British regulators warned June 10, 2003 that the use of the popular antidepressant Paxil could increase the risk of suicide up to 3 times in children and adolescents under 18. The British drug regulators warned that children should not be prescribed Paxil from now on due to recent findings. GlaxoSmithKline, Paxil’s maker, announced the company would not warn U.S. doctors of the link between Paxil children and higher risk of suicide.

Each has experienced similar withdrawal reactions and problems such as:

On January 10, 2003, U.S. District Court Judge, Mariana Pfaelzer, denied Plaintiffs' motion for class certification of the proposed nationwide class of Paxil withdrawal victims, but gave Plaintiffs permission to resubmit their motion for class certification. The Court's primary concern appeared to be the viability of a multi-state class and the varying laws in the different states. Judge Pfaelzer stated, however, that: "With this many putative plaintiffs, Plaintiffs should have no problem forming classes in other jurisdictions that are large enough to justify the litigation expenses in other jurisdictions."

On March 24, 2003, Plaintiffs filed their new motion for class certification which seeks to enjoin Paxil's maker (SmithKline Beecham, dba Glaxo SmithKline, "GSK") from making false and misleading statements in its promotional and advertising materials and activities regarding Paxil in relation to withdrawal and dependence. This second motion also seeks certification of a California statewide class to determine, on a class-wide basis, the issue of whether Paxil causes dependence/withdrawal symptoms (also known as "general causation").

Baum Hedlund has, in conjunction with co-counsel, filed, and are continuing to file, state class actions related to Paxil withdrawal/dependency in a number of states throughout the United States.

PAXIL CLASS ACTION PLAINTIFFS FILE NEW MOTION FOR CLASS CERTIFICATION

On March 24, 2003, the class action Plaintiffs filed a new class certification motion seeking to enjoin Paxil’s maker, SmithKline Beecham (dba Glaxo SmithKline, “GSK”) from stating that: 1) Paxil is “non-habit forming;” 2) that it causes only mild, usually temporary or transient, side effects; 3) that it has been studied both in short-term and long-term use and is not associated with dependence or addiction;” 4) that Paxil “discontinuation symptoms” or discontinuation syndrome” are identical to or similar to other SSRIs (or antidepressants, or other psychotropic drugs); 5) that Paxil is not addictive and does not cause dependence (because this has never been studied); 6) that “discontinuation symptoms” or “discontinuation syndrome” are/is not withdrawal; 7) that Paxil withdrawal or “discontinuation symptoms” are infrequent; and 8) characterizing Paxil withdrawal symptoms or “discontinuation” symptoms as “relapse.”

The class action Plaintiffs continue to allege that the public’s (and medical community’s), lack of awareness of Paxil withdrawal is due, in large part, to GSK’s efforts to counter the available data regarding Paxil withdrawal with marketing messages designed to downplay the problem. These claims are based on California’s consumer protection statute, which is considered the most powerful consumer protection statute in the country. While these claims are brought on behalf of a California statewide class pursuant to this statute, they are designed to address GSK’s misleading marketing campaign. Certification of this class would allow the court to decide these claims for the entire class, rather than over and over again on an individual basis. In the motion, the Plaintiffs assert that these claims can be most efficiently and fairly resolved through a certified class action.

This second motion also seeks certification of a California statewide class to determine, on a class-wide basis, the issue of whether Paxil causes dependence/withdrawal symptoms (also known as “general causation”). What this means is that, if granted, Plaintiffs will be able to present evidence to one jury concerning Paxil’s propensity to induce withdrawal/dependence in the general population on behalf of all Californians (rather than on a case by case basis). By certifying this particular issue, individual plaintiffs can avoid the costs associated with the case work-up involving: (1) expert witness testimony; (2) scientific literature and studies; (3) clinical trial data; (4) foreign labels; (5) GSK’s internal documents; and (6) Paxil’s post approval adverse event reports. Plaintiffs have asserted that deciding this issue on a class-wide basis is the most fair and efficient way to litigate this issue.

GSK’s Opposition is due April 23, 2003. Plaintiffs’ reply to GSK’s opposition is due May 23, 2003. The Court will have a hearing on June 23, 2003, and will issue an order sometime thereafter.

As part of the January order denying certification (but allowing Plaintiffs to re-file), Judge Pfaelzer stated: “With this many putative plaintiffs, Plaintiffs should have no problem forming classes in other jurisdictions that are large enough to justify the litigation expenses in other jurisdictions.” Baum Hedlund has, in conjunction with co-counsel, filed, and are continuing to file, state class actions related to Paxil withdrawal/dependency in a number of states throughout the United States. Currently, there are cases filed in Connecticut, Florida, Louisiana, Maryland, Massachusetts, New Mexico, New York, Ohio, Texas and Wisconsin.

Baum, Hedlund and its co-counsel are committed to doing all they can through whatever procedural tools the legal system permits to achieve the fairest and most efficient adjudication of the claims of the thousands of individuals who have suffered from Paxil withdrawal.

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In the summer of 2002, the class action Plaintiffs in California sought to preliminarily enjoin GSK from stating in its advertising and marketing materials that 1) Paxil "is non-habit forming," 2) Paxil "may cause mild, usually temporary, side effects in some individuals," and 3) "Paxil has been studied both in short-term and long-term use and is not associated with dependence or addiction." Prior to the hearing on Plaintiffs' preliminary injunction motion, GSK agreed that it would no longer distribute the promotional brochures that contained statements 2 and 3 above. The only issue remaining, therefore, was GSK's television advertisements which claimed that Paxil is "non-habit forming."