Nonparty discovery in drug cases: when you hand a defense witness a document that shows how the company worked with third parties to downplay a drug's risks, it's a moment the jury won't forget. Thorough nonparty discovery can get you there.

Relevant information in a pharmaceutical case is not limited to what the defendant has. It also includes documents in the possession or control of--and the testimony of people who work for--marketers and trade groups that promote pharmaceutical products and the industry as a whole.

Drug makers hire vendors, including marketing and advertising agencies, to favorably alter doctors' and consumers' views about the benefits and risks of pharmaceutical products. These agencies use traditional marketing methods, such as paid-for advertising and public relations campaigns, but they also employ other marketing vehicles--like arranging for ghostwritten medical articles--to shape the "conventional wisdom" about the utility and safety of drug products. (1)

Professional trade organizations with financial ties to drug companies also have tremendous influence over the medical community's perception of a drug's value. These organizations can influence a drug's popularity by issuing favorable advisories about a product to organization members, who then prescribe the drug to their patients, and by holding continuing medical education (CME) seminars at their conventions that paint the product in a favorable light.

Organization members may join drug company speakers' bureaus and talk about a drug with professionals and professional organizations at meetings and luncheons organized by the drug company. Members may also accompany physicians in hospital grand rounds--the formal hospital meetings in which physicians discuss medical cases--and deliver favorable "messages" about the product.

As a result of these efforts, a drug's warnings may get watered down, failing to accurately reflect the dangers associated with its use. This can affect a drug company's ability to rely on the learned-intermediary defense to a failure-to-warn claim.

There are three situations in which it may be helpful to obtain information from nonparties.

The defendant does not produce documents. Sometimes, defendants are unable to produce relevant documents because those items have been destroyed according to a document-retention schedule. Other times, documents are not produced either because the defendant cannot locate them or does not want to produce them or admit that they exist.

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Deposing a defendant's employees about the whereabouts or substance of the documents not produced is not always successful. By the time litigation has started, key employees may be difficult to locate because they have left the company, or they may simply be unavailable to testify. When they do testify, they may say they do not recall the substance or whereabouts of unproduced documents.

When this happens, you might be able to locate the documents you need or information about the facts of an event through nonparty discovery.

The defendant denies that it had contact with a nonparty. If a defendant disputes or denies claims that it worked with a nonparty to promote its products, discovery of information directly from the nonparty might shed light on whether it did--and what occurred pursuant to that relationship. This discovery also should determine the specifics of any transactions between the drug maker and the nonparty and the scope of the nonparty's work.

Trade associations and vendors have promoted the drug's use. When professional organizations--such as the American College of Obstetricians and Gynecologists--publicly support use of a drug or its generic equivalent, nonparty discovery from these organizations can

* reveal a drug company's funding of nonparty organization events (to show bias).

* show that members of the organization serve as paid "advocates" or "opinion leaders"--well-known and respected physicians who favorably critique or promote a manufacturer's product or respond to product criticism or concerns in a favorable light, who serve as members of the defendant's speakers bureau, or who are involved in manufacturer-sponsored CME programs that promote the drug.

* establish that the manufacturer met with and helped the organization draft an advisory to its members that was favorable to the drugs' use.

Nonparty vendors, such as medical writers and advertising agencies, may have worked in the background to advertise drugs through carefully crafted publication plans. These plans place media articles, editorials, infomercials, or ghostwritten medical literature in targeted publications for specific audiences.

Use nonparty discovery to locate

* copies of published products and their drafts

* correspondence to the advertising agency from the defendant approving or instructing placement of advertising or infomercials that fail to fully disclose a drug's risks

* ghostwritten medical literature drafts and other documents proving ghostwriting, including assignment forms to freelance writers, vendor payments to ghostwriters, and letters or memoranda to locate "authors."

Identifying nonparties

The first wave of discovery typically includes interrogatories designed to determine the defendant's corporate structure. Make specific requests for the names and departments of employees whose documents and testimony might be relevant to issues in the case. Other important initial discovery includes noticing the depositions of corporate representatives under Rule 30(b)(6) of the Federal Rules of Civil Procedure.

In a second wave, request production of custodial files for people identified in the first wave of discovery. At this point, you should depose the employees who have personal knowledge of the corporate publication-planning process. Information in these documents and depositions should identify nonparty vendors who played a role in shaping the perception of the drug's safety.

If the defendant's production appears to be incomplete, identify and request nonparty documents to fill in the gaps. For example:

* If the defendant provides a draft outline of a medical article stamped on its face "Prepared by ABC Medical Writing Company for Drug Company X," this should raise red flags about ghostwriting. A request for production of those documents will determine the scope of the ghostwriting effort.

* If you receive a bill paid to a nonparty consulting company for "review of labels," this indicates that the manufacturer had notice and knowledge of the inadequacy of its warning label. A request for production will determine the consultant's notice, and possibly advice, to beef up the warning.

* You may obtain evidence of payments to a professional organization for convention seminars, poster presentations at the conventions, or the production and mailing of "supplements" to its magazine consisting of medical articles about the defendant's drug. Any payment to the organization should alert you to the organization's possible bias and could lead to evidence showing that its influence may have helped weaken the manufacturer's warnings about its product.

Long arm of the law

Federal Rule 45 (d) governs discovery requests for documents from nonparties and subpoenas for depositions of nonparty witnesses.

To subpoena a nonparty that resides outside the jurisdiction in which the matter is pending, you must follow special rules. Generally, an attorney of record on the pending matter can file a miscellaneous case in the jurisdiction where the nonparty resides. Once the action is filed, a court in that jurisdiction can issue a subpoena. If a discovery dispute arises in this context, the court that issued the subpoena has the authority to address the dispute.

However, a court with jurisdiction over a discovery dispute for an action pending in another jurisdiction generally has limited exposure to, and understanding of, the primary action. (2) A court in this situation should be cautious in determining relevance of evidence and err on the side of permissive discovery. (3)

In a multidistrict litigation (MDL) context, plaintiffs need not file a miscellaneous case in the jurisdiction where the nonparty resides because judges assigned to MDLs are given the power to supervise nonparty discovery outside the MDL district. (4) This power allows the judge to "quash, modify, or enforce nonparty discovery subpoenas issuing from courts in other districts." (5) While discovery proceedings remain anchored in the courts of the district where they are being conducted, policy reasons dictate that the MDL judge has the power to supervise nonparty discovery in other jurisdictions. (6)

On its face, the law governing MDLs appears to convey to judges only the power to conduct pretrial depositions in any other jurisdiction, but many courts have concluded that this includes the power to enforce a subpoena duces tecum. (7) A few courts have limited MDL judges' enforcement authority solely to depositions. (8)

Using nonparty discovery

The first and most obvious use of nonparty discovery is to prove an issue in the case. As with any other direct evidence--presuming foundation, business records, and relevance requirements are met--documents discovered from a nonparty (and authenticated) can be used for any purpose at trial.

A second use involves comparing the defendant's documents with the nonparty's. If the defendant fails to produce something that the nonparty has provided, this maybe an indication that the defendant has intentionally ignored your discovery request and may have even destroyed documents.

A third use is for impeachment. If in deposition an employee of the defendant has testified that all relevant documents have been produced, and you later discover relevant documents from a nonparty that the defendant should have provided, you can use this at trial to challenge the employee's veracity.

Case study 1: In re Prempro Products Liability Litigation. In the ongoing hormone replacement therapy (HRT) litigation, women have brought claims against manufacturers, including Wyeth, which makes Premarin and Prempro. (9) The claims against Wyeth are principally overpromotion of the drugs' benefits and failure to warn about their true risks, particularly breast cancer.

In pretrial discovery, Wyeth produced documents identifying a company, DesignWrite, that contracted to provide a publication plan that included, among other things, the development of medical articles. But the documents Wyeth produced were few, and their story was incomplete; accordingly, the plaintiffs served DesignWrite a nonparty subpoena and document request under Rule 45.

Documents obtained from DesignWrite and the testimony of its subpoenaed employees completed the story. DesignWrite and Wyeth were involved in developing medical articles favorable to Wyeth's hormone therapy products. The ghostwritten articles were misleading and failed to identify Wyeth and DesignWrite employees' substantial contributions in originating, drafting, and developing the articles. They did not disclose the fact that Wyeth paid DesignWrite for the articles' development.

In the bellwether MDL trial of Rush v. Wyeth, Wyeth and DesignWrite documents provided evidence of the publication process and the development of a particular ghostwritten medical article relevant to the case. (10) The documents revealed that DesignWrite and Wyeth employees met to "talk about potential publications in the future." (11) At one of the "strategic publication committee" meetings, Wyeth and DesignWrite conceived an article that called into question the risk of breast cancer with use of hormone therapy. DesignWrite prepared an outline and sent it to Wyeth for review by a marketing department employee.

A member of the Wyeth/DesignWrite committee subsequently called a physician to ask if he "would be willing to author a paper ... questioning the role of progestins as a causative factor" of breast cancer. (12) But the physician did not write the manuscript. Instead, DesignWrite sent a "project assignment form" to a freelance writer detailing the specifics of the manuscript to be written, including a conclusion that "progestins may not be responsible for the incidence of breast cancer in ... HRT users...." (13) The freelancer wrote the article and was paid by Wyeth/DesignWrite. When the manuscript was eventually published, it did not reveal the freelance writer's contribution, that Wyeth/DesignWrite originated the idea for the article, or that Wyeth paid for it.

Case study 2: In re Vioxx Products Liability Litigation. Claims in this case against Merck & Co., the manufacturer of Vioxx, concern Merck's alleged failure to warn physicians and patients of the risk of cardiovascular events associated with the drug. (14) In Dedrick v. Merck & Co., deposition testimony of subpoenaed nonparty physicians supported the plaintiffs' allegations and demonstrated to the jury Merck's attempts to influence the scientific debate concerning the safety of Vioxx by using intimidation and veiled threats. (15)

While chairman of the Department of Cardiovascular Medicine at the Cleveland Clinic Foundation, Dr. Eric Topol had written articles about Vioxx claiming that its use posed cardiovascular risks. (16) In a paper published in the Journal of the American Medical Association (JAMA) in 2001, Topol and his colleagues discussed those risks and called for a study to determine whether Vioxx was safe for arthritics with heart disease. (17) The article "urge[d] caution in prescribing these agents to patients at risk for cardiovascular morbidity" until the study was performed. (18)

In a videotaped deposition played to the jury, Topol testified that he attended a meeting requested by Merck before the publication of his 2001 JAMA paper and suggested that one of Merck's purposes in calling the meeting was to "neutralize" his opinions. (19) At the meeting, Topol said, a Merck employee told him that he and his coauthors had "got it wrong." Topol was asked in deposition whether he "observed a pattern of conduct by Merck every time ... an investigator ... did a critical analysis and questioned the safety of the drug Vioxx." He responded that "each time ... there would be immediately a PR attack on the report." (20)

Topol also buttressed the plaintiffs' claims regarding the inadequacy of the Vioxx label to warn of risks associated with the drug. He testified in deposition that the "original label and then the revisions in April 2002 did not show adequate safety concerns about heart attacks, strokes, and death that could occur from the medicine." (21) In his opinion, "the black-box warning was long overdue in August 2004." (22)

Another nonparty deponent in that case, Dr. James Franklin Fries, a professor of medicine at Stanford University, testified that Merck made veiled threats to silence a physician in his department who Merck believed was unduly critical of Vioxx. (23) Dr. Louis Sherwood, a Merck employee, called Fries in October 2000 and complained that one of Fries's associates, Gurkipal Singh, had been giving talks in public that criticized Vioxx. (24) Sherwood told Fries that he believed the talks were not balanced and that Fries, as Singh's immediate supervisor, should take action. (25) Sherwood said that if Singh continued to criticize Vioxx, his career would "flame out" and there would be consequences for both Stanford University and Fries. (26)

In another bellwether MDL trial, Mason v. Merck & Co., (27) the plaintiff introduced testimony from nonparty physician Dr. David Graham, a medical officer and an associate director for science and medicine in the FDA's Office of Drug Safety. (28) Graham testified that, in his opinion, Vioxx was an "unsafe drug" and that "it should not have been approved at the time it was approved." (29) He said Merck never did a risk-benefit analysis for the drug and stated that "the scales are tilted greatly against Vioxx in terms of safety versus benefit." (30) Graham expressed the opinion that Vioxx was a public health catastrophe because it was a toxic drug that had severe cardiovascular effects that increased the risk of heart attack.

The hormone replacement therapy and Vioxx cases offer just a few examples of the power of nonparty documents to support plaintiffs' claims and to show drug companies' efforts to influence the medical literature and public discussion about their drugs. These documents are discoverable, will add to the evidence in your case, and can be used effectively to show that the defendant has failed to turn over all documents in discovery.

Nonparty documents fill in the evidentiary gaps left by a pharmaceutical company's failure to disclose and produce documents and its employees' failure to either recall or know of specific facts or incidents. Most important, these documents and the testimony about them will aid in determining the actual warning doctors and patients have received.

Notes

(1.) World Assn. Med. Writers, Ghost Writing Initiated by Commercial Companies, www.wame. org/resources/policies#ghost (revised June 20, 2005); see also Jerome P. Kassirer, Ghostwriters and Ghostbusters, on page 38.

(2.) Anker v. G.D. Searle & Co., 126 F.R.D. 515, 518 (M.D.N.C. 1989).

(3.) Id.

(4.) 28 U.S.C. [section] 1407(b); Long v. Abbott Labs., 1999 WL 33545517 at * 8 (N.C. Super. 1999).

(5.) 28 U.S.C. [section] 1407(b). see also Don Zupanec, Discovery, Multidistrict Litigation--Subpoena--Jurisdiction to Enforce, 21 Fed. Litig. 17 (2006); United States ex rel. Pogue v. Diabetes Treatment Ctrs. of Am., Inc., 444 F.3d 462 (6th Cir. 2006) ; In re Corrugated Container Antitrust Litig., 662 F.2d 875, 879 (D.C. Cir. 1981).

(6.) In re Corrugated Container Antitrust Litig., 662 F.2d at 880-81.

(7.) See e.g. In re Factor VIII, 174 F.R.D. 412,415 (N.D. Ill. 1997); In re Sunrise Secs. Litig., 130 F.R.D. 560, 586 (E.D. Pa. 1989); In re San Juan Dupont Plaza Hotel Fire Litig., 117 F.R.D. 30 (D.ER. 1987); Arnelien v. SmithKline Beecham Corp., 2005 WL 850844 at * 16 (Pa., Phila. Co. Comm. PI. Mar. 28, 2005). See also Don Zupanec, Multidistrict Litigation--Subpoena--Jurisdiction to Enforce, 18 Fed. Litig. 11 (2003).

(8.) See e.g. VISX, Inc. v. Nidek Co., 208 F.R.D. 615 (N.D. Cal. 2002).

(9.) In re Prempro Prods. Liab. Litig., No. MDL-1507 (E.D. Ark. transferred Mar. 4, 2003).

(10.) No. 4:05-CV-00497-WRW (E.D. Ark. Mar. 18, 2005). The plaintiff took Prempro, a combination estrogen and progestin therapy, to alleviate postmenopausal symptoms and alleged that it caused her breast cancer.

(11.) Id., Tr. Transcr. 852: 18-22 (Jan. 25, 2007).

(12.) Id. at 856: 9-15.

(13.) Id. at 857: 4-25; 858: 1-12.

(14.) In re Vioxx Mktg., Sales Prac. & Prods. Liab. Litig., MDL-1657 (E.D. La. transferred Feb. 16, 2005).

(15.) No. 05-CV-2524-L (E.D. La. June 21, 2005).

(16.) Id., Tr. Transcr. 1221: 14-17 (Dec. 2, 2006) ; see e.g.Juhana Karha & Eric J. Topol, The Sad Story of Vioxx, and What We Should Learn from It, 71 Clev. Clin. J. Med. 933, 933-34, 936, 938-39 (2004); Eric J. Topol, Failing the Public Health--Rofecoxib, Merck, and the FDA, 351 N. Eng. J. Med. 1707 (2004).

(17.) Debabrata Mukherjee et al., Risk of Cardiovascular Events Associated with Selective COX-2 Inhibitors, 286 JAMA 954 (2001 ).

(18.) Dedrick, No. 05-CV-2524-L, Tr. Transcr. 1245: 10-14 (Dec. 2, 2006).

(19.) Id. at 1245: 18-25; 1246: 1-19.

(20.) Id. at 1246: 3-11; 1261: 16-25.

(21.) Id. at 1259: 20-25; 1260: 1.

(22.) Id. at 1261: 4-5.

(23.) Id., Tr. Transcr. 1917: 22-23; 1921: 4-25; 1922: 1-12 (Dec. 6, 2006).

(24.) Id. at 1920: 13-18; 1921: 4-9.

(25.) Id. at 1921: 11-16.

(26.) Id. at 1921: 23-25; 1922: 1-4.

(27.) MDL-1657, No. 06-CV-810-L (E.D. La. Feb. 16, 2006).

(28.) Id., Tr. Transcr. 593: 22-25; 594: 1-2 (Nov. 1, 2006).

(29.) Id. at 600: 2-10.

(30.) Id. at 603: 1-22.

JAMES F. SZALLER is partner at Brown & Szaller in Cleveland.JEFF GIBSON practices law with Cohen & Malad in Indianapolis.