Search "regulate the practice of medicine"

We are no  strangers to odd facts leading to odd results. The law develops in response to situations.  When new or different situations arise, courts have to interpret the existing law and then apply it to the new circumstances.  Usually the changes evolve over time – a twist here, a turn there.  Legal precedent is hardly ever a straight line.  There are even a few right angle turns and the occasional u-turn.  Sure, there are a few straightaways as well – concepts so deeply rooted as to withstand almost any challenge.  But more often than not, when there is a true dispute, it’s about those twists and turns. The places where authority is split or where the precise issue has yet to be dealt with.  And when you have both unique facts and split authority – you get decisions like Raab v. Smith & Nephew, Inc., — F.Supp.3d –, 2015 WL 9026631 (S.D.W.Va. Dec. 15, 2015).

Plaintiff underwent a hip resurfacing surgery in which defendant’s PMA, Class III medical device was implanted.   Due to a fracture of the device, a revision surgery was needed during which some of the PMA device components were replaced with Class II, §510k cleared components.  Plaintiff suffered complications after that surgery as well and eventually underwent a third surgery where all of the defendant’s devices were removed.  Id. at *1.

Recognizing that she would be facing a preemption challenge to any allegations concerning the PMA device, plaintiff broke her complaint into three sections.  Section I focused exclusively on the first surgery and purported to allege parallel violation claims premised on the FDCA’s Current Good Manufacturing Practices (CGMPs). Section II focused on the revision surgery and off-label use/promotion allegations.  Id. at *2.  Section III was directed only at the Class II device that was inserted during the second surgery and alleged strict products liability, breach of implied and express warranties, and failure to warn.  Id. at *3.

The Raab decision is long and thorough.  It devotes pages to discussing the FDCA, pre-market approval and 510k clearance. It also contains a detailed discussion of the core preemption decisions – albeit slightly skewed in our opinion. It is in the application of that precedent where things get a little wonky.Continue Reading Odd Facts Lead to Unfortunate Split Preemption Decision

This post is from the non-Reed Smith side of the blog only.

For the last two years during the week of Halloween, we’ve posted about the scary case of United States v. King-Vassel, 728 F.3d 708 (7th Cir. 2013), trial court decision at 2012 U.S. Dist. LEXIS 152496 (E.D. Wisc. Oct. 23, 2012).  It is an eerie tale in which one doctor tries to hold another doctor liable under the False Claims Act for prescribing a drug off-label.  The trial court dismissed the case but on narrow grounds – leaving the door open to resurrection.  Think Glenn Close springing out of the tub at the end of Fatal Attraction.  The district court only drowned the claims and instead of putting a bullet through the heart of the complaint, the Seventh Circuit administered CPR.    While there were a lot of weird and frightening things going on in that case, what was more important to us was why the case wasn’t thrown out on the general principle that off label prescriptions are not false claims.

Well if the last two years were all Freddy and Jason and Chucky — this year is more like It’s the Great Pumpkin, Charlie Brown or Monsters, Inc., or even Casper, The Friendly Ghost.  No zombies, demons or ghouls this year.  This year we’re celebrating the treat of a judge who gets it.

The claim in United States v. DJO Global, Inc., __ F. Supp.2d __, 2014 WL 4783575 (C.D. Cal, Sep. 2, 2014) reads like a sequel – actually more like the 20th installment in a franchise.   The recurring plot being use of the False Claims Act to reap financial windfalls from appropriate off-label prescriptions involving federal payors.  Plaintiffs allege that the defendants, manufacturers of spinal stimulators (PMA, Class III medical devices), submitted false claims to Medicare seeking reimbursement for devices that were used off-label.  To be covered under Medicare, a medical device needs to be “reasonable and necessary” to diagnosis or treatment.  Part of the determination of whether something is reasonable and necessary is whether the device is safe and effective.  Id. at *3-4.  Because the FDA determines safety and efficacy as part of the pre-market approval process, the Department of Health and Human Services (HHS) has determined that PMA devices generally may be covered under Medicare.  Id. at *4.Continue Reading Qui Tam Off-Label Treat

Just how far can a state go in regulating prescription drugs?  The simple answer is that states can go nowhere and that FDA is king in this field under the FDCA and the Supremacy Clause.  But we all know that it is not that simple.  We are reminded every day when we come to work that states regulate prescription drugs by allowing state-law tort lawsuits, although federal preemption is a mighty shield where it applies.  We are also aware that states regulate the practice of medicine, as well as regulating the pharmacies that dispense prescription drugs on doctors’ orders.

So before we blithely tell our various state regulators to stand down and keep their hands off, let’s take a more nuanced view, including revisiting what is going on in Massachusetts over the narcotic pain medication Zohydro.  As we have previously said, Zohydro ER is an extended release version of hydrocodone, but it is the only hydrocodone analgesic on the market whose sole active ingredient is hydrocodone.  Others contain acetaminophen, and removing that component mitigates the risk of liver damage for which acetaminophen is well known.
After the FDA approved Zohydro in December 2013, the state of Massachusetts and others tried to prohibit its use because of concerns over abuse.  In Massachusetts, the state issued an emergency order banning the prescription, ordering, dispensing, and administration of Zohydro—essentially a state-law order taking an FDA-approved drug off the market.  On April 15, 2014, the District of Massachusetts enjoined the law as an obstacle to the purposes and objectives of Congress.  In other words, it was a textbook example of implied conflict preemption, and the only solution was for the state requirement to give way, which is what the district court held in granting a preliminary injunction. Zogenix, Inc. v. Patrick, No. 14-11689-RWZ, 2014 WL 1454696 (D. Mass. Apr. 15, 2014).  Our post on that decision is here.

Continue Reading Testing the Limits of Prescription Drug Preemption

In July, 2011 we posted about the post-Sorrell citizen petition that seven major drug companies filed with the FDA concerning the Agency’s restrictions on truthful off-label promotion.

On June 6, 2014, the FDA “granted” the petition.  It’s nothing like D-Day, however.  Nothing earth-shattering here.  The FDA’s “grant” is more like a “dodge.”

That being said, the FDA’s response is still interesting, sometimes as much for what the Agency didn’t say as for what it did.  The petition dealt with the FDA’s convoluted regulatory positions on four situations involving the dissemination of medical and scientific information about off-label uses:

  1. Manufacturer responses to unsolicited requests;
  2. Scientific exchange;
  3. Interactions with formulary committees, payors, and similar entities; and
  4. Dissemination of third-party clinical practice guidelines.

FDA Response at 2.  The petitioners also asked in a 2013 supplement (that is, after the Caronia decision) “that [FDA] provide clear interpretations of key definitions to assure that our regulatory scheme better aligns with . . . the limitations under the First and Fifth Amendments.”  Id. at 3.Continue Reading Less To This “Grant” Than Meets The Eye

Every now and then we run into a decision that we think is wrong in so many different ways that we call it an example of “spherical error” – that is, error no matter how one looks at it.  We only do that rarely.  Back in May, 2010 we first applied that description to In re Gadolinium-Based Contrast Agents Products Liability Litigation, 2010 WL 1796334 (N.D. Ohio May 4, 2010).  Then in September of that year we likewise identified spherical error in Sheet Metal Workers Local 441 Health & Welfare Plan v. GlaxoSmithKline, PLC, 737 F. Supp.2d 380 (E.D. Pa. 2010) – or at least the Pennsylvania part of it, which dealt with the law we knew best.

That’s it – two cases earned that sobriquet in the blog’s six-plus years of existence.

Make that three.

The recent decision in Arters v. Sandoz Inc., 2013 WL 308768 (S.D. Ohio Jan. 25 2013), likewise bollixed up the law in so many different ways that we think it rises (falls?) to the level of spherical error.

Arters involved a question that a lot of courts have considered lately with almost (but not quite) uniformly good results – preemption in the context of generic drugs following PLIVA v. Mensing, 131 S. Ct. 2567 (2011).  As in many generic preemption cases, the defendant sought to have the case dismissed under Rule 12.

That – Rule 12 – is the first error in Arters.  The decision states:

A motion for judgment on the pleadings pursuant to Rule 12(c) should not be granted “unless it appears beyond doubt that the plaintiff can prove no set of facts in support of his claim which would entitle him to relief.”  Conley v. Gibson, 355 U.S. 41, 45–46, 78 S.Ct. 99, 2 L.Ed.2d 80 (1957).

Arters, 2013 WL 308768, at *1.

Umm….  No.

Someone must have been the second coming of Rip Van Winkle and slept through the last five years.  In a rather well-publicized decision, back in 2007, the Supreme Court expressly overruled Conley on specifically this “no set of facts” point.  See Bell Atlantic Corp. v. Twombly, 550 U.S. 544, 561-63 (2007).
Twombly?  Maybe you’ve heard of it.  If so, you’re already one up on Arters.  Anyway, the Supreme Court in Twombly explicitly “retired” the Conley standard relied upon in Arters:

On such a focused and literal reading of Conley’s “no set of facts,” a wholly conclusory statement of claim would survive a motion to dismiss whenever the pleadings left open the possibility that a plaintiff might later establish some set of undisclosed facts to support recovery. . . .  It seems fair to say that this approach to pleading would dispense with any showing of a reasonably founded hope that a plaintiff would be able to make a case; Mr. Micawber’s optimism would be enough.

Seeing this, a good many judges and commentators have balked at taking the literal terms of the Conley passage as a pleading standard.  [many citations omitted]  We could go on, but there is no need to pile up further citations to show that Conley’s “no set of facts” language has been questioned, criticized, and explained away long enough. . . .  [A]fter puzzling the profession for 50 years, this famous observation
has earned its retirement.  The phrase is best forgotten as an incomplete, negative gloss on an accepted pleading standard.

Twombly, 550 U.S. at 561-63 (emphasis added).  Then, a couple of years later, the Court made clear that Twombly’s interment of the Conley language cited in Arters applies across the board to all types of cases.  See Ashcroft v. Iqbal, 556 U.S. 662, 684 (2009).Continue Reading Spherical Error Revisited

Off-label use — using a drug or medical device for an indication other than that set forth in the FDA-approved label — poses tricky legal issues.
Off-label use is entirely legal: The FDA doesn’t regulate the practice of medicine, so physicians can use drugs or devices for any appropriate purpose, approved by the FDA or…

Virtually all physicians prescribe drugs and medical devices for off-label uses. The pace of FDA approval of new drugs and devices (or of new indications for existing drugs) necessarily lags behind the pace of medical research. Physicians will therefore always be aware of a recent study showing that a drug offers hope to a patient…

Drug & Device Resources

Bexis’ Book

FDA-regulated products now account for an estimated one-fifth of overall economic activity in the U.S. They have also been the focus of a litigation explosion. This timely guide covers all aspects of litigation involving drugs, medical devices, vaccines and other FDA-regulated prescription products.
Learn More About This Book