Today we bring you the DDL blog version of the “duck test.”  The “duck test” goes like this – if it walks like a duck, swims like a duck, and quacks like a duck, then it probably is a duck.  When you see a duck swimming in a pond, you don’t normally say:  “hey, look at that bird.”  You know a duck when you see one and that’s what you call it.  Well, we think the same rule applies to medical devices and medical devices are not consumer goods.

The court in McCurdy v. Wright Med. Tech., Inc., 黑龙江福彩网app官方下载 U.S. Dist. LEXIS 31804 (D. Del. Feb. 25, 黑龙江福彩网app官方下载) agreed.  Plaintiff had hip replacement surgery in which hip replacement components manufactured by the defendant were implanted in 2011.  Id. at *3.  Plaintiff developed problems requiring removal of the device in 2017.  Id.  Plaintiff’s complaint included claims for strict liability, negligence, negligent misrepresentation, fraudulent misrepresentation, and breach of express and implied warranty.  Id. at *2.

Defendant moved to dismiss the breach of warranty claims on the ground that they were time barred.  At the heart of the issue was whether the hip replacement device was a consumer good or a non-consumer good.  Under Alabama law, for a non-consumer good, the statute of limitations begins to run at the time the tender of delivery was made which would be at the time of implant in 2011.  For consumer goods, the statute runs from the date of injury which plaintiff argues would have been at the time of explant in 2017.  Alabama defines consumer goods as “goods that are used or bought for use primarily for personal, family, or household purposes.”  Id. at *14.  At this point, from a completely non-legal, practical application point of view, you should be thinking about things like toasters, hair dryers, televisions, and washing 黑龙江福彩网app官方下载.  We don’t think anyone, if being honest, when asked to identify a consumer good would say “my metal hip,” “my hernia mesh,” “my pacemaker,” or my “my bone screws.”  If it doesn’t walk, swim, or quack like a duck, it’s probably not a duck.

The Alabama Supreme Court has not ruled on this issue, but a federal Alabama court considering a similar argument found that a medical device “is clearly inconsistent with [Alabama’s] definition of consumer good.”  Id. at *16.  Plaintiff offered no authority or reasoned argument for the Delaware court to find differently.  Therefore, plaintiff’s breach of warranty claims were dismissed as time barred.

There are a smattering of references on the blog to other cases holding that implanted medical devices are not “consumer goods.”  The issue arises in various contexts and has various consequences, most of which are good for defendants – such as barring breach of warranty claims.  The issue has also been used to successfully defeat consumer fraud claims as most consumer protection statutes similarly limit recovery to goods for personal, family or household use.  So, while the holding led to a time-barred claim in this case, if followed, it could have other favorable consequences in other cases.

One way to remove a case to federal court that we haven’t discussed much is where the defendant is either a “federal officer” (not terribly relevant to our line of work), or else is a “person acting under that officer . . . for or relating to any act under color of such office.”  28 U.S.C. §1442(a)(1).  We haven’t paid it much heed since the disastrous Watson v. Philip Morris Cos., 551 U.S. 142 (2007), decision seemingly closed the door on cases involving regulatory compliance.  Our post on Watson is here.

A recent decision by the en banc Fifth Circuit suggests that our side should take another look at federal officer removal in certain FDA regulatory compliance situations.  See Latiolais v. Huntington Ingalls, Inc., ___ F.3d ___, 黑龙江福彩网app官方下载 WL 878930 (5th Cir. Feb. 24, 黑龙江福彩网app官方下载) (en banc).  In a rarity for en banc decisions, Latiolais was unanimous, save only a couple of concurrences in the result with no opinion.

The chief reason federal officer removal warrants reconsideration is that – since the 2007 Watson decision – in 2011 Congress amended §1442(a)(1) specifically to “broaden” defendants’ ability to remove on this basis.  Latiolais, 黑龙江福彩网app官方下载 WL 878930, at *3.  Here’s the meat of the decision:

The amending legislation . . . states, “Section 1442(a) of title 28, United States Code, is amended . . . by striking “capacity for” and inserting “capacity, for or relating to.”  Following this amendment, section 1442(a) makes removable to federal court “[a] civil action . . . that is against or directed to . . . any person acting under [a federal] officer … for or relating to any act under color of such office.”

This change plainly expresses that a civil action relating to an act under color of federal office may be removed (if the other statutory requirements are met). . . . [T]he ordinary meaning of the words “relating to” is a broad one. . . .  Congress added this “broad” term to “for”. . . .  By the Removal Clarification Act, Congress broadened federal officer removal to actions, not just causally connected, but alternatively connected or associated, with acts under color of federal office.

Id. at *3 (citations and quotation marks omitted) (emphasis added).  Since Congress changed the statute to broaden removal, the restrictive, pre-amendment reading in Watson isn’t the last word anymore.

So, what “other statutory requirements” are there?  Chiefly these:

[W]e overrule [prior precedent] to the extent that those cases erroneously relied on a “causal nexus” test after Congress amended section 1442(a) to add “relating to.”  Henceforth, to remove under section 1442(a), a defendant must show (1) it has asserted a colorable federal defense, (2) it is a “person” within the meaning of the statute, (3) that has acted pursuant to a federal officer’s directions, and (4) the charged conduct is connected or associated with an act pursuant to a federal officer’s directions.

Latiolais, 黑龙江福彩网app官方下载 WL 878930, at *7 (footnote omitted).

Well, in cases where a medical device manufacturer is acting pursuant to specific FDA requirements imposed on its product, or a prescription drug manufacturer is complying with an FDA directive to use X rather than Y warning due to the FDA’s assessment of current science, preemption would seem to be a “colorable federal defense.”  As Latiolais also held:

To be “colorable,” the asserted federal defense need not be clearly sustainable, as section 1442 does not require a federal official or person acting under him to win his case before he can have it removed.  Instead, an asserted federal defense is colorable unless it is immaterial and made solely for the purpose of obtaining jurisdiction or wholly insubstantial and frivolous.

Id. (citations and quotation marks omitted).

That’s a far cry – and much more friendly to removal − from the general federal question jurisdiction test under Grable & Sons Metal Products, Inc. v. Darue Engineering & Manufacturing, 545 U.S. 308 (2005), and its progeny, where no federal officer is involved.  As we’ve discussed, a federal defense like preemption is not usually enough to support federal question jurisdiction under 28 U.S.C. §1331.

Further, the same facts that support preemption in these situations also support arguments that a prescription medical product manufacturer defendant “acted under” the FDA’s direction as required by the more relaxed, post-2011 test for federal officer jurisdiction.  As Latiolais held, any “action” “not just causally connected, but alternatively connected or associated, with” obeying the dictates of a federal officer such as the FDA is sufficient to support federal jurisdiction under §1442(a)(1).  Thus, “any civil action that is connected or associated with an act under color of federal office may be removed.”  黑龙江福彩网app官方下载 WL 878930, at *7.  Another advantage of federal officer removal is that it doesn’t require the consent of anyone else.

In light of Latiolais, we recommend that defense counsel in prescription medical product liability litigation – when they have a preemption argument that is at least “colorable” − take another look at federal officer jurisdiction under §1442(a)(1) as a possible basis for removal to federal court.

We don’t write a lot about our neighboring state of Arizona, but a recent hip replacement case in the District of Arizona caught our eye.  We lived in Arizona for a year back in the mid-1990s, and it is a genuinely interesting and underestimated place.  The 2010 census results have Phoenix as the sixth largest city in the U.S., but it has since surpassed Philadelphia to move into fifth place, behind only New York, Los Angeles, Chicago, and Houston.  Since the time we lived there, Phoenix has gained a baseball team, a hockey team (hockey in the desert?!), and a glimmering new football stadium that has hosted numerous Super Bowls.  If you go to the state Capitol, you will see a maritime memorial in the plaza, which seems odd for a landlocked state—until you move closer and see that the memorial is an anchor from the U.S.S. Arizona, which remains at its final resting place (minus one anchor) in Pearl Harbor.

The Arizona State Courts Building, where the state Supreme Court resides, was completed in 1991, and the inscription carved above the public entrance reads “Where Law Ends, Tyranny Begins.”  That jewel was suggested by a prominent local attorney, and it was selected for use by a then-sitting justice, the late Robert Corcoran.  We had the good fortune to know Justice Corcoran (the Drug and Device Law Spouse clerked for him), and we think his chosen quote is as instructive today as it was when Arizona broke ground for its new courthouse 30 years ago. Maybe more.

But what about the hip case.  The case is Casey v. Wright Medical Technology, Inc. No. CV-19-05360, 黑龙江福彩网app官方下载 WL 736306 (D. Ariz. Feb. 13, 黑龙江福彩网app官方下载), and there are two points that we will highlight:  First, the district court is one of several within the Ninth Circuit that has applied Rule 9(b)’s heightened pleading standard to negligent misrepresentation claims.  Other district courts have gone the other way, but the Casey order sets forth an analytical framework that deserves some attention.

The plaintiff was treated with the defendant’s hip replacement device and unfortunately underwent a number of revision surgeries.  She later sued the manufacturer and alleged, among other things, that the manufacturer negligently misrepresented properties of the device, but otherwise offered few specifics.  Id. at *1-*2.  The defendant moved to dismiss the complaint on a number of bases, including that the plaintiff failed to plead fraudulent misrepresentation with sufficient particularity under Federal Rule of Civil Procedure 9(b).  Id. at *3.

This is not an obscure issue.  Defendants have often implored federal courts to require plaintiffs to plead negligent misrepresentation with particularity, but courts have split on the issue.  The Casey case applied a two-step analysis that the court pulled from Ninth Circuit authority:

When deciding whether Rule 9(b) applies to a claim, a court must first determine whether fraud is an essential element of that claim.  If so, Rule 9(b) applies. . . .  If not, Rule 9(b) can nevertheless apply if “the claim is said to be ‘grounded in fraud’ or to ‘sound in fraud.’” . . .  As the Court of Appeals explained in Vess [v. Ciba-Geigy Corp. USA, 317 F.3d 1097, 1106 (9th Cir. 2003)], should a plaintiff allege a “unified course of fraudulent conduct” and rely “entirely on that course of conduct as the basis of a claim,” that claim is “grounded in fraud . . . and the pleading of that claim as a whole must satisfy the particularity requirement of Rule 9(b).”

Casey, 黑龙江福彩网app官方下载 WL 736306, at *4 (quoting Vess).  Applying the first step, fraud was not an essential element of the plaintiff’s claim for negligent misrepresentation, which is a separate tort under Arizona law “governed by the principles of . . . negligence.”  Id. at *5.

The second step, though, triggered Rule 9(b), as the Casey plaintiff’s claim was “grounded in fraud.”  Id.  The plaintiff alleged that the defendant consciously disregarded risks and consciously marketed its product despite awareness of an “unreasonably dangerous condition,” which echoes boilerplate descriptions of a product defect.  Id.  The court ruled that these allegation s were “more indicative of fraud” and further ruled that the plaintiff’s allegations were not sufficiently particular.  Id. at *5-*6.  She did not allege who made the alleged misrepresentations, who published and distributed allegedly false marketing materials, when they were published, and to whom.  “In short, Casey has not come close to averring the ‘who, what, when, where, and how of the misconduct charged.’”  Id. at *6 (quoting Vess).

Second, the district court dismiss the plaintiff’s prayer for punitive damages under an Arizona statute barring punitive damages where the product gained governmental approval or clearance, which is true for all implanted medical devices legally marketed in the United States.  The statute is Arizona Revised Statutes section 12-689, and we commend it to anyone litigating product liability claims under Arizona law.  For those who split hairs over the difference between an “approved” medical device and a “cleared” medical device, Arizona law should cover either kind:  The statute applies to products sold “according to the terms of an approval, conditional approval, clearance, license or similar determination of a government agency.”  Id. (emphasis added).  Because the FDA cleared the plaintiff’s hip devices under the 510k Premarket Notification process, and because none of the statute’s four exceptions applied, the district court dismissed the prayer for punitive damages without prejudice.  In all, a good result from the Valley of the Sun.