Buried Treasure

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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 touse it, so we obtained the actual decision.
If you make Riegel-based PMA preemptionarguments, 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.

Preemption Wonderland

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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 PreemptionA beautiful sight,We're happy tonight.Walking in Preemption wonderland.
Gone away, negligence per seEnforcing regs, that’s for FDAWe 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 downHe says: Are these claims?Court says: Buckman, They can’t do the jobGet 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

And Now For A Word From The Grinch

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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 lumpof coal when it denied the defendant’s motion for summary judgment in a Zometacase last week.  In Rutz v. Novartis Pharmaceuticals Corp., 2012 U.S.Dist. LEXIS 177779 (S.D. Ill. Dec. 17, 2012), plaintiff claimed that hisdecedent developed bisphosphonate-related osteonecrosis of the jaw (“BRONJ”)after taking Zometa for 3 years while undergoing treatment for breastcancer.  In considering defendant’ssummary judgment motion, the court looked first at the evidence on specificcausation, then considered the evidence on warnings.   Because the warnings discussion is the mosttroubling - 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 tookZometa 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 amendedits labeling in September 2003, February 2004 and September 2004; it also sentDear Doctor letters in September 2004.  Id. at *12.  Ms. Rutz’s doctor got this letter, but continuedto prescribe the drug for her until August 2005.  Id. at*5.   That’s right: he continued toprescribe for two years after the first label change.  Perhaps not surprisingly, the defendantargued that there was no evidence that it should have acted more quickly toimplement a different warning.    Id. at*12.   The court merely found that thedefendant’s actions created an issue of fact as to whether it should havewarned sooner or differently.  Id. at *14-15.  Completely absent is any discussion of the prescriber’s  testimony on the warnings, or why he decidedto continue prescribing the drug through three label changes and a Dear Doctorletter – for nearly a year after the latter, in fact.  While we don’t know the doctor’s thinking, asBexis noted in a prior post,  where the alternative to therapyis likely to be death from cancer, it’s tough to prove that a doctor wouldchoose not to prescribe a drug based on the possibility of a lesser injury.
Plaintiff argued that the prescriber was not a learnedintermediary, and also, that he would have heeded a warning if it had beenadequate.  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 determinesthat the prescriber was not sufficiently warned, but the court didn’t take thison.  Instead, it punted on deciding as amatter of law whether this prescriber was a learned intermediary.  Id.at 18.  This muddied the waters for thediscussion on heeding presumption, as the court admitted that if thedoctor was a learned intermediary, it was not clear whether a heedingpresumption would apply.  Undaunted bythis fact, the court handled this obstacle by deciding that even if thisprescriber was considered a learned intermediary, a heeding presumption wouldapply (again, that’s after admitting that there was no controlling Illinoisauthority on this point).  Id. To support this conclusion, the court relied on a decision from theIllinois Appeals Court, which applied Texas law and found a heedingpresumption 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 appellateopinion 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 Circuitfound that the heeding presumption does not apply to learned intermediaries,and that even if it did, it would mean only that the doctor “would haveincorporated the additional risk into his [or her] decisional calculus.”  However, relying on the incorrectstatement of Texas law and one decision from a sister court (the NorthernDistrict of Illinois), the Rutz courtproclaimed that “the heeding presumption is a natural result of or corollary tothe learned intermediary doctrine.”  Id. at *20.  Thus, if Mrs. Rutz’s prescriber was a learnedintermediary, there was a presumption that he would have heeded an adequatewarning.   While this seems dangerously close to circularlogic to us (and not at all natural), it’s also contrary to the law in a numberof jurisdictions.  As the blog hasdiscussed in the past, Thomas v. HoffmanLaRoche , 949 F.2d 806 (5^th Cir. 1992), contains a goodsubstantive discussion of why the heeding presumption should not apply inlearned intermediary cases. 
Continuing with the theme of things that don’t existin Illinois law . . . . Illinois does not have a statutory presumption ofadequacy for FDA-approved drugs, so as you might have guessed, there was nochance the defendant was getting judgment as a matter of law on thatbasis.  But the court was unwilling toconsider the adequacy of the warning as a matter of law in general, based onwhat 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 inwhich the MDL court - applying Florida law, no less - found that the adequacyof the warning was a question for the jury. 
Based on the warnings analysis, a discussion of thecourt’s treatment of the specific causation argument may be unnecessary, buthumor us.  In his deposition, theplaintiff’s expert had admitted that Rutz’s condition did not meet the accepteddefinition of BRONJ developed by the medical community.  Id.at *7.  The court found several ways toget around this troubling admission. First, it noted that the definition had not been developed until afterthe decedent was diagnosed.  Then, thecourt rejected the definition itself. According to the criteria in the definition, in order to support adiagnosis 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 couldbe present with only 4-5 weeks of exposed bone. The problem with this opinion (besides the fact that it goes against thethinking of the rest of the medical community)?   This decedent didn’t have a singleincident of exposed bone documented in her medical records.  Remarkably, the court handled thisinconvenient fact by holding:
Given that Rutz may have had exposed bone which wasnot recorded, it would be unfair to permit [defendant] to use the absence of arecord to conclude that BRONJ was not present . . . . [a] jury could determinethat other indicia of BRONJ – such as non-healing wounds – made it likely thatexposed bone was present.” 
Id. at *10-11. The court also glossed over the defendant’s argument that this decedenthad 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 Christmasespast. 

Anti-Bartlett Arguments

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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").

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

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We hope all our readers had an excellentholiday-of-your-choice.  We did, andwe’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 of2012.  This time, we have to admit,there’s no obvious winner, since the year passed without a United StatesSupreme Court decision from our area of interest to top our tree.  But that’s happened before and we certainlyhaven’t let that stop us.  All that meansis that, who knows, maybe an intermediate state appellate decision might make thislist.  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 in2012.
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 statewhere 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 semblanceof a direct-to-consumer exception to the rule (the recognition of which landedthe intermediate decision that Hamilton reversed in #-4 of our worst of2010).  If a DTC exception lurks out thereafter Hamilton, it would only be in a case of intentional and deliberatefalsehood (which just isn’t in all those bland TV ads), that must gobeyond mere “fraud” – which the court held doesn’t vitiate the rule.  Hamilton also held that the learnedintermediary rule wasn’t an affirmative defense.  Thus the plaintiff retains all relevantburdens of proof.  The learnedintermediary rule requires warnings only to prescribing physicians – not to anyother health care provider with which the plaintiff may happen to come intocontact.  Nor does information designedfor patient consumption in any way trump the learned intermediary rule.  Finally, Hamilton applied the rule andheld as a matter of law that prior prescriber knowledge broke any possiblecausal link.  So the result went from amulti-million plaintiff’s verdict to judgment n.o.v.  It’s hard to win a more total victory thanthat.  We exulted in Hamilton here.
2.                 Walker v. Medtronic, Inc., 670 F.3d 569 (4thCir. 2012).  Walker is ourfavorite preemption case of 2012.  In Walkerthe court interpreted the “parallel claim” exception to preemption in a PMAmedical device case in a quite limited fashion. The plaintiff claimed that a statistic in the FDA-approved packageinsert wasn’t met by this particular device and thus could be a violation supporting a parallelclaim.  The Fourth Circuit said “not sofast.”  Unless the FDA had promulgated aformal “performance standard” by notice and comment rulemaking, no standardexisted to be violated.  Instead, theplaintiff was asserting a tort requirement “different from or in addition to”the FDA’s oversight of the device.  Shortof a formal performance standard, mere deviations from expected performancecould not support parallel claims.  Thus,an arguable device malfunction, by itself, did not defeat preemption under Riegel.  If only every circuit took the skeptical viewof parallel claims adopted in Walker, we’d be pretty happy.  We praised Walker here.
3.                 Lofton v. McNeil Consumer & SpecialtyPharmaceuticals, 672 F.3d 372 (5th Cir. 2012).  This is another really good appellatepreemption case.  It slips in under Walkermostly because Lofton is not as unique. Preemption is a bit of a hash in the Fifth Circuit right now, but Loftonis on the good side of that morass.  In Lofton,the court held that the fraud on the FDA exception to the Texas FDA complianceimmunity statute was preempted by Buckman.  In so doing, the court explicitly rejectedthe Desiano approach (which we revile), for all the right reasons – chiefly because Buckman is more than amere pleading case and to follow Desiano would ignore the practicalconsequences that drove the result in Buckman.  Sooner or later the Supreme Court is going tohave 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 hotall over the country right now, and the state of the art defense is at theheart of almost all of these cases.  Inthe first published appellate ruling on the issue, Rodriguez affirmedsummary judgment, holding that the hodgepodge of old, largely tangentialarticles 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 oflaw.  These articles were “isolated instances”relating to other substances.  Aninference that anesthetics would have the same consequences wasunreasonable.  The snippets that theplaintiffs offered were “too conjectural and too many steps removed from theproblem that developed.”  Nor did theFDA’s rejection of a §510k (substantial equivalence) application establishanything about safety.  All that meant isthat there was no predicate device to compare the pain pump to.  Lohr established that §510k did notevaluate safety – and plaintiffs have to live with that decision just likedefendants do.  Nor is there a duty totest a product in the absence of any knowable risk.  A defendant is not an insurer.  Nor does off-label promotion create any kindof claim, in the absence of any knowable risk. Finally, the prescriber’s testimony failed to show that any warningwould have made changed the outcome, so Rodriguez is a win on warningcausation as well.  We haven’t conductedcomplete research, but we think that Rodriguez is probably the best Painpump decision to date.  We urged othercourts to emulate Rodriguez here.
5.                 In re Pelvic Mesh/Gynecare Litigation, 43 A.3d1211 (N.J. Super. App. Div. 2012).  We’vebeen kvetching for years about the ongoing erosion of defense rights to contact treating physicians(supposedly guaranteed by the Stempler decision) in New Jersey mass tortlitigation.  In Pelvic Mesh, anappellate court finally did something about this.  The Pelvic Mesh mass tort procedureswere very restrictive of defense access to treating physicians, so that defendants had ahard time simply finding experts.  A high percentage (over 1,000 innumber) of the relevant medical specialists had treated one or another of theplaintiffs and thus were forbidden to serve as defense expert witnesses.  On mandamus (a toughstandard) the court reaffirmed a simple principle – that plaintiffs waive anyphysician/patient privilege as to relevant injuries when they bring lawsuits.  Physicians have no duty of loyalty requiringthem to support their patients in litigation. We looked forward to the ultimatedemise of New Jersey limitations on the equal availability of criticalphysician evidence to both sides here.
6.                 In re Schering Plough Corp. Intron/Temodar ConsumerClass Action, 678 F.3d 235 (3d Cir. 2012). We don’t like third-party payer class actions, whether formal class actions or broughtunder some other purported method of aggregation.  Unless somebody was actually harmed by a drugor device, these suits are artificial contrivances by which TPPs attempt to getout of what they have contracted to do – that is, to pay for prescribedtreatments that help patients.  Intronhits all the right notes – particularly that TPP plaintiffs can’t use RICO ascover for improper attempts to enforce the FDCA with respect to off-labelpromotion.  In the absence of proof thatreal people were exposed to products that were unsafe or ineffective (insteadof 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) ofthis bogus class action, and hopefully others like it, here.
7.                 United States v. Caronia, ___ F.3d ___, 2012 WL5992141 (2d Cir. Dec. 3, 2012).  It wouldrank higher, maybe even #1, if the same ruling had occurred in a productliability action.  Still, Caronia’sholding, even in the purely criminal context, that the First Amendment protectstruthful promotion of off-label uses, is significant enough to make our topten.  Courts and the common law are partof the government, and thus equally subject to First Amendment limits, as wediscussed here.  Thus, neither tort plaintiffs, norTPPs, nor FCA relators, nor state AGs, nor the federal government in its own FCAactions, can base liability (assuming Caronia remains good law) ontruthful statements about the benefits and risks of off-label uses.  We’ve been waiting for a ruling like Caroniafor a long time, ever since we began piecing together a First Amendment defensein 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.3d1170 (9th Cir. 2012).  This is another casethat suffers a bit from being somewhat out of our target area.  Pom Wonderful is a Lanham Act casebrought by a very litigious (search the name sometime) purveyor of pomegranatejuice against the defendant’s FDA-approved food labeling.  For our purposes, Pom Wonderful isimportant because it applies one of our favorite principles, that the is noprivate right of action (direct or indirect) to enforce the FDCA, in order toestablish the principle of FDA primary jurisdiction as an alternative topreemption.  California notoriouslyleads the country in bogus “consumer protection” litigation over the labelingof many FDA-approved products, so to get an appellate decision tellingplaintiffs to lay off labeling that's within the FDA’s regulatory sphere is a majorwin for the good guys.  We savored PomWonderful here.
9.                 Holmes v. Merck & Co., 697 F.3d 1080 (9thCir. 2012).  Yes, the Supreme Courtreally meant what it said in Bruesewitz (we’ve finally memorized how tospell it).  That’s essentially theholding in Holmes, and with Holmes probably falls the lastserious post-Vaccine Act product liability litigation involving thesestatutorily-protected products – which is precisely what Congressintended.  Even if the vaccine litigationdoes not involve a covered claim (the plaintiff was a parent, rather than theactually injured child, a common ruse to try avoiding the Act), the plaintiffcouldn’t escape the Act’s limits on liability. Preemption under the Vaccine Act applies to all suits against vaccinemanufacturers.  Thus, summary judgmentaffirmed.  It’s a home run for vaccinemanufacturers, but since there’s much less litigation nowadays over vaccines thanover 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-jurisdictionalclass action tolling.  In Caseythe Virginia Supreme Court unanimously decided that it did too.  The court held that a meritless and nevercertified federal class action involving Fosamax did not have any effect onthat state’s statute of limitations.  Allin 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 presentsunder the tree.  So here are our Honorable Mentions:  (11) Sandoz, Inc. v. State, 100 So.3d514 (Ala. 2012) – Would rank higher, except it’s largely a reprise of anexcellent 2009 (2009 #1) decision.  Reversesa $70+ million verdict in an AG suit over purported fraud on state health carereimbursement programs.  We reviewed ithere.  (12) In re Abbott Laboratories,Inc., 698 F.3d 568 (7th Cir. 2012) – Nice CAFA decision that plaintiffscan’t consolidate separate cases for trial without triggering the statute’s massaction provisions.  We discussed it here.  (13) Zimmerman v. NovartisPharmaceuticals Corp., ___ F. Supp.2d ___, 2012 WL 3848545 (D. Md. Sept. 5,2012) – We saw a lot of Aredia/Zometa decisions in 2012; butliked this one the best.  It’s good onfraud on the FDA/Buckman, and even better on FDA prosecutorialdiscretion, 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 highcourt, but the reasoning was thin and hard to follow; we’ll take it, but not onthe big list.  We discussed it here.  (15)  Metz v. Wyeth, Inc., 872 F. Supp.2d1335 (M.D. Fla. 2012) – It was close, but we think it’s the best of a raft of genericpreemption trial-level cases.  That itwas 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 excellentdecision on generic preemption, rejecting Conte, and affirming Erieconservatism.  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 thedefendant’s black box warning was held adequate as a matter of law.  Because it’s to be published,  Chantix beats out asimilar 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 theyear, occurring in the context of PMA preemption.  Demolishes Hofts.  We covered it here.  (19) Marsh v. Genentech, Inc., 693F.3d 546 (6th Cir. 2012) – Given a chance to back down, the Sixth Circuitdidn’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.  Gekilled such a claim in the False Claims Act context where preemption doesn’tapply.  Not even in D. Mass.  We discussed it here.
Looking back, all of our top ten from 2011 remainintact.  We did lose one of our honorablementions, however, when the Degelman case (2011 #14) was settled whileon en banc review, and thusvacated.  The Dobbs SSRIpreemption decision (2011 #8) is currently before the Tenth Circuit.  On the other side of the ledger, as wepointed 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 maybewe’ll have good news to report on those fronts in 2013.  The Lance case (2010 #-6) remainspending 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 rankhighly on our top ten of 2013.  The awfulCaldwell case (2012 #-2) from Louisiana is also being appealed, but asso 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 Courtwill become the first state high court to rule on Conte brandedliability where only generic drugs were consumed.  In Stengel, the Ninth Circuit en bancwill address what can and can’t constitute a “parallel claim” under Riegeland Buckman.  Finally, we’re awareof 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 genericdrugs and medical devices under Mensing and Riegel are in theappellate process in federal and state appellate courts.
So now it’s on to 2013.  Happy New Year to all our readers.

Company Settles EEOC Suit Alleging Refusal To Hire 7th Day Adventist

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The EEOC announced last week that Altec Industries, Inc., a Birmingham, Alabama based manufacturing company, has agreed to settle a religious discrimination lawsuit brought against it by the EEOC. The suit claims that Altec refused to hire Seventh Day Adventist, James Wright, at its Burnsville, N.C. manufacturing  facility after it learned that Wright could not work on his Sabbath (sundown Friday to sundown Saturday).  Altec will pay $25,000 in damages to Wright, and will also provide training on religious discrimination to certain managers and supervisors, post notices of employee rights and report periodically to the EEOC.

Justice Sotomayor Denies Injunction Pending Appeal In Hobby Lobby's Contraceptive Coverage Challenge

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As previously reported, Hobby Lobby Stores and its sister corporation Mardel, Inc. have been seeking a temporary injunction to prevent enforcement of the Affordable Care Act contraceptive coverage mandate against them as they litigate their religious liberty challenges to the health care insurance rule.  After the 10th Circuit denied them an injunction, they sought a injunction from Supreme Court Justice Sotomayor in her role as Circuit Justice.  Yesterday, Sotomayor refused to grant the injunction.  In an in chambers opinion in Hobby Lobby Stores, Inc. v. Sebelius, (Sup. Ct., Dec. 26, 2012), Justice Sotomayor wrote in part:

Applicants do not satisfy the demanding standard for the extraordinary relief they seek.  First, whatever the ultimate merits of the applicants’ claims, their entitlement to relief is not “indisputably clear.”... This Court has not previously addressed similar RFRA or free exercise claims brought by closely held for-profit corporations and their controlling shareholders alleging that the mandatory provision of certain employee benefits substantially burdens their exercise of religion.... Moreover, the applicants correctly recognize that lower courts have diverged on whether to grant temporary injunctive relief to similarly situated plaintiffs raising similar claims....

AP reports on the decision, as does SCOTUS Blog.

Parents Sue Rabbi For Sexual Assault and Defamation After He Received Light Criminal Sentence

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Yesterday's Albany (NY) Times-Union reports on a civil suit for sexual assault and defamation that has been brought in state court in Albany County, New York against a former Chabad rabbi. In January 2010, Rabbi Yaakov Weiss plead guilty to misdemeanor charges of child endangerment after admitting inappropriate sexual contact with two 13-year old boys. Apparently Weiss' conduct with the boys took place in a mikveh (ritual purification pool). Under the plea agreement, Weiss was sentenced to 60 days in jail and 3 years probation, and was not required to register as a sexual offender. Weiss has also been suspended from his position with the local Chabad organization.  The boys parents, upset at the light sentence Weiss received, have now filed this civil suit which will come to trial next month. The defamation charges in the suit stem from Weiss' claim that the boys' allegations were "100% untrue." Meanwhile Weiss has complained to a rabbinical tribunal in Rockland County about the parents filing of the civil lawsuit.  The religious tribunal could potentially excommunicate the parents for bringing the lawsuit in civil court rather than submitting it to a religious tribunal for adjudication.

President Extends Best Wishes To Those Celebrating Kwanzaa

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The White House yesterday issued a statement (full text) from the President and the First Lady extending best wishes to all those celebrating Kwanzaa. The statement describes the festival as a "week-long celebration of African-American history and culture through the seven principles of Kwanzaa: unity, self determination, collective work and responsibility, cooperative economics, purpose, creativity, and faith."

Iran Bars Overflights During Call-To-Prayer Times

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The New York Times reported yesterday that Iran's Civil Aviation Organization has issued a directive prohibiting all aircraft from flying across the country during Adhan, the 5-times daily Muslim call for prayer. However the directive did not indicate whether planes in flight would be re-routed or forced to land.  Also under the new directive, no planes may take off in the morning until 30 minutes after the pre-dawn call to prayer. The head of the Civil Aviation Organization said the new rules were designed to give air travelers the time to carry out their religious duties. [Thanks to Scott Mange for the lead.]

Proposed Changes to Federal Rules on Preservation of Evidence

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            Not exactly a catchy title.  And probably not enough to compete with all the other distractions of this time of year – wandering through a snow-covered field to chop down a Christmas tree, hand-dipping your own candles to give as gifts, delicately decorating gingerbread men baked from scratch.  No wait – we really meant setting up the artificial snowing Christmas tree (nothing says happy holidays like millions of tiny pieces of Styrofoam floating through your home), waiting to see if Amazon is going to get you the complete second season of Shameless on DVD before the 25^th, and popping a Mrs. Smith’s frozen apple pie in the oven.  Whether your holidays are like the former, the latter or somewhere in between, you probably have something more pressing to attend to than reading this blog.  So, we thought we’d give you something to think about for the future – a proposed change to Federal Rule of Civil Procedure 37 regarding when sanctions can be imposed for failure to preserve evidence.  See Excerpt from Report of Civil Rules Advisory Committee here.              Honestly, we just happened upon this ourselves and haven’t had much time to fully digest all the implications.  As with any rule change, the real ramifications won’t be known until the courts start to apply it.  But since the proposed change looks to be slated for discussion early in the new year by the Civil Rules Advisory Committee, we thought we’d take a look.   Right now Rule 37(e) concerns the standard for sanctioning a party for the loss of electronically stored information – so in our products liability world, it mainly applies to defendants.  The rule currently provides -- no sanctions, “absent exceptional circumstances,” if electronic data is “lost as a result of routine, good-faith operation of an electronic information system.”  That already sounds like a good starting point.  Despite that language, however, the Committee report indicates that application of the rule and the imposition of sanctions have varied widely by circuit.  Eliminating that variance, as well as overturning Residential Funding Corp. v. DeGeorge Fin. Corp., 306 F.3d 99 (2d Cir. 2002), which authorized sanctions for negligent failure to preserve (and which apparently continues to be applied despite the language of the current rule), are the main goals of the proposed changes.  Here is the text of the proposed rule:(e) FAILURE TO PRESERVE DISCOVERABLE INFORMATION. If a party failed to preserve discoverable information that reasonably should have been preserved in the anticipation or conduct of litigation,            (1)        The court may permit additional discovery, order the party to undertake curative measures, or require the party to pay the reasonable expenses, including attorney’s fees, caused by the failure.             (2)        The court may impose any of the sanctions listed in Rule 37(b)(2)(A) or give an adverse-inference jury instruction only if the court finds:                                 (A)       that the failure was willful or in bad faith, and caused substantial prejudice in the litigation; or                         (B)       that the failure irreparably deprived a party of any meaningful opportunity to present a claim or defense.            (3)        In determining whether a party failed to preserve discoverable information that reasonably should have been preserved, and whether the failure was willful or in bad faith, the court should consider all relevant factors, including:                        (A)       the extent to which the party was on notice that litigation was likely and that the information would be discoverable;                        (B)       the reasonableness of the party’s efforts to preserve the information;                        (C)       whether the party received a request that information be preserved, the clarity and reasonableness of the request, and whether the person who made the request and the party engaged in good-faith consultation regarding the scope of preservation;                        (D)       the proportionality of the preservation efforts to any anticipated or ongoing litigation; and                        (E)       whether the party sought timely guidance from the court regarding any unresolved disputes concerning the preservation of discoverable information.While stricter guidelines requiring a showing of bad faith or willfulness before a court can sanction a corporate defendant for failing to preserve electronic data are a good thing in our book, the proposed Rule 37(e) broadens the scope of the rule to cover any unpreserved discoverable information.  So that means it applies to plaintiffs as well, including plaintiffs who lose the very products that are the subject of their lawsuits.  We are obviously opposed to any rule or ruling that allows a party to benefit from his/her own destruction of evidence – whether intentional or not.  We’ve talked about this before.A quick look at the proposed rule suggests that a plaintiff’s failure to preserve the product may fit under proposed 37(e)(2)(B) -- that the failure irreparably deprived a party of any meaningful opportunity to present a claim or defense -- that doesn’t appear to require bad faith.  We think the intent of this subsection may well be to account for the type of evidence lost.  If what was discarded or destroyed was of critical importance to the case – i.e. the product – something less than a showing of bad faith will be required.  For instance, in a manufacturing defect case if the product was lost before it could be inspected and/or tested, the defendant is certainly stripped of its ability to defend by demonstrating that the particular product wasn’t defective.  The new rule appears to leave open the possibility of sanctions or an adverse-inference in that situation.  Or, where a plaintiff (or a defendant, for that matter) loses the product in question, (e)(2)(B) should allow the court to bar any pre-loss expert report without a showing of bad faith.  Like we said, this is still a proposal and subject to change.  And if adopted, subject further to interpretation by the courts.  So, after the gifts have been opened, the cookies eaten, the eggnog drunk and Auld Lang Syne sung – here’s something to think about for 2013.

Shout Outs

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Our thanks go to the following readers for thefollowing reasons.
First, to Glenn Lammi over at the Washington Legal Foundation, who inresponse to our Caronia Roundup, pointed out that WLF was having a Web Seminaron the subject.  Unfortunately, it was today.  Too bad we didn’t getaround to posting this in time for the seminar.  We'll try to be better next time.
Then there’s Calvert Crary, who sent us a PDFof his Caronia analysis (which wemissed - even knowing about it we'll be damned if we can find it on the Web anywhere), which is interesting because it breaks down possible effectsof the decision by large branded, small branded, and generic companies.  This is the only analysis that we’ve seen that analyzes things this way.
Finally, thanks to Dr. John Duke (yes, some M.D.sactually read the blog) an assistant professor at Indiana University MedicalSchool whoinforms us of his studydiscovering that there were more discrepancies between generic and branded labeling than wethought, although most of them were quite minor.  A word to the wise – this time our readersin the generic business – since generic preemption is based on “sameness”between generic and branded labeling, it would be a good idea not to risk your best defense but not having labels that actually are thesame.

Minnesota Musings on Primary Jurisdiction and the Platonic Ideal of Greek Yogurt

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A couple of weeks ago we praised a primary jurisdiction caseout of California. It was a food case, but we wondered whether primaryjurisdiction could be a more active, robust line of defense in drug and devicecases now that Wyeth v. Levine has curtailed the preemption defense.  Just last week we showered praise upon a Minnesota judge for showing the door to aforum-shopping plaintiff.  Now we have the privilege of reporting on aMinnesota case that applied the primary jurisdiction doctrine to put the brakeson a product liability case.  Again, it is a food case, but this is thetime of the year when we often end up with unexpected food gifts.  And thenext time we get disappointed by such a gift or turn it down will be thefirst.  Yes, that even goes for fruitcake.
 
In Taradejna v. General Mills, Inc., 2012 U.S. Dist. LEXIS174264 (D. Minn. Dec. 10, 2012), the plaintiff brought a class action allegingviolations under the Minnesota Prevention of Consumer Fraud Act, the MinnesotaUnlawful Trade Practices Act, and the Minnesota Uniform Deceptive TradePractices Act, related to the alleged mislabeling of Yoplait Greek yogurtproducts.  The plaintiff contended that “Yoplait Greek yogurt is neitheryogurt nor Greek.”  Taradejna, 2012 U.S. Dist. LEXIS 174264 at *3. (We are reminded of that European History class we took, where one could beassured of at least a B on the final exam by beginning the essay withthis:  "The Holy Roman Empire was neither Holy nor Roman nor anempire."  To this day, we do not know what that means, but we stilldeclaim it whenever we want to show off the benefits of a liberal artseducation.  It’s like referring to Proust without ever having read a wordhe wrote.  We also remember the Linda Richman character from the old Saturday Night Live "Coffee Talk" skits, who would pose similar topics for her audience.  For example, "Rhode Island is neither a road nor an island.  Discuss.")
 
How can yogurt lie?  The plaintiff has a story totell.  According to that story, the defendants were unprepared for thepopularity of Greek yogurt.  So far so good.  We confess that we feelambushed by Greek yogurt – ambushed by luscious goodness.  Be that as it may, theunexpected huge demand for Greek yogurt prompted the defendants to use Milk ProteinConcentrate (MPC). A blend of dry dairy products, MPC is sold in a powderedform.  We do not know whether that is good or bad.  We do not knowwhether that MPC is somehow anti-Greek.  But we do know this much: the labeling of Yoplait Greek yogurt discloses MPC as an ingredient.  Itis not as if that MPC is being smuggled in via a dairy Trojan Horse. 
 
Nevertheless, the plaintiff argued that the inclusion of MPC makes theYoplait Greek yogurt an impostor.  In 1981, the FDA promulgated standardsof "identity" for yogurt.  21 C.F.R. § 131.200.   Aspart of yogurt identity (admit it – you never expected a legal blog to discuss“yogurt identity”  did you?), the FDA proposed to limit “other optionalingredients” that could be included in yogurt.  47 Fed. Reg. 41519 (Sept.21, 1982). The FDA drafted a provision limiting the use of “other optionalingredients” in yogurt to certain milk-derived ingredients (e.g., concentratedskim milk, nonfat dry milk, buttermilk, whey), sweeteners, flavorings, coloradditives, and stabilizers. 21 C.F.R. §131.200 (d)(1)-(5).  Surely younoticed that the FDA’s list of “other optional ingredients” does not includeMPC. Bad news for our defendant yogurt-slingers, right?
 
Well, because we are in FDA-land, nothing is as clear as onewould like.  In response to comments and objections, the languageregarding “other optional ingredients" was stayed,and the limitation, while published, was not put into effect. We are in yogurtlimbo.  But the key to the plaintiff’s claim in the Taradejna case is thatbecause MPC is not an ingredient expressly listed or described within theapplicable standards of identity for yogurt, use of this ingredient is notpermitted in yogurt.  Okay, says the defendant, we see your FDA paralyticreticence, and we raise you a belated FDA answer to a public question at a 2004milk seminar: "May whey protein concentrate (WPC) and/or milk proteinconcentrate (MPC) be used as ingredients in yogurt to increase the nonfat solidscontent? Yes, 21 C.F.R. 131.200(d), which would have precluded WPC or MPC use,was one of several provisions of the standard of identity for yogurt that werestayed in 1982."
 
Still with us, or have you decided to put the lid on thisyogurt stuff and get yourself a proper breakfast, like waffles?  (Mmmmm …waffles.)
 
Now let’s turn to the FDA’s issuance of a Proposed Rule in2009 (mind you, this yogurt saga started in 1981).  The rule would allowfor certain modifications to the standards of identity for yogurt, including“the use of reconstituted milk and whey protein concentrate as standard dairyingredients.” 72 Fed. Reg. 2443 (Jan. 15, 2009). The FDA observed that whilethe published standards do not permit the use of certain ingredients such aspreservatives or a reconstituted dairy ingredient as a basic ingredient,“because of the stayed provisions, FDA has not taken enforcement action againstthe use of these ingredients in yogurt.…” 74 Fed. Reg. at 2224.  The FDAexplained that, as of 2009, it has not held a public hearing to resolve theseissues “due to the competing priorities and limited resources.” Id. at2444.  It was apparently a very busy 28 years.  (True that – thinkabout all the stuff that happened between 1981 and 2009.  The Soviet Unioncollapsed.  Then there were all those disasters:  Chernobyl, theChallenger explosion, Tiananmen Square, O.J., Katrina, the Wyeth v. Levine decision, Ishtar).
 
In the 2009 Proposed Rule, the FDA advocated incorporationof “technological flexibility into standards so long as the basic nature andessential characteristics of the food are not adversely affected.” Therefore, the FDA proposed to permit the optional use of any safe and suitablemilk-derived ingredient as an optional dairy ingredient in the manufacture ofyogurt to increase the nonfat solids content of the food above the minimumrequired 8.25 percent, provided the ratio of protein to total nonfat solids ofthe food and the protein efficiency ratio of protein present in the food arenot decreased as a result of the use of such ingredients.  That ProposedRule remains a Proposed Rule.  The Taradejna court points out, perhaps ruefully,that “[i]t appears that no public hearing has yet been held on the 2009Proposed Rule.”  2012 U.S. Dist. LEXIS 174264 at *10.   As wesaid, the FDA has been busy.
 
The plaintiff, an Illinois resident, filed the complaint inMarch 2012, in Minnesota state court. The defendants removed the case to federal court.  The plaintiff alleged that in March 2012,he “purchased a serving of Yoplait Greek yogurt, which brandished the labeldeveloped and approved by Defendants” at a Chicago grocery store. (So, as inthe Minnesota case discussed last week, we have another carpet-baggingplaintiff in pursuit of snowdrifts and hospitable jurisprudence.)  Theplaintiff alleged that while MPC was listed as an ingredient on the label, thelabel was “inadequate to disclose the fact that what Plaintiff was going topurchase and ultimately eat, was not actually ‘yogurt’ as marked.”  Id. at*11.
 
The defendant interposed a number of defenses.  The onethat worked was primary jurisdiction.  Primary jurisdiction “applies wherea claim is originally cognizable in the courts, and comes into play wheneverenforcement of the claim “requires the resolution of issues which, under aregulatory scheme, have been placed within the special competence of anadministrative body.” Id. at * 14-15.  Agency expertise is the most commonreason that courts apply the doctrine of primary jurisdiction. “In addition,courts apply the doctrine to promote uniformity and consistency within theparticular field of regulation.”  Id. at 15.  When the primaryjurisdiction doctrine applies, the “district court has discretion either tostay the case and retain jurisdiction or, if the parties would not be unfairlydisadvantaged, to dismiss the case without prejudice.”  Id.
 
In the Taradejna case, the underlying issue was whether MPCis a proper, permitted ingredient in yogurt. The court reasoned that“resolution of this question falls squarely within the competence and expertiseof the FDA.”  Id. at *16.   Issues of food labeling aresufficiently complex that they “are best left to FDA for consideration prior tojudicial review.” Id.  And here, just as with last week’s case, theMinnesota judge delivers some prose that is precise and delicious:  “Thecurrent standard of identity for yogurt, the stayed 1982 limitations, theAgency’s subsequent public statements about the standard, and the 2009 ProposedRule do not constitute a model of clarity.”  Id. at *16-17.  The FDA is in the best position to resolve any ambiguity about the standard ofidentity for yogurt – a matter requiring scientific and nutritional expertise.Moreover, “given that the FDA has issued its 2009 Proposed Rule on the standardof identity for yogurt, it would be imprudent for the Court, at this juncture,to substitute its judgment for that of the Agency’s while revision of thestandard of identity is pending.”  Id. at *17. 
 

And then of coursethere is that concern for uniformity and expertise.  Either it’s all Greekto America, or it isn’t.  Or something like that.  And here’s anon-surprise:  “several recently-filed yogurt lawsuits throughout thecountry involve the same or similar issues as found in the instant suit. Theincreasing volume of this litigation creates the potential for inconsistentjudicial rulings.”   Id.  Accordingly, the court dismissed thecase without prejudice and directed the parties to initiate the properproceedings with the FDA. 


Call it a blow against an overly litigious culture. 
 
As we said a couple of weeks ago, FDA expertise and the needfor uniformity also exist in the drug and device arena.  If primary jurisdiction applies in Taradejna, imagine how much stronger the primary jurisdiction argument would be where the FDA has actually done more on a subject than one proposed rule in 30 years.  Moreover, now that we knowthat FDA-created confusion can also be a factor in favor of applying primaryjurisdiction, we are rubbing our hands together and getting ready to fire upsome motions. 
 
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One week ago, the post was entitled “Good News and BadNews.”  Some bad news is especially tough to endure.  Some bad newsis beyond our capacity to understand.  Some bad news is beyond our capacityto discuss without fury or despair. 
 
For most schools in this area, Winter break starts in themiddle or end of this week.  The commuter trains have been full of littlekids, some on field trips and some accompanying their parents to the holiday displaysin Philadelphia.  We have been laying down our newspaper, closing our eyes, andlistening to the laughter of the children.  It is much needed music. 
 
 
 
 

At Risk Claims Sufficient To Support Federal CAFA Jurisdiction

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Back when Bexis was still at Dechert, we put up acautionary post called “CAFA Not With Standing.”  In that post we cautioned againstusing constitutional standing as a defense to class actions with questionableand attenuated damages claims.  RememberCAFA, we pointed out.  The damages soughtin state-court class actions need to support federal Article III standing, orelse defendants won’t be able to keep the actions in federal court.
Well, yesterday the court in Bouldry v. C.R.Bard, Inc., No. 12-80951-CIV, slip op. (S.D. Fla. Dec. 18, 2012), addressed precisely the situation discussed in thatpost.  Fortunately, our side won, and theclass action stayed in federal court, where there are plenty of other argumentsagainst its validity.
First, we have to point out that ReedSmith wasinvolved in the Bouldry case, so we can’t say as much as we’d like.  We’ll have to stick to the legal propositions.  As for the facts, all we can say is that the Bouldryopinion should be applicable to other attenuated injury class actions, regardlessof the product or conduct involved.
Bouldry involved a state class action inFlorida alleging that a medical device had a higher risk of failure than itshould.  The class consisted of peoplewho had not suffered any failure.  Thereare good arguments that this sort of at-risk damages are not recoverable undermost states’ laws − see our no injury scorecard, and in particular the Shiley heart valve cases from the late 1980s and early1990s, which addressed similar allegations. Hint:  the defendant won almostall of them.
Defendant removed Bouldry under CAFA.  Plaintiffs sought remand by alleging that atrisk claims didn’t constitute “injury in fact” under Article III of the U.S.Constitution, and thus there was no standing to support the exercise of federaljurisdiction under CAFA.  Bouldry,slip op. at 2.  In so doing, plaintiffsin Bouldry advanced precisely the argument we worried about in ourearlier CAFA post.
The court concluded that claims for risk of futureinjury satisfied the constitutional “injury in fact” requirement, regardless ofwhether such damages were recoverable under state law. Id. at 4-5 (citing Pisciotta v. Old Nationall Bancorp, 499F.3d 629, 634 (7th Cir. 2007); Central Delta Water Agency v. United States,306 F.3d 938, 947-48 (9th Cir. 2002); and Friends of the Earth, Inc. v.Gaston Copper Recycling Corp., 204 F.3d 149, 160 (4th Cir. 2000) (enbanc)).  The court also cited medicalmonitoring cases that reached the same conclusion about alleged risk of futureharm.  Bouldry, slip op. at 5(citing Sutton v. St. Jude Medical S.C., Inc., 419 F.3d 568, 574-75 (6thCir. 2005); In re Paoli Railroad Yard PCB Litigation, 916 F.2d 829, 861(3d Cir. 1990); In re Welding Fume Products Liability Litigation, 245 F.R.D.279, 287 n.37 (N.D. Ohio 2007); and Carlough v. Amchem Products, Inc.,834 F. Supp. 1437, 1452 (E.D. Pa. 1993)).
Essentially, even if the claim may fail as a matterof substantive law for lack of cognizable injury, constitutional standing toadjudicate damages-related (and all other) arguments will exist as long as theplaintiff “has “a sufficient stake in a justiciable controversy.”  Bouldry, slip op. at 6 (citing Floridacases).
Finally, to the extent that plaintiffs alleged intheir complaint that they did not have standing under Article III, thoseallegations were conclusions of law that could be ignored under TwIqbal.  Bouldry, slip op. at 7-8.
For all of these reasons, the court held that,under CAFA, the damages allegations were sufficient to support removal tofederal court.  We believe this to be thefirst time this standing issue has been resolved in the specific CAFA context,so anyone facing similar no-injury or at-risk class actions may want to take alook.