Canadian Court Rejects Pharmaceutical Class Action

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.
 

Federal Court Reverses Self On Drug Preemption

Judge David F. Hamilton of the U.S. District Court for the Southern District of Indiana has reversed a prior decision and reinstated a Paxil suicide case that had been dismissed – properly in the view of MassTortDefense --  on preemption grounds last year. See Tucker v. SmithKline Beecham Corp./d/b/a Glaxosmithkline, No. 04-1748, (S.D. Ind. 7/18/08). See opinion here.  In granting plaintiff’s motion for reconsideration, the court violated the rule “if it ain’t broke, don’t fix it.”

Plaintiff Debra Tucker sued GSK on behalf of her brother, Rick Tucker, alleging that her brother committed suicide in September 2002 as a result of taking Paxil for three weeks. The claim was that GSK breached a duty to warn of an alleged increased suicide risk among Paxil patients. (MassTortDefense notes that the scientific evidence actually does not establish that paroxetine (the active ingredient in Paxil) causes suicide, suicide attempts, self-harm or suicidal thinking. On the basis of research in tens of thousands of patients taking antidepressants, including Paxil, there is no significantly increased risk of suicidal thinking or behavior in people age 24 and older and, in fact, in patients older than 65, there was a reduction in risk in suicidal thoughts and behavior.)

The defendant sought summary judgment on preemption grounds. The court correctly determined in September, 2007, that her claims conflicted with the FDA's labeling requirements for Paxil. The court said it believed the record showed that the FDA had rejected the hypothesis that there is a causal link between Paxil and suicide.

In granting the plaintiff's motion for reconsideration, the court said it had "failed to appreciate the fact that the ongoing ability, authority, and responsibility to strengthen a label still rest squarely with the drug manufacturer." In its new decision, the court first noted that under 21 C.F.R. §201.80, a manufacturer must revise labeling "to include a warning as soon as there is reasonable evidence of an association of a serious hazard with a drug; a causal relationship need not have been proved." Under 21 C.F.R. §314.70(c), a manufacturer may unilaterally add or strengthen a contraindication, warning, precaution or adverse reaction upon submission of a "changes being effected" [CBE] supplement. The court now thinks that the FDA's power to disapprove a label "does not make the manufacturer's voluntarily strengthened label a violation of federal law, which is what it would take to establish an actual conflict between state tort law and federal law.”  If the agency disapproves the revised label, the manufacturer simply stops distribution; there is no retroactive illegality.

The court’s new order rejected the FDA’s position that such failure to warn claims are preempted, calling the agency's position on preemption an "180-degree reversal" of its earlier stance. On reconsideration, the court thus gave "relatively little weight to the FDA's opinion on the preemptive effects of its regulations." In 2006, the FDA amended its regulations governing prescription drug labeling, clarifying the preemption of certain warning claims. The court adopted plaintiff’s argument that the 2006 Preamble was promulgated without notice-and-comment.

GSK argued that drug manufacturers will be forced to place scientifically unsubstantiated warnings on their drug products unless state law tort claims are preempted. But the causation requirements on plaintiffs will guard against this risk, the court said. In fact, thought the court, failure to warn litigation can reinforce the FDA's regulations, which already place the obligation to strengthen the warnings on a drug's label “squarely on the shoulders of the drug's manufacturer."  GSK's possible future risk of prosecution for distributing a misbranded drug would present a conflict only if GSK could say with absolute certainty that it will never have new evidence sufficient to trigger its regulatory obligations to revise its label to strengthen a warning with Paxil-specific language, but is forced to do so by state tort law, stated the new opinion.

Here’s why the new opinion got it wrong.
Regarding CBE, proposed changes in labeling typically are first submitted to the FDA for
approval. 21 C.F.R. § 314.70(a)-(d). A limited exception is with the use of a changes being effected supplement. 21 C.F.R. § 314.70(c). When a new safety issue emerges with a product, the pharmaceutical company may temporarily add to the product's labeling under this rule, which describes "changes that may be made before FDA approval." 21 C.F.R. § 314.70(c). Nonetheless, the FDA must still be notified and will subsequently review the modified labeling to ensure compliance with FDA regulations. In 1982, when the CBE procedure was proposed, the FDA stated, "these supplements would describe changes placed into effect to correct concerns about newly discovered risks from the use of the drug." 73 Fed. Reg. 2849 (Jan. 16, 2008) (quoting 47 Fed. Reg. 46622, 46623 (Oct. 19, 1982)). FDA’s longstanding position is that a CBE supplement “is appropriate to amend the labeling for an approved product only to reflect newly acquired information . . . to add or strengthen a contraindication, warning, precaution, or adverse reaction only if there is sufficient evidence of a causal association." 73 Fed. Reg. 2848 (Jan. 16, 2008). The FDA explicitly defines "newly acquired" as "data, analyses, or other information not previously submitted to the agency." Id. at 2850.

The holding of the court that any label change adding or strengthening warnings could always be made unilaterally, without FDA pre-approval, would lead to absurd and unreasonable results. If manufacturers were free to make unilateral changes to labeling the day after FDA’s approval based on information that was previously available to the agency, the approval process would be greatly undermined and the agency’s careful balancing of risks and benefits thwarted. And plaintiff’s proposed reading of the rule would require manufacturers to make the same CBE change over and over again – despite FDA rejection of the change – in order to avoid liability, because a jury would be free to say – despite the FDA decision – that the manufacturer was free to make the change anyway. It just doesn’t make any sense for the CBE process to permit (and thus obligate, under plaintiffs’ view), a manufacturer to ignore an FDA-mandated label by unilaterally changing the warning to something else. Plaintiffs' construction of the current CBE regulation would permit (and thus obligate) manufacturers to repeat such changes again and again, each time the FDA rejects the proposed change – all without any new scientific evidence to warrant any change at all. Plaintiffs could argue that the “weight” or “accumulation” of evidence required a label change, even as the FDA has rejected changes based on each individual “new” evidence. The only way to prevent the CBE exception from becoming a vehicle for ignoring FDA labeling decisions is to limit it to new information. Any changes to a drug’s labeling without prior FDA approval must be based on new information establishing that risks arising from use of the drug are of a different type or greater severity than the risks of which FDA had previously been made aware – not cumulative new information that does not add to the information that was previously available to the agency.

Second, since this part of the argument is about interpretation of the scope of the FDA’s own CBE regulation, government views concerning that regulation are entitled to substantial deference, not the little weight given. Judicial deference to administrative positions on preemption, typically expressed in amicus briefs, has more or less been the rule, rather than the exception.

Third, regarding the supposed “reinforcing” aspect of tort claims, the new decision in this case would allow a jury to determine whether an FDA-approved label adequately informs physicians about a medication's risks and benefits, as the label generally has to be found to be inadequate before the manufacturer can be held liable. This could result in a patchwork of labels/warning information that vary from state to state for no good reason – the science in Maine is the same in California, even if the juries are not. And this would place doctors and patients in an untenable position. Indeed, state common-law tort actions based on the manufacturers’ failure to warn present the pharmaceutical manufacturers with particular difficulties. State standards of care undoubtedly would differ from state to state. Absent a determination that the FDA-approved labeling and the FDA’s refusal to require the warnings suggested by plaintiffs in this case preempt state tort actions, the manufacturers may be subjected to considerable liability based on varying standards, with no benchmark that they should follow.

The FDA, rather than a jury, has the responsibility to determine whether the labels on medicines offered in the U.S. are appropriate. The FDA has actively monitored the possible association between SSRIs and suicide for nearly twenty years, and has concluded that the suicide warnings desired by plaintiffs are without sufficient scientific basis and would therefore be false and misleading. This claim of supposed harmony or reinforcement by tort law is belied by what the plaintiffs always ask for:  that state courts provide a check on agency power; that state juries be allowed to make their own judgment on whether the label was adequate; and that FDA approval of a label, or rejection of an alternate label, doesn’t mean anything to the company’s potential liability.

Finally, regarding misbranding, a pharmaceutical company that independently institutes a change in labeling may be subject to penalty or seizure if the drug is deemed misbranded by the FDA. See 21 U.S.C. § 333 (authorizing penalties); 21 U.S.C. § 334 (authorizing seizure); 21 C.F.R. § 7.45(a) (providing authority to request recall). And it has never been required, for a conflict to exist, to show how many times the federal law was applied, or how significant the sanctions were. That the federal agency has the legal power to enforce the federal rule is, and ought to be, sufficient.

In its next term, the U.S. Supreme Court will take up a preemption question in Wyeth v. Levine, and we may see if the court got it right the first time or the second time.