Can you recall what you were doing back in March of this year? To be more precise the day before St. Patty’s Day and the day after the Ides. No? Well, apparently the defendants in the Risperdal and Invega Products Liability Cases pending in California state court were celebrating but they forgot to invite us to the party. We just learned about the very nice preemption decision entered by the trial court in that litigation. Since it’s never too late to celebrate a preemption victory, here are the highlights.

Before we get into the case specifics, the court’s general preemption analysis merits a minute of our time. ‘[I]f the tort plaintiff’s failure to warn theory was already tested by FDA action or inaction or would have required the use of a label on a prescription drug which the FDA would have prohibited,” the claim is preempted. Risperdal and Invega Product Liability Cases, 2017 WL 4100102 at *5 (Cal. Super. Mar. 16, 2017). What remains for private plaintiffs to challenge in a tort setting, therefore, is the adequacy of the label or the reasonableness of the manufacturer in updating the label based on new or additional information not already considered by the FDA. Id.

 In discussing whether information was presented to the FDA for consideration, of course, fraud-on-the-FDA and Buckman enter the discussion. The court nicely summarized the public policy reasons supporting Buckman preemption:

The understandable concern is that allowing a private right of action for “fraud on the FDA” would embroil the agency’s staff, particularly its scientific staff, in court litigation to the derogation of their performance of their primary duties. This would result both from the consumption of time in litigation activity and from a concern that their routine duties, decision-making processes and public communications would all have to be vetted with litigation avoidance in mind.

Id. at *6.

Next the court establishes that the Wyeth v. Levine “clear evidence” standard does not require indisputable evidence, but rather defendants must establish impossibility preemption by “clear and convincing evidence.” Id. And finally, the court found that preemption is a question of law, not fact and therefore an issue for the court, not the jury. To the extent deciding preemption requires the court to rule on a factual dispute regarding what the FDA would do, “the dispute is one regarding a legislative fact, not an adjudicative fact. Thus it presents a legal question for judicial resolution.” Id. at *7.

With that as background, we turn to the specific facts of the case. Risperdal is an anti-psychotic medication. Id. at *1. The Risperdal label that plaintiffs claim is inadequate was modified in 2006 to include language about prolactin elevation and the reported rate of gynecomastia (enlargement of male breasts) among Risperdal users. Id. at *3. Plaintiffs allege that defendants failed to adequately warn of this risk because the labeling did not include the “true” rate of gynecomastia and should have included an instruction to physicians to monitor blood prolactin levels. Id. at *1. Defendants moved for summary judgment on preemption grounds in 5 cases involving plaintiffs from 4 different states. Id.

With respect to the rate of gynecomastia set forth in the label, the FDA specifically approved the pooling of data from 18 studies to arrive at the rate that was used in the labeling. Id. The FDA re-examined the label in 2007-2008 and concluded that it required no labeling changes regarding gynecomastia or prolactin elevations. Id. Plaintiffs argue that the pooled average was lower and that defendants should have disclosed the higher incident rates observed in 2 of the 18 studies. Id. at *8. Because those 2 studies were among those considered by the FDA during the approval process, “the FDA’s position is clear [as to] how information regarding the 18 studies should be described in the label.” Id. This portion of plaintiffs’ claim is therefore preempted.

As to plaintiffs’ allegation that defendants failed to adequately warn about monitoring prolactin levels, plaintiffs rely on “Table 21.” This is a table containing an analysis of 5 studies purportedly showing a statistically significant association between elevated prolactin levels and gynecomastia. Id. The table was in a draft of a journal article but not in the final publication and therefore not submitted to the FDA during the approval process. The studies reviewed in the table, however, were among those considered by the FDA. Id.

 Plaintiffs argued that based on the information in the table, defendants should have independently changed their label under the Changes Being Effected (“CBE”) regulations. However, to implement a CBE label change without prior FDA approval, the change must be based on “newly acquired information” which is defined as

data, analyses, or other information not previously submitted to the agency, which may include (but are not limited to) data derived from new clinical studies, reports of adverse events, or new analyses of previously submitted data (e.g., meta-analyses) if the studies, events or analyses reveal risks of a different type or greater severity or frequency than previously included in submissions to FDA.

Id. at *9. Table 21 doesn’t fit that definition. It may be a different analysis of the data, but it did not show a different type or greater severity or frequency of the risk of gynecomastia which is the focus of the CBE regulation. To the extent plaintiffs also tried to rely on their litigation experts’ analysis of the data, the court point out that that was a tactic tried and rejected in several other litigations as a means of avoiding preemption. Id. So, plaintiffs’ claims are also preempted because the data they rely on to suggest defendants could have changed the label is not newly acquired and could not serve as the basis for an independent label change.

Not only could defendants not have changed the label on their own, the court found clear evidence that the FDA also wouldn’t have approved it.  In 2012, one plaintiffs’ counsel submitted a Citizen’s Petition to the FDA alleging that the Risperdal label did not adequately address elevated prolactin levels, the need to monitor for elevated prolactin levels, or the rates of gynecomastia. Id. at *4. Essentially the same allegations raised in the litigation. In its response denying the petition, the FDA stated that it was commonly known that Risperdal increases prolactin and that gynecomastia is one of the manifestations of increased prolactin. Id. at *5. Based on that the court concluded:

This Court is persuaded that these reasons articulated by the FDA in response to the very claims alleged here provide the kind of “clear evidence” of “legislative fact” which the U.S. Supreme Court requires before a court can hold that impossibility preemption applies. By any standard, there is “clear evidence” that Plaintiffs’ entire theory of label inadequacy focused on prolactin levels was not only considered and rejected by the FDA but also rests on information (and allegations) known to the FDA and the medical community. The FDA’s review of the 18 clinical studies—which form the underlying data of any theory that Plaintiffs posit—both pre-approval and in subsequent reviews, and its subsequent inaction, seem to be the definite upshot of a conscious FDA choice on information before the agency. It is not this Court’s job to revisit a decision made by the FDA.

Id. at *11.

It may not be the court’s job to revisit FDA decisions, but it is certainly this blog’s job to visit strong preemption decisions like this one. So, just a reminder that if you get a good decision – forward it along. Don’t make us wait 6 months to join the party.

The trial judge in the second Risperdal trial denied plaintiff’s post-trial motion for a new trial, upholding the jury’s determination that plaintiffs hadn’t proven that Risperdal caused plaintiffs’ gynecomastia (male breast growth).  Cirba v. Janssen Pharmaceuticals, Inc., 2015 WL 4081909 (Pa. Ct. Comm. Pl. June 30, 2015).  Given the court’s summary of plaintiff’s weight and history of Risperdal use, the jury’s verdict seems pretty darn reasonable:

There was clear evidence that [plaintiff] had gained significant weight after he stopped taking the drug in 2007.  He is presently 6’1” and 272 pounds.  Since Defendant is clearly overweight, had not consumed Risperdal since 2007, had never complained of gynecomastia until 2013, and there were no photos prior to puberty to support his causation claim, the jury came to the reasonable conclusion that Risperdal did not cause his present condition.

Id. at 2.

Nonetheless, plaintiff tried to get the verdict overturned in several ways.

He argued that the court should have disallowed causation testimony by his nurse practitioner, who had prescribed him Risperdal and treated him for almost eight years, including a six-year period leading up to his first complaint of gynecomastia during which he took no Risperdal.  She testified that weight gain, not Risperdal, caused the growth in his chest.

Continue Reading Court of Common Pleas Leaves Standing Janssen’s Victory in Second Risperdal Trial

This just in:  The Louisiana Supreme Court has reversed the $300 million+ state Medicare verdict in Caldwell v. Janssen Pharmaceutica, Inc., Nos. 2012-C-2447, -2466, slip op. (La. Jan. 28, 2014).  The State Attorney General failed to prove any case under three different statutes – therefore judgment as a matter of law is appropriate.  There could be no false claims without proof that the defendant did something wrong:

Having determined the legislature’s intended scope of [the Louisiana anti-fraud statute], we find the Attorney General failed to establish sufficient facts to prove a cause of action. . . .  There was insufficient evidence adduced that any defendant engaged in fraud, misrepresentation, abuse or other ill practices seeking to obtain, pursuant to a claim made against the medical assistance program funds, payments to health care providers or other persons to which the health care providers or other persons were not entitled.  Because we find the Attorney General failed to prove a violation . . ., we pretermit discussion of the remaining evidentiary and penalty issues.  We hereby reverse the district court’s judgment in favor of the Attorney General, and render judgment in favor of the defendants.

Caldwell, slip op. 21-22.  More later after we’ve had time to digest this.

Philadelphia has seen more than its share of perplexing decisions. This is where the Founders gave Delaware the same number of Senators as New York. The great painter Thomas Eakins scandalized his high-strung, high society patrons by permitting female students to paint male nude models. Bad career move. Fregosi let Mitch Williams pitch to Joe Carter. Another bad career move. Somebody here thought of pouring cheez-wiz over low-grade, high-grease meat. Oddly, a good career move. And as for John Oates’s porn stache — well, the less said the better. And, yes, there have been some judicial decisions that made us scratch our cyber noggins.

But sometimes courts here get it right. That happened a couple of weeks ago in the Commonwealth’s case against Janssen over Risperdal. The court issued a nonsuit that was a model of clear thinking. The written opinion came out on Friday, and it was well worth the wait. Commonwealth v. Ortho-McNeil-Janssen Pharmaceuticals, Inc., No. 2181 (Phila. Ct. Comm. Pleas June 25, 2010).

Speaking of perplexing decisions, let’s depress ourselves for a moment by remembering how the Commonwealth decided to bring cases against manufacturers of atypical antipsychotics. (We’ve blogged about that case a number of times, including here.) A Texas plaintiff firm shopped the representation to the Pennsylvania Attorney General, who politely declined. (Chalk that up to prescience). Then the Governor’s office, in an unusual move, took over the case and hired the Texas firm. It was a no-bid, contingent contract. Did we mention that the Texas firm had made significant campaign contributions to the Governor? The propriety of this smelly deal is in front of the Pennsylvania Supreme Court, and we’re keeping our fingers crossed that the Justices will put an end to these shenanigans, which reek of conflicts of interest and pay-to-play politics. (Disclosure: Bexis wrote much of the WLF amicus brief on this issue, so it’s not as if we’re disinterested.)

Continue Reading A Typically Splendid Philadelphia Decision