But the facts of the case and the legal claims asserted aren’t what caught our attention. Nope, it’s the way the trial court slammed the two non-Tarheel plaintiffs’ lawyers when the court learned that those lawyers had been in contact with Abbott’s consulting expert. It turns out that these plaintiffs (and Abbott) were no strangers to Similac litigation. In fact, these same lawyers had been involved in Similac litigation in Kentucky, in a case called Hill. After the Hill case settled, but before an order of dismissal was entered, the plaintiffs’ lawyers contacted and retained Abbott’s consulting expert with respect to another Similac case, called Froman. At the time of the contact, Abbott was not yet a party in the Froman case, but it was added later, leading to the disqualification of Abbott’s consulting expert in Froman. Abbott was understandably upset, and moved to disqualify plaintiffs’ counsel for their tactics. The Kentucky court refused to disqualify or sanction the lawyers, finding that they did not knowingly violate the Kentucky Rules of Professional Conduct.

The North Carolina trial court, on the other hand, determined that the attorneys, by contacting and conflicting out Abbott’s expert, did engage in sanctionable conduct, and the court yanked the attorneys’ pro hac vices as a result. After the court of appeals overturned the revocation, relying on the Kentucky court’s refusal to sanction the conduct, the North Carolina Supreme Court reinstated the trial court’s sanctions decision. The Supremes noted that trial judges have wide latitude to discipline attorneys – especially those who are practicing pursuant to a pro hac vice. Id. at *4. In this case, the trial court did not abuse its wide discretion, because the facts showed that the plaintiffs’ attorneys contacted Abbbott’s consulting expert during the pendency of one case (Hill) in order to work on a second case (Froman), the attorneys wanted to keep the expert “in the black” about possible additional defendants in the Froman case (including Abbott), and the expert was unrepresented at the time of the contact. Id. at *5-7. Furthermore, the attorney for Abbott certified that after the plaintiffs’ attorneys contacted the expert, the expert would no longer return phone calls, letters, or messages, effectively denying Abbott the assistance of its retained expert. Id. at *5.

The Supreme Court also praised the trial court’s conclusions of law as “reasoned” and “carefully worded.” Id. at *6-7. The plaintiffs’ big beef, which was adopted by the court of appeals, was that a Kentucky court had previously declined to find a violation of the Kentucky Rules of Professional Conduct. The plaintiffs argued that under the North Carolina Rules, it is inappropriate to discipline attorneys whenever the conduct was permitted by the rules of the state where the conduct occurred. Id. at *8. The Supreme Court rejected this argument, because the cited rule applied to discipline by the Council of the State Bar – not the independent and inherent power of a trial judge to discipline attorneys appearing before him or her. The trial court reached twin conclusions of law: (1) counsel’s conduct constituted the appearance of impropriety; and (2) counsel’s conduct appeared to be inconsistent with fair dealing as reflected in Professional Rule 4.3. Id. at *7. Those conclusions were amply supported by the record, and well within the authority of the trial judge. The judge’s reference to Rule 4.3 for guidance, as well as its carefully worded conclusion – that the conduct at issue was “inconsistent” with the rule (rather than a “violation” of the rule) – was appropriate and “displayed a nuanced understanding of the discretion accorded” to the court. Id. at *8.

The lessons of this case are pretty simple. Don’t mess with the other side’s experts in order to get them disqualified, like Tony Soprano did when he tried to retain every divorce lawyer in New Jersey so as to deprive Carmela of a good lawyer. Don’t play fast and loose with the rules, especially when you’re appearing pro hac vice. And don’t mess with North Carolina.

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The first case, Hughes v. Stryker Sales Corp., Case No. 1:08-cv-00655-WS-N (S.D. Ala. May 13, 2010), involved an allegedly defective hip prosthesis. The plaintiff brought a host of state-law claims, including claims under Alabama’s product liability act and common law negligence and “wantonness” claims. Supporting those claims? No expert to testify that the product was defective. No expert to testify that the alleged defect was capable of causing, and did cause, injury. Instead, the plaintiff said she didn’t need no stinkin’ expert, and instead essentially tried to make out a res ipsa claim. According to the plaintiff, she could get to a jury because:

(1) The product was recalled, which amounted to an admission of defectiveness. Slip Op. at 6. Uh, ever hear of Rule 407’s prohibition on subsequent remedial measure evidence to prove liability?

(2) The defendant’s overseas manufacturing affiliate, Stryker Ireland, Ltd., received a Warning Letter from the Department of Health and Human Services, stating that an inspection of manufacturing facilities revealed “several violations” of FDCA regulations. Id. at 7. The plaintiff actually argued that this was enough to give rise to an inference of defect and causation in her specific case.

(3) Finally, the plaintiff argued that, well, she needed to get a new hip prosthesis, so something must have been wrong with her first prosthesis and it must have been the defendant’s fault – or at least a jury should be allowed to speculate that this is what happened, without the benefit of any expert guidance. Id. at 6, 9-10, 11 n. 10. In support of this argument, the plaintiff dumped a ton of unrelated medical records into the record – something that annoyed the court to such a degree that it felt compelled to write a lengthy footnote criticizing this record “dump.” Id. at 6 n.6.

The court easily shot these (frankly silly) arguments down. See id. at 7-12. The court didn’t go so far as to say a plaintiff always needs an expert to prove defect and causation in every products case – of course, the court didn’t rely on drug and device cases to reach that conclusion, see id. at 3-4 and n.4 – but in a device case, expert defect and causation testimony was required and the failure to provide it was fatal to all the claims.

The second case is equally egregious. In Maxwell v. Howmedica Osteonics Grp., Case 5:07-cv-01062-GTS-DEP (N.N.N.Y. May 10, 2010), the plaintiff alleged defect and failure to warn claims related to a total knee replacement system. The claim was that the system had a “high percentage” of nickel, which caused an allergic reaction in the plaintiff, and Howmedica should have warned of this risk. Slip Op. at 2. The plaintiff actually disclosed one “expert” – the doctor who had performed the second knee replacement. That doctor, however, offered no opinions on design, manufacture, the metallic composition of the system, and the adequacy of the warnings. Id. at 3 n.1. There was no risk-utility analysis, and no evidence that nickel is highly toxic, although the plaintiff asked the court to take judicial notice of this “fact” without providing any reports or studies supporting the assertion. Id. at 13. When it came to the warning claims, the plaintiff failed even to respond to the defendant’s arguments establishing the adequacy of the warning. Id. at 15. Maybe those arguments were compelling, or maybe the plaintiff’s lawyer just gave up because it would cost too much or take too long to respond – we don’t know. But the court nonetheless had to analyze on its own the sufficiency of those claims; it concluded the warning was adequate as a matter of law because the package inserts contained specific information about the metallic composition of the knee system, and provided risk information about the “rare” risk of metal sensitivity. Id. at 16-17.

These two cases are nice wins, even if they seem to be slam dunks. But they also beg the question of what to do when a plaintiff puts a defendant (and the court system) through the ringer, only to bail (or put on at best a half-hearted effort) when the case is finally subjected to any real scrutiny. TwIqbal, as we now call it, is a nice start to weeding out meritless cases. But how much time and money did the defendant have to spend defending these cases? How much disruption of regular business did these cases cause? How much judicial time and effort was required to manage these cases and ultimately dispose of them when it turned out the plaintiff didn’t bother to get experts or even really support their claims? Much as we would like to have a blanket rule that plaintiffs must pay costs and attorney’s fees any time they file a dog of a case, we recognize that’s an uphill battle. But at a minimum, in cases like these, where the plaintiff gets to the summary judgment altar only to reveal she didn’t bring an expert (even though it was obvious he needed one), and no longer pursues a claim (even though she has not dismissed that claim from the case), it seems only fair that the plaintiff should have to pay for the whole party. We get it: Times may be tough for a lot of plaintiff’s lawyers out there, and we know it is expensive to pursue cases. But that’s the point – it’s expensive to defend them too, and highly disruptive, so courts need to do something to curb this annoying and wasteful practice of plaintiffs filing cases, spending no money to develop those cases, and then rolling the dice that they can get to a jury.

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Something similar seems to be happening in the Accutane litigation. There’s a new opinion, Palazzolo v. Hoffman-La Roche Inc., No. A-3789-07T3, slip op. (N.J. Super. App. Div. Feb. 3, 2010), in which another plaintiff’s experthas gotten called out for essentially the same thing– publishing an article in a medical journal that failed to accurately describe what was actually done.

Be ready to hold your nose, here’s what went down, and it ain’t pretty:

In Palazzolo the plaintiff’s expert, James Bremner, was hired to offer an opinion that Accutane caused depression and suicide. The sticky situation began when, in the words of the Court, “Plaintiffs paid Bremner to undertake a further study. There is no dispute that the study was commissioned specifically for use in this litigation.” Slip op. at 3. That study – bought and paid for by plaintiffs’ counsel – was nevertheless published at J. Douglas Bremner, M.D., et. al., “Functional Brain Imaging Alterations in Acne Patients Treated With Isotretinoin,” 162 Am. J. Psychiatry 983 (May 2005). Slip op. at 4. You can read the whole thing on line here.

According to the opinion, the study protocol (we use the term advisedly) injected some patients with “radioactive glucose” and then “sliced” their brains with something called a “PET scan” – “PET” being short for “positron emission tomography.” Slip op. at 3. However, there didn’t seem to be much dispute that PET scans can’t diagnose depression, therefore, the court held a hearing. Id. at 4 (“the judge questioned how the PET scan study, which all parties agreed did not diagnose depression, nonetheless allowed Bremner to reach the conclusion that Accutane caused depression”).
That hearing was beginning of the end for Dr. Bremner’s study, because the court ordered him deposed, and cross-examination brought out what four judges (the trial judge and the unanimous three-judge panel) all agree happened:“Bremner did not actually use the methodology he claimed to have used. Although his PET scan article was peer-reviewed, he admitted that he did not in fact follow the steps described in the article.” Slip op. at 10.“[C]ontrary to representations made in the article, he did not get before-and-after. . .questionnaires from many of the subjects.” Id. at 10-11.”Bremner also could not document much of the data on which his published results were based.” Id. at 11.“[H]e admitted that some of the statistical analysis was inaccurate. For example. . .Bremner admitted that, for each study participant, comparing the activity in the orbital frontal cortex with the activity in the whole brain revealed no difference between the subjects who took Accutane and those who took antibiotics.” Id.“[H]e testified. . .that the ‘absolute metabolic rates’ for the two groups was significantly different, and contended that was the key finding of the PET study. However, Bremner. . .could not produce the source data for that analysis because [it] was on an optical computer drive that could not be opened.” Id.“[H]e admitted that some of the [data] he used in his calculations were inaccurate, [but] could not check the accuracy of the remaining numbers because the original data could not be retrieved.” Id. at 12.Thus the court affirmed throwing the study out even under New Jersey’s relatively liberal standard for admissibility of expert evidence. “An expert’s scientific peers cannot fairly judge the expert’s written work. . .if his article does not accurately represent either the underlying data or what the author did to produce his results.” Slip op. at 12. Four judges unanimously agree that “Bremner’s study was not soundly and reliably generated.” Id.
But just when we’re getting ready to cheer the panel for calling out Dr. Bremner’s faked article, we nearly swallow our tongues. The trial court’s order excluded Bremner altogether, probably (we haven’t seen it) reasoning along the lines of the old legal maxim, “falsus in uno, falsus in omnibus.” State v. Wesler, 59 A.2d 834, 837 (N.J. 1948);see, e.g., Howard v. Fortuna, 2009 WL 2031060, at *7 (N.J. Super. A.D. July 15, 2009) (unpublished, affirming trial judge’s decision on basis of “false in one, false in all” doctrine).The appellate court reversed the total exclusion and – despite all the findings about how the article had been faked – remanded at plaintiff’s insistence to determine if, “without reference to the PET study,” Dr. Bremner could nonetheless give a causation opinion. Slip op. at 20. Our own words fail us, so we rely upon Joseph Welch’s retort to Sen. Joseph McCarthy: “Have you no sense of decency, sir, at long last? Have you left no sense of decency?”
Thus, even after holding that Dr. Bremner’s main basis for his testimony was an “article [that] does not accurately represent either the underlying data or what the author did,” the court was nevertheless willing to allow him to offer an opinion in the same matter. Amazing.
On a more general level, we are, frankly, sick and tired of hearing the academic types and the popular press moan and wring their hands about the fact that our clients fund a lot of published studies in the medical literature. If they didn’t, there wouldn’t be very much literature, and the journals would have to print more junk science along the lines of the Lancet and the American Journal of Psychiatry articles.

Compared to that kind of litigation-inspired trash,the safeguards built into FDA-regulated clinical trials are … well, there’s no comparison, really. A drug manufacturer’s studies have to meet rigorous FDA standards. These studies are subject to written, detailed protocols, those protocols have to be followed or there’s Hell to pay (and a great deal of money down the drain), every step of the way has to be documented, and after that, everything is submitted for review by independent FDA scientists who can require submission of any additional data that they want.
Those are a lot of reasonable guarantees of genuineness – to steal a phrase from hearsay evidence cases. They’re not perfect, of course, but FDA-regulated clinical trials are already subject to pretty stringent standards.
What’s really appalling is what happened twice this week – exposure of the kind of shenanigans that turn up all too often when studies are actually paid for by litigants for litigation purposes. Where’s the outrage (other than here)? We think that if academic journals don’t already ask authors whether they’ve been retained as experts in litigation concerning any drug/device/vaccine they are studying, they damn well should.

And mere disclosure’s not enough. The ordinary peer review process doesn’t seem to be robust enough to ferret out litigation-driven academic fraud. So we think that if the answer to the disclosure question is “yes,” more needs to be done.If there’s a litigation expert seeking to publish about anything litigation related, we think academic journals – to safeguard their own integrity – should include at least one opposing-side litigation expert in the peer review process.
Note that we’re not limiting our proposal just to plaintiff-side experts, although that seems to be from where most of the “smoke” is now rising. That’s because: (1) we trust our experts more than we trust the other side’s, so we’re comfortable with increased scrutiny across the board, and (2) if we’ve got a bad apple with a rotten study, we’d like to know about that sooner rather than later.
If special scrutiny is not paid to studies being pushed by litigation experts, there are only going to be more embarrassments on the order of what we’ve seen this week. Junk science doesn’t stop being junk science just because some academic journal is bamboozled into publishing it.

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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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In Morrison v. Eli Lilly, the drug helped the plaintiff with fewer adverse effects than any of the other medications he tried. There was evidence that the plaintiff refused to be taken off the drug despite weight gain. Plaintiff’s medical records and his treater’s deposition demonstrated knowledge of associations between the drug and weight gain/diabetes, well before the statute of limitations ran. Thus, under the Missouri discovery and learned intermediary rules, the claims were time barred. There was also no causation, as the physicians prescribed and maintained the plaintiff on the drug with knowledge of its potential effects because it was effective in treating the plaintiff’s psychological condition.

In Leggett v. Eli Lilly, the plaintiff had been locked up as criminally insane, but the drug helped enough that he could be released. For almost twice the period of the relevant California statute of limitations, plaintiff’s medical records and his treater’s deposition demonstrated knowledge of associations between the drug and weight gain/diabetes. There was also no causation under the learned intermediary rule because the treater testified that he would prescribe the drug regardless of any diabetes warning because it helped the plaintiff so much.

In Neal v. Eli Lilly, use of the drug alleviated the plaintiff’s various auditory hallucinations and suicidal depression. All four of the treating physicians were aware of the alleged diabetes association, and prescribed the drug anyway, given its beneficial effect on his condition. Because no additional warning would have changed the result, there was no causation under California law. There was no medical causation either, because the plaintiff’s expert had been thrown out, and his treaters doubted that the drug caused plaintiff’s diabetes.

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