Lone Pine orders — case management orders requiring plaintiffs to detail and substantiate the cause and occurrence of the alleged injury early in mass tort proceedings — offer an attractive case management strategy in the defense of pharmaceutical manufacturers in mass tort actions.

What Is A Lone Pine Order?

In 1986, a trial court in New Jersey entered a case management order requiring the over 400 plaintiffs who had sued a landfill operator over toxic exposure injuries and damage to property values to offer details regarding their alleged exposure, reports of physicians regarding causation, and specific information supporting claims of property damage.¹ The plaintiffs were unable to meet the burden of the case management order, and the case was eventually dismissed. Thus, the “Lone Pine order” was born.

Since that time, Lone Pine orders have been implemented in state and federal courts in various types of actions and are becoming more common. Lone Pine orders are a particularly appropriate remedy for the inefficiencies inherent in multi-plaintiff pharmaceutical actions and can be an effective tool to streamline the defense of such cases.

Mass Torts Often Include Plaintiffs With No Legitimate Claim

The problems confronted by pharmaceutical manufacturers in defending mass tort claims are no secret. The sheer number of plaintiffs involved, sometimes in the thousands or even tens of thousands, results in an expensive and unwieldy process from the start. This is true regardless of the legitimacy of the underlying claims. In August of last year, six industry leaders — Eli Lilly, Johnson & Johnson, Merck, Novartis, Pfizer and Wyeth — sent a joint letter to the Financial Accounting Standards Board (FASB). The specific purpose of the letter was to address the equity of proposed changes in accounting rules regarding how pending lawsuits should be reported, and in explaining why mass tort cases are so difficult to predict, they illustrated the problems caused by the volume of these actions. The companies explained that:

[…] mass tort defendants often lack the most basic information about plaintiffs who are asserting claims. A mass tort may develop, multiply, diminish, or disappear based on a host of procedural or legal rulings, fact-findings, and other events, none of which can be predicted in advance.²

The manufacturers also zeroed in on the stark lack of information regarding the plaintiffs in such cases:

Plaintiffs and their counsel often have never met, and ‘client meetings’ may be nothing more than e-mail intake forms or phone calls to call centers. Typically, neither the plaintiffs nor their counsel have collected the relevant medical records, much less had them evaluated by an expert. Any particular mass tort plaintiff thus may never have ingested the defendant’s drug; if the plaintiff ingested the drug, the plaintiff may not have suffered any injury; if a plaintiff ingested the drug and suffered an injury, the injury may not have been related to the claimed defect.³

The problem is one known all too well to pharmaceutical manufacturers. Mass tort litigation takes on a vast, costly, and unpredictable life of its own before even the most basic information is known about the plaintiffs and the facts behind their alleged injuries. A single complaint filed on behalf of thousands of plaintiffs may state only the most basic allegations to substantiate the claims — that the listed plaintiffs ingested the drug at issue and that the plaintiffs suffered injuries therefrom. Traditional discovery requires interrogatories, requests for production, procurement and analysis of medical records, depositions of plaintiffs and treating physicians, and expert discovery in order to determine even the basic details of a given individual’s ingestion of a drug and the nature of the alleged injury. Often in the context of mass torts, this long discovery process reveals that a substantial number of plaintiffs have no case. The time, money, and energy spent defending the baseless claims harms both the manufacturers, who have been forced to defend baseless actions, as well as plaintiffs with potentially legitimate claims but who have been forced to stand in a line crowded by illegitimate plaintiffs.

The inclusion of spurious plaintiffs has several causes. Ordinarily, plaintiffs’ attorneys have an incentive to pursue only legitimate claims, as those are the cases with actual value at the end of the day. However, in the mass tort context, the incentives change as a large number of plaintiffs may be seen in the early stages as a sign of strength. Additionally, just as it is costly and unwieldy for manufacturers to defend claims numbering in the thousands, it is likewise difficult for plaintiffs’ counsel to investigate and verify the validity of claims being filed in such numbers. Even sending a form letter to each plaintiff is a massive undertaking for plaintiffs’ counsel when so many plaintiffs are involved, as is gathering the details and documentation of each plaintiff’s medical history and alleged injury. Thus, a properly drafted and enforced Lone Pine order can force plaintiffs and their lawyers to do early in the process what often is left until years later: specifically set out medical records, medical testimony, and expert proof to support each individual claim of exposure and injury.

The Lone Pine order essentially places the horse where it belongs: in front of the cart; prior to full-scale discovery, the order requires plaintiffs to demonstrate the basic facts supporting a claim of ingestion of the drug, the fact that an injury was suffered, and a medical opinion to establish causation.

The Practical Effect

The practical value of Lone Pine orders may differ in each case depending on how stringently a court is willing to draft the order. In some cases, such as the original Lone Pine case, the order may result in all-out dismissal early in the life of the case. In other cases, the order may result in efficiently weeding out unsubstantiated claims early in the process, resulting in a smaller group of potentially legitimate claims for which full discovery is warranted. Even for plaintiffs’ claims that survive the order, the information provided pursuant to the order — evidence of ingestion, specific claims of injury, and medical opinions — allows defendants to hone their strategy earlier in the litigation. This information aids in prioritization of individual plaintiffs, targeted discovery, and overall strategy, whether toward exploring settlement or preparing for trial. Even if a given Lone Pine order does not result in the dismissal of a single plaintiff, the consistent and proper use of such orders in pharmaceutical cases may help create an environment in which plaintiffs’ counsel are motivated and expected to file complaints on behalf of plaintiffs for whom they are immediately prepared to give specific evidence of exposure and injury. Creating such norms in the world of pharmaceutical mass tort would help avoid the problems created by a morass of non-specific claims like those that necessitated the implementation of the Lone Pine order in the first place.

Strategic Considerations

Lone Pine orders, as case management tools, are within the discretion of the trial court. Thus, a party pushing for a Lone Pine order must succeed not only in convincing the court that the case warrants such treatment but also that the order should contain the “teeth” necessary to require plaintiffs to comply with meaningful requirements or face dismissal. Anyone with any experience in litigation has learned that rules and procedures may appear iron-clad but often are not strictly followed by the parties or enforced by the court. Courts tend to be hesitant to subject clients to what some may view as draconian punishments for failure to comply with procedural requirements. For this reason, getting a Lone Pine order entered is only part of the battle. The real utility comes with an order that is drafted with clear and enforceable terms, with all parties and the court understanding the requirements and consequences of failing to meet them. Then, it becomes the job of defense counsel to hold plaintiffs to the requirements of the order.

Horse Of A Different Color: Plaintiffs’ Perspective

Plaintiffs’ counsel in some instances may be willing to agree to Lone Pine orders but generally oppose them. While it may seem that such an order merely requires the plaintiffs to demonstrate the details of a good-faith claim with a reasonable degree of specificity, plaintiffs may argue that the burden the Lone Pine order places on them is far beyond what it ought to be. After all, the argument goes, a plaintiff defending against a summary judgment motion need only demonstrate to the court that disputed issues of material fact exist. A Lone Pine order, on the other hand, essentially requires plaintiffs to defend against summary judgment immediately by setting forth a prima facie case within weeks of filing suit and prior to gaining any meaningful discovery from the defendants.⁴ Courts often may find such arguments persuasive.

Admittedly, Lone Pine orders may increase the burden and costs on mass tort plaintiffs and their attorneys, but the question, of course, is whether they do so appropriately. After all, Rule 11 requires that claims made in the course of litigation be warranted by law and evidence. The question presented to the trial court is this: In a case with thousands of plaintiffs that have been widely solicited by plaintiffs’ counsel who may not have had the opportunity to research each individual’s claim, who should shoulder the burden and expense of separating the legitimate claims from the spurious ones? The concept behind the Lone Pine order is that the burden, heavy though it may be, should be placed in large part on plaintiffs and their counsel.

Lone Pine Orders In Pharmaceutical Actions

While such orders are not routine, courts have entered Lone Pine orders in several pharmaceutical actions. Most recently, in August 2008, a California federal court entered a Lone Pine order in the Celebrex litigation requiring that within forty-five days an expert report be produced for each plaintiff, detailing the specific dates the drugs at issue were taken and specific references to the medical records as to adverse conditions.⁵ Lone Pine orders have been implemented by federal and state courts in the Rezulin litigation and Baycol litigation, and a Lone Pine order was entered in conjunction with the Vioxx settlement as well.⁶ The continued application of Lone Pine principles to case management in pharmaceutical actions has the potential to build a body of law enabling a more equitable allocation of the burdens involved in pharmaceutical mass tort cases — a welcome development for manufacturers, their counsel, and the legal system at large.

Conclusion

Pharmaceutical manufacturers and their defense counsel should petition courts to enter Lone Pine orders in appropriate cases, work to ensure that the orders contain reasonable and enforceable terms, and seek to enforce the terms of the order. The willingness of courts nationwide to enter such orders will be a topic of interest to pharmaceutical manufacturers and their counsel for years to come.

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[1] Lore v. Lone Pine Corp., 1986 N.J. Super.

[2] Letter from Eli Lilly, Johnson & Johnson, Merck, Novartis, Pfizer & Wyeth to Financial Accounting Standards Board, August 8, 2008, available at <http://www.fasb.org/ocl/fasb-getletters.php?project=1600-100>.

[3] Id.

[4] See Hopp, Anthony G., “Making Lone Pine Orders Work: Planning, Execution, and Follow-through,” ABA Mass Torts Newsletter, Vol. 3, No. 1, Summer 2005.

[5] In re Bextra and Celebrex Marketing sales Practices and Product Liability Litigation, No. M:05-CV-01699 (N.D. Cal., Pretrial Order No. 29, August 1, 2008).

[6] See In re Rezulin Prods. Liab. Litig., MDL No. 1348, No. 00 Civ. 2843, 2005 WL 1105067 (S.D.N.Y. May 9, 2005); In re Baycol Prods. Liab. Litig., MDL No. 1431, 2004 WL 626866 (D. Minn. Mar. 18, 2004); In re: N.Y. Rezulin Prods. Liab. Litig., (N.Y. Sup. Ct. N.Y. Co. July 7, 2004); In re Baycol Litig., November Term, 2001, No. 0001, (Ct. Com. Pl. Phila. Co. Dec. 12, 2003).

Finis