Call It Standing

While it remains true that our role in bringing about the Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001), preemption decision is probably the highlight of our (read Bexis’) legal career to date, sometimes there may be reasons when we don’t want to rely upon the Buckman Court’s preemption-based analysis for why no private Food, Drug & Cosmetic Act (“FDCA”) rights of action exist:

[W]e have clear evidence that Congress intended that the MDA be enforced exclusively by the Federal Government. 21 U.S.C. § 337(a). . . .  We must also reject [Plaintiffs’] attempt to characterize both the claims at issue in [Lohr] (common-law negligence action against the manufacturer of an allegedly defective pacemaker lead) and the fraud claims here as claims arising from violations of FDCA requirements.  Notwithstanding the fact that [Lohr] did not squarely address the question of implied pre-emption, it is clear that the [Lohr] claims arose from the manufacturer's alleged failure to use reasonable care in the production of the product, not solely from the violation of FDCA requirements.  In the present case, however, the fraud claims exist solely by virtue of the FDCA disclosure requirements.  Thus . . . [Lohr] does not and cannot stand for the proposition that any violation of the FDCA will support a state-law claim.

Buckman, 531 U.S. at 352-53 (there are too many Medtronic-related preemption decisions, so we preferentially use the plaintiff's name).

One reason for downplaying the Buckman angle is that some courts give more than lip service to the “presumption against preemption” that briefly saw its moment in the sun in Wyeth v. Levine, 555 U.S. 555 (2009), before being consigned to 4-4 limbo in PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011).  Another reason is that, particularly in state court, some judges simply react poorly (from our perspective) to arguments denominated as “preemption.”

Thus, we’d like to point out that the §337(a) proposition − that private causes of action to enforce claimed FDCA violations are barred − can be advanced just about as effectively under the rubric of “standing” as it can under the rubric of preemption.  The United States Supreme Court, for one, has said so.  E.g., Federal Election Com’n v. National Conservative Political Action Committee, 470 U.S. 480, 486-88 (1985) (“exclusive” agency enforcement authority means that private parties “do not have standing to bring a private action against another private party” under statute).

More importantly − especially in state court − is that in any given state, there’s probably also going to be precedent that plaintiffs have no “standing” to claim violations of statutes generally (that is, non-FDCA cases) that don’t permit private rights of action.  For the heck of it, we’ll take a stab at our home state of Pennsylvania….

OK., we’re back.  That didn’t take long.  The very first case our search brought up makes the desired point.  It involves a contract claim predicated on a violation of some “Nonprofit Law” that doesn’t allow private rights of action.  The Pennsylvania Supreme Court held last year:

[Defendant] contends [plaintiffs’] claim fails because a party cannot do indirectly what it cannot do directly; thus, appellants cannot base a breach of contract claim on an alleged Nonprofit Law violation when the Nonprofit Law does not provide for a private cause of action.  [Defendant] also claims [plaintiffs’] incorporation argument fails as the entire Nonprofit Law, including [its] standing provisions, would be incorporated into the contract. . . . We find [plaintiffs] lack standing to pursue a common law breach of contract claim in this case.

Petty v. Hospital Service Ass'n of Northeastern Pennsylvania, 23 A.3d 1004, 1013 (Pa. 2011) (emphasis added).  There are probably several other Pennsylvania cases for the same proposition in that search, which pulled up 25 cases, but we stopped with the first one since we don’t really care what the particular state statute is.  Our point is that it’s relatively easy to find state-law precedent for the proposition that, in the absence of a private right of action, private plaintiffs lack “standing” to claim statutory violations.

With that proposition established in any given state, than the question becomes, what standing precedent is there specifically concerning the FDCA?

Glad you asked.

We’re happy to help.  Here are some cases we’ve found (some pre-Buckman) that use the §337(a)’s prohibition against private enforcement as the jumping off point for a conclusion that private plaintiffs claiming FDCA-related violations of whatever sort simply lack standing to assert those claims.  Murungi v. Touro Infirmary, 2012 WL 1014811, at *2 (E.D. La. March 21, 2012) (“No private right of action exists under . . . the FDCA, and Plaintiff lacks standing to bring those claims”); Enzymotec Ltd. v. NBTY, Inc., 2011 WL 2601500, at *6 (E.D.N.Y. June 29, 2011) (plaintiff “cannot gain . . . standing by attempting to privately enforce the FDCA”); Stengel v. Medtronic, Inc., 2010 WL 4483970, at *3 (D. Ariz. Nov. 9, 2010) (“§337(a) makes clear that the United States is the only party that has standing to bring such a claim”); Conger v. Danek Medical, Inc., 27 F. Supp.2d 717, 720 (N.D. Tex. 1998) (“plaintiffs would have no standing to assert that defendants engaged in a conspiracy to violate the FDCA because the statute does not provide for a private right of action”); In re Orthopedic Bone Screw Products Liability Litigation, 1997 WL 186325, at *10 (E.D. Pa. April 16, 1997) (same); Martinez Caraballo v. Intermedics, Inc., 886 F. Supp. 974, 979 (D.P.R. 1995) (given the language of §337(a), “plaintiff does not have standing to enforce FDA regulations”); Ginochio v. Surgikos, Inc., 864 F. Supp. 948, 957 (N.D. Cal. 1994) (because no private FDCA right of action exists “summary judgment on the ground of no standing by plaintiff to bring a cause of action to enforce the Food, Drug, and Cosmetic Act is granted”).

So the next time your client is faced with a plaintiff that’s making noise about purported FDCA violations, consider whether it might be useful to raise a "standing" argument in addition to the more usual response that such attempts at private FDCA enforcement are preempted under Buckman.

Oh, yes, and if you win the argument, be sure to let us know.

A Pro-defense Decision – Good for the Digestion

            As an openly defense-oriented blog, most of our posts deal with cases in which plaintiffs could not make out their claims.  They didn’t have sufficient evidence of a design defect.  They couldn’t prove proximate causation.  That type of thing.  But, what if plaintiff’s claim is that the defendant can’t prove its claim about its product?  Well, in California, you can’t do that. 

            That was the issue addressed by the court in Stanley v. Bayer Healthcare LLC, 2012 U.S. Dist. LEXIS 47895 (S.D. Cal. Apr. 3, 2012).  Plaintiff’s doctor recommended she take probiotics to help relieve the diarrhea she had been experiencing as a result of her diverticulitis.  Based on her pharmacist’s recommendation, plaintiff purchased Phillips’ Colon Health Probiotic Caps (“PCH”), which contained the following statement: “Helps Defend against Occasional DIARRHEA.”  She used the product for about a week without any relief.  She filed a consumer fraud class action complaint one week later.  Id. at *2-4.  Seems to be curious timing, but we’ll refrain from further comment on that.  Because, despite the quick filing of the suit, plaintiff had almost a year to develop her allegations and theories – without success.

            Attempting to state a claim under California’s Consumer Legal Remedies Act (“CLRA”) and Unfair Competition Law (“UCL”), plaintiff alleged that defendant’s statements about the digestive and health benefits of PCH were false and misleading because defendant had “a complete lack of scientific or clinical data to support its claims,” and defendant “fail[ed] to provide the consumer with a single bit of information that would support its claims about the benefits of the [PCH],” and defendant’s claims “are not substantiated by the vast majority of generally accepted scientific literature.”  Id. at *5.   Putting aside whether plaintiff could prove any of those allegations, she had a bigger problem – California doesn’t recognize a private cause of action for failure to substantiate an advertising claim:

Private individuals may not bring an action demanding substantiation for advertising claims. Instead, pursuant to Cal. Bus. & Prof. Code § 17508, only prosecuting authorities may require an advertiser to substantiate its advertising claims.

Id. at *9 (citations omitted).  See National Council Against Health Fraud, Inc. v. King Bio Pharmaceuticals, Inc., 107 Cal. App. 4th 1336, 1344 (2003) (“[p]rosecuting authorities, but not private plaintiffs, have the administrative power to request advertisers to substantiate advertising claims before bringing actions for false advertisement ....”).

Faced with this clear statement of the law, plaintiff acknowledged that a claim based on lack of substantiation wasn’t actionable, but then responded to defendant’s motion for summary judgment on this ground by arguing that defendant failed to substantiate its claims.  Stanley, 2012 U.S. Dist. LEXIS 47895, at *12.  Huh?  If you are shaking your head in confusion, so are we and apparently so was the court:

Plaintiff argues at length both in her motion for class certification and in opposition to the summary judgment motion that Defendant's claims regarding the general digestive and immune system health benefits of PCH are actually false because they lack proper scientific substantiation. However, the alleged lack of substantiation does not render claims false and misleading under the UCL or CLRA.

Id. at *12.  Plaintiff’s expert evidence suffered from the same fatal flaw – none of plaintiff’s experts opined that defendant’s statements about the product’s benefits were “actually false, or explain[ed] how those statements might mislead a reasonable consumer.”  Id. at *15-16.  Rather, they focused on an alleged lack of substantiation – for which there is no private cause of action.

 

            Apparently waking up to the reality of having targeted a non-actionable claim, at the time of the class certification and summary judgment hearing, plaintiff argued for the first time that she could maintain her action under the “unlawful conduct” arm of the UCL.   The alleged unlawful conduct was defendant’s failure “to properly substantiate its claims pursuant to standards set by the FDCA.”  Id. at *19.  The court had several reasons for discounting plaintiff’s “unlawful conduct” argument, including that it raised issues regarding preemption that would have required briefing and that it was still essentially a lack of substantiation claim.  Id.  But the court examined the underlying evidence anyway, which didn’t further plaintiff’s cause. 

            Under the Dietary Supplement Health and Education Act of 1994 (“DSHEA”), manufacturers of dietary supplements, which PCH is, are allowed to make certain “structure/function claims” without pre-approval by the FDA.  Id. at *21.  Structure/function claims are statements that

describe[] the role of a nutrient or dietary ingredient intended to affect the structure or function in humans or that characterize[] the documented mechanism by which a nutrient or dietary ingredient acts to maintain such structure or function.

Id.  (quotation marks omitted).  A dietary supplement manufacturer must provide notice to the FDA within 30 days of first use of a structure/function claim, and must include a disclaimer on the label stating that “the FDA has not evaluated the claim and that the product is not intended to diagnose, treat, cure or prevent any disease.”  Id. (citations and quotation marks omitted).

            Plaintiff’s experts, therefore, attempted to opine that the statements on the PCH labeling were health claims – which require more rigorous substantiation -- not structure/function claims.  However, plaintiff’s experts had to admit that they didn’t know how the FDA defines a health claim.  To which the court had this to say:

Plaintiff cannot create a genuine issue of material fact regarding whether Defendant met the level of substantiation required under federal law by presenting opinions from experts who are not aware of the relevant regulatory standards.

Id. at *23.  We certainly like the sound of that.

            Plaintiff tried a few other avenues to attempt to save her claim, but they proved to be as full of potholes as the lack of substantiation claim:

• The product didn’t work for me – OK, but “nothing on the PCH box, internal packaging, or advertisement represents to consumers that the product is intended to relieve diarrhea. The fact PCH did not relieve Plaintiff's diarrhea does not mean a reasonable consumer would be mislead into believing it would work as Plaintiff suggests. The Plaintiff has failed to produce any evidence that the product does not work for the purposes for which it is advertised - to promote overall digestive health and to defend against occasional diarrhea and other gastrointestinal issues.”  Id. at *24.

• They didn’t tell me I had to take it continuously – But the packaging said:  “Daily Probiotic Supplement” and the label directs that PCH is “to be taken Daily or Everyday to support digestive health.”  So, “what additional material fact [did] Defendant [have] an affirmative duty to disclose?”  The court agreed that plaintiff left that question unanswered.  Id. at *27-28. 

• A different size bottle of PCH that I didn’t buy contained a statement that I didn’t rely on about scientific studies that I allege is misleading – The court’s conclusion is self-explanatory:  “There is no evidence Plaintiff . . .ever saw the [statement].  Thus, the statement cannot form the basis of Plaintiff's false advertising claim.”  Id. at *30. 

So, no private cause of action for lack of substantiation plus no evidence to prove any statement was false or misleading equals no class action.   Toss in the good expert sound bites and this case certainly sits well in our stomachs. 

Not Health Insurance

The class action lawyers must be getting desperate, if Reeves v. Pharmajet, Inc., 2012 WL 380186 (N.D. Ohio Feb. 3, 2012), is any indication.  In one fell swoop, this plaintiff sought:  (1) to take over enforcement of the Food, Drug and Cosmetic Act (“FDCA”) from the FDA, and (2) turn product liability into a form of health insurance with attorneys’ fees.

A bit of background – the defendant’s product is a really cool way of injecting vaccines without the need for needles (millions of little kids, and their parents, will be eternally grateful), and also without the infection potential inherent in needles.  See Riley v. Becton Dickinson Vascular Access, Inc., 913 F. Supp. 879 (E.D. Pa. 1995) (one of Bexis’ first medical device cases).  We don’t claim to understand all the technology, but the device uses some sort of spring-loaded form of jet injection to push vaccines and other medicines directly through the skin.  Anyway here’s a background article, if anyone’s interested.
The injector was FDA-cleared, but unfortunately most vaccines (other entities' products) were labeled only for needle injection.  Thus, using the defendant’s product was a different “method of administration,” making it – GASP! – an off-label use.  In October, 2011, the FDA issued two “communications” – only the “updated” one is still on the website, here – stating that the manufacturers of the vaccines had not studied this new form of injection.  See 2012 WL 380186, at * 2 (discussing FDA communique).  It was typical FDA-speak . The Agency did not suggest that there was anything wrong with the new technology, only that “[d]ata to support the safety or effectiveness of inactivated influenza vaccines delivered by jet injector have not been submitted to FDA.”  Indeed, the FDA specifically stated (twice) that there was no reason for anybody to get vaccinated a second time:

Based on limited information from recent publications using currently licensed inactivated influenza vaccines, FDA and the Centers for Disease Control and Prevention (CDC) believe that it is not necessary for people who received their influenza vaccine via jet injector to be re-vaccinated.

Doctors, of course, are perfectly free to use any medical device they want off-label.  21 U.S.C. §396.  The FDA admitted that what studies there were showed “comparable” effectiveness – but those studies were, of course, limited.

As far as we can tell from the opinion (since none is mentioned), the defendant never received so much as a warning letter from the FDA.

Didn't matter.  Within days, a putative class action gets filed under – of course – the local consumer protection statute (this time, Ohio’s).  Reeves, 2012 WL 380186, at *2.  The plaintiff alleged he got a flu shot with jet injection.  The class itself was far more ambitious – seeking to apply the Ohio statute extraterritorially, to every person in the country who got any medication (not just a flu shot) through jet injection.  The would-be class consisted of:

all other persons similarly situated, throughout the United States, who are domociled [sic] in one of the fifty states, including Ohio, and who are consumers who received ANY vaccine or drug with a PharmaJet injector device where the specific vaccine or specific drug does not have the stated approval by the FDA for administration with a “needleless injector” or “needle-free injector,” also know [sic] as “jet injectors”.

2012 WL 380186, at *1 (N.D. Ohio Feb. 3, 2012) (emphasis added).

The relief sought was not quite as impressive – but equally overreaching.  “Plaintiff seeks the establishment of a national prospective clinical study of all people who received a flu shot via jet injection.”  Id. at *2. Anybody who caught the flu (other vaccines/drugs seemed to fall by the wayside) would receive medical monitoring monthly (the Ohio Supreme Court has never recognized medical monitoring in any context – let alone as a remedy for consumer fraud).  Essentially, the plaintiffs demanded free insurance, from the injector manufacturer, even though the vaccines themselves are nowhere near 100% effective – 75% at best, according to the Centers for Disease Control.

On top of all that, nothing in the complaint alleged that the purported class representative ever came down with the flu. 2012 WL 380186, at *1.  Can you say "atypical" (the court didn't, as it never had to reach certification issues)?

Fortunately, this monstrosity never made it past the starting gate.  The court granted the defendant’s motion to dismiss.

First, the court saw the action for what it was – a prohibited attempt by private plaintiffs to enforce the FDCA:

The FDCA, however, does not provide a private right of action for violation of federal regulations. As set forth in the FDCA. . . .  [T]he absence of a private right of action to enforce the FDCA means not only is a private party precluded from bringing suit to enforce the provisions of the FDCA, they also may not use other federal statutes or state unfair competition laws as a vehicle to bring a private cause of action that is based on violations of the FDCA.  Thus, a private litigant cannot bring a state-law claim against a defendant when the state-law claim is in substance (even if not in form) a claim for violating the FDCA – that is, when the state claim would not exist if the FDCA did not exist.

2012 WL 380186, at *4 (citations and quotation marks omitted).  This is as fine a statement of the no private enforcement principle as we’ve seen anywhere.

Despite the FDA’s lack of any enforcement activity (or even a revaccination recommendation), plaintiff claimed to be bringing a “parallel” claim under Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996).  The court held otherwise, finding the claims to be “squarely within the parameters” of Buckman Co. v. Plaintiff’s Legal Committee, 531 U.S. 341 (2001), because the claims were 100% dependent upon the alleged FDCA violations, and thus impliedly preempted.  2012 WL 380186, at *4.

Sometimes really bad cases (defining “bad” as “meritless”) can make really good law.

And there’s more.

Reeves also found no valid claim under state law.

Plaintiff tried to package his FDCA claim as a consumer protection action – but not very effectively.  For one thing, the Ohio statute (like many others) has a reliance/causation component to it.  The purported off-label promotion statements were on the defendant’s website – that the plaintiff never visited.  Of course, the plaintiff didn’t plead any sort of reliance, because that would tank any chance of class certification.

So the plaintiff ended up tanking his substantive claim instead:

Whether it be termed an issue of reliance or an issue of proximate cause, an appropriate rule is that where the defendant is alleged to have made material representations or misstatements, there must be a cause and effect relationship between the defendant's acts and the plaintiff's injuries.

Reeves, 2012 WL 380186, at *5 (citation and quotation marks omitted).  The only advertising concerning jet injection that the plaintiff actually saw before getting vaccinated was by the store where the vaccine was offered, not by the defendant.  Id. at *6.

As the coup de grace, the court also held that prescription medical devices were not “consumer goods” as required by the statute.  “[Defendant’s] prescription medical device is not a good for personal, family or household use and thus is not a consumer good as defined by the [Ohio Act].”  Id. at *6 n.2.

This last proposition is of particular interest, as many other (but not all) consumer protection statutes contain a similar “consumer” limitation.  Reeves thus adds to this list of cases finding prescription drugs or devices not to be “consumer” goods covered by such statutes:  Williams v. Purdue Pharma Co., 297 F. Supp.2d 171, 174-175 (D.D.C. 2003); Herzog v. Arthrocare Corp., 2003 WL 1785795, at *10 (D. Me. 2003); In re Minnesota Breast Implant Litigation, 36 F. Supp.2d 863, 876 (D. Minn. 1998); Goldsmith v. Mentor Corp., 913 F. Supp. 56, 63 (D.N.H. 1995); Kemp v. Pfizer, Inc., 835 F. Supp. 1015, 1024 (E.D. Mich. 1993) (applying Minnesota law); Kanter v. Warner-Lambert Co., 122 Cal. Rptr.2d 72, 86 (Cal. App. 2002); Stein v. Sonus USA, Inc., 2005 WL 6198234 (Ariz. Super. Sep. 8, 2005), aff’d, 150 P.3d 773 (Ariz. App. 2007).

Thanks to Dustin Rawlin of Tucker, Ellis & West for both winning the case and tipping us off.

Many Happy Returns

Today is Boxing Day, when we, along with millions of other Americans, scamper off to the Mall to return those Christmas presents that just didn't quite fit (physically or spiritually or aesthetically) our needs. So buh-bye jelly-of-the-month club (we're diabetic), Hello Kitty lounge pants (wrong size), Three Stooges talking bottle-opener (we love hearing "nyuck, nyuck, nyuck" whilst popping the top off a Yuengling, and that's why we already have one), and the boxed DVD set of all the episodes of Punky Brewster (like we said, we're diabetic).

We wish we could take back some of the crummier cases we saw this year, and exchange them for something better. Luckily, something like that happened with one of the cases that made it onto last week's Ten Worst list. We bemoaned Lefaivre v. KY Pharmaceuticals Co., 636 F.3d 935 (8th Cir. 2011), for permitting an improper private FDCA violation claim to go forward. More recently, a subsequent iteration from that litigation suggests the claims won't go very far forward, because there is no ascertainable loss. In Polk v. KV Pharmaceuticals Co., 2011 WL 6257466 (E.D. Mo. Dec. 15, 2011), the same basic claim was dismissed pursuant to Fed. R. Civ. P. 12(b)(6). The plaintiffs filed a putative class action, alleging that they had used Metoprolol Succinate tablets, and had gotten less than they expected because the FDA found that the defendants were not in compliance with current good manufacturing practices. That FDA finding means that the tablets were "adulterated" within the meaning of 21 U.S.C. section 351(a)(2)(B).

The plaintiffs tried to rely on the Consent Decree entered into between the defendants and the FDA. But in the Consent Decree preamble the parties disclaimed liability, The plaintiffs argued that the disclaimer was "inconsequential" and that the findings in the Consent Decree provided evidence of liability. The court disagreed and concluded that the Consent Decree contained "only allegations that were neither admitted nor denied by Defendants as well as the express denial of liability by the Defendants." 2011 WL 6257466 at *4. Therefore, the Consent Decree was evidence of nothing except that a settlement was reached between the defendants and the FDA. So far so good.

And it's about to get better. The plaintiffs' central claim is that the medication was worth less than what they paid for it, in light of the adulteration. But there was no evidence that the tablets posed any health risk to consumers. The court then followed the reasoning of Myers-Armstrong v. Actavis Totowa, LLC, 2009 WL 1082026 (N.D. Cal. April 22, 2009), a case we applauded here. Noncompliance with good manufacturing practices is insufficient in the face of no actual "manifestation of a defect that results in some injury or rational fear of injury" to state a cognizable claim. 2011 WL 6257466, quoting Myers-Armstrong. Put simply, there's no evidence that "adulteration" equals ascertainable loss. Therefore, the claims under both the Missouri consumer protection statute and breach of warranty fail.

The Polk case is like finding another present under the tree after you thought you were all done. Or it's like taking back that weird "The Scream" inflatable and exchanging it for something serviceable and solid, like a Yellow Submarine ice cube tray, or a nice, pro-defense ruling.

Twice Nice?

Every now and then there’s a piece of litigation that boldly goes where no court has gone before and opens up a host of new legal issues.  Bone Screw was like that, with plaintiffs inventing new causes of action (fraud on the FDA and regulatory informed consent) and our side having to invent new defenses.  We also felt that way while we were involved in the Fagan v. AmsourceBergen litigation involving the then novel concept of liability of non-counterfeitors for injuries caused by counterfeit drugs.

We’ve just seen another opinion, Kapps v. Biosense Webster, Inc., ___ F. Supp.2d ___, 2011 WL 4470701, slip op. (D. Minn. Sept. 27, 2011), that makes us feel the same way.  We can’t recall ever seeing an opinion previously that addressing liability issues in the context of a reprocessed medical device that allegedly failed due to defects introduced by the reprocessing.

Kapps involves something analogous to the aftermarket for automobile parts, only in the medical device field.  The product, a heart catheter, was originally manufactured as a single-use product – expressly stated in the product’s original labeling.  2011 WL 4470701, at *3.  Apparently the FDA has chosen not only to tolerate, but to affirmatively allow the particular type of off-label use:  the reprocessing and reuse of products whose labeling is limited to single use.  Id. at *5-6 (describing FDA regulation of reprocessing/reuse of single-use devices).  After being completely relabeled and refurbished according to relevant FDA regulations, the heart catheter was reused and broke inside the plaintiff’s heart.  Id. (refurbishing changed the device’s serial number, and replaced its labeling with its own).  Plaintiff sued both the aftermarket and original equipment manufacturers.

The 68-page Kapps opinion raises, and in some cases decides for the first time, many fascinating issues.

Futile Dear Doctor letters:  In a claim analogous to what we’ve been seeing post-Mensing against generic drug manufacturers (indeed, the court references generic drugs explicitly, 2011 WL 4470701, at *24), the plaintiff claimed that the original manufacturer should have issued a Dear Doctor letter warning against use of reprocessed products.

The court assumed a duty and then assumed that such a letter was permissible under FDA regulations – but still blew out the claim.  There was no possible causal effect in warning heart surgeons to be especially careful during heart surgery:

[I]f a plaintiff's proposed warning would not have changed anyone’s behavior, a product cannot be defective for lacking that warning.  Would a doctor who is manipulating a catheter inside a patient’s heart near the mitral valve become more careful if he read a warning saying, “Be careful not to get this catheter trapped in the mitral valve”?  Surely doctors know, based both on their training and on common sense, that they must be “very careful” when manipulating an instrument inside a human heart.

2011 WL 4470701, at *24.  Whoop!  Whoop!  Common sense alert!

There was also “not a shred of evidence” that this kind of content-free advice would have changed the result, id., particularly since, after learning the hard way the very information the Dear Doctor letter would have provided, the surgeons in question hadn’t changed their behavior in any way.  Id. at *25.

Regulatory informed consent asserted against a manufacturer. Say what?  We've seen plaintiffs sue doctors claiming that they wouldn’t have consented to a treatment if they knew it was off-label.  That’s one of the claims we killed in Bone Screw.  In Kapps, however, the plaintiff tried to turn the same argument on a manufacturer, claiming that since the prescriber testified he wouldn’t have used the product had he known there was no FDA approval (this argument assumes that minor modifications = unapproved), then the learned intermediary rule gives him a cause of action against the manufacturer.  2011 WL 4470701, at *20.

Umm....  No it doesn't.

First we find a ringing endorsement of the learned intermediary rule as a shield, not a sword:

The learned-intermediary doctrine is a defensive doctrine, not an offensive one.  It is raised by makers of drugs or medical devices who are accused of failing to warn about the dangers associated with their products.

2011 WL 4470701, at *20.  The court follows with equally good language about the limits of the duty to warn under the rule:

A manufacturer does not have a duty to communicate any and all information that might affect a customer’s decision to use one of its products.  For example, a manufacturer does not have to communicate that the product was made with child labor or that the manufacturer’s president has been convicted of fraud, even though such “warnings” might induce customers not to use the product.  The duty to warn is much narrower . . . .:  (1) The duty to give adequate instructions for safe use; and (2) the duty to warn of dangers inherent in improper usage.  [Defendant’s] alleged failure to warn that its reprocessing techniques had not been approved by the FDA breached neither of these duties.

Id. (citation and quotation marks omitted) (emphasis added).  We love it when FDA-regulatory-status claims get dismissed.

Buckman-FDCA private right of action.  In a unique setting, plaintiffs challenged the reprocessor’s decision to “extend” its line of reprocessed products to include the catheter in question by means of a “minor modification” procedure (it wasn't one of the 68 that the FDA actually approved for reprocessing).  We’ve always had some liability worries about the minor modification process, where the device manufacturer decides to act, essentially unilaterally, by means of its own memo to file.  The court refused to allow the claim, first finding that approval-related violations couldn’t possibly prove a tort:

Whether [defendant’s] reprocessing procedures damaged the failed catheter is an entirely separate question from whether [it] sought FDA approval for those procedures through the proper route.  That is, even if [defendant] had received 510(k) approval for reprocessing [the] catheters, [it] could still be liable for selling a defective . . . catheter if, in reprocessing a particular catheter, [defendant] damaged the catheter and rendered it defective.  And, conversely, if [defendant] did not damage a catheter during reprocessing, then even if [it] should have sought 510(k) approval for its reprocessing procedures, [its] failure to seek such approval would not render an undamaged catheter defective.

2011 WL 4470701, at *19. This is an important point, since practically any claim founded on a “you didn’t get the right FDA approval” argument will fail under the same analysis.  The court went on to hold that allegations of misuse of the minor modification procedure were nothing more than an improper attempt to enforce the FDCA despite its lack of a private right of action.  Id.

Meeting a similar fate is an alleged duty to warn doctors about the purported FDA lack of approval.  Such a warning has nothing to do with a state-law tort claim, but rather is “superfluous,” since if the product was defective, no FDA regulatory status warning could save the manufacturer, and if it’s not defective, then the FDA regulatory status couldn't create liability.  2011 WL 4470701, at *21.

Negligence per se. You can’t have negligence per se under the FDCA unless there’s an analogous state law claim.  We’ve harped on this, so we’re always pleased to encounter additional supportive precedent.

In a negligence per se case, the plaintiff seeks to hold the defendant liable because the defendant violated a statute.  And that is why a claim of negligence per se cannot be based on a violation of the FDCA . . . .  [T]o avoid preemption under Buckman, a state-law tort claim must be premised on 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.  A negligence-per-se claim that is predicated on an alleged violation of the FDCA is, by definition, a claim that would give rise to liability under Minnesota law only because of the FDCA’s enactment.  Such a claim is preempted under Buckman.

2011 WL 4470701, at *19.  The context may be new, but the principle isn’t.  Approval-based claims can’t be negligence per se because they’re a form of licensing claim, and tort law has nothing to do with licensing.

Warning claims in a reprocessing situation:  The opinion offers some interesting dictum that, since the reprocessor had removed the original manufacturer’s warnings and substituted its own, the reprocessor had “usurped” the manufacturer’s “function” and any prior failure to warn would be non-causal:

[I]f [plaintiff’s] claim depended on an argument that [defendant] negligently failed to include certain warnings in its instructions for use, [that] warning-defect claim against [defendant] would fail for lack of causation:  [Plaintiff’s] damages could not have been caused by the omission of a warning from [defendant’s] instructions for use, because [the reprocessor] replaced [the manufacturer’s] instructions with its own, and thus [the original] instructions did not accompany the catheter that injured [Plaintiff].

2011 WL 4470701, at *23.

Nor was the original manufacturer obliged to warn that reprocessing was dangerous.  The label already explicitly stated that the devices were intended for single use only:

Even if it is true that reprocessing renders [defendant’s] catheters unsafe, the Court finds, as a matter of law, that in light of the fact that [defendant] warned doctors not to use reprocessed catheters at all, [it] had no duty to emphasize that it was serious about its warning or to elaborate on the reasons for its warning.

2011 WL 4470701, at *25.  More common sense.

Can someone become a manufacturer by estoppel?  The reprocessor gave its own manufacturer’s warranty and had marketing materials in which it stated “legally and practically, we are the manufacturers of our reprocessed and remanufactured devices.”  2011 WL 4470701, at *4.  Even though the reprocessor claimed that it only provided a service, and had contracts to that effect, the court held that it could be considered a manufacturer for purposes of strict liability:

[S]everal aspects of [the reprocessor’s] business strongly suggest that it should be treated as a manufacturer.  First, [it] removed [the manufacturer’s] instructions for using the . . . catheter and substituted its own instructions. . . .  Second, [the reprocessor] removed [the manufacturer’s] lot number from the catheter, thus preventing subsequent users from learning about the catheter’s manufacturing history.  Third, [the reprocessor’s] entire marketing strategy depended on convincing customers that devices reprocessed by [it] were exactly equivalent to, and perfect substitutes for, devices made by original equipment manufacturers. . . .  Fourth (relatedly), [the reprocessor] warranted the functionality of the catheter. And finally, [the reprocessor] tells doctors that “legally and practically, we are the manufacturers of our reprocessed and remanufactured devices.”

Id. at *30. If it quacks like a duck, it’s a duck.  We don't begrudge the plaintiff this one.

The expert who didn’t do his homework.  The court blew out most of a really horrible expert report.  The expert invented some pretty wild hypotheses about a smear of polyurethane glue on the recovered part of the product, but didn’t bother to learn anything about polyurethane or how it interacted with the chemicals useds in reprocessing.  There’s nice “ipse dixit” language.  2011 WL 4470701, at *16.  Ultimately some of the expert’s testimony was allowed in support of a res ipsa manufacturing defect theory – which, since oftentimes an expert’s testimony isn’t needed at all – is just about the lowest and worst use of an expert.  Id. at *18.

Punitive damages:  Reprocessing a single use medical device isn’t enough to support a punitive damages claim, since the FDA allows this to be done:

Given that the FDA regulates the medical-device-reprocessing industry and [finds benefit to reprocessing], the fact that [defendant] reprocesses catheters that [the original manufacturer] markets for a single use cannot be a basis for awarding punitive damages.

2011 WL 4470701, at *33.  We like decisions that find FDA regulatory approval preclusive of punitive damages.  Nor was a mere “regulatory mistake” (plaintiff’s attack on the minor modification process) anything suggesting “deliberate disregard” for patient rights.  Id. We like that even better.

Res ipsa: You can’t bring a res ipsa claim against the original manufacturer of a reprocessed medical device, because the reprocessing and reuse, contrary to labeling, are an obvious other cause for any post-reprocessing malfunction.  2011 WL 4470701, at *22.

Heeding presumption:  Minnesota doesn’t recognize a heeding presumption, but in any event, warning someone to be careful, when they probably already are, doesn’t show any different result whether the warning is heeded or not.  2011 WL 4470701, at *25 n.22.

Some of the issues in Kapps are completely novel.  None of them have (as far as we know) been raised in the context of the reprocessing of single use devices.  For this reason, Kapps should be required reading for anyone defending a case involving a reprocessed device – whether representing the original manufacturer or the reprocessor.

Yesterday's Santa Clara Decision and Its Implications for the FDCA

We fingered Astra v. Santa Clara County as a potentially interesting case from the moment that the Supreme Court granted cert.  Here's how we described the case on four days after certiorari was granted:

The statute in question is the Public Health Service Act because the case involves Medicare drug pricing issues.  But to us, the case fairly screams out "Food, Drug & Cosmetics Act."  The issue boils down to whether private plaintiffs can use "federal common law" as a way to get around the fact that certain statutes (such as the FDCA) don't allow private enforcement.

"Interesting Supreme Court Cert. Grants" (DDLaw 9/30/10)

Well, yesterday, the court decided the case.  And we'd have to say that it didn't disappoint.

But first, the background.  As we've stated time and time again, Congress explicitly precluded private rights of action under the FDCA.  The Supreme Court so held in Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001).  The relevant FDCA provision is 21 U.S.C. §337(a), which states:

“[A]ll such proceedings for the enforcement, or to restrain violations, of this chapter [the entire FDCA] shall be by and in the name of the United States.”

Because of §337(a), Buckman held that attempts by private litigants to enforce the FDCA, disguised as common-law actions for "fraud on the FDA," were preempted.  Violation claims that “exist solely by virtue of the FDCA disclosure requirements,” 531 U.S. at 353, were impliedly preempted because the FDCA “leaves no doubt that 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 (citing §337(a)).  Absent any independent state-law basis, private FDA fraud claims conflicted with and were preempted by the FDCA’s exclusive grant of federal prosecutorial authority.  Id. at 353-54.

There are a lot of cases that follow Buckman and do this.  For example, in Goldsmith v. Allergan, Inc., 2011 WL 147714 (C.D. Cal. Jan. 13, 2011), the court reached the same conclusion concerning a consumer fraud claim that, in substance, sought simply to litigate a supposed FDCA violation:

[T]he Court agrees with Defendants suggestion that Plaintiff's [consumer protection] claims are based on conduct promoting [the drug] for off-label use. . . . These, and related allegations . . . constituted an attempt to shoehorn allegations that Defendant had engaged in off-label promotion in violation of the FDCA into state consumer fraud causes of action.

Id. at *3 (quotation marks omitted).

For courts that have difficulty dealing with the word "preemption," we've always thought that the same result can be reached through a standing analysis or something similar.

That brings us to Astra v. Santa Clara, which demonstrates the "something similar."  Like Buckman the case involves a statute, the Public Health Services Act, that doesn't permit private rights of action, because Congress stated numerous times in the statute, 42 U.S.C. §256b, that "the secretary" (meaning the federal Dept. of HHS) "shall establish . . . mechanism[s]" to ensure compliance with the Act's requirements.  See §256b(a)(5)(A)(ii), (a)(5)(D), (a)(7)(A), (a)(D)(1)(b)(i), (d)(1)(B)(i), (d)(1)(B)(iv)(I), (d)(2)(A).  It's a really complex statute, folks.  Between the two, we'd say the FDCA's preclusion of private actions is even more explicit, because it directly addresses who does, and doesn't, get to do the enforcing.

But the result is the same - no private enforcement.  Because of Congress' repeated reservation of the "secretary's" powers, in Astra v. Santa Clara, "[i]t is conceded that Congress authorized no private right of action under [the Act] for covered entities who claim they have been charged prices exceeding the statutory ceiling."  Slip op. at 1-2.  Or, as the Court stated later:

Recognition of any private right of action for violating a federal statute, currently governing decisions instruct, must ultimately rest on congressional intent to provide a private remedy. Congress vested authority to oversee compliance with the [the Act] in HHS and assigned no auxiliary enforcement role to covered entities.

Slip op. at 5-6.

The Court did not buy into the idea that supposedly invoking the common law to sue over something identical to what the statute requires was any different than suing over the statute itself:

The form agreements . . . serve as the means by which drug manufacturers opt into the statutory scheme. A third-party suit to enforce an HHS-drug manufacturer agreement, therefore, is in essence a suit to enforce the statute itself.  The absence of a private right to enforce the statutory ceiling price obligations would be rendered meaningless if [the Act's] entities could overcome that obstacle by suing to enforce the contract’s ceiling price obligations instead. The statutory and contractual obligations, in short, are one and the same.

Slip op. at 6-7 (emphasis added) (citations omitted).


Again, since we're products lawyers, our interest is in making the analogy to the FDCA.  A supposed private "common law" action that simply parrots the FDCA's regulatory standards "is in essence a suit to enforce the statute itself."  Such an action can't be disguised as a common-law suit because it is "one and the same" with the statute itself, and Congress forbade private enforcement actions.

We further note that in Astra v. Santa Clara, the Court gave short shrift to the same sort of "common law litigations accords with the purpose of the statute" argument that the Court used in Wyeth v. Levine.  According to the court, if that was what Congress wanted, it wouldn't have restricted enforcement powers to the government:

Suits like the County’s, the Court of Appeals reasoned, would spread the enforcement burden instead of placing it entirely on the government.  But spreading the enforcement burden . . . is hardly what Congress contemplated when it centralized enforcement in the government. . . .  Far from assisting HHS, suits by [the Act’s] entities would undermine the agency’s efforts to administer both Medicaid and [the Act] harmoniously and on a uniform, nationwide basis.  Recognizing the County’s right to proceed in court could spawn a multitude of dispersed and uncoordinated lawsuits. . . .  With HHS unable to hold the control rein, the risk of conflicting adjudications would be substantial.

Slip op. at 8-9 (various citations omitted).

This is preemption language without calling it preemption.  If it works for the PHSA, it's worth making the same arguments - supported by Buckman, as well - with respect to "parallel violation" claims under the FDCA, which even more emphatically bars private enforcement.  Buckman by any other name will smell as sweet. 

Buckman Preemption – The Good, The Bad, And The Ugly – And (This Just In) The Funky

We’re returning to the topic of implied Buckman preemption today to discuss three recent decisions, Hughes v. Boston Scientific Corp., ___ F.3d ___, 2011 WL 184554 (5th Cir. Jan. 21, 2011); LeFaivre v. KV Pharmaceutical Co., ___ F.3d ___, 2011 WL 148730 (8th Cir. Jan. 19, 2011); and Goldsmith v. Allergan, Inc., 2011 WL 147714 (C.D. Cal. Jan. 13, 2011).  But before we get to these cases, we have to reiterate some things that we said not too long ago in our Bashing Bausch post.  These have to do with the relationship between implied preemption under Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001), and express preemption under Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), and Riegel v. Medtronic, Inc., 552 U.S. 312 (2008).  Specifically, defendants need to keep in mind what implied Buckman preemption can and can’t do.


Specifically, as a matter of express preemption, Lohr created – under the rationale that remedies don’t matter – an exception for largely undefined state-law claims that are “identical” to FDA regulatory standards.  “Nothing in §360k denies [a state] the right to provide a traditional damages remedy for violations of common-law duties when those duties parallel federal requirements.”  518 U.S. at 495.  We have to live with that.  The Supreme Court was unanimous on the point.  Then there’s the Riegel dictum that MDA preemption “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.”  552 U.S. at 330.

Keep that in mind.  Express preemption allows “parallel” state law duties “premised on a violation of FDA regulations.”  If such a claim exists, it may well fail for other reasons, but it won’t be expressly preempted.

Now we turn to implied preemption.  We know now – even if we don’t like it – after Wyeth v. Levine, 129 S. Ct. 1187 (2009), and Altria Group, Inc. v. Good, 555 U.S. 70 (2008), that with implied preemption, we have a presumption against preemption to deal with.  That is, where, under Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001), there isn’t.

When isn’t there a presumption?

There's no presumption when we’re concerned with the dealings between the FDA and the manufacturer in question.  “[T]he relationship between a federal agency and the entity it regulates is inherently federal in character because the relationship originates from, is governed by, and terminates according to federal law.”  531 U.S. at 348.

Keep that in mind, too.

Finally, Buckman – as a matter of implied preemption – held that preemption (akin to lack of standing) applies to bar certain types of FDCA violation claims by virtue of 21 C.F.R. §337(a), the statute’s preclusion of private enforcement.

Where is this reservoir of implied preemption found?

Where the federal claims aren’t parallel.

And when aren’t violation claims parallel?

Where the claim doesn’t have a state-law equivalent to be parallel to, but instead is wholly a creature of the FDA regulatory scheme:

[T]he fraud claims exist solely by virtue of the FDCA disclosure requirements.  Thus, although [Lohr] can be read to allow certain state-law causes of actions that parallel federal safety requirements, it does not and cannot stand for the proposition that any violation of the FDCA will support a state-law claim. In sum, were plaintiffs to maintain their fraud-on-the-agency claims here, they would not be relying on traditional state tort law which had predated the federal enactments in questions. On the contrary, the existence of these federal enactments is a critical element in their case.

531 U.S. at 353 (emphasis added).

To recap:

(1) Parallel violation claims aren’t expressly preempted by the statute’s “different from or in addition to” language.

(2) Parallel violation claims must parallel “traditional” state tort law.

(3) Buckman implied preemption is the converse – it preempts violation claims that are not grounded in “traditional” tort law.

(4) With Buckman implied preemption, there’s a presumption against preemption, again, with respect to traditional state law violation claims.

(5) With Buckman implied preemption, there’s not a presumption against preemption for claims grounded in the “relationship” between the FDA and (we’ll presume) the defendant.

The Bad – Hughes v. Boston Scientific

With those propositions in mind, we turn to the most recent case, Hughes, 2011 WL 184554.  Hughes “focus[ed] primarily on [plaintiff’s] claim that [the defendant] failed to provide adequate warnings.”  So we’re not dealing with a manufacturing defect claim.  Is this claim parallel to “traditional” tort claims? That’s the key question.  The answer, evident from the face of the complaint is (to us) no:

[Plaintiff] proceeded on the theory that [defendant] failed to comply with the FDA’s MDR regulations requiring a manufacturer of a Class III device to report incidents.

2011 WL 184554, at *3.  Specifically, the plaintiff claimed that the defendant’s reporting “algorithm” caused a failure to report certain injuries (burns similar to hers) that the FDA required be reported.  Id.  That claim is supported by your usual FDA expert spouting legal conclusions - that the defendant broke the law.

Think about that claim for a minute.  Where's the parallel tort duty?  What state common-law doctrine (as opposed to statutory-based requirement) requires anybody to report anything to a governmental agency?   Whether it's child abuse, adverse events, financial improprieties, whatever, the source of all obligations to report to the government - as opposed to duties to warn individuals - is statutory or regulatory.

There's no state common-law tort duty at all to report anything to the FDA.

Thus, as we see it, Hughes is the same as Buckman, in that the the obligation to report arises from the "relationship" between the FDA and the manufacturer, and nothing else. So that claim should have been preempted.

We call Hughes “bad” because that didn't happen.

It's not all bad.  The Hughes court first affirmed the throwing out all of the plaintiff’s standard product liability claims (manufacturing, design, and warnings).  2011 WL 184554, at *5. So far, so good. That illustrates another point we've made.  Riegel preemption remains extremely broad.  The easy to prove product liability claims, even under the worst decisions, are gone.  All the plaintiffs have left, no matter how much slack they get cut, is a rather technical regulatory based claim.

The first statement in Hughes that we really don’t like looks innocuous.  The court “[a]ssum[es] that a failure to warn claim may be pursued under Mississippi law as [plaintiff] argues.”  2011 WL 184554, at *6.

Assuming?

Why?

Where’s the legal argument that it doesn’t?

Apparently there wasn’t any.  That doesn’t look like a screw up by the court.  Instead, the defendant – for who knows what reason (money?) – chose to litigate with one hand tied behind its back.

Any defendant that does that – does not give the court state-law bases why these violation claims fail – is more likely to lose.  Period.  A good state-law ground:  (1) may induce the court not to reach preemption at all (that is preferentially to choose the non-constitutional ground), or (2) improves the atmosphere by demonstrating that the claim in question is pretty darn poor in any event and isn't worth salvaging.

Folks, there are lots of state-law obstacles to tort claims asserting FDCA violations.  We’ve dealt with these extensively in our negligence per se-related posts – particularly here and here.  They need to be utilized.

Defense counsel who litigate only half a case – particularly when the half they do pursue is preemption – aren’t doing their clients any favors by saving a little money.  It’s a case of penny-wise and pound foolish.  All they’re doing is increasing the likelihood of losing.

We don't like defendants losing, even when it's not our case.  It's the reverse of the rising tide floating all boats.  It's a major reason why we write this blog.

Turning back to Hughes’ treatment of the law, we have the statement “a failure to warn claim limited to an assertion that the defendant violated a relevant federal statute or regulation is ‘parallel’ to federal requirements as defined in Riegel.”  2011 WL 184554, at *6.  That’s true, as far as it goes, which is limited to Riegel and express preemption. The minimal discussion of such claims in Riegel is limited to reiterating Lohr’s conclusion that a violation claim isn’t “different from or in addition to” under the MDA preemption clause.

Hughes analogizes to an earlier case called Gomez. However, Gomez involved a very different kind of violation claim – a “negligence claim alleging that the defendant had defectively manufactured the device.” Hughes, 2011 WL 184554, at *7 (describing Gomez).

But a manufacturing-related claim is about as "traditional" a tort claim as anyone could ask for.  Such a claim is a world away from a claim that the defendant didn’t report stuff to the FDA.  But Hughes missed that distinction entirely, lumping blindly lumping together manufacturing defect claims in other cases with the peculiar warning claim before it, based entirely on failure to report, as unpreempted violation claims.  Id. at *8.

Where’s Buckman?

Where’s any discussion of violation claims that aren’t “traditional,” but rather are grounded in the “relationship” between the FDA and its regulated manufacturers?

Not yet.  That holding was limited to express preemption.

Then Hughes turns to “negligence per se” and dodges most issues – limiting itself to preemption.

[Defendant’s] preemption defense only requires us to decide which of [plaintiff’s] state law causes of action are foreclosed under § 360k. . . .  We need not decide, therefore, whether Hughes will be able to invoke the doctrine of negligence per se as a matter of Mississippi law.

Id. at *8.

There's that damn waiver again - the defendant throwing away half its defense.

What do we mean?  Well, how about Sumrall v. Mississippi Power Co., 693 So.2d 359 (Miss. 1997)?  In that case, the Mississippi Supreme Court rejected negligence per se based upon OSHA violations because, similarly to the FDCA, Congress expressed an intent that OSHA violations not become mixed up in private civil litigation:

In Otto v. Specialties, Inc., 386 F.Supp. 1240, 1244-45 (N.D. Miss. 1974), the District Court for the Northern District of Mississippi was forced to make an Erie determination of whether OSHA regulations were admissible as evidence of negligence under Mississippi negligence law. In finding the regulations to be not admissible, the district court stated:

We believe the Supreme Court of Mississippi, if faced with this question, would recognize, as we do, that what is at stake here is a question of judicial buttressing of legislative goals.  We believe that with this recognition would come a realization that, before the judiciary undertakes to supplement legislatively designed sanctions it should first inquire whether any supplementation was foreseen or is needed.  Such an inquiry into OSHA has been made by the federal courts, which have concluded that no private civil remedy is needed to fulfill the goals established by Congress in its adoption of the statute.  That this determination was made in the context of a federal civil remedy and not within the framework of the negligence per se doctrine is to us irrelevant, since both concepts share a common raison d'etre - a judicial addition to statutory penalties thought to be inadequate to the purposes the legislative branch sought to promote.

We concede that the Mississippi courts need not be bound in this matter by the federal determination of OSHA's purpose and effect.  We believe, however, that the Supreme Court of Mississippi would be persuaded by the logic of those opinions to refuse to permit the utilization of OSHA safety standards in this case, either as conclusive proof or evidence of negligence by [the defendant].

Otto, 386 F.Supp. at 1245.

We are persuaded by the district court's reasoning and hold that, in light both of it and of this Court's clearly stated rule that governmental codes and regulations are not admissible unless given compulsory force by the state legislature, evidence of OSHA regulations is not admissible to show negligence.

693 So.2d at 366-67 (emphasis added).  Cf. Chisolm v. Mississippi Dept. of Transportation, 942 So.2d 136, 143 (Miss. 2006) (negligence per se is “a tool for assessing a breach of duty only after a legal duty has already been established.  It cannot be used to create a legal obligation under Mississippi law”).

Why give away the argument that Mississippi negligence per se principles would not, as a matter of state law, recognize a cause of action predicated on the violation of a statute expressly intended by its legislative draftes to be enforced only by governmental entities?

Hughes in this respect is no different than Bausch – where the defendant also gave away this argument, likewise soundly grounded in state supreme court precedent.  Perhaps predictably, Hughes blindly follows Bausch, holding that, simply because state law generally allows “negligence per se,” there’s an unpreempted FDCA-based cause of action.  2011 WL 184554, at *8 (plaintiff “is not foreclosed by §360k from arguing at trial that the doctrine of negligence per se is available”) (citing Bausch).

But again, under express preemption, if the claim is assumed (because nobody bothers to argue otherwise) to be a “traditional” state-law tort claim, then, yes there’s no preemption because of the way Lohr read the “different from or in addition to” language.

So while Hughes so far is bad, it’s not necessarily wrong.

What was left in Hughes is fighting in the trenches, against paid FDA experts opining on what the law supposedly is.  2011 WL 184554, at *9-10.  Apparently, there are some bad facts:

[A]ny danger that the jury in this case may apply the plain terms of the MDR regulations in a different or more stringent manner than the FDA intended is considerably mitigated by the summary judgment evidence indicating that the FDA disapproved of [defendant’s] reporting practices. . . .  [T]he FDA told [defendant] that when information regarding a burn is “ambiguous” as to whether the burn requires medical treatment or intervention, the burn must be reported.

Id. at *10.  When a defendant has bad facts, it can’t afford to give up available defenses.

Finally, we get to Buckman, and here everything heads south.  Instead of evaluating whether the failure-to-report claim implicates the “relationship” with the FDA, as per Buckman, the court simply says this isn’t fraud on the FDA claim.  “The plaintiffs in Buckman were attempting to assert a freestanding federal cause of action based on violation of the FDA's regulations; the plaintiffs did not assert violation of a state tort duty.”  2011 WL 184554, at *11.  Well, that’s simply wrong as a matter of history.  Buckman was postured as being predicated on a state law duty - the duty not to commit fraud.  Cf. Cipollone v. Liggett Group, Inc., 505 U.S. 504, 530 (1992) (discussing such state law duty).  What resulted in preemption in Buckman was that the purported fraud occurred entirely in the context of the defendant’s dealings with the FDA.

Hughes then states that there’s a “recognized state tort claim,” 2011 WL 184554, at *11, but doesn't cite any case in the history of Mississippi law that created any common-law (as opposed to statutory) duty to report something to a government agency.  Hughes thus entirely papers over the yawning gap between a failure to warn and a failure to report claim.  Once again Bausch raises its ugly head.  Id.  But Bausch, wrong as it was on a lot of things, at least involved a manufacturing defect claim predicated on violation of FDA good manufacturing practices.  There's simply no traditional state law claim in Hughes.  Instead, the court did just what the Mississippi Supreme Court rejected in Chisolm, 942 So.2d at 143 – it allowed plaintiffs to use a reporting violation to “to create a legal obligation under Mississippi law.”

Hughes goes from bad to even worse at the end of its preemption discussion.  We’ll quote the language first:

[Defendant’s] interpretation of Buckman barring this otherwise parallel state claim is inconsistent with the Supreme Court’s reasoning in Riegel, decided long after Buckman.  Riegel unequivocally held that parallel state claims survive a defendant’s preemption defense under the MDA because states may impose an additional “damages remedy for claims premised on violation of FDA regulations.”  Riegel, 522 U.S. at 330.  Our conclusion in this respect is also supported by our decision in Gomez, decided years after Buckman, in which we permitted a negligence claim for defective manufacturing to proceed.

2011 WL 184554, at *12.

This passage reminds of a certain scuplture on the campus of Harvard University known as the “statue of three lies.”  In all of three sentences, Hughes committed three major legal blunders.  (1) It ignored that Buckman was entirely an implied preemption case, whereas Riegel was entirely an express preemption case, thus there is no inconsistency at all between the two because they dealt with different doctrines.  (2) It overlooked that the entire violation question in Riegel was waived (552 U.S. at 229 (“we decline to address that argument”)) - so Riegel didn’t “unequivocally hold” anything at all about such claims.  (3) It ignored the fundamental difference between the “manufacturing” claim in Gomez, and the failure-to-report claim before it, with the former being a long-recognized tort claim, and the latter being a creation solely of FDCA reporting requirements.

So we think Hughes is really bad.  As to preemption it’s worse than Bausch, which for all its faults, at least involved a something that bore passing resemblance to a traditional state-law claim.  But us kvetching isn’t going to get either decision off the books.  As we already mentioned, Hughes and Bausch have one notable thing in common.  In neither case was the FDCA violation claim proper on state law, but in both cases the defendants never bothered to make state law arguments.

You can’t do that guys – not with the post-Levine legal climate surrounding preemption in the FDCA context.  We’ve said before that 2011 would probably the year that the contours of the parallel violation exception to PMA preemption would be decided.  So far, we'd have to say that the year's not off to a very good start.

The Ugly – LeFaivre v. KV Pharmaceutical

We’re sticking LeFaivre, 2011 WL 148730, with our “ugly” moniker because while we could see some logical way of arriving at the court’s result, we can’t stomach the route that the Eighth Circuit took to get there.  LeFaivre involved improperly manufactured drugs.  That much is not in dispute.  The FDA “filed a complaint” over certain manufacturing violations, and the defendant (actually more than one, but the court treated them as a unit) entered into a “consent decree” in which it “stipulated . . . that it had sold drugs that were ‘adulterated’” under the FDCA.  Id. at *1.

So LeFaivre is another “bad facts” case.  A civil suit, seeking economic damages for the same conduct was filed.  There isn’t any express preemption in prescription drug cases, so the defendant raised an implied preemption defense under Buckman.  It got lucky.  The trial court threw the case out, finding it to be nothing more than an attempt at private enforcement of the FDCA, which was barred under §337(a) as construed in Buckman.  LeFaivre, 2011 WL 148730, at *2.

Recall the last three of the five propositions that we listed above with respect to Buckman preemption.  They have to do with the distinction between “traditional” common-law claims and “non-traditional” claims arising as a consequence of what the FDCA requires manufacturers to do.

Well, as we’ve already said in connection with Hughes, a manufacturing defect claim can be a state-law analogue to an allegation of violation of FDA good manufacturing practice regulations (assuming the regulations aren’t too vague – a state-law ground, and that the violation actually pertains to the product at issue).

So it would have been rational for an anti-preemption court to view the manufacturing violation claims in LeFaivre as paralleling a “traditional” state-law tort theory and, under Buckman, escaping preemption.

But the Eighth Circuit didn’t do that.  Instead, it construed the §337(a) argument as some sort of “field preemption” case – which it really isn’t, unless the “field” is so shrunken as to correspond to the sort of non-traditional tort claims that Buckman addressed.  “The Court’s comments in [Levine] regarding drugs and drug labeling strongly imply that field preemption does not apply in the present case.”  LeFaivre, 2011 WL 148730, at *5.  It also found no conflict preemption, since there was no impossibility or obstacle raised by requiring the defendant to manufacture its drugs in compliance with FDA regulations applicable to all drug manufacturers.  Id.  Well, duh.
Turning to Buckman, LeFaivre didn't couch its analysis in terms of a manufacturing defect claim having a state-law analogue and thus not being preempted because it wasn't solely a creature of federal law.  Instead, it construed Buckman as a field preemption case:

The Court in Buckman specifically applied field preemption to state-law fraud-on-the-FDA claims because policing fraud against federal agencies “is hardly a field which the States have traditionally occupied.”  Buckman, 531 U.S. at 347

2011 WL 148730, at *8.

That’s just ugly.  Buckman has nothing to do with “field preemption.”  It is purely an implied conflict preemption case.  Use of the word “field” didn't occur in the court’s preemption analysis, but rather in the context of whether a presumption against preemption applied:

Policing fraud against federal agencies is hardly a field which the States have traditionally occupied, such as to warrant a presumption against finding federal pre-emption of a state-law cause of action.  To the contrary, the relationship between a federal agency and the entity it regulates is inherently federal in character because the relationship originates from, is governed by, and terminates according to federal law.  Here, petitioner’s dealings with the FDA were prompted by the MDA, and the very subject matter of petitioner's statements were dictated by that statute's provisions.  Accordingly – and in contrast to situations implicating federalism concerns and the historic primacy of state regulation of matters of health and safety – no presumption against pre-emption obtains in this case.

531 U.S. at 347-48 (all citations and quotation marks omitted) (emphasis added).  If Buckman had been about “field preemption,” it would have had to deal with all the other defendants and all the other myriad causes of action that had been alleged in the Bone Screw litigation.  Further, as we’ve discussed before, “field preemption” is where the unfortunate presumption against preemption was invented.  Buckman would never have found that the presumption didn't apply to a field preemption claim..

Having twisted Buckman into something unrecognizable, LeFaivre went on to conclude that “the present case is distinguishable from Buckman because [plaintiff’s] state-law claims are not fraud-on-the-FDA claims, as they focus on harm that is allegedly perpetrated against consumers rather than the FDA.”  2011 WL 148730, at *8.  We don’t know all the facts of LeFaivre, but as described in the opinion, both the nature of the claim – improper/defective manufacturing – and the nature of the facts – a violation already administratively adjudicated and thus well beyond a bare allegation – are such that we can’t say that the result violates either the language or policy of Buckman.

So we can’t describe the result in LeFaivre as necessarily bad (even though the defendant lost the preemption issue), but it sure was ugly.

The Good – Goldsmith v. Allergan

We saved the best for last, Goldsmith v. Allergan, Inc., 2011 WL 147714 (C.D. Cal. Jan. 13, 2011) – and a tip of the cyber cap to Kurt Karst at Hyman, Phelps for originally sending it along to us .

We consider Goldsmith to be an unimpeachable (if conservative) use of Buckman preemption in that the decision concluded that a purported state-law violation claim unrelated to any “traditional” state tort theory was preempted.  Goldsmith was a consumer fraud claim out of California alleging that the defendant should have to pay for “allegedly market[ing a drug] as a “multi-use” product to encourage administering physicians to use a single vile [sic] of [the drug] for more than one patient.”  2011 WL 147714, at *1.

Goldsmith offered no allegations that there was anything wrong with the design, manufacturing or labeling of the drug.

Thus Goldsmith did not involve any traditional product liability claim, only an allegation of off-label promotion.

As in Buckman, therefore, the claim arose solely because of an FDCA violation.  State common law doesn’t have a concept of off-label promotion.

[T]he Court agrees with Defendants suggestion that Plaintiff's [consumer protection] claims are based on conduct promoting [the drug] for off-label use. . . .  These, and related allegations . . . constituted an attempt to shoehorn allegations that Defendant had engaged in off-label promotion in violation of the FDCA into state consumer fraud causes of action.

2011 WL 147714, at *3 (quotation marks omitted).  Allegations of this sort are simply attempts to enforce the FDCA privately in violation of §337(a).  “No matter how artfully the Complaint is pleaded in attempting to enforce the FDCA, Plaintiff cannot enforce the FDCA’s off-label advertising provisions simply by calling it a violation of [a consumer fraud statute].”  Id. at *8.

Goldsmith contains a lot of discussion about pleading fraud under Fed. R. Civ. P. 9(b), and concludes that the complaint was insufficient with respect both the misrepresentation and reliance elements.  2011 WL 147714, at *5 (“Plaintiff never alleges that he saw any ads and relied on them”), at *7 (“Plaintiff has not alleged facts showing that Defendant's alleged representations were false or misleading”).  Thus Goldsmith contains a caveat – that such allegations might escape Buckman preemption if instead they paralleled a state-law fraud claim.  2011 WL 147714, at *3 (“Plaintiff’s [consumer protection] claims are actionable if they include properly pleaded allegations of false or misleading representations that resulted in Plaintiff's injuries”).  That also fits within Buckman’s rationale, which as discussed above, predicates §337(a) preemption/lack of standing on the state law claim at issue being purely a creature of the FDCA without any common-law analog.

For these reasons – its fidelity to Buckman in both rationale and result – we bestow our “good” designation on Goldsmith.

The Funky – Funk v. Stryker

Finally, while we were writing this post (yesterday) we noticed Funk v. Stryker Corp., No. 10-20022, slip op. (5th Cir. Jan. 25, 2011), had appeared on the Fifth Circuit’s website.

Even though it's not a Buckman case, we decided to add Funk because it’s an important appellate decision.  It creates a circuit split with Bausch, as both decisions arise from the same defect allegations involving the same device.  Circuit splits are one criteria the United States Supreme Court uses to decide whether to accept a case for appeal, and if any case deserves further review, it's Bausch.

But Funk – there’s no other way to say it –is rather funky.  Unfortunately (maybe even for us on the defense side), the plaintiff screwed up his appeal and only appealed from the original, pretty pathetically pleaded, complaint.  Slip op. at 5.  That original complaint was so poor that there wasn’t much question that the claims were all preempted.

Thus, the conflict between Funk and Bausch is more with respect to TwIqbal than preemption.  Contrary to Bausch, Funk holds that a parallel violation isn’t adequately pleaded without specifying both how the FDCA was violated and that the violation caused the plaintiff’s injury:

This complaint is impermissibly conclusory and vague; it does not specify the manufacturing defect; nor does it specify a causal connection between the failure of the specific manufacturing process and the specific defect in the process that caused the personal injury. Nor does the complaint tell us how the manufacturing process failed, or how it deviated from the FDA approved manufacturing process.

Funk, slip op. at 7.  Instead, an adequately pleaded complaint “specifies with particularity what went wrong in the manufacturing process and cites the relevant FDA manufacturing standards [the defendant] allegedly violated.”  Id. at 8.

Because Funk found that the only arguably unpreempted (violation) claim was insufficiently pleaded under TwIqbal, it didn’t have to reach any controversial preemption questions under Riegel or (as discussed above) under Buckman.

Funk does, however, hold that it’s proper to take judicial notice of “publically-available documents and transcripts produced by the FDA, which were matters of public record.”  Slip op. at 9. T hat’s a useful – if we think rather self evident – holding.