Mass Tort Defense : Mass Tort Defense Lawyer & Attorney : Sean P. Wajert : Dechert Law Firm : Products Liability, Class Actions, Pharmaceutical Litigation

The court in the welding fume MDL litigation has dismissed the claims of the  plaintiff who had been chosen for the seventh bellwether trial in this national consolidated welding fume products liability litigation. In re: Welding Fume Products Liability Litigation [Ernest Ray, No. 04-18252], MDL 1535, No. 03-17000, N.D. Ohio.

Plaintiff Ray had moved to dismiss his claim, with prejudice, last November. Thousands of claims have been dismissed in this litigation, so why post about this one?  A reminder to readers of MassTortDefense to travel all lanes of the information superhighway in doing fact investigation, including the so-popular social media hubs.

It appears that plaintiffs were forced to move to dismiss the Ray case after plaintiff’s claims of severe disability were refuted by Internet (specifically Facebook) photos discovered by defendants that appeared to show plaintiff competing in strenuous high-speed powerboat races.

In 2006, the MDL Court implemented a new case evaluation process to try to ensure that only “trial-worthy” cases reached the later stages of pre-trial litigation. This process, which required medical records collection and a certification by plaintiffs’ attorneys that cases were trial‐worthy, prompted plaintiffs to dismiss thousands of cases.  Even with that, this is about the sixth trial-ready case plaintiffs have been forced to dismiss due to revelations in discovery.

Appropriate review of public web sites requires no disclosure to opposing counsel, and can be done relatively cheaply. Today's technology, via the Internet, can result in a wealth of information on the opposing party or witness.  Web sites like the popular myspace.com and facebook.com can now provide a profile of a witness or opposing party, or, like here, information on interests and activities. An individual might have posted comments about his condition, as well. Good luck surfing!

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We love to hear from our faithful readers, and one recently asked us to update the status of the proposed amendments to Rule 26. We posted on them last year, noting that there would be public comment opportunities throughout 2009.

Below, a review of those comments.  But first a reminder of the proposed changes. The amendments would extend work-product protection to the discovery of draft reports by testifying expert witnesses and, with three important exceptions, to the discovery of communications between testifying expert witnesses and retaining counsel. The amendments also provide that a lawyer relying on a witness who will provide expert testimony but is not required to provide a Rule 26(a)(2)(B) report – because the witness is not retained or specially employed to provide expert testimony and is not an employee who regularly gives expert testimony – must disclose the subject matter of the witness’s testimony and summarize the facts and opinions that the witness is expected to offer. The 1993 amendments to Civil Rule 26 have been interpreted by some courts to allow discovery of all draft expert witness reports and all communications between counsel and testifying expert witnesses. The experience under those amendments revealed significant practical problems in the eyes of many litigators.

The comments? First, the arguments in favor:

• Lawyers and expert witnesses take elaborate and costly steps to avoid creating any discoverable draft report or any discoverable communications between the lawyer and expert. These steps can include hiring two sets of experts, one to testify and one to consult; avoiding any note-taking by the expert; and avoiding the creation of any draft report. At the same time, lawyers take elaborate and
costly steps to attempt to discover all of the other side’s drafts and communications.

• Experience has shown that the elaborate steps to avoid creating discoverable drafts or communications result in inefficient, costly, and wasteful litigation behavior. At the same time, experience has also shown that extensive, time-consuming, and costly efforts to discover every change in draft reports by experts and every communication between experts and retaining counsel rarely produces information that bears on the strengths or weaknesses of the experts’ opinions.

• Many experienced lawyers routinely stipulate that they will not seek to discover draft reports from each other’s experts or communications between the experts and the retaining lawyers. That good lawyers stipulate to avoid the present rule indicates problems with it.

• Some states have implemented procedures similar to the proposed amendments.  State  practitioners representing both plaintiffs and defendants report a degree of consensus about the success of these procedures in improving the ability to use expert witnesses and to discover the basis for their opinions.

• The proposed amendments would not limit discovery into the areas that are genuinely important for learning the strengths and weaknesses of a testifying expert’s opinion. The proposed amendments specifically allow discovery into communications between a lawyer and testifying expert about: (1) the compensation for the expert’s study or testimony; (2) the facts or data provided
by the lawyer that the expert considered in forming opinions; and (3) the assumptions provided by the lawyer that the expert relied upon in forming an opinion.

Opposing Views:

• The proposed amendments limit discovery that could show the extent of the retaining lawyer’s influence on the testifying expert’s opinions. That could make it easier for lawyers to influence the opinions their testifying experts present.

• The proposed amendments only limit discovery of draft reports and certain communications. They do not apply to inquiries into such matters at the trial itself. It may be unclear whether the draft reports and communications will be protected from disclosure at trial. As a result, the amendments may not eliminate the costly and wasteful steps to avoid creating draft reports or records of attorney/expert communications. (MassTortDefense wonders how many lawyers will venture into these issues at trial without the benefit of any discovery.)

Overall, comments received during the notice-and-comment period made it appear that the vast majority of practitioners, on both the plaintiff and defense sides, support the proposed rule amendments. Interestingly, lots of academics spoke up against the rule.

So what's the status? On September 15, 2009, the Judicial Conference met and approved the recommendations of the Committee on Rules of Practice and Procedure and approved the proposed rules. The rules were then transmitted to the Supreme Court in December with a recommendation that they be approved and transmitted to Congress in accordance with the Rules Enabling Act.  The schedule would still have them taking effect, if not rejected by the Court or Congress, on December 1, 2010.

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The federal court has ordered plaintiffs in the MDL concerning the heart medication Digitek to respond to discovery relating to whether the individuals in each identified case had sufficient evidentiary support to justify filing their claim.  The decision is also interesting for all those in mass torts struggling with plaintiffs' typically inadequate responses to initial fact discovery and Plaintiff Fact Sheets. In re: Digitek Products Liability Litigation, MDL-1968 (S.D. W.Va.).

In April, 2008, the FDA announced a recall of the drug Digitek® (Digoxin) distributed by Mylan Bertek Pharmaceuticals, Inc. and UDL Laboratories, Inc. The recall stated that certain lots of the tablets may have contained more than the approved level of the drug’s active ingredient, thereby exposing patients with renal failure who consumed the drug to the risk of digitalis toxicity. Soon thereafter, the plaintiffs filed civil actions against the defendants in state and federal courts across the country. In August, 2008, the Judicial Panel on Multidistrict Litigation entered an order establishing a multidistrict litigation proceeding, which consolidated federal Digitek® related actions for joint case management. The plaintiffs generally allege that the defendants manufactured, marketed, tested, promoted, and/or distributed Digitek® with inconsistent amounts of the active ingredient.

As is fairly typical, plaintiffs were required to fill out basic fact information about their use of the drug and alleged injuries in Plaintiff Fact Sheets.  Such fact sheets are often used instead of  interrogatories, and allow the parties and the court to assess the various types of cases in the mass tort. They can be crucial to decide on trial plan, the scope and timing of additional discovery, and even settlement analysis. 

Defendants served three requests for admission in 39 individual cases, seeking information relating to whether the plaintiff in each identified case had sufficient evidentiary support to justify filing a claim. The requests at issue asked the plaintiff or their counsel  to "admit that you did not serve Defendants with any of Plaintiff’s medical records when you served the Plaintiff Fact Sheet;"  to "admit that you did not have any of Plaintiff’s medical records or pharmacy records in your possession when you filed the Complaint in this case;" and to "admit that you did not have Plaintiff’s medical records or pharmacy records in your possession when you served Defendants with the Plaintiff Fact Sheet."

The Plaintiffs’ Steering Committee in the MDL submitted the plaintiffs’ master objections to the defendants’ requests. They argued that the discovery was premature: before the parties may begin
discovery on an individual case, that case must be selected for inclusion in a trial group. Second, they allege that the defendants are attempting to cure deficient Plaintiff Fact Sheets with the
requests, rather than through the deficiency process outlined in previous pre-trial orders.  Third, in a preemptive strike, they argued that since the Plaintiff Fact Sheets constitute discovery responses,  defendants cannot pursue sanctions for them under Rule 11.  Finally, plaintiffs also asserted that the requests were not reasonably calculated to lead to the discovery of admissible evidence, and alleged that the targeted information is protected by the attorney-client privilege and/or the work product doctrine.

The court noted that the defendants have expressed serious concerns about the merits of many of the cases filed in the MDL. They believe that a large number of cases lack sufficient evidentiary support demonstrating that the identified plaintiffs exhibited digitalis toxicity as a result of ingesting nonconforming Digitek® tablets. The defendants are attempting to determine whether the plaintiffs served with the requests possessed their medical and pharmacy records at the time their complaints were filed and the Plaintiff Fact Sheets were submitted. The defendants suspect they were not. If their suspicions prove true, the answers to the requests may be used to support future Rule 11 motions for sanctions.

The court first held that the provisions and stipulations contained in previously entered pretrial orders do not prohibit the defendants from serving requests for admission on individual plaintiffs at this time.

Next, regarding the deficiency process, the court noted that the defendants were not seeking information that must be contained in a Plaintiff Fact Sheet. Rather, they are seeking Rule 11 information relating to whether the plaintiffs had a sufficient evidentiary basis to file suit. The requests specifically target information concerning whether the plaintiffs possessed their medical and pharmacy records at particular times. This information is outside the scope required to be disclosed in a Plaintiff Fact Sheet. The deficiency process described in pretrial orders has no application in determining whether the defendants’ requests for admission are proper.

Third, while the plaintiffs are correct that Plaintiff Fact Sheets are considered discovery responses according to the case management order, their argument about Rule 11 is premature because the defendants have not yet filed a Rule 11 motion for sanctions. Even so, the plaintiffs again missed the point of the defendants’ requests. The defendants were not attempting to discover whether the plaintiffs committed sanctionable conduct in their Plaintiff Fact Sheets. Instead, they were trying to gather information as to whether there were appropriate Rule 11 prefiling investigations.

Also, the court found that the requests were specifically aimed at discovering information relevant
to the defendants’ defense. If the plaintiffs in the 39 cases in fact failed to comply with Rule 11, serious issues arise as to the merits of those plaintiffs’ claims. The defendants would
be able to use the information gathered from the requests to support a defense that the claims lack
evidentiary basis. Thus, the information sought by the defendants is within the scope of discoverable material under Rule 26(b)(1).

Finally, the court acknowledged that information relating to Rule 11 may raise potential privilege
and conflict issues. However, if the information received by an attorney from a client is relevant to
whether a complaint is well-founded, it probably will eventually be disclosed, either in a pleading
or in later discovery. Schwarzer, Sanctions Under the New Federal Rule 11--A Closer Look, 104
F.R.D. 181, 199 (1985). Thus, the fact that information may be incorporated into work product does
not immunize it from disclosure.

In summary, based upon the allegations contained in the complaints, a prefiling investigation without first obtaining medical and pharmacy records would be reasonable only in an extremely
limited set of circumstances. The records would be essential in determining whether the plaintiffs
have a colorable claim. Rule 11 applies to the same extent in mass tort and multidistrict litigation as it does in more conventional disputes.The defendants’ requests for admission were sufficiently and narrowly tailored to reveal whether the plaintiffs were in possession of the relevant records at the time suit was initiated. The requests would not cause the plaintiffs any undue burden or hardship as the information necessary to answer the requests should be readily ascertainable. 

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The judge in charge of multidistrict litigation involving Wyeth Pharmaceuticals' hormone replacement pill, Prempro, has decided to sanction a law firm representing hundreds of plaintiffs, for its failure to timely produce completed client fact sheets. In re: Prempro Products et al., No. 4:03-cv-01507 (E.D. Ark.). 

Judge Wilson of the U.S. District Court for the Eastern District of Arkansas recently granted Wyeth's motion for sanctions against a Texas-based firm, although he declined to dismiss the plaintiffs.

Readers of MassTortDefense know the role plaintiff fact sheets (PFT) play in mass tort litigation, replacing some aspects of basic fact discovery; allowing defendants to gather information for early case assessment; beginning the process that winnows the number of cases that will be subjected to fuller case-specific fact discovery and expert discovery; and eventually informing the pool of cases available for initial trials if the case management process includes bellwether trials. 

The information requested on the PFT is often a negotiated topic, but typically includes information that any plaintiff's attorney who has done a good faith, Rule 11 assessment of the claim should have, or could readily access. The Manual for Complex Litigation notes that in lieu of interrogatories, questionnaires directed to individual plaintiffs in standard, agreed-on forms were used successfully in the breast implant and diet drug litigation.  It also includes sample case management orders regarding, inter alia, plaintiff fact sheets. (For other examples of plaintiff fact sheets, see In re Baycol Products Litigation, MDL 1431, Pretrial Order No. 10 (D. Minn. Mar. 18, 2002) and In re Phenylpropanolamine (PPA) Products Liability Litigation, MDL No. 1407, Case Management Order No. 6 (W.D. Wash. Mar. 21, 2002)).

Wyeth showed the court that the plaintiff firm missed several court deadlines to serve completed fact sheets for each of its clients. Wyeth first argued in 2008 that plaintiffs represented by the firm had repeatedly submitted incomplete fact sheets in which they provided merely a “will supplement” answer to several questions. Judge Wilson agreed and issued an order on Dec. 17, 2008,
directing the firm to produce completed fact sheets by Feb. 2, 2009.  In February, defendant again complained to the court that hundreds of fact sheets had not been served by the deadline and that many of those that had been produced remained incomplete, with plaintiffs replacing “will supplement” with the vague language that plaintiffs do "not recall and do not have reasonable access to the information that would be responsive to this question without undue burden or cost.”
Plaintiffs were then given until April 13 to resubmit the fact sheets in accordance with the order, and the responses led Wyeth to renew its bid for sanctions including dismissal.

The judge directed the firm to pay $5,000 to Wyeth to partially compensate it for the time and effort involved in seeking adequate fact sheets.  The firm must also assign an associate or paralegal to immediately contact all plaintiffs identified by Wyeth as still having insufficient fact sheets and to have the documents filled out by August 5th.

The court warned that it was likely that additional sanctions — and perhaps considerably more severe sanctions — will be imposed if substantial effort is required to review the adequacy of fact sheets filed by Aug. 5, 2009. 

The court indicated it had seriously considered dismissing all the affected cases without prejudice, and with the proviso that if a case was refiled it must have a reasonably accurate fact sheet attached and that sanctions against counsel would likely be imposed if additional fact sheets were attached with non-answers.  Only the administrative burden of dealing with amended complaint filings prevented this.

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California Gov. Arnold Schwarzenegger has signed into law a new enactment governing e-discovery in that state.  Readers of MassTortDefense know what a significant issue electronic discovery has been in products litigation, particularly since the amendments to the Federal Rules of Civil Procedure more specifically focused on e-discovery issues. Rather than a device to uncover relevant facts for the litigation, e-discovery often is about plaintiffs’ attempt to find some alleged misstep by the defendant that will bring sanctions.

The Governator signed the Electronic Discovery Act, establishing new rules and procedures for litigants who seek electronically stored information.  The law is designed to make discoverable only  those reasonably accessible sources of electronic data, and it provides that litigants shouldn't be sanctioned for losing data through the ordinary operation of an electronic system. The law establishes that a party may move for a protective order from an electronic discovery request on the grounds that the information sought is inaccessible, though it gives courts discretion to require limited discovery in those cases if the demanding party shows good cause, subject to specified restrictions in specified circumstances.

California courts may also limit electronic discovery from accessible sources if they determine that the information sought could be obtained by other means, is duplicative, or if the expense of
the discovery outweighs its likely benefit. While the Electronic Discovery Act allows courts to
impose sanctions on parties which fail to comply adequately with discovery requests, the courts shall not impose sanctions on a party (or any attorney of a party) for failure to provide electronically stored information that has been lost, damaged, altered or overwritten as the result of the routine, good faith operation of an electronic information system.

The new law also requires discovered materials to be produced in the form in which they are kept in the ordinary course of business.

MassTortDefense noted that a survey by the U.S. Chamber of Commerce Institute for Legal Reform of chief legal officers at Fortune 100 companies revealed that:

-On average, 45‐50% of respondents’ civil litigation costs in 2007 related to discovery activities.

-Discovery of ESI accounted for, on average, a significant share (between 33‐39%) of total discovery costs.

-Costs associated with e‐discovery vendors were reported in 63% of large cases. When used, e‐discovery vendors accounted for, on average, 10‐12% of total costs.

-About 61% of case respondents felt that certain discovery requests received from the opposing party were designed to impose undue settlement pressure by increasing the costs to continue the litigation.

-In both state and federal court, the company respondents reported that more than half of their civil litigation matters involved the receipt of discovery requests that sought information beyond the claims or defenses at issue.

- About 31% of company respondents reported that at least 40% of the time ESI requested from them by the opposing party is not reasonably accessible.

This bill is to take effect immediately as an urgency statute.
 

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The certification decision in a proposed class action may be the most important aspect of such litigation. Few certified class actions go to jury verdict (they settle), and, frequently, cases in which class certification is denied are dismissed without even named plaintiffs’ claims being adjudicated. Accordingly, the preparation for the class certification hearing/briefing is crucial. Both sides have important tactical decisions to make about the amount and nature of pre-certification discovery they wish to conduct. Discovery of named plaintiffs and absent class members, when available, can show important distinctions among the class members, which in turn demonstrate an absence of commonality, a predominance of individual issues, and manageability problems. Not infrequently, plaintiffs object to defendants’ attempted discovery as allegedly "going to the merits" and thus as inappropriate for the certification stage. In an interesting, recent little decision in the Ketek antibiotic litigation, the show was on the other foot.

Plaintiffs, who alleged the maker of the antibiotic Ketek fraudulently concealed the drug's dangers, were denied the right to depose various non-party witnesses at the certification stage of this litigation. Sergeants Benevolent Association Health and Welfare Fund v. Sanofi-Aventis U.S. LLP, 2009 WL 1181808 (E.D.N.Y., 4/30/09). The plaintiffs are employee benefit plans that paid for Ketek, known generically as telithromycin. The FDA approved Ketek in 2004 for treatment of three medical conditions. Plaintiffs assert that this approval was based in part on data generated in a study that allegedly “was contaminated by fraudulent activity.”

As part of class certification discovery, plaintiffs proposed to take the deposition of nine non-party witnesses, all of whom were involved with the challenged study and the FDA's approval of Ketek. The court found “unconvincing” plaintiffs' assertion that the proposed non-party depositions were necessary to establish common impact through a “loss of value” methodology; the court found that plaintiffs had misunderstood that methodology in the Zyprexa litigation, which they claimed to be mirroring. Second, the proposed non-party depositions were highly unlikely to produce or lead to evidence relevant to numerosity, typicality, or adequacy of representation. Evidence relating to the complexity of attempting to prove plaintiffs' civil RICO claim may be relevant to predominance and superiority, but plaintiffs need not actually prove their RICO claim, or conduct the discovery necessary to prove that claim, in order to make this showing. Third, defendants did not dispute that the evidence relating to the study was common to all members of the putative class. Thus, discovery postponed to merits phase.
 

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The Digitek MDL Judge, on March 5th,  entered PTO # 16, which details important case management and scheduling deadlines in this mass tort. 

For those interested in some of the nuts and bolts of managing an MDL: the Order  requires that within 45 days, each defendant named in the Master Complaint shall file a Master Answer or a Fed. R. Civ. P. 12 motion in response to the Master Complaint.

The Order sets deadline for plaintiffs to request and brief class certification of any wrongful death, personal injury or medical monitoring putative class in September, 2009.

Plaintiffs are required to fill out and sign Plaintiff Fact Sheets, providing basic fact discovery.  It sets up a process for handling deficiencies in the responses.

Plaintiffs are to provide signed undated authorizations for the gathering of medical records, and addresses for each health care provider, including hospitals, clinics and outpatient treatment centers, and any other custodian of records identified in a plaintiff’s Fact Sheet.

Plaintiffs are ordered to produce medical and pharmacy records in their  possession establishing that the plaintiff was prescribed Digitek and the date(s) on which each prescription issued.

The Order set up a procedure for governing the oft-debated ex parte contact by defendants of treating physicians.

Defendants are ordered to provide organizational chart information as well as QC/QA structures. Also specifications, instructions, test methods and standard operating procedures relating to the manufacture of  Digitek;  quality assurance/control and testing records for Digitek, and any of its component ingredients, including but not limited to records related to batch sampling, post-manufacturing testing and finished goods testing. 

The Order establishes a procedure for privilege logs. The parties were directed to reach an agreement concerning a document production protocol to include the production format of paper and electronic documents, objective coding and metadata, privilege logs and any other applicable issues. In the event the parties cannot agree, the issues will be presented to Magistrate Judge Stanley for resolution.

The PTO also sets deadlines for service of interrogatories, document requests, and company witness depositions. As to expert discovery: Plaintiffs shall serve their reports from liability experts no later than January 1, 2010. The parties shall complete their depositions of Plaintiffs’ liability  experts no later than March 12, 2010.  Defendants shall serve their reports from liability experts no later than March 31, 2010.  The parties shall complete their depositions of Defendants’ liability experts no later than June 11, 2010.

To efficiently manage discovery for all currently pending and future cases in the MDL, the cases will be divided into groups, with each group having a separate scheduling order. Following completion of the first wave of Plaintiffs’ Fact Sheets the Court shall schedule a hearing for purposes of  selecting the initial trial pool of cases (“Group 1”). No later than 5 days before the hearing, Plaintiffs shall select 15 cases and the Defendants shall select 15 cases, and each side shall exchange lists of such selections and submit them to the Court.  Within 10 days after the scheduled hearing, the Court shall select a total of no more than twenty of the proposed trial pool cases to constitute Group 1.

Case specific discovery is set up by Group, with staggered dates of initial discovery (DID),  corresponding discovery deadlines, and Daubert and dispositive motions deadlines 310 days after  DID.

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Experts play a vital role in mass tort defense.  Selection, preparation, and discovery of experts are crucial pre-trial tasks of the defense attorney.  Thus, the rules of civil procedure governing those tasks really matter.

The end of the time period for public comment on proposed changes to Federal Rule of Civil Procedure 26 is rapidly approaching. The formal process to amend the rule governing expert discovery began in early 2008 when the Advisory Committee on civil rules met to consider rule changes recommended by the American Bar Association. After drafting a proposed rule, the committee published the changes for public comment. Written comments are due by February 17, 2009.  There will be a final public Judicial Conference hearing in San Francisco, California, on February 2, 2009.  Guidelines for submitting comments can be found here.

After the comment period ends in February, the advisory committee is expected to consider comments and, if needed, redraft the rule.  Under the Rules Enabling Act, the rule will then be forwarded to the Standing Committee on Rules of Practice and Procedure, which must consider the changes. The standing committee would review the rule at a meeting planned for June, and submit it to the Judicial Conference for consideration at its September session. The proposed changes could go to the U.S. Supreme Court in time for the October session. Assuming this timeline holds up, the Supreme Court must act on the changes by May, 2010. The final step will require consideration by Congress, which will have seven months to act on the proposal. By statute, non-action would allow the rule changes to take effect early as December, 2010.

But the first deadline is the looming end to the public comment period.

What would the rule do?

The key changes extend work-product protection to drafts of Rule 26(a)(2)(B) expert reports and 26(a)(2)(C) party disclosures, and also to certain attorney-expert communications. The proposed amendments are designed to reflect what the Standing Committee calls the “lessons of experience” as opposed to theory, and to provide useful discovery while reducing practices that now impede the best use of expert trial witnesses.

Under the proposal, Rule 26(b)(4) would be amended to extend work-product protection to drafts of expert reports, drafts of party disclosures, and communications between expert witnesses and counsel. Exceptions are carved out for discovery of compensation, identification of facts or data the attorney provided to the expert and that the expert considered in forming the opinions to be expressed; and any assumptions that the attorney provided to the expert and that the expert relied upon in forming opinions.

Some courts have interpreted the Advisory Committee note on existing Rule 26(a)(2)(B) to allow parties to inquire into all communications between experts and counsel, multiplying expenses with little benefit to the parties, and impeding the way cases are actually prepared for trial. This approach has also contributed to the practice of retaining two experts, one to testify and the other to consult. Many lawyers will stipulate out of discovery of draft reports and attorney-expert communication because the costs of such discovery seem higher than the infrequent, small benefits that may be gained. The changes thus are needed to create efficiencies and to reduce litigation costs.

Some academics and the plaintiffs’ bar argue, however, that any restriction on inquiry into the expert's relationship with retaining counsel is a bad idea. Some have even started a letter-writing campaign opposing the proposed amendments. Comments from DRI, on the other hand, suggest that the protections should extend to communications between attorneys and the expert's staff as well.
 

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Two interesting developments in the ongoing discovery battles in the Zyprexa MDL, which involves claims by several states and health entities alleging that defendant Eli Lilly made misleading statements about the medication. The states allege that they would not have funded Medicaid patients taking Zyprexa had they known about the risks of the drug...But don't seem eager to prove it.

First, the magistrate judge denied defendant’s motion for sanctions against Montana, New Mexico, Louisiana, and Mississippi, but ordered the states that have not yet produced their complete Medicaid databases as requested to do so on pain of sanctions.

Second, the court ordered the states to produce non-party medical records requested by Lilly. The defendant, not surprisingly, wanted to be able to compare the records of other antipsychotic medications in the relevant periods. As the court said, "the records are in fact relevant to Lilly’s defenses. For example, as Lilly notes, the use of a statistically significant sample of Medicaid patient records can help to explain information obtained from Medicaid databases, and may provide information on potential confounding variables."

The states argued that their respective physician-patient privilege laws prohibited discovery of the patient medical records. It is axiomatic that state privilege laws do not govern in federal question cases. Although several of the plaintiff states did not allege violations of federal law in their
complaints, and each has vigorously challenged the basis for federal jurisdiction, Judge
Weinstein has held that jurisdiction lies under federal law. 

The court also felt that the states’ doctor-patient privilege argument was not well taken, because the order was for the production of de-identified medical records with patient names redacted. Federal statutes and regulations make clear that de-identified health information is discoverable in litigation in federal court, with or without patient consent, and it appears that the states’
respective privilege laws would not apply to de-identified information either.

The court also denied the states' request that Lilly subpoena the records, as a step that would needlessly prolong discovery.  Significantly, Lilly does not know the identities of the patients whose medical records it seeks. Moreover, the states are in a better position to ensure that the medical records produced are a randomly selected, statistically significant sample. If Lilly were constrained to subpoena the medical records, it would likely target only certain records, which would inevitably lead to protracted argument over whether the records subpoenaed represent a statistically significant sample, said the court.

MassTortDefense has posted on this litigation before. It continues to be an excellent example of the type of attenuated and indirect injury claim that requires in-depth and detailed discovery to defend. Also an example of plaintiffs who are more willing to assert complex damages theories than to provide the evidence to test those claims.
 

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The Magistrate Judge in the Kugel Mesh Hernia Repair Patch MDL has refused to allow defendants to retain as experts any physicians who have treated any of the plaintiffs. See In re: Kugel Mesh Hernia Repair Patch Litigation, MDL Docket No. 07-1842ML (Order 9/19/08).

The Court had previously ordered that defendants were precluded from engaging in substantive ex parte communications with plaintiffs’ treating physicians. Defendants proposed, however, to have the ability to retain a plaintiff’s treating physician as a consulting or testifying expert as long as they do not call the expert in his/her patient’s case and refrained from discussing with him/her the medical history of that patient/plaintiff.

The Court saw the motion as requiring it to balance the trust and confidentiality embodied
in the physician-patient relationship against a litigant’s right to reasonably assemble and present a defense.

The reality of some mass torts is that:

-the sheer number of plaintiffs may preclude defendants from retaining any consultants who are not also treating physicians of some plaintiffs;

-this is especially true in the case of medical devices in which the experts in the devices are experts mainly because they treat people using those devices;

-in mass torts, with thousands of cases in multiple venues, defendants need multiple experts;

-allowing defendants access to treaters -- who are not automatically experts for the plaintiff, but who possess knowledge needed by both sides – may accelerate the discovery process.

The Court here, however, adopted the balancing performed by the Rhode Island Superior Court, which currently sees more than 1000 of these cases. See In re: All Individual Kugel Mesh Cases, 2008 R.I. Super. LEXIS 101 (R.I. Super. August 26, 2008). The state court concluded that any “potential inconvenience” to defendants in engaging experts was “significantly outweighed” by plaintiffs’ right to confidentiality in their medical matters. Id. at *9.

The Court may have given insufficient weight to the protection available from the fact that the treater, if consulted by the defense on plaintiff X, is under an independent ethical duty not to disclose confidential information about patient Y. And the doctor is always available to be deposed about whether he or she was even asked any questions about a patient.

The Court criticized the defendants for not specifically identifying the “small group of hernia repair specialists” who were inevitable, likely treaters of one or more plaintiffs. (“The fact that only one surgeon to date has fallen into the consultant/treating physician category belies Defendants’ claims of prejudice.”) However, generally, and without any knowledge of this specific MDL, MassTortDefense would assert that the issue was not whether defendants had already identified many potential experts who were also treaters. The prejudice comes when defendants cannot find qualified experts who are not treaters and thus must turn to the treater pool –even if they haven’t already done so and thus cannot identify the specific overlapping people. Defendant has no easy way, absent revealing substantial confidential work product, of showing that it cannot find adequate and sufficient experts without resort to the treater pool. Courts, particularly MDL courts, may need to seek a deeper understanding of the reality of expert retention.
 

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Managing the potentially vast scope of discovery requests in life sciences industry litigation can be daunting. The discovery requests in such litigation may be quite broad, following the product through its entire life cycle, and under the new(ish) Federal Rules can be even broader than in the past. They may now involve requests for samples, requests for access to databases, requests for technical support and IT depositions.

Companies in the life sciences area know well that multiple kinds of litigation now regularly arise from same product issue or nucleus of facts, including
– product liability
– medical monitoring
– securities
– consumer fraud class action
– DOJ and government investigations

The vast array of litigation raises the potential for inconsistent positions in the different parts of the litigation concerning same subject. In addition, defendants must be on guard against spoliation attacks and the plaintiffs’ new favorite, the “Gotcha” Game, in which plaintiffs seek discovery not for information, but to find and challenge wherever defendant drew the line in document or data preservation. All in all, the management and conduct of e-discovery has become an area of true specialization.

Defendants may have wondered whether discovery is a two-way street under the new rules. Plaintiffs don’t have as much data, perhaps, and courts have been reluctant to hold individual plaintiffs to the same standards as corporate defendants. In a recent decision in the Zyprexa litigation, a governmental plaintiff may have been, however.

The magistrate judge overseeing discovery in the MDL has weighed in on the state of New Mexico’s apparent failure to properly respond to discovery requests in a lawsuit it filed against Eli Lilly & Co. over Zyprexa. Madrid v. Eli Lilly & Co., No. 07-cv-1749 (MDL-1596 E.D.N.Y.).

As is typical in this branch of the litigation, the state alleges that it would not have spent Medicaid funds on Zyprexa if it had known more about the supposed risks of the drug. The lawsuit was removed to the U.S. District Court for the District of New Mexico in 2006 after it was originally filed in state court. It was transferred for pretrial proceedings to the U.S. District Court of the Eastern District of New York by the panel on multidistrict litigation.

Earlier this month, Eli Lilly challenged the adequacy of the state's responses to interrogatories and document demands it had made in June. The magistrate judge's Order concluded that New Mexico had neither replied to Lilly's attempts to confer in good faith on this issue nor had it provided the court with any justification whatsoever for its boilerplate objections. The state's silence on this issue “underscores the indefensible nature of its responses.” Apparently, the state had ignored the specificity requirement for objection and merely labeled each request as “unintelligible” or “irrelevant.” The court also faulted the state for not including a privilege log.

Discovery is supposed to be a two-way street.

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