Private Right Of Action

            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

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

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,

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. AmerisourceBergen litigation involving the then novel concept of liability of non-counterfeiters 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.


Continue Reading Twice Nice?

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

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.


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

One of us had a conversation yesterday with a lawyer (who will remain nameless because we haven’t asked otherwise) about off-label use issues in a malpractice case against a doctor who used something called a Nidek Laser in eye surgery.  We haven’t looked at any facts of any case or about the device.  We know

We have a weakness for holiday-themed posts, so it’s a pity the recent Vicks Vitamin C case didn’t come out around Mother’s Day. You’ll see why in a few short paragraphs.

The case, Loreto v. Procter & Gamble, No. 1:09-cv-815 (N.D. Ohio Sept. 3, 2010), was a class action claiming that Defendant misled consumers

The Ninth Circuit just issued a major decision reaffirming the principle that FDA exclusive enforcement powers prohibit plaintiffs from bringing what amount to private FDCA violation claims in the guise of private civil litigation.  See Photomedex, Inc. v. Irwin, No. 07-56672, slip op. (9th Cir. April 15, 2010).

First, an aside. Are we reading that number right?  This is a 2007 appeal?  We’ve heard criticism that the Ninth Circuit has become too big and ponderous, but we never thought about it all that much – being on the opposite coast.  Well, if the Ninth Circuit’s got a three-year appeal backlog, that’s just too much, and something really ought to be done to divide that court in half, or some other approach.  Justice delayed is justice denied, and so on and so forth….  Is the Ninth Circuit simply to big to succeed?

But back to the main point.

We’ve gone on until we’re blue in the face about how 21 U.S.C. §337(a) represents express congressional policy that nobody but the government (that is, the Department of Justice or the FDA) can seek to enforce the Food, Drug and Cosmetic Act (“FDCA”) in a court of law.  We’d list some posts, but there are, frankly, too many of them, so here’s the search results for “337(a).”

The no-private-right-of-action argument is especially important in dealing with negligence per se claims and the so-called “parallel violation” claims that are essentially the only avenue arguably left open to plaintiffs in Class III PMA medical device cases after Riegel v. Medtronic, Inc., 552 U.S. 312 (2008).


Continue Reading FDA Exclusive Enforcement, Lanham Act Division