its records and produce relevant correspondence to and from the FDA within the January 28, 2005 through March 20, 2006 time period pursuant to the aforementioned Stipulation of Confidentiality and Protective Order once fully executed by the parties.

The Mylan Defendants attempt to limit production to correspondence “concerning the ANDA” and “relevant correspondence to and from the FDA within the January 28, 2005 through March 20, 2006 time period.” But all correspondence between Mylan and the FDA regarding approval and labelling of the Mylan Products, the fentanyl patches at issue in this case, could lead to discoverable information relating to Plaintiff's claim that the Mylan Defendants failed to warn that use of the Mylan Products can cause death ( See Pl.'s Compl. ¶¶ 12, 16, 18.) Thus, Plaintiff requests the objections be overruled and production of all correspondence with the FDA relating to the approval and labelling of the Mylan Products be compelled.

REQUEST NO. 23: Produce all documents relating to or constituting any communication with or submissions to the FDA or any Foreign Government Regulatory Authority regarding the recall of any Mylan Product.

RESPONSE: Mylan objects that this Request is overly broad, repetitive, unduly burdensome, vague, ambiguous and seeks production of privileged, confidential and/or proprietary information. Subject to, and without waiving its foregoing General Objections and specific objections, Mylan states that it is not currently in possession of any relevant documents responsive to this Request.

REQUEST NO. 37: All documents or written communication between you and the Center for Disease Control in regard to any Mylan Product.

RESPONSE: Mylan objects that this Request is overly broad, unduly burdensome, vague, ambiguous and repetitive. Mylan further objects that this Request seeks disclosure of privileged and/or confidential information, and is irrelevant and immaterial to Plaintiffs claims. Finally, Mylan objects that this Request is irrelevant to Plaintiffs claims and is not reasonably calculated to lead to the discovery of admissible evidence.

Documents showing communications between the Mylan Defendants and the Center for Disease Control (and similar organizations and agencies) regarding the Mylan Products could lead to the discovery of admissible evidence relating to Plaintiff's claim that the Mylan Defendants knew or should have know about the dangerous condition of the Mylan Products. For example, the CDC or another organization or agency may have expressed to the Mylan Defendants its concerns about the risk of death associated with the Mylan Products. Accordingly, these documents should be produced.

REQUEST NO. 38: All documents or written communication between you and the National Institute of Health in regard to any Mylan Product.

RESPONSE: Mylan objects that this Request is overly broad, unduly burdensome, vague, ambiguous and repetitive. Mylan further objects that this Request seeks disclosure of privileged and/or confidential information, and is irrelevant and immaterial to Plaintiffs claims. Finally, Mylan objects that this Request is irrelevant to Plaintiffs claims and is not reasonably calculated to lead to the discovery of admissible evidence.

REQUEST NO. 39: All documents or written communication between you and the World Health Organization in regard to any Mylan Product.

RESPONSE: Mylan objects that this Request is overly broad, unduly burdensome, vague, ambiguous and repetitive. Mylan further objects that this Request seeks disclosure of privileged and/or confidential information, and is irrelevant and immaterial to Plaintiffs claims. Finally, Mylan objects that this Request is irrelevant to Plaintiffs claims and is not reasonably calculated to lead to the discovery of admissible evidence.

REQUEST NO. 40: All documents or written communication between you and the Drug Enforcement Agency in regard to any Mylan Product.

RESPONSE: Mylan objects that this Request is overly broad, unduly burdensome, vague, ambiguous and repetitive. Mylan further objects that this Request seeks disclosure of privileged and/or confidential information, and is irrelevant and immaterial to Plaintiffs claims. Finally, Mylan objects that this Request is irrelevant to Plaintiffs claims and is not reasonably calculated to lead to the discovery of admissible evidence.

REQUEST NO. 92: All documents relating, referring to or embodying any communications with the FDA or any Foreign Government Regulatory Authority regarding any discussion or suggestion that Defendants withdraw any Mylan Product from the market.

RESPONSE: Mylan objects that this Request is irrelevant to Plaintiffs claims, overly broad, unduly burdensome, vague, ambiguous, repetitive, contains undefined terms requiring speculation and is not reasonably calculated to lead to the discovery of admissible evidence. Subject to, and without waiving its foregoing General Objections and specific objections, Mylan responds that it is not currently in possession of any relevant documents responsive to this Request.

REQUEST NO. 93: All documents relating or referring to any discussion, suggestion or study of whether any Mylan Product should be withdrawn temporarily or permanently from the market, including but not limited to internal memorandum, notes of conversations, communications with the FDA or any Foreign Government Regulatory Authority, and communications with other manufacturers, licensors, licensees, distributors, or marketers.

RESPONSE: Mylan objects that this Request is irrelevant to Plaintiffs claims, overly broad, unduly burdensome, vague, ambiguous, repetitive, contains undefined terms requiring speculation and is not reasonably calculated to lead to the discovery of admissible evidence. Subject to, and without waiving its foregoing General Objections and specific objections, Mylan responds that it is not currently in possession of any relevant documents responsive to this Request.

REQUEST NO. 126: Copies of any and all documents or written communication provided or sent by you to the FDA in connection with its investigation referenced in the FDA's July 15, 2005 Public Health Advisory regarding fentanyl transdermal patches.

RESPONSE: Mylan objects that this Request is overly broad, unduly burdensome, vague, ambiguous, irrelevant to Plaintiffs claims and is not reasonably calculated to lead to the discovery of admissible evidence. Mylan further objects that this Request is nonsensical, thereby precluding Mylan from formulating a reasonable response.

REQUEST NO. 158: The FDA Advisory Board transcript related to the approval of Mylan Products.

RESPONSE: Mylan objects that this Request on the grounds that it is overly broad, unduly burdensome, vague and ambiguous and seeks confidential, privileged and/or proprietary information. Subject to, and without waiving its foregoing General Objections and specific objections, Mylan refers Plaintiff to the ANDA for FTS submitted to the FDA for approval pursuant to 21 U.S.C. § 3550), the correspondence to and from the FDA concerning the ANDA, and the packaging and labeling for FTS which Mylan will produce once a Stipulation of Confidentiality and Protective Order has been executed between the parties and subject to the terms thereof.
B. REQUESTS RELATED TO INSPECTIONS OF FACILITIES THAT MANUFACTURE THE MYLAN PRODUCTS

The Mylan Defendants object that these requests relating to Establishment Inspection Reports are vague and ambiguous. As major pharmaceutical manufacturers, the Mylan Defendants must know that Establishment Inspection Reports are generated each time FDA investigators inspect a factory or warehouse. Thus, the Requests are not vague and ambiguous.

In addition, the Requests are not overly broad. Plaintiff seeks only documents relating to Establishment Inspection Reports and inspections performed on the “Mylan Facility” defined as the location where Mylan Products at issue in this litigation are manufactured.

Finally, these reports could lead to the discovery of admissible information relating to Plaintiff's allegations of negligence and manufacturing defect. If the FDA inspectors observed issues or problems with the manufacturing process, they would be contained in these reports.

REQUEST NO. 58: Any and all Establishment Inspection Reports, and all attachments to those reports, for any and all inspections performed by the FDA and/or any other state or federal entity of the Mylan Facility.

RESPONSE: Mylan objects that this Request is overly broad, unduly burdensome, vague, ambiguous and contains undefined terms requiring speculation. Mylan further objects to this Request on the grounds that it seeks information that is not within the time period relevant to this lawsuit and is not reasonably calculated to lead to the discovery of admissible evidence. Mylan also objects to this Request on the grounds that it seeks to elicit information and/or documents that may require divulging confidential, proprietary business information, or trade secrets.

REQUEST NO.59: Any and all responses, including attachments, prepared by the Defendants, their agents, servants or employees, to any Establishment Inspection Reports for any and all inspections performed by the FDA and/or any other state or federal entity of the Mylan Facility.

RESPONSE: Mylan objects that this Request is overly broad, unduly burdensome, vague, ambiguous and contains undefined terms requiring speculation. Mylan further objects to this Request on the grounds that it seeks information that is not within the time period relevant to this lawsuit and is not reasonably calculated to lead to the discovery of admissible evidence. Mylan also objects to this Request on the grounds that it seeks to elicit information and/or documents that may require divulging confidential, proprietary business information, or trade secrets.
C. REQUESTS RELATED TO RECALLS OF THE MYLAN PRODUCTS

REQUEST NO. 147: Any and all notices or letters issued to the public at large, patients, doctors or pharmacists related to any recall of any Mylan Product since Mylan Product was approved by the FDA.

RESPONSE: Mylan objects that this Request is overly broad, unduly burdensome, vague, ambiguous, irrelevant to Plaintiffs claims and is not reasonably calculated to lead to the discovery of admissible evidence. Subject to and without waiving the foregoing General Objections and specific objections, Mylan states that is not in possession of any relevant documents responsive to this Request.

This Request relates to recalls of the Mylan Products. Plaintiff is not aware of any product recalls. But, if such recalls have occurred, documents relating to that recall could lead to admissible evidence supporting Plaintiff's negligence and product liability claims. Thus, Plaintiff requests that the Court overrule the Mylan Defendants' objections so that Plaintiff can be certain that no such documents exist.
D. REQUESTS RELATED TO MYLAN PRODUCTS BATCH RECORDS

These three requests relate to Mylan Products batch records. 21 CFR § 211.188 requires the Mylan Defendants to maintain records related to each batch of the Mylan Products produced. These batch records contain information related to production of the Mylan Products including (1) what equipment and lines were used, (2) laboratory control results, (3) sampling performed, and (4) other issues with the manufacturing process. Plaintiff alleges that the Mylan Products were defective because of a manufacturing flaw that rendered the product unreasonably dangerous at the time it left the Mylan Defendants' control. (Pl.'s Original Compl. ¶¶ 11, 16.) Thus, records relating to the manufacturing process are clearly discoverable.

Furthermore, these requests are narrowly tailored and relate only to batch records concerning “Mylan Products” (the fentanyl patches at issue in this litigation).

Finally, as discussed above, the Mylan Defendants have not met their burden to justify their repeated confidentiality objections. See Cipollone 785 F.2d at 1122.

REQUEST NO. 53: All Batch Records concerning any Mylan Product from 2002 to the present.

RESPONSE: Mylan objects that this Request is overly broad, unduly burdensome, vague, ambiguous and contains undefined terms requiring speculation. Mylan further objects to this Request on the grounds that it seeks information that is not within the time period relevant to this lawsuit and is not reasonably calculated to lead to the discovery of admissible evidence. Mylan also objects to this Request on the grounds that it seeks to elicit information and/or documents that may require divulging confidential, proprietary business information, or trade secrets.

REQUEST NO. 148: All Batch Records related to the lot or batch of the patch(es) the subject deceased had on at the time of his or her death.

RESPONSE: Mylan objects that this Request is overly broad, unduly burdensome, vague and ambiguous, and is not reasonably calculated to lead to the discovery of admissible evidence. Mylan further objects that Plaintiff has not provided lot or batch information associated with the subject patch decedent was allegedly wearing at the time of his death and, therefore, Mylan is unable to formulate a reasonable response to this Request.

REQUEST NO. 149: All Batch Records related to the three lots manufactured immediately prior to the lot of the patch(es) the subject deceased had on at the time of his or her death.

RESPONSE: Mylan objects that this Request is repetitive, overly broad, unduly burdensome, vague, ambiguous and contains undefined terms requiring speculation. Mylan further objects that this Request is not reasonably calculated to lead to the discovery of admissible evidence, is irrelevant, immaterial and not within the time period relevant to this lawsuit and seeks disclosure of privileged and/or confidential information.
E. REQUESTS RELATED TO OPERATING AND QUALITY CONTROL PROCEDURES USED TO MANUFACTURE THE MYLAN PRODUCTS

These thirteen requests relate to Standard Operating Procedures (“SOP”) and other quality control measures and procedures that the Mylan Defendants utilize to manufacture the Mylan Products. The SOP will show the specific manufacturing practices the Mylan Defendants use to make the Mylan Products. These SOP could relate directly to Plaintiffs allegation that the Mylan Defendants failed to use due care and proper materials when manufacturing the Mylan Products. (Pl.'s Original Compl. ¶ 16.) Thus, these Requests are reasonably likely to lead to admissible evidence.

Like Plaintiffs other Requests, these Requests seek only SOP and quality control practices relating to the Mylan Products at issue in this case and are not overly broad. Accordingly, the Mylan Defendants' objections should be overruled and production compelled.

REQUEST NO. 60: A copy of the documents which contain the Standard Operating Procedures (hereinafter “SOP”) in place at the Mylan Facility governing the manufacturing of any Mylan Products from January 1, 2003 to the present.

RESPONSE: Mylan objects that this Request is overly broad, unduly burdensome, vague, ambiguous and contains undefined terms requiring speculation. Mylan further objects to this Request on the grounds that it seeks information that is not within the time period relevant to this lawsuit and is not reasonably calculated to lead to the discovery of admissible evidence. Mylan also objects to this Request on the grounds that it seeks to elicit information and/or documents that may require divulging confidential, proprietary business information, or trade secrets.

REQUEST NO. 61: Any and all documents which contain discussion, analysis or consideration of any modifications, alterations, changes or revisions to the SOP's in place at the Mylan Facility governing the manufacturing of any Mylan Products from January 1, 2003 to the present.

RESPONSE: Mylan objects that this Request is overly broad, unduly burdensome, vague, ambiguous and contains undefined terms requiring speculation. Mylan further objects to this Request on the grounds that it seeks information that is not within the time period relevant to this lawsuit and is not reasonably calculated to lead to the discovery of admissible evidence. Mylan also objects to this Request on the grounds that it seeks to elicit information and/or documents that may require divulging confidential, proprietary business information, or trade secrets.

REQUEST NO. 62: Any and all documents which contains describe or set forth the Defendants' quality control and quality assurance guidelines, procedures, and protocols applicable to the manufacturing of any Mylan Products at the Mylan Facility from January 1, 2003 to the present.

RESPONSE: Mylan objects that this Request is overly broad, unduly burdensome, vague, ambiguous and contains undefined terms requiring speculation. Mylan further objects to this Request on the grounds that it seeks information that is not within the time period relevant to this lawsuit and is not reasonably calculated to lead to the discovery of admissible evidence. Mylan also objects to this Request on the grounds that it seeks to elicit information and/or documents that may require divulging confidential, proprietary business information, or trade secrets.

REQUEST NO. 63: Produce the following documents for all Mylan Products manufactured at the Mylan Facility from January 1, 2003 to the present:

a. Field complaints;

b. Field sample returns;

c. Field sample return analyses;

d. Retain samples and/or retain sample analyses;

e. Corrective and preventive actions and/or reports;

f. Sampling plans, or reports or other documents concerning sampling plans;

g. Quality specification records, and/or reports or other documents concerning quality specification reports;

h. Operation quality reports, operation qualification final reports and/or reports or other documents concerning operation quality reports or qualification final reports;

i. Installation material qualification reports and/or reports or other documents concerning installation material quality reports;

j. Validation protocols, including those for installation qualification (IQ), operational qualification (OQ), performance qualification (PQ), and/or reports or other documents concerning validation protocols for utilities, facilities, equipment, processes and cleaning validations;

k. Validation records of batches that passed and failed validation runs;

1. In-process and quality control checks and/or reports or other documents concerning in-process and quality control checks;

m. Departure notices, and/or reports or other documents concerning departure notices;

n. Documents evidencing or containing reference to problems or complaints regarding the patch.

o. Documents evidencing or containing reference to errors or defects in the patch or manufacturing process.

RESPONSE: Mylan objects that this Request, including subparts a-o, on the grounds that they are overly broad, unduly burdensome, vague, ambiguous and contains numerous undefined terms requiring speculation. Mylan further objects to this Request on the grounds that it seeks information that is not within the time period relevant to this lawsuit and is not reasonably calculated to lead to the discovery of admissible evidence. Mylan also objects to this Request on the grounds that it seeks to elicit information and/or documents that may require divulging confidential, proprietary business information, or trade secrets.

REQUEST NO. 64: Any and all documents describing, discussing, or setting forth the Acceptance Criteria for Mylan Products manufactured at the Mylan Facility from January 1, 2003 to the present.

RESPONSE: Mylan objects that this Request is overly broad, unduly burdensome, vague, ambiguous and contains undefined terms, including “Acceptance Criteria” requiring speculation. Mylan further objects to this Request on the grounds that it seeks information that is not within the time period relevant to this lawsuit and is not reasonably calculated to lead to the discovery of admissible evidence. Mylan also objects to this Request on the grounds that it seeks to elicit information and/or documents that may require divulging confidential, proprietary business information, or trade secrets.

REQUEST NO. 74: Any and all policies, guidelines or protocols for production speed applicable to the manufacturing of Mylan Products at the Mylan Facility from January 1, 2003 to the present.

RESPONSE: Mylan objects that this Request is overly broad, unduly burdensome, vague, ambiguous and contains undefined terms, such as “production speed”, requiring speculation. Mylan further objects to this Request on the grounds that it

seeks information that is not within the time period relevant to this lawsuit and is not reasonably calculated to lead to the discovery of admissible evidence. Mylan also objects to this Request on the grounds that it seeks to elicit information and/or documents that may require divulging confidential, proprietary business information, or trade secrets.

REQUEST NO. 75: Any and all of your training policies, procedures and/or manuals applicable from January 1, 2003 to the present to the training of your employees directly involved on a day to day basis in the manufacturing at the Mylan Facility of Mylan Product (hereinafter “Training Procedures”).

RESPONSE: Mylan objects that this Request is overly broad, unduly burdensome, vague, ambiguous and contains undefined terms, such as “directly involved” and “Training Procedures”, requiring speculation. Mylan further objects to this Request on the grounds that it seeks information that is not within the time period relevant to this lawsuit and is not reasonably calculated to lead to the discovery of admissible evidence. Mylan also objects to this Request on the grounds that it seeks to elicit information and/or documents that may require divulging confidential, proprietary business information, or trade secrets.

REQUEST NO. 76: Any and all documents referencing, containing, evidencing, analyzing or considering changes or modifications to the Training Procedures.

RESPONSE: Mylan objects that this Request is overly broad, unduly burdensome, vague, ambiguous and contains undefined terms, such as “Training Procedures”, requiring speculation. Mylan further objects to this Request on the grounds that it seeks information that is not within the time period relevant to this lawsuit and is not reasonably calculated to lead to the discovery of admissible evidence. Mylan also objects to this Request on the grounds that it seeks to elicit information and/or documents that may require divulging confidential, proprietary business information, or trade secrets.

REQUEST NO. 77: Any and all documents referencing, containing, evidencing, analyzing or considering the effectiveness of the Training Procedures.

RESPONSE: Mylan objects that this Request is overly broad, unduly burdensome, vague, ambiguous and contains undefined terms, such as “Training Procedures”, requiring speculation. Mylan further objects to this Request on the grounds that it seeks information that is not within the time period relevant to this lawsuit and is not reasonably calculated to lead to the discovery of admissible evidence. Mylan also objects to this Request on the grounds that it seeks to elicit information and/or documents that may require divulging confidential, proprietary business information, or trade secrets.

REQUEST NO. 78: Any and all documents analyzing, considering or investigating the ability of persons to spot or identify defects in Mylan Product manufactured at the Mylan Facility from January 1, 2001 to the present.

RESPONSE: Mylan objects that this Request is overly broad, unduly burdensome, vague, ambiguous and contains undefined terms, such as “defects”, requiring speculation. Mylan further objects to this Request on the grounds that it seeks information that is not within the time period relevant to this lawsuit and is not reasonably calculated to lead to the discovery of admissible evidence. Mylan also objects to this Request on the grounds that it seeks to elicit information and/or documents that may require divulging confidential, proprietary business information, or trade secrets.

REQUEST NO. 82: All documents that set forth the process by which decisions were made as to which Mylan Patches, or lots or batches of patches, were accepted or rejected at the Mylan Facility during the period January 1, 2003 to the present.

RESPONSE: Mylan objects that this Request is overly broad, unduly burdensome, vague, ambiguous and contains numerous undefined terms requiring speculation. Mylan further objects to this Request on the grounds that it seeks information that is not within the time period relevant to this lawsuit and is not reasonably calculated to lead to the discovery of admissible evidence. Mylan also objects to this Request on the grounds that it seeks to elicit information and/or documents that may require divulging confidential, proprietary business information, or trade secrets.

REQUEST NO. 87: All documents that set forth or describe ways or methods by which Mylan Products have been examined, checked, inspected, or otherwise monitored since January 1, 2003 to ensure they are properly manufactured.

RESPONSE: Mylan objects that this Request is overly broad, unduly burdensome, vague, ambiguous and contains numerous undefined terms requiring speculation. Mylan further objects to this Request on the grounds that it seeks information that is not within the time period relevant to this lawsuit and is not reasonably calculated to lead to the discovery of admissible evidence. Mylan also objects to this Request on the grounds that it seeks to elicit information and/or documents that may require divulging confidential, proprietary business information, or trade secrets.

REQUEST NO. 150: All SOPs applicable to the manufacturing of the lot or batch of the patch(es) the subject deceased had on at the time of his or her death.

RESPONSE: Mylan objects that this Request is overly broad, unduly burdensome, vague, ambiguous, contains undefined terms requiring speculation and is not reasonably calculated to lead to the discovery of admissible evidence. Mylan further objects to this Request on the grounds that it seeks to elicit information and/or documents that may require divulging confidential, proprietary business information or trade secrets. Mylan further objects that Plaintiff has not provided lot or batch information associated with the subject patch decedent was allegedly wearing at the time of his death and, therefore, Mylan is unable to formulate a reasonable response to this Request.
F. REQUESTS RELATED TO MYLAN PRODUCTS DEFECTS AND RETURNS

These nine requests for documents concerning Mylan Products defects and returns relate directly to Plaintiff's allegations of negligence, negligent misrepresentation, and manufacturing, marketing, and design defect. Plaintiff also specifically alleges that the Mylan Defendants failed to properly inspect the Mylan Products for defects. (Pl.'s Original Compl. ¶ 16.) Documents relating to defective and returned products could show, among other things, (1) flaws in the manufacturing process, (2) flaws in the inspection and quality control process, and (3) the Mylan Defendants' knowledge that the Mylan Products were not functioning properly. Because these requests relate directly to the claims at issue, production should be compelled.

Mylan contends that these requests are overly broad and unduly burdensome. Most of the Requests pertain to “Returned Product.” “Returned Product” is defined as all “Mylan Products which have been returned to you by a customer, patient, distributor, sales person, doctor, health care provider or pharmacy since January 1, 2003.” Thus, the requests are both limited specifically to the fentanyl patch products at issue in this case and also limited to a specific time period, and, as a result, are not overly broad or unduly burdensome.

REQUEST NO. 65: All documents that set forth, list, discuss or explain the categorization of Mylan Products which are found to have any defect.

RESPONSE: Mylan objects that this Request is overly broad, unduly burdensome, vague, ambiguous and contains undefined terms, such as “categorization” and “defect”, requiring speculation. Mylan further objects to this Request on the grounds that it seeks information that is not within the time period relevant to this lawsuit and is not reasonably calculated to lead to the discovery of admissible evidence. Mylan also objects to this Request on the grounds that it seeks to elicit information and/or documents that may require divulging confidential, proprietary business information, or trade secrets.

REQUEST NO. 66: Any and all documents concerning any investigations or inquiries into nonconformities relating to any Mylan Product manufactured at the Mylan Facility from January 1, 2003 to the present.

RESPONSE: Mylan objects that this Request is overly broad, unduly burdensome, vague, ambiguous and contains undefined terms, such as “nonconformities”, requiring speculation. Mylan further objects to this Request on the grounds that it seeks information that is not within the time period relevant to this lawsuit and is not reasonably calculated to lead to the discovery of admissible evidence. Mylan also objects to this Request on the grounds that it seeks to elicit information and/or documents that may require divulging confidential, proprietary business information, or trade secrets.

REQUEST NO. 67: Any and all documents evidencing, referencing or listing all Mylan Products which have been returned to you by a customer, patient, distributor, sales person, doctor, health care provider or pharmacy since January 1, 2003 (hereinafter “Returned Product”).

RESPONSE: Mylan objects that this Request is overly broad, unduly burdensome, vague, ambiguous and contains undefined terms requiring speculation. Mylan further objects to this Request on the grounds that it seeks information that is not within the time period relevant to this lawsuit and is not reasonably calculated to lead to the discovery of admissible evidence. Mylan also objects to this Request on the grounds that it seeks to elicit information and/or documents that may require divulging confidential, proprietary business information, or trade secrets.

REQUEST NO. 68: Any and all testing done on Returned Product.

RESPONSE: Mylan objects that this Request is overly broad, unduly burdensome, vague, ambiguous and contains undefined terms requiring speculation. Mylan further objects to this Request on the grounds that it seeks information that is not within the time period relevant to this lawsuit and is not reasonably calculated to lead to the discovery of admissible evidence. Mylan also objects to this Request on the grounds that it seeks to elicit information and/or documents that may require divulging confidential, proprietary business information, or trade secrets.

REQUEST NO. 69: Any and all documents containing analysis of Returned Product.

RESPONSE: Mylan objects that this Request is overly broad, unduly burdensome, vague, ambiguous and contains undefined terms requiring speculation. Mylan further objects to this Request on the grounds that it seeks information that is not within the time period relevant to this lawsuit and is not reasonably calculated to lead to the discovery of admissible evidence. Mylan also objects to this Request on the grounds that it seeks to elicit information and/or documents that may require divulging confidential, proprietary business information, or trade secrets.

REQUEST NO. 70: Any and all documents relating to any examination of Returned Product.

RESPONSE: Mylan objects that this Request is overly broad, unduly burdensome, vague, ambiguous and contains undefined terms requiring speculation. Mylan further objects to this Request on the grounds that it seeks information that is not within the time period relevant to this lawsuit and is not reasonably calculated to lead to the discovery of admissible evidence. Mylan also objects to this Request on the grounds that it seeks to elicit information and/or documents that may require divulging confidential, proprietary business information, or trade secrets.

REQUEST NO. 71: Any and all documents containing policies, procedures, guidelines or protocols that governed the testing, analysis or examination of Returned Product.

RESPONSE: Mylan objects that this Request is overly broad, unduly burdensome, vague, ambiguous and contains undefined terms requiring speculation. Mylan further objects to this Request on the grounds that it seeks information that is not within the time period relevant to this lawsuit and is not reasonably calculated to lead to the discovery of admissible evidence. Mylan also objects to this Request on the grounds that it seeks to elicit information and/or documents that may require divulging confidential, proprietary business information, or trade secrets.

REQUEST NO. 72: Any and all documents containing policies, procedures, guidelines or protocols that governed the retention, destruction or storing of Returned Product.

RESPONSE: Mylan objects that this Request is overly broad, unduly burdensome, vague, ambiguous and contains undefined terms requiring speculation. Mylan further objects to this Request on the grounds that it seeks information that is not within the time period relevant to this lawsuit and is not reasonably calculated to lead to the discovery of admissible evidence. Mylan also objects to this Request on the grounds that it seeks to elicit information and/or documents that may require divulging confidential, proprietary business information, or trade secrets.

REQUEST NO. 146: Any and all of your internal documents since 2000 referencing or relating to patches with defects, whether caught during the manufacturing process or the quality assurance process, or whether learned as a result of field returns or complaints from patients, pharmacists or doctors.

RESPONSE: Mylan objects that this Request is repetitive, overly broad, unduly burdensome, vague, ambiguous and contains undefined terms requiring speculation. Mylan further objects that this Request is not reasonably calculated to lead to the discovery of admissible evidence, is irrelevant, immaterial and not within the time period relevant to this lawsuit and seeks disclosure of privileged and/or confidential information.
G. REQUESTS RELATED TO PLAINTIFF AND DECEDENT

These requests relate to documents in the Mylan Defendants' possession concerning the Plaintiff or Decedent including medical records, employment records, and any criminal history. These documents could lead to admissible information concerning both liability and damages and should be produced.

REQUEST NO. 141: Any and all medical, mental health or pharmacy records of the subject deceased or Plaintiff(s).

RESPONSE: Mylan objects that this Request is irrelevant to Plaintiffs claims, overly broad, unduly burdensome, vague, ambiguous, repetitive, contains undefined terms requiring speculation and is not reasonably calculated to lead to the discovery of admissible evidence. Mylan further objects that this Request seeks disclosure of information that is privileged and/or confidential, including that which is protected by the Health Insurance Portability and Accountability Act (“HIPAA”). Mylan further objects to this Request on the grounds that the information sought is as accessible to Plaintiff as it is to Mylan.

REQUEST NO. 142: Any and all employment records of Plaintiff(s) or the subject deceased.

RESPONSE: Mylan objects that this Request is overly broad, unduly burdensome, vague, ambiguous, irrelevant to Plaintiffs claims and is not reasonably calculated to lead to the discovery of admissible evidence. Mylan further objects to this Request on the grounds that the information sought is as accessible to Plaintiff as it is to Mylan.

REQUEST NO. 143: Any and all documents obtained by use of any authorization signed by Plaintiff(s).

RESPONSE: Mylan objects that this Request is overly broad, unduly burdensome, vague, ambiguous, irrelevant to Plaintiffs claims and is not reasonably calculated to lead to the discovery of admissible evidence. Mylan further objects to this Request on the grounds that the information sought is as accessible to Plaintiff as it is to Mylan.

REQUEST NO. 144: Any and all records related to any criminal history of Plaintiff(s) or the subject deceased.

RESPONSE: Mylan objects that this Request is overly broad, unduly burdensome, vague, ambiguous, irrelevant to Plaintiffs claims and is not reasonably calculated to lead to the discovery of admissible evidence. Mylan further objects to this Request on the grounds that the information sought is as accessible to Plaintiff as it is to Mylan.
H. REQUESTS RELATED TO THE LEVEL OF SERUM FENTANYL INTENDED TO BE DELIVERED BY THE MYLAN PRODUCTS

These two requests relate to the maximum concentration of serum fentanyl intended to be delivered through the use of Mylan Products. They pertain directly to Plaintiff's contention that the Mylan Products malfunctioned. Decedent died from fentanyl intoxication. (Pl.'s Original Compl. ¶ 9.) Plaintiff asserts that the Mylan Products malfunctioned by giving Decedent “a much higher dose of fentanyl than a properly functioning patch should have given him.” ( Id. ¶10.) A critical issue in the litigation is the maximum concentration of serum fentanyl that Defendants intended the Mylan Products to deliver. Thus, the Mylan Defendants' assertion that these two requests are overly broad or unduly burdensome is without merit.

The Mylan Defendants attempt to limit production of documents to Mylan's ANDA provided to the FDA. While Plaintiff certainly recognizes this document is relevant and should be produced, Plaintiff also contends that the Mylan Defendants' internal documents related to the intended and maxiumum concentration of serum fentanyl, including, but not limited to, memoranda, correspondence, emails, notes, and reports, are also relevant and should be produced.

REQUEST NO. 11: Any and all documents related to the maximum concentration of serum fentanyl intended to be delivered through use of Mylan Products.

RESPONSE: Mylan objects that this Request is repetitive, overly broad, unduly burdensome, vague and ambiguous and seeks confidential, privileged and/or proprietary information. Subject to, and without waiving its foregoing General Objections and specific objections, Mylan refers Plaintiff to its ANDA which Mylan will produce once a Stipulation of Confidentiality and Protective Order has been executed between the parties and subject to the terms thereof.

REQUEST NO. 12: Any and all documents related to the concentration of serum fentanyl intended to be delivered through use of Mylan Products.

RESPONSE: Mylan objects that this Request is repetitive overly broad, repetitive, unduly burdensome, vague, ambiguous and seeks production of privileged, confidential and/or proprietary information. Subject to, and without waiving its foregoing General Objections and specific objections, Mylan refers Plaintiff to its ANDA which Mylan will produce once a Stipulation of Confidentiality and Protective Order has been executed between the parties and subject to the terms thereof.

IV. CONCLUSION

For the foregoing reasons, Plaintiff respectfully requests this Court overrule the Mylan Defendants' objections and compel production of documents responsive to the forty five different requests for production.