Friday, April 29, 2016

Preemption: Oregon Has Not Gone Bananas

Can you get sued over a picture of a banana?  It seems the answer might depend on where you live and probably not in Oregon.  That is one takeaway from a good preemption case that came out of the District of Oregon last week, Henry v. Gerber Products Co., No. 3:15-cv-02201, 2016 U.S. Dist. LEXIS (D. Or. Apr. 18, 2016).  In Henry, a concerned mother sued because the baby “Puffs” she purchased depicted a banana on the label, but contained only “natural banana flavor.”  Not actual bananas.  Never mind that label stated the product’s ingredients truthfully and clearly in black and white.  Never mind that if a parent wants his or her toddler to snack on bananas, he or she could purchase, you know, bananas.  For whatever reason, this parent preferred banana puffs, with bright yellow bananas on the label.  And it resulted in a federal lawsuit. 
How did we get here?  Like most every other state, Oregon has an Unfair Trade Practices Act that prohibits product sellers from representing that their products have “particular characteristics, ingredients, benefits, or qualities that they do not have.”  See Or. Rev. Stat. § 646.608(1)(e).  A right and just law when applied properly, to be sure. 
It becomes interesting, however, when talking about food because federal law is extraordinarily specific in regulating food labels.  Surely you read our guest post on the FDA’s regulation of non-functional slack-fill (whatever that is) and its impact on product packaging.  Or our post on food “standards of identity” which dictate what food sellers can and cannot call their products.  You probably also knew that a food label’s Nutrition Facts have to appear in a certain place on the package, unless the package has less than 40 square inches of surface area, except when the packaging includes a cellophane window, which does not count as available surface area, unless the window is itself used as a label (such as with a sticker), in which case the window does count as available surface area, and provided that the manufacturer has not applied for special allowance to affix something to the packaging that might obscure the Facts, such as a straw.  See 21 C.F.R. § 101.9.  You get the idea—the FDA has put a lot of thought into the uniform regulation of food labels.
The tie in to drugs and medical devices is preemption.  The Nutrition Labeling and Education Act gives the FDA authority to oversee food labeling, and the statute has an express preemption clause that forbids states from establishing any requirement that “is not identical to” the federal requirements in five areas of food labeling, including labeling on ingredients and flavorings.  21 U.S.C. § 343-1(a)(2) & (3).  In Henry, the plaintiff alleged that the banana puff manufacturer led customers to believe that the puffs actually contained “the prominently depicted fruits,” e.g., bananas, which allegedly violated Oregon’s UTPA.  2016 U.S. Dist. Lexis 52638, at *18. 
But, as it turns out, the FDA’s regulations provide that it is perfectly okay to represent a food’s flavor with a picture of a fruit, even where the food contains only “natural flavor” and not the actual fruit.  The manufacturer just has to say so on the label in a mind-bogglingly particular way.  (We won’t quote the regulation here; you’ll have to read the opinion to get its flavor, but trust us, its detail is exceptional.)  The banana puffs manufacturer complied to a tee, which led it to argue justifiably that the plaintiff’s Oregon law claims sought to impose requirements that were “not identical to” federal requirements.  Id. at **12-13. 
That means federal preemption, and the district court agreed: 

The gravamen of Henry’s complaint is that “[the manufacturer’s] marketing and labeling of Puffs lead consumer to believe that Puff’s actually contain the prominently depicted fruits or vegetables for which each variety is named.”

. . . .

[However, the] law, as applied to the situation presented to this Court, is clear:  “FDA regulations permit illustrations of fruit on product labels to indicate that product’s ‘characterizing flavor,’ even where the product contains no ingredients derived from the depicted fruit.”  []  Henry’s state law claims under the UTPA are, therefore preempted. 

Id. at **18-19 (citations omitted).  This is a pretty straightforward application of express preemption, but there are two points that we think make this order particularly interesting. 
First, in its discussion of preemption law, the district court invoked the “presumption against preemption,” under which it would “start with the assumption that the historic police powers of the State were not to be superseded by [federal law] unless that was the clear and manifest purpose of Congress.”  Id. at *13 (citing Medtronic v. Lohr, 518 U.S. 470 (1996)).  Don’t get Bexis started on the presumption against preemption.  (See, for example, here)  The presumption (or assumption) is a false concept, a makeweight invoked when consistent with a no-preemption result.  In Henry, the express preemption was so clear that the “presumption” did not matter.  The district court found preemption regardless.
Second, the district court distinguished the case from another from its neighbor to the south, the Golden State.  You see, the Nutrition Labeling and Education Act has a catch-all, which prohibits food labeling that is “false or misleading in any particular.”  21 U.S.C. § 343(a).  Because the preemption provision does not expressly cover the catch-all, the plaintiff argued that any claim under the catch-all was not preempted, citing an order from the Central District of California, Zupnik v. Tropicana Products Inc., No. 09-cv-6130 (C.D. Cal. Feb. 1, 2010). 
The district court rejected this argument as overly simplistic.  Just because a label allegedly falls within a catch-all for “false or misleading” labeling does not mean that it all of a sudden falls outside the FDA’s more specific regulations, which permit exactly that labeling.  As the district court put it, “[W]here the challenged conduct is expressly required or permitted by FDA regulations, the claims fall within the core of the preemption provision because they would ‘impose different requirements on precisely those aspects . . . that the FDA had approved.’”  Id. at *20 (citations omitted).  Moreover, where the FDA regulations permit particular labeling, that labeling is not considered “false or misleading” under federal law by definition.  Id.  According to the Henry judge, the Zupnik order from California was an outlier and “quite perfunctory” in an area of the law that was complex and nuanced.  As Californians, we say “ouch.”  But setting our native pride aside, we have to say that we agree. 
Food litigation may continue in California, but manufacturers should continue to push back with preemption and its lesser sibling, primary jurisdiction.  Preemption carried the day in Oregon, and it should continue to do so. 

Thursday, April 28, 2016

Complete PMA Preemption Win in Texas

            We talk a lot about PMA preemption on this blog.  And why shouldn’t we.  It’s probably been the most consistent source of defense wins in the last five plus years.  The body of preemption law that has grown out of Riegel v. Medtronic, Inc. is something we’ve watched with admiration.  Likewise, we’ve watched plaintiffs’ counsel try to thwart, dodge, and squeeze by or around PMA preemption for just as long.  Plaintiffs have met with occasional limited success, which while not our favorite topic, doesn’t usually give us significant pause because even if a claim or two sneaks by – preemption usually guts most of plaintiffs’ causes of action.   But then every so often, we get the complete win.  Total victory, dismissal with prejudice.  And as routine as a PMA preemption win might be – the complete win is still something blog-worthy.

            That brings us to today’s case – Yosowitz v. Covidien, Civil Action No. H-15-2902 (S.D. Tex. Apr. 25, 2016).  Plaintiff underwent a surgical procedure to repair intracranial aneurysms during which defendant’s embolization device was implanted.  Plaintiff alleges that a defect in the device caused her to suffer a blocked blood vessel which led to mini-strokes and resultant injuries.  Yosowitz, slip op. at 1-2. The device was a Class III, Pre-Market Approved device.  So, the court’s first stop in its decision was a fairly thorough of PMA preemption law.  Id. at 7-13.  Following that discussion, you’ll see this section heading:  Plaintiffs’ Claims are All Preempted or Fail to Properly Allege a Claim which was followed by Plaintiffs Have Not Pleaded Any Parallel Claim. Id. at 13.  Pretty much guaranteed we were going to like the rest of the opinion.

              Applying all that preemption law to the claims in Yosowitz, the court started with the state law claims for negligence, strict liability, breach of express warranty and breach of implied warranty.  Since all four impose requirements on medical devices, they must not be different from or in addition to the requirements imposed by the FDCA.  Id. at 16-17.  To establish that, plaintiff’s allegations must identify the “specific PMA requirements that have been violated.”  Id. at 14.  “[S]cattered allegations of federal law violations” do not suffice.  Id. at 13. 

The court summed up plaintiff’s negligence claims as failure to manufacture, market and label a product that was (1) safe and/or (2) consistent with the original design and/or (3) consistent with FDA regulations.  Id. at 18.  As to point 1, the device received FDA PMA approval – any state law that required defendant to manufacture or label its device in a way other than the way the FDA approved it, is preempted.  Id. at 18.  Plaintiff tried to argue that points 2 and 3 were parallel claims, but the court found the unsupported allegations failed to provide any information on how the device’s design differed or was inconsistent with federal regulations.  Id. at 21.  All the negligence claims were dismissed.

Plaintiff’s strict liability claim did not contain any allegations that defendant failed to comply with any federal regulations – therefore, any requirement plaintiff sought to impose on defendant would be different from or in addition to federal regulations.  Id. at 22.   All the strict liability claims were dismissed.

With breach of express warranty, there again is no allegation of a violation of any federal regulation.  So, any finding of breach of warranty would necessarily involve a decision by a jury that the device was “unsafe and ineffective.”  Id. at 24.  “The FDA determined otherwise through the PMA process, so the state claim is based on different or additional requirements and is expressly preempted.”  Id.  Moreover, plaintiff’s complaint failed to allege the actual representations constituting the express warranty or when and how the plaintiff received notice of them.  Id. at 24-25.  Finally, if the alleged representations were made in the label, warnings or instructions for use – they were FDA approved.  Another basis for express preemption.  Id. at 25. 

Plaintiff’s breach of implied warranty claim suffered from the same problems, because plaintiff only alleged that she “believes” there was a violation that was a cause of her injuries.  Id. at 26.  Belief may be strong enough for Santa Claus and the Tooth Fairy, but it’s not enough to satisfy federal pleadings standards.  All the breach of warranty claims were dismissed.

With the traditional state law claims disposed of, plaintiff’s remaining claim was for failure to comply with the FDCA and its implementing regulations.  Had plaintiffs never heard of Buckman?  Is this anything other than a private cause of action to enforce FDCA regulations?  This claim is impliedly preempted.  Id. at 27-28.  Even if it weren’t preempted, it doesn’t contain any allegations of how defendant failed to comply the regulations nor any allegations of a causal connection between failure and the plaintiff’s injuries.  Id. at 28. 

And with that, the case was dismissed with prejudice.  An excellent result for which extend congratulations to our friends Lori Cohen and Victoria Lockard at Greenberg Trauig who passed this along to us. 

Wednesday, April 27, 2016

C.D. Cal. Dismisses Infusion Pump Complaint

The plaintiff in Frere v. Medtronic, Inc., 2016 WL 1533524 (C.D. Cal. April 6, 2014), was an 80 year-old woman who had an infusion pump implanted to treat her chronic low-back pain.  According to the plaintiff, the device never delivered the pain relief she had experienced during her pre-implantation pump trial, and she ultimately suffered complications. The device is a Class III medical device, requiring FDA premarket approval.  Product liability litigation involving Class III devices does not get very far without bumping into federal preemption issues.  Frere is no exception.   


The problem with the plaintiff’s complaint was that it was either unclear or clearly preempted.  The strict liability claims failed because they consisted of conclusory allegations that the purported defects or failure to warn caused her injuries.  For example, in the manufacturing defect claim, the plaintiff alleged: (1) that “the catheters at issue were occluded, fractured, obstructed, and/or malfunctioning, which caused Plaintiff to suffer severe injuries and which required multiple surgeries and medical procedures to correct these defects”; and, (2) “as a direct result of the defects, Plaintiff suffered crippling injuries which left Plaintiff with permanent and significant disabilities compensable under the law.”  There is no there there.  Similarly, in connection with her failure to warn claim, the plaintiff alleged that “[a] foreseeable, direct and proximate result of [Defendants’] failure to warn Plaintiff, Plaintiff’s medical providers, and the FDA . . . about the defective condition of the [Device], Plaintiff suffered crippling injuries that left Plaintiff with permanent and significant disabilities.”  The court refused to accept those mere “labels and conclusions.”  The complaint was bereft of any facts as to how the alleged manufacturing defect and failure to warn caused her injuries.  All we get is the conclusion of causation itself.


That’s before we even get to preemption.  The claims run afoul of either implied, Buckman preemption by asking the court to second-guess the FDA, or run afoul of express Medical Device Amendment preemption by asking the court to impose a requirement different from or in addition to federal law.  The plaintiff argued that “[t]he sum and substance of [her] claim is that the product in question was manufactured at a time when Defendants were in violation of federal regulations dealing with manufacturing processes.”  That argument walks into Buckman and does not identify “specific federal requirements” that parallel California law.  The plaintiff also alleged that the defendants “failed to inform or otherwise warn the FDA, medical providers, and consumers such as Plaintiff of the high failure rates” of “the catheters at issue.”  But federal regulations required the defendants to report adverse events to the FDA, not to doctors, so the claim sought to impose additional requirements.


Other claims fared no better. The court was just as exacting with respect to the inevitable warranty claims as with the defect and warning claims.   The plaintiff failed to plead facts that plausibly indicated that the defendants breached a warranty made beyond any statements approved by the FDA during the premarket approval process.  The plaintiff alluded to “articles in medical journals, advertising and/or other documents and/or promotional materials,” but offered no reason to infer that such statements became “part of the basis of the bargain” sufficient to state a claim for breach of express warranty. Moreover, in basing an implied warranty claim solely on conduct allegedly violating the FDCA, the plaintiff once again walked off the Buckman cliff. 


The fraud/misrepresentation claims walked off that same cliff, because the allegedly offending marketing materials had all been reviewed by the FDA as part of the PMA process.  The plaintiff never suggested that the statements exceeded the scope of any statements approved by the FDA.  Moreover, and predictably, the fraud claims flunked the Rule 9 particularity requirement.  The complaint did not allege the when and where of the misrepresentations, to whom they were made, and how they were false.


The complaint also included an allegation that the defendants had failed to  train the plaintiff’s medical providers regarding how to install the device.  The court held that such a claim can survive “only to the extent the manufacturer failed to provide the training required by the premarket approval process.”  Here, the plaintiff did not allege any facts regarding how the defendants’ training procedure deviated from the training procedure approved by the FDA in the premarket approval process.  Nor did the plaintiff assert any causal connection between the potential training deviations and her injuries.  Those failures derailed the training claim.


Finally, the court dismissed the plaintiff’s claim under California’s Unfair Competition Law.  That claim sounded in fraud and was therefore subject to the same particularity pleading requirement that knocked out the fraud claims.  Again, the complaint failed to state how the alleged misrepresentations “immediatel[ly]” caused the plaintiff’s injuries.  


These rulings resulted in a dismissal of the entire Frere complaint.  But the court saw a possibility that the plaintiff could reallege her claims “to evade preemption,” so dismissal was with leave to amend.  In all likelihood, we will report again on this case in the not-too-distant future. 


Tuesday, April 26, 2016

Handy-Dandy Checklist for Admissibility of Electronic Evidence

For years we’ve advocated about ediscovery for defendants – consisting mostly of material gathered from a plaintiff’s social media postings.  OK, so let’s assume some degree of success.  Defense-side ediscovery has generated some good stuff, and come trial, we want to get it admitted into evidence.  Now what?

That’s the subject of today’s rather short post.  Since we’re hardly the source of all useful information, we’d like to pass along a handy 4-page checklist for the admissibility of electronic evidence.  It covers evidence in the form of:  e-mail, internet website posts; text messages/tweets; computer stored information; animations and simulations; and digital photos.  It has the following headings:

1. Preliminary Rulings on Admissibility

2. Is the Evidence Relevant?

3. If Relevant, Is It Authentic?

4. Is Evidence Hearsay?

5 Original Writing Rule

6 Practice Tips

It’s what it purports to be – a checklist – it doesn’t provide case law, but it’s the kind of thing that lends itself to use in trial, rather than pretrial, situations.

This nifty guide was prepared jointly by Hon. Paul W. Grimm and Kevin F. Brady of Redgrave LLP, so give credit where credit is due.  We’ve been in touch with both of them, and they have graciously allowed us to disseminate their work.

Monday, April 25, 2016

Discovery − Oppenheimer’s Half Life Has Long Been Exceeded

As we’ve discussed previously, and as the legal profession is by now well aware, the discovery provisions of the Federal Rules of Civil Procedure were significantly amended effective December 1, 2015.  One of the foundational changes was to Rule 26(b)(1), and was intended to reduce the scope of discovery generally.  The old excuse for ridiculous over-discovery – “reasonably calculated to lead to the discovery of admissible evidence” – is no more.  The new, more restrictive, language defining the scope of discovery is “any nonprivileged matter that is relevant to any party’s claim or defense and proportional to the needs of the case.”  Fed. R. Civ. P. 26(b)(1).  As the committee notes to this amendment explain, the old language was frequently misunderstood to permit discovery into material that was itself irrelevant to litigation:

The former provision for discovery of relevant but inadmissible information that appears “reasonably calculated to lead to the discovery of admissible evidence” is also deleted.  The phrase has been used by some, incorrectly, to define the scope of discovery.  As the Committee Note to the 2000 amendments observed, use of the “reasonably calculated” phrase to define the scope of discovery “might swallow any other limitation on the scope of discovery.”  The 2000 amendments sought to prevent such misuse by adding the word “Relevant” at the beginning of the sentence, making clear that “‘relevant’ means within the scope of discovery as defined in this subdivision ...”  The “reasonably calculated” phrase has continued to create problems, however, and is removed by these amendments.  It is replaced by the direct statement that “Information within this scope of discovery need not be admissible in evidence to be discoverable.”

Committee Note to Rule 26, 2015 US Order 0017 (April 29, 2015).

That’s all well and good, but since amended Rule 26 became effective, it has become evident that some courts continue to do the same thing they’ve always done, giving lip service to the new rule, but effectively applying the old standard.  One recent example is Hodges v. Pfizer, Inc., 2016 WL 1222229 (D. Minn. March 28, 2016) – yet another Stevens-Johnsons Syndrome case, this time against Advil − in which the plaintiff sought, and obtained, excessive discovery concerning:  (1) dealings with foreign regulators (“seven countries and three areas,” id. at *3) who do not follow the same standards as the FDA; (2) “financial documents” concerning Advil, including “profits (gross and net) . . . sales forecasts, advertising budgets, business plans, marketing plans, and financial plans” for a ten-year period, id. at *4; and (3) old “sales and marketing documents . . . from before June 2005, when the FDA required manufacturers to include new warnings about” this condition.  Id. at *4.  While the opinion doesn’t mention the date of injury, we thought it might be 2010 (five years after the label change) and since we have a PACER account and know how to use it, we were able to confirm that date as correct.

All three requests were granted despite their obvious remoteness from a U.S. case involving a single injury in 2010.  Indeed, in 2010, any Advil made in 2005 would have long since been expired.  While the new rule was cited, it was construed solely by reference to pre-amendments cases – in particular, one holding that “relevance” in Rule 26 “is to be construed broadly and encompasses ‘any matter that bears on, or that reasonably could lead to other matter that could bear on, any issue that is or may be in the case.’”  Id. at *2 (quoting a 1997 D. Minn. case that in turn quotes Oppenheimer Fund, Inc. v. Sanders, 437 U.S. 340, 351 (1978)).

That’s where at least part of the problem lies.  Oppenheimer is obsolete – overtaken by at least two sets of rules amendments.  The case is almost 40 years old.  To use it to perpetuate the same broad view of discovery scope that the 2015 “claims or defenses” amendment to Rule 26 expressly rejected is unsupportable.  We discussed the intent of the 2015 amendments at length here, relying upon Chief Justice Roberts’ contemporaneous report concerning them.

So, what went down in Oppenheimer?  Oppenheimer was a securities class action.  Through discovery, the plaintiff demanded that the defendant essentially do plaintiff’s work for him – to provide the information that would identify who was, and was not, a member of the putative class.  Id. at 350.  The Court was asked to determine whether identification of class members war properly addressed by discovery, or alternatively under Fed. R. Civ. P. 23.  The Court held that Rule 23 controlled:

Rule 23 . . . deals comprehensively with class actions, and thus is the natural place to look for authority for orders regulating the sending of notice.  It is clear that Rule 23(d) vests power in the district court to order one of the parties to perform the tasks necessary to send notice. . . .  Since identification simply is another task that must be performed in order to send notice, we agree . . . that Rule 23(d) also authorizes a district court in appropriate circumstances to require a defendant’s cooperation in identifying the class members to whom notice must be sent.

Id. at 354-55 (footnotes omitted).  What about the discovery rules?  “[W]e do not think that the discovery rules are the right tool for this job.”  Id. at 354.

What that tells us is that what the Court had to say about the discovery rules generally – as they stood in 1978 – is entirely dictum.  Oppenheimer did not make any precedential ruling about discovery, or about Rule 26.  To the contrary, it held that that discovery rules were inapplicable.

Beyond that, the dictum in Oppenheimer is facially inapplicable to the new language of Rule 26.  The Court stated:

The key phrase in this definition − “relevant to the subject matter involved in the pending action” − has been construed broadly to encompass any matter that bears on, or that reasonably could lead to other matter that could bear on, any issue that is or may be in the case.

Id. at 315 (citing Hickman v. Taylor, 329 U.S. 495, 501 (1947) – a case about work-product protection) (emphasis added).  That “key phrase” no longer exists.  The phrase was precisely what the 2015 amendments got rid of, and the committee that drafted those amendments did so equally precisely (as quoted above – and there are more quotes to the same effect) to reduce the scope of discovery.

The phrase that Oppenheimer described in 1978 is simply no longer the test of discoverability.  Rather, “[p]roportional discovery relevant to any party’s claim or defense suffices, given a proper understanding of what is relevant to a claim or defense” is.  Committee Note to Rule 26, 2015 US Order 0017 (April 29, 2015).  Nor would Oppenheimer even support discovery into old labeling used long before an accident.  “[I]t is proper to deny discovery of matter that is relevant only. . . to events that occurred before an applicable limitations period, unless the information sought is otherwise relevant to issues in the case.”  437 U.S. at 352.

Unfortunately, Hodges is not alone in erroneously relying on the Oppenheimer’s obsolete observation as if it were somehow applicable to the “claims or defenses” scope-of-discovery standard in current Rule 26(b)(1).  The “key element” language is found in headnote six of Oppenheimer.  According to Westlaw, Oppenheimer has been cited in 73 cases since December 1, 2015.  Of those 73 cases, obsolete headnote six has been cited in 53 of them.  Plainly, a concerted effort is underway to misquote Oppenheimer – leaving out that the “key element” is precisely the language amended out of the rule – in order to gut the 2015 amendment.

A few examples should suffice.  The most recent case of the lot, Rhone v. Schneider National Carriers, Inc., 2016 WL 1594453 (E.D. Mo. April 21, 2016), granted a motion to compel while citing the Oppenheimer language – conveniently omitting the “key phrase” part and beginning its quotation with “broadly construed.”  Id. at *1.  In Lightsquared Inc. v. Deere & Co., 2015 WL 8675377 (S.D.N.Y. Dec. 10, 2015), although conceding that “discovery no longer extends to anything related to the ‘subject matter’ of the litigation,” the opinion nevertheless cited to Oppenheimer to hold that “relevance is still to be ‘construed broadly to encompass any matter that bears on, or that reasonably could lead to other matter that could bear on’ any party’s claim or defense.”  Id. at *2.  United States ex rel. Shamesh v. CA, Inc., 2016 WL 74394 (D.D.C. 2016), is even worse – using the obsolete Oppenheimer dictum to evade the 2015 amendments altogether:  “Like before, relevance is still to be ‘construed broadly to encompass any matter that bears on, or that reasonably could lead to other matter that could bear on’ any party's claim or defense.”  Id. at *7 (quoting Oppenheimer).

These decisions are simply erroneous.  Oppenheimer expressly construed language deleted by the 2015 amendments because it was being used to allow excessively broad discovery.  To the extent Oppenheimer is relevant to anything anymore, we recommend its holding that plaintiffs – the requesting party − be required to pay for discovery that they sought of electronically stored information:

Both opinions [below] suggest that the fact that part of these records are kept on computer tapes justifies imposing a greater burden on [defendants] than might be imposed on a party whose records are kept in another form. . . .

*          *          *          *

We do not think these reasons justify the order in this case.  There is no indication or contention that these petitioners have acted in bad faith to conceal information from respondents.  In addition, although it may be expensive to retrieve information stored in computers when no program yet exists for the particular job, there is no reason to think that the same information could be extracted any less expensively if the records were kept in less modern forms.  Indeed, one might expect the reverse to be true, for otherwise computers would not have gained such widespread use in the storing and handling of information.  Finally, the suggestion that petitioners should have used “different systems” to keep their records borders on the frivolous. . . .  [W]e do not think a defendant should be penalized for not maintaining his records in the form most convenient to some potential future litigants whose identity and perceived needs could not have been anticipated.

437 U.S. at 362-63

In short, it is disingenuous in the extreme for those pursuing discovery to justify their overreaching demands with obsolete dictum from Oppenheimer.  To do so only undermines the years of efforts that went into the reform of discovery represented by 2015 Amendments.

Friday, April 22, 2016

Innovator Drug/510k Medical Device Impossibility Preemption and the Meaning of “A Fortiori”

According to Black’s Law Dictionary, “a fortiori” is legal Latin meaning:

By even greater force of logic; even more so it follows .

We’ve been arguing for some time – since PLIVA v. Mensing, 131 S. Ct. 2567 (2011), and Mutual Pharmaceutical Co. v. Bartlett, 133 S. Ct. 2466 (2013), were first decided that − because they apply implied impossibility preemption − the principles that these cases enunciate are equally applicable to non-generic drug products, such as branded drugs and §510k-cleared medical devices.  Some cases have agreed with us.  You can find those (at least as to innovator drugs) on our post-Levine drug preemption cheat sheet.

The contrary cases, and there are a number of them, largely refuse to evaluate implied preemption on its merits.  Instead, they state that innovator drugs/§510k medical devices are “not generic drugs” and leave it at that.  E.g., Shipley v. Forest Laboratories, Inc., 2015 WL 4199739, at *9 (D. Utah July 13, 2015); In re DePuy Orthopaedics, Inc. Pinnacle Hip Implant Products Liability Litigation, 2014 WL 3557392, at *10-11 (N.D. Tex. July 18, 2014); In re Actos (Pioglitazone) Products Liability Litigation, 2014 WL 60298, at *8 (W.D. La. Jan. 7, 2014).  Occasionally a court gets into more detail, and the result is really hard to follow.  For example, Mullins v. Ethicon, Inc., ___ F. Supp.3d ___, 2015 WL 7761033 (S.D.W. Va. Dec. 2, 2015), gets off on the wrong track by holding the express preemption analysis in Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), “directly applicable” to implied impossibility preemption.  Mullins, 2015 WL 7761033, at *5.  Cf. Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341, 352 (2001) (“neither an express pre-emption provision nor a saving clause bars the ordinary working of conflict pre-emption principles”) (citation and quotation marks omitted).  Then Mullins invoked the “uniqueness” of generic drugs to reject preemption of design claims even though it was undisputed that the FDA would have to approve a supplement before the design change could be implemented:

The impossibility in Mensing arose from the unique “duty of sameness” imposed on generic drugs, which has no corollary in the medical device context. . . .  The Supreme Court has cited Mensing in two subsequent majority opinions, but has nowhere referred to “special permission and assistance” in a preemption analysis. . . .  In Mensing, there was no official regulatory process by which a generic could change its label, so the generic manufacturer was “barred” from taking the action state law required.  This is completely different from the defendants’ situation . . . [where] [t]he law simply requires that manufacturers making a “significant change” submit another 510(k) notification, which the FDA will clear if  making a “significant change” submit another 510(k) notification, which the FDA will clear if it determines the device is substantially equivalent to a device already on the market.

Mullins, 2015 WL 7761033, at *5-6 (citations omitted).

Mullins and similar cases, however, do not accurately describe either Mensing or Bartlett.

What Mensing really held was this:

If the Manufacturers had independently changed their labels to satisfy their state-law duty, they would have violated federal law. . . .  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.

*          *          *          *

The question for “impossibility” is whether the private party could independently do under federal law what state law requires of it.

131 S. Ct. at 2578-79.

What Bartlett really stated was that it was equally “impossible” to comply with an immediate state-law duty to change a design where FDA pre-approval was required, because “[o]nce a drug − whether generic or brand-name − is approved, the manufacturer is prohibited from making any major changes.”  Id. at 2471.  The manufacturer could not “independently chang[e]” its product, “[t]hus, federal law prohibited [defendant] from taking the remedial action required to avoid liability under [state] law.”  Id. at 2476.  “When federal law forbids an action that state law requires, the state law without effect.”  Id. at 2477 (citation and quotation marks omitted).

However, it’s getting harder for courts to stick their fingers in their ears and chant “not generic, not generic, not generic” in response to preemption arguments based on agency pre-approval arguments.  As we’ve already chronicled, two courts of appeals have previously made the easiest jump – the one mentioned in Bartlett – and have applied Mensing/Bartlett impossibility preemption to innovator drugs.  See Yates v. Ortho-McNeil-Janssen Pharmaceuticals, Inc., 808 F. 3d 281 (6th Cir. 2015); In re Celexa & Lexapro Marketing & Sales Practices Litigation, 779 F.3d 34 (1st Cir. 2015).

Now there are three, and the latest is the most a fortiori of the lot.

The Third Circuit has applied the Mensing/Bartlett impossibility preemption rationale outside of the FDCA altogether, to preemption of design defect claims involving airplanes.  Sikkelee v. Precision Airmotive Corp., ___ F.3d ___, 2016 WL 1567236 (3d Cir. April 19, 2016).  Since the Mensing/Bartlett preemption rationale can apply to a completely different statutory scheme – a fortiori it applies to other FDCA-governed and FDA-regulated products such as innovator drugs and §510k medical devices.

After rejecting a field preemption argument under the Federal Aviation Act (something with no FDCA-related analogy), Sikkelee turned to impossibility preemption:

In addition to field preemption, federal law may supersede state law through conflict preemption.  This occurs when a state law conflicts with federal law such that compliance with both state and federal regulations is impossible[.]  PLIVA, Inc. v. Mensing, 131 S. Ct. 2567, 2577 (2011).

Sikkelee, 2016 WL 1567236, at *5.

Skikelee held that Mensing/Bartlett impossibility preemption would preempt “analogous” design defect claims that FAA regulations classified as “major” and thereby must be approved by the FAA before being implemented:

[W]hen confronting an analogous preapproval scheme for pharmaceutical labeling, the Supreme Court has held that, where manufacturers are unable to simultaneously comply with both federal and state requirements, state law design defect claims are conflict preempted. . . .  [citing Mensing and Bartlett].  Before a new drug may legally be distributed in the United States, both its contents and its labeling must be preapproved by the FDA. . . .  [C]laims against generic drug manufacturers cannot survive a conflict preemption analysis because the generic manufacturers are bound by federal law to directly mimic their brand-name counterparts.  [citing Mensing and Bartlett].  Ultimately, where a party cannot “independently do under federal law what state law requires of it,” the state law is conflict preempted.  [citing Mensing].

Sikkelee, 2016 WL 1567236, at *18 (emphasis added) (various citations and footnote omitted).

There’s that “independent” action implied preemption principle again.

That principle – that mandatory agency action prior to approval equals impossibility preemption − applies equally to airplanes subject to FAA pre-approval design requirements for “major” design changes:

The same considerations apply to the case before us.  The FAA’s preapproval process for specifications . . . precludes a manufacturer from making at least “major changes” to a design aspect without further preapproval, means a manufacturer may well find it impossible to simultaneously comply with both [FAA] specifications and a separate − and perhaps more stringent − state tort duty.  Thus, there may be cases where a manufacturer’s compliance with both the [FAA] and a state law standard of care “is a physical impossibility”. . . .  In such cases, the state law claim would be conflict preempted.  For, even if an alternative design aspect would improve safety, the mere “possibility” that the FAA would approve a hypothetical application for an alteration does not make it possible to comply with both federal and state requirements: As the Supreme Court observed in [Mensing], if that were enough, conflict preemption would be “all but meaningless.”

Sikkelee, 2016 WL 1567236, at *19 (emphasis added) (various citations and footnote omitted).

But what about Lohr?  Sikkelee addressed the difference between express and implied preemption as well:

Together these cases [Lohr and Riegel] reflect a narrow, rather than sweeping, approach to analyzing the preemptive contours of a federal premarket approval scheme. . . .  Here, confronted with a similarly exhaustive preapproval process governing aircraft manufacture and design and no express preemption clause, we see no justification for going further than the Supreme Court elected to go in Riegel or Lohr. . . .

Sikkelee, 2016 WL 1567236, at *19.  Therefore, while there was no “field” preemption of product liability claims under the FAA, there could be implied preemption of particular design claims where prior FAA approval precluded immediate adoption of a plaintiff’s supposedly safer design under state law.

We thus read Riegel not to bestow field preemptive effect on [aircraft designs], but rather to counsel in favor of narrowly construing the effect of federal regulations on state law − much like the conflict preemption analysis undertaken in Bartlett and [Mensing].


As a last gasp, the plaintiffs in Sikkelee criticized the quality of FAA oversight, much as our opponents have criticized the FDA.  Once again, the Third Circuit recognized that the two situations were analogous:

This very same argument, however, was raised in Bartlett and failed to carry the day.  While the dissenters decried that granting “manufacturers of products that require preapproval . . . de facto immunity from design-defect liability” would force the public “to rely exclusively on imperfect federal agencies with limited resources,” the majority held that because generic drug manufacturers are required to directly mirror the preapproved labels of their brand-name counterparts and are thus “prohibited from making any unilateral changes” to their labels, state law design defect claims were foreclosed by “a straightforward application of pre-emption law”. . . .  Thus, the reasoning of the Bartlett majority, and the consideration we must give to the FAA’s views under separation of powers principles, lead us to conclude that the FAA’s preapproval process for aircraft component part designs must be accorded due weight under a conflict preemption analysis.

Sikkelee, 2016 WL 1567236, at *23 (emphasis added) (citations omitted).  Thus, while there is no field preemption of product liability claims under the FAA, like there isn’t under the FDCA, design claims remain “subject to traditional conflict preemption principles.”  Id.

While not accepting the defendants’ field preemption arguments, Sikkelee is a resounding reaffirmance of the universality of implied conflict preemption principles.  Since Mensing/Bartlett impossibility preemption applies to airplanes – governed by a totally separate statutory scheme – “by even greater force of logic” those same principles must apply to other FDA-regulated products, such as innovator drugs and §510k medical devices, whenever plaintiffs contend that some state-law duty forces these products’ manufacturers to make an immediate product alteration that, under the FDCA, requires prior FDA approval.

Thursday, April 21, 2016

Georgia MDL Court Muddles Utah Law

            We aren’t going to mince words today.  We don’t like Christiansen v. Wright Medical Technology Inc., MDL 2329, 2016 U.S. Dist. LEXIS 46409 (N.D. Ga. Apr. 5, 2016).  It is an opinion on post-trial motions in a case that went to trial in the Conserve Hip Implant Products Liability Litigation.  It’s a beautiful spring day here in the Mid-Atlantic and we hope that’s true where you are.  If it is, and if anything in this post makes you interested in the greater details and nuances of the decision, we recommend taking it outside, sitting under a tree, and enjoying some fresh air.  You should at least have pleasant surroundings while you try to get through it.  It’s long, and tedious, and frankly, muddled.  So, we are going to try to focus in on the key parts – so that we might also try to get out and enjoy some of this fine weather.

            Christiansen is a hip implant case.  It went to trial on 5 theories of liability:  strict liability design defect, negligent design defect, fraudulent misrepresentation, fraudulent concealment, and negligent misrepresentation.  Id. at *2-3.  Apparently the court had dismissed plaintiff’s failure to warn claim on summary judgment.  Id. at *69 n.18.  The jury ultimately returned a verdict finding the hip implant was defectively designed and caused plaintiff’s injuries and awarded $550,000 in compensatory damages.  The jury also found in favor of the defendant on the fraudulent misrepresentation and concealment claims, but awarded another $450,000 to plaintiff on his negligent misrepresentation claim and $10 million in punitives.  Id. at *18. 

But that wasn’t the jury’s first verdict.  It’s first verdict, delivered days earlier, answered the first question on the Verdict Form – do you find the hip implant was defectively designed – in the negative.  Id. at *6.   While that should have been the end of the inquiry, the jury didn’t understand the instruction to not go any further and they kept answering the verdict form.  So, they went on to find that defendant had made negligent misrepresentations and awarded plaintiff $662,500 in compensatory damages and $2.5 million in punitives.  Id. at *7. 

Clearly the jury was confused.  Clearly the responses on the verdict form were inconsistent.  But, just as clearly – a unanimous jury found that the hip implant was not defective.  We, like the defendant, believe that’s where the case should have ended.  Without a defect, plaintiff had no right to recovery against defendant.  Id. at *5.  That’s why the verdict form was written the way it was.  The jury may have mistakenly gone on to respond to the question about misrepresentation – but that shouldn’t have mattered.   

Instead the court sent the jury back with the form and told them to read it again.  When they still didn’t understand, the court decided it needed to be rewritten.  You read that right.  After the jury had deliberated to a verdict, the court decided to rewrite the verdict form and send the jury back to deliberate a second time.  Maybe that’s been done before, but we’ve never encountered it.  It plainly should have been a mistrial at worst, and a defense verdict at best.

Anyway, then the court re-charged the jury and sent them back with modified – pro-plaintiff – instructions.  At this point, a new wrinkle is added.  With the new instructions – the jury is no longer unanimous.  One juror is no longer on board.  We, like the defendant, think this juror likely understood the first verdict form and now disagreed with the remaining jurors’ changing the answer to the defect question, as the sole reason to change the answer to that question was to award the plaintiff money.  The facts hadn’t changed.  The charge hadn’t changed.  What had changed was the jury’s understanding that they had to say yes to question 1.

Mistrial now?


Instead, the court purged the jury of its evidently most pro-defense member, and with him so too disappeared those parts of the verdict form that had previously favored defendant. 

The defendant challenged the verdict on the original no-defect ruling being dispositive, juror confusion, and on the dismissal of the juror.  Not surprisingly, given that the same judge had made these prior rulings, that challenge was to no avail.  We’ll leave the details to your leisure time reading.  Id. at *22-55. 

            The flubs surrounding the verdict, however, were not the only problems with this case.  Defendant had ample substantive challenges as well.  The most significant of which was the court blatantly ignoring Utah law on comment k and design defect.  While comment k is applied differently state-to-state, make no mistake that Utah is one of the most solid comment k states for prescription products:

We agree with the principle comment k embodies, that manufacturers of unavoidably dangerous products should not be liable for a claim of design defect.  We are persuaded that all prescription drugs should be classified as unavoidably dangerous in design because of their unique nature and value, the elaborate regulatory system overseen by the FDA, the difficulties of relying on individual lawsuits as a forum in which to review a prescription drug's design, and the significant public policy considerations. . . .

Grundberg v. Upjohn Co., 813 P.2d 89, 95 (Utah 1991).  Based on this, we don’t understand how the design defect claims even made it to trial.  But, since they did, and since Utah law is so strong, the jury charge should have been clear.  Nope.  The Utah model jury instruction on comment k says that to establish a product is unavoidably unsafe, a defendant must prove that “(1) when the product was made, it could not be made safe for its intended use even applying the best available testing and research; and (2) the benefits of the product justified its risk.”  Christiansen, at *61.  Easy enough for a prescription-only medical device.  But the Christiansen court tacked on a third requirement.  Defendant also had to prove that the device “was accompanied by proper directions or warnings.”  Id. at *63.  Not only is this not Utah law (the citations in the opinion are to Georgia, not Utah law), but there was no warning-related claim in this case.  That’s right, after failure to warn was dismissed on summary judgment, the court brought it back under the guise of (certainly not Utah) comment k.  But more than that, the court effectively shifted the burden at trial to defendant to prove its warning adequate. 

            And when the jury found the device was defective, guess which is the only element of the court’s comment k charge it found defendant failed to prove – warnings.  Id. at *65.  So, if the court had correctly applied Utah law at the outset, the design defect claim would have been dismissed.  If the court had correctly charged the jury on Utah law, the jury would have found in favor of defendant.  Two strikes.  The third was finding no error.  Id. at *66-75.

            At this juncture, we have to point that this process was entirely ultra vires under Erie v. Tompkins, 304 U.S. 64 (1938).  As we have pointed out many times in the past -- a federal court sitting in diversity is not supposed to create new expansive forms of state-law liability, as this court did – twice – with comment k and design defect.

            Finally, on the misrepresentation and concealment claims, the jury found for the plaintiff on negligent misrepresentation based on statements by a sales rep that went beyond the package insert.  The jury did not find defendant’s actions rose to the level of fraudulent conduct.  But the court went on to allow a punitive damages claim anyway based on reckless indifference to a “substantial risk.”  But the decision seems to ignore the substantiality of the risk, and allows punitive damages solely on the basis that the device had not been adequately tested and the risk wasn’t known, not that it was actually substantial.  Id. at *95-97.  That’s not proper either, as our post last year on substantiality and punitive damages points out, both Utah and Georgia require a high likelihood of injury before punitive damages are allowed.  Action Marine, Inc. v. Continental Carbon Inc., 481 F.3d 1302, 1313 (11th Cir. 2007) (punitive damages permissible “where the actor believes that the consequences of his act are substantially certain to result from [it]”) (applying Georgia law) (emphasis added); Daniels v. Gamma W. Brachytherapy, LLC, 221 P.3d 256, 269 (Utah 2009) (punitive damages permissible where the conduct involved a “high degree of risk”) (following Restatement (Second) §500) (emphasis added).

            While the court reduced the amount of the punitive award to $1.1 million, under the evidence described in the opinion, punitive damages had no business going to the jury in the first place.

            There is a lot going on in this decision and most of it is bad.  We hope the defendant has better luck with a do-over on appeal than it did with the jury’s do-over verdict.