1. It is a commonplace that a defendant cannot move to dismiss based on the statute of limitations. The Kester court rightly observed that such a motion is permissible if the complaint’s untimeliness is apparent from the facts alleged in the complaint. Id. at *43 n.11. Plaintiff’s complaint was facially time barred because she filed the complaint more than two years after the date alleged in the complaint that she received the pain pump. Id. at *44. Plaintiff argued that the discovery rule saved her from dismissal and that it was “nonsensical” to think she would have known immediately upon receiving the pain pump what caused her injuries. But she had the burden under Pennsylvania law to prove the diligence required by the discovery rule, the court said, and therefore her complaint had to allege facts showing such diligence. Id. at *45-47. Without those allegations, her complaint was time barred on its face and would be dismissed. Id.

2. The court joined many other pain pump decisions and held that the complaint had to identify which of the many named defendants actually made the product that allegedly caused plaintiff’s injury. Id. at *17-24. The court rejected her argument that Rule 8(d), which allows pleading in the alternative, authorizes her to sue several potentially responsible defendants until she figured out which one made the product. Id. at *19-221. The court also rejected the plea we have heard time and again from plaintiffs – “Your Honor, even if my complaint is inadequate, just let me take some discovery and I will find facts to support my claim.” The court said she had to plead a valid claim before taking discovery. Id. at *22-23. And because she could not identify who actually made the products given to her, plaintiff also could not say who made which misrepresentations to whom. and her fraud-based claims were dismissed for failure to satisfy Rule 9(b). Id. at *40-41.

3. Plaintiff’s breach of implied warranty and strict liability claims were dismissed because Pennsylvania law does not recognize those claims for prescription drugs and medical devices. Id. at *25-27, 32-33.

4. The learned intermediary doctrine barred plaintiff’s claim under Pennsylvania’s Unfair Trade Practices and Consumer Protection Law. “[A] private right of action under the UTPCPL requires proof of justifiable reliance and causation, and such requirements cannot be present when the defendant is a pharmaceutical company that did not sell its product directly to the patient.” Id. at *42-43 (citation omitted).

The court gave plaintiff leave to amend, and we’ll see if she can fix these deficiencies. No matter what happens, the decision has given defendants a few more arrows in our quivers.

druganddevicelaw.blogspot.com

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here is a link to the Superior Court’s April 26, 2010 Opinion in favor of the defense in the case of Gormley v. Edgar.

The issue presented was whether the Philadelphia County Court of Common Pleas correctly ruled that the defense should be entitled to discovery of a pre-accident mental health consultation medical record pertaining to a plaintiff who had pled emotional distress claims in a civil litigation matter.

The Plaintiff argued that they were only pleading ordinary emotional distress claims attendant with a personal injury action.

The defense argued that, once the Plaintiff put her mental health condition in issue in the case with claims of severe, disabling and indefinitely continuing mental distress, anguish and anxiety, the discovery of the pre-accident record should be allowed.

The Superior Court panel, consisting of Judge Gantman, Judge Bowes, and Senior Judge Kelly ruled that, where the Plaintiff made allegations in the Complaint that she sustained “anxiety” as a result of an accident, which is a recognized mental health disorder, the Plaintiff put her mental health status at issue. As such, the Superior Court found that the trial court properly ruled that the defense was entitled to discovery of medical records pertaining to the Plaintiff’s pre-accident mental health treatment records.

In the Opinion, the Superior Court did note that general averments of shock, mental anguish and humiliation, which are routinely recoverable damages for non-economic loss in Pennsylvania, are not sufficient to place a Plaintiff’s mental condition at issue or cause a waiver any privilege against the production of mental health records.

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In a pair of newer summary judgment decisions, Judge Weinstein considered these types of issues on an individual basis. These show how incredibly weak plaintiffs’ claims can be in the Zyprexa litigation. Both plaintiffs claimed that the company had failed to warn that the drug could cause weight gain and diabetes. Both cases were thrown out on summary judgment. And it wasn’t even close.

In both decisions — 2009 U.S. Dist. Lexis 117777 (E.D.N.Y. Dec. 10, 2009) and 2009 U.S. Dist. Lexis 117778 (E.D.N.Y. Dec. 10, 2009) – Judge Weinstein begins (as usual) by furnishing his stock summary of the course of the Zyprexa litigation. That summary highlights many of the problems inherent in mass tort MDLs, such as:
complexity and expensemassive, asymmetrical discovery “quasi-class actions” opportunistic, parasitic actionsample, one-sided press coveragesettlements that don’t end the case but, rather, invite endless dumping of new cases into the MDLetc. (And there’s a lot in that “etc.”)
The opinions then recite some common facts, such as:the original 1996 Zyprexa label listed the relevant adverse events; in 2003 the FDA announced that it would require a hyperglycemia and diabetes warning; the American Diabetes Association and other groups in 2003 held a conference and issued a consensus statement on antipsychotic and weight gain and diabetes; and a Dear Doctor Letter went out in March 2004.The court once again concluded that March 2004 is the latest possible date that doctors are deemed to be aware of the risks. Depending on the facts, such as diabetes diagnosis and particular knowledge, the date could be sooner, and the statute of limitations clock starts ticking that much sooner.

Then we get to the facts of the particular cases, and they are truly pathetic (as in weak, not as in evoking sympathy).Plaintiff Gove (2009 U.S. Dist. Lexis 117777) had bipolar disorder and had attempted suicide multiple times. She started taking Zyprexa in 1998. She tolerated it, but was concerned about weight gain. (Red flag.) She stopped taking any antipsychotics at allfor a couple of years, but went back on Zyprexa in 2002 after another suicide attempt. To put it in plain terms, Zyprexa worked for her. Gove’s treater certainly thought so. Gove had been obese for a long time, so it couldn’t have been too surprising when she was diagnosed with diabetes in 2002. (Redder flag.) The treater was aware of the association between Zyprexa and diabetes, but kept prescribing it because the benefits were worth the risks. In March 2003 the treater discussed with Gove the potential for Zyprexa to elevate blood glucose. But she didn’t want to switch to another agent. (Where are we now on the color spectrum? Crimson? Fuchsia?) In May 2004 Zyprexa started working less well (it happens) and Gove was taken off of Zyprexa because of concerns regarding — wait (weight?) for it — weight gain and diabetes. In short, the treater was actively engaged in making well-informed risk-benefit decisions.

Judge Weinstein had several independent bases for issuing summary judgment against this plaintiff. First, by August 2003 at the latest, Gove knew that Zyprexa might have played a role regarding her diabetes. Since she didn’t file her case until well after the limitations period ran, she was outof luck (and out of court). Second, plaintiff couldn’t show that different (stronger, clearer, faster, higher, etc) warnings would have made any difference. The treater had been deposed and said that different warnings would not have affected the prescription decision. Third, the learned intermediary doctrine is alive and well in Arizona (which supplied the substantive law) and the treater in this case was pretty darned learned on the potential risks of Zyprexa. So much for the Gove case.

If anything, the other case was even weaker. Plaintiff Broderick (2009 U.S. Dist. Lexis 117778) had a history of obesity, hyperlipidemia, heart disease, depression, schizoaffective disorder, and multiple suicide attempts. She began taking Zyprexa in December 1999. Plaintiff’s expert witness submitted a report indicating that Broderick’s diabetes post-dated her Zyprexa use, but Judge Weinstein actually read the medical records and found that Broderick had been diagnosed with diabetes in 1998 and was taking insulin in June of 1999. (Aaah, plaintiff experts – it’s so refreshing when they play true to form!) Just as with Gove, the treaters were well-informed. Just as in Gove, the treaters thought that Zyprexa worked well for the patient and that the benefits were worth the risks. And, just as in Gove, Judge Weinstein had no difficulty concluding that the statute of limitations had run and that the learned intermediary doctrine (this time under California law) ended the case. There was also a causation dimension to Broderick, but now it involved medical injuries. Unless plaintiff’s expert was also going to discuss the possible role of a time-machine (don’t laugh, could happen with some of those experts), it was not possible for a jury to conclude that Zyprexa caused a case of diabetes that was diagnosed before the plaintiff ever took the drug. Nor was there any evidence that Zyprexa had exacerbated the condition.

And there you have it. A couple of nice, well-reasoned summary judgment opinions. Reassuring, isn’t it?

Well … not entirely. Because this pair of frail cases is just the tip of the iceberg. For anybody who labors in the fields of mass tort, it is not at all unusual for plaintiff lawyers to cobble together inventories of thousands of cases, many of which involve plaintiffs:

who never used the drug or devicewhose usage was so de minimus as to preclude any rational finding of causationwho are not injured at allwho had the injury before they ever used the drug or devicewho knew or should have known of the bases of their claims so long ago that every statute of limitations in the country has runwhose treaters were learned intermediaries making a conscious risk-benefit decision, and such decision would be unaffected by whatever purple prose the plaintiff thinks should have been crayoned into the warningswho are homicidal, prone to serial child-molesting, or already in jail. (You probably think we just threw that in to see if you were really following along. But no, that’s something we’ve actually seen in MDLs.)
Anybody who works on drug and device litigation – the extra-strength MDL versions – knows that (often well) over 90% of the cases filed would never be filed as individual actions. Plaintiff lawyers exploit the overwhelming numbers of cases in MDLs knowing that the forest hides the (Charlie Brown Christmas) trees: that it’s just too hard to discover the gnarly facts of all the casesDefendant-companies know it too, and that makes settlement considerations rather difficult to swallow. It’s hard to justify paying for cases when most are pure bilge.Even though some courts don’t believe it, it really, really makes sense to devise methods for testing the cases and making sure that the specious cases get tossed aside. If plaintiff lawyers won’t do it (and one would think that things like Rule 11 would concentrate one’s mind on such things, but alas …) then judges need to employ mechanisms such as LonePine orders (how about aLone Pine-type procedure for the statute of limitations?)or bundling, or pilot discovery programs to ensure that cases like Gove and Broderick are teed up for dismissal sooner rather than later.
In the end, we like these December 10, 2009 decisions. We just wish they could have come a couple of years earlier, and without all the need to waste discovery resources on cases that never should have been filed in the first place.

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