Let's Put A Stop To This Right Away

In Whitener v. PLIVA, Inc., 2012 WL 3948797, at *4 (E.D. La. Sept. 10, 2012), the court recently allowed “a state-law tort claim based on alleged promotion of [a generic drug] for off-label purposes in violation of federal law” to escape preemption on a motion to dismiss.  This claim was presented as a “parallel claim”:

Plaintiffs argue that their complaint involves parallel state law claims − in other words, they claim that Defendants’ violations of federal law also violated Defendants’ state law duties to Plaintiffs.

Id. at *5 (emphasis original).  The only case plaintiff cited in favor of these allegations wasn’t even a generic drug case, but rather a medical device case, Lofton v. McNeil Consumer & Specialty Pharmaceuticals, 672 F.3d 372, 378–79 (5th Cir. 2012) (a very good case for defendants, by the way).  2012 WL 3948797, at *5.

The court let the allegation skate, finding it different from Mensing because plaintiffs “allege that Defendants simultaneously violated both state and federal law by actively engaging in off-label promotion despite known risks not listed on the label.”  Id. (emphasis original).  It wasn’t a particularly strong endorsement, however, as the court stated:

The [Mensing] Court simply did not reach the issue of whether federal regulations preempt state tort claims that are not based on failure to change the label in violation of federal regulations.  Furthermore, the parties still have not cited a case on point for this issue.  Accordingly, the Court remains “hesitant to hold as a matter of law that there is not a kernel of a viable claim somewhere in Plaintiffs’ allegations.”

Whitener, 2012 WL 3948797 at *6.

Next thing we know, the very next day in fact, we see a routine order in different litigation, concerning amendment of complaints, suggesting that − once again − plaintiffs suing generic drug manufacturers are “asserting off-label promotion“ as a supposedly unpreempted claim.  In re Prempro Products Liability Litigation, 2012 WL 3985752, at *1 (E.D. Ark. Sept. 11, 2012).

We’d like to see a stop put to such allegations right away, before they gain any real traction.  The simple fact is that the idea of a “parallel claim” is a principle of express − that is, medical device preemption − not implied generic drug preemption under PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011).  The existence of a preemption exception (assuming for purposes of this post that it exists) for “parallel” claims in medical device cases is based entirely on the specific language of the express preemption clause (21 U.S.C. §360k) concerning medical devices, which preempts state law that is “different from or in addition to” an FDA “requirement“ concerning medical devices.  This was made perfectly clear in Lohr itself:

Nothing in §360k denies Florida the right to provide a traditional damages remedy for violations of common-law duties when those duties parallel federal requirements.  Even if it may be necessary as a matter of Florida law to prove that those violations were the result of negligent conduct, or that they created an unreasonable hazard for users of the product, such additional elements of the state-law cause of action would make the state requirements narrower, not broader, than the federal requirement.  While such a narrower requirement might be “different from” the federal rules in a literal sense, such a difference would surely provide a strange reason for finding pre-emption of a state rule insofar as it duplicates the federal rule.  The presence of a damages remedy does not amount to the additional or different “requirement” that is necessary under the statute; rather, it merely provides another reason for manufacturers to comply with identical existing “requirements” under federal law.

Medtronic, Inc. v. Lohr, 518 U.S. 470, 495 (1996) (emphasis added).  The dictum in Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), says the same thing, more succinctly:

State requirements are pre-empted under the MDA only to the extent that they are “different from, or in addition to” the requirements imposed by federal law.  §360k(a)(1).  Thus, §360k does not prevent a State from providing a damages remedy for claims premised on a violation of FDA regulations; the state duties in such a case “parallel,” rather than add to, federal requirements.

Id. at 330.  Essentially, the only reason why a “parallel” claim exception can exist in medical device preemption is the language of the preemption clause − which does not extend to any kind of prescription drug, generic or branded.

Preemption in the generic drug context, by contrast, is implied − arising from the impossibility of maintaining “the same” warning if state tort plaintiffs could demand changes in generic labeling independently from the FDA-approved language.  These are separate concepts.  “[T]he absence of express pre-emption is not a reason to find no conflict pre-emption.”  Mensing, 131 S. Ct. at 2577 n.5 (emphasis original); see Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341, 352 (2001) (“neither an express pre-emption provision nor a saving clause bars the ordinary working of conflict pre-emption principles”).  Under Mensing anything that would “change” the labeling violates this federal “sameness” requirement, and is preempted.

If the Manufacturers had independently changed their labels to satisfy their state-law duty, they would have violated federal law.  Taking [plaintiffs’] allegations as true, state law imposed on the Manufacturers a duty to attach a safer label to their generic [drug].  Federal law, however, demanded that generic drug labels be the same at all times as the corresponding brand-name drug labels.  Thus, it was impossible for the Manufacturers to comply with both their state-law duty to change the label and their federal law duty to keep the label the same.

131 S. Ct. at 2578.

What about the allegations of off-label promotion in Whitener?  Without some kind of informationally-based allegation − that is to say that the FDA-approved “same” labeling is inadequate − there is simply no causation.  “Promotion” necessarily involves the transmission of information, which means that it concerns what the FDA considers “labeling,” and all generic labeling is subject to the “sameness” requirement that underlies Mensing.

To the extent any investigation, testing, or marketing surveillance would have revealed the dangers of the drug, that knowledge would have been helpful only to the extent it was communicated through labeling − which would not have made any difference as long as the Generic Defendants were following the FDA's labeling regulations.  The Generic Defendants could not have unilaterally improved the labeling of the drug any further even if they had wanted to.

Truddle v. Wyeth, LLC, 2012 WL 3338715, at *4 (N.D. Miss. Aug. 14, 2012).  Thus, in order to avoid a “pure” FDCA-based claim (off-label promotion being considered within the FDA’s definition of “labeling”), of the type preempted under Buckman, there must be something inadequate about the label that has to do with the allegedly promoted off-label use.  There’s no other way for a manufacturer violate state common law.  Off-label promotion is not a state common-law concept.  State law theories predicate liability, not on “intended uses,” but only on the inaccuracy or inadequacy of the information itself.

You don’t have to take our word for it.  Although apparently not before the court in Whitener, a number of cases have recognized that express preemption concepts, such as “parallel” claims, have no place in implied preemption analysis involving generic drugs.

Plaintiff’s focus on decisions involving express preemption is misplaced. Mensing involved conflict preemption, which does not depend on the limitations of the language in a preemption provision.  In other words, no parallel state-law claims or alternative theories of liability survive the Supreme Court's ruling in Mensing.

Guarino v. Wyeth LLC, 823 F. Supp.2d 1289, 1292 (M.D. Fla. 2011) (emphasis added), reconsideration denied, 2012 WL 28810 (M.D. Fla. Jan. 5, 2012).  It's hard to get more direct than that.

Express preemption concepts such as “parallel” claims cannot be imported into implied preemption cases solely governed by Mensing.  “[E]xpress preemption is not applicable here because the Supreme Court [in Mensing] clearly identified the conflict between the LPLA and the FDA labeling rules as a case of conflict or impossibility preemption.”  Morris v. Wyeth, Inc., 2011 WL 4973839, at *2 (W.D. La. Oct. 19, 2011), reconsideration denied, 2012 WL 601455 (W.D. La. Feb. 23, 2012).  To argue otherwise is “misguided”:

The Supreme Court very clearly based its decision in Mensing on conflict or impossibility pre-emption, which determines whether the private party could independently do under federal law what state law requires of it.  Thus, [plaintiff’s] attempt to analyze the claim under express pre-emption is misguided.

Del Valle v. PLIVA, Inc., 2011 WL 7168620, at *6 (Mag. S.D. Tex. Dec. 21, 2011), adopted, 2012 WL 2899406 (S.D. Tex. June 22, 2012).

Likewise, in Phelps v. Wyeth, Inc., ___ F. Supp.2d ___, 2012 WL 1499343 (D. Or. April 24, 2012), the plaintiff sought to assert (among other things) “misbranding” claims alleging FDCA violations to get around Mensing preemption.  The court correctly recognized that such claims did not alter the federal “sameness” requirement at the heart of Mensing:

When enacting the FDCA, Congress was explicit that only the federal government may bring an action to enforce its provisions.  Consequently, failure to comply with the FDCA cannot form the basis for a state-law claim.  Plaintiffs cannot sue to enforce the federal statute. . . .  Plaintiffs’ reliance on Hughes v. Boston Scientific Corp., 631 F.3d 762 (5th Cir. 2011) [a medical device “parallel claim” case] is misplaced.  Hughes involved a medical device and whether the plaintiff’s claims were expressly preempted under §360k of the Medical Device Amendments.  The court’s holding in Hughes does not change the preemption analysis outlined in Mensing.  Here, plaintiffs’ claims are preempted by impossibility; they are not expressly preempted.

Id. at *9.

Thus, there isn’t a “kernel of a viable claim” in a generic drug case alleging off-label promotion.  “Parallel” claim analysis is about as useful in a Mensing implied preemption case as a bicycle is to a fish.  The generic plaintiffs are still asserting that the label is inadequate − which they simply can’t do under Mensing. They’re only offering a different reason (a claimed FDCA violation) for the inadequacy.  Whether or not that creates a “requirement” that’s “different from or in addition to” under Lohr express preemption analysis, such allegations do not change the Mensing requirement of labeling “sameness” one iota .

Bad Parallel Violation Decision, But Plaintiff May Have Nowhere to Go

When we first read Steiden v. Genzyme BioSurgery, 2012 U.S. Dist. LEXIS 99689 (July 18, 2012), we didn’t know which bothered us more: the court’s parallel violation ruling or its TwIqbal ruling.  It’s still a close call, but TwIqbal might have won in a photo finish.  It’s not all doom and gloom, however.  There may be an upside. 

There was nothing distinct about the plaintiff’s claim.  He alleged that he had a serious adverse reaction to a knee injection of Synvisc-One®, which is regulated as a medical device.  Id. at *1-2.  He brought product liability claims.  The defendant moved to dismiss on the basis of preemption under the Medical Device Amendments to the Food, Drug and Cosmetics Act.  The plaintiff then conceded that his product liability claims were preempted.  Id. at *4. 

Routine enough so far.  Here’s where parallel violation claims came into play.  Plaintiff asked to amend his complaint to add the following allegations:

(1) Genzyme failed to comply with the FDA’s premarket approval requirements in the continued manufacture, distribution and sale of Synvisc-One®;

(2) Genzyme manufactured, held, sold, and delivered an adulterated dose of Synvisc-One®;

(3) Genzyme did not meet the FDA's Current Good Manufacturing Practices (“cGMPs”) in the manufacture, distribution and sale of Synvisc-One®; and

(4) Genzyme violated KRS 217.175 by manufacturing, holding, selling and delivering an adulterated dose of Synvisc-One®, the violation of which constitutes negligence per se.

Id. at *5.  The upshot is that plaintiff wanted to allege that the defendant didn’t follow PMA approval and cGMP requirements and parlay those alleged failures into a parallel violation claim under Kentucky’s negligence per se statute. 

The court allowed this claim to go forward.  The problem is that there is no private right of action under the FDCA.  The FDCA itself says so: “all such proceedings for the enforcement, or to restrain violations, of this chapter shall be by and in the name of the United States.”  21 U.S.C. §337(a).  Accordingly, as we’ve discussed before here, the FDCA should not be a proper candidate for private negligence per se enforcement.  But there’s no reason to get worked up about it here again. 

It’s harder, though, with the TwIqbal ruling.  The totality of the plaintiff’s factual allegations in his proposed amended complaint is as follows:

William L. Steiden, a patient of Dr. Edward Tillett, an orthopedic surgeon who practices in Jefferson County, Kentucky, had both of his knees injected with Synvisc-One® (HYLAN G-F 20) on July 22, 2010. The plaintiff suffered an immediate adverse reaction after the injection of Synvisc-One® (HYLAN G-F 20) in his right knee.

Id. at *5-6.  That’s it.  In fact, the court acknowledged that the allege facts were sparse: “There are indeed precious few facts alleged.”  Id. at *12.  The rest of the complaint consists of the type of conclusory incantations mentioned above as to unspecified violations of cGMPs and PMA requirements.  Yet the court let the complaint stand, a decision that may ultimately serve as an invitation to fill-in-the-blank parallel violation complaints: name the device, allege a reaction, and allege violations of unnamed GMPs and PMA approval requirements.  Voilἁ!  You’re in federal court, and on to discovery.  Frankly, the court all but admitted that that’s all it required:

[W]e find that the allegation of adulteration based on the occurrence of an immediate adverse reaction in one knee to the injection of Synvisc-One® contains sufficient specificity to satisfy Iqbal and Twombly.

(Practitioner’s note: the importance that this court seemed to place on the immediacy of the reaction in the knee may be a basis to distinguish this case, if the argument that this decision was badly decided won’t work.)  Nonetheless, to simply allege a reaction to a device (or drug) doesn’t equate to a violation of a cGMP, adulteration or even to a defect.  Nor does adding to that the factually devoid allegation that an unnamed FDA requirement was violated in some unnamed way.  There’s no substance to the claim, nothing on which to judge its plausibility under Twiqbal: no identification of the supposed manufacturing or design defect; no specific PMA approval or cGMP requirement that was violated; no allegation on how that requirement was violated; and no connection between those things and plaintiff’s injury. 

While TwIqbal certainly doesn’t require a plaintiff to prove his claim in a complaint, he must state facts that make it plausible.  Other than the general notion (for which plaintiff’s complaint wasn’t necessary) that parallel violation claims are possible, plaintiff’s complaint provided nothing to make his claim plausible.  It’s boilerplate pleading, which is precisely what TwIqbal does not allow. 

But, again, we’ll try not to get worked up about this. 

There may be some good news.  All the product liability claims are gone.  The court dismissed them (after the plaintiff conceded them).  Id. at *14.  What’s left – plaintiff’s parallel violation claim – may be difficult for plaintiff to establish. 

The plaintiff will have to prove that the defendant violated a PMA approval or cGMP requirement, and that this violation caused his injury.  Moreover, we believe that he must also show that the FDA found or would have found such a violation.  His claim must truly be “parallel” to the FDA’s position.  It cannot be, as the MDA prohibits, “different from” or “in addition to” the FDA’s findings.  This further limits the proof that the plaintiff must show to make his claim.  So we very well may see the Steiden case back here on a motion for summary judgment, one with a much more favorable holding.

Plaintiff’s Second Bite at the Apple Leaves a Sour Taste in Our Mouth

            Back in December we blogged about a medical device case that was dismissed for failure to state a claim – it involved a voluntarily recalled heart pump (which is a Class III medical device that received premarket approval).  At that time, the court found plaintiff’s claims preempted by Buckman v. Plaintiff's Legal Commmittee, 531 U.S. 341 (2001) (fraud-on-the-FDA preempted) and Riegel v. Medtronic, Inc., 522 U.S. 312 (2008) (§360k of Medical Device Amendments expressly preempts claims against manufacturers of Class III medical devices).  However, the court afforded plaintiff an opportunity to amend her complaint to see if she could state a parallel state law claim of the type found not preempted by Hughes v. Boston Scientific Corp., 631 F.3d 762 (5^th Cir. 2011).  Guess what – according to the court, she did. 

            We have not hidden our dislike for Hughes (here) and we are not overly fond of Bass v. Stryker Corp., 669 F.3d 501 (5^th Cir. 2012) (here) – and therefore, are not particularly enamored of the Fifth Circuit’s track record on PMA preemption.  Both of those decisions push open wider the door the Supreme Court left slightly ajar in Riegel – allowing a state law claim “premised on a violation of FDA regulations” as “parallel” to rather than in addition to federal requirements.  Riegel, 552 U.S. at 330.  Both of those cases involved allegations of failure to comply with “generally applicable” FDA regulations – incident-reporting regulations in Hughes  and quality-control regulations in Bass.  And, so for her second bite at the apple, plaintiff in Bush v. Thoratec Corp., 2012 U.S. Dist. LEXIS 89685 (E.D. La. June 27, 2012), found her own “generally-applicable” regulation and alleged it as the basis for her state law failure to warn claim. 

            Now, on a positive note, we have to acknowledge a fairly thorough analysis by the court of whether there is a parallel state law claim.  Unfortunately, we don’t agree with the result.  Under Louisiana law, a manufacturer has a post-sale duty to warn “of a characteristic of the product that may cause damage and the danger of such characteristic.”  La. Rev. Stat. §9:2800.57(C).  So plaintiff needed to find a “federal hook on which to hang the parallel state law failure-to-warn claim.”  Bush, 2012 U.S. Dist. LEXIS 89685 at *14.  Her “hook” was 21 U.S.C. §7.49 – “guidelines” for medical device recall notices (remember, we said the product was voluntarily recalled).  Guidelines?  Can “guidelines” really be the basis for a claim of violation of federal law?  Aren’t guidelines by definition not “requirements”?  Don’t guidelines offer non-specific guidance without establishing any hard and fast rules?  No definitions?  No parameters?  So, how exactly do you violate a “guideline”?  And, who’s to say a jury’s interpretation of a guideline wouldn’t be more stringent than the FDA’s interpretation – making the claim no longer parallel?  These were the types of questions/arguments raised by the defendant in Bush.  We don’t find the court’s answers particularly satisfying.

            First, a quick look at some of the language in the recall notice guidelines.  Section 7.49 says a recall notice “should be commensurate with the hazard of the product being recalled.” Boy, that’s loaded with subjectivity.  The content “guidelines” provide:  a recall notice should be “brief and to the point;” “clearly identify the product;” “explain concisely the reason for the recall and the hazard involved;” and “provide specific instructions on what should be done with . . . recalled products.”  Bush at *15.  And, the recall guidelines themselves provide that §7.49 “recognize[s] the voluntary nature of recall by providing guidance.”  Id. at *21 (emphasis in original). 

            Defendant posed several arguments why the guidelines could not form the basis for a parallel violation claim:

• The guidelines are vague, imprecise and do not “define the parameters of what constitute specific instructions in a recall notice” and therefore “there is no specific requirement to be violated, and any requirement imposed by state tort law would necessarily be a preempted additional requirement inconsistent with federal regulation.”  Id. at *17-18 (quotation marks omitted).  The court even agreed that §7.49’s guidelines are “more general than” the reporting requirements or quality-control standards allegedly violated in Hughes and Bass.  Id. at *18.  But apparently not general enough.

• The guidelines are not mandatory and “therefore, a state tort claim enforcing those standards would be different from or in addition to federal requirements.”  Id. at 21.  How do you violate something that is voluntary?

• The content allegedly missing from the recall notice “goes beyond the § 7.49 guidelines, rendering Plaintiff's state claim not genuinely equivalent or parallel to the corresponding federal violation.”  Id. at *22.  Again, we’re not sure what §7.49 really requires, so any finding that the notice was deficient strikes us as an additional federal requirement.

Despite these, in our opinion, valid arguments, the court summed up the issue this way:

Thus, Louisiana law requires a manufacturer to give post-sale “adequate warning” of a potentially dangerous and damaging characteristic of a product . . . Federal law dictates that recall notices should be “commensurate with the hazard of the product being recalled,” and should be drafted in accordance with “guidelines” to include “the reason for the recall and the hazard involved” and “specific instructions on what should be done with respect to the recalled products.” Putting the two together, Plaintiff argues that Defendant violated § 7.49 by failing to include sufficiently specific instructions or a more emphatic description of the risks to the [medical device], and that the violation of that federal requirement is remediable through a state failure-to-warn claim.

Id. at *16.  And the court found that that was enough to get by a motion to dismiss.  Where we take some solace is in the court’s recognition that while plaintiff has done enough for now, defendant’s arguments might hold more water at the summary judgment stage.  See id. at *23-24 (“the meaning of § 7.49 may be more thoroughly explored in a motion for summary judgment, and it is entirely possible that Plaintiff's claim will be defeated at that stage.).  So, we’ll be on the lookout for our second bite at the apple and hoping for a sweeter result. 

To Linsanity and Beyond (to the Tierney case)

Some of us on this blog have rooting interests that lie far from where The Schuylkill and The Delaware meet.  They’re up past the New Jersey Turnpike, all the way to New York City.  For us, ever since the echoes of the Giants’ raucous ride through the Canyon of Heroes faded, it’s been all about the Knicks and Linsanity!  And after watching the Linsane 3-pointer to win the game last night, we must admit that we expected it to be difficult to sit down calmly, think, and then write a post about medical device decisions.  But that’s what we’re here for, and it gave us another thing to occupy our time while we wait for Linsanity to tip off once again tonight.

Fortunately, the case we’d like to discuss, Tierney v. AGA Medical Corp., No. 4:11CV3098 (D. Neb), has two recent opinions that contain so many things that we like that discussing it isn’t difficult at all.  It has preemption.  It has Twiqbal-like pleadings standards.  It has enforcement of the rules.  And it displays the type of judicial distaste for the use of discovery as a fishing expedition that heartens us. 

The background of the case is rather ordinary.  The plaintiff filed negligence and strict liability claims against the manufacturer of a heart-related medical device, claiming that the device contained nickel elements that caused an allergic reaction.  Slip Op. at 1-2.  But the device was approved under the FDA‘s pre-market approval process.  That means that the claims are preempted.  In fact, the plaintiff himself responded to the manufacturer’s motion to dismiss by outright conceding that his claims are preempted.  Slip Op. at 5. 

But what’s heartening about this case is how the court handled the procedural machinations from the plaintiff.  For instance, after conceding, the plaintiff requested the court to grant him 180 days to conduct discovery and amend his complaint to bring a parallel violation claim – i.e., that the manufacturer didn’t follow FDA specifications.  Slip Op. at 6-7.  In other words, the plaintiff wanted the court to authorize him to go on a search for a claim that he didn’t have.  The court didn’t do it and gave numerous reasons why.  A request to amend must be made by motion, not in opposition papers like plaintiff tried.  Id.  That motion should attach a proposed amended complaint, which the plaintiff didn’t do.  Id.  The proposed amendment should be backed by “sufficient factual allegations,” not the bare legal conclusion about not following FDA specifications that the plaintiff provided.   Accordingly, the court dismissed the complaint with prejudice, noting along the way that a plaintiff must “show that he or she is not merely engaged in a fishing expedition.”  Id. 

It didn’t end there, though.  A few weeks later, the plaintiff tried again.  He filed what seems to have been styled as a motion under Rule 59 to alter or amend the previous judgment, under Rule 60 for relief from the previous judgment, and/or under Rule 15 for leave to amend his complaint, and this time the plaintiff attached an amended complaint.  This filing also had a litany of procedural and pleading problems, and the court addressed them all.  Tierney v. AGA Medical Corp., 2012 U.S. Dist. LEXIS 14212 (D. Neb. Feb. 7, 2012).

First, plaintiff wanted to proceed on the failure to warn claim that he stated in his first complaint but now under the theory that the manufacturer failed to file required adverse event reports, an allegation contained in his amended complaint.  Id. at *9-10.  But this particular allegation was nowhere to be found in the original complaint, so dismissing it with the court’s previous order could not have been “manifest error” under Rule 59.  Id. at *10-11.  Plaintiff also failed to show that his new parallel violation claim rested upon evidence that could not have been discovered earlier.  So there also was no basis under Rule 60(b)(2) to alter the judgment.  Id. at *11-12.  Second, the plaintiff tried to rely on a patient guide that he had downloaded from the manufacturer’s web site, arguing that the guide showed a failure to warn about allergic reactions to nickel.  But, again, the plaintiff made no showing that this evidence could not have been discovered earlier.  Moreover, he provided no factual allegation to indicate that this alleged omission was material to any FDA specification, or even something that the plaintiff himself relied on.  Id. at *12-13.  Finally, the plaintiff asked the court to simply accept his allegation that the manufacturer did not follow the FDA’s standards.  Explaining once again that “bare legal conclusions” with “no supporting factual allegations whatsoever” are not enough, the court rejected this argument, and with that upheld its previous judgment.  Id. at *13-15.

It’s not often that we see such strong products liability decisions rendered at the motion to dismiss stage.  While the Tierney court’s decisions are loaded with procedural discussion, they’re important.  Proper application of the rules allowed the court to dismiss a claim that was clearly preempted and stop the plaintiff from getting around that dismissal.  But, even more important, reading and reporting on the Tierney decisions has taken up some time.  We’ve moved closer to tonight.  Linsanity tips-off at 7:30 EST.

Young: Recall Alone Does Not Prove Defect

It’s reassuring to read decisions in which a court embraces its role as gatekeeper and stops a claim from proceeding to trial with evidence that, by its very nature, would require a jury to speculate.  For us, it’s doubly reassuring when it involves a medical device claim. 

Young v. Olympus America, Inc., 2012 U.S. Dis. LEXIS 9096 (W.D. Tenn. Jan. 26, 2012), involved plaintiffs who claimed that the defendant’s medical device (a bronchoscope) was defective and, when used during their father’s bronchoscopy procedure, caused an infection.  Id. at *2-3.  Plaintiffs’ only claim remaining at the time of this summary judgment decision was an implied warranty claim, which when applied under the Tennessee Products Liability Act reads much like a manufacturing defect claim.  Id. at *7-8. 

Plaintiffs believed they had sufficient evidence to get to a jury.  In particular, they offered evidence that only a few months after the father’s bronchoscopy procedure the defendant instituted a recall of several models of its bronchoscopes due to a manufacturing defect (a loose biopsy port) that plaintiffs’ expert claimed led to the infection.  Id. at *4-5, 11.  Moreover, plaintiffs had interrogatory responses in which the hospital at which the bronchoscopy was performed admitted that it received a recall notice, it inspected the bronchoscopes in its inventory, it found two different models in stock, and “one or both” of those models were subject to the recall.  Id. at *12-13.  Plaintiffs argued that these admissions and the expert’s opinion, along with the fact the father contracted an infection, should be enough to present the case to a jury.  Unfortunately, some courts might agree. 

But the Young court did not.  It gave this evidence a close review and determined that it would only invite a jury to speculate on whether the device used actually contained the defect.  First off, the hospital’s admission addressed bronchoscopes that were in its inventory months after the procedure.  Id. at *13.  So there was no connection to the device used during the procedure.  More important, the hospital said that “one or both” of the devices in its inventory were subject to the recall.  That, at best, proves only that one was subject to the recall, not both.  With that evidence, the jury could find defect only by speculating:

Plaintiffs have failed to adduce evidence from which a reasonable juror could find that the bronchoscope used in [the] procedure . . . was in defective condition. . . . On the contrary, this evidence without more would only invite a jury to speculate about whether the bronchoscope used in [this] case had the [defect].

Id.  The plaintiffs also failed to present evidence to support the “prudent manufacture test,” which among other things required plaintiffs to prove that the defendant knew of the bronchoscope’s dangerous condition yet marketed it anyway.  Id. at *22-23.  Plaintiffs needed an expert to make this showing but did not have one.  The expert that they did have never actually looked at any bronchoscopes and only “assume[d]” that the bronchoscope used in the procedure was defective.  Id. at *23.  That’s not good enough.

One other note: While Young is certainly worth discussing if for no other reason than that it shows a court doing what it’s supposed to do on a summary judgment motion – review the evidence and halt cases that have no business being heard by a jury – it also offers helpful precedent for the ever-more-present “parallel violation” claims.  If preemption fails, one of the best remaining defenses to a “parallel violation” claim is failure of the plaintiff to present evidence that the device that he or she used actually had the defect.  This places a significant burden on plaintiffs and, as the Young decision highlights, they cannot meet it by inviting speculation.

On Performance Standards and Preemption

As we’ve mentioned before, the supposed “parallel violation claim” exception to medical device preemption has been frustratingly vague.  That’s because it originated in a complaint’s vague language that Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996) – decided on a motion to dismiss – speculated might have stated such a claim.  A single paragraph of dictum in Riegel v. Medtronic, Inc., 552 U.S. 312, 330 (2008), seemingly recognizing the exception in the course of explaining that the plaintiffs had waived it, only made things worse.  So the question of when a claim of a "violation" of FDA regulations is actually "parallel" to the FDA's actual requirements is probably the hottest topic in PMA preemption-land right now.

A new case, Walker v. Medtronic, Inc., No. 10-2219, 2012 WL 206036, slip op. (4th Cir. Jan. 25, 2012), is the first court of appeals case that really takes a close look at what “parallel” claims entail post-Riegel.  While we’d prefer that this phantom exception not exist at all, the court’s discussion keeps it tightly constrained and thus gets a thumbs up from us.  Perhaps it was fitting that Walker was decided on Bexis’ birthday.

Walker involved what’s essentially a spinal version of a pain pump – designed to infuse a preset amount of specific drugs into the fluid that surrounds the spinal cord.  It’s supposed to be accurate within ± (that’s “plus or minus”) 15% of whatever it’s set for, but both the FDA’s approval letter, and the FDA-approved materials that accompany the pump make clear that this 15% is not some kind of absolute guarantee, but only a best estimate, and there are a lot of problems that can lead to a deviation (such deviations being reportable to the FDA as adverse events).  Slip op. at 7-8, 14-15.

The pump was “undisputedly a Class III device.”  Slip op. at 7.  Cf. Duggan v. Medtronic, Inc., ___ F. Supp.2d ___, 2012 WL 45503, at *5 (D. Mass. Jan. 10, 2012) (rejecting argument that based upon claim that not all components of different pump system weren’t all originally PMAed).  Thus Riegel preemption applied.

Because Walker is a product liability case, it doesn’t take much to describe what happened.  The decedent was taking a bunch of painkilling drugs at the same time and died from “[c]ombined hydromorphone, hydrocodone, diazepam, and venlafaxine intoxication."  Slip op. at 9. Only one – hydromorphone – was being infused using the pump, so that’s the one the plaintiff targeted.  Plaintiff obtained some sort of "expert" who, through some unexplained process (probably assuming the pump had been filled to the brim when it wasn’t) claimed there had been an overdose.  Id.

Whether there was or was not an overdose was not germane to the preemption summary judgment motion.  Slip op. at 9-10 n.3.  That underscores why preemption is so powerful.  It applies irrespective of the merits of the underlying litigation.

Trying to turn the ±15% language in the product literature into a “guarantee of performance,” slip op. at 17, plaintiff argued that she had stated some sort of unpreempted “parallel” violation claim because she had some evidence that the device was outside this range.  The court held that no such claim existed.

In so doing, Walker had to decide how broadly to construe the “parallel” claim loophole to preemption.  Fortunately its construction was relatively restrictive.  The FDA has a formal type of specification, called a “performance standard,” under which a manufacturer must guarantee a particular level functioning upon pain of violating the Medical Device Amendments:

The FDA may condition its grant of premarket approval upon certain requirements.  Significantly for our purposes, the FDA may require that a device meet certain performance standards if it “determines that a performance standard is necessary to provide reasonable assurance of the safety and effectiveness of the device.”  21 U.S.C. §360d(a)(1).

The establishment of a performance standard is a formal process specifically governed by the MDA.  It requires publication of a notice of proposed rulemaking in the Federal Register setting forth justification why the performance standard is necessary, “proposed findings with respect to the risk of illness or injury that the performance standard is intended to reduce or eliminate,” and invitation for comments from interested persons.  Id. at §360d(b)(1)(B). . . .  When the FDA establishes a performance standard for a Class III device, it does so as a precursor to the grant of premarket approval.  21 C.F.R. §861.1(b)(3).

Walker, slip op. at 5-6 (footnote omitted) (emphasis added).

When a plaintiff, under state law, tries to take some statement, or other device attribute, that hasn’t jumped through the hoops to become a “performance standard,” and through litigation tries to make it into such a mandatory standard is something that's “different from or in addition to” within the meaning of the Act’s preemption clause.  Therefore, preemption bars the claim:

Whether the plus or minus 15 percent specification is a formal performance standard is pertinent because only such a performance standard could create the type of binding requirement that would make [plaintiff’s] claims impose requirements parallel to, as opposed to more restrictive than, those imposed by the FDA.

Slip op. at 14 (emphasis added).  The court revisits the same point, at greater length, a little later:

[It] is incontrovertible under FDA regulations:  the only mechanism for creating a binding, ongoing performance requirement is the creation of a performance standard.  And [plaintiff] does not dispute that, here, the plus or minus 15 percent specification is not a performance standard. . . .  [I]f we were to treat the flow rate as a requirement, we would be imposing a heightened standard beyond that of the FDA – which is impermissible under Riegel.  Moreover, as we have noted, such a holding would upend the carefully calibrated construct Congress created in the MDA, balancing the potential rewards of such devices following the rigorous process of FDA approval against the cost of preempting common law claims based on standards different than those imposed by the FDA.

Id. at 15 (emphasis added).  No formal "performance standard" – that's simple, easy to apply, and above all, rare.

The device in question was manufactured sold, etc. in full compliance with everything the FDA required, including those aspects that underlay the expected ±15% flow rate.  Plaintiff did not contest that.  E.g. slip op. at 16 n.5.  But that expectation was not the same as a real FDA requirement that the device could not, for any reason, ever deviate from that rate.  For plaintiff to use state law to convert any deviation into a “violation” that did not, in fact, exist was dissimilar from what the FDA required and therefore preempted:

[N]othing in the [device’s] premarket approval application – which was approved in its entirety by the FDA – purported that the device would always dispense medication within the range of the plus or minus 15 percent. . . .  To the extent that [plaintiff] interprets the plus or minus 15 percent specification as a guarantee of performance, she seeks to impose a more demanding standard than that of the FDA, rather than a parallel one.

Id. at 17.

As anyone reviewing the cases on our device preemption scorecard can attest, this is one version – and a rather restrictive one – of the elusive “parallel” violation claim that post-Riegel courts have adopted.  While not tying the analysis explicitly to “performance specifications,” numerous courts have rejected the theory that underlay the plaintiff’s arguments in Walker, which is that the mere malfunction of a device somehow establishes a non-preempted violation claim.  See Carrelo v. Advanced Neuromodulation Systems, 777 F. Supp.2d 303, 314 (D.P.R. 2011) (“the failure of a Class III medical device does not establish the existence of a manufacturing defect”); Haynes v. Cyberonics, Inc., 2011 WL 3903238, at *3 (N.D. Ga. Sept. 6, 2011) (“a manufacturer could comply with all FDA regulations, but nevertheless produce a product containing an unintended flaw or abnormal condition”); Timberlake v. Synthes Spine, Inc., 2011 WL 711075, at *9 (S.D. Tex. Feb. 18, 2011), (“plaintiff “must plead and prove the specific way in which Defendants’ manufacturing process differed from that approved by the FDA in order to show that his manufacturing defect claim is truly ‘parallel’”); Cafferty v. Cayuga Medical Center, 2011 WL 541809, at *5 (N.D.N.Y. Feb. 8, 2011) (“under the federal law governing the PMA process, there is no demand that a product be risk-free, only that its benefits, if manufactured according to specifications, outweigh its risks”; res ipsa loquitur is “refuted by Riegel”); Gelber v. Stryker Corp., 752 F. Supp.2d 328, 334 (S.D.N.Y. 2010) (preemption because plaintiffs “have not pointed to evidence of device-specific violations of federal law”); Rankin v. Boston Scientific Corp., 2010 WL 672135, at *4 (E.D. Ky. Feb. 19, 2010) (“[defendant] received premarket approval”; “that the [device] allegedly failed during normal use does not override the clear language of §360(a) or . . . Riegel”); Banner v. Cyberonics, Inc., 2010 WL 455286, at *4 (D.N.J. Feb. 4, 2010) (“FDA approves the process by which a Class III device is manufactured, but it does not guarantee that every device manufactured in that process will work”; “if the FDA approves a manufacturing process and the defendant-manufacturer conforms with it, a [malfunction] does not give rise to liability”); Ilarraza v. Medtronic, Inc., 677 F. Supp.2d 582, 588 (E.D.N.Y. 2009) (“vague and open-ended . . . regulations . . . cannot serve as the basis for a parallel claim[, s]ince these regulations are open to a particular manufacturer’s interpretation”); Funk v. Stryker Corp., 673 F. Supp.2d 522, 532 (S.D. Tex. 2009) (plaintiff “essentially relies on a circular argument that because he was injured and because the device (allegedly) contained impurities, [it] therefore violated FDA regulations.  Such reasoning is contrary to the holding in Riegel”), aff’d, 631 F.3d 777 (5th Cir. 2011); Williams v. Cyberonics, Inc., 654 F. Supp. 2d 301, 306, 308 (E.D. Pa. 2009) ("[t]o avoid federal preemption, a plaintiff must make some showing that the medical device was not manufactured in accordance with FDA standards”; “[w]ithout proof that the [device] did not adhere to the premarket approval, [plaintiffs’] claim must fail”), aff’d, 388 Fed. Appx. 169 (3d Cir. 2010); Miller v. DePuy Spine, Inc., 638 F. Supp.2d 1226, 1230 (D. Nev. 2009) (preemption where there is “no evidence to show that the [device] was manufactured out of conformity with the materials or manufacturing specifications approved by the FDA”); In re Medtronic, Inc. Sprint Fidelis Leads Products Liability Litigation, 592 F. Supp.2d 1147, 1158 (D. Minn. 2009) (“In the absence of any specific requirement . . . holding [defendant] liable for such a [specific] ‘defect’ would impose requirements ‘different from, or in addition to’ those under federal law”), aff’d, 623 F.3d 1200 (8th Cir. 2010); Delaney v. Stryker Orthopaedics, 2009 WL 564243, at *6 (D.N.J. March 5, 2009) (plaintiff “does not specify in what way [device] deviated from the manufacturing process that the FDA approved”; “mere occurrence of an accident” insufficient for preemption); Clark v. Medtronic, Inc., 572 F. Supp. 2d 1090, 1094-95 (D. Minn. 2008) (“[p]laintiff is ultimately wrong when he assumes that premarket approval guarantees the device is completely safe”; his “claims are not based on a breach of the MDA as enforced by the FDA”; “[t]hus plaintiff’s claims are preempted”); In re Medtronic Sprint Fidelis Lead Products Liability State Court Litigation, 2009 WL 3417867 (Minn. Dist. Oct. 29, 2009) (“that the FDA specifically approved the design and proposed manufacturing processes” requires preemption); Colombini v. Westchester County Health Care Corp., 2009 WL 2170230, at *4 (N.Y. Sup. July 6, 2009) (“plaintiffs cite to no document from the FDA which specifically mandates [the items at issue] as the only solutions to the problems.  Plaintiffs therefore have not demonstrated that they have any parallel claims”) (in table at 899 N.Y.S.2d 58).

As the court in Walker observed, “[n]either [plaintiff] nor the dissent point to any case law, nor have we found any, in which a court has reached a contrary conclusion.”  Slip op. at 19.  We haven't seen any either.

So Walker is the first appellate court explicitly to hold that the mere assertion of a device malfunction is not, at least under anything approaching ordinary circumstances, enough to establish a “parallel” violation claim.  The court provides a narrow escape hatch – that a parallel claim would be established if the FDA had adopted a “performance standard” that set a particular characteristic as an absolute floor, the non-attainment of which, without more, constitutes a violation.  That’s all well and good, but such device-specific “performance standards,” if not quite as rare as hen’s teeth, come close.  We’ve only seen one even asserted in any of the post-Riegel device preemption cases we’ve read (and we think we’ve read them all).  Burgos v. Satiety, Inc., 2011 WL 1327684, at *5 (E.D.N.Y. Apr. 5, 2011), and even there it wasn’t sufficiently described that we could be sure such a thing actually existed.

Thus, while we’d rather not have a “parallel” requirement exception to preemption at all (they’re disguised attempts at private enforcement of the FDCA, which the statute bans), if we have to have one, the articulation in Walker – requiring the presence of a “performance standard” – is the kind of bright line we can live with.

Why Does the Parallel Violation Exception Remind us of Nietzsche and Frampton?

Last week saw the birth of the seven billionth current human on the planet. This week sees us comment on the parallel claim exception to Riegel preemption for what feels like the seven billionth time. It puts us in mind of Nietzsche's theory of the eternal return, where everything we've done we'll do again an infinite number of times. Really? We've got to go through that junior prom again, with all the plaid bell-bottoms and the awful Peter Frampton "tribute" band playing "Show Me the Way" as we fought off the effects of smuggled-in Southern Comfort?

We wish courts would do a better job of showing us the way on the parallel claim exception. Is it possible that the parallel claim exception is poorly conceived and poorly described, thereby prompting plaintiffs to parade various attempts to plead around it, leading to courts issuing rulings on the issue that are inconsistent and opaque? Yes, it is. Some parallel claims decisions have been reasonably coherent; others have blessed complaints resembling mackerels in the moonlight -- they shine, they stink. Bausch is an example of the latter, and yet the Seventh Circuit waved it by. We'll not regale you again with our Why We Hate Bausch litany, though the U.S. Supreme Court's recent refusal to review it led to a marathon teeth-grinding session here on the West Bank of the Schuykill.

Can our BFF TwIqbal save us from the craziness? Sometimes yes and sometimes no. Here is how we think the analysis ought to play out:

(1) What exactly is the alleged violation of federal law? Cite the specific regulation and the specific problem with the product.

(2) How exactly does state law make such violation actionable? (And here we will confess our esurient desire to appropriate Judge Posner's identicalness test from the Turek case we blogged about a couple of weeks ago. Yeah, yeah, it's a different statute. That being said…. Oh, heck, maybe it's asking too much for drug-and-device law to make sense.)

(3) How exactly did the alleged infraction cause the plaintiff's alleged injury?

We do not get that elegant tripartite analysis in Rhynes v. Stryker Corp., 2011 WL 5117168 (N.D. Cal. Oct. 27, 2011), but what we do get is pretty good. It sure ain't Bausch. (More on that later.) The plaintiff's first complaint alleged injuries arising from a defective artificial hip, asserting claims for negligence, strict liability, violation of California's Unfair Competition Law, and wanton and reckless misconduct. That last bit sounds bad. The court dismissed with leave to amend.

In the first amended complaint, the plaintiff reasserted claims for negligence, strict liability, and wanton and reckless miscounduct. The defendants again moved to dismiss, based on the statute of limitations and Riegel preemption. The court held that the discovery rule saved the plaintiff from the statute of limitations, but that the complaint was preempted.

As you've all heard before again and again, the preemption clause of the Medical Device Amendments to the Food, Drug and Cosmetics Act (21 U.S.C. section 360(a)) provides that states cannot impose requirements that are "different from, or in addition to, any requirement applicable under [the FDCA]." The defendants pointed out "that at least fourteen district courts have dismissed actions brought against Defendants' hip replacement system based on the Supreme Court's holding in Riegel." Rhynes, 2011 WL 5117168 at *4 (citing a nice collection of cases). Naturally, the plaintiff argued that its "claims impose 'requirements that are parallel with, not in addition to, federal requirements.'" Id. Cue up the Frampton. Pin on the corsage (this time don't stick the poor girl). Dance more. But: Do. Not. Do. "the Worm." It's happening again. Plus, the plaintiff cites Bausch, which is like making us reenact the climactic scene in Carrie.

What, pray tell, are the parallel claims in Rynes? The plaintiffs alleged that "the FDA warned Defendants about 'bad manufacturing and quality control practices.'" Id. at *5. That's a bit vague, isn't it? Luckily, that's how the Rynes court saw it: "Plaintiffs do not allege what FDA requirements were violated, much less how Defendants' manufacturing process deviated from those particular requirements." Id. That is a refreshingly sane take on the issue. TwIqbal to the rescue. We admire the court's clarity.

We also sort of admire the way the court dances around Bausch. First, the Rynes court says that the claims in that case were vaguer than in Bausch. Maybe. But, as you know, we think the claims in Bausch were plenty vague. Second, the defendants in Rynes had the temerity (and good sense) to argue that Bausch (and another crummy case, Warren), contravened Rule 8 and TwIqbal. The Rynes court concluded that it "need not presently address this issue as it finds that, even under Bausch and Warren, Plaintiff's allegations are inadequate." Id. at 5 n. 7. So the Rynes court finesses the Bausch issue. We cannot blame the court for doing so, and we have a sneaking suspicion that the defendants' double-pronged approach -- both distinguishing and attacking Bausch -- is exactly the right way to go.

We're not going to say our junior prom ended badly, but let's just say it ended ambiguously. Call it unfinished business, half-measures, or the typical kind of clumsiness attending that time and place. We sort of get that from Rynes. Sadly, and almost inevitably, the court gave the plaintiff leave to amend. Talk about eternal return.
　

There'll Always Be Posner: Thumbs Up on Preemption

The New Yorker's current issue has a fine article on Pauline Kael. The weekend Wall Street Journal had a similar piece. Why the wall-to-Wall Street coverage of a film critic who wrote reviews from 1953 to 1991 and died in 2001? Two reasons: (1) the Library of America is coming out with a collection of Kael's reviews -- it's called "The Age of Movies," and that title says something about Kael's preeminence; and (2) there's a new biography by Brian Kellow -- "Pauline Kael: A Life in the Dark."

All of this reminded us of how excited we were back in the 70's and 80's every week to pull a copy of The New Yorker out of the mailbox and flip to Kael's latest review. Her opinions mattered and she made movies matter. She dismantled silly critical systems (her attack on Andrew Sarris's auteur theory spills as much blood as ink on the page) and demolished fatuous high-culture/low culture distinctions (Kael and John Simon had some nasty exchanges). There's no doubt that Kael could be inconsistent and overwrought. Her famous review of the Italian neo-realist classic "Shoeshine" was as much about her personal romantic travails as about the movie. Kael wrote some incendiary, almost nutty things, comparing the premiere of "Last Tango in Paris" to the first perfomance of Stravinsky's "Rites of Spring," denigrating "Chinatown" for celebrating nostalgia "openly turned to rot," and praising Brian DePalma incessantly, even for possessing a "gassy, original comic temperament."

If one goes back and reads Kael's reviews, they can come across as artifacts of a culture war that ended long ago, where nobody won. Her prose was incandescent -- illuminating, politically incorrect, and done. The New Yorker article says that Kael's followers (critics like Edelstein and Denby have been called "Paulettes") and fans simply had faith that Kael's judgment was right. Think of Aristotle's "Rhetoric" and its tripartite analysis of what makes someone persuasive: Kael won us over not as much by logos (logic), or pathos (emotional appeal), as by ethos (the audience's sense of the inherent excellence of the speaker). Few readers knew Kael personally, so it was the power of her prose itself that convinced us of Kael's superiority. In fact, Kael is one of the very few writers whose every fresh word would reliably command our attention, change our minds, and make us want to fling our pens or keyboards in despair because somebody else out there wrote miles better than we ever could.

Another such writer, as you have likely guessed from the title of this post, is Judge Posner. His writing matters rather more to us than that of a film critic. We merely watch movies; we practice law. Thinking about Kael's opinions prompted us to think some more on why Posner's opinions are compelling. He, too, is bigger than any single system or theory. His writing is concrete and confident. (We read recently that interviews with jurors showed that the single attribute that made them credit witnesses was conspicuous confidence. It's easy to trust someone when it's clear that they trust themselves.) It's also true that Posner's opinions persuade on a level beyond pure logic. Indeed, we espy as much ethos as logos or pathos working on behalf of a Posner opinion.

The recent opinion in Turek v. General Mills, Inc., No. 10-3267 (7th Cir. October 17, 2011), is an example. There is no doubt it's a Posner opinion. It begins with an observation that both the parties and the lower court flubbed important matters of jurisdiction and class action procedure. It ends with a refusal even to address some of the plaintiff's arguments because they are so frivolous or unintelligible. We see this again and again in Posner's opinions. It may be that he does this just because these sorts of mistakes are more common than we'd like to admit, and because it's important that they be addressed. Maybe advocates will do a better job for fear of a judicial skewering. After all, if you had a case in front of Posner, wouldn't you prepare extra hard? But we can't help but think that Posner is also marking territory with these rhetorical maneuvers. It's as if he's saying, before the argument and at its close, something like, 'Now, you all understand who I am, right? And that I'm much. much smarter than anyone else in the room, right?' Yes. Yes, we understand that.

Turek is a food case, not a drug or device case. But Posner's treatment of the preemption issue has relevance for us. He discusses preemption in clear, concrete terms, and it makes us forget for a moment how tortuous the issue can seem in so many cases. And when it's Posner doing it, it convinces us that the issue really is simple. And, oh, by the way, the defendant wins.

The plaintiff in Turek complained that advertisements for chewy bars misleadingly claimed that the bars supplied "35% of your daily fiber." That claim was allegedly misleading because the principal fiber, by weight, was inulin extracted from chicory root. According to the plaintiff, inulin extracted from chicory root is less beneficial and less "natural" than fiber one gets from eating bananas, onions, and other vegetables. Hmmm. Isn't chicory root also natural? As Posner reasons, the complaint attempts to state a "garden variety consumer protection claim." Slip op. at 5. That garden variety claim is preempted by the Food, Drug, and Cosmetic Act, which forbids states from imposing any requirement in food labeling that is not "identical" to the federal act. Thus, the only way for the plaintiff's claim to survive is if state law (here, Illinois) imposes a requirement identical to federal law. It has to be state law, because the FDCA provides no private right of action.

This is all familiar stuff for drug-and-device-law fanboys and fangirls, isn't it? It sounds like the parallel violation exception discussed by some courts analyzing federal preemption issues. We used the word "discussed" but too often the correct word is "butchered." We can think of no worse mangling of preemption and parallel violations than the misbegotten opinion in Bausch, which we wept over here and many other places. Bausch is a Seventh Circuit opinion. Posner was not on the panel. We cannot believe that the Bausch opinion, which is bereft of logos, ethos, pathos, or common sense, could have survived Posner's scrutiny. Bausch is bathos.

Turek shows why. Rather than mooning over whether some clause or comma in the FDCA might support the plaintiff's argument that consumers shouldn't suffer the inferiority of chicory fiber (assuming any such inferiority exists -- and we don't even if the court must), Posner concludes that the issue is quite simple: are any of the plaintiff's proposed disclaimers about chicory fiber found in "identical" form in the federal law? They are not. "[C]onsistency is not the test; identity is." Slip op. at 7-8. Simplicity itself. Why is such simplicity, to say nothing of clarity, almost never found in preemption opinions?

And then Posner adds "icing on the cake." Id. at 8. The Illinois Consumer Fraud and Deceptive Business Practices Act does not apply to "actions or transactions specifically authorized by laws administered by any regulatory body or officer acting under statutory authority of this State or the United States." 815 ILCS 505/10b(1). The labeling of the chewy bars was all specifically authorized by federal law. The plaintiff bit off more than she could chew. (And courts like Bausch, which strain to find a parallel action, chew more than they bite off.) Will we surprise you when we say that some courts purporting to do a preemption and parallel violation analysis, where the issue supposedly is whether state law parallels federal law, end up so exhausted teasing some sort of requirement out of federal law that they actually forget to see whether state law supports the claim?

We don't insist in happy endings in movies, but we do in judicial opinions. For some reason, we are reminded of Kael's review of "Funny Girl," and how she described the end of the movie as a "gorgeous piece of showing off, that makes one intensely, brilliantly aware of the star as performer" and of the star's "pride in performance: The pride is justified."

We're not comparing the Seventh Circuit to Ziegfeld's Follies. Reading a judicial opinion on a computer monitor isn't quite like sitting in the dark and watching a performance. But, yeah, we like Posner's opinion.

Thin Pleadings Doom Another Not-So-Parallel Claim

Today is the birthday of Adam West, the great television Batman, so we are pleased to see a court deliver a Bam! Pow! and Socko! to another attempt to escape Riegel preemption via a bogus parallel claim. The case is called DeSabio v. Howmedica Osteonics Corp., 2011 U.S. Dist. LEXIS 103288 (W.D.N.Y. September 13, 2011). It's not just another attempt to escape preemption; it's another attempt in a Trident artificial hip case.

We. Have. Seen. This. Before. Same Bat time, same Bat channel.

The plaintiff alleged that "the device squeaked and he 'suffered severe grinding and pain.'" 2011 U.S. Dist. LEXIS 103288 at *2. There were claims for negligence and res ipsa loquitur. There was also a claim for breach of express warranty. The plaintiff argued that the Trident components were negligently manufactured and carelessly designed. He also argued that because the component parts were solely in the control of the defendants, negligence could be presumed under the doctrine of res ipsa loquitur. But the court had little difficulty concluding that these claims were "based squarely" on a "purported breach of state tort duties of care." Id. at * 12. Moreover, the court had the benefit of five other cases involving the same Trident product, the same claims, and meeting the same fate of Riegel preemption. Id. at ** 12-13.

But like a persistent Batman villain (Joker? Mr. Freeze?) the plaintiff keeps coming back for more. The plaintiff sought permission to amend the complaint to allege a parallel claim. And here is what we get:

-- the components "were not in compliance with the [FDA's] [PMA] standards for Class III devices in general and this device in particular."

-- the components were "not in compliance with the requirements approved by the FDA and had an impurity, imperfection and/or other product defects allowed to be created, contained or placed within the product in the Defendant's manufacturing process."

-- this "impurity" was a "deviation from the Defendants' design and quality manufacturing standards for the [Trident System] approved by the FDA."

Id. at **14-15.

The court correctly saw these new and not-so-improved allegations as the sort of mere incantations disapproved by most courts that have encountered them. Note that we say "most." The DeSabio court caught on that these empty gestures toward federal violations were drawn directly from the hated Hofts case, which we have criticized before and at which we still shake a clenched fist. But Bam! - the DeSabio court "respectfully disagrees" with Hofts. Id. at * 16. The proposed amendments do not solve the plaintiff's preemption problem. There is no cliffhanger to keep us in suspense; further pleadings would be futile, and the case is dismissed.

Perhaps more interestingly, or even slyly, the DeSabio court distinguishes the plaintiff's allegations from those that passed "parallel" muster in a couple of other cases, including the one device preemption case that we revile even more than Hofts: the Seventh Circuit's abomination called Bausch. This case, too, has met the fury of our pen (or keyboard). The DeSabio court points out that at least in Bausch, the plaintiff alleged a recall for "dimensional anomalies" and that the FDA had informed the defendants of "numerous deficiencies" in manufacturing. Riddle me this: how does that threadbare stuff satisfy Twombly?

We get the sense that the DeSabio court wonders the same thing. In a sentence that we think is almost mischievous, the DeSabio court says this about Bausch: "The Court acknowledged that the complaint would have been stronger had the plaintiff specified the precise product defect or the specific federal requirements violated, but found she had pled with enough specificity to satisfy Rule 8 and Twombly." Id. at *19. That "would have been stronger" is a delicious understatement. Bausch is as wrong as Hofts, and the judge in DeSabio no doubt knew that the author of Bausch also authored Hofts. Bausch is an aberration that provokes excuse-making or denial. It's like trying to explain how the sublime Julie Newmar got replaced by Eartha Kitt to play Catwoman. Some things just don't make any sense.


A word about the DeSabio plaintiff's claim for breach of warranty. Riegel did not address such claims, but the reason behind preemption still applies. To prove breach of express warranty, "a plaintiff would need to show that the device was not fit for its intended use, and such a finding 'would directly conflict with the FDA's premarket approval of the device as reasonably safe and effective,' such that preemption applies." Id. at * 20-21 (quoting Leonard v. Medtronic, Inc., 2011 U.S. Dist. LEXIS 93176, at *30 (N.D. Ga. Aug. 19, 2011). (We discussed Leonard here.) Finding that a defendant violated state law by not living up to FDA-approved promises "would necessarily conflict with the FDA's determination that the label was not false or misleading." Id. at * 21. Zonk!

The plaintiff simply could not execute a last-minute escape from the preemption pit. The problem is that the pleadings were way too thin. Somehow that's an appropriate point to end with, because today is also the birthday of Twiggy. She was the British model who convinced 1960's mods that thin was in.

Gelber: The Narrow Gap Between Medtronic and Bausch?

There have been some great duels throughout history: Plato-Aristotle, Stalin-Trotsky, Jolie-Aniston, us vs the Drug-and-Device Teenaged Daughter. It's hard not to root for one vs the other. (We pick Aristotle, Trotsky, Aniston, and us).

Lately, we've said a few things about the Medtronic (8th Cir.) vs Bausch (7th Cir.) holdings on the parallel requirements exception to Riegel preemption. (Here, for example.) Medtronic applies TwIqbal and actually insists that the plaintiff plead facts and a specific federal violation. Bausch allows plaintiffs to allege general, factless violations, on the theory that the confidentiality of company documents makes it hard for plaintiffs to be specific - at least until plaintiffs get the opportunity to take expensive, settlement-extorting discovery.

Last week, an opinion emerged from SDNY, and we think the court mostly sided with Medtronic - though not as much as we'd have liked. Gelber v. Stryker Corp., 2011 WL 1483927 (SDNY April 18, 2011) is yet another Trident hip replacement case. The plaintiff underwent the hip arthroplasty on July 21, 2004. The plaintiff started feeling pain in 2007 She had a hip revision surgery on January 26, 2009, where the Trident system was removed. Upon inspection, the surgeon saw a stripe on the ceramic head component, as well as wear on the ceramic insert.

The plaintiff filed a complaint in New York state court in 2009, it was removed to federal court, and it was dismissed on preemption grounds. But the court granted leave to amend the complaint. So the plaintiff amended. We mean, really amended. The amended complaint alleged multiple federal violations wholly absent from the original complaint. There were claims for strict liability based on defective manufacturing, negligence, breach of warranty, and loss of consortium. There were also factual allegations that the court generously construed as a claim for failure to warn.

It's hardly surprising that the defendant again moved to dismiss on the grounds of preemption. It worked once and it looked like it should work again. The Gelber court begins by saying a lot of the right things. It quotes the Medtronic district court language about how "Riegel and Buckman create a narrow gap through which a plaintiff's state-law claim must fit if it is to escape express or implied preemption." It also quotes the Medtronic language that "Plaintiffs cannot simply incant the magic words 'defendants violated FDA regulations' in order to avoid preemption.".

But the Gelber court also starts quoting Bausch. Uh oh. And then Gelber cites Bausch and the dissent in Medtronic about how critical information needed for specific pleading is kept confidential as a matter of federal law. Yikes. It's as if Gelber is trying to bridge the "narrow gap" between Medtronic and Bausch.

Some of that is good and some of that is bad. The bad part is that the court preserved the manufacturing defect claim on the theory that the plaintiff had adequately alleged a violation of FDA current good manufacturing practices (CGMP) requirements - specifically, the court construed the amended complaint "liberally" to allege that the Trident system was defective because it was manufactured with "manufacturing residuals" and was therefore "adulterated". What facts underly such allegations? Not much. The plaintiff pointed to a 2007 warning letter and a 2008 voluntary recall at a manufacturing facility. Again, construing things "liberally," the court concluded that the plaintiff "plausibly alleged that the excessive levels of manufacturing residue was one of the 'several different factors' that ultimately led to breaks in the lubrication layer and the stripe found" on the implanted system.

Look: we don't think a CGMP violation is enough for a parallel violation. Other courts, including Medtronic, have said so, pointing how they are simply too generic. But even aside from that doctrinal point, the facts of Gelber (the stripe) should make a factual distinction - dare we say it? - plausible.

The Gelber court gets more right than it gets wrong. The court dismisses the failure to warn claims for lack of causation, lack of any applicable federal regulation, and for preemption. The court holds that Buckman preempts the plaintiff's claim that the defendant failed to report certain clinical findings to the FDA. The plaintiff also claimed violations of CGMP requirements to identify and correct device problems, but here the court read the relevant CGMP requirements closely and found that the plaintiff's interpretation wasn't just liberal - it was a rewrite. Similarly, the court rejected the plaintiff's "vague and conclusory allegations" that the defendant "failed to develop practices and procedures" to assure compliance with multiple federal regulations. That sounds like bootstrapping. It is also madness to say that private citizens can become roaming enforcers of federal regulations. The court dismissed those claims.

In effect, the Gelber court splits the difference between Bausch and Medtronic. (It also splits the difference on the warranty claims in a way that is not especially interesting or useful). So maybe what we said at the outset is wrong; not everybody feels the need to pick sides. But law, like sports, is more fun when there's a rooting interest.

Mingling with Our FDA Friends

Last week we attended a Food and Drug Law Institute Conference in Our Nation's Capital. Like other firms, we sponsored a table and, like other firms, we offered trinkets. Call it the Swag Battle. We tempted passersby with clips that magnetically stick to your refrigerator - the perfect way to preserve a bag of potato chips, assuming you don't down all those sour cream crisps of goodness in one fell swoop. Two firms distributed flashlights (obvious symbolism there), another had whistles (potential creepy symbolism about whistle blowers), another had rubber brains (great for the kids), and one had weird magnetic pebbles that crashed together to make a sound like the beginning of the old Outer Limits television show. We were mightily impressed when one of the sponsors placed a white chocolate wafer with its name on top of the cheesecake dessert. Presumably when you actually eat the name you've made the ultimate oral commitment to the brand.

But the real benefit of the conference isn't these crazy goodies. Rather, it's in meeting colleagues, clients, and counterparts. Mostly, we met folks from the FDA. Many of the top personnel from FDA were there, as were a number of staffers and administrators and lawyers doing important work in CDER, ORA, etc. Confession: we liked and respected everybody we met. They all seemed like smart, well-intentioned, hard-working people. One of the speakers said that drug development is the most complex activity that humans currently do. Regulation of that activity is also complex.

That said, it got a little monotonous how almost every FDA speaker devoted time to fending off criticism of the FDA as being unfair and destructive. We wondered about that, but not because we disagreed. The fact is that we couldn't think of any time when we criticized the FDA -- and we're plenty critical. What was there to be so defensive about? And then we remembered. Well, actually, we were reminded rather directly, because there was a presentation by two people from the GAO (and you'd better know that the A is for "Accountability" not "Accounting") about findings that certain FDA practices and procedures regarding regulation of food and drugs created a high-risk of not completely fulfilling the FDA's mission.

Where do we litigators hear about the GAO criticisms of the FDA? We hear it when plaintiff lawyers cross-examine our FDA experts. Even putting aside preemption, compliance with extensive FDA regulation can be a compelling defense. It has jury appeal. Smart plaintiff lawyers know this, so right after our expert explains FDA regulation and how bright and diligent FDA regulators are, we hear the plaintiff lawyer read snippets from the GAO and other sources about how FDA is undermanned and how it occasionally has hiccups. Let's face it: the plaintiff lawyer doesn't even care what our expert says. And let's also face this: it's a tremendously unfair criticism ... and it is effective. We wish GAO and other nattering nabobs of negativity would add balance and context to their critiques. As Dr. Evil would say, can you give me a frickin' bone here? How about an acknowledgment that FDA by and large does a fine job, and how it's improper for litigants to cherrypick and render a distorted picture of FDA performance? Hey GAO: call us. We'll help you write it.

Meanwhile, it became crystal clear at the conference that FDA is being asked to do more and more with less money. You might think that lends credence to the criticisms, but the amazing thing is how well FDA responds to the challenge. Globalization affects food and drug regulation (as it affects pretty much everything) and FDA is seeking harmonization and collaboration with sister regulatory bodies. FDA will increasingly look at importers and their ability to own up to the quality and safety of the products they bring in. Inspections and enforcement will be increasingly risk-based. FDA is developing new algorithms to decide who and how to target. Some of the tools discussed by the regulators involve collection and sharing of data. We know about adverse events, but the FDA Sentinel system represents a movement toward a much more active surveillance system. We also heard about Risk Evaluation and Mitigation Strategy, as well as the CPSC database, which recently went online. (http://www.saferproducts.com/).

These are, to be sure, regulatory, not litigation initiatives. But the implications for product liability litigation are undeniable. That is especially true in the wake of the Supreme Court's Matrixx decision. As one of the speakers put it, the Supreme Court was nice enough to say that adverse events by themselves are not probative of causation, but was not nice enough to tell us what sort of context makes such adverse events material. It seems that if litigants and competitors are gaming the reporting system, then the adverse events should not come in at trial, but at this point we certainly have more questions than guidance.

Finally, while there was much more talk about regulation than litigation, everybody seems fascinated by the parallel requirements debate set up by Bryant (8th Cir) and Bausch (7th Cir). It looks as if a lot hinges on whether you buy Judge Melloy's Bryant dissent, where he focused on confidential documents making it impossible for plaintiffs to satisfy TwIqbal. We're already on record that such concern is overblown and that, in Bausch anyway, that concern was used to mask a number of other deficiencies in the plaintiff's pleading. And, of course, right after returning from the FDLI conference, we saw the bad Burgos (EDNY) decision that followed Bausch rather than Bryant. It certainly made us miss our friends at FDA.

Timberlake Summary Judgment In Sync with Preemption

We've been following Timberlake for a while. See here and here. We mean the product liability case against Synthes, not the pop singer (though, in truth, his appearances on SNL have been consistently superb and have convinced us, against all expectation, that he really is a talented fellow). The plaintiff Timberlake claimed injuries from an allegedly defective artificial intervertebral spinal disc (the ProDisc). What first caught our attention was that the plaintiff sued not only the manufacturer but also a couple of doctor-entrepreneurs who formed the company that researched and developed the ProDisc. We thought the theory of fraud liability against non-manufacturers was worse than novel; it was "funky." The court agreed and dismissed those defendants.

What was left was no longer funky. It became merely familiar. The ProDisc is a Class III medical device. It went through the FDA's rigorous premarket approval (PMA) process. The FDA made many requests for information and insisted on numerous revisions. The ProDisc's full application was approximately 8800 pages long. On August 14, 2006, ProDisc received premarket approval by the FDA. The FDA-approved labeling consisted of a number of documents, including a package insert, technique guide for surgeons, and a patient guide -- the contents of all of which were specified by the FDA.

So why aren't the plaintiff's product liability claims preempted? Last week, the court held that the claims are preempted, and that they are not saved by the dreaded "parallel" claim exception. Timberlake v. Synthes Spine, Inc., 2011 U.S. Dist. LEXIS 17034 (S.D. Texas February 18, 2011). It's a well-reasoned, clear decision, with no strings attached.

In addition to claims for product liability in strict liability and negligence, the plaintiff also alleged breach of express warranty and fraud/misrepresentation. The court concluded that those claims rested either on assertions that the product was defective -- even though the FDA had found the ProDisc was safe and effective -- or that patients and physicians had not been properly warned -- even though the the PMA process necessarily involves a determination that the FDA-approved label for the device is neither "false nor misleading." Timberlake, 2010 U.S. Dist. LEXIS 17034 at *22-24. The plaintiff's argument is in a box. The box is not quite the same box that Justin Timberlake and Andy Samberg sang about, though it is similar because it is a sort of gift for drug and device defendants. It is a preemption box.

But not so fast, said the plaintiff, who offered two arguments: (1) the FDA approved the product and labeling only because it had been lied to, and (2) the defendants violated FDCA requirements, thus committing a parallel" violation. The first argument takes about as long to get rid of as it takes to mouth the two syllables Buck-man. Id. at 26.

The second argument takes a little longer, if only to unpack the plaintiff's argument and scan the evidence ... or the lack of it. To the extent that the plaintiff alleged parallel claims based on violations of the FDA approval process, that would be "equivalent to fraud on the FDA claims, and thus Buckman preemption applies." Id. at * 28. The plaintiff also suggested that the defendants did not manufacture or label the ProDisc in a manner consistent with that approved by the FDA in the ProDisc's PMA. Note our use of the word "suggested." The problem is that the plaintiff failed to offer proof sufficient to create an issue of fact on the parallel claim. The plaintiff "failed to cite to any evidence in the record, including his own experts' testimony, showing that Defendants violated the specifications imposed by the FDA as part of the ProDisc's PMA with respect to the manufacturing and labeling of his ProDisc." Id. at * 33-34 (emphasis in original). The plaintiff's expert stated that the defendants failed an FDA inspection at one of their manufacturing facilities. But the plaintiff offered no evidence that the particular device in question had been manufactured at the facility that failed the FDA inspection. Id. at *34 n. 8.

Timberlake is the latest in a recent string of decision where courts have required specificity to support invocation of the parallel claims exception. See here, for example. Maybe it's a trend. Or maybe it's a case of what goes around comes around. (Yeah, at this point we're sacrificing all logic just to squeeze in another Timberlake song title. Just be grateful that, given the device at issue, we didn't allude to Sexyback. Oops -- darn it.) It reminds us of another pop culture icon, Charlie Sheen, and one of the odd parts of his recent radio rant (okay, the whole thing was plenty odd) where he blurts out that he is "winning." It's nice to be winning and we'd like to think that we're not delusional or intoxicated. Rather, the summary judgment result in Timberlake, especially the hemming in of parallel claims, seems fully justified.