A To Z Revisited

A reader contacted us the other day, a little miffed because we hadn’t updated one of our “scorecards.” That surprised us, because we do try to keep our scorecards, and our cheat sheets, up to date as new cases are decided.  So we replied, interested to find out what we had apparently been missing.

It turns out that what we hadn't updated wasn’t anything we considered a scorecard at all.  Rather, it was a comparison we had run between two mass torts, Aredia/Zometa and Zyprexa.  He was right, we hadn’t updated that, but also wrong in that it wasn't something we intended to keep updated.

But we can’t expect our readers to know that if we don’t tell them.  So first, the explanation.  Our “scorecards” involve issues where the defense clearly has the upper hand.  In the scorecards, we keep track of every decision we know on a subject, good or bad.  However, most of the decisions will be good.  After all, we’ve said on numerous occasions, that because we’re an unabashedly defense blog, we don’t do the other side’s research for them.

Our “cheat sheets” are a little different.  Cheat sheets cover important issues where the law isn’t overwhelmingly favorable to our side.  It can be said (and we’ve said it) that, because those issues are more evenly divided, that it’s even more critical to get the word out about the caselaw that's favorable to our position.  Our cheat sheets try to do precisely that. But, since we don’t care to do the other side’s research, we only include the favorable cases.

Everything else is just a post.

Our Aredia (and Zometa) versus Zyprexa post was simply that. We were interested in those two litigations because they had gotten to the stage where the defense wasn’t killing off the entire mass tort at one fell swoop (something that only preemption is really capable of doing – see Sprint Fidelis), nor was it killing off entire categories of injury at a stroke (which is what successful Daubert motions do (see Seroquel)).  Rather Aredia and Zyprexa are both like our old Bone Screw lititgation – a mass tort being litigated, case by case, on (usually) learned intermediary rule issues.

But maybe it is time to check in again.  After all, our comparative post is now over two years old – my,  how time flies when we’re having fun.

But we were pushed over the edge the other day when we received from Robert Johnston, at Hollingsworth a copy of Eberhart v. Novartis Pharmaceuticals Corp., No. 1:08-cv-2542-WSD, slip op. (N.D. Ga. Oct. 31, 2011), making it a Happy Halloween indeed.  Eberhart is as good a place to start as any.  It demonstrates what good defense counsel have to do in difficult learned intermediary situations – keep pushing and keep asking questions.

In Eberhart, the plaintiff (as in all the A-Z cases) had some form of metastatic cancer. She took Zometa, a bisphosphonate (so is Aredia). That medication probably saved her life.  Slip op. at 3 (“[a]fter starting the Zometa treatment, Plaintiff’s hypercalcemia immediately improved and she remains alive”).  Nonetheless, the plaintiff got a bad (but not fatal) adverse reaction – osteonecrosis of the jaw (“ONJ”), basically parts of the jawbone start dying.  While it might seem like blaming Louis Pasteur because rabies vaccine has some nasty side effects, ingratitude isn’t a defense to a tort claim, so the plaintiff sued.

In the A/Z litigation, there’s at least enough of a causal basis for a link between bisphosphonate and ONJ that the defendant hasn’t succeeded with Daubert motions.  That's not today's topic, so on to the learned intermediary rule and warning causation.

The theory in these cases is that patients on these drugs shouldn't have tooth extractions because that procedure can touch off ONJ.  Allegedly, without such a warning in the drug label, the plaintiff in Eberhart did just that.  So the question becomes would a better warning have made any difference?  We start with the oncologist who prescribed Zometa against breast cancer.  She testified that, no, she wouldn’t have changed either her prescription or her treatment of the plaintiff.  Eberhart, slip op. at 14.  Point to defendant.

However, the plaintiff fought back.  The treating oncologist did change one thing after learning about the ONJ risk – she prepared some new handouts and discussed dental issues in more depth with patients who are prescribed these drugs. Id. at 13.  As always happens in a “changed warning” claim, the plaintiff claimed that, had she too been warned, she would have have sought dental treatments short of extraction.  Id. at 14.  Point to plaintiff.

There appear to be two problems with that testimony:  (1) it’s probably not true, since plaintiff had testified at least twice that “she did not want to have a root canal done and preferred to have the tooth extracted.”  Eberhart, slip op. at 9; see also id. at 9 (“she did not want a root canal or to even talk with [the specialist] about it, so she wanted [the tooth] removed”).  (2) The kind of dental work the plaintiff claimed she would have had simply wasn’t available.  The dental specialist on the case testified that he “would not have performed any endodontic treatment on [Plaintiff’s] teeth.”  Id. at 14.  Point back to defendant.

The first of the plaintiff’s problems, perhaps unfortunately, can only be decided at trial.  It’s not the job of a court to find testimony incredible, however blatantly self-interested and contradictory a party’s story might be.  The second problem, however, was a legitimate basis for summary judgment.  If the alternative medical treatment that the plaintiff claims a different warning would have prompted was not, in fact, available from the only specialist the plaintiff was seeing – there’s no causation, because there wasn’t really any alternative:

[O]n the record here that Plaintiff has not shown that [defendant’s] failure to warn was a cause of her alleged injury and has not shown that there is an issue of fact on causation.  Based on the evidence in the record as presented by the parties, the Court concludes that there are no facts to support that endodontic treatment was available to avoid the extraction of [the tooth in question], which was the site of Plaintiff’s claimed ONJ.  Accordingly, the Court finds there is no disputed fact regarding causation and the motion for summary judgment is required to be granted.

Eberhart, slip op. at 32.  We omitted a lot of pages dealing with the plaintiff’s technical objections to the doctor’s testimony (including an interesting flip flop from the A/Z plaintiffs' usual position on treater expert testimony), because we don’t think they matter in this context.  The plaintiff has the burden of proof, so even if there’s nothing negative, there’s still nothing positive on this causation point, and the defendant should win.

Anyway, the point of Eberhart to us is that defense counsel have to keep probing.  A smart plaintiff’s lawyer will try to find a way around a prescriber’s testimony that defeats warning causation, be it “I already knew,” “I wouldn’t do anything differently,” or “I didn’t read it at all.”  Sometimes the other side will be successful in breaching the first wall of causation.  At that point, the defense has to pursue secondary avenues of cutting off causation, as in Eberhart.

But Eberhart’s only one case.  How have other Aredia/Zometa cases fared in the two years since our earlier post?

Not so hot, actually.  We don't sense any problem in discussing them, because the other side already knows all about these.

We’ve already discussed the recent Winter case here, and it’s bad.  The prescriber decided that he couldn’t be bothered with warnings – any warnings.  The opinion's rather mushy analysis held that there was a fact issue whether the defendant should have tried in some other way (sales reps? Dear Doctor letters?) to warn the willfully ignorant doctor.  2011 WL 5008008, at *3.

There’s also Stevens v. Novartis Pharmaceuticals Corp., 247 P.3d 244 (Mont. 2010).  The opinion didn't spend much time on warning causation (as opposed to experts and other legal issues), but did state this: “The testimony also showed that [the dental specialist] would not have undertaken the tooth extraction if he had known of the risks of ONJ in Zometa patients such as [plaintiff].” Id. at 267.  So Stevens appears to have involved the kind of causation evidence missing in Eberhart.

We also found In re Aredia & Zometa Products Liability Litigation, 2010 WL 5136142 (M.D. Tenn. Dec. 7, 2010) (McDaniel).  Again the defendant attempted a causation defense, but it was a tough case.  The prescriber’s notes indicated he was considering restarting the plaintiff on Aredia even after an ONJ diagnosis, but that might not have happened had the warnings been different:

[T]here are genuine issues of material fact as to whether, given different warnings, [plaintiff] would have agreed to any suggestion that she continue or restart Aredia.  Her Aredia was, in fact, discontinued.  There are genuine issues of material fact as to whether different warnings would have changed the behavior of [plaintiff] or her health care providers.

Id. at *3.  In addition there was a heeding presumption under Arkansas law, although we’re not sure how relevant it was in this particular instance.

We also took a look at In re Aredia & Zometa Products Liability Litigation, 2010 WL 5072022 (M.D. Tenn. Dec. 7, 2010) (Brown).  This was in some ways similar to Eberhart, except that the plaintiff was effectively rewarded for being even less credible.  Like the prescriber in Eberhart, the prescriber in Brown now gives different warnings, even though he would still have prescribed (we’re dealing with an effective treatment for metastatic cancer, remember).  The plaintiff in Brown – ignoring the life-saving effect of A/Z – simply testified that “he would not have taken the drugs.”  Id. at *2. Taking that testimony at face value, the court denied summary judgment on warning causation grounds.  Id.  That plaintiff would rather be dead, it seems - at least now that there's money to be had.

There’s also In re Aredia & Zometa Products Liability Litigation, 2010 WL 5092784 (M.D. Tenn. Dec. 7, 2010) (Talley), where the prescriber reduced the plaintiff’s Zometa dosage after learning of the risk.  The plaintiff avoided summary judgment by claiming that “she would have reduced her dosage earlier and would have insisted on greater vigilance and dental monitoring to protect her jaw.”  Id. at *2.  Not a great summary judgment case, either.

The only other A/Z learned intermediary rule causation decisions our search pulled up were duplicates.  In re Aredia and Zometa Products Liability Litigation, 2010 WL 5136148 (M.D. Tenn. Dec. 7, 2010), is an earlier decision in the Eberhart case, with a less complete record, so it really shouldn’t count separately.  Ditto for Fussman v. Novartis Pharmaceuticals Corp., 2010 WL 4104707 (M.D.N.C. Oct. 18, 2010), which duplicates a case discussed in our prior post.

So, adding together these new A/Z opinions, we calculate the defendant’s score on warning causation (these are tougher than usual cases because there are two independent sets of treaters – oncology and dentistry) to stand at 5-11.  Not good, although we hasten to add that a significant number of the cases mentioned in the earlier post wound up getting thrown out on other grounds.  See Thomas v. Novartis Pharmaceuticals Corp., 2011 WL 3701816 (6th Cir. Aug. 23, 2011) (affirming summary judgment in Thomas, Melau, and Anderson on medical causation grounds); Emerson v. Novartis Pharmaceuticals Corp., 2011 WL 3701835 (6th Cir. Aug. 23, 2011) (affirming summary judgment in Emerson on Florida-specific FDA compliance grounds).

In the Zyprexa litigation, by contrast, the beat goes on - most of the time:

• In re Zyprexa Products Liability Litigation, 2011 WL 4962349 (E.D.N.Y. Oct. 18, 2011) (McClamrock) (prescriber already knew of relevant risk) (applying North Carolina law).
• In re Zyprexa Products Liability Litigation, 2011 WL 4963048 (E.D.N.Y. Oct. 18,2011) (Waheed) (prescriber already knew of relevant risk) (applying Arkansas law).
• In re Zyprexa Products Liability Litigation, 2011 WL 2516333 (E.D.N.Y. June 23, 2011) (Shepherd) (prescriber already knew of relevant risk) (applying Oklahoma law).
• In re Zyprexa Products Liability Litigation, 2011 WL 182489 (E.D.N.Y. Jan. 20, 2011) (Modley) (prescriber already knew of diabetes risk) (applying Mississippi law).
• In re Zyprexa Products Liability Litigation, 2011 WL 4052913 (E.D.N.Y. Oct. 14, 2010) (Gaskins) (prescriber already knew of relevant risk; case not within “mass immunization” exception) (applying North Carolina law).
• In re Zyprexa Products Liability Litigation, 2011 WL 348276 (E.D.N.Y. Jan. 22, 2010) (Trimble) (prescriber already knew of relevant risk; prescriber not “biased” despite receiving speaker’s fees from various drug companies) (applying Illinois law).
• In re Zyprexa Products Liability Litigation, 2009 WL 5216930 (E.D.N.Y. Dec. 21, 2009) (Treuchel) (prescriber already knew of relevant risk; prescriber did not read or otherwise rely upon defendant’s information) (applying Minnesota law).
• In re Zyprexa Products Liability Litigation, 2009 WL 5062109 (E.D.N.Y. Dec. 10, 2009) (Chavez) (prescriber already knew enough of the relevant risks and would have prescribed anyway) (applying Arizona law).
• In re Zyprexa Products Liability Litigation, 2009 WL 5062114 (E.D.N.Y. Dec. 10, 2009) (Guillen) (prescriber already knew of relevant risk and would have prescribed anyway) (applying California law).
• In re Zyprexa Products Liability Litigation, 2009 WL 3596982 (E.D.N.Y. Oct. 20, 2009) (Blume) (no evidence from prescribers; plaintiff personally already knew of relevant risk) (applying California law).
• In re Zyprexa Products Liability Litigation, 2009 WL 3596526 (E.D.N.Y. Oct. 16, 2009) (Folse) (prescriber would have prescribed anyway) (applying Louisiana law).
• In re Zyprexa Products Liability Litigation, 2009 WL 3597194 (E.D.N.Y. Oct. 16, 2009) (Quirarte) (prescriber already knew of relevant risk) (applying Illinois law).
• In re Zyprexa Products Liability Litigation, 2009 WL 3597447 (E.D.N.Y. Oct. 16, 2009) (Belcher) (prescriber already knew of relevant risk and would have prescribed anyway) (applying California law).

There have been three adverse Zyprexa rulings since our previous look see.  In In re Zyprexa Products Liability Litigation, 2010 WL 3257712 (E.D.N.Y. Aug. 16, 2010) (Harvard), where the plaintiff was able to muddy an informational timeline that “favor[ed the defendant’s] position” with testimony about a sales representative – “[the prescriber’s] testimony, however, raises questions about the extent to which she was influenced by information supplied by [defendant’s] sales representative.  Id. at *7 (applying New Jersey law).

In In re Zyprexa Products Liability Litigation, 2009 WL 5125636 (E.D.N.Y. Dec. 29, 2009) (Gurovitsch), the prescribers were less than specific about whether their knowledge of the drug’s effects occurred before or after treating the plaintiff, and one of them subsequently changed his procedures.  The court found a jury issue under Minnesota law. Id. at *13-14.

Finally, there’s little any defendant could do about the adverse prescriber testimony in a case decided the day after our original post:  In re Zyprexa Products Liability Litigation, 688 F. Supp.2d 130 (E.D.N.Y. 2009) (Earl) (applying Alabama law), except not bring a motion at all.  Not only was the prescriber “uncertain” about the state of his knowledge at relevant times, but he testified that he “would have pursued other options” had he known more.  Id. at 149.

For those keeping score, that puts the defendant’s summary judgment totals in Zyprexa at a still sterling 26-4 – although we’re still scratching our heads about raising warning causation as a defense in Earl.

Anyway, there’s our update, from A to Z.

Another TPP RICO Class Cert Denial

You may have heard Einstein’s definition of insanity: doing the same thing over and over and expecting different results. Well, if that’s right, then squirrels must be looking for TPP plaintiffs, because they’re nuts at this point if they think they’re going to get a RICO class certified (in the Second Circuit, at least).

We’ve previously reported on the Second Circuit blowing out a putative class in Zyprexa; in fact, it came in number one on our 2010 Top Ten Opinions list. Now we have more good news to report: a Magistrate Judge Report & Recommendation finding class certification inappropriate in a RICO/consumer fraud class action involving Ketek. See Sergeants Benevolent Assn. Health & Welfare Fund v. Sanofi-Aventis U.S. LLP, Case No. 1:08-cv-00179-SLT-RER (E.D.N.Y. Feb. 16, 2011) (we’re just going to call it Ketek). Hat-tip to Gary Spahn for sending along the opinion.

Ketek is a prescription antibiotic; plaintiffs were third-party payors (TPPs) who alleged the defendant fraudulently marketed Ketek by misrepresenting its safety and efficacy, and when the “truth” came out, prescriptions of Ketek plummeted. Plaintiffs sued on behalf of a nationwide class of TPPs, alleging claims under RICO, the consumer protection laws of forty-four states, and “unjust enrichment.”

The magistrate’s report and recommendation addressed only the RICO claims and deferred the pendent state claims, as plaintiffs suggested. Slip op. at 8 and n.7. The magistrate, following Zyprexa, found that individual issues predominated and doomed class certification.

The magistrate quickly zeroed in on the key issue, and the issue that hung up the Zyprexa TPPs – RICO reliance. “To prove injury by reason of a RICO violation, a plaintiff must demonstrate that the violation caused his injury in two ways: First, that the defendant’s conduct was the prximate cause of his injury – ‘there was a direct relationship between the plaintiff’s injury and the defendant’s injurious conduct.’ Second, that ‘but for’ the defendant’s conduct he would not have been injured. Although a plaintiff’s direct reliance is not a formal element of her RICO claim, there is no question that in cases such as this a plaintiff must allege and prove at least third-party reliance as part of the chain of causation. Because reliance is a necessary part of the causation theory Plaintiffs must be able to prove it through common evidence in order to obtain class certification.” Slip Op. at 18.

The Ketek plaintiffs couldn't make this showing, for the same reason that TPP RICO claims routinely fail to get certified: those pesky prescribing physicians and their intervening decision-making. Plaintiffs tried to get around this indivualized inquiry in a couple ways. According to plaintiffs’ expert Meredith Rosenthal, Ketek prescriptions plummeted in 2005, and then again in 2006 “once the true efficacy and safety risks were made known to the market.” Slip Op. at 18. Rosenthal contended that once this supposed “truth” was known, Ketek was allegedly restricted or removed from three-quarters of all TPP formularies, id., and the prescription drop was thus “common” proof that the alleged fraud must have caused a significant number of purchases. Id. at 21. Plaintiffs also offered the opinions of a number of medical experts, who opined as to Ketek’s safety profile and the information environment available to doctors. Id. at 23. One doctor went so far as to opine that prescribing Ketek was contrary to the applicable standard of care, and Ketek would not have been prescribed had the “truth” been known. Id.

None of that persuaded the magistrate, who efficiently summarized the many individual factors that may go into a particular doctor’s prescribing decision, id. at 24, before concluding: “physicians prescribe medications to their patients based on a variety of factors, which may or may not include information provided by drug companies. Based on the common evidence Plaintiffs proffer there is simply no way to determine whether all, or even most, of the physicians who previously prescribed Ketek for their patients based their decisions on Aventis’s purported misinformation. Indeed, the fact that Ketek sales plummeted…does not mean that prior thereto any physician based her decision to prescribe Ketek on Aventis’s fraud. It may well be that physicians prescribed Ketek based on factors other than Aventis’s fraud, and then later decided to discontinue prescribing Ketek once they knew of the true efficacy and health risks. Plaintiffs’ proffered common evidence simply does not prove reliance.” Id. at 30-31.

The magistrate didn't even need to seriously tangle with the other huge flaws in plaintiffs’ proposed proofs, including the fact that Rosenthal’s model did not attempt to account for other potential causes of the prescription decline, the fact that some doctors continued to prescribe Ketek for certain indications even after FDA withdrew those indications, the fact that other doctors may have switched to an antibiotic that cost as much or more than Ketek, and the fact that P&T Committees, PBMs, and TPPs, just like doctors, consider a host of different factors when deciding how to position drugs on a formulary and reimburse for those drugs. Id. at 25-26, 30-31. In fact, some of the named plaintiffs continued to reimburse for Ketek even after the adverse FDA actions. Id. at 26.

Most significant, of course, the magistrate had cover from the Second Circuit’s opinion in Zyprexa, which rejected a similar RICO causation theory proposed by a putative class of TPPs. Quoting extensively from Zyprexa, the magistrate concluded the same result was appropriate in Ketek – no class certification – and rejected plaintiffs’ specious attempts to distinguish the Second Circuit opinion (the relevant portion of Zyprexa was “purely dicta”? Really?).

This is clearly not the last word on Ketek – it is an R&R, after all, and we need to see what happens before the District Court. And there are still those nagging state-law claims. But this is still a good result, and maybe we’ll start to see a decline in TPP plaintiffs filing prescription drug RICO class actions. Unless they’re nuts, that is.

A Recent Zyprexa Ruling Lifts Our Mood

Yesterday, our 15-year-old son looked at the falling flakes and wondered aloud whether it was ever going to stop snowing. He's prone to complaint (future plaintiff lawyer) but, in truth, the ten-foot high snowbanks and the sheets of devilish, black ice are a bit depressing. We knew the arrival of 30 page Zyprexa opinion by Judge Weinstein, In re Zyprexa Products Liability Litigation, 2011 U.S. Dist. LEXIS 6207 (E.D.N.Y. Jan. 20, 2011), would move us along the happy-sad meter, but we didn't know which direction.

Not to put too fine a point on it, but Zyprexa rulings are a big deal. The Zyprexa litigation involves a big-selling medicine prescribed for important psychological maladies (including schizophrenia and bipolar disorder), with allegations that the drug is contributing to the American epidemics of obesity and diabetes. It involves claims for wrongful death, personal injury, consumer fraud, and securities violations. There have been third-party claims, federal and state civil actions, and a federal criminal action. Decisions in the Zyprexa litigation made our ten-best list in 2010 (the Second Circuit's reversal of Judge Weinstein's certification of a RICO class action by third-party payors), our ten-best list in 2009 ("Pigs Get Fat, Mississippi Got Slaughtered"), and our ten-worst list in 2008 (Judge Weinstein's certification of the RICO action). Zyprexa rulings have kept us rather busy. We've blogged about the case's treatment of Daubert challenges, caps on attorney fees, and sanctions for disclosure of confidential documents. And much more.

It's been riveting. Maybe that shouldn't come as a surprise, because the stakes have been so high, the lawyers on both sides have been so energetic and creative, and the judge has been so ... well, it's Judge Weinstein, after all. We might not agree with more than thirty percent of what Judge Weinstein writes, but there's no getting around the fact that he is brilliant, careful, and prolific. So a 30 page opinion by Judge Weinstein is like a new Oliver Stone film -- we know it'll be interesting and fear it'll be infuriating.

Except that the first 26 pages consists of listing counsel. That is one of the perils of an MDL. We flipped through the pages quickly and ended up reading a very short, straightforward discussion about learned intermediaries. Anxiety gave way to delight. Judge Weinstein granted summary judgment in a case because the plaintiffs' treating physicians testified that they "were aware of the potential metabolic side-effects of Zyprexa, including diabetes, at the time they made their prescription decisions." 2011 U.S. Dist. LEXIS at *95. Two of the doctors supplied the strongest possible statements: "none of the information they have learned about Zyprexa would have changed their treatment." Id. A third doctor stated that "he would not necessarily have treated [plaintiff] differently, and that today he would still 'tend not to change that a medicine' that a patient is already taking." Id. at *95-96. That's the sort of testimony that makes your average defense lawyer somewhat content, but also somewhat uneasy, as he or she is walking away from the deposition. It's enormously useful to know that even Judge Weinstein agrees that such testimony can end a case.

As is typical, the plaintiff did not take this sort of thing lying down. First, they submitted expert reports to the effect that a "reasonably prudent doctor" would not have prescribed the drug if they had known the truth. Id. at *97. Nice try. But the actual treating doctors testified that "they were already aware of the risks of diabetes at the time Zyprexa was prescribed." Id. Apparently, Judge Weinstein did not buy the implicit assertion by the plaintiff's experts that the treaters committed malpractice. Moreover, the plaintiffs' experts shaved things a bit too fine. They said that an informed physician would not have prescribed Zyprexa as a first-line agent. But, as is often the case with antipychotics, the plaintiff had already tried other drugs. Zyprexa here was not a first-line agent. Id. Next?

There always is a next, isn't there? And that "next" was something we've seen as often as the Seinfeld "The Contest" episode (with some striking similarities). The plaintiff trotted out the "overpromotion" theory. Judge Weinstein gave it short shrift: the plaintiff's doctors were aware of the risks, and there was no evidence that they were misled by detailers. Id. at * 98. Perhaps this was the part of the opinion that gladdened our hearts most. If Judge Weinstein can scrape the overpromotion theory off his shoe in a single paragraph, maybe that threadbare theory really is headed for the dustbin of history.

None of this clears our driveway or makes the trains run on time, but it puts us in a sunnier mood and maybe that makes it easier to deal with the insults of Winter.