Wednesday, June 30, 2010

Pomegranate Turf Wars Implicate FDA Regulatory Scheme

Ah, pomegranates. In ancient times, the Greeks believed pomegranates were responsible for the seasons. Demeter’s daughter Persephone couldn't resist the urge to eat a few pomegranate seeds while visiting the Underworld, condemning her to marry Hades and spend six months in hell. During those months, Demeter was so upset that she ignored the harvest. Hence, fall and winter.

In modern times, some researchers believe that pomegranates may unlock the secret to better health. It turns out that pomegranates are high in antioxidants, which may have cardiovascular benefits. Team up pomegranate juice with other juices like blueberry, and you have a potent cocktail of health claims.

This has been an emerging area of focus, both in grocery stores and with the FDA. It turns out that the world of juices is both highly competitive and increasingly the target of FDA scrutiny. In February of this year, the FDA issued a warning letter to POM Wonderful, LLC (one guess what they make). The FDA took the position that POM, by making health claims in its label and advertising, converted its 100% pomegranate juice into an unapproved new drug. Just to be clear, we think this is bogus paternalism – we don’t think pomegranate juice is a drug. Meanwhile, POM faced simultaneous pressure from a competitive source – Coca-Cola, who manufactures an enhanced (juiced up?) blend of juices with the catchy title, “Minute Maid ® Enhanced Pomegranate Blueberry Flavored 100% Juice Blend.” Coca-Cola marketed this blended juice as containing a host of benefits that contribute to brain development.

So what did POM do when faced with this competitive challenge from Big Juice? It sued, of course (POM also sued Welch’s, Ocean Spray, and Tropicana on similar grounds). And recently, a federal court in California, having examined POM’s claims, split the baby and let some claims proceed while tossing other core claims. See POM Wonderful LLC v. The Coca Cola Company, 2010 U.S. Dist. LEXIS 55400 (C.D. Cal. May 5, 2010). Importantly, POM did not contest the scientific accuracy of the claims made by Coca-Cola. Id. at *5. Rather, POM was annoyed because the blended juice contained predominantly apple and grape juice – standby, sweet juices that we all remember and love from our childhood – but marketed the pomegranate and blueberry aspects of the blend. In fact, POM alleged that the blended juice contained only 0.3% pomegranate juice and 0.2% blueberry juice. Id. at *14. This, POM claimed, was deceptive to consumers (and, incidentally, competitively harmful to POM), so POM sued under the Lanham Act and a collection of California consumer/unfair trade statutes.

POM came out swinging, alleging that the blended juice bottle prominently featured pictures and language intended to highlight the pomegranate and blueberry ingredients, that the print, television, and website advertising was all similarly misleading, and that Coca-Cola had in fact received a number of vitriolic complaints about the blended juice (the quoted consumer complaint threw out words like “fraud” and “scumbags,” and called the blended juice a “crock,” just to give you a flavor). Id. at *4-16. POM also had a consumer survey conducted by a consumer research/behavioral opinion consultant. Id. at *18.

The court easily dispatched of the state law claims, because POM lacked standing under California’s Unfair Competition Law (§ 17200) and False Advertising Law (§ 17500). Id. at *55. POM clearly wasn’t entitled to any restitution, and a lost business opportunity is only contingent; that’s not enough to confer standing under the UCL and FAL. Id. at *56-58.

The Lanham Act claim, however, was a little trickier. POM was required to show “that Coca-Cola made false or misleading advertisements, and that Coca-Cola’s advertisements deceived a substantial segment of its audience.” Id. at *28 n.13. When considering the Lanham Act claim, however, the court had to be mindful of the FDA’s prior and ongoing regulation in this area pursuant to the Food, Drug, and Cosmetic Act (FDCA). For years, the FDA has been all over health claims in the juice market, as evidenced by the Warning Letter the FDA sent POM in February. And, as you might imagine, the FDA has for years controlled numerous aspects of juice labeling, advertising, and even the pictures of fruit on the bottle (known as “vignettes”). We know, shocking that the FDA would be such a paternalistic control freak. So, for example, the FDA controls when you must call juice a “pomegranate flavored juice drink,” as opposed to “pomegranate juice,” what it means to be a “juice blend,” whether you are allowed to highlight aspects of the blend that are not the major ingredients, and whether you need to put pictures of all included fruits in the “fruit vignette,” or whether you can instead highlight certain fruits. Id. at *34-44. Now Coca-Cola’s catchy name – “Minute Maid ® Enhanced Pomegranate Blueberry Flavored 100% Juice Blend” – makes a bit more sense.

Given that the court wasn’t starting from scratch, it had to determine what, if anything, to make of the prior FDA activity in this area. Citing to a number of pharma cases (as well as a bunch of juice cases), the court fashioned a few rules of thumb:

1) “Lanham Act claims are barred where private litigants ask the court to determine preemptively how the FDA will interpret and enforce its own regulations.” Id. at *44. In other words, don't tread on the FDA’s turf.

2) At the same time, Lanham Act claims are appropriate where: (a) the defendant misrepresents that it complied with FDA regulations; or (b) the court needs only to verify whether the defendant’s conduct conforms to FDA requirements. Id. at *45.

So to recap: if you need to interpret FDA rules and regs to determine whether something’s misleading, no go on the Lanham Act claim. If, on the other hand, the falsity of the statement is ”easily verifiable,” “without requiring the truth of the fact to be determined by the FDA, “ the claim does not implicate the FDCA or FDA regulations. Id. at *48. Got it? Yeah, seems pretty fuzzy to us too.

The POM court ultimately decided it could consider POM’s Lanham Act claim, as long as the court construed it a particular way. Thus, for example, the court found that the name of the juice blend was OK, because the FDA “has concluded that manufacturers of multiple-juice beverages may identify their beverages with a non-primary characteristic, as Coca-Cola has done here.” Id. at *64. On the other hand, it was inappropriate for the court to consider POM’s complaints about the positioning and prominence of certain information in the label, because it “would necessarily be for the FDA to determine” in the first instance. Id. And, to the extent POM criticized FDA-compliant labeling as “false and misleading,” it was inappropriate for the court to “second-guess the considered judgments of the FDA.” Id. at *65.

In the end, the court dumped the vast majority of POM’s claims, finding Coca-Cola’s labeling, naming, and “fruit vignettes” complied with FDA requirements, but when it came time to sound the death knell on POM’s related claims of misleading advertising and marketing, the court hesitated. First, the court got off to a good start, heavily criticizing the methodology of POM’s survey evidence, which was being offered to establish the “consumer confusion” element. The court went so far as to deem the survey evidence “seemingly unreliable” because it “does not appear to relate to Coca-Cola’s advertising and marketing, and only implicates the naming and labeling of the Juice bottle.” Id. at *75-76. So why not toss the claim? There’s a huge fit issue lurking here. But for whatever reason, the court got cold feet and refused to address these Daubert issues, instead ruling that those issues are “best considered at trial.” Id. at *76. That's not the type of rigorous gatekeeping we need.

Second, the court addressed POM’s contention that Coca-Cola engaged in “willful deception,” which would shift the burden to Coca-Cola to demonstrate that consumers were not misled. Coca-Cola poked gaping holes in the “willful deception” evidence presented by POM, and the court agreed: “Coca-Cola’s claims are seemingly meritorious.” Id. at *77. So what happened? Why did the court let the claims survive? Because the court apparently believed that “POM should have the opportunity to demonstrate otherwise.” Id. So the court issued an opinion killing most of the case, expressed grave doubts about the remainder, but ultimately blinked when it came time to toss the whole shooting match.

It took us a long time to get to the end of the opinion, and when we did, it took us an even longer time to get our minds around the abrupt about-face of the court. And it made us think of how often we face similar issues in drug and device cases – shaky “experts” who are somehow allowed to survive because the court believes you have to let it all play out at trial, and plaintiffs who are permitted to use the specter of "intentional fraud" and "deception" to imbue the case with a maleficent odor and thus somehow avoid stricter judicial scrutiny. We keep hoping that more rigorous Daubert and TwIqbal practice will tip the scales back a bit, and it’s getting better out there, but decisions like this are a reminder that there’s still work to be done.

Monday, June 28, 2010

A Typically Splendid Philadelphia Decision

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 cheeze-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.)

There have been tens of thousands of cases filed claiming that atypical antipsychotics, such as Risperdal, aren't all they're cracked up to be and that they can cause weight gain and diabetes. The trouble with those cases is that every time there's a real, live plaintiff -- someone who actually took the atypical antipsychotic -- it looks like the medicine did confer a benefit. Plus there's no way to say with any scientific rigor that the alleged harm was caused by the drug. Newsflash: weight gain and diabetes are common in our society. That is particularly true among the mentally ill. It's also hard to show that a prescriber's decision was affected in any way by whatever alleged misrepresentation, or nondisclosure, or item of unattractive conduct dredged up by plaintiff lawyers after trolling through millions of documents. (Further disclosure: some of the authors of this blog represent another manufacturer of atypical antipsychotics.)

But file an action on behalf of a third-party payor, such as a state, and that pesky plaintiff problem might go away. Adios causation and reliance. And the state probably doesn't have a criminal record, or a nasty streak that will scare jurors, or any of those other features that can make actual plaintiffs so ... inconvenient. So goes the thinking anyway.

The Commonwealth's case against Janssen was an effort to cobble something out of nothing. And after one trial week (or one weak trial), it became clear that the Commonwealth had less than nothing. Plaintiff's theory was that "Janssen fraudulently represented that Risperdal was superior (safer and more effective) than both conventional antipsychotic drugs (first generation, 'FGA'), as well as newer antipsychotic drugs (second generation, 'SGA' or 'atypical')." Slip op. at 6. Plaintiff asserted that absent those misrepresentations, doctors would have prescribed cheaper drugs. To the extent the state paid for Risperdal, it now wanted the amount of overpayment back. That added up to $289 million. Or $148.8 million. Plaintiff offered "a patchwork of changing damage claims." Id. at 24. Anyway, it's a lot. This clumsy money-grab was dressed up in fraud and unjust enrichment claims.

At trial, the Commonwealth brought in government witnesses plus a couple of professional experts. Dr. Plunkett showed up. (It really wouldn't be a drug-or-device case without Dr. Plunkett, would it?) One problem: as Al Pacino says in his notorious opening statement in And Justice for All, plaintiff forgot to bring a case. Plaintiff offered no evidence that the defendant had uttered any alleged misrepresentation to anyone in Pennsylvania, or that any prescription had been affected by such nonexistent misrepresentation.

Plaintiff's approach was simple: we don't need any of that stuff. Don't need a misrepresentation, because, in one of many theory-shifts in the case, (the case originally focused on the off-label issue, which apparently went nowhere) there was a duty to disclose an FDA untitled letter griping about some marketing. Why was there a duty? Because there was a confidential relationship between Janssen and the Commonwealth. Why was there a confidential relationship? Because the company and the state exchanged some confidential pricing information about the "unit rebate amount" and because plaintiff's experts kept inserting the word "confidential" into their canned testimony. Id. at 9.

Seriously?

The Judge easily discounted this nonsense. This was not an arrangement between a big, bad company and some poor vulnerable, dependent party. We're talking about a state for crying out loud. "[T]he parties here are independent, sophisticated business and government entities entrusted with equal knowledge of the complicated federal and state mandates." Id. at 11.

The FDA's untitled letter is probative of pretty much nothing. It applied regulatory concepts that have nothing to do with the materiality requirement for a fraud claim. And why exactly did the company have a duty to disclose that the FDA disapproved of a claim when there's no evidence that such claim was ever made to anyone in Pennsylvania?

In addition, the judge held that the learned intermediary doctrine still applied, even if it was a third-party payor case. "Absent proof that if the defendant manufacturer had issued the proper warning or a different warning then the prescribing physicians would change his or her prescription habits, thus causing a different and lower price, this plaintiff cannot meet its burden and the case cannot go forward to the jury." Slip op. at 18. Pennsylvania law does not presume that doctors turn themselves into dupes. Sometimes facts are stubborn. Different antipsychotics work differently for different people on different problems. There was no evidence that the cheaper drug could be a substitute for every Risperdal prescription. Plaintiff's theory was mindless. Risperdal was the better option for some patients, and why shouldn't it cost more?

Plaintiff insisted it didn't need any proof from any doctors. Instead, it argued that "aggregate proof" could support its claims. The Commonwealth relied on In re Zyprexa Products Liability Litigation, 671 F Supp 2d 397 (EDNY 2009). That's amusing, because in that case Judge Weinstein acknowledged that permitting aggregate proof would likely not survive Second Circuit scrutiny: "There is some doubt in that case about the appellate court's willingness to accept aggregate proof....". Id. at 460. Judge Weinstein then stayed proceedings pending appeal.

In the end, the Commonwealth was pursuing a fraud-on-the-market theory, and the judge refused to extend that theory beyond the securities area. There was simply no evidence that the Risperdal market was "responsive in terms of numbers of sales to adverse information." Slip op. at 14. Because the Commonwealth "failed to present economic analysis, aggregate statistical proof, or any other expert evidence ... the Commonwealth was not entitled to a presumption of reliance and causation." Id. at 15.

Nor did plaintiff present any expert testimony as to calculation of damages. Because the case involved more than the "basic arithmetic" promised by the Commonwealth, the absence of damages experts was fatal. Id. at 21. There wasn't even the pretense of a survey of doctors. Plaintiff did not ask any doctors in Pennsylvania why they prescribed Risperdal and if they would have switched to Haldoperidol.

Let's see: no misrepresentation, no reliance, no causation, and no damages. Not much of a fraud case, is it?

As for the unjust enrichment theory, it fared no better because "Pennsylvania law precludes the availability of this equitable doctrine where as here, 'the relationship between the parties is founded on a written agreement or express contract.'" Slip op. at 25-26 (citing cases). That's right. The state had entered into a contract. And all the evidence suggests that it did just fine under that contract.

Certainly better than it did under the contingent fee contract for this ill-conceived, misbegotten litigation.

Friday, June 25, 2010

Causation Where A Multi-Drug Regimen Is Involved

We can't say a whole lot about it because we're involved in the litigation, but anybody defending a prescription drug product liability case where the plaintiff was prescribed more than one drug concurrently should take a look at the warning causation reasoning in Simon v. Wyeth Pharmaceuticals, Inc., 2010 WL 2243661 (Pa. C.P. Phila. Co. May 5, 2010).  The court found an inconsistent verdict where the same prescriber had jointly prescribed two different drugs, but the jury found only one manufacturer's labeling inadequate as to the same risk.  The finding that one label was adequate meant that the prescriber, when the prescription was made, had received an adequate warning about that risk.  That necessarily defeated causation as to every defendant, because - regardless of the source of the warning - the prescriber had gone ahead after having been adequately warned.

Causation thus makes a multi-drug regimen failure-to-warn case an all or nothing proposition.  If any of the defendants' warnings is adequate as to the risk at issue, then all defendants win, because that means the prescriber acted after having been adequately warned.  Make sure the jury instructions are phrased accordingly.

Thursday, June 24, 2010

Class Action Denial Federal Cheat Sheet

Almost from the day this blog was founded, we’ve been arguing that class actions have no place in prescription medical product liability litigation. We’ve put up several posts containing lists of cases to that effect - but none of them were complete (or purported to be).


One of the things that we’ve often thought about doing someday was putting together a truly comprehensive list of all the decisions denying class certification in prescription medical product liability litigation.  Well, today’s that day, at least as far as federal class action litigation (more important since the passage of the Class Action Fairness Act) is concerned.  This cheat sheet assembles all the failed Rule 23 class actions – and there’s a lot of them – in product liability actions involving prescription drugs, medical devices, and similar products.

This list only includes cases that deny class certification across the board.  We’re not including any opinions that deny even 90% of the claims sought to be certified, if they actually allow certification of any class action.  We're picky that way.

For reasons we’ve discussed, we don’t expect plaintiffs' repeated failure to succeed with these sorts of class actions to make them go away, given the (we think erroneous) effect that even bogus class actions can have on the statute of limitations in some jurisdictions.  Given that incentive, plaintiffs will keep trying and failing - and we’ll be updating this cheat sheet as needed.

  1. Ryan v. Eli Lilly & Co., 84 F.R.D. 230 (D.S.C. July 10, 1979) (DES – increased risk of injury).  Statewide class certification denied.  No predominance due to plaintiff-specific variations.
  2. McElhaney v. Eli Lilly & Co., 93 F.R.D. 875 (D.S.D. April 8, 1982) (DES – increased risk of injury).  Statewide class certification denied.  No properly defined class.  No typicality and predominance due to plaintiff-specific variations.  No adequacy.
  3. In Re Northern District of California, Dalkon Shield IUD Products Liability Litigation, 693 F.2d 847 (9th Cir. June 18, 1982) (Dalkon Shield – personal injury).  Nationwide punitive damages class certification reversed on mandamus.  Statewide class certification reversed on mandamus.  Limited fund certification rejected.  No typicality.  No predominance due to plaintiff-specific variations.  No superiority.
  4. Thompson v. Procter & Gamble Co., 1982 WL 114 (N.D. Cal. Dec. 8, 1982) (tampon – personal injury, increased risk of injury).  Nationwide class certification denied.  Mandatory class improper due to state law variations.  No predominance due to plaintiff-specific variations.
  5. Mertens v. Abbott Laboratories, 99 F.R.D. 38 (D.N.H. July 27, 1983) (DES – personal injury). Statewide class certification denied.  Mandatory class improper due to plaintiff-specific variations.  No predominance due to plaintiff-specific variations.  No superiority.
  6. Payton v. Abbott Laboratories, 100 F.R.D. 336 (D. Mass. July 30, 1983) (DES – increased risk of injury).  Statewide class decertified.  No predominance due to plaintiff-specific variations.  No superiority and manageability.
  7. In re Bendectin Products Liability Litigation, 749 F.2d 300 (6th Cir. Oct. 26, 1984) (Bendectin – personal injury).  Nationwide settlement class certification reversed on mandamus.  Limited fund certification rejected.
  8. Linkous v. Medtronic, Inc., 1985 WL 2602 (E.D. Pa. Sept. 4, 1985) (pacemaker – personal injury, medical monitoring, increased risk of injury).  Nationwide class certification denied.  No predominance due to plaintiff-specific variations.  No superiority.  No issue certification as to punitive damages.
  9. In re Tetracycline Cases, 107 F.R.D. 719 (W.D. Mo. Oct. 1, 1985) (Tetracycline – personal injury).  Statewide class certification denied.  No issue certification due to lack of superiority and plaintiff-specific variations.
  10. Rall v. Medtronic, Inc., 1986 WL 22271 (D. Nev. Oct. 15, 1986) (pacemaker – personal injury, emotional distress from increased risk).  Nationwide class certification denied.  No commonality due to multiple products and plaintiff-specific variations.  No typicality due to plaintiff-specific variations.
  11. Raye v. Medtronic Corp., 696 F. Supp. 1273 (D. Minn. Oct. 19, 1988) (pacemaker – personal injury).  Nationwide class certification denied.  No predominance due to multiple state laws and plaintiff-specific variations.
  12. Mehornay v. Pfizer Inc., 1991 WL 540731 (C.D. Cal. June 3, 1991) (heart valve prosthesis – emotional distress from increased risk).  Nationwide class certification denied.  No typicality due to plaintiff-specific variations.  No predominance due to plaintiff-specific variations.  No superiority.
  13. Pasternak v. Upjohn Co., 1994 WL 16495152 (E.D.N.Y. Sept. 19, 1994) (Halcion – personal injury, emotional distress, economic loss).  Nationwide class certification denied.  No predominance due to plaintiff-specific variations.  No typicality.
  14. In re Orthopedic Bone Screw Products Liability Litigation, 1995 WL 273597 (E.D. Pa. Feb. 22, 1995) (pedicle screws – personal injury, medical monitoring).  Nationwide class certification denied.  Limited fund certification rejected.  No predominance due to plaintiff-specific variations.
  15. Kurczi v. Eli Lilly & Co., 160 F.R.D. 667 (N.D. Ohio Feb. 27, 1995) (DES – personal injury).  Statewide class certification denied.  No commonality due to multiple defendants, multiple state laws, and plaintiff-specific variations.  No typicality.  No adequacy due to conflicts of interest.  No predominance due to plaintiff-specific variations.  No superiority.
  16. In re Rhone-Poulenc Rorer, Inc., 51 F.3d 1293 (7th Cir. March 16, 1995) (blood products – personal injury).  Nationwide class certification reversed on mandamus.  No manageability due to multiple state laws.  No issue certification due to Seventh Amendment jury trial right.
  17. Martin v. American Medical Systems, 1995 WL 680630 (S.D. Ind. Oct. 25, 1995) (penile implant – personal injury).  Nationwide class certification denied.  No typicality and adequacy due to plaintiff-specific variations, particularly varied injuries. No predominance due to plaintiff-specific variations.  No superiority.
  18. In re American Medical Systems, Inc., 75 F.3d 1069 (6th Cir. Feb. 15, 1996) (penile prosthesis – personal injury).  Nationwide class certification reversed on mandamus.  No commonality and predominance due to plaintiff-specific variations.  No typicality and adequacy.
  19. Harding v. Tambrands Inc., 165 F.R.D. 623 (D. Kan. March 15, 1996) (tampon – personal injury).  Nationwide class certification denied.  No predominance due to multiple products and multiple state laws.  No superiority.  No manageability due to multiple state laws.  No issue certification.  Reargument denied, Hayes v. Playtex Family Products Corp., 168 F.R.D. 292 (D. Kan. 1996).
  20. In re Norplant Contraceptive Products Liability Litigation, 168 F.R.D. 577 (E.D. Tex. Aug.. 5, 1996) (Norplant – personal injury).  Nationwide class certification denied.  No predominance and superiority due to immature tort.
  21. Valentino v. Carter-Wallace, Inc., 97 F.3d 1227 (9th Cir. Oct 7, 1996) (Felbatol – personal injury, increased risk of injury).  Nationwide settlement class certification reversed.  Inadequate consideration of predominance and superiority issues.
  22. Haley v. Medtronic, Inc., 169 F.R.D. 643 (C.D. Cal. Dec 12, 1996) (pacemaker lead – personal injury, fraud, medical monitoring).  Nationwide class certification denied.  No manageability due to multiple state laws, large number of plaintiffs, and plaintiff-specific variations.  No issue certification due to multiple state laws.  No medical monitoring injunctive class due to monetary damages.
  23. Kemp v. Medtronic Inc., 1998 WL 35161989 (S.D. Ohio Feb. 11, 1998) (pacemaker lead – personal injury).  Statewide class certification denied.  No predominance and superiority due to plaintiff-specific variations.  No manageability.
  24. Fisher v. Bristol-Myers Squibb Co., 181 F.R.D. 365 (N.D. Ill. May 28, 1998) (Stadol – personal injury, consumer fraud).  Nationwide class certification denied.  No predominance due to plaintiff-specific variations, particularly causation.  No manageability due to multiple state laws.  No superiority.
  25. Woodell v. Proctor & Gamble Manufacturing Co., 1998 WL 686767 (N.D. Tex. Sept. 29, 1998) (Aleve – injunctive relief, personal injury).  Nationwide and statewide class certification denied.  Injunctive relief does not predominate.  No superiority due to plaintiff-specific variations.
  26. Dhamer v. Bristol-Myers Squibb Co., 183 F.R.D. 520 (N.D. Ill. Nov 18, 1998) (Stadol – personal injury, medical monitoring, consumer fraud/economic loss).  Nationwide class certification denied; addiction subclass denied.  No medical monitoring injunctive class due to monetary damages.  No predominance due to plaintiff-specific variations, particularly learned intermediary.  No manageability due to multiple state laws.
  27. Rosmer v. Pfizer, Inc., 2001 WL 34010613 (D.S.C. Mar 30, 2001) (Trovan – medical monitoring).  Nationwide class certification denied.  No adequacy due to South Carolina’s rejection of medical monitoring.
  28. Zinser v. Accufix Research Institute, Inc., 253 F.3d 1180 (9th Cir. June 15, 2001), amended, 273 F.3d 1266 (9th Cir. 2001) (pacemaker lead – personal injury, medical monitoring).  Denial of nationwide class certification affirmed.  No predominance due to multiple state laws and plaintiff-specific variations.  No superiority.  No manageability due to plaintiff-specific variations.  No medical monitoring subclass.  No medical monitoring injunctive class due to monetary damages
  29. Neely v. Ethicon, Inc., 2001 WL 1090204 (E.D. Tex. Aug. 15, 2001) (Vicryl suture – personal injury).  Nationwide class certification denied.  No issue certification due to Seventh Amendment jury trial right.  No predominance due to multiple state laws and plaintiff-specific variations.
  30. Block v. Abbott Laboratories, 2002 WL 485364 (N.D. Ill. March 29, 2002) (Total beta-hCG test kit – injunctive relief, consumer fraud).  Nationwide class certification denied.  No predominance due to multiple state laws and plaintiff-specific variations.  No adequacy due to lack of standing.
  31. In re Propulsid Products Liability Litigation, 208 F.R.D. 133 (E.D. La. June 4, 2002) (Propulsid – medical monitoring).  Nationwide class certification denied.  No medical monitoring injunctive class due to monetary damages.  No manageability due to multiple state laws.  No predominance due to plaintiff-specific variations.
  32. In re Phenylpropanolamine Products Liability Litigation, 208 F.R.D. 625 (W.D. Wash. June 5, 2002) (PPA – personal injury, increased risk of injury, emotional distress from increased risk).  Nationwide and statewide class certification denied.  No proper class definition due to plaintiff-specific variations.  No predominance due to multiple products and plaintiff-specific variations.  No limited fund or other mandatory class.
  33. Lewallen v. Medtronic USA, Inc., 2002 WL 31300899 (N.D. Cal. Aug. 28, 2002) (AneuRx stent – medical monitoring, fraud).  Nationwide class certification denied.  No medical monitoring injunctive class due to monetary damages.  No predominance due to plaintiff-specific variations and multiple state laws.  No superiority.
  34. In re Rezulin Products Liability Litigation, 210 F.R.D. 61 (S.D.N.Y. Sept. 12, 2002) (Rezulin – personal injury, economic loss, medical monitoring, fraud, restitution).  Nationwide class certification denied.  No predominance due to plaintiff-specific variations particularly causation and reliance, and economic loss and multiple state laws.  No superiority.  No medical monitoring injunctive class due to monetary damages.  No medical monitoring subclass due to plaintiff-specific variations and multiple state laws.  Reconsideration denied, In re Rezulin Products Liability Litigation, 224 F.R.D. 346 (S.D.N.Y. 2004) (no medical monitoring injunctive class).
  35. Foister v. Purdue Pharma Co., 2002 WL 1008608 (E.D. Ky. Feb. 26, 2002) (Oxycontin – personal injury).  Nationwide class certification denied.  Improper class definition due to plaintiff-specific variations.  No numerosity.  No commonality, typicality, and adequacy due to plaintiff-specific variations.
  36. Gevedon v. Purdue Pharma Co., 212 F.R.D. 333 (E.D. Ky. Oct. 17, 2002) (Oxycontin –personal injury).  Statewide class certification denied.  Improper class definition due to plaintiff-specific variations.  No adequacy because class representatives not within class definition.  No numerosity.  No typicality and adequacy due to plaintiff-specific variations.
  37. In re Paxil Litigation, 212 F.R.D. 539 (C.D. Cal. Jan. 13, 2003) (Paxil – personal injury, medical monitoring, economic loss, fraud).  Multistate class certification denied.  No issue certification due to multiple state laws.  No proper class definition, manageability, typicality, and adequacy due to plaintiff-specific variations.  No predominance due to plaintiff-specific variations, particularly causation.  No superiority.  No injunctive or punitive damages subclasses.  No limited fund.
  38. In re Phenylpropanolamine (PPA) Products Liability Litigation, 214 F.R.D. 614 (W.D. Wash. Feb. 7, 2003) (PPA – economic loss).  Nationwide class certification denied.  No manageability due to proof of injury and multiple products.  No fluid recovery.  No superiority.
  39. Benner v. Becton Dickinson & Co., 214 F.R.D. 157 (S.D.N.Y. March 28, 2003) (needles – personal injury, emotional distress).  Statewide class certification denied.  No commonality and typicality due to multiple products.  No predominance due to plaintiff-specific variations.  No issue certification.  No superiority.
  40. In re Paxil Litigation, 218 F.R.D. 242 (C.D. Cal. Aug. 29, 2003) (Paxil – economic loss/consumer fraud).  Equitable and causation nationwide issue subclass certification denied.  No typicality and adequacy due to lack of cohesion.  No equitable subclass due to monetary damages.  No issue certification.
  41. In re Baycol Products Liability Litigation, 218 F.R.D. 197 (D. Minn. Sept. 17, 2003) (Baycol – personal injury, medical monitoring, economic loss).  Nationwide class certification denied.  No typicality due to plaintiff-specific variations.  No adequacy.  No predominance due to multiple state laws and plaintiff-specific variations.  No issue certification.  No superiority.  No medical monitoring class due to multiple state laws and plaintiff-specific variations.  No restitution class due to plaintiff-specific variations.  No punitive damages class.
  42. Perez v. Metabolife International, Inc., 218 F.R.D. 262 (S.D. Fla. Sept. 26, 2003) (ephedra – medical monitoring).  Nationwide and statewide medical monitoring class certification denied.  Improper class definition due to plaintiff-specific variations and multiple state laws.  No commonality, typicality, adequacy, predominance, and superiority due to plaintiff-specific variations.  No injunctive or other mandatory class.  No conditional certification.
  43. Wethington v. Purdue Pharma L.P., 218 F.R.D. 577 (S.D. Ohio Sept. 30, 2003) (Oxycontin – personal injury).  Multistate class certification denied.  No commonality due to plaintiff-specific variations, particularly learned intermediary.
  44. Harris v. Purdue Pharmaceuticals L.P., 218 F.R.D. 590 (S.D. Ohio Sept. 30, 2003) (Oxycontin – medical monitoring).  Nationwide class certification denied.  No commonality or cohesiveness due to plaintiff-specific variations, particularly learned intermediary.
  45. Campbell v. Purdue Pharma, L.P., 2004 WL 5840206, slip op. (E.D. Mo. June 25, 2004) (Oxycontin – personal injury, medical monitoring).  Statewide class certification denied.  No commonality, typicality, adequacy, predominance, and superiority due to plaintiff-specific variations.  No injunctive or other mandatory class.  No medical monitoring injunctive class due to monetary damages.
  46. Bostick v. St. Jude Medical, Inc., 2004 WL 3313614 (W.D. Tenn. Aug. 17, 2004) (Symmetry aortic connector – medical monitoring, personal injury).  Nationwide and statewide class certification denied.  No commonality due to multiple state laws.  No standing due to Tennessee’s rejection of medical monitoring.  No proper class definition, typicality and adequacy due to plaintiff-specific variations.
  47. Zehel-Miller v. AstraZenaca Pharmaceuticals, L.P., 223 F.R.D. 659 (M.D. Fla. Aug. 25, 2004) (Seroquel – medical monitoring, economic loss).  Nationwide class certification denied.  No medical monitoring injunctive class due to monetary damages.  No medical monitoring class due to multiple state laws and plaintiff-specific variations defeating cohesiveness.  No refund class due to multiple state laws and plaintiff-specific variations.
  48. In re Factor VIII or IX Concentrate Blood Products Litigation, 2005 WL 497782 (N.D. Ill. March 1, 2005) (blood products – personal injury, fraud).  Worldwide class certification denied.  No issue certification due to multiple state/national laws and undue settlement pressure.
  49. Foster v. St. Jude Medical, Inc., 229 F.R.D. 599 (D. Minn. July 26, 2005) (Symmetry bypass connector – medical monitoring).  Nationwide class certification denied.  No adequacy due to claim splitting.  No predominance due to multiple state laws.  No superiority due to improper class definition incorporating plaintiff-specific variations.  No injunctive medical monitoring class due to lack of cohesiveness.
  50. In re Prempro Products Liability Litigation, 230 F.R.D. 555 (E.D. Ark. Aug. 30, 2005) (hormone replacement therapy – medical monitoring, economic loss/consumer fraud).  Multistate class certification denied.  No manageability or superiority due to multiple state laws.  No predominance and cohesiveness due to multiple state laws and plaintiff-specific variations, particularly reliance.
  51. Dumas v. Albers Medical, Inc., 2005 WL 2172030 (W.D. Mo. Sept. 7, 2005) (counterfeit Lipitor – economic loss/consumer fraud/RICO).  Nationwide class action denied.  No predominance due to plaintiff-specific variations.  No manageability due to lack of proper class definition.  No fluid recovery.
  52. In re St. Jude Medical, Inc., 425 F.3d 1116 (8th Cir. Oct. 12, 2005) (Silzone heart valve – medical monitoring, economic loss/consumer fraud).  Certification of nationwide class reversed.  Failure to conduct choice of law analysis.  No medical monitoring class due to plaintiff-specific variations.
  53. Sweet v. Pfizer, 232 F.R.D. 360 (C.D. Cal. Nov. 15, 2005) (Mirapex – personal injury, loss of consortium, economic loss).  Nationwide and statewide class certification denied.  No typicality and superiority due to plaintiff-specific variations.  No adequacy due to counsel’s incompetence.  No predominance due to multiple state laws.  No mandatory class due to lack of cohesiveness.  No loss of consortium subclass.
  54. Sanders v. Johnson & Johnson, 2006 WL 1541033 (D.N.J. June 2, 2006) (Intergel adhesion prevention solution – personal injury, medical monitoring).  Nationwide class certification denied.  No predominance and cohesiveness due to multiple state laws and plaintiff-specific variations.
  55. In re Vioxx Products Liability Litigation, 239 F.R.D. 450 (E.D. La. Nov. 22, 2006) (Vioxx – personal injury).  Nationwide class certification denied.  No typicality, adequacy, predominance, and superiority due to multiple state laws and plaintiff-specific variations, particularly causation and damages.  No issue certification.
  56. Blain v. Smithkline Beecham Corp., 240 F.R.D. 179 (E.D. Pa. Jan. 25, 2007) (Paxil – personal injury).  Nationwide class certification denied.  No commonality, typicality, adequacy, and predominance due to plaintiff-specific variations.  No superiority.  No manageability due to multiple state laws.  No issue certification.
  57. Miller v. Janssen Pharmaceutica Products, L.P., 2007 WL 1295824 (S.D. Ill. May 1, 2007) (Duragesic patch – personal injury, economic loss/consumer fraud).  Nationwide class certification denied.  Improper class definition due to plaintiff-specific variations.  No predominance or manageability due to plaintiff-specific variations, particularly causation, damages, and reliance.
  58. In re Neurontin Marketing & Sale Practices Litigation, 244 F.R.D. 89 (D. Mass. Aug. 29, 2007) (Neurontin – economic loss/consumer fraud/RICO).  Nationwide class certification denied.  No predominance due to plaintiff-specific variations, particularly learned intermediary and causation/reliance.  Improper class definition due to plaintiff-specific variations.
  59. In re Aredia & Zometa Products Liability Litigation, 2007 WL 3012972 (M.D. Tenn. Oct. 10, 2007) (Aredia/Zometa – medical monitoring).  Multistate certification denied.  Improper class definition due to plaintiff-specific variations.  No typicality and adequacy due to multiple state laws and plaintiff-specific variations.
  60. In re Fosamax Products Liability Litigation, 248 F.R.D. 389 (S.D.N.Y. Jan. 3, 2008) (Fosamax – medical monitoring).  Statewide certification denied.  Improper class definition due to plaintiff-specific variations.  No typicality and predominance due to plaintiff-specific variations.  No adequacy due to plaintiff-specific variations and claim splitting.  No superiority and manageability.
  61. Krueger v. Wyeth, Inc., 2008 WL 481956 (S.D. Cal. Feb. 19, 2008) (hormone replacement therapy – economic loss/consumer fraud).  Statewide certification denied.  No adequacy due to claim splitting.
  62. St. Jude Medical, Inc., Silzone Heart Valve Products Liability Litigation, 522 F.3d 836 (8th Cir. Apr. 9, 2008) (Silzone heart valve – economic loss/consumer fraud).  Nationwide class certification reversed.  No predominance due to plaintiff-specific variations, particularly reliance and causation.  No issue certification.
  63. In re Baycol Products Litigation, 265 F.R.D. 453 (D. Minn. Aug. 25, 2008) (Baycol – economic loss/consumer fraud).  Statewide certification denied.  No predominance due to plaintiff-specific variations, particularly causation.
  64. Ballew v. Matrixx Initiatives, Inc., 2008 WL 4831481 (E.D. Wash. Oct. 31, 2008) (Zicam – personal injury, economic loss/consumer fraud).  Statewide issue certification denied.  Single abstract question does not create commonality, typicality, adequacy, and predominance.  No mandatory class certification.  No injunctive class due to monetary damages.  No superiority.
  65. Thompson v. Bayer Corp., 2009 WL 362982 (E.D. Ark. Feb. 12, 2009) (Vitamins – economic loss/unjust enrichment).  Nationwide class certification denied.  No predominance and superiority due to multiple state laws.
  66. In re Neurontin Marketing, Sales Practices & Products Liability Litigation, 257 F.R.D. 315 (D. Mass. May 13, 2009) (Neurontin – economic loss/consumer fraud/RICO/unjust enrichment).  Nationwide class certification denied.  No predominance due to plaintiff-specific variations, particularly causation and learned intermediary.  No fraud on the market.  Reconsideration denied, slip op. (D. Mass. May 17, 2011).
  67. In re St. Jude Medical Inc. Silzone Heart Valves Products Liability Litigation, 2009 WL 1789376 (D. Minn. June 23, 2009) (Silzone heart valve – economic loss/consumer fraud/omissions).  Nationwide class allegations stricken.  No predominance due to plaintiff-specific variations, particularly causation and reliance.
  68. Thompson v. Bayer Corp., 2009 WL 2424352 (E.D. Ark. Aug. 6, 2009) (Vitamins – economic loss/unjust enrichment).  Statewide class certification denied.  No predominance due to plaintiff-specific variations, particularly reliance.
  69. Solo v. Bausch & Lomb Inc., 2009 WL 4287706 (D.S.C. Sept. 25, 2009) (contact lens solution – economic loss/consumer fraud/unjust enrichment).  Statewide class certification denied.  Improper class definition due to plaintiff-specific variations.
  70. In re Panacryl Sutures Products Liability Cases, 263 F.R.D. 312 (E.D.N.C. Nov. 13, 2009) (Panacryl absorbable sutures – personal injury).  Nationwide class certification denied.  No typicality and adequacy due to multiple state laws.  No predominance and superiority due to multiple state laws and plaintiff-specific variations.  No issue certification.  Reconsideration was denied at 2010 WL 3081389 (E.D.N.C. Aug. 1, 2010), again rejecting issue certification for multiple state-specific subclasses.
  71. In re Digitek Products Liability Litigation, 2010 WL 2102330 (S.D.W. Va. May 25, 2010) (Digitek – economic loss/consumer fraud).  Nationwide and statewide class certification denied.  No typicality and adequacy due to plaintiff-specific variations and multiple state laws.  No predominance due to plaintiff-specific variations.  No superiority.
  72. Sergeants Benevolent Assn. Health & Welfare Fund v. Sanofi-Aventis U.S. LLP, 2011 WL 824607, slip op. (E.D.N.Y. Feb. 16, 2011) (Ketek – economic loss/consumer fraud/RICO/unjust enrichment).  Nationwide class certification denied.  No predominance due to plaintiff-specific variations, particularly causation and learned intermediary.
  73. In Re Yasmin & Yaz (Drospirenone) Marketing, Sales Practices & Relevant Products Liability Litigation, ___ F.R.D. ___, 2011 WL 1692163, slip op. (S.D. Ill. May 4, 2011) (Yasmin/Yaz – personal injury).  Nationwide class action allegation struck.  No predominance due to plaintiff-specific variations and multiple state laws.  No issue certification.
  74. Rader v. Teva Parenteral Medicines, Inc.276 F.R.D. 524 (D. Nev. Oct. 5, 2011) (propofol - medical monitoring).  Class action of all persons allegedly exposed to pathogens at particular clinic denied.  No proper class definition due to plaintiff-specific variations.  No adequacy due to class representative's bankruptcy and claim splitting.  No predominance due to multiple products and plaintiff-specific variations.
  75. In re Yasmin & Yaz Marketing, Sales Practices & Products Liability Litigation, MDL No. 2100, 2012 WL 865041 (S.D. Ill. March 13, 2012) (Yasmin/Yaz – economic loss/consumer fraud).  No adequacy due to class representative's close ties to plaintiff's counsel.  No properly defined class.  No typicality or predominance to plaintiff-specific variations, particularly reliance, causation, and learned intermediary.
  76. Haggart v. Endogastric Solutions, Inc., 2012 U.S. Dist. Lexis 89767 (W.D. Pa. June 28, 2012) (EsophyX – personal injury).  Nationwide class certification denied.  No typicality due to most procedures being successful.  No injunctive class due to monetary nature of relief and injunctive relief not benefiting class members.  No predominance or superiority due to plaintiff-specific variations.  Alternative class failed due to lack of proper class definition and lack of numerosity.
  77. In re Celexa & Lexapro Marketing & Sales Practices Litigation, 291 F.R.D. 13 (D. Mass. Feb. 5, 2013).  Nationwide and statewide (California) class certification denied.  No superiority for nationwide classes due to multiple state laws.  No predominance in California statewide action due to plaintiff-specific variations.

Wednesday, June 23, 2010

SPILL Act Spills Over: An Intended Consequence?

We’re off to cheer on the United States in the World Cup, but first we wanted to share this recent proposed legislation. The Securing Protections for the Injured from Limitations on Liability Act (or SPILL Act) is sponsored by Representative John Conyers. As the acronym suggests, it relates to the Gulf Coast oil spill. It is ostensibly designed to amend the Death on High Seas Act, a century-old law, to allow families of the deceased oil workers to recover non-pecuniary damages such as pain and suffering, and loss of care, comfort, and companionship.

So what does the SPILL Act have to do with drug and device law? As it turns out, quite a bit. Tucked into the SPILL Act is Section 5, an “Amendment to Class Action Fairness Act.” This proposed amendment redefines “class action” to exclude actions “brought by a State or subdivision of a State on behalf of its citizens.” In other words, the amendment would allow state AGs to avoid federal jurisdiction – which is appropriate in most class action contexts, thanks to the Class Action Fairness Act (CAFA) – and try to maximize their home field advantage by pursuing parens patriae actions in state court.

Those of you who have been paying attention might remember that we blogged about this issue a month ago, when a federal court here in the Eastern District of Pennsylvania (properly) recognized that a West Virginia parens patriae action should stay in federal court because it was just a dressed-up class action. But this proposed amendment, buried in the middle of the SPILL Act, would undo that decision and allow state AGs to continue flag-waving in their home courts.

Congress passed CAFA, and it has the power to amend the act to exclude parens patriae actions from CAFA’s jurisdictional reach. If you want to look at this in a “glass half full” way, the amendment confirms that CAFA as currently constructed can apply to parens patriae actions – so if the bill fails (or this proposed amendment is stricken), parens patriae actions should continue to be largely subject to federal jurisdiction. Overall, though, we say thumbs down to the amendment. Fundamentally, we don’t like supercharging state AG actions by allowing them to proceed in a potentially partisan forum. There's also something a bit sly about trying to sneak this amendment through on the coat-tails of a bill that ostensibly has a different focus. The preamble says it best – this is a proposed bill “[t]o revise laws regarding liability in certain civil actions arising from maritime incidents, and for other purposes.” Those nebulous “other purposes” appear to include efforts to rewrite CAFA so broadly that state AGs can escape federal jurisdiction in any parens patriae case. Sure, the state AGs would rather litigate parens patriae actions relating to the oil spill in state court – but if the bill passes, they’ll also be able to litigate their parens patriae drug and device cases in state court. And we realize we’re spitting in the wind here, because riders are a time-honored Congressional tradition…but it doesn’t mean we have to like it.

Tuesday, June 22, 2010

Pennsylvania Punts Pain Pump Plaintiff’s Postponed Pleading

One side effect of the Judicial Panel on Multidistrict Litigation’s refusal to make the pain pump cases an MDL is that many different courts are ruling on the inadequacy of the pain pump complaints. The Western District of Pennsylvania took its turn last week in Kester v. Zimmer Holdings, Inc., 2010 U.S. Dist. LEXIS 59869 (W.D. Pa. June 16, 2010). The opinion contains a few useful rulings.

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.

Monday, June 21, 2010

Standing Up To Pain Pump Litigation

We don't subscribe to the theory of collective conscience, though when Julie Delpy talks about it in Waking Life it's hard to disagree. Still, there are times when you find yourself repeatedly stumbling against the same idea in ways that seem beyond coincidence. Last week we praised a federal judge in New Jersey who sent Intron plaintiffs packing for want of standing. The week before, we blogged about potential TwIqbal misfires, including one painful pain pump case. And before that, we've discussed the various ways courts deal with pain pump plaintiffs' stubborn refusal to identify the products that allegedly caused injury. Some courts have made plaintiffs identify the products, applying our TwIqbal friend. Some, sadly and bafflingly, don't. And some act the slacker and merely await discovery. Then somebody sent us a nice decision out of the Northern District of Texas that applied the standing requirement to pain pump litigation. It's a ruling that visits pain on plaintiff lawyers who don't identify the relevant products. Guess what? We like it.

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 TwIqbal cheatsheet. Whether you think that's cheating or not, add standing to the armamentarium, right next to TwIqbal, when taking aim at sloppy complaints.

Friday, June 18, 2010

Scholarship We Can Use

Everybody knows the excuses that courts use to justify imposing - and expanding - product liability:  (1) It induces the manufacture of safer products; (2) it causes the prices of products to reflect their "true" cost by internalizing risk; (3) victims will be compensated for their losses.  Courts say these things all the time, but is there really any support - actual, real life support, not just circular citations to other cases - for any of them?

We've never seen any.

A recent article in the Harvard Law Review discusses what the authors found when they actually went out and looked for empirical support for these three hoary tort platitutes.  Guess what?  There isn't any.  Quite the opposite, actual studies of the cost/benefit ratio of product liability demonstrate the opposite - that due to the externalities of product liability litigation, litigation doesn't actually confer any measurable safety benefits over other alternatives.  Polinsky & Shavell, "The Uneasy Case For Product Liability," 124 Harv. L. Rev. 1437 (April 2010).  We also found a copy on the Cantabs' website, here.

Here's the authors's summary of the findings of their article:
In this Article we compare the benefits of product liability to its costs and conclude that the case for product liability is weak for a wide range of products.  One benefit of product liability is that it can induce firms to improve product safety.  Even in the absence of product liability, however, firms would often be motivated by market forces to enhance product safety because their sales may fall if their products harm consumers.  Moreover, products must frequently conform to safety regulations.  Consequently, product liability might not exert a significant additional influence on product safety for many products - and empirical studies of several widely sold products lend support to this hypothesis.  A second benefit of product liability is that it can improve consumer purchase decisions by causing product prices to increase to reflect product risks.  But because of litigation costs and other factors, product liability may raise prices excessively and undesirably chill purchases.  A third benefit of product liability is that it compensates victims of product-related accidents for their losses.  Yet this benefit is only partial, for accident victims are frequently compensated by insurers for some or all of their losses.  Furthermore, the award of damages for pain and suffering tends to reduce the welfare of individuals because it effectively forces them to purchase insurance for a type of loss for which they ordinarily do not wish to be covered.  Opposing the benefits of product liability are its costs, which are great.  Notably, the transfer of a dollar to a victim of a product accident through the liability system requires more than a dollar on average in legal expenses.  Given the limited nature of the benefits and the high costs of product liability, we come to the judgment that its use is often unwarranted.  This is especially likely for products for which market forces and regulation are relatively strong, which includes many widely sold products. Our generally skeptical assessment of product liability for such products is in tension with the broad social endorsement of this form of liability.
Id. (emphasis added).

here aren't many law review articles that we think that practicing defense litigators in product liability really need to read - but this is one of them.  If you've got somebody on the other side spouting these platitudes, this article provides the best counter we've seen in quite some time.

Thursday, June 17, 2010

On Substantive Due Process

We’ve posted quite a bit on the substantive due process aspects of punitive damages. Other than that, we frankly hadn’t thought about substantive due process being applicable to other aspects of product liability litigation.


Well, it’s time to start thinking.

A decision has just come down that accepts the argument that the expansion of state common-law tort liability can be so overreaching and so contrary to settled legal expectations as to violate a defendant's right to due process.  See Gibson v. American Cyanamid, Inc., slip op. (E.D. Wisc. June 15, 2010).

We’re particularly pleased with Gibson because it dispatched one of our longest-standing bête noirs – market share liability.  When Bexis first encountered the market share liability concept way back in law school, he was so offended by it that he put on his “to do” list making sure that Pennsylvania never adopted such a cockamamie theory.  Mission pretty much accomplished:  see Skipworth v. Lead Industries Ass’n, 690 A.2d 169 (Pa. 1997) (represented amicus PLAC); City of Philadelphia v. Lead Industries Ass’n, 994 F.2d 112 (3d Cir. 1993) (same).

Then Bexis took that show on the road, with more mixed results.  He won a diethylstibestrol (DES) case in Ohio (Sutowski v. Eli Lilly & Co., 696 N.E.2d 187 (Ohio 1998)) and a gun case in New York (Hamilton v. Beretta USA Corp., 750 N.E.2d 1055 (N.Y. 2001).  But when Bexis took his act to Wisconsin, he got his head handed to him in Thomas v. Mallett, 701 N.W.2d 523 (Wis. 2005).  Bexis’ ears are still ringing from that one.  He didn’t know it at the time, but Thomas was part of a more generalized running amok of a pro-plaintiff majority on the Wisconsin Supreme Court in 2005-06 – for more about that go here.

Which brings us back to Gibson – because the wholesale expansion of market share liability to non-fungible products in Thomas is what was just declared unconstitutional in Gibson.  Both Thomas and Gibson arise from lead paint pigment litigation.  In that litigation plaintiffs have sought to leverage their self-inflicted (because they choose to sue only raw lead-based pigment manufacturers rather than identifiable paint stores or paint manufacturers) inability to identify product manufacturers as an excuse for doing away with product identification as an essential element of causation.  Thomas was their one big win.

An aside (another one) – you may be wondering what does this have to do with drugs and medical devices?  It does.  Market share liability was first imposed in prescription drug litigation involving DES, and plaintiffs have tried to extend it to other drug and vaccine cases ever since (we expect it will rear its ugly head in pain pump cases when plaintiffs have to put up or shut up). So, yeah, it’s relevant.

Market share liability was created to deal with a generic drug problem before anybody had ever heard the term "generic drug".  As originally applied, it was limited to chemically identical products. That changed in Thomas, which imposed a version of market share liability on a motley selection of lead-based chemicals, none of which was used in residential house paint after 1974 – at least.  Here’s how the Gibson court described what happened in Thomas:

Thomas was a dramatic and novel departure from established legal principles.  The Wisconsin Supreme Court . . . relied upon Article I, Section 9 of the Wisconsin Constitution, which states, in pertinent part, that every person is “entitled to a certain remedy in the laws for all injuries, or wrongs which he may receive in his person, property, or character.”  By reading a due process standard into this section, the court found that the injured Thomas should not be foreclosed from recovery simply because he could not prove causation.  In essence and effect, when the court’s view of due process requires it, every person is “entitled to a certain remedy for all injuries.” When an adequate remedy does not exist to “provide due process, the courts, under the Wisconsin Constitution, can fashion an adequate remedy."
Slip op. at 2.

Ordinarily, unless there’s legislative tort reform (not likely in Wisconsin), that’s been the end of it.  No matter what how idiotic the common-law tort theory – strict liability, market share liability, malfunction theory, medical monitoring, public nuisance – once a state’s high court adopts it, well they never go back, do they?  Pro-plaintiff courts play by one rule, “what’s mine is mine; what’s yours is negotiable.”

Well, wonder of wonders!  In Gibson the court discovered that defendants have due process rights, too – and the defendants’ rights under the federal constitution trump (dare we whisper, “preempt”) the weird universal right to recover that Thomas extracted from the poor, mistreated Wisconsin constitution.

In Gibson the court concluded that defendants are protected by Due Process from excessive retroactive tinkering with the law under the Supreme Court’s decision in Landgraf v. USI Film Products, 511 U.S. 244 (1994).  Slip op. at 23.  Landgraf was one of these decisions in which the Court splintered every which way, and one has to count votes carefully to figure out what it stands for.  Landgraf involved a congressional statute affecting the coal industry’s responsibility for certain injuries suffered by retirees a long, long time before.  It assigned responsibility for medical insurance for over 1000 retirees to a company that had been out of the coal business for a quarter century – to the tune of an extra $5 million a year.

Landgraff found that to be a constitutional no-no – but by the infamous score of 4-1-4 (anybody remember Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996)?).  Four justices (two of whom are no longer on the Court) were of the view that the retroactive imposition of all this additional liability violated the Taking Clause.  511 U.S. at 534-37 (statute unconstitutionally operated “retroactively, divesting [plaintiff] of property long after the company believed its liabilities . . . to have been settled”) (O’Connor, J., et al.).  Another justice took the position that, for essentially the same reason, the statute violated Due Process (but not the Taking Clause).  Id. at 548 (a retroactive law that “change[s] the legal consequences of transactions long closed . . . can destroy the reasonable certainty and security which are the very objects of property ownership”) (Kennedy concurring).  Four other justices, in dissent as to the result, agreed with Justice Kennedy that retroactive acts could give rise to Due Process problems:

[Due process] can offer protection against legislation that is unfairly retroactive at least as readily as the Takings Clause might, for as courts have sometimes suggested, a law that is fundamentally unfair because of its retroactivity is a law that is basically arbitrary. . . .
To find that the Due Process Clause protects against this kind of fundamental unfairness – that it protects against an unfair allocation of public burdens through this kind of specially arbitrary retroactive means – is to read the Clause in light of a basic purpose: the fair application of law, which purpose hearkens back to the Magna Carta.
Id. at 557-58 (various citations omitted) (Breyer, J, et al.). These four, however, found that the retroactivity wasn’t bad enough to be unconstitutional, because the company had, in its past life, actually employed the miners in question.  Id. at 560-61.

As Gibson read Landgraff, there were five definite votes for retroactive imposition of liability being unconstitutional if the person ordered ld to pay didn’t have a sufficient nexus to the liability being imposed.  There were four other votes for retroactive liability being a governmental taking, and thus unconstitutional.  Slip op. at 25-26.

Gibson made quick work of that purported distinction between the statute in Landgraff and a common-law scheme of the sort at issue in Thomas.  “The federal guaranty of due process extends to state action through its judicial as well as through its legislative, executive, or administrative branch of government.”  Slip op. at 23 (quoting Shelley v. Kramer, 334 U.S. 1, 15 (1948)).  “State power may be exercised as much by a jury’s application of a state rule of law in a civil lawsuit as by a statute.”  Id. (quoting BMW, Inc. v. Gore, 517 U.S. 559, 573 n.17 (1996)).

Having thus set the table, Gibson proceeds to sweep Thomas away.  The expansion of market share liability was undoubtedly retroactive – imposing unprecedented liability for products that had been sold many decades earlier, with no maximum limit.  Slip op. at 30 (“the risk contribution rule is retroactive because it attaches new legal consequences to . . . manufacturing operations that occurred between 1936 and 1946”).

The effect of Thomas was also severe, since the cumulative effect of the additional liability could amount to many millions of dollars, which was of the same magnitude as the retroactive liability declared unconstitutional in LandgraffSlip op. at 29-30.

Thomas targeted a disfavored class of “unpopular groups or individuals.”  Slip op. at 30-31.  Gibson didn’t go into detail, but it didn’t really have to.  All one has to do is read the lengthy hatchet-job (called a “backdrop”) that Thomas did on the lead pigment industry, 701 N.W.2d at 533-48, to know that the decision was designed as a form of judicial retribution.

Thomas also upset settled expectations. The decision greatly altered contractual assumptions of liability that were decades old in a way that was “impossible” to anticipate.  Slip op. at 31.

The liability imposed by Thomas was disproportionate.  Quick and dirty is what market share liability is all about. It makes defendants liable for injuries allegedly inflicted by products that they never made or had anything to do with.  Slip op. at 31-32.

The liability imposed in Thomas also was arbitrary and irrational.  We sure think so.  Again, because it was a form of market share liability, the effect of Thomas was a massive creation of liability towards persons as to whom there was utterly no evidence of any contact with any defendant’s product:

The [product] that allegedly injured [plaintiff] could have been applied at any time during [an] expansive time period, even when [defendant] was no longer producing or marketing white lead carbonate. This raises a substantial possibility that defendants not only could be held liable for more harm than they actually caused, but also could be held liable when they did not, in fact, cause any harm to plaintiff at all.
Slip op. at 33.

Finally, the court found additional Due Process support in the Supreme Court’s punitive damages decisions – specifically those portions of State Farm Mutual Automobile Insurance Co. v. Campbell, 538 U.S. 408 (2003), and Philip Morris USA v. Williams, 549 U.S. 346 (2007), that require punitive damages to be imposed solely for harm caused to the specific plaintiff before the court:

[W]hether the damages in a risk contribution case are considered compensatory or punitive is not particularly relevant to the due process concerns expressed in State Farm and Philip Morris.  These cases stand for the principle that it violates due process to impose damages for the wrongful conduct of others.  Stated another way, it violates due process when there is no nexus or provable connection between a damages award and the harmful conduct of the defendant.  When liability is imposed under the risk contribution rule, the end result is the same as that condemned in State Farm and Philip Morris.
Slip op. at 37 (emphasis added).

Wow.  This is good enough that we went and dug up a copy of the defense brief, so everybody can see just how this was done.

We’re so accustomed to seeing Due Process arguments raised by plaintiffs trying to get tort reform declared unconstitutional, that you’ll have to forgive us for just stopping and gawking for a minute….

OK, we’re done now.

We’ll have to see how well Gibson survives inevitable appellate review, but we have to admit that the decision’s got possibilities.  We only wish we’d had it when Sindell v. Abbott Laboratories, 607 P.2d 924 (Cal. 1980), was first decided.  We might well have been spared the monstrosity of market share liability altogether.

But there’s more potential than that.  If Gibson holds up on further review, we can think of a whole judicial rogue’s gallery of grossly expansive liability theories that we’d like clear out – starting with West Virginia v. Karl, 647 S.E.2d 899 (W. Va. 2007), and Conte v. Wyeth, Inc., 85 Cal. Rptr. 3d 299 (Cal. App. 2008).   Speaking of West Virginia, Gibson's "upset settled expectations" rationale holds promise as a Due Process counter to forum-friendly choice of law doctrines that have tempted forum-shopping plaintiffs to bring out-of-state cases in West Virginia courts in the hope getting West Virginia's anti-learned intermediary law applied to cases having no factual connection with the state - something we've bemoaned here.

Then there’s public nuisance, medical monitoring, and who knows maybe bizarre extensions of “unjust enrichment” liability.

But let's not react like kids in a candy store just yet.  That’s all for the future.  Right now we’re more than happy enough to see that Due Process can apply to to kill off market share liability.

Wednesday, June 16, 2010

Diggin' Digitek

First the Digitek MDL gave us a new weapon – the “Digitek Order” – to ensure plaintiffs’ counsel comply with their Rule 11 obligations to actually investigate their clients’ claims before filing thousands of cases. Novel concept, right? And now we have another helpful opinion – a new decision out of the MDL denying class certification. See In re Digitek Prods. Liab. Litig., 2010 WL 2102330 (S.D. W. Va. May 25, 2010).

There were a number of putative consumer class actions lurking in the MDL, all of them (essentially) seeking “economic damages:” items like refund of co-pays and money for doctors’ check-ups following the recall of Digitek. See In re Digitek, 2010 WL 2102330, at *2. The putative classes disavowed any request for personal injury or medical monitoring damages in the class actions, although there were some bizarre damage claims lurking in the class (New glasses? Toll charges? Insurance premiums? The cost of two enemas? This is an example of not wanting to pick up that class action rock to see what funky individual issues are living underneath.) Id. at *2 n.2, 18.

The plaintiffs sought certification of nationwide classes to pursue consumer fraud, warranty, and unjust enrichment claims – the typical passel of “economic damage” claims that we’re accustomed to seeing in these class actions. The first issue the court tackled, of course, is a biggie in class certification: choice of law. If 50 different states’ laws apply, it is a lot harder to get a class certified. So of course, the plaintiffs argued that all class members could and should proceed under New Jersey law; in the alternative, the Digitek plaintiffs were graciously willing to proceed with individual state classes. Id. at *5.

The plaintiffs’ choice-of-law workaround didn’t fly with the court. To its credit, the court spent a lot of time looking at the issue, analyzing and applying the choice-of-law rules of four transferor jurisdictions (the four jurisdictions from whence the putative class actions came – and no, Tartarus was not one of those jurisdictions). See generally id. at *8-12. That analysis, in turn, revealed:

(1) There are conflicts in the various state laws governing consumer fraud, warranty, and unjust enrichment. Id. at *8-9. No surprise there, although plaintiffs always argue to the contrary.

(2) Under the choice-of-law rules of Kansas, Kentucky, New Jersey, and West Virginia, the states of injury – i.e., the class members’ home states – was a significant factor suggesting those states’ laws should apply. See id. at *9-12.

Having decided that the laws of all 50 states applied, the court could have just ruled that individual issues predominated over class issues and called it a day. Instead, however, the court went on to analyze in more detail the individual problems plaguing these putative class actions. Typicality was the first significant speedbump. The court framed the typicality question helpfully; “plaintiff’s claim cannot be so different from the claims of absent class members that their claims will not be advanced by plaintiff’s proof of his own individual claim.” Id. at *14. Putting aside the obvious legal differences in the class claims that arose from the court’s choice-of-law analysis, there were also factual differences that troubled the court, particularly those weird damage claims we mentioned earlier. Id. at *15. Both the legal and factual differences doomed the plaintiffs’ attempt to establish typicality. Id.

The court also took several shots at the plaintiffs’ predominance arguments. The plaintiffs listed a litany of supposed “common issues” that predominated over any individual issues – or so the plaintiffs thought. Id. at *15-16. The court systematically critiqued and dismantled these “common issues,” observing that many of the identified issues were “drawn too broadly” or “not issues at all.” Id. at *15. For example, the question of whether the defendants violated any consumer fraud acts was not a “common” question; rather, it required the court to consider whether each putative class member suffered an “ascertainable loss” and if so, whether there was a “causal relationship” between the loss and the defendants’ conduct. Id. at *16. Those are really central questions in any consumer fraud case, and it is nice to see a court getting after it at the class cert stage, instead of just sweeping those individual questions under the rug or kicking them down the road for later resolution. This is a fine example of the rigorous analysis that every court should undertake at the class certification stage:


“[T]he representatives must concede that a number of their fellow class members used nearly all of their Digitek supply just prior to the recall. After doing so, they experienced a physical benefit far outweighing any minimal economic loss associated with discarding the remaining dose or few doses they had left…Additionally, those class members who visited their doctors following the recall might have been experiencing generalized symptoms that would have prompted the visit anyway. The highly individualized inquiry associated with separating the wheat from the chaff in just these two areas alone diminishes much of the hoped-for benefit from using the class device.”
Id. at *16.

Gotta love that quote. Other individual issues disguised as common issues? You bet. How about the defendants’ conduct in designing, manufacturing, and selling Digitek? The court concluded this was a “counterfeit” common issue “not at all divorced from the particular claim being analyzed.” Id. at *17. In other words, double-dipping. How about product ID? Also not common, given some “lingering” factual issues arising from the depositions of class representatives. Id. Instead, the court envisioned a nightmare of “individualized investigative work as to each class member” to determine who actually took Digitek. Id. What about damage to the putative class? Again, an individual issue because of the “vast array of individualized damages the representative or their predecessors seek,” the need to sort out putative class members who were already fully compensated via a refund, and the need to analyze on an individual basis whether any third-party actors were “independent cause[s] of economic damages suffered.” Id. at *18. You know, intervening actors like doctors and pharmacists, nobody too important in these kinds of cases…

Finally, having found no typicality and no predominance, the court didn’t waste a lot of ink on the lack of superiority. The court mentioned briefly that a class action would derail a carefully managed MDL and coordinated state proceedings that have been moving towards bellwether trials, so we mention it too, but at this point in the opinion, it was pretty clear which way the wind was blowing – no class. Id. at *18-19. Of course, the plaintiffs haven’t been sitting tight; they recently filed a motion for reconsideration, urging the court (again) to just adopt New Jersey law wholesale to the class claims, or else certify individual state classes, and not worry about those pesky individual issues because they can all be addressed by that magical "claims administrator." Good luck with that, plaintiffs. We’re not holding our breath.

Tuesday, June 15, 2010

Hip Hip Hooray for D.N.J.

We’ve reported before on the good decisions from the federal district court in New Jersey rejecting putative class actions based on off-label marketing, including a decision earlier this year and the Intron/Temodar decision last year. The first Intron/Temodar decision gave the third-party payer plaintiffs leave to amend their complaint. They did, and the court has now found their amended complaint insufficient and dismissed the action. In re Schering-Plough Corp. Intron/Temodar Consumer Class Action, 2010 U.S. Dist. LEXIS 56613 (D.N.J. June 9, 2010) (“Intron/Temodar II”). The same day, the court also dismissed a complaint by a patient. In re Schering-Plough Corp. Intron/Temodar Consumer Class Action, 2010 U.S. Dist. LEXIS 56621 (D.N.J. June 9, 2010) (“Intron/Temodar III”). Because we have covered this litigation extensively before, we’ll just give you the highlights.

Intron/Temodar II

Intron/Temodar I held that the third party payer plaintiffs failed to allege standing – that is, their complaint did not plead facts plausibly supporting plaintiffs’ assertions that they had been injured in a way capable of remedy under the alleged causes of action or that their loss was causally connected to defendants’ alleged misconduct. 2010 U.S. Dist. LEXIS 56613 at *8. Plaintiffs’ amended complaint added a lot more noise about off-label marketing practices. Perhaps plaintiffs believed that if they tried to make defendants look really, really, really bad, the court will be bamboozled into thinking that the allegedly bad defendants should give the good plaintiffs some money.

The court was not fooled. The plaintiffs’ original complaint wasn’t dismissed because the defendants allegedly weren’t bad enough. Rather what wasn’t pleaded was that the defendants’ alleged bad conduct somehow hurt the plaintiffs. In that respect the amended complaint was just as bad, if not worse. Plaintiffs’ amended complaint never alleged actual injury because they didn’t (and no doubt couldn’t) allege that the drugs purchased by the third party payers actually were ineffective or unsafe. That the drugs were used or even marketed off label didn’t make them ineffective or unsafe. Plaintiffs tried a slightly different angle by arguing that Schering’s studies were inadequate to support its off-label marketing claims, but that angle remained obtuse. The court held that “is a far cry from pleading that the Subject Drugs were in some way not appropriate to treat a condition and fraudulently marketed by Schering to the contrary.” Id. at *28.

In other words, the third party payer was not harmed by paying for a drug absent evidence that the drug didn’t work or was unsafe. That makes sense. No one gets a refund for a product that works simply because they don’t like the ads for the product.

In addition to not alleging an actual injury, the amended complaint failed to allege facts establishing a causal connection between defendants’ conduct and the named plaintiffs’ off-label purchases. Plaintiffs asked the court to infer a connection based on the volume of off-label sales, but the court refused to do so. Id. at *32-33. Plaintiffs also filled their amended complaint with allegations that Schering committed “bribery” by paying physicians for speaking engagements and consulting agreements, but the amended complaint “does not allege that any doctor who wrote Subject Drug prescriptions for a Named Plaintiff’s beneficiary did so in return for cash or gifts from Schering.” Id. at *35.

The court concluded by roundly rejecting piggybacking. The court stressed that other governmental authorities were responsible for and had punished Schering for the alleged off-label marketing, and the third party payers’ civil case could survive only if that alleged misconduct conduct caused them injury. Id. at *36-38. Because the amended complaint did not plead facts establishing a cognizable injury traceable to the misconduct, plaintiffs had no standing to bring their claims. Id. at *38-39.

Intron/Temodar III

Unlike the third party payer plaintiffs in Intron/Temodar II, an actual consumer and patient filed the amended complaint at issue in Intron/Temodar III, but the outcome was the same. She claimed that her doctor initially did not prescribe her the subject drugs but changed his mind, which allegedly must have been caused by off-label marketing. The court reiterated what it said in 2009 – “that off-label marketing is not inherently fraudulent” – and said that plaintiff had to connect her doctor’s decision to an off-label promotional claim that was false or misleading. 2010 U.S. Dist. LEXIS 56613 at *26-27. Because she did not, she lacked standing, and her case was dismissed. Id. at *29-30.

The procedural fetishists in the audience (you know who you are) will be interested in one other aspect of the court’s ruling on this motion to dismiss: it referred repeatedly to the plaintiff’s medical records, some but not all of which were attached to the amended complaint. The court explained that it did so because the plaintiff’s medical records were “the explicit basis for many of [her] allegations” and therefore “are properly considered by the Court in adjudicating the instant motion.” Id. at *12 n.8 (citing In re Burlington Court Factory Secs. Litig., 114 F.3d 1410, 1426 (3d Cir. 1997)).

The Intron/Temodar decisions should drive another stake into plaintiffs’ idea that they are entitled to money because a company is found to have engaged in off-label marketing – a regulatory violation at most, but not deceptive or fraudulent conduct and not an actionable sin. They simply can’t get a piggyback ride on a civil penalty or even an criminal conviction for off-label marketing.

Well done, District of New Jersey. Some of New Jersey’s state courts may qualify for judicial hellhole status, but the Garden State’s federal courts are a bit of all right.

Monday, June 14, 2010

Food for Thought

When it comes to food, we're more often like the kids singing "Food, Glorious Food" in the beginning of the musical Oliver! than like the serious legal mavens we pretend to be. As noted earlier, we usually bloviate over the "D" part of the FDCA, not the "F" part.
Nevertheless, sometimes food litigation has useful things to say about the drug-and-device stuff that we work on day after day -- our bread-and-butter, if you will.

The Food Liability Law Blog recently posted an interesting item with a real grabber of a title: "Dismissal of 'I Can't Believe it's Not Butter' Claims: Another example of Iqbal/Twombly Succeeding Where Preemption Cannot." Recently, it has often felt as if TwIqbal is a necessary alternative to, or consolation for, Levine. The Food Liability Blog discussed a case, Rosen v. Unilever United States, Inc., 2010 U.S. Dist. LEXIS 43797 (N.D. Cal. May 3, 2010), in which the plaintiff claimed that both the label and advertising for I Can't Believe it's Not Butter are misleading because they hawk a "blend of nutritious oils" when one of those oils is partially hydrogenated oil, which food fascists say isn't nutritious at all.

First the bit about preemption not succeeding. The issue was whether the claims were preempted by the Nutrition Labeling and Education Act (NLEA), 21 USC section 346 et seq and the dormant Commerce Clause. The analysis on this issue is very different from what we see in drug and device cases. (Hence our refusal to say 'We Can't Believe It's Not Preempted.') There is no reference to Levine. Nor should there be. Instead, the court says that regulating food marketing is squarely within historic police powers, citing Farm Raised Salmon Cases, 42 Cal 4th 1077, 1088 (2008). (We blogged about the Farm Raised Salmon cases here and here and other posts referenced therein.) Then the court draws a distinction between the parts of food labelling that are regulated by the NLEA and the parts that are not. It's not like drug labels, where the entire label is subject to the FDA's approval. According to the court, the I Can't Believe it's Not Butter label's listing of ingredients is subject to the NLEA, but the allusion to the "nutritious blend" is advertising in the label, and is subject to state consumer protection laws, not the NLEA. (Query whether calls for heightened food label regulations will expand preemption in that area. But we digress.) Anyway, from the perspective of defense lawyers, the first course here is not so tasty.

But the main course is much more satisfying. When we see TwIqbal on the menu it's as if Pavlov rang the dinner bell and we start to salivate. The court breaks TwIqbal down into the two prongs of (1) substantive fact pleading vs. conclusory blathering, and (2) stating a plausible, rather than merely possible, claim for relief. And then the court proceeds to skewer the Complaint on both prongs. The way it does so is interesting and instructive -- and, we think, worthy of emulation.

What we get is a heaping helping of logic. The court reasons that plaintiff is asserting a categorical syllogism: "For the representation 'blend of nutritious oils' to be true, all constituent oils must be nutritious. One of the constituent oils in the product [partially hydrogenated oil] is not nutritious. Therefore, the product representation is false." Rosen, 2010 U.S. Dist. LEXIS 43797 at *13. (Another quick digression: The court defines "categorical syllogism" by citing Aylett v. Secretary of HUD, 54 F.3d 1560, 1567-68 (10th Cir. 1995). The author of that opinion is Senior Judge Aldisert. We are familiar with Judge Aldisert because he is from our Circuit, the Third. Judge Aldisert has written a book called "Logic for Lawyers." We might start citing that book more often in the future.) The Rosen syllogism breaks down because one non-nutritious ingredient doesn't necessarily mean the blend can't be nutritious. That's merely a conclusion, not a factual assertion, so it flunks TwIqbal.

Maybe we ought to defer to chemists and chefs, but what the court is saying seems to make sense. Vitamin-enriched cardboard (which we think we might've actually eaten this morning) would still contain vitamins, right? This post that you are reading right now might include a lot of mindless twaddle and bad ideas, but if it contains a good idea or two can't we brag about that? (Yes, we know - that's truly a hypothetical.) The Complaint alleged no facts showing that something non-nutritional somehow negated components that are nutritional. The court goes on to say that the Complaint does not even state any facts showing why partially hydrogenated oil is not nutritious. Again, plaintiff serves up pure conclusions.

As for the second prong of TwIqbal … well, in this case it ends up looking pretty similar to the first, except it's heavily seasoned with Latin and more logic. The court espies the fallacies of petitio principii (begging the question), composition (properties of the part must be attributed to the whole), and division (properties of the whole are ascribed to each part) in plaintiff's notion that a blend cannot be nutritious unless every single constituent is nutritious. It's like Wittgenstein on Torts. It's a fancy way of saying 'So what?' to the presence of partially hyrdogenated oil. But it works, so who are we to complain?

And now here comes the dessert: the court dismisses the Complaint with prejudice, because "there is no cure for the lack of logical tie." Id. at *17. Crème brulee with a nice, ever-so-slightly-burnt crust. We have to admit that even a ham-fisted defense lawyer had to wonder a moment about that conclusion. Isn't there some way for the plaintiff to insert some sort of factual allegation that would save the Complaint? But unless there's some morsel of break-through science out there that plaintiff knows about (we sure don't), the court is correct.

As we said recently, not every case is suitable for a Rule 12 motion. Believe it or not, every once in a while a plaintiff alleges something factual and plausible. But it's frustrating when bare-bones, muddle-headed (dare we say, non-nutritious) complaints get by (thereby commencing expensive, assymetrical discovery and possibly setting the table for what's politely called settlement but is really the last letter in the acronym used by Ernst Stavro Blofeld's villainous group that was always out to kill James Bond) because TwIqbal is more often cited than followed. TwIqbal is a test, and the Rosen case is an example where a judge applied that test about as rigorously and logically as possible. Just think if that sort of logic were applied to issues of learned intermediary, causation, and reliance. A lot of plaintiffs' lawyers would be out to lunch - on thin gruel.