Friday, December 28, 2012

Our Favorites - The Best Prescription Drug/Medical Device Decisions Of 2012


We hope all our readers had an excellent holiday-of-your-choice.  We did, and we’re back just in time for our favorite (and nearly last) post of the year, our choices for the best prescription medical product liability decisions of 2012.  This time, we have to admit, there’s no obvious winner, since the year passed without a United States Supreme Court decision from our area of interest to top our tree.  But that’s happened before and we certainly haven’t let that stop us.  All that means is that, who knows, maybe an intermediate state appellate decision might make this list.  Keep reading and you’ll find out.

Without further ado, let’s start the celebrations.  Here are our ten favorite judicial decisions (and some honorable mentions) involving drugs, medical devices, and vaccines in 2012.

1.                  Centocor, Inc. v. Hamilton, 372 S.W.3d 140 (Tex. 2012).  We had to think a bit on this one – as we do any time we list a case in which any of us were involved.  But only a little.  Texas was by far the largest remaining state where its supreme court had not adopted the learned intermediary rule.  Not anymore.  In Hamilton, the court did that in unanimous fashion.  And there’s lots more.  The court all but did away with any semblance of a direct-to-consumer exception to the rule (the recognition of which landed the intermediate decision that Hamilton reversed in #-4 of our worst of 2010).  If a DTC exception lurks out there after Hamilton, it would only be in a case of intentional and deliberate falsehood (which just isn’t in all those bland TV ads), that must go beyond mere “fraud” – which the court held doesn’t vitiate the rule.  Hamilton also held that the learned intermediary rule wasn’t an affirmative defense.  Thus the plaintiff retains all relevant burdens of proof.  The learned intermediary rule requires warnings only to prescribing physicians – not to any other health care provider with which the plaintiff may happen to come into contact.  Nor does information designed for patient consumption in any way trump the learned intermediary rule.  Finally, Hamilton applied the rule and held as a matter of law that prior prescriber knowledge broke any possible causal link.  So the result went from a multi-million plaintiff’s verdict to judgment n.o.v.  It’s hard to win a more total victory than that.  We exulted in Hamilton here .

2.                  Walker v. Medtronic, Inc., 670 F.3d 569 (4th Cir. 2012).  Walker is our favorite preemption case of 2012.  In Walker the court interpreted the “parallel claim” exception to preemption in a PMA medical device case in a quite limited fashion.  The plaintiff claimed that a statistic in the FDA-approved package insert wasn’t met by this particular device and thus could be a violation supporting a parallel claim.  The Fourth Circuit said “not so fast.”  Unless the FDA had promulgated a formal “performance standard” by notice and comment rulemaking, no standard existed to be violated.  Instead, the plaintiff was asserting a tort requirement “different from or in addition to” the FDA’s oversight of the device.  Short of a formal performance standard, mere deviations from expected performance could not support parallel claims.  Thus, an arguable device malfunction, by itself, did not defeat preemption under Riegel.  If only every circuit took the skeptical view of parallel claims adopted in Walker, we’d be pretty happy.  We praised Walker here .

3.                  Lofton v. McNeil Consumer & Specialty Pharmaceuticals, 672 F.3d 372 (5th Cir. 2012).  This is another really good appellate preemption case.  It slips in under Walker mostly because Lofton is not as unique.  Preemption is a bit of a hash in the Fifth Circuit right now, but Lofton is on the good side of that morass.  In Lofton, the court held that the fraud on the FDA exception to the Texas FDA compliance immunity statute was preempted by Buckman.  In so doing, the court explicitly rejected the Desiano approach (which we revile), for all the right reasons – chiefly because Buckman is more than a mere pleading case and to follow Desiano would ignore the practical consequences that drove the result in Buckman.  Sooner or later the Supreme Court is going to have to clear this up, but until now, we’ll hail decisions such as Lofton, as we did here .

4.                  Rodriguez v. Stryker Co., 680 F.3d 568 (6th Cir. 2012).  Pain pump litigation is hot all over the country right now, and the state of the art defense is at the heart of almost all of these cases.  In the first published appellate ruling on the issue, Rodriguez affirmed summary judgment, holding that the hodgepodge of old, largely tangential articles the plaintiff had collected did not establish inquiry notice of the causal connection in question (that certain anesthetics could damage joint cartilage) as a matter of law.  These articles were “isolated instances” relating to other substances.  An inference that anesthetics would have the same consequences was unreasonable.  The snippets that the plaintiffs offered were “too conjectural and too many steps removed from the problem that developed.”  Nor did the FDA’s rejection of a §510k (substantial equivalence) application establish anything about safety.  All that meant is that there was no predicate device to compare the pain pump to.  Lohr established that §510k did not evaluate safety – and plaintiffs have to live with that decision just like defendants do.  Nor is there a duty to test a product in the absence of any knowable risk.  A defendant is not an insurer.  Nor does off-label promotion create any kind of claim, in the absence of any knowable risk.  Finally, the prescriber’s testimony failed to show that any warning would have made changed the outcome, so Rodriguez is a win on warning causation as well.  We haven’t conducted complete research, but we think that Rodriguez is probably the best Pain pump decision to date.  We urged other courts to emulate Rodriguez here .

5.                  In re Pelvic Mesh/Gynecare Litigation, 43 A.3d 1211 (N.J. Super. App. Div. 2012).  We’ve been kvetching for years about the ongoing erosion of defense rights to contact treating physicians (supposedly guaranteed by the Stempler decision) in New Jersey mass tort litigation.  In Pelvic Mesh, an appellate court finally did something about this.  The Pelvic Mesh mass tort procedures were very restrictive of defense access to treating physicians, so that defendants had a hard time simply finding experts.  A high percentage (over 1,000 in number) of the relevant medical specialists had treated one or another of the plaintiffs and thus were forbidden to serve as defense expert witnesses.  On mandamus (a tough standard) the court reaffirmed a simple principle – that plaintiffs waive any physician/patient privilege as to relevant injuries when they bring lawsuits.  Physicians have no duty of loyalty requiring them to support their patients in litigation. We looked forward to the ultimate demise of New Jersey limitations on the equal availability of critical physician evidence to both sides here.

6.                  In re Schering Plough Corp. Intron/Temodar Consumer Class Action, 678 F.3d 235 (3d Cir. 2012).  We don’t like third-party payer class actions, whether formal class actions or brought under some other purported method of aggregation.  Unless somebody was actually harmed by a drug or device, these suits are artificial contrivances by which TPPs attempt to get out of what they have contracted to do – that is, to pay for prescribed treatments that help patients.  Intron hits all the right notes – particularly that TPP plaintiffs can’t use RICO as cover for improper attempts to enforce the FDCA with respect to off-label promotion.  In the absence of proof that real people were exposed to products that were unsafe or ineffective (instead of just improperly promoted), there is simply no injury, and thus no standing, for any sort of claim by a TPP or other beneficiary for purely economic loss.  We praised the demise (on the pleadings) of this bogus class action, and hopefully others like it, here.

7.                  United States v. Caronia, ___ F.3d ___, 2012 WL 5992141 (2d Cir. Dec. 3, 2012).  It would rank higher, maybe even #1, if the same ruling had occurred in a product liability action.  Still, Caronia’s holding, even in the purely criminal context, that the First Amendment protects truthful promotion of off-label uses, is significant enough to make our top ten.  Courts and the common law are part of the government, and thus equally subject to First Amendment limits, as we discussed here .  Thus, neither tort plaintiffs, nor TPPs, nor FCA relators, nor state AGs, nor the federal government in its own FCA actions, can base liability (assuming Caronia remains good law) on truthful statements about the benefits and risks of off-label uses.  We’ve been waiting for a ruling like Caronia for a long time, ever since we began piecing together a First Amendment defense in Bone Screw cases in the mid-1990s.  Maybe the millennium has finally arrived.  We discussed Caronia here and here (the latter making us first on the web with the decision).

8.                  Pom Wonderful LLC, v. Coca-Cola Co., 679 F.3d 1170 (9th Cir. 2012).  This is another case that suffers a bit from being somewhat out of our target area.  Pom Wonderful is a Lanham Act case brought by a very litigious (search the name sometime) purveyor of pomegranate juice against the defendant’s FDA-approved food labeling.  For our purposes, Pom Wonderful is important because it applies one of our favorite principles, that the is no private right of action (direct or indirect) to enforce the FDCA, in order to establish the principle of FDA primary jurisdiction as an alternative to preemption.  California notoriously leads the country in bogus “consumer protection” litigation over the labeling of many FDA-approved products, so to get an appellate decision telling plaintiffs to lay off labeling that's within the FDA’s regulatory sphere is a major win for the good guys.  We savored Pom Wonderful here .

9.                  Holmes v. Merck & Co., 697 F.3d 1080 (9th Cir. 2012).  Yes, the Supreme Court really meant what it said in Bruesewitz (we’ve finally memorized how to spell it).  That’s essentially the holding in Holmes, and with Holmes probably falls the last serious post-Vaccine Act product liability litigation involving these statutorily-protected products – which is precisely what Congress intended.  Even if the vaccine litigation does not involve a covered claim (the plaintiff was a parent, rather than the actually injured child, a common ruse to try avoiding the Act), the plaintiff couldn’t escape the Act’s limits on liability.  Preemption under the Vaccine Act applies to all suits against vaccine manufacturers.  Thus, summary judgment affirmed.  It’s a home run for vaccine manufacturers, but since there’s much less litigation nowadays over vaccines than over drugs and devices, we had to move Holmes down a few notches.  We lauded Holmes here .

10.              Casey v. Merck & Co., 722 S.E.2d 842 (Va. 2012).  We hate cross-jurisdictional class action tolling.  In Casey the Virginia Supreme Court unanimously decided that it did too.  The court held that a meritless and never certified federal class action involving Fosamax did not have any effect on that state’s statute of limitations.  All in all it was a good year on the cross-jurisdictional class action tolling front, with other big wins in Louisiana (non-drug/device) and Massachusetts (A-Z).  We cheered Casey on here .

So that’s our top ten, but as we have in the past, we just couldn’t limit ourselves to ten.  2012 was good to defendants, and Santa Judge left us a lot more presents under the tree.  So here are our Honorable Mentions:  (11) Sandoz, Inc. v. State, 100 So.3d 514 (Ala. 2012) – Would rank higher, except it’s largely a reprise of an excellent 2009 (2009 #1) decision.  Reverses a $70+ million verdict in an AG suit over purported fraud on state health care reimbursement programs.  We reviewed it here.  (12) In re Abbott Laboratories, Inc., 698 F.3d 568 (7th Cir. 2012) – Nice CAFA decision that plaintiffs can’t consolidate separate cases for trial without triggering the statute’s mass action provisions.  We discussed it here .  (13) Zimmerman v. Novartis Pharmaceuticals Corp., ___ F. Supp.2d ___, 2012 WL 3848545 (D. Md. Sept. 5, 2012) – We saw a lot of Aredia/Zometa decisions in 2012; but liked this one the best.  It’s good on fraud on the FDA/Buckman, and even better on FDA prosecutorial discretion, so it’s our highest-ranked district court case.  See our posts here and here .  (14) Weston v. Kim’s Dollar Store, 731 S.E.2d 864 (S.C. 2012) − Nice PMA preemption result, and from a state high court, but the reasoning was thin and hard to follow; we’ll take it, but not on the big list.  We discussed it here.  (15)  Metz v. Wyeth, Inc., 872 F. Supp.2d 1335 (M.D. Fla. 2012) – It was close, but we think it’s the best of a raft of generic preemption trial-level cases.  That it was early, and thus more of a trailblazer, helped us choose.  See our post here.  (16) In re Darvocet, Darvon & Propoxyphene Products Liability Litigation, 2012 WL 3610237 (E.D. Ky. Sept. 5, 2012) – MDLs do ensure that issues get thoroughly briefed.  In Darvocet it produced an excellent decision on generic preemption, rejecting Conte, and affirming Erie conservatism.  We discussed it here .  (17) In re Chantix (Varenicline) Products Liability Litigation, ___ F. Supp.2d ___, 2012 WL 3030097 (N.D. Ala. July 23, 2012) – Yes, MDLs are indeed thoroughly briefed, and here the defendant’s black box warning was held adequate as a matter of law.  Because it’s to be published,  Chantix beats out a similar Accutane ruling from about the same time.  We discussed it here .  (18)  Ali v. Allergan USA, Inc., 2012 WL 3692396 (E.D. Va. Aug. 23, 2012) – Maybe the best pure TwIqbal decision of the year, occurring in the context of PMA preemption.  Demolishes Hofts.  We covered it here.  (19) Marsh v. Genentech, Inc., 693 F.3d 546 (6th Cir. 2012) – Given a chance to back down, the Sixth Circuit didn’t, and reaffirms that its broad application of Buckman in Garcia.  We cheered here .  (20) United States ex rel. Ge v. Takeda Pharmaceutical Co. Ltd., 2012 WL 5398564 (D. Mass. Nov. 1, 2012) – We don’t like fraud on the FDA claims.  Ge killed such a claim in the False Claims Act context where preemption doesn’t apply.  Not even in D. Mass.  We discussed it here .

Looking back, all of our top ten from 2011 remain intact.  We did lose one of our honorable mentions, however, when the Degelman case (2011 #14) was settled while on en banc review, and thus vacated.  The Dobbs SSRI preemption decision (2011 #8) is currently before the Tenth Circuit.  On the other side of the ledger, as we pointed out in our discussion of Hamilton, the Murthy case (2011 #-8) is no longer a proper prediction of Texas law.  Appeals are pending in both Daniel (2011 #-7), and in the E.D. Pa. “nerve center” (2011 #-10) cases, so maybe we’ll have good news to report on those fronts in 2013.  The Lance case (2010 #-6) remains pending in the Pennsylvania Supreme Court, some two years after oral argument.  Another holdover, the Kiobel Alien Torts Statute case we mentioned last year, was pushed back to the pending term by the Supreme Court, which broadened the questions to be considered.

Looking ahead, we have Bartlett (our worst case of 2012) now pending in the Supreme Court.  We are cautiously optimistic that the Court, having decided Mensing, will not reverse course in Bartlett, and we hope the result will rank highly on our top ten of 2013.  The awful Caldwell case (2012 #-2) from Louisiana is also being appealed, but as so far the writ hasn’t been acted upon by the Louisiana Supreme Court.  That’s another excellent candidate for reversal.  In Weeks, the Alabama Supreme Court will become the first state high court to rule on Conte branded liability where only generic drugs were consumed.  In Stengel, the Ninth Circuit en banc will address what can and can’t constitute a “parallel claim” under Riegel and Buckman.  Finally, we’re aware of an interesting Vioxx class action/All Writs Act case, Plubell, currently on appeal in the Fifth Circuit.  Of course, numerous other preemption-related decisions involving generic drugs and medical devices under Mensing and Riegel are in the appellate process in federal and state appellate courts.

So now it’s on to 2013.  Happy New Year to all our readers.

Thursday, December 27, 2012

Anti-Bartlett Arguments


It’s no surprise that we don’t like. Bartlett v. Mutual Pharmaceutical Co., 678 F.3d 30 (1st Cir. 2012). It topped the list of our least favorite decisions of 2012, and we have openly rooted for the Supreme Court first to take the appeal, and now that they have, to reverse.

There are, as we see it, four rock solid arguments for reversing Bartlett. Two of them broadly focus on the decision’s implications for the FDA’s authority over the marketing of prescription drugs. Two others focus more narrowly on the Hatch-Waxman amendments to the FDCA, which largely created the generic drug industry.

The first broad argument rejects Bartlett’s holding that that state-law re-weighing of the risks and benefits of an FDA-approved drug can peacefully coexist with the FDA’s drug approval function. "Yes" and "no" simply aren’t complementary. Instead a duty-to-withdraw claim strikes at the heart of the FDA’s power to determine what prescription drugs are properly sold in interstate commerce in the United States:


[A] state law duty that would compel generic manufacturers to stop production of a drug that under federal law they have the authority to produce . . . would directly conflict with the federal statutory scheme in which Congress vested sole authority with the FDA to determine whether a drug may be marketed in interstate commerce.

Gross v. Pfizer, Inc., 825 F. Supp.2d 654, 659 (D. Md. 2011), reconsideration denied, 825 F. Supp.2d 661 (D. Md. 2012). "The conflict between state and federal law would be much more pronounced if the state courts upheld a decision that an FDA-approved drug should not have been on the market." In re Reglan Litigation, 2012 WL 1613329 (N.J. Super. Law Div. May 4, 2012) Allowing such a claim "would be tantamount to conferring supremacy upon the state law." Jacobsen v. Wyeth, LLC, 2012 WL 3575293, at *9 (E.D. La. Aug. 20, 2012). Accord Eckhardt v. Qualitest Pharmaceuticals, Inc., 858 F. Supp.2d 792, 801 (S.D. Tex. 2012). ("a state law requirement that the drug be completely withdrawn from the market, based solely on a theory that the federally mandated label was inadequate, would also impermissibly conflict with federal law"); Cooper v. Wyeth, Inc., 2012 WL 733846, at *6 (M.D. La. March 6, 2012 ("[i]f state law could require a generic drug manufacturer to wholly withdraw from the market . . . it necessarily must repudiate the label approved by the FDA"). See also Demahy v. Schwarz Pharma, Inc., ___ Fed. Appx. ___, 2012 WL 5261492, at *6 (5th Cir. Oct. 25, 2012) (dictum); Fulgenzi v. PLIVA, Inc., 867 F. Supp.2d 966, 9715 n.5 (N.D. Ohio 2012); Moretti v. Mutual Pharmaceutical Co., 852 F. Supp.2d 1114, 1118 (D. Minn. 2012); Pirello v. Qualitest Pharmaceuticals, Inc., 2012 WL 5363243, at *4 (M.D. La. Oct. 30, 2012); Strayhorn v. Wyeth Pharmaceuticals, Inc., ___ F. Supp.2d ___, 2012 WL 3261377, at *16 (W.D. Tenn. Aug. 8, 2012); Aucoin v. Amneal Pharmaceuticals, LLC, 2012 WL 2990697, at *8-9 (E.D. La. July 20, 2012); Johnson v. Teva Pharmaceuticals USA, Inc., 2012 WL 1866839, at *5 (W.D. La. May 21, 2012); Metz v. Wyeth LLC, 872 F. Supp.2d 1335, ___, 2012 WL 1058870, at *4 (M.D. Fla. March 28, 2012); Bowman v. Wyeth, LLC, 2012 WL 684116, at *6 (D. Minn. March 2, 2012); Coney v. Mylan Pharmaceuticals, Inc., 2012 WL 170143, at *5 (S.D. Ga. Jan. 19, 2012); In re Fosamax Litigation, 2011 WL 5903623, at *6 n.5 (D.N.J. Nov. 21, 2011); Fullington v. PLIVA, Inc., 2012 WL 1893749, at *6 (E.D. Ark. May 23, 2012). Cf. Mensing v. Wyeth, 658 F.3d 867 (8th Cir. 2011) (per curiam) (vacating prior order that had allowed a failure to withdraw claim post Mensing without explanation).

The second broad argument is that Bartlett’s rationale that a "decision to make the drug and market it in [a state] is wholly [defendant’s] own," 678 F.3d at 38, is the same type of excuse that Mensing rejected when presented as a possibility of obtaining assistance from the FDA to change otherwise unchangeable warnings. See 131 S. Ct. at 2578-79. That excuse didn’t defeat impossibility preemption because it proves too much – it "would render conflict pre-emption largely meaningless." Id. at 2579. One could seek the aid of an agency, or even of Congress, to change practically anything:


We can often imagine that a third party or the Federal Government might do something that makes it lawful for a private party to accomplish under federal law what state law requires of it. . . . [I]t is also possible that the Manufacturers could have convinced the FDA to reinterpret its regulations [or] . . . to rewrite its generic drug regulations entirely or talked Congress into amending the Hatch–Waxman Amendments.
If these conjectures suffice to prevent federal and state law from conflicting for Supremacy Clause purposes, it is unclear when, outside of express pre-emption, the Supremacy Clause would have any force.
Id. (footnote omitted).

The Bartlett argument that a manufacturer always has the option to leave the market entirely is similarly overexpansive. "[T]he idea that they should have simply stopped selling propoxyphene is an oversimplified solution that could apply anytime the issue of impossibility preemption arises: avoid a conflict between state and federal law by withdrawing from the regulated conduct altogether." In re Darvocet, Darvon & Propoxyphene Products Liability Litigation, 2012 WL 718618, at *3 (E.D. Ky. March 5, 2012) ("Darvocet I") (citing to Mensing). The virtually unlimited scope of this argument is illustrated by how plaintiffs, both before and since Bartlett, have indiscriminately brought failure-to-withdraw claims involving a bunch of generic drugs. See Gross v. Pfizer, Inc., 825 F. Supp.2d 654, 659 (D. Md. 2011) (metoclopramide – one of many such attempts); Aucoin, 2012 WL 2990697, at *8-9 (tramadol); Darvocet I, 2012 WL 718618, at *3 (propoxyphene); Coney, 2012 WL 170143, at *5 (phenytoin); Fosamax, 2011 WL 5903623, at *6 n.5 (alendronate).

The first of the narrower arguments is that the Supreme Court’s "sameness" rationale in Mensing is equally applicable to design as well as warning defect claims. The FDCA and FDA regulations require all generic drugs to be the same as branded drug as to which bioequivalence is being claimed. See 21 U.S.C. §355(j)(2)(A)(ii) ("active ingredients" must be the "same"; 21 C.F.R. §314.127(a)(3) (dissimilar "active ingredients" will cause rejection of application for approval of generic drugs). Thus, to market a generic drug, the manufacturer is "required to produce a drug that was equivalent to the brand-name drug and [is] not free to unilaterally pursue a safer alternative design in order to comply with state law." Eckhardt, 858 F. Supp.2d at 801. Therefore, "the ‘federal duty of sameness,’ also applies in the context of generic drug design, and federal law preempts state laws imposing a duty to change a drug's design on generic drug manufacturers." In re Pamidronate Products Liability Litigation, 842 F. Supp.2d 479, 484 (E.D.N.Y. 2012) (citation omitted). Accord Frazier v. Mylan, Inc., ___ F. Supp.2d ___, 2012 WL 6641626, at *5-6 (N.D. Ga. Dec. 18, 2012); Jacobsen, 2012 WL 3575293, at *9; In re Accutane Products Liability Litigation, 2012 WL 3194952, at *2-3 (M.D. Fla. Aug. 7, 2012); Aucoin, 2012 WL 2990697, at *8-9; Johnson, 2012 WL 1866839, at *4; Metz, 2012 WL 1058870, at *4; Darvocet I, 2012 WL 718618, at *2; Lyman v. Pfizer, Inc., 2012 WL 368675, at *4 (D. Vt. Feb. 3, 2012); Stevens v. Pliva, Inc., 2011 WL 6224569, at *2 (W.D. La. Nov. 15, 2011).

The second narrower argument sounds in purposes and objectives preemption (which Justice Thomas, the author of Mensing, doesn’t like). If ever there is a place for P&O preemption, however, Bartlett is the case. The express congressional purpose of the Hatch-Waxman amendments is to "make available more low cost generic drugs by establishing a generic drug approval procedure." H.R. Rep. No. 98-857, pt. 1, p. 14 (1984). Claims that would give state juries the power, in effect, to ban generic drugs right and left directly conflict with that congressional purpose. Darvocet I, 2012 WL 718618, at *2 (pointing out "the special, and different, regulation of generic drugs that allowed the generic drug market to expand, bringing more drugs more quickly and cheaply to the public").

Thus, for all of these reasons, most courts even after Bartlett have disagreed with the First Circuit’s rationale and continued to find design defect/failure to withdraw claims preempted:


Having reviewed the Bartlett decision, the Court agrees with the Generic Defendants. In Bartlett, the First Circuit adopted the "failure-to-withdraw" argument previously rejected by this Court and others. This argument − which failed to persuade either the Supreme Court or the Eighth Circuit on remand in Mensing, and the Sixth Circuit in Smith v. Wyeth − is no more availing now. Moreover, the First Circuit offered little explanation for accepting it, noting simply that the Mensing opinion had not specifically addressed design-defect claims.
In re Darvocet, Darvon and Propoxyphene Products Liability Litigation, 2012 WL 2457825, at *1 (E.D. Ky. June 22, 2012) (citation omitted) ("Darvocet II").   Accord Frazier, 2012 WL 6641626, at *6 (refusing to follow Bartlett because "the logic of Mensing is applicable to design defect claims"); Strayhorn, 2012 WL 3261377, at *10 (agreeing with Darvocet II); Purvis, 2012 WL 5364392, at *4 (court "not persuaded" by Bartlett); Pirello, 2012 WL 5363243, at *4 n.3 (same); Lashley v. Pfizer, Inc., ___ F. Supp.2d ___, 2012 WL 2459148, at *9 (S.D. Miss. June 27, 2012) (finding Bartlett "unpersuasive and not a proper basis for relief").

Wednesday, December 26, 2012

And Now For A Word From The Grinch

This post is contributed by Melissa Wojtylak, of ReedSmith, one of our regular guest bloggers whom we're trying to convince to join us on a more formal basis.  Take it away Melissa:

******************

 The Southern District of Illinois delivered a giant lump of coal when it denied the defendant’s motion for summary judgment in a Zometa case last week.  In Rutz v. Novartis Pharmaceuticals Corp., 2012 U.S. Dist. LEXIS 177779 (S.D. Ill. Dec. 17, 2012), plaintiff claimed that his decedent developed bisphosphonate-related osteonecrosis of the jaw (“BRONJ”) after taking Zometa for 3 years while undergoing treatment for breast cancer.  In considering defendant’s summary judgment motion, the court looked first at the evidence on specific causation, then considered the evidence on warnings.   Because the warnings discussion is the most troubling - and basically obviates the need for a specific causation discussion – we’ll look at the court’s warnings analysis first. 

The record indicated that plaintiff’s decedent took Zometa from June 2002 through August 2005.  Id. at *6.   According to the opinion, the defendant learned of the drug’s association with BRONJ in 2002, and subsequently amended its labeling in September 2003, February 2004 and September 2004; it also sent Dear Doctor letters in September 2004.  Id. at *12.  Ms. Rutz’s doctor got this letter, but continued to prescribe the drug for her until August 2005.  Id. at *5.   That’s right: he continued to prescribe for two years after the first label change.  Perhaps not surprisingly, the defendant argued that there was no evidence that it should have acted more quickly to implement a different warning.    Id. at *12.   The court merely found that the defendant’s actions created an issue of fact as to whether it should have warned sooner or differently.  Id. at *14-15.  Completely absent is any discussion of the prescriber’s  testimony on the warnings, or why he decided to continue prescribing the drug through three label changes and a Dear Doctor letter – for nearly a year after the latter, in fact.  While we don’t know the doctor’s thinking, as Bexis noted in a prior post,  where the alternative to therapy is likely to be death from cancer, it’s tough to prove that a doctor would choose not to prescribe a drug based on the possibility of a lesser injury.

Plaintiff argued that the prescriber was not a learned intermediary, and also, that he would have heeded a warning if it had been adequate.  Id. at * 17.  Loose language in some Illinois cases permits plaintiffs to argue that the learned intermediary doctrine should be set aside (what they really mean is that the warning can be found inadequate) if the jury determines that the prescriber was not sufficiently warned, but the court didn’t take this on.  Instead, it punted on deciding as a matter of law whether this prescriber was a learned intermediary.  Id. at 18.  This muddied the waters for the discussion on heeding presumption, as the court admitted that if the doctor was a learned intermediary, it was not clear whether a heeding presumption would apply.  Undaunted by this fact, the court handled this obstacle by deciding that even if this prescriber was considered a learned intermediary, a heeding presumption would apply (again, that’s after admitting that there was no controlling Illinois authority on this point).  Id.  To support this conclusion, the court relied on a decision from the Illinois Appeals Court, which applied Texas law and found a heeding presumption applies to learned intermediaries.  Bexis undoubtedly had an aneurism when he read that, given Erie, predicting expansions of state law, and all that.
 
See, the problem with the Rutz court’s reliance on the Illinois appellate opinion was that the appellate court not only didn't apply Illinois law, but got Texas law wrong.   Readers of the blog will remember that in Ackermann v. Wyeth, the Fifth Circuit found that the heeding presumption does not apply to learned intermediaries, and that even if it did, it would mean only that the doctor “would have incorporated the additional risk into his [or her] decisional calculus.”  However, relying on the incorrect statement of Texas law and one decision from a sister court (the Northern District of Illinois), the Rutz court proclaimed that “the heeding presumption is a natural result of or corollary to the learned intermediary doctrine.”  Id. at *20.  Thus, if Mrs. Rutz’s prescriber was a learned intermediary, there was a presumption that he would have heeded an adequate warning.   While this seems dangerously close to circular logic to us (and not at all natural), it’s also contrary to the law in a number of jurisdictions.  As the blog has discussed in the past, Thomas v. Hoffman LaRoche , 949 F.2d 806 (5th Cir. 1992), contains a good substantive discussion of why the heeding presumption should not apply in learned intermediary cases. 

Continuing with the theme of things that don’t exist in Illinois law . . . . Illinois does not have a statutory presumption of adequacy for FDA-approved drugs, so as you might have guessed, there was no chance the defendant was getting judgment as a matter of law on that basis.  But the court was unwilling to consider the adequacy of the warning as a matter of law in general, based on what it called the law-of-the-case doctrine.   For this argument, however, the court relied not on rulings from the Rutz case, but on another Zometa case in which the MDL court - applying Florida law, no less - found that the adequacy of the warning was a question for the jury. 

Based on the warnings analysis, a discussion of the court’s treatment of the specific causation argument may be unnecessary, but humor us.  In his deposition, the plaintiff’s expert had admitted that Rutz’s condition did not meet the accepted definition of BRONJ developed by the medical community.  Id. at *7.  The court found several ways to get around this troubling admission.  First, it noted that the definition had not been developed until after the decedent was diagnosed.  Then, the court rejected the definition itself.  According to the criteria in the definition, in order to support a diagnosis of BRONJ, the patient must have at least eight weeks of exposed bone.  However, the Rutz court accepted plaintiff’s expert’s opinion that BRONJ could be present with only 4-5 weeks of exposed bone.  The problem with this opinion (besides the fact that it goes against the thinking of the rest of the medical community)?   This decedent didn’t have a single incident of exposed bone documented in her medical records.  Remarkably, the court handled this inconvenient fact by holding:

Given that Rutz may have had exposed bone which was not recorded, it would be unfair to permit [defendant] to use the absence of a record to conclude that BRONJ was not present . . . . [a] jury could determine that other indicia of BRONJ – such as non-healing wounds – made it likely that exposed bone was present.” 

Id. at *10-11.  The court also glossed over the defendant’s argument that this decedent had other disease processes that could cause ONJ.  Id. at *7.   Where did the burden of proof go?  The record has nothing to support causation.  Absence of evidence is just that ... absence of evidence.

Let’s hope this opinion, with its many missteps, doesn’t haunt defendants in drug cases like some sort of ghost of Christmases past. 

Monday, December 24, 2012

Preemption Wonderland

For the holidays, we have for you the story of Littlebear v. Advanced Bionics, LLC, 2012 U.S. Dist. LEXIS 179388 (N.D. Ok. Dec. 19, 2012).  The story is to be sung, of course, to the tune of Winter Wonderland.  Enjoy boys and girls.


Preemption Wonderland 

Sleigh bells ring, Buckman Preemption,
In the lane, PMA Preemption
A beautiful sight,
We're happy tonight.
Walking in Preemption wonderland.

Gone away, negligence per se
Enforcing regs, that’s for FDA
We sing a love song,
As we go along,
Walking in Preemption wonderland.

In the complaint plaintiff has a strawman,
Fix the PMA mark your AEs down
He says: Are these claims?
Court says: Buckman,
They can’t do the job
Get out of town.

Later on, plaintiff conspires,
Obligations, his own desires,
They’re not FDA made,  
Or just too darn vague,
Walking in Preemption wonderland.

In the complaint some claims they don’t go man,
They’re parallel and get to hang around,
But that’s not a lot,
don’t you know man,
Later the defense
can knock ‘em down.

When courts preempt, ain't it thrillin’,
Plaintiff’s nose gets a chillin’
We'll frolic and play, the pro-defense way,
Walking in Preemption wonderland


Friday, December 21, 2012

Buried Treasure


Take a look at what we just found.  We were reading another case and came across (in a long string citation) an intriguing reference to Purchase v. Advanced Bionics, LLC, No. 2:08-cv-02442-JPM-tmp, slip op. (W.D. Tenn. Aug. 4, 2011) (McCalla, C.J.), in the context of PMA preemption.  We'd never heard of that opinion before.  Well, we have a PACER account and know how to use it, so we obtained the actual decision.

If you make Riegel-based PMA preemption arguments, you’ll probably be interested in these holdings in Purchase:

  • A defendant’s alleged failure to obtain supplemental FDA approval of a change to a device involves an “administrative,” not a “safety” requirement.  Such allegations are thus preempted “disguised fraud on the FDA” and as improper private FDCA causes of action.
  •  “Derivative” misbranding/adulteration claims based on the same allegations are likewise preempted.
  • A defendant’s alleged failure to notify the FDA of a major change to a device in its annual report likewise involves an “administrative,” not a “safety” requirement, and is equally preempted.
  • Various FDA GMP regulations (21 C.F.R. §§ 820.20, 820.80, 820.100, and 820.198) are “too generic to provide a requirement that could support a parallel claim.”

Happy holidays to all.

The Bottom Ten – The Worst Prescription Drug/Medical Device Decisions Of 2012


Do we have to?  That depends on whether we mean “must” or should.”  There’s relatively little that’s really a “must,” but quite a bit that’s a strong “should.”  So yes, we have to.  It’s that time of year again, and we’re looking back over the past twelve months for the decisions that, in this instance, we liked the least.  Because we like to end the year on a high note, we always examine the bad decisions before the good ones, and this year’s no exception.

This post thus goes to show that you – that is, we – can’t win them all.  So for our fifth straight year we’re looking at the coal that has found its way into our Christmas stockings, specifically the ten worst prescription medical product liability decisions of 2012.  There's no particular pattern, these blots on the law are from all over, both in federal and state court.  While we’ve seen ATRA’s latest list of hellhole jurisdictions, our bottom ten doesn’t particularly correspond, probably since ATRA’s latest list has less to do with drugs and medical devices than the in some prior years.

Yeah, we’re procrastinating.  Like most lawyers, we’d rather focus on wins than losses – that and 2012 still has a week and a half left for still more bottom-dwelling decision to come down.  That said, we can’t delay any longer.  Here are the jurisprudential dregs of 2012.

1.                  Bartlett v. Mutual Pharmaceutical Co., 678 F.3d 30 (1st Cir. 2012).  Terrible result and worse reasoning, on several levels.  After the plaintiff lost his warning claims for the prescriber’s failure to read the warning, he pursued a design defect claim with no alternative design that amounted to a demand that an FDA-approved generic drug should be removed from the market altogether.  All that was before Mensing.  After Mensing we couldn’t see how the plaintiff could retain this $20 million+ verdict, but the First Circuit found a way – a bad way, but a way.  Even though the opinion all but conceded that design claims would fail under the “sameness” analysis used by the Supreme Court in Mensing, the First Circuit decided that reasoning didn’t matter, dug in its heels, and ruled that, no matter what, it wasn’t going to preempt the plaintiff’s sole surviving claim.  Period; full stop.  The decision's rationale was that nothing requires a manufacturer actually to sell a drug that the FDA has approved, but argument that (like the lobbying argument rejected in Mensing) proves way too much.  The same thing could be said about any product in any case.  Moreover, nothing could more directly conflict with the FDA’s authority over drug approval than a state-law claim that says, “So what?  You can’t sell that here.”  "Yes" directly conflicts with "no." Finally, to the extent that Hatch Waxman was supposed to promote the availability of generic drugs, banning them outright is the antithesis of that purpose.  We blogged about this stinker here and here.  The only good thing we can say about Bartlett is that the Supreme Court recently accepted the challenge and granted certiorari.  So we’re hopeful that the worst decision of 2012 might produce the best of 2013.  Fingers crossed.

2.                  Caldwell ex rel. State v. Janssen Pharmaceutical, Inc., ___ So.3d___, 2012 WL 3761900 (La. App. Aug. 31, 2012).  What do you get when a state hires contingent fee counsel and lets that counsel pick the most pro-plaintiff county (called “Parishes” in Louisiana) in the state to sue over alleged failures to warn that were never actually hurt anybody?  How about an eye-popping $257 million verdict along with an extra $73 million fee and cost award for said counsel.  Most ginned up state false claims suits like this one get thrown out, at least on appeal, but not in Louisiana (at least not yet).  On appeal, the court found no error in the trial court’s allowing the plaintiff to proceed on an absolute liability theory from West Virginia that (unmentioned in Caldwell) the West Virginia Supreme Court later threw out as a matter of law.  The language of the relevant statute was outright ignored in Caldwell, and both injury and causation were effectuvekt presumed (the “materials in and of themselves cause harm and injury”).  The opinion also affirmed total exclusion of evidence (including statistics) that the defendant’s supposedly false statements were in fact scientifically valid.  The opinion itself is an embarrassment, consisting mostly of the court quoting the trial court’s barely coherent rulings and reciting that there was no “manifest error.”  The only saving grace is that the Louisiana Supreme Court might think so too.  We excoriated Caldwell here.

3.                  Dolan v. Hilo Medical Center, 278 P.3d 382 (Haw. App. 2012).  In this absurd medical device decision, the manufacturer was found liable where:  (1) the hospital never inventoried the device kit that it received, and (2) the surgeon used a screw driver as a substitute for a spinal rod when he couldn’t find the right part during surgery.  The screw driver, of course, broke almost immediately, since it was not designed (let alone FDA approved) for implantation.  Oh ... and the defendant manufacturer produced an undisputed packing slip indicating that it had shipped all the proper parts to the hospital.  And there's more:  the doctors and hospital concealed from the patient what they had done.  The jury got it right – hammering the malpractice defendants and excusing the manufacturer.  Inexplicably, however, the appellate court reversed, on the lame excuse that the judge used an outdated jury instruction on substantial change.  So what?  This wasn’t a substantial change case, rather it involved blatant and outrageous product misuse.  It may not be the worst decision of the year, but it sure is the dumbest.  We dissented here.

4.                  In re Chantix Varenicline Products Liability Litigation, ___ F. Supp.2d ___, 2012 WL 3871562 (N.D. Ala. Aug. 21, 2012).  A really, really bad Daubert decision.  Seven causation experts were allowed to testify that the drug caused suicide (of all injuries, one of the hardest to prove) despite lacking even one medical study (at least none were cited) to support their opinions.  Basically, the decision holds that qualifications are enough and everything else is cross-examination fodder.  Daubert?  What Daubert?  Opinions based on statistically insignificant data?  That’s OK.  Adverse reactions that the FDA itself says aren’t to be used for drawing causation conclusions?  That’s OK, too.  Extrapolation from animal studies with huge dosages?  You bet.  Ditto for cherry-picked data.  The defendant’s labeling mentioning the risk also supported causation.  Damned if you do; damned if you don’t – even though FDA regulations outright specify that “a causalrelationship need not have been proven.”  Also, any decision that favorably cites the pre-Daubert Wells v. Ortho decision raises our hackles.  Even the good rulings (corporate intent, misleading the FDA), were precluded on a lame “speculative” basis rather than for being blatantly improper subjects of expert testimony.  We found this opinion largely indigestible here.

5.                  Cornett v. Johnson & Johnson, 48 A.3d 1041 (N.J. 2012).  Usually adverse state supreme court cases rank pretty high on our list.  Cornett isn’t ranked higher because all of it isn’t bad – specifically the court blew out the lead plaintiff’s case on unrelated statute of limitations grounds, whichought to count for something (not all that much), and placed some decent summary judgment limits on the claims it permitted to go forward (somewhat better).  But those good points can’t make up for messing up two of our favorite issues, preemption and off-label use, in the same opinion.  In a PMA medical device case, the court allowed a plaintiff to get by the pleading stage with a “parallel claim” based on off-label promotion, even though there’s not any FDA regulation that bars such promotion (the regs call it no more than “evidence”), and the FDA guidance that enunciates an outright ban doesn’t have force of law and thus shouldn’t support any negligence per se action at all.  The off-label promotion claim was nothing more than an ill-disguised inadequate warning claim (preempted under Riegel), but the court went along with the plaintiffs' ruse of renaming the claim.  Still, the court did impose some decently strong restrictions on the claim before it could survive summary judgment.  If the trial courts enforce these, there may not be all that many claims.  But the tough nut remains, how can a state law claim be “genuinely equivalent” to anything when it’s based on a document that the FDA itself does not give legal force?  Cornett ends up with a “parallel” claim that in fact isn’t parallel to anything, since essential elements of fraud/misrepresentation such as reliance are simply not present in the FDA’s scheme of things (that’s still true even after Caronia.  For setting such a claim loose on the law, Cornett makes our bottom ten.  We scratched our heads over Cornett here.

6.                  Hawkins v. Medtronic, Inc., ___ F. Supp. ___, 2012 WL 4364171 (S.D. Ohio Sept. 24, 2012), interlocutory certification denied, 2012 WL 6059361 (S.D. Ohio Dec. 6, 2012).  Ugly times two on medical device preemption and TwIqbal.  It’s a PMA device, so there’s Riegel preemption.  The plaintiff’s attempt to plead a parallel claim was pathetic.  The complaint simply listed a bunch of statutory and regulatory sections and alleged, without any explanation, that they were “violated” − classic boilerplate conclusions of law that aren’t allowed any more, except in Hawkins.  The opinion mentions “precise contours” but from the indefinite “contours” in this complaint, Cleveland might as well still be part of Connecticut.  On this flimsy pleading, the opinion allowed claims such as warning, design defect and warranty, that other decisions almost uniformly dismiss on the pleadings, to survive.  Then, on a second motion, the fact that Lohr preceded TwIqbal was likewise ignored.  Hawkins is a good candidate for the worst PMA device preemption decision of the year.  It’s only saving grace is that, on summary judgment, the plaintiff will have to back up these vague allegations (after the defendant, of course, has to spend lots of time and money).  We sounded off on Hawkins here.

7.                  Whitener v. PLIVA, Inc., 2012 WL 3948797 (E.D. La. Sept. 10, 2012).  There’s express preemption and there’s implied preemption.  As the Supreme Court has held repeatedly, these two forms of preemption operate independently.  Whitener didn’t get the memo from the Supreme Court.  The case involved generic drug preemption under Mensing.  The plaintiffs alleged illegal off-label promotion.  Even putting aside the problem (highlighted in recent opinions) that neither the FDCA nor any FDA regulation prohibit off-label promotion, the proper response is, so what?  Assuming there was an FDCA violation, that doesn’t matter in an implied preemption case.  The notion of a “parallel violation claim” is wholly a consequence of the particular language of an express preemption clause applicable only to medical devices.  It has nothing to do with generic drugs or implied impossibility preemption.  For completely messing up fundamental preemption concepts and giving generic drug plaintiffs an out they are not entitled to under Mensing, this decision makes our list.  We tried to put a stop to things here.

8.                  Bonander v. Breg, Inc., 2012 WL 4128386 (D. Minn. Sept. 18, 2012).  Reading this decision, you wouldn’t believe that the plaintiff had the burden of proving causation in warning cases.  These facts – that the doctor never read the allegedly defective warning and didn’t listen to sales reps – have resulted in summary judgment in innumerable cases, but not in Bonander.  Instead, the decision allowed rank speculation unsupported by any affirmative testimony to substitute for proof.  The prescriber changed his practice based on a medical journal article years after the fact.  Maybe something from the manufacturer (whom the prescriber already testified he didn’t pay attention to) would have done the trick.  “Foreclosing a possibility” simply isn’t the same as testimony that would meet the burden of proof.  As Carl Sagan was fond of saying, “absence of evidence is not evidence of absence.”  At best, Bonander was an absence of evidence case, which the plaintiff should have lost, and that’s being charitable.  The most vacuous warning causation case of 2012.  We analogized it to monkeys at a typewriter here.

9.                  Shiff v. Hurwitz, 2012 WL 1971320 (W.D. Pa. June 1, 2012); Shiff v. Hurwitz, 2012 WL 1828035 (W.D. Pa. May 18, 2012); and Shiff v. Hurwitz, 2012 WL 1355613 (W.D. Pa. April 18, 2012).  Three differently situated defendants moved to dismiss this oddball case alleging that the plaintiff was injured during the course of an allegedly underground, totally unauthorized clinical trial.  The result was a troika of opinions that disregarded multiple settled principles of federal and/or Pennsylvania law – those being:  (1) no separate duty to test; (2) no private FDCA causes of action are permitted (3) no strict liability against manufacturers (except maybe manufacturing defect); (4) no strict liability, ever, against doctors or hospitals; (5) no consumer fraud claims involving medical treatment; (6) hospitals don’t obtain informed consent; (7) informed consent is limited to risks, benefits, and alternatives to medical procedures; and (8) federal courts sitting in diversity aren’t supposed to make up novel claims and call them predictions of state law.  We described exactly how all this doesn't fit together here.  Shiff would have ranked higher but for only one state’s law being impacted.

10.              Murthy v. Abbott Laboratories, 2012 WL 6020157 (S.D. Tex. Dec. 3, 2012).  This case is a repeat performer.  Last year, a decision on payments to investigators and the (non-existent) direct-to-consumer exception made the bottom 10 at #8 (the DTC ruling now being overruled under Texas law – see our upcoming Top 10).  Murthy’s latest mangling of Texas law misreads the state’s immunity statute to allow the plaintiff to amend to allege a claim under the exceptions for off-label marketing.  The exception, however, is worded to apply where the “defendant prescribed” off-label, so that obviously is intended to preserve claims against physicians.  The opinion pounds the square peg of a claim against a manufacturer into this very round hole by asserting that the prescriber could be the manufacturer’s “agent.”  Thus, Murthy appears to be doubling down on the investigator payments = non-independence rationale of last year’s lump of coal.  This case might rank higher, except for it being so state specific.  We called out this “bad penny” of a case here.

So there they are.  We hope none of these not-just-wrong-but-loud-wrong losses were yours – if they were, we sympathize.  We did consider several other candidates; those that came closest to making the cut were:  Schilf v. Eli Lilly & Co., 687 F.3d 947 (8th Cir. 2012) (the facts were arguably squishy); Bass v. Stryker Corp., 669 F.3d 501 (5th Cir. 2012) (the bad parts were tempered by affirmance of the dismissal of so much of the case); Winter v. Novartis Pharms. Corp., 2012 WL 827305 (Mag. W.D. Mo. March 8, 2012) (it’s a bad Parisian decision, but the worst was excluded – and the defendant later won (verdict less than the costs of trying the case) at trial); and the reconsideration in Fisher v. Pelstrung, 817 F. Supp.2d at 830-40 (D.S.C. Jan. 11, 2012) (while it was bad, it was only a reconsideration).

Now that our unpleasant and masochistic exercise in recapitulating our side’s worst defeats is over, stay tuned for next week (or possibly the following Monday) when we have fun – reviewing and celebrating the top ten best drug/device decisions of 2012. 

Thursday, December 20, 2012

What We Like To See From A To Z

We appreciate being on Joe Hollingsworth’s mailing list – we really do.  Much of the Aredia/Zometa stuff he sends us is manifestly blogworthy.  That, and all things being equal, we’d rather discuss a defense win than a defense loss.  Joe doesn’t send us his bad ones (although certain plaintiff lawyers do pass them along to us).

But not all bloggable decisions are created equal.  It’s one thing to get summary judgment on warning causation because the prescribing doctor wouldn’t have done anything differently, or because the plaintiff’s experts’ opinions were thrown out.  It’s another thing entirely to win on an issue of law that will impact many cases far into the indefinite future.  We appreciate what Joe’s trying to do here – “win” a mass tort on the remand side of an MDL − because we’ve been there and done that, and it isn’t easy.

Mass torts post-MDL remand are like fighting zombies in the movies.  The other side has hundreds of plaintiffs, and the defense has to find ways to eliminate enough of the zombies to reduce the assault to something that eventually can be settled for a reasonable sum.  In Bone Screw that required a summary judgment record of 182-2 (and an equally good record on appeal).  In such a fight, decisions that move the generally applicable law in the defense direction are at a premium.  Not only can they dispatch bunches of zombies at the same time, but they build barriers to entry of new plaintiffs, and raise obstacles to litigation generally, thus hitting the other side where it hurts the most – in the litigation pipeline.

Patterson v. Novartis Pharmaceuticals, Inc., ___ F. Supp.2d ___, 2012 WL 6618397, slip op. (D.R.I. Dec. 19, 2012), is one of the really good ones.  The plaintiff, a Massachusetts resident, decided to bring suit for some reason in D.C. federal court, on the basis of diversity of citizenship.  That action was swept into the Aredia-Zometa MDL, dismissed under TwIqbal, and the dismissal affirmed by the Sixth Circuit.  See Patterson v. Novartis Pharmaceuticals Corp., 451 Fed. Appx. 495 (6th Cir. 2011).  But even dismissal with prejudice couldn’t stop this plaintiff.  Like a zombie looking for life after death, plaintiff filed yet another action, this time in the District of Rhode Island.

The second action, however, was barred by the relevant (Massachusetts) statute of limitations.  First, the court held that the TwIqbal dismissal was a decision on the merits so that a Massachusetts tolling statute could not resurrect the zombie claims.  Patterson, 2012 WL 6618397, at *2-3.  OK, but we’re not all that interested in state-specific statute of limitations decisions.  So we move on.

Then (from our perspective) Patterson really gets interesting.  The plaintiff alleged that a bogus Aredia-Zometa class action, filed in Tennessee and never certified (see In re Aredia & Zometa Products Liability Litigation, 2007 WL 3012972 (M.D. Tenn. Oct. 10, 2007)) tolled the Massachusetts statute of limitations for several critical years despite the class action being meritless.  That raised one of the blog’s (numerous) pet peeves – cross-jurisdictional class-action tolling.  The plaintiff claimed that, although no Massachusetts court had ever actually so held, it was a “virtual certainty” that Massachusetts would recognize this doctrine.  Patterson, 2012 WL 6618397, at *4.

Patterson flatly rejected cross-jurisdictional class-action tolling.  It found no basis for predicting that Massachusetts would recognize this “controversial” concept:

The Massachusetts Supreme Judicial court has not addressed the issue of cross-jurisdictional class-action tolling. . . .  [It] is a somewhat controversial theory.  The jurisprudence [on cross-jurisdictional tolling] is not yet thoroughly developed.  The majority of states have not yet had occasion to address the issue directly and the states that have considered cross-jurisdictional tolling have been split in their acceptance of the doctrine and the rationale for their decisions. . . .  One federal court has declined to import the doctrine of cross-jurisdictional tolling into Massachusetts law in the absence of authority that establishes that Massachusetts law recognizes such tolling.

Patterson, 2012 WL 6618397, at *5 (citations and quotation marks omitted).

But the court in Patterson doesn’t content itself with merely holding that there was no basis for predicting that Massachusetts would adopt an outrĂ© theory such as cross-jurisdictional class-action tolling.  To our great pleasure, the court went further and declared that plaintiff – having filed in federal rather than state court – shouldn’t even have advanced that kind of theory.  Federal courts, as this blog has pointed out time and time again, have no business predicting novel expansions of liability under state law.  That’s the province (although we hope they don't) of state courts:

Plaintiffs, Massachusetts residents, chose to file this complaint in Federal Court in Rhode Island instead of in Massachusetts state court.  Plaintiffs are . . . empowered to choose the court system and venue in which litigation will proceed.  [They] were well aware that Massachusetts state law on tolling would play a crucial, if not decisive, role in this matter.  Notwithstanding that important consideration, Plaintiffs chose a federal venue. . . .  [A] plaintiff should not choose a federal forum when it seeks to assert a novel state law theory.  We have warned, time and again, that litigants who reject a state forum in order to bring suit in federal court under diversity jurisdiction cannot expect that new trails will be blazed.  In effect Plaintiffs have asked the Court to stretch Massachusetts law to reach an unknown and unexplored frontier. . . .  Without a well-plotted path showing an avenue of relief that the Massachusetts Supreme Judicial Court would take on cross-jurisdictional class-action tolling, and with no apparent consensus among the few states that have addressed the question, this Court declines Plaintiffs’ invitation and refuses to embark into an unexplored frontier and import cross-jurisdictional class-action tolling into Massachusetts state law.

Patterson, 2012 WL 6618397, at *5-6 (citations and quotation marks omitted).  This passage is simply one of the best statements of the principle of legal restraint under the Erie doctrine that we have ever come across.

Sharp-eyed readers of Patterson may note the citations to Maestas v. Sofamor Danek Group, Inc., 33 S.W.3d 805 (Tenn. 2000).  Patterson, 2012 WL 6618397, at *4, *5 n.8.  Maestas is a Bone Screw case – one of many.  Twelve years after Maestas was decided, it remains among the leading, persuasive precedents nationwide against cross-jurisdictional class-action tolling.  Part of fighting off the mass tort zombies − that is, beating a mass tort on the remand side of the MDL − is the use of precedent as a weapon of mass destruction.  Bone Screw was won, in large part, because the other side realized that:  (1) their cases were really weak for many reasons, and (2) because of those weaknesses, our side was using them to establish favorable law that under stare decisis would help wipe out other hordes of zombies for decades to come (Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001), being Exhibit A).  We’re pleased to see the same strategy being followed to good effect in Aredia/Zometa, and we wish Joe and his team much success in the coming years, especially on appeal.