Vaccine Act Preemption - Post-Bruesewitz

Breaking news here.  The Ninth Circuit has upheld a preemption-based dismissal of a Vaccine Act case. See Holmes v. Merck & Co., No. 08-16557, slip op. (9th Cir. Sept. 25, 2012).  As the docket number indicates, the Holmes appeal has been pending for over about 4 years.  It was resubmitted in 2011 after Bruesewitz v. Wyeth, 562 U.S. ___, 131 S. Ct. 1068 (2011).

Holmes involved MMR vaccine administered to a one-year-old baby.  Plaintiffs claimed that the vaccine caused seizures, brain damage and ultimately death.  Slip op. at 11794.  Plaintiffs sought compensation on the child's behalf through the federal system and received $250,000.  Id.  Not satisfied with that, they sought to ring the tort bell as well, on their own behalf, filing a wrongful death action in Clark County (Las Vegas) Nevada court.  Fortunately, there was diversity of citizenship.

The defendant received summary judgment on the basis of Vaccine Act preemption, and plaintiffs appealed.  The main issue was whether the parent's could dodge preemption by filing an action in their own behalf while simultaneously taking advantage of the Act's compensation system on behalf of their minor child.

Plaintiffs hinged their arguments mostly on the fact that the Vaccine Act only provides compensation and requires exhaustion of administrative remedies to those allegedly (we say allegedly because the Act does not require that causation be proven - as long as the vaccine and injury are on the Act's administrative list) physically injured by vaccines, not to next of kin.  Plaintiffs claimed that, by filing a separate wrongful death action on their own behalf, they could in effect double dip, receiving both federal and common-law compensation.  Slip op. at 11800.

In Holmes, the Ninth Circuit said no:

The exhaustion requirement in Section 11 is only a subsection of Congress’s larger statutory scheme to ensure that vaccine manufacturers have an affordable and predictable way of handling injured parties’ compensation claims.  Though parents are not bound by Section 11’s exhaustion requirement, they are not free from the Act’s tort liability limitations.  Regardless of whether a plaintiff is the vaccine-recipient or the parent of one, Section 22 expressly preempts design-defect claims seeking compensation for injury or death caused by a accine’s unavoidable side effects.  §300aa-22(b). Section 22 expressly preempts tort suits based “solely” on the manufacturer’s failure to provide direct warnings to the injured party.  §300aa-22(c).

Slip op. at 11800.

The Act's triple-barrelled elimination of design claims, imposition of a warning compliance defense and mandating of the learned intermediary rule "indicates that Congress expressly intended to prohibit states from regulating large aspects of tort suits against vaccine manufacturers."  Id. at 11802.  Thus, technicalities of state law (whether the plaintiff was the injured person or somebody bringing a wrongful death action) did not affect the Act's preemption of substantive claims - the design and warning claims were the same no matter who the plaintiff was:

Given the structure and broad purpose of the Act as a whole, it is most reasonable to apply Section 22 to all design defect and failure to warn claims arising out of a vaccine-related injury or death, not just those that could have first been brought in the Vaccine Court.

Slip op. at 11805.  Instead, the Act's preemption clauses apply to "any civil action for damages arising from a vaccine-related injury" without limiting the identity of the plaintiff.  Id. at 11806 (quotation marks omitted).  Moreover, to allow different claims for different categories of plaintiff would "create[] a convoluted trial and liability scenario," since where the vaccine recipient was not dead, both sets of claims would otherwise be tried together.  Id.  There was no basis for believing that "Congress gave greater rights" to family members than to the injured persons themselves.  Id.

 To allow parents to bring claims that were otherwise barred by the Vaccine Act also was at war with the broader purposes of the Vaccine Act:

[I]f we were to conclude that the parents of those suffering a vaccine-related injury could bring design defect and failure to warn claims outside of [preemptive] limitations, we would be acting contrary to the statute’s central purpose of managing vaccine manufacturers’ liability because our construction would do little to protect the vaccine manufacturers from suit.

 

Slip op. at 11807.  Protection from liability, after all was why Congress acted in the first place.

Preemption Amongst the Palmettos

There have been two recent state supreme court decisions concerning PMA medical device preemption under Riegel v. Medtronic, Inc., 552 U.S. 312 (2008).  One of them, Cornett v. Johnson & Johnson, ___ A.3d ___, 2012 WL 321094 (N.J. Aug. 9, 2012), will be the subject of Monday’s post, as our Dechert colleagues are from New Jersey and wanted to write about that one.


The other one, Weston v. Kim’s Dollar Store, ___ S.E.2d ___, 2012 WL 3205150 (S.C. Aug. 8, 2012), comes from South Carolina and involves one of the more unusual PMA products − non-corrective, UV light protective contact lenses.  That’s right − some decorative, colored contact lenses are PMA approved (due to UV protection), and thus protected by Riegel preemption.

The plaintiff in Weston didn’t seem to believe it either.  Almost all of her argument in the intermediate appellate court, and some of her argument in the high court, was devoted to claiming that the product was really “cosmetic” and thus didn’t deserve to be subject to pre-market approval.  Weston, 2012 WL 3205150, at *2-3.  The court wisely refused to let state-court plaintiffs attack whether a product should be subject to FDA PMA requirement:

There is no dispute that the lenses [plaintiff] purchased were UV lenses.  [Defendant] received a letter from the FDA approving PMA supplement . . ., which “requested approval for incorporating an ultra-violet absorber” into [the relevant] lenses.  Additionally, the FDA approved a supplemental PMA in 1999. . . .  Thus, because of the presence of the UV-absorbing component, we find that these lenses were subject to device-specific FDA requirements.  The record establishes as a matter of law that these lenses are covered by PMAs . . . therefore, express preemption is triggered.

Weston, 2012 WL 3205150, at *3.

The plaintiff in Weston also complained that the defendant “knew its [contact] lenses were frequently sold without a prescription and by unauthorized sellers, yet . . . failed to take steps to ensure customers received lenses by prescription only.”  Id. at *1.  Interesting claim − one we don’t see every day.  However, in the context of this PMA device, the plaintiff offered no evidence of any FDA requirement that obligated a device manufacturer to police its supply chain to ensure that the “prescription-only” sales limitation was enforced.  “Any claim that imposes requirements different from or additional to those set forth in the PMA is expressly preempted.”  Id. at *4.

The court in Weston did hold that a manufacturing-based claim (conceded by the defendant to be unpreempted) should survive, along with any “any claim that parallels applicable federal requirements.”  Id.  Unfortunately, that was as far as the court thought it could go − “due to the lack of specificity in Petitioner's complaint and the trial court's order granting summary judgment, we regret we cannot be more specific in delineating which claims survive the partial grant of summary judgment.”  Id.

That is unfortunate.  The original order granting summary judgment on preemption grounds was entered way back in 2006 − well before Riegel.  See Weston v. Kim’s Dollar Store, 2006 WL 4911566 (S.C.C.P. Nov. 28, 2006).  We sure hope it doesn’t take the plaintiff another six years to litigate whether she has any viable parallel claims beyond the one conceded by the defendant (not that we think there are any).

Excellent New Pain Pump Preemption Decision – The Details

            We were so enthused by this new decision, we gave you the link to it yesterday.  Stengel v. Medtronic, Inc., No. 10-17755, slip op.  (9th Cir. April 16, 2012).  Nothing lifts our spirits quite like a dismissal based on both explicit and implied preemption.  But, if like us, you had a busy Monday, and haven’t had a chance to read it yet – here are the highlights.

            First, the product -- a Class III pain pump that received initial PMA in 1988 (modifications received PMA about a decade later).  Slip op. at 4089.  Next, the claims – state law tort claims for “strict liability, negligence, and breaches of express and implied warranties.”  Id.  Huh?  Someone is still filing these cases?  The Ninth Circuit didn’t even blink when it dismissed these claims pursuant to Reigel v. Medtronic, Inc., 552 U.S. 312 (2008):

The Stengels’ claims, as they appear in the initial complaint, are expressly preempted under section 360k and Riegel.  The claims generally challenged the safety and effectiveness of Medtronic’s pump without any hint of an allegation that Medtronic’s conduct violated FDA regulations.  To be successful, the claims would have required the trier of fact, as a matter of state tort law, to conclude that the device should have either been designed differently from what the FDA required through premarket approval, or labeled with warnings different from what the FDA required. Therefore, the district court correctly dismissed the Stengels’ initial complaint.

Stengel, slip op. at 4092. 

So the plaintiff, having belatedly become familiar with Riegel, attempted to amend his complaint to allege the same four causes of action, but this time tried to beef up his failure to warn claim with a “newly-proffered theory” that plaintiff’s injury was caused by defendant’s failure “to report information to the FDA, as was required by FDA regulations.”  Id. at 4089.  In short, the plaintiff tried to put forward a parallel violation claim.  But, plaintiff should have kept studying, because in his attempt to dodge Riegel and express preemption, he ran head first into our old friend Buckman v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001) and implied preemption.

While the Ninth Circuit acknowledged that Riegel left open the possibility (as not expressly preempted) for a state law claim for alleged violations of federal regulations (a parallel violation claim), it also found that for such a claim to survive, it had to pass the test for implied preemption.  Stengel, slip op. at 4092-93.  In this case, that means Buckman.  Briefly, in Buckman the Supreme Court held that:  (1) implied preemption operates independently in the absence of express preemption, 531 U.S. at 352, and (2) claims for fraud-on-the-FDA were implied preempted because they interfere with the operation of the FDA’s enforcement and oversight responsibilities.  Id. at 348.  Similarly, in Stengel, “although the defendant had allegedly violated federal requirements, allowing the plaintiffs to bring a state cause of action to remedy the injuries caused by the violations would interfere with the congressional scheme.”  Slip op. at 4093. 

The Supreme Court reasoned that where a claim – such as fraud-on-the-FDA – is not based on a state law cause of action, but rather “exist[s] solely by virtue of the FDCA disclosure requirements,” Buckman, 531 U.S. at 352-53, it is preempted.  Relying on 21 U.S.C. § 337(a) (no private right of action to enforce FDCA), the Court found “it is the Federal Government rather than private litigants who are authorized to file suit for noncompliance with the medical device provisions.”  Id. at 349 n.4. 

And, that’s where plaintiff Stengel’s parallel violation claims failed – they were nothing more than statutorily prohibited attempts to raise private claims that the defendant violated the FDCA.  Functionally, the failure-to-report claim was indistinguishable from the fraud on the FDA claim in Buckman.  The defendant’s purported lack of disclosure merely being “tacit” rather than “overt”:

There is no meaningful distinction between [plaintiff’s] failure-to-warn claims and the “fraud-on-the-FDA” claims held to be preempted in Buckman. . . .  The only difference is that, in Buckman, the defendant allegedly misinformed the FDA overtly by providing false information, whereas here the defendant allegedly misinformed the FDA tacitly by failing to report information that it had a duty to report. The policing of such conduct in both instances is committed exclusively to the federal government, and recognizing a state cause of action based on such conduct would conflict with the statutory scheme established by Congress. 

Stengel, slip op. at 4095.  The speculative nature of the claim was also the same – that is, like Buckman, Stengel also invited a jury to speculate that the FDA would have done something different (required a label change) had it received different information than it actually did from the defendant manufacturer.  Id. at 4094 (“[plaintiff’s] theory is that if Medtronic had acted with reasonable care in complying with the regulations . . . the FDA would have required Medtronic to warn physicians about the danger of inflammation connected to its pump”).

The plaintiff’s claims were also, as in Buckman, naked allegations of regulatory violations, not resembling any traditional tort claim.  The Stengel decision recognized that failure to report claims were creatures of federal, rather than state, law:

The federal regulations that Medtronic is alleged to have violated, which require investigation and disclosure to the FDA in a particular manner so that the FDA can make a decision whether notification of consumers is necessary, are not tied to this general duty to warn consumers under Arizona law. Thus, the Stengels’ failure-to-warn claims, to the extent they survive express preemption, exist solely by virtue of the FDCA disclosure requirements and are, therefore, impliedly preempted.

. . .

We offer no opinion as to whether a particular state claim that is tied directly to compliance with federal law would be preempted under Buckman. In this case, the duty of manufacturers under federal law to report to the FDA information regarding their devices is not tied directly to the duty of manufacturers under state law to warn consumers of a device’s dangerous condition. On the contrary, the enforcement of the duty to report is an element of the federal scheme that is committed solely to the federal government.

Stengel, slip op. at 4096 and 4097.   

            So, plaintiff tried another dodge – arguing that his case was distinguishable from Buckman because here, unlike in Buckman, the FDA had sent the defendant a warning letter, “show[ing] that the FDA had already determined that [defendant] violated its federal disclosure obligations.”  Id. at 4097.  Plaintiff, therefore, contended that he could prove his claims “without second-guessing the FDA’s decision making.”  Id.  But, the Ninth Circuit made short work of this argument because it was based on the concurrence in Buckman (see 531 U.S. at 354 (Stevens, J., concurring in the judgment)).  A concurrence “which disagreed with the majority specifically because the majority did not take the position now advocated by the Stengels.”  Stengel, slip op. at 4097.  Hence, it is not the law.

            The remainder of the Ninth Circuit’s discussion on preemption is about the circuit split on the very issue of whether state failure to warn claims based on a defendant’s alleged failure to provide the FDA with information are preempted by Buckman.  The Ninth Circuit joined the Eighth Circuit in finding the claims preempted, see In re Medtronic Inc., Sprint Fidelis Leads Prods. Liab. Litig., 623 F.3d 1200, 1205-06 (8th Cir. 2010), and rejected the reasoning – which we also criticized – of the Fifth Circuit in Hughes v. Boston Scientific Corp., 631 F.3d 762, 775-76 (5th Cir. 2011) which reached an opposite conclusion.  See Stengel, slip op. at 4098-99.   Since Hughes also earned our #2 worst decision ranking for last year , we think you can figure out who we think got it right.

            And finally, the cherry on top:  Stengel (like practically every recent decision) approves of taking judicial notice of FDA approval documentation to establish the PMA nature of the defendant’s device.  Slip op. at 4099-4100. That means plaintiffs can’t resort to strategic omissions in their complaints to avoid Rule 12 dismissal.

            Today’s lesson:  what Riegel giveth (parallel violation claim), Buckman taketh away – at least when the allegation is based solely on FDA disclosure requirements (and except in the Fifth Circuit).

Excellent New Pain Pump Preemption Decision - Ninth Circuit

Here's a copy of a brand new Ninth Circuit decision upholding dismissal of a pain pump case on the grounds of express (Riegel) and implied (Buckman) preemption:  Stengel v. Medtronic, Inc., slip op. (9th Cir. April 16, 2012).  It's good on a lot of things.  A full report tomorrow (sorry, too busy today).

We're Not Grossed Out

From the beginning of Gross v. Stryker Corp., 2012 WL 876719 (W.D. Pa. March 14, 2012), discussing PMA medical device preemption, to the end of the opinion, pointedly referring to the Rule 11 obligation to investigate cases before bringing them, we liked what we read.  As you’ve probably already gathered, Gross is a Riegel-based preemption dismissal.  Definitely worth a read by anyone defending PMA cases.

Gross is another Trident hip case – litigation that, but for Riegel, may well have grown up to be a mature mass tort.  But after preemption, there isn’t very much there there any longer (assuming there ever was).  Indeed, our medical device preemption scorecard is rife with decisions holding that all, or virtually all, claims involving this product are preempted.  See Funk v. Stryker Corp., 631 F.3d 777 (5th Cir. 2011); Gelber v. Stryker Corp., 788 F. Supp.2d 145 (S.D.N.Y. 2011); Rhynes v. Stryker Corp., 2011 WL 5117168 (N.D. Cal. Oct. 27, 2011); Desabio v. Howmedica Osteonics Corp., ___ F. Supp.2d ___, 2011 WL 4074391 (W.D.N.Y. Sept. 13, 2011); Wilhite v. Howmedica Osteonics Corp., 2011 WL 2530984 (N.D. Ohio June 20, 2011); White v. Stryker Corp., ___ F. Supp.2d ___, 2011 WL 1131496 (W.D. Ky. Mar. 25, 2011); Gelber v. Stryker Corp., 752 F. Supp.2d 328 (S.D.N.Y. 2010); Lewkut v. Stryker Corp., 724 F. Supp.2d 648 (S.D. Tex. 2010); Lemelle v. Stryker Orthopaedics, 698 F. Supp.2d 668 (W.D. La. 2010); Cornwell v. Stryker Corp., 2010 WL 4641112 (D. Idaho Nov. 1, 2010); Van Dyke v. Howmedica Osteonics Corp., 2010 WL 8490858 (D. Mont. Apr. 23, 2010); Anthony v. Stryker Corp., 2010 WL 1387790 (N.D. Ohio Mar. 31, 2010); Yost v. Stryker Corp., 2010 WL 1141586 (M.D. Fla. Mar. 23, 2010); Horowitz v. Stryker Corp., 613 F. Supp.2d 271 (E.D.N.Y. 2009); Hayes v. Howmedica Osteonics Corp., 2009 WL 6841859 (D.N.J. Dec. 15, 2009); Covert v. Stryker Corp., 2009 WL 2424559 (M.D.N.C. Aug. 5, 2009) Delaney v. Stryker Orthopaedics, 2009 WL 564243 (D.N.J. Mar. 5, 2009); Parker v. Stryker Corp., 584 F. Supp.2d 1298 (D. Colo. 2008).

Thus, some parts of the Gross decision only repeat what has been decided before.  We’ll simply note those parts of the opinion and move on:  (1) a recall is not a revocation of approval for preemption purposes, 2012 WL 876719, at *2 n.13; (2) TwIqbal applies to actions removed from state court (see our prior post here), id. at *4 n.9; (3) Pennsylvania’s across-the-board application of Restatement §401A, comment k to bar strict liability applies to medical devices as well as drugs, id. at *7-9; (4) lots of different kinds of FDA documents are subject to judicial notice on a Rule 12 motion to dismiss, id. at *9 & n.26 (see our prior post here); (5) all components of a PMA-approved device are protected by Riegel preemption, including those with earlier §510k clearance, id. at *13-15; (6) just as Pennsylvania does not recognize strict liability, it does not recognize implied warranty in prescription medical product cases (see our prior post here), id. at *17 n.34; (7) to plead causation, a warning letter and/or a recall must cover the plaintiff’s particular device, id. at 23; (8) the ultra-liberal Hofts opinion is not a proper statement of TwIqbal pleading standards (see our prior post here), id. at *25; and (9) pleading an express warranty claim requires stating what the warranty is and how it became part of basis of the bargain.  Id. at *27.

Gross also comes down on the side of those courts ruling that general GMP regulations are too vague to support parallel violation claims.  2012 WL 876719, at *20-22.  The main reason given by prior courts for rejecting vague GMP claims is that they’re not “genuinely equivalent” because their vagueness allows plaintiffs to interpret them differently from the FDA and thus to impose obligations that the FDA itself does not impose.  While Gross does not disagree, and indeed embraces this vagueness argument, id. at *21, the court also offers another rationale – that reliance upon generalized GMP regulations applicable to all devices is incompatible with the preemption rationale in Riegel, which bases preemption on “device specific” requirements imposed through PMA approval:

Under the premarket approval process, the FDA imposes federal “requirements” that are “specific to individual devices.”  Allowing a plaintiff to plead nonspecific regulations as a basis for a parallel claim is inconsistent with the Supreme Court’s reasoning in Riegel, as well as the pleading requirements articulated in Twombly, Iqbal, and Fowler [a Third Circuit TwIqbal case].  This Court requires a greater level of specificity in pleading a parallel claim, rather than allowing claims premised on violations of general regulations to go forward merely because plaintiffs will supplement their pleadings at trial.

Gross, 2012 WL 876719, at *22 (all quotes to Riegel) (emphasis added).  Riegel requires device-specific PMA requirements to establish preemption, and thus also requires a violation of device-specific PMA requirements to avoid preemption through the parallel violation loophole:

[P]ursuant to the premarket approval process, medical device manufacturers must adhere to device-specific requirements.  As such, violations of same, and not merely any requirement, properly serve as the basis of a parallel claim. . . .  In the instant case, the CGMPs cited by Plaintiff . . . are not only general; they apply to all Class III PMA medical devices.  Furthermore, because these regulations do not address the manufacturing of the specific device at issue . . ., they cannot establish the requisite standard of care that a particular manufacturer must meet.  The regulations delegate the maintenance of device-specific quality control to the manufacturer.  Yet, Plaintiff does not plead that [defendant] violated its own policies regarding product safety.  Plaintiff, instead, alleges that [defendant] violated very broad CGMPs that are not device-specific to the [device at issue].  As a result, Plaintiff does not plead sufficient facts to support a claim that [defendant] did not comply with these CGMPs.

Id. at *22-23 (citation and quotation marks omitted) (emphasis original).  In short, since the device-specific PMA process is what created preemption in Riegel, only a device-specific violation claim can avoid preemption.

Because we haven’t seen a court articulate this rationale in this way before, we thought we’d point it out. Since Riegel hinges preemption on device specific requirements, which the GMPs are not, and because TwIqbal does not allow discovery based upon inadequate pleadings, Gross thus disagreed with the Fifth Circuit bootstrap approach in Bass v. Stryker Corp., ___ F.3d ___, 2012 WL 266985 (5th Cir. Jan. 31, 2012), insofar as the Fifth Circuit let plaintiff slide on pleading GMP violations because later discovery would provide the necessary specificity.  2012 WL 876719, at *22.

The court in Gross also engages in a more detailed analysis of res ipsa loquitur than we’re accustomed to seeing in preemption (or TwIqbal) opinions.  Essentially, if the FDA’s GMPs are too vague to support a parallel claim – well res ipsa loquitur is even vaguer:

[T]his Court declines to infer the existence of such negligence in accordance with the doctrine of res ipsa loquitur under Pennsylvania law.  Finding res ipsa loquitur here would require the Court to rely on even fewer facts than Plaintiff pled in support of his negligence claim.

Gross, 2012 WL 876719, at *24.  In addition, nothing in the complaint ruled out the alternative cause of physician error, particularly since infection (the plaintiff’s claimed injury) was specifically warned of as both an adverse reaction and a contraindication.  Id. at *24-25.  So remember Gross for another proposition – TwIqbal requires a plaintiff pleading res ipsa loquitur to plead it plausibly by including some factual basis for excluding alternative causes.

A third particularly interesting aspect of Gross, from our standpoint at least, comes in its discussion of the FDA’s recall of some of these devices for “impermissible, excessive manufacturing residuals.”  The plaintiff, however, admitted in the complaint that “he has not yet determined whether the residues on the hip prosthesis were” what the FDA had recalled.  Gross, 2012 WL 876719, at *2.  The court was none too pleased with this failure:

An attorney must conduct a reasonable inquiry before filing a lawsuit, and cannot pursue the action unless he or she reasonably believes that facts exist to support the allegations.  Plaintiff underwent the [surgery in question] in October 2008.  Almost two years later . . ., Plaintiff's counsel [brought suit].  During this approximately two-year time period, Plaintiff's attorney had a duty to investigate whether the residues on Plaintiff's initial hip prosthesis were foreign bodies or native material from the manufacturing process.

Id. at *2 n.11 (citing, inter alia, Rule 11).  Rule 11 “imposes on counsel a duty to look before leaping and may be seen as a litigation version of the familiar railroad crossing admonition to ‘stop, look, and listen’.”  Id. at *5 (citation and quotation marks omitted).

For similar reasons, the court in Gross rejected plaintiff’s plea for discovery prior to dismissal.  In TwIqbal, the Supreme Court had specifically stated that discovery was available only after the plaintiff pleaded a plausible claim.  In order to plead a claim, a plaintiff may engage in self-help and nothing more:

To obtain additional information from the FDA to aid in drafting his Complaint, Plaintiff could have submitted a Freedom of Information Act (“FOIA”) request. . . .  Plaintiff also had an opportunity to conduct pre-complaint discovery when he commenced this action in [state court]. . . .  Finally, the Court finds Plaintiff's request for discovery to be inapposite to Rule 8 and Rule 11(b) of the Federal Rules of Civil Procedure.  Rule 8 . . . does not unlock the doors of discovery for a plaintiff armed with nothing more than conclusions.  A plaintiff who fails to meet the pleading requirements of Rule 8 is not entitled to conduct discovery with the hope that it might permit her to state a claim.  In addition, Rule 11(b) requires a pleading to be a representation of “the best of the person’s knowledge, information, and belief, formed after an inquiry reasonable under the circumstances.”  An attorney must conduct a reasonable inquiry before filing a lawsuit, and cannot pursue the action unless he or she reasonably believes that facts exist to support the allegations.  Allowing Plaintiff to “file first and investigate later” contradicts the reasonable inquiry requirement in Rule 11(b).

Id. at 29 (citations and quotation marks, except to Rule 11, omitted).

The court’s several references to Rule 11 echo our own feelings.  It’s time for courts to crack down on knee-jerk filings in PMA preemption cases (and everywhere else, for that matter, but that’s a different gripe).  Even the barest of investigations would have revealed the preemption issues involving this product.  As our earlier list demonstrates, preemption has been on the front burner literally for years.  In this situation, it’s not enough “reasonable inquiry” to plead “I dunno but I’ll find out later.”  Preemption is a manifestation of congressional intent that certain types of actions should not be brought, and more courts, like Gross, should be willing to uphold that intent, rather than assist evasive plaintiffs.

Needless to say, Gross now enjoys a position of honor on both our device preemption scorecard and our TwIqbal cheat sheet.

Because it found that plaintiff had not come close to pleading an unpreempted claim, and indeed had not properly pleaded most of his preempted claims, the court in Gross dismissed all of the claims with prejudice and without leave to amend.  That means there is an appealable order.  We’ll keep watching Gross to see what the Third Circuit does with it.

Bass Riffs

There's an important new opinion, Bass v. Stryker Corp., No. 11-10076, slip op. (5th Cir Jan. 31, 2012), that provides a pretty decent rundown of what a plaintiff has to have to plead, under TwIqbal, an unpreempted "parallel violation" claim of the manufacturing defect variety.

Here are the elements that must be pleaded under Bass (which the court held that the plaintiff did):

• (1) The particular product that the plaintiff claims caused injury ("he received a Shell implant");
• (2) The nature of the claimed "parallel" violation ("the FDA had previously warned [defendant] of bioburden in excess of FDA regulations in its final rinse of the Shells");
• (3) That the violation could be causal in that it pertained to the plaintiff's device ("after [plaintiff's] surgery, [defendant] ultimately voluntarily recalled those Shells, including the Shell specifically used in [plaintiff's] implant");
• (4) The nature of the plaintiff's injury ("[plaintiff] suffered from a loose Shell due to a lack of bony ingrowth"); and
• (5)  That the violation could be causal in that it bore a relation to the plaintiff's claimed injury ("the lack of bony ingrowth is a known effect of an excess of bioburden and manufacturing residuals on Shells").

Bass, slip op. at 10.  Where we find plaintiffs falling down is usually on items (2), by failing to plead that the FDA action pertained to the device the plaintiff had, (3) by pleading scattershot FDA actions that, giving timing or location, have nothing to do with the case, and (5) claiming violations that don't have anything to do with the injury in the case.

One more thing:  the plaintiff must plead the violation of a sufficiently specific FDA requirement.  Bass, slip op. at 12-13.  That can be done by alleging that the defendant either a specific regulation, or a more general regulation (such as certain Good Manufacturing Practices), as applied to the device by particular specifications in the PMA that the FDA actually approved.  Id. at 13 ("The PMA application that is approved by the FDA is more specific than the regulations").



Do all that, and there's a properly pleaded violation claim that entitles the plaintiff to discovery.  Bass, slip op. at 12. 

Remembering that this is only at the pleading stage, where a preliminary FDA warning letter, while it might be "plausible" as an allegation, id. at 15, but would be admissible as proof, we're not terribly offended by these pleading requrements.



That's particularly so because Bass goes out of it's way to specify that a plaintiff can't argue that the specifications themselves should have been different from what the FDA approved:

[I]f the plaintiff challenges the suitability of the precise processes or procedures chosen by the maker, and approved by the FDA, to achieve the broader regulatory goals, such a claim could not proceed.

Id. at 14; see also id. (example that demanding something more or different would be preempted, but not failure to meet what the FDA approved).

There's other good stuff in Bass, too.  The court rejects the rather ridiculous parsing arguments that we've seen with various multi-component devices, holding that the PMA covers all of the device's components.  Slip op. at 6-7.  More broadly favorable, is the court's affirmation of the district court's using judicial notice of FDA documents to establish the fact and scope of the PMA approval on a motion to dismiss.  Id. at 5-6.  The scope of the FDA's approval is a question of law, and thus a plaintiff's allegations on this issue need not be treated as true.  Id. at 5-6.

We're less sanguine about Bass' handling of whether Texas common law would allow "negligence per se" based on FDA violations.  The court dodges that main point, and in another stretch of Erie principles, equates cases saying such claims "aren't preempted" with the recognition of an underlying cause of action.  Bass, slip op. at 17.  Still, the court in Bass didn't go all the way and hold there was a negligence per se claim, but that the allegations might support "negligence."  Id. at 17.

Bass closes with a detailed (one of the most detailed we've ever seen) specification of what's in and not in.  Slip op. at 18-23.  Everything that's left in relates to the manufacturing-related claim predicated on the FDA's warning letter and recall, whether it's called "strict liabilty," "negligence," "warranty" or whatever.  All warning/marketing claims are out - preempted - as are any other claims that would impose liability despite compliance with FDA regulations.  See id. at 22 (discussing implied warranty).
Bass isn't the greatest decision in the world, but it's not horrible either.  Remember, this is just at the pleading stage.  The plaintiff still has to prove the violation allegations with admissible evidence.  The linchpin to Bass seems to be that the plaintiff pleaded the link between the FDA violation and that plaintiff's actual injuries.  If, either in Bass or some other case, that allegation is actually baseless (such as a false statement that a recall applied to the plaintiff's device), such bad-faith pleading would be a situation where Rule 11 and other cost-shifting would be appropriate, TwIqbal is based in large part on preventing unnecessary imposition of cost.

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.

Medical Device Preemption Developments

Boring title, but accurate.  Here’s the latest.


First, Medtronic won another one the other day.  Duggan v. Medtronic, Inc., ___ F. Supp.2d ___, 2012 WL 45503 (D. Mass. Jan. 10, 2012), involved an insulin delivery system.  It had a number of components, including the pump, which physically moved the insulin from where it’s stored into the body.  Plaintiffs alleged that the pump malfunctioned and caused undisclosed injuries.

The insulin system was a PMA device, so the defendants moved for summary judgment on grounds of preemption.  Plaintiffs targeted the pump, rather than any other aspect of the system, because the pump had originally been §510k cleared (unpreempted under Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996)) – by itself – in 2004.  The insulin delivery system predated the pump, and was PMA approved.  By PMA supplement in 2006, the FDA approved incorporation of the pump into the system.  The plaintiff was prescribed that system.  Duggan, 2012 WL 45503, at *3-4.

Plaintiffs’ primary argument for avoiding preemption was that the components in the system should be parsed, the 2006 PMA supplement ignored, and the pump treated as a “mere” §510k device.  They got nowhere.  The same argument had been made, and rejected, in other device system litigation (mostly knee implants, if we recall):

Many courts have held that once premarket approval is granted, all claims relating to all components of the device are preempted. This analysis applies even where a component of a PMA-approved device had previously been approved through the § 510(k) process.

Id. at *4 (citations omitted).

Plaintiffs then tried component part argument 2.0, claiming that the data in the defendant’s supplement was insufficient to support PMA approval of the pump.  Id. at *5.  The opinion doesn’t detail the basis of that argument, but we assume that some malleable FDA “expert” was involved.  The court refused to allow PMA preemption turn on a litigant’s after-the-fact deconstruction of the approval submission.  What the FDA decided, not what a litigant claimed that the FDA should have decided, controlled:

[T]he sufficiency of the data submitted to the FDA with respect to the safety and efficacy of a device does not govern the scope of the premarket approval.  Whether a product is FDA-approved is determined by the language in the approval letter, not by the application documents submitted to it for review.  The FDA, not litigants, is entrusted with the responsibility to police the sufficiency of the evidence to support a PMA approval.

Duggan, 2012 WL 45503, at *5 (citing our old pal, Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001)).  We view this holding as the most important takeaway from Duggan.

Interestingly, plaintiffs also tried to intervene with the FDA itself, attempting to depose Agency personnel and filing an FDA citizen’s petition challenging the scope of the PMA.  2012 WL 45503, at *3.  Both moves backfired.  It’s really difficult to depose government personnel when the government doesn’t want it.  E.g., United States ex rel. Touhy v. Regan, 340 U.S. 462 (1951).  That goes double for the FDA in the First Circuit.  See Giza v. Secretary of HEW, 628 F.2d 748 (1st Cir. 1980).  Oops.  Duggan, 2012 WL 45503, at *5 (plaintiffs forced to drop subpoena).  On top of that, the FDA denied the petition, reaffirming that the PMA covered the entire system.  Really oops.  Id. (“[t]o the extent there was any ambiguity about the scope of the approval letter, this rejection of the Citizen Petition is the cherry on the icing”).  Observing that plaintiffs had thusly shot themselves in the foot, the court granted summary judgment.  Id.

Second, Boston Scientific won a preemption motion in a rather unusual case in Erickson v. Boston Scientific Corp., No. SACV 10-698 AG (ANx), slip op. (C.D. Cal. Dec. 12, 2011).  We’re only just finding out about it, though.  The unusual nature of the case is the general attack on the life expectancy of several of the defendant’s products (pacemakers powered by batteries).  The plaintiff claimed that he had been told that four different pacemakers “would last ten years” but that none of them (except the last, which hadn't been implanted very long) came close to that lifespan.  Slip op. at 2.

Erickson was dismissed via judgment on the pleadings.  So, initially, it is a valuable judicial notice decision, as the court took judicial notice of the FDA approvals of all four pacemakers (six total FDA documents) – a PMA, two PMA supplements, and several supplemental product development protocols (“PDPs”).  Slip op. at 3-4.  Judicial notice, of course, allows for dismissal on the pleadings, thereby saving considerable discovery expense and reducing the nuisance value of plainly preempted litigation.

Erickson held that both of these regulatory avenues – the PMA supplements and supplemental PDPs – were equivalent to pre-market approval, and thus preemption under Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), barred the action.   Slip op. at 7.  The decision discussed supplemental PDPs at some length:

Some of Defendants’ pacemakers were not subject to the FDA’s PMA process, but were instead approved through the FDA’s supplemental Product Development Protocol (“PDP”).  In Reigel, the Supreme Court stated that an application for supplemental premarket approval is “evaluated under largely the same criteria as an initial application.”  Riegel v. Medtronic, Inc., 552 U.S. 312, 319.  Courts have interpreted Reigel to mean that preemption applies equally to both the PMA and PDP processes.

Slip op. at 8 (other citations omitted).  We’ve seen supplemental PMA and PDP preemption decisions before (see our device preemption scorecard for details), but Erickson is the first case we can recall specifically discussing a supplement to a PDP in the context of preemption.  That’s probably the most important takeaway from Erickson.

In Erickson the plaintiff also trotted out the “parallel violation” exception.  Slip op. at 9-10.  The defendant made mincemeat of it – aided significantly by the plaintiff's failure to plead anything resembling an adequate parallel claim.  Plaintiff did not allege what was violated or how that related to his claim.  Id. at 9-10. That didn’t cut it:

[A] plaintiff cannot simply incant the magic words “[defendant] violated FDA regulations” in order to avoid preemption.  Rather, a plaintiff must allege that the defendant violated a particular federal specification referring to the device at issue, or identify specific PMA requirements that have been violated.

Slip op. at 9 (citations and quotation marks omitted).

The only thing specific that the plaintiff in Erickson alleged was that some of the pacemakers had been recalled.  A bare allegation of a recall, however, wasn’t nearly enough.  First, “[m]any courts have recognized that product recalls do not create a presumption that FDA requirements have been violated.” Slip op. at 10 (citations omitted).  Second, recalls do not amount to withdrawal of approval.  Id. Third, the recall wasn't even relevant, since there was no allegation “that the recall was prompted by defects relating to the pacemakers’ longevity.”  Id.

The treatment of the recall is a second very usable takeaway from Erickson. Finally, for the record, Erickson also dismissed fraud claims as insufficiently pleaded, slip op. at 10-11, and throws out several of the claims (the older pacemakers) under the statute of limitations.  Id. at 13-15.

Successful Class II Medical Device Preemption Decision

We don't see many successful applications of preemption with respect to 510k, Class II medical devices since Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), so when we do, it's a big deal.  Here's one.  Today, in Degelmann v. Advanced Medical Optics, Inc., No. 10-15222, slip op. (9th Cir. Sept. 28, 2011), the Ninth Circuit held that a claim that a contact lens solution manufacturer should have tested its product against a particular microorganism was preempted.

Here's the reasoning, in a nutshell.  (1) there can be "specific requirements," even in 510k, Class II cases; (2) an FDA guidance document (significantly, not a formal regulation) allowed contact lens solutions to come to market under 510k provided the manufacturer did certain specific things; (3) one of those things was the "primary performance criteria" of a "stand alone procedure" - that the solution "show[] the prescribed level of efficacy in killing five representative microorganisms"; (4) the defendant's solution undisputably met this test in wiping out the five specified bugs; (5) plaintiff's claim demanded that the solution also kill a different microorganism that was not on the FDA's list; (6) since plaintiff's demand related to a different microorganism, it was "different from" and "in addition to" the FDA's device specific requirement; (7) all claims "different from" or "in addition to" a device specific requirement" are expressly preempted.  Degelman, slip op. at 18567-70.

So if you're a 510k, Class II device manufacturer, and the FDA's tagged your product with a device-specific guidance document, you may be able to assert preemption after all, at least against some claims.

Given the strength of the preemption defense, it's something worth looking into.

Preemption Notes

A couple of recent preemption developments warrant mention.

Horned In; Horned Out

In Horn v. Boston Scientific Neuromodulation Corp., 2011 U.S. Dist. Lexis 102164 (S.D. Ga. Aug. 26, 2011), the defendant, a manufacturer of a PMA medical device, won preemption of a claim that’s often lost, and lost preemption of a claim that’s often won.  The upside (from our defense standpoint) in Horn was the court’s treatment of negligence per se, which can be a form of unpreempted “parallel violation” claim.  To escape preemption, the plaintiff alleged that the defendant’s representative violated an FDA “quality system regulation” about “storage areas” because she kept devices in her home overnight before delivering them to hospitals for use in surgery.  The court held the claim preempted because that regulation – “or any QSR for that matter” – was too broad and vague to be a basis for a parallel claim.  Id. at *20-25.  So Horn is precedent for knocking out a whole category of FDA regulations (QSRs) for preemption purposes.

On the downside, the plaintiff’s express warranty claim in Horn survived.  That’s because it wasn’t the usual allegation of some sort of broad, generic guarantee of device “safety.”  Instead, the defendant offered an express five-year limited warranty.  Because the plaintiff alleged that the device’s battery malfunctioned less than five years after implantation, the court held that this warranty – not anything the FDA reviewed – gave rise to an unpreempted claim.  Id. at *28-31. Then the court unilaterally changed the terms of the warranty, eliminating its warranty’s express limitation remedies to replacement as “unconscionable,” id. at *31-33, citing the UCC's provision regarding "consumer" products.   We think that's wrong because prescription medical products, particularly implantable devices, can only be used by licensed doctors, and are not available to patients.  Thus they're not “consumer” products.  But the court in Horn decided that no good deed would go unpunished. The takeaway – a PMA manufacturer making a non-FDA warranty should expect to get sued.

Totally Useless, But Who Cares?

After PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011), generic plaintiffs are picking through the wreckage much like we had to do after Wyeth v. Levine, 555 U.S. 555 (2009).  One straw that they seem to have grasped is the “Dear Doctor” or “DHCP (that stands for ‘dear health care professional’)” letter.  Specifically, they’re claiming that they can gin up a state-law duty obligating generic manufacturers to send out such letters as long as they are the same as existing drug labeling.

From a policy standpoint, we can hardly think of anything so useless.  Doctors are overwhelmed with reading material already – now they’re supposed to be inundated with Dear Doctor letters that don’t even purport to tell them anything new?  And how is such a thing supposed to be causal?  Almost every state’s law rejects claims based upon warnings that only tell people what they already know/have already been told.

Nevertheless, in Brasley-Thrash v. Teva Pharmaceuticals USA, Inc., 2011 U.S. Dist. Lexis 102858 (S.D. Ala. Sept. 12, 2011), the court held that such a futile claim is, at least, unpreempted.  Only in March, 2008 did the FDA require pre-approval of Dear Doctor letters.  Id. at *7.  Therefore an allegation of a duty to send redundant Dear Doctor letters before that date is not preempted.  Id. at *8.  Fortunately, however, state law came to the rescue.  Because state law only allows liability where the warnings are inadequate, and Mensing precludes any challenge to the adequacy of warnings, the claim nonetheless fails.  2011 U.S. Dist. Lexis 102858, at *9.

Then there’s Henderson v. Sun Pharmaceuticals Industries, Ltd, ___ F. Supp.2d ___, 2011 WL 4015658 (N.D. Ga. Aug. 22, 2011), where the plaintiff attempted to retrench after Mensing with some sort of manufacturing defect claim.  Although there was an FDA warning letter to the defendant, plaintiff couldn’t link it to the drug in question – let alone the units of the drug actually ingested.  Id. at *4.  The same problem befell their negligence claim – nothing in their panoply of allegations had any relationship to the pills that the plaintiff took.  Id. at *5.

While these cases knocked down a couple of off-the-wall theories, we expect for generic drug litigation to generate bizarre allegations for the foreseeable future.

Product Development Protocol? Preempted.

Just a note about Malbroux v. Jancuska, 2011 U.S. Dist. Lexis 96590 (W.D. La. Aug. 29, 2011), an otherwise forgettable opinion throwing out medical device claims on the basis of preemption under Riegel v. Medtronic, Inc., 552 U.S. 312 (2008).  Malbroux is forgettable:  (1) because it’s a pretty much routine application of Riegel to allegations that don’t even attempt to make any sort of violation claims, and (2) because the plaintiff was pro se, so he probably didn’t know he needed to in any event.


What’s interesting to us is the nature of the device as to which preemption was found.  Rather than the usual pre-market approval, the device in Malbroux (an “Inflatable Penile Prosthesis” according to the complaint), was being marketed according to a “product development protocol.”  The court found no material difference between that and PMA, and dismissed on express preemption grounds:

This preemption clause operates to safeguard the Food and Drug Administration's (“FDA”) comprehensive analysis concerning both PMA (Premarket Approval process)-approved and PDP (Product Development Protocol process)-completed devices from modification or interference through the varying tort law principles of the fifty states.

Malbroux, 2011 U.S. Dist. Lexis 96590, at *5.  Later on, the court reiterates the point:

PDP completion is equivalent to PMA approval, thus, if a device is PMA-approved or has received a declaration of PDP completion, then the first prong of the preemption analysis is satisfied . . . . [The device] that is the subject of this lawsuit received a declaration of PDP completion. The conditions of PDP approval governs [the] design, manufacturing and labeling of the device. Therefore, through the PDP process, the FDA has established federal “requirements” that apply specifically to the Penile Prosthesis.

Id. at *6-7.

Thus we’ll add Malbroux to our still small (but growing) pile of product development protocol preemption decisions.  See Nimtz v. Cepin, 2011 WL 831182, at *3-4 (S.D. Cal. March 3, 2011); Cowen v. American Medical Systems, 2006 WL 3542704, at *1-2 (E.D. Mich. Dec. 7, 2006); Betterton v. Evans, 351 F. Supp.2d 529, 535-36 (N.D. Miss. 2004); Clement v. Kaiser Foundation Health Plan, Inc., 2004 WL 3049753, at *4-5 (C.D. Cal. Dec. 17, 2004).

Implied Preemption And Medical Devices

Was anyone else out there struck, like we were, that the Court described the preemptive FDA action it recognized in Pliva, Inc. v. Mensing, ___ U.S. ___, 2011 WL 2472790 (U.S. June 23, 2011), in terms of “equivalence”?  Here’s what we mean:

Under this law [Hatch-Waxman], “generic drugs” can gain FDA approval simply by showing equivalence to a reference listed drug that has already been approved by the FDA.  This allows manufacturers to develop generic drugs inexpensively, without duplicating the clinical trials already performed on the equivalent brand-name drug.

Id. at *5 (as usual various citations we don’t care about omitted) (emphasis added on what we do care about).

Equivalence?  Where have we seen that before in preemption cases?

Anybody remember Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996)?  That case involved a medical device cleared by the FDA under a similar sort of procedure, so-called “510k” “substantial equivalence.”  Here’s how the Court described that process in Lohr:

[T]he Act also permits devices that are “substantially equivalent” to pre-existing devices to avoid the PMA process. . . .  “[S]ubstantially equivalent” Class III devices may be marketed without the rigorous PMA review [if their manufacturers] submit a “premarket notification” to the FDA. . . .  If the FDA concludes on the basis of the §510(k) notification that the device is “substantially equivalent” to a pre-existing device, it can be marketed without further regulatory analysis.

518 U.S. at 478.

Mensing recognized that Hatch-Waxman shortened the approval process for generic drugs to make it fast and cheap.  2011 WL 2472790, at *5, see id. at *12 (“bringing more drugs more quickly and cheaply to the public”).  The same was true of the substantial equivalence procedure in Lohr.  518 U.S. at 478 (process “ensure[s] that improvements to existing devices can be rapidly introduced”).

Mensing found that implied preemption existed against warning (and probably other) claims.  Lohr found no express preemption against anything.

In Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), the Court took a look at FDA pre-market approval for medical devices – the long-form (“rigorous”) type of medical device approval.  PMA approval, the Court held, “is in no sense an exemption from federal safety review – it is federal safety review.”  Id. at 323 (emphasis original).  Because of the FDA’s “rigorous” review and detailed involvement in PMA, almost any claim (save a violation claim) would be “different from or in addition to” the FDA’s requirements, thus leading to broad express preemption.

However, when the Court took a look at the prescription drug equivalent of PMA approval – “new drug” FDA approval – in Wyeth v. Levine, 129 S. Ct. 1187 (2009), it sang a different, discordant tune.  The Court cared very little about the overall rigor of the process - that such approval "is federal safety review.”  Instead, Levine fixated on a narrow exception to FDA pre-approval (the “changes being effected” (CBE) exception), and found that this exception, even though little used, defeated “impossibility” implied preemption.  Id. at 1197-98 (CBE gets broad reading because “the manufacturer bears responsibility for the content of its label at all times”), at 1199 (impossibility is a “demanding defense”).  As for “purposes and objectives” implied preemption, the Court basically decided that it liked tort plaintiffs better than the FDA.  Id. at 1201-02.

So the net result of these four cases – Mensing/Levine for drugs and Lohr/Riegel for devices is that preemption in medical device and in prescription drug product liability litigation are treated bass ackwards from one another.  In drugs, the less rigorous “equivalence” based form of FDA review provides more preemption – because of identity requirements – than does the FDA’s more rigorous new drug approval process.  Conversely, in devices, the less rigorous “equivalence” based form of FDA review leads to less (actually, no) preemption, compared to the extensive preemption provided by the more rigorous PMA process.

What’s going on?

Well, aside from the bizarre now-you-see-it-now-you-don’t quality of the presumption against preemption, the chief difference between medical device and prescription drug preemption is that, in medical devices, the Court addressed express preemption and in prescription drugs, it addressed implied preemption.

That’s important.

Express preemption, because it is “express” – that is, dependent upon specific statutory language addressing preemption – is inherently limited to the statute containing the express preemption clause at issue (except maybe for cases of identical statutory language, which we're not dealing with today).

Thus, the Court’s express preemption medical device decision in Riegel wasn’t a lot of help to the prescription drug manufacturer in Levine when the Court was considering the otherwise analogous more rigorous form of prescription drug approval.  See Levine, 129 S. Ct. at 1200 (distinguishing Riegel because “Congress has not enacted such a provision for prescription drugs”).

The reverse, however, is not true.  Implied preemption principles cut across statutory lines because they stem directly from the Supremacy Clause itself.  Thus the finding that fraud on the FDA claims were impliedly preempted in Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001), supports preemption against analogous allegations of fraud involving other federal agencies governed by completely different statutes.

So while Riegel isn’t going to help much in prescription drug litigation because it’s based upon express preemption, there’s no reason that Mensing can’t come to the rescue of medical device manufacturers who don’t enjoy express preemption as a result of Lohr.

Counsel defending product liability litigation involving 510k devices should thus read Mensing and give it close consideration.

Lohr has nothing to do with implied preemption.  It doesn’t even mention it.  Therefore, nothing in Lohr precludes Mensing’s implied preemption “sameness” rationale from being applied to “substantially equivalent” medical devices.  Abundant Supreme Court precedent, most recently in Mensing itself, establishes the proposition that lack of express preemption doesn’t affect the existence of implied (often called “conflict”) preemption.  See Id. at *8 n.5 (“the absence of express pre-emption is not a reason to find no conflict pre-emption”) (emphasis original).

The core rationale for impossibility preemption in Mensing was that state tort suits demanding different warnings necessarily conflicted with the federal identity requirement imposed upon generic drugs:

If the Manufacturers had independently changed their labels to satisfy their state-law duty, they would have violated federal law.  Taking [plaintiff’s] 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.

2011 WL 2472790, at *9 (emphasis added).

Is there an analogous “sameness” requirement applicable to 510k medical devices?  If a plaintiff argued that a defendant’s medical device should have been drastically re-designed to make it safer, would that purported state-law duty conflict with the terms of the device’s clearance?

We don’t have time to answer these questions in depth, but attorneys with pending 510k cases will.  What we can say is that the FDA’s regulations delineating the substantial equivalence clearance process at issue in Lohr do appear to impose similarity requirements that, under Mensing, might well give rise to implied preemption.  The relevant regulation uses the magic word “same” and several functional equivalents:

(b) FDA will determine that a device is substantially equivalent to a predicate device using the following criteria:

(1) The device has the same intended use as the predicate device; and

(2) The device:

(i) Has the same technological characteristics as the predicate device; or

(ii)(A) Has different technological characteristics, such as a significant change in the materials, design, energy source, or other features of the device from those of the predicate device;

(B) The data submitted establishes that the device is substantially equivalent to the predicate device and contains information, including clinical data if deemed necessary by the Commissioner, that demonstrates that the device is as safe and as effective as a legally marketed device; and

(C) Does not raise different questions of safety and effectiveness than the predicate device.

21 C.F.R. §807.100 (emphasis added).  There are undoubtedly Guidance Documents, device-specific clearance letters, and other FDA materials that give flesh to the sameness requirements of §807.100.

Thus, it seems to us – mere bloggers that we are – that any state-law tort claims made against 510k medical devices which either:  (1) demand labeling/design changes that would alter the intended use, technological characteristics or safety and effectiveness of the device, or (2) conflict with the FDA’s determination that substantial equivalence exists, should be subject to implied preemption under the same rationale recognized by the Supreme Court in Mensing.

Go on ... prove us right (or wrong).

Score One-Half For IDE Preemption

It’s a little stale, by our standards at least, but we thought we ought to say something about Burgos v. Satiety, Inc., 2011 WL 1327684 (E.D.N.Y. April 5, 2011).  It’s got some good things about it – especially that it’s another case recognizing broad preemption in the context of investigational (“IDE”) medical devices.  Id. at *2 (“negligent manufacture is one of the many state law tort claims that is preempted by the federal regulatory scheme that governs the testing and approval process for experimental medical devices”).  Since there are still some plaintiffs who argue that Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), doesn’t apply to IDE devices, Burgos is OK to that extent.


The decision also kicks out a somewhat bizarre claim based on purported improper record-keeping that, while invoking 21 C.F.R. §§812.110, 812.140, sounds like a disguised claim for spoliation.  The court holds that the allegations don’t parallel anything at state law because of remoteness.  Burgos, 2011 WL 1327684, at *3 (plaintiff “cannot establish that her injury was ‘substantially caused’ by [defendant’s] alleged breach of its record-keeping duties”).

But then the Court goes all flabby.  Plaintiff alleges “adulteration” because the defendant somehow violated the terms of its IDE.  How?  The court admits that, from the complaint, it has no idea.  Plaintiff “does not allege how the . . . device's manufacture violated the IDE, nor does she specify the terms, conditions, standards, or specifications that she claims were violated.”  Burgos, 2011 WL 1327684, at *3.  The court cuts the plaintiff a break, saying that because the IDE documents are non-public, plaintiff can’t be expected to plead anything specific:

[A]t this stage of the proceedings she cannot reasonably be expected to do so [plead what violation happened], because the information she requires to provide the requisite degree of specificity – the IDE documentation submitted by [the defendant] to the FDA – is confidential and not available to the public.

Id. at *4 (relying on dissent in Sprint Fidelis).  Instead, plaintiff gets “cabined” discovery in order to engage in a pure fishing expedition to “explore” whether there’s anything she can gin into a regulatory violation:

[Plaintiff] is entitled to a brief and strictly-cabined period of discovery in order to determine the terms of [defendant’s] IDE, and to explore whether or not the specific device used in her procedure was manufactured in accordance with the IDE.

Id. at *5.

Feh.

“Cabined discovery”…. Let’s see, where have we heard that phrase before?

Oh, right.  That’s what the plaintiffs claimed they should get in Ashcroft v. Iqbal, 129 S. Ct. 1937 (2009), because – surprise, surprise – the government defendants were also engaged in secret conspiracy to violate the law.  The Supreme Court said “no,” no discovery before actually pleading a claim:

We decline respondent’s invitation to relax the pleading requirements on the ground that the Court of Appeals promises petitioners minimally intrusive discovery. . . .  Because respondent’s complaint is deficient under Rule 8, he is not entitled to discovery, cabined or otherwise.

Id. at 1953-54 (emphasis added).

So there you have it – the spectacle of a plaintiff being allowed in Burgos to get exactly what the Supreme Court held in Iqbal she was “not entitled” to.

Sure, courts thumb their noses at Supreme Court precedent they don’t like all the time, but rarely do they do so in such a blatant fashion.

Another Medtronic Preemption Win

It's not a complete win, but 8 out of 9 ain't bad.

In Kinetic Co. v. Medtronic, Inc., No. 08-CV-6062, slip op. (D. Minn. April 19, 2011), a third-party payer filed suit over a recalled implantable cardiac defibrillator ("ICD").  In a classic example of "no good deed goes unpunished," after Medtronic went above and beyond the terms of the recall, by both withdrawing the device from the market and offering to pay patients to replace it, and got sued by the TPP plaintiff for not also paying it - in other words, for not paying for everything twice because the TPP never sought to get the money that Medtronic paid patients.  Ironically, the TPP's double-dipping claim was all that survived.

That's because Medtronic won - yet again - on preemption, and on judgment on the pleadings (meaning no discovery expense).  In so doing it effectively wiped from the books one of the worst pre-Riegel preemption decisions around, In re Medtronic, Inc. Implantable Defibrillators Litigation, 465 F. Supp.2d 886 (D. Minn. 2006), against which we railed in one of our earliest posts.  See Kinetic, slip op. at 3 n.3 (refusing to give earlier Medtronic case collateral estoppel effect because of subsequent, controlling preemption authority).

Most of the TPP's claims were the same sorts of claims we've seen in similar suits across the country.  TPP claims are nothing if not redundant.  Here, they were:  (1) false advertising, (2) deceptive trade practices, (3) consumer fraud under Minnesota law, (4) consumer fraud under every other state's law, (5) unjust enrichment, (6) breach of express warranty, (7) breach of implied warranty, (8) breach of "assumed" contractual obligation, and (9) misrepresentation by omission.  Slip op. at 2-3.

Number eight was the only claim that survived.  The others were various ways of repackaging claims that the defendant should have changed its warnings about the device in some way not required by the FDA.  That kind of claim was blatantly preempted under Riegel and Sprint Fidelis, because "different from or in addition to" means what it says.  Slip op. at 6-7.  Since the TPP "admits that there is no federal requirement to disclose this information," express preemption followed as a matter of course.  Id. at 6.

The TPP complaint also contained some vague allegations that some sort of misrepresentations were made to the FDA.  But that didn't work because there's no independent state duty to make truthful statements to federal agencies - thus the claim was a bare FDCA violation claim that went down under Buckman:

But to avoid being impliedly preempted under Buckman, a claim must rely on traditional state tort law which had predated the federal enactments in question.  In other words, the conduct on which the claim is premised must be the type of conduct that would traditionally give rise to liability under state law - and that would give rise to liability under state law even if the FDCA had never been enacted.  Obviously, a claim premised on a defendant’s violation of an FDA regulation requiring that information be reported to the FDA is not a claim that would give rise to liability under state law even if the FDCA had never been enacted.  It is, instead, simply an attempt by private parties to enforce the MDA - an attempt that is preempted under Buckman.

Slip op. at 6-7 (citations and quotation marks omitted).  It's a really good quote, so remember and use it.  The court pithily summarized the Buckman half of "parallel" claims - that there must be something in state law for the purported violation claim to be parallel to, otherwise it's just a prohibited attempt at private FDCA enforcement.

The warranty claims go the same way, since - as usual - they're not based on anything specific, but only on general allegations that a device is "safe" - which would require a jury to find the opposite - which runs straight into a preemption brick wall.  Slip op. at 7-8.

Plaintiff also made the "I need discovery" pitch, but not very well.  Since the TPP claims didn't even come close to avoiding preemption, the plaintiff was not entitled to raise the nuisance value of the case by putting the defendant through the cost of discovery.  Another good quote coming:

[Plaintiff] misunderstands the purpose of discovery.  A plaintiff is permitted to take discovery to find evidence to support a properly pleaded claim for relief; a plaintiff is not permitted to take discovery to fish for claims of which it is not aware.  Because the misrepresentation, express-warranty, and unjust-enrichment claims pleaded by [plaintiff] are clearly preempted . . ., [plaintiff] is not entitled to take discovery on those claims.

Slip op. at 8.

Thus there's good law on parallel claims, express warranty, and discovery all in the same case.

As we mentioned above, the only thing left was the TPP's attempt to punish the defendant for voluntarily doing more than the law required it to.  But the TPP's "pay twice" claim isn't preempted (the only basis of the motion) because it doesn't relate to anything the FDA required the defendant manufacturer to do:

[Plaintiff] is alleging that [defendant] promised patients in whom the devices had been implanted that [defendant] would pay certain costs associated with removing and replacing the devices.  [Plaintiff] apparently alleges that, by not making such payments to third-party payors (such as [plaintiff]), [defendant] breached the promise that it made to patients.  At oral argument, [defendant] conceded that [this claim] has nothing to do with the safety or effectiveness of the devices and thus is not preempted.

Slip op. at 9.

Still, we don't think the "pay twice" claim ultimately goes anywhere, because either the TPP has a contractual right to get moneys paid to its subscribers back or it doesn't.  Either it hasn't exercised an existing contractual right, in which case the TPP should lose, or it doesn't have the right, in which case the TPP has no basis for claiming to be a third-party beneficiary.

It's another nice preemption win for Medtronic, that we all can use to our advantage.  We can only hope that the rest of us don't screw up the good law that Medtronic keeps making.