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A federal judge has refused to certify a class action on behalf of minors who took the antidepressant drug Paxil and later attempted or committed suicide, finding that the handful of common legal issues shared by the class would be “overwhelmed” by factual and legal issues in the individual cases.

In his 32-page opinion in Blain v. SmithKline Beecham Corp., U.S. District Judge Timothy J. Savage found that the proposed class failed to satisfy nearly all of the key requirements of Rule 23 of the Federal Rules of Civil Procedure – commonality, typicality, predominance, superiority and adequacy of representation.

Savage also found that the case would prove to be unworkable as a class action since the class members hail from different states and the court would become mired in a slew of choice-of-law questions.

“The proposed class will be unmanageable because there is no way to apply the varied state laws and, at the same time, guarantee procedural fairness,” Savage wrote.

In the suit, plaintiffs’ lawyers allege that, despite having specific knowledge of Paxil’s association with an increased risk of suicidality in pediatric patients, GlaxoSmithKline (GSK) failed to warn doctors, the medical community and the public of the danger.

More than 50 such suits have been filed in federal courts around the country, and court papers show that as many as 7,000 families may have potential claims.

In seeking class certification, the plaintiffs lawyers conceded that the individual plaintiffs would ultimately be required to litigate the final stages of their cases in their home states, but argued that several common legal issues relating to GSK’s conduct could be litigated in a class action.

The suit sought a trial on three questions relating to GSK’s liability – whether Paxil can cause suicidality in pediatric patients; whether GSK knew or should have known that it can; and whether GSK failed to adequately warn of the danger.

Attorney Karen Barth Menzies of Baum Hedlund in Los Angeles said her firm was hoping to use the class action mechanism as a procedural tool to assist all of the plaintiffs by consolidating discovery on issues that hinge primarily on expert witness testimony.

Trying those issues “again and again” is daunting, she said, because the expert witnesses will not be available to testify in dozens of trials.

But Menzies also said she recognized that the proposal was a “creative” one and that she accepted Savage’s decision to reject it.

Savage concluded that the named plaintiffs could not be deemed typical under Rule 23 “because the individual circumstances of the named plaintiffs are markedly different from those of the putative class members and GSK can raise unique defenses to almost each class member’s claim.”

And those factual differences, Savage said, “result in interests so divergent that the named plaintiffs are inadequate representatives of the absent class members.”

Rule 23 also requires that common issues “predominate” the case such that a class action is a “superior” method of litigating it.

Savage found the predominance factor wasn’t satisfied “because the proposed common issues are overwhelmed by the differences among the factual and legal issues affecting individual causation, damages and defenses.

Superiority was also lacking, Savage said, “because the proposed class would be unmanageable in light of the choice-of-law conflicts that are resolved in favor of each individual’s home state.”

In sum, Savage said, “the plaintiffs have failed to define a class capable of ascertaining membership without individualized fact-finding.”

Paxil, one of a class of drugs called selective serotonin re-uptake inhibitors, or SSRIs, was first approved for sale in the United States in 1992 for the treatment of depression in adults and was later granted expanded approval by the Food & Drug Administration for treatment of obsessive compulsive disorder, social anxiety disorder and generalized anxiety disorder in adults.

Although the drug has never been approved by the FDA for treatment of any condition in children, doctors are nonetheless allowed to prescribe “off-label” for an “unapproved” population, such as children or adolescents.

Beginning in 2005, GSK added a “Black Box” warning to Paxil that said “Antidepressants increased the risk of suicidal thinking and behavior (suicidality) in short-term studies in children” and that any child who is prescribed Paxil should be “observed closely for clinical worsening, suicidality, or unusual changes in behavior.”

In the suit, the plaintiffs allege that between 1998 and 2001, GSK conducted at least three placebo-controlled studies of Paxil for pediatric depression that showed that the drug is ineffective in children and is associated with a high increased risk of suicidal events.

But instead of warning the public, the suit says, GSK “reacted by seeking to hide the data from the public,” and began a marketing campaign to promote the off-label use of Paxil among children.

In their motion for class certification, plaintiffs lawyers argued that the issue of GSK’s liability in all cases where a minor taking Paxil had either attempted or committed suicide hinged on two issues – whether Paxil can cause suicide or suicidality, and whether it did cause the suicide or suicidality in the case of a particular plaintiff.

The first issue – general causation – was one that could be decided on a class-wide basis, they argued, leaving specific causation to be determined at each individual’s trial.

Savage disagreed, saying “the two parts of the causation issue cannot be separated. Answering the question whether Paxil can cause suicidality in pediatric patients is only the starting point in the causation inquiry. The answer to the first part reveals only who are potential members of the class. It is the answer to the second part, that is, who suffered harm as a result of the drug, that defines the class.”

The “determinative question” for class membership, Savage said, was “whether the drug did cause the individual plaintiff’s suicidality.”

As a result, Savage concluded that the issue did not lend itself to class action treatment because “the answer to the specific causation question depends upon a number of individualistic factors, such as: the patient’s diagnosis; the dosage taken; the duration of treatment; the patient’s age and physical characteristics; the patient’s family, mental and medical histories; and whether the patient previously suffered from suicidality.”

Since that plaintiff-specific analysis “dominates the causation inquiry,” Savage said, the issue of causation “does not provide a common question.”

Savage also found that a class action is not the superior method of litigating the issues because it would not “materially advance” the litigation.

The plaintiffs team argued that litigating the three common issues will involve scientific evidence, voluminous documents, a multitude of witnesses and volumes of discovery.

Many class members, they argued, cannot individually afford the expense of proving a prescription drug product liability case.

But Savage said “this argument overlooks the fact that most, if not all, cases of this type are litigated on a contingency fee basis. Consequently, the individual plaintiff need not bear the cost of proceeding during the pendency of the case.”

The “most significant portion” of the litigation of causation, Savage said, “will take place in the context of each individual’s claim where liability will consume the fact-finding process.”

As a result, Savage said, “even though the issues proposed by the plaintiffs must be tried in each trial, it may be more beneficial for a jury to assess the individual claims in the context of these issues.”

Plaintiffs lawyers also proposed that Savage could apply Pennsylvania law in deciding the common legal issues.

But Savage disagreed, saying “there is no way to apply Pennsylvania law to part of the liability determination, as proposed by the plaintiffs, without disregarding the comity afforded the other states whose interests are in protecting their citizens from tortious harm caused within their boundaries.”

The plaintiffs, Savage said, “are actually asking that Pennsylvania law be applied to only a part of the liability equation. However, the issue of liability cannot be determined piecemeal. It must be decided by taking into consideration all parts of the question, including defenses.”

Plaintiffs’ lawyers argued that because the proposed common questions are so narrow, the differences in the state laws are “inconsequential.”

But Savage found that “the variances in the laws of the various jurisdictions are hardly inconsequential.”

Some states, Savage noted, apply a strict liability standard to prescription drug manufacturers for failure to warn of known or reasonably scientifically knowable risks; but others, recognize negligence as the only basis of recovery.

Differences in affirmative defenses also exist, Savage noted, with some states holding that assumption of the risk is a complete defense to a products liability claim, while others call for a comparative fault analysis and yet others use a “pure comparative fault” approach.

GSK was represented by attorneys Chilton Davis Varner, Todd P. Davis and Sarah T. Sloan of King & Spalding’s Atlanta office, along with Joseph T. Hetrick and Joshua G. Schiller of Dechert’s Philadelphia office.

(Copies of the 32-page opinion in Blain v. SmithKline Beecham Corp. , PICS No. 07-0133, are available from The Legal Intelligencer . Please call the Pennsylvania Instant Case Service at 800-276-PICS to order or for information. Some cases are not available until 1 p.m.)

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