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

In the right case, we are big fans of the "Lone Pine" order as a tool of case management.  Named for Lore v. Lone Pine Corp., No. L-33606-85, 1986 WL 637507 (N.J.Super. Ct. Law Div. Nov. 18, 1986), Lone Pine orders are designed to handle the complex issues and potential burdens on the parties and the court in mass tort and toxic tort litigation. Acuna v. Brown & Root Inc., 200 F.3d 335, 340 (5th Cir.2000).   The term refers to case management orders that require the plaintiffs to make a showing regarding causation, injury, and/or damages to demonstrate, typically at an early stage, some minimal level of evidentiary support for the key components of their claims which will be in dispute.

While the 1986 New Jersey Superior Court case involved traditional toxic tort claims, the device has gotten good use in drug cases as well.  E.g., In re Vioxx Products Liab. Litig., 2010 WL 2802352 (5th Cir. July 16, 2010). After a tentative settlement was reached in the Vioxx litigation, the MDL court entered several pre-trial orders with respect to the claims of those plaintiffs who could not or chose not to participate in the Master Settlement Agreement.  The order required non-settling plaintiffs to notify their health-care providers that they must preserve evidence pertaining to the plaintiffs' use of Vioxx. Plaintiffs were also required to produce pharmacy records and medical authorizations, answers to interrogatories, and a Rule 26(a)(2) report from a medical expert attesting that the plaintiff sustained an injury caused by Vioxx and that the injury occurred within a specified time period. Failure to comply eventually resulted in dismissal of several of the plaintiffs' claims with prejudice.

And the federal judge overseeing the MDL for Celebrex and Bextra found that a “Lone Pine” order was appropriate for managing the claims of the remaining, non-settling plaintiffs. In re: Bextra and Celebrex Marketing Sales Practices and Product Liability Litigation, No. M:05-cv-01699 (N.D. Cal.) (Pretrial Order No. 29, Aug. 1, 2008).

In the drug context, a Lone Pine order might require plaintiffs to submit a case-specific expert report on the issue of medical causation; or to turn over medical records that documented an injury, prescription records that showed medication history and dosages prescribed, and/or proof of dosage in relation to the injury. The benefit to the court of requiring plaintiffs to supply this information is that the parties will not have to engage in protracted discovery in hundreds or thousands of cases just to see whether each one has some threshold evidence of medical causation. The production of such basic and threshold evidence is simply a part of a good-faith investigation that should precede the filing of a lawsuit.

Requiring plaintiffs to identify basic information about injuries and causation is not unreasonable given the costs that mass tort claims have on the legal system, and on defendants in particular. Lone Pine orders allow courts to weed out the frivolous suits where there is insufficient exposure, or no sufficient scientific connection between injury and exposure. Accordingly, Lone Pine orders can be effective when entered early in the game. Early disposal of frivolous claims allows the parties to focus their attention on the serious cases. Ideally, the order will actually phase discovery, and motions practice as well, with the Lone Pine issues pushed up front.

But the device also has a role later in mature mass torts when, as seen above, a chunk of the litigation has settled and there still remain numerous claims of questionable strength.

In the MDL involving the the diabetes medication Avandia, In re Avandia Marketing, Sales Practices, and Products Liab. Litig., MDL No. 1871 (Pretrial Order No. 121)(E.D. Pa. Nov. 15, 2010), the federal court has recently adopted a Lone Pine order.  The court found that many of the remaining claims lacked sufficient support or detail even after submission of the Plaintiff Fact Sheets.  Thus, additional detail about the plaintiffs' claims was necessary in furtherance of settlement agreements, for the selection of cases for bellwether trials, and for the timely remand of cases to the transferor courts for resolution.

The court's overriding concern was having sufficient information to objectively identify which of the many thousands of remaining plaintiffs have injuries that could credibly be linked to the drug usage.  The order calls for information that the court said the plaintiffs should have had before filing their claims.

Specifically, plaintiffs have to have a licensed physician identify the plaintiff's Avandia usage, the alleged injury, the time lag between drug usage and injury, and a certification that the drug usage caused the injury.

Failure of a plaintiff to submit these required expert certification (and supporting documents) in a timely fashion may result in the dismissal of that plaintiff's claims with prejudice.

A defendant in such litigation should not bear the burden of winnowing cases that never should have been filed, nor should the court be saddled with consideration of claims that would not have survived reasonable pre-complaint investigation.

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A federal appeals court last week reversed an order by a district court certifying a class action of insurers, labor unions, and pension funds who alleged that they overpaid for a drug when the manufacturer allegedly didn't reveal all of the drug's adverse side effects. UFCW Local 1776, et al. v. Eli Lilly & Co., No. 09-0222 (2d Cir. 9/10/10).

Plaintiffs acted as third-party payors (TPP) who underwrite the purchase of prescription drugs by their members or insureds; they brought a putative class action against Eli Lilly, manufacturer of the drug Zyprexa, alleging that Lilly had misrepresented Zyprexa’s efficacy and side effects to physicians. The putative class alleged they paid for the many Zyprexa prescriptions. Plaintiffs argued that they were injured in two ways: first, by paying for Zyprexa prescriptions that would not have been issued but for the alleged misrepresentations; and second, by paying a higher price for Zyprexa than would have been charged, absent the alleged misrepresentations.

In a nearly 300-page opinion issued in  2008, Judge Jack Weinstein of the Eastern District of New York granted class certification to the third-party payors. Specifically, the district court certified a class of TPPs on RICO claims predicated on the overpricing theory of damages, but refused to certify a class related to state consumer protection law claims. The lower court concluded that the proposed TPP class presented common questions of law and fact because the “only difference among class third-party payors is how much of the total overcharge each shall receive in damages.” The lower court  had  addressed whether the losses suffered by the class could be established with sufficient precision, a huge issue in these kinds of cases, concluding that damages could be estimated based on the difference between what was paid for Zyprexa and the actual value of the product. The computation would supposedly require: (i) estimating the total out-of-pocket expenditures for the class members and (ii) using "well-accepted  techniques" in applied economics to determine the actual value or appropriate launch price of Zyprexa.

The district court also found that reliance could be proven for the class simply because the alleged fraud was “directed through mailings and otherwise at doctors who relied, causing damages in overpayments by plaintiffs.” This reliance, the district court concluded, could appropriately be shown by generalized proof, but without resort to the “fraud on the market” theory rejected in cases like McLaughlin v. Am. Tobacco Co., 522 F.3d 215 (2d Cir. 2008).

Defendant appealed.  The Second Circuit noted that to determine whether the proposed TPP class was properly certified, it had to consider whether substantial elements of the claim against Lilly may be established by generalized, rather than individualized, proof.  (Predominance of common or individual issues under Rule 23(b) was the focus.)  Even if the issue whether an act of marketing of the drug was in violation of RICO is considered common, Lilly disputed that the other elements required to recover damages – proof of an injury and proof that such injury was by reason of the RICO violation – were common to the proposed class.  To show injury by reason of a RICO violation, a plaintiff must demonstrate that the violation caused his injury in two senses. First, he must show that the RICO violation was the proximate cause of his injury, meaning there was a direct relationship between the plaintiff’s injury and the defendant’s injurious conduct. Second, he must show that the RICO violation was the but-for (or transactional) cause of his injury, meaning that but for the RICO violation, he would not have been injured.

Traditionally, to show causation in a fraud context, reliance needed to be shown. But in Bridge v.
Phoenix Bond & Indemnity Co., 128 S. Ct. 2131, 2134 (2008), the Court lessened the emphasis on traditional reliance as an element of the RICO fraud claim to show causation in some cases.  But how a plaintiff can or must prove causation is bound up in what the factual claim is. The Bridge Court also said that in “most cases, the plaintiff will not be able to establish even but-for causation if no one relied on the misrepresentation.” 128 S.Ct. at 2144.  Here, while reliance may not be an element of the cause of action, there was no question that the plaintiffs alleged, and thus had to prove, third-party reliance as part of their factual chain of causation.  Plaintiffs alleged an injury that was caused by physicians relying on Lilly’s supposed misrepresentations and prescribing Zyprexa accordingly. Because reliance was a necessary part of the factual causation theory advanced by the plaintiffs, they had to show it to prevail, and show it by generalized proof if they wished to proceed in a class action.

The court of appeals concluded that plaintiffs’ excess price theory was not susceptible to generalized proof with respect to either but-for or proximate causation, and therefore class certification based on this theory was an abuse of discretion.

The evidence in the record made clear that prescribing doctors do not generally consider the price of a medication when deciding what to prescribe for an individual patient. Any reliance by doctors on alleged misrepresentations as to the efficacy and side effects of a drug, therefore, was not a but-for cause of the price that TPPs ultimately paid for each prescription.  Moreover, the TPP plaintiffs, who unlike the doctors were in a position to negotiate the prices of drugs in their formularies, were unable to show proximate causation.  The TPP plaintiffs drew an alleged chain of causation in which Lilly distributed misinformation about Zyprexa, physicians relied upon that misinformation and prescribed Zyprexa for their patients, and then the TPPs overpaid.  But this narrative skipped several crucial steps: after the doctors prescribe the drug, TPPs relying on the advice of Pharmacy Benefit Managers and their Pharmacy and Therapeutics Committees, placed Zyprexa on their formularies as approved drugs, and then TPPs failed to negotiate the price of Zyprexa below the level set by Lilly.  Thus, in this case, the conduct directly causing the harm was distinct from the conduct giving rise to the fraud. The plaintiff TPPs could not and did not allege that they themselves relied on Lilly’s alleged misrepresentations. But because only the TPPs were in a position to negotiate the price paid for Zyprexa, the only factual reliance that might show proximate causation with respect to price was reliance by the TPPs, not reliance by the doctors.

Since plaintiffs could not show the entire factual causal chain by generalized proof, individual issues would abound, and class certification was improper. The court of appeals also remanded for reconsideration of defendant's summary judgment motion in light of its ruling.

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A New Jersey appellate court recently affirmed a trial court's decision that an Accutane plaintiff's expert's study must be excluded as unreliable. See Palazzolo v. Hoffmann La Roche Inc., 2010 WL 363834 (N.J. Super. Ct., 2/3/10).

Plaintiffs filed a product liability and consumer fraud complaint against defendants claiming that Accutane, a drug used to treat acne, caused their family member to develop depression which led to his suicide. They contended that at the time of his death in 1997, Accutane should have carried a warning label concerning the possibility that the drug could cause depression and suicide.

As one element of their product liability cause of action, plaintiffs needed to establish “general causation,” by showing that Accutane can cause depression and suicide. See Kemp v. State, 174 N.J. 412, 417 (2002); Coffman v. Keene Corp., 133 N.J. 581, 594 (1993). On that issue, plaintiffs retained Dr. James Bremner, as an expert.  Plaintiffs paid Bremner to undertake a study of the issue; there was no dispute that the study was commissioned specifically for use in this litigation.

In the study at issue, Bremner and a team of other scientists used positron emission tomography (PET) technology to compare changes in brain metabolism between two groups of subjects being treated for acne. One group was receiving antibiotic treatment and the other group was being treated with Accutane.  According to Bremner, the PET study demonstrated that the subjects treated with Accutane showed decreased metabolism in the orbital frontal cortex, a portion of the brain associated with depression. He published an article about the study in a scientific journal, describing his methodology and his conclusions. Based largely but not entirely on the PET study, he issued an expert report opining that Accutane can cause depression and suicide.

Defendants challenged the evidence. In deposition and at a hearing, Bremner was repeatedly confronted with potential problems in the PET study, including missing data, inaccurate data, and deviations from the methodology he claimed to have followed. As a result, in the middle of the Rule 104 hearing, the court permitted Bremner to re-work his study data and issue a supplemental expert report and allowed defendant to re-depose him. The trial court then excluded the evidence.

The court of appeals affirmed. First, Bremner did not actually use the methodology he claimed to have used. Although his PET scan article was peer-reviewed, he admitted that he did not in fact follow the steps described in the article. Significantly, contrary to representations made in the article, he did not get before-and-after questionnaires from many of the subjects.  Those questionnaires were designed to elicit the extent to which the subjects might be worried about their acne. This was relevant because some scientists were of the view that worrying, as well as depression, could affect activity in the orbital frontal cortex.

Secondly, Bremner also could not document much of the data on which his published results were based. Third, he admitted that some of the statistical analysis was inaccurate. For example, in the hearing session, Bremner admitted that, for each study participant, comparing the activity in the orbital frontal cortex with the activity in the whole brain revealed no difference between the subjects who took Accutane and those who took antibiotics.

The court noted that an expert's scientific peers cannot fairly judge the expert's written work, including whether it is worthy of publication, if his article does not accurately represent either the underlying data or what the author did to produce his results. In essence, Bremner's study was not  soundly and reliably generated.

There also was no error in precluding Bremner from providing supplemental reports or information after the Rule 104 hearing record closed. The judge allowed Bremner multiple opportunities to correct errors in his study before the record closed. The orderly conduct of litigation demands that expert opinions reach closure. See Miller v. Pfizer, Inc., 356 F.3d 1326, 1334 (10th Cir.), cert. denied, 543 U.S. 917 (2004).

The court of appeals remanded the case for consideration whether, even without the PET study, Dr. Bremner can still offer an opinion that Accutane can affect the brain and produce depression.

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Readers of MassTortDefense know how the conduct and results of clinical trials can reach out and affect later product liability litigation: plaintiffs frequently assert that drug makers missed or ignored safety signals present in those trials. 

In reality, developing new therapies to treat disease and to improve quality of life is a long and complex process. And a critical part of that process is clinical research -- without clinical research studies, no new medicines could be made available to patients.

Last week PhRMA issued revised Principles on Conduct of Clinical Trials and Communication of Clinical Trial Results with a goal of helping assure that the clinical research conducted by pharmaceutical research and biotechnology companies continues to be carefully conducted and that meaningful medical research results are communicated to healthcare professionals and patients.

Among the key changes in the updated Principles: Increased transparency about clinical trials for patients and healthcare professionals; enhanced standards for medical research authorship; and improved disclosure to better manage potential conflicts of interest in medical research.

PhRMA members have indeed had a longstanding commitment to sponsoring clinical research that fully complies with all legal and regulatory requirements. And actually, many different entities and individuals contribute to the safe and appropriate conduct of clinical research, including not only sponsoring companies but also regulatory agencies; investigative site staff and medical professionals who serve as clinical investigators; hospitals and other institutions where research is conducted; and Institutional Review Boards and Ethics Committees.

The key issues addressed are:
• Protecting Research Participants
• Conduct of Clinical Trials
• Ensuring Objectivity in Research
• Providing Information About Clinical Trials

Of particular note to my readers may be the document's call for consistency with standards of the International Committee of Medical Journal Editors as journal guidelines for authorship;  under these, anyone who: (1) provides substantial contributions into the conception or design of a study, or data acquisition, or data analysis and interpretation; and/or (2) writes or revises the manuscript involving important intellectual content; and/or (3) has final approval of the version to be published, should receive appropriate recognition as an author when the manuscript is published. Conversely, individuals who do not contribute in this manner do not warrant authorship. We have posted about this issue before.

As always, the guidelines are purely voluntary, and even member companies are free to adopt their own best practices and mold general guidance to their particular situations.

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We have posted before about just how difficult Canada is becoming as a jurisdiction for class actions defendants, particularly companies in the pharmaceutical industry. Frequently, identical consumer products, drugs, and medical devices are marketed in Canada as well as the U.S.  When a product is recalled, or new science suggests risks in a product leading to American product liability and mass tort litigation, Canadian plaintiff attorneys have not been bashful about bringing copycat litigation, borrowing from U.S.-conducted theories and discovery.

A ray of hope to the north?  The Quebec Superior Court last week declined to certify (authorize is the term they use) a class action for Canadians claiming to have experienced side effects from the use of GlaxoSmithKline Inc.’s antidepressant Paxil.  This is the first time a Quebec court has rejected a class action involving a prescription pharmaceutical product -- ever as far as we can tell. See Goyette v. GlaxoSmithKline Inc., Quebec Superior Court, No. 500-06-000157-020 (8/17/09).

Plaintiff sought to represent a national class of Paxil users. Three issues were prominent: Did the claims of the class members raise identical, similar or related questions of law or fact?  Did the facts alleged seem to justify the relief sought? And was the plaintiff an adequate class representative?  Importantly, at the time of the complaint, the class rules required plaintiff to submit a supporting affidavit (on which she was cross-examined).  Since that time, Quebec has sought to minimize the amount of factual material presented to the court in support of class certification (making opposition a bit more difficult).

The first issues sounds like the commonality aspect of U.S. class procedure. GSK argued that the highly subjective nature of the alleged symptoms in the present case, such as headaches, nausea, vertigo, the infinite variations on the symptoms, and the intensity and duration are so subjective that they cannot be decided collectively and so cannot satisfy the common question element.  Nevertheless, the court found that while the claim for exemplary damages was not common, there were common questions concerning the warnings GSK had given.

However, even in the absence of a true predominance requirement, some Canadian courts will look at whether and what issues will require individual determination. Here, the court agreed that the underlying question is whether allowing the suit to proceed as a representative one will avoid duplication of fact-finding or legal analysis. Thus an issue will be “common” only where its resolution is necessary to the resolution of each class member’s claim. The court found that if  "a class action were permitted here, there would be no saving in judicial time since there is no real common question and each case must be litigated on its on merits."  The court noted that each year there was a different set of information in the CPS (Canadian PDR), and accordingly, there would be different sub-classes depending on changes in the relevant wording in each of the years.

Similarly, in this case, civil liability must be determined by assessing the specific risks disclosed for each individual patient which risks vary depending on multiple factors:

 a) whether the adverse effects occur during the use of the product and lead to discontinuation;

 b) whether adverse effects follow discontinuation;

c) whether the user was advised prior to use, by either their physician or pharmacist, of whether they may experience dependency or withdrawal symptoms;

d) whether the symptoms suffered were described in the C.P.S. (PDR);

e) whether the symptoms were not described in the C.P.S. but are proved to be directly related to the use of Paxil; or

f) to the extent that the symptoms arose following discontinuation, whether such symptoms were "mild and transient" and were described in the C.P.S.

Next, the court determined that the facts alleged do not support the relief requested. All of the symptoms that Ms. Goyette alleges to have experienced were mentioned by GSK in the C.P.S. and that any fault must have been through the misreading of the C.P.S. by Ms. Goyette's prescribing physician.  And she made no specific allegations about the injuries of the absent class members.  Accepting as true the well-pleaded allegations, in essence, the facts that are taken as proven do not include impressions, opinion, legal argument, inferences or hypotheses that are not verified.

Finally, adequacy of representation is evaluated on three criteria:

 1- an interest in undertaking the legal proceedings;

 2- an ability to instruct counsel; and

 3- absence of a conflict with the other group members.
 

Based on the previous analysis, the court found that Ms. Goyette could not represent a class since she herself does not have a valid cause of action.  Moreover, plaintiff had shown a singular lack of interest in that she never sought to speak with any of the other members of the proposed class, none of whom she knows; she has never sought to communicate with any of the individuals alleged to have signed up at her attorneys' website; and she could provide no explanation as to why these legal proceedings which started on May 2, 2002 remained dormant for several years.

An analysis with a little bit of teeth.
 

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