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.

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In Daughtery v. I-Flow, Inc., et al., 2010 WL 2034835 (N.D. Texas April 29, 2010), the plaintiff brought an action on behalf of a class of folks allegedly injured by pain pumps that deliver post-surgery anesthetic. The action was brought against pretty much every manufacturer under the sun that made the pumps or anesthetics. Once again, the plaintiff did not allege which particular pump and which particular anesthetic were used on him. Maybe this is a bit of collective conscience — all pain pump plaintiff lawyers seem to have decided that ignorance is bliss, or lassitude is a-okay, or that dreaded market-share liability will enter the fray. We imagine the plaintiff lawyers would tell us that that they don’t know the specifics and that’s what litigation is for. (Yes, we imagine them ending a sentence with a preposition — the sort of bad grammar up with which we will not put.) But why can’t the lawyers ask a few questions of the hospital or doctor before pecking away at their word processors and hailing people into court? Are they dazed and confused? In the case we wrote about last week, the plaintiff served interrogatories on the defendant, and that seemed to prevent the court from granting the motion to dismiss. But how is the manufacturer supposed to know the answer to the question about which particular products the hospital used for a particular patient? Does the defendant have to turn around and ask the hospital? Since when is the defendant obligated to discharge the plaintiff lawyer’s Rule 11 duty?

Well, the Texas court wasn’t standing for this nonsense. Or, to be more precise, it employed the standing doctrine to put an end to this nonsense. The many, many defendants filed many, many motions, both for a more definite statement, and to dismiss on many different grounds. But standing is a threshold doctrine, and the judge rather elegantly got rid of the whole mess by holding that the plaintiff hadn’t alleged a connection between his injury and “any particular defendant(s),” that the plaintiff failed to identify “which of the defendants manufactured the pain pump or the anesthetic(s) that were administered to him,” and that, therefore, he had not “pled facts sufficient to establish that he has Articled III standing to pursue a direct claim against any of the defendants for his own personal injury.” Goodbye individual action, and goodbye class action.

Again, we don’t know if there is a zeitgeist or collective judicial conscience, but we think it would be mighty fine if other courts picked up on the Daughtery court’s efficient way of disposing of lazy pleading. TwIqbal doesn’t show up at all in this very short opinion, but the sense and effect of the standing requirement in this case is so similar to TwIqbal that we’re adding it to our TwIqbalcheatsheet. Whether you think that’s cheating or not, add standing to the armamentarium, right next to TwIqbal, when taking aim at sloppy complaints.

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The reasons for denial are fairly straightforward:

1. The Court had earlier declined the Section 1407 motion. In re: Shoulder Pain Pump-Chondrolysis Products Liability Litigation, 571 F. Supp. 2d 1367, 1368 (J.P.M.L 2008). (The slip opinion we received had a typo in it, stating that “In August 1988″ the earlier MDL motion had been denied. 1988? Wow. That’s when the Dow was under 2000, Greg Oden and Kevin Durant were born, and “Faith” by George Michael was the #1 song. That creeped us out in so many ways.) Two years later there were now 102 cases, as opposed to only 13 in 2008, but every other factor cut against an MDL. We’ll get to those factors, but permit us a brief philosophical interlude. Prior failure is a pretty good predictor of future failure. That’s why prosecutors usually exercise peremptory strikes against jurors who had served on hung juries. Or why the pass rate on the February bar is typically lower. Moreover, sequels are never as good as the original. (Never you mind about Godfather 2.)

2. Just as in 1988 — oops, 2008 — “An indeterminate number of different pain pumps made by different manufacturers are still at issue, as are different anesthetics made by different pharmaceutical companies.” By the way, that fact has led some pain pump plaintiffs to file complaints where they name the entire industry as defendants, rather than do the minimal work necessary to figure out which products were used in that particular case. Some courts let plaintiffs get away with that, and some don’t. We blogged about that here. In any event, most defendants “are named in only a minority of actions.”

3. Most of the defendants opposed centralization. No big surprise there. But get this: several plaintiffs requested exclusion from centralized proceedings, and the plaintiffs were a long way from agreeing on exactly where the MDL should be based. (Note: if you’re going to forum shop, at least get your stories straight.)

4. “[I]ndividual issues of causation and liability to continue to appear to predominate” because the products come in different designs and sizes with different volumes and flows, and plaintiffs “have different medical histories.” (Wait a minute — doesn’t that last point apply in loads of MDLs that the Panel blessed? Are we witnessing a sea-change? Should we get excited? Or are we now starting to act like Cubs fans in the Fall – giddiest just before grotesque disappointment?)

5. Now the constituent actions “are at widely varying procedural stages.” Some were nearly done with discovery. That’s why some plaintiffs asked to exclude their cases. What’s the point of MDL-ing such mush?

Interestingly, in a delightful feel-good sort of way, the Panel notes that despite plaintiffs’ assertion that the data demonstrate that the infusion of anesthetic into the joint space destroys cartilage, “the science is, in fact, not so certain.” That does not bode well for our friends who sit on the side of the courtroom nearer to the jury.

Will we see a round 3? Perhaps plaintiffs will come up with some proposed subclass involving certain manufacturers or cases in a nascent procedural posture. But we’re betting against success. (Think Godfather 3.)

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A recent and infuriating example of that can be found in Jozwiak v. Stryker Corp., et al., 2010 WL 743834 (M.D. Fla. Feb. 26, 2010). Plaintiff sued Stryker, McKinley Medical, Moog, Inc., and Curtin Medical for cartilage injuries allegedly caused by a shoulder pain pump. Plaintiff’s theories included failure to warn, failure to test, and misrepresentation regarding FDA approval for the particular use of the pain pump. Defendants filed motions to dismiss on various theories, but most centered around Plaintiff’s failure to allege “facts plausibly establishing which of the Defendants manufactured the pain pump at issue.” You see, Plaintiff had not identified the specific manufacturer; rather, she simply sued likely suspects.

The court begins its analysis by saying all the right things. It quotes Iqbal quoting Twombly (a twofer!): “Once a court ‘identif[ies] pleadings that, because they are no more than conclusions, are not entitled to the assumption of truth,’ the court must next determine whether the well-pled facts ’state a claim to relief that is plausible on its face.’” Now we’re talking. This is going to be good.

Only it’s not. According to the court, “Plaintiff plausibly establishes that the Defendants owed her a duty to use reasonable care by alleging that ‘each of the [Defendants] designed, manufactured, marketed, distributed, sold, or promoted the pain pump’ that was installed in her shoulder during surgery.” That’s it? Wait, there’s more: “Finding no factual allegations in the Amended Complaint to the contrary, both the Stryker Defendants and the McKinley Defendants are alleged to have owed Plaintiff a duty.” Huh? So general, formulaic, conclusory — and, by the way, impossible in the real world — allegations are plausible unless the plaintiff herself generously pleads implausibility? What is the authority for that remarkable proposition?

Stryker argued that the Amended Complaint “should be dismissed because both they and the McKinley Defendants could not have manufactured the pain pump at issue and they both could not have owed her a duty.” Good point. This reminds us of John Adams’s statement that “facts are stubborn things.” But apparently a court looking to dodge Twombly/Iqbal can be equally stubborn: “The argument is not proper at this stage of the proceedings because it assumes facts not alleged in the Amended Complaint or referenced or incorporated therein.” Groan. This is one of those courts that thinks there’s a right to discovery no matter how stupid, lazy, or impossible the complaint is. For such courts, Twombly/Iqbal is an obstacle to be surmounted, preferably by general, hollow allegations (really conclusions) in the complaint, followed by the court’s muttering of the “plausibly establishes” incantation.

The Jozwiak court supplies further examples of how to ignore or circumvent the Supreme Court’s holding:
“Finally, Plaintiff plausibly establishes that these breaches caused her harm by alleging that the she [sic] has sustained severe and permanent injuries as a result of the Defendants’ manufacture, marketing, advertising, off-label promotion, distribution, and sale of pain pumps and the installation of one [!] such pain pump into her shoulder.” (The bracketed [!] is ours — read it as a guffaw.) “Jozwiak sufficiently pleads that the Defendants manufactured or distributed the pain pump at issue [repeat - impossible] by alleging that ‘[e]ach of the [Defendants] designed, manufactured, marketed, distributed, sold, or promoted the pain pump’ that was installed during her surgery.”
There’s more, but why go on? It’s all the same. Plaintiff got away with precisely what Twombly/Iqbal forbade — mere conclusory allegations that make no sense when viewed through the prism of reality. Here’s a test to see whether a complaint contains factual allegations, as opposed to mere conclusions: how would the allegations fit into a closing argument? If the allegations really are the sort of meaty bits that one would argue to the jury, they probably are factual allegations. But if they merely present a standard from, say, jury instructions, that facts must be read against, then they are mere conclusions. Can you imagine Jozwiak’s lawyer arguing to the jury that his client “sustained severe and permanent injuries as a result of the Defendants’ manufacture, marketing, advertising, off-label promotion, distribution, and sale of pain pumps and the installation of one such pain pump into her shoulder?” Of course not — the jury would witness a parade of juicy, specific facts, maybe even who said or did what when. None of that is in the Jozwiak complaint, what was in it plainly does not satisfy Twombly/Iqbal, and the court simply didn’t care.

It doesn’t have to be that way. Courts more often than not get this issue right. We posted here that there are many examples of courts applying Twombly/Iqbal to dispose of implausible allegations, including allegations regarding product identification.
Further, standing in stark contrast to Jozwiak is Sherman v. Stryker Corp, et al., 2009 WL 2241664 (C.D. Cal. 2009). In Sherman, the plaintiff sued a raft of defendants for cartilage injury allegedly sustained from a shoulder pain pump. Sound familiar? The result won’t. This court also quoted Twombly, and it quoted a passage that was missing from Jozwiak: “The complaint need not contain detailed factual allegations, but it must provide more than ‘a formulaic recitation of the elements of a cause of action.’” The Jozwiak complaint offered only “a formulaic recitation of the elements of a cause of action.” The Sherman court was more faithful to Twombly/Iqbal than the Jozwiak court was. It was therefore considerably more demanding. The Sherman court rejected the plaintiff’s effort to lump together a number of potential defendants: “At most, the complaint alleges that they could have been one of many different brands or medications that might have been administered to Sherman. This is insufficient under Twombly.” Exactly.

The Sherman court drops an interesting footnote, mentioning something that has probably already occurred to many of our readers: Sherman alleged no theory for holding the defendants liable under the dreaded market share liability of Sindell v. Abbot Labs, 26 Cal. 3d 588, cert. denied, 449 U.S. 912 (1980). Wow – that citation takes us back to our first year torts class, where we were treated to a series of batty decisions from California where courts permitted plaintiffs to bring actions when they had no clue who harmed them. But even those cases involved defendants who were sort of on the scene, e.g. Ybarra v. Spangard, 25 Cal. 2d 486 (Cal. 1944)(one of the doctors or nurses in the operating room screwed up), or Summers v. Tice, 33 Cal.2d 80 (Cal. 1948) (it was hard to say which of the negligent hunters fired the injuring shot).

So much for nostalgia. Neither Jozwiak nor Sherman fit into those entertaining paradigms. Or maybe Jozwiak’s lawyers were going to argue that, as in Murder on the Orient Express, all of the suspects acted together to cause the injury. (Should we have posted a spoiler alert? We don’t think so. It’s an old movie. Plus, we love spoilers. Here are more: the Bruce Willis character is dead; the mean, heavy-breathing dude in the black helmet is Luke’s daddy; the people in the hospital are the imaginings of a kid staring at a snow globe; and only Ishmael survives. Oh, and it was a sled.)

No spoiler is as wretched as the Jozwiak decision. It’s hard to say whether it reflects hostility to Twombly/Iqbal, or mere indolence. And we left out something. It turns out that Jozwiak’s counsel sent an email stating that “Plaintiff’s treating physician told Plaintiff’s counsel that he exclusively used Stryker pain pumps.” The court declined to consider that email. After all, this was a Rule 12 motion. After all, there’s always discovery. That of course, is cold comfort for the other defendants who are being sued for no good (i.e., “plausible”) reason.

Twombly/Iqbal were designed to prevent such defendants from being subjected to frivolous litigation. (Whither Rule 11?) The Jozwiak decision seems designed to evade Twombly/Iqbal.

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A couple of weeks ago, a defendant got good news in one of those cases. In Kilpatrick v. Breg,Inc., No. 08-10052-CIV-MOORE/SIMONTON, slip op. (S.D. Fla. June 25, 2009) (link here, courtesy of the Products Liability Prof Blog), Judge K. Michael Moore found that plaintiff’s proffered proof of general causation linking a pain pump to chondrolysis didn’t satisfy Daubert, which doomed the plaintiff’s case.

Kilpatrick operated a charter fishing guide service in the Florida Keys. He underwent arthroscopic shoulder surgery to repair the ring of tissue surrounding the shoulder socket. To control post-operative pain, the surgeon implanted a shoulder pain pump manufactured by Breg.

A couple of years later, Kilpatrick’s shoulder started to hurt again. His physician diagnosed him with glenohumeral chondrolysis — a breakdown of the cartilage in Kilpatrick’s shoulder joint. Kilpatrick ultimately had to undergo a total shoulder replacement.

Kilpatrick filed the customary complaint — a few product liability counts, negligence, and alleged violation of the Florida Deceptive and Unfair Trade Practices Act. Breg filed a motion for summary judgment on the ground that Kilpatrick didn’t demonstrate that its pain pump could cause the type of injury Kilpatrick suffered.

Judge Moore agreed.

Kilpatrick seems to have hired a real doctor as an expert witness: Gary Poehling, M.D., a long-time orthopedic surgeon and professor of orthopedics who had served as editor-in-chief of a leading orthopedics journal. But there wasn’t any science to back up Dr. Poehling’s opinion that a pain pump could cause chondrolysis.

Poehling relied on four published articles to support his general causation opinion.

The Hansen study examined 152 patients who underwent 177 shoulder surgeries. Only 19 shoulders in 17 patients “had bupivacaine-dispensing pain pumps inserted in them.” Slip op. at 9. “Of those, twelve shoulders in ten patients developed chondrolysis.” Id. The Hansen study, however, included no statistical analysis and thus didn’t demonstrate statistical significance or whether it was “statistically meaningful to extrapolate from the relatively small sample size.” Id. Additionally, the study acknowledged that “[t]hermal and/or radiofrequency, suture material, and reabsorbable suture anchors may have played a role not yet completely understood” in causing the chondrolysis. Id. And Neither the Hansen study nor Dr. Poehling could explain “why nearly 40% of patients treated with pain pumps did not develop chondrolysis,” id., leaving “an unexplained 40% error rate in Poehling’s hypothesis.” Id.

So much for the first, and strongest, of the four studies that Poehling relied upon.

The Gomoll study was a controlled study of rabbits. The court noted the many difficulties in animal studies and rejected the Gomoll study as proof of general causaion in humans. Id. at 11.

The Greis report, a case study of two female swimmers, recognized on its face that “the exact cause of the chondrolysis remains unknown.” Id. at 12. Moreover, “anecdotal reports of two individuals are, of course, not statistically significant evidence of causation.” Id.

And Dr. Poehling’s own 228-word editorial said nothing about general causation and in fact acknowledged that “‘idiopathic’ chondrolysis — that is, chondrolysis caused by unknown factors — has also been described in the medical literature.” Id. at 12-13.

Absent scientific evidence of general causaion, the court could have stopped there.

But it didn’t.

It went on to note that Poehling said nothing about the background risk of chondrolysis and conceded that the scientific literature has not reached a conclusion about the cause of chondrolysis. Id. at 13-15. Finally, Dr. Poehling’s differential diagnosis, ruling out other causes of Kilpatrick’s chondrolysis, could not overcome the absence of evidence proving that the pain pump could have been the cause. Id. at 16.

There was thus no evidence linking the pain pump to Kilpatrick’s injury, and all of his causes of action failed.

Perhaps “pain pumps” will prove to be another example of a mass tort that wasn’t.

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