We recently read a recent (3/15) Bloomberg piece (here, for those with a subscription) entitled “Off-Label Promotion Could Mean More Drug Company Liability.”  This article consists largely of the interviews with two avatars of the other side of the “v.”:  fellow blogger Max Kennerly (who regularly writes intelligent critiques of our posts) and Lou Bogrod, with whom we’ve tangled before over off-label issues.  Needless to say, we disagree with the “more liability” spin they put on any would-be FDA retreat on off-label promotion.

Here’s why – and we apologize to all of you who can’t read the article we’re responding to, but it’s behind a paywall, but Michael Bloomberg didn’t get to be a billionaire by giving things away that he could charge for (that’s what we do).  Like the Bloomberg article, we’re also limiting our focus to product liability, recognizing that truthful off-label promotion also arises frequently in False Claims Act cases.

The first contention is that, once truthful off-label promotion is legal, “drug companies would lose the protection afforded by preemption.”  We don’t think that’s grounds for “more liability.”  First of all, “drug companies” – at least those making innovative branded drugs, don’t have much of a preemption defense.  The Supreme Court unfortunately took care of that in Wyeth v. Levine, 555 U.S. 555 (2009), limiting preemption to cases of “clear evidence” that the FDA would have rejected the label change in question.  There are other possible preemption grounds concerning design defect claims (which we’ve advocated here), but off-label promotion doesn’t involve design.  So, while there may be liability issues raised concerning specific instances of off-label promotion, we don’t see any basis for calling it “more” liability than already exists for on-label promotion.  Most branded drug warnings don’t have a preemption defense now.

Indeed, the result could very well be less liability. Even if truthful off-label promotion were to become broadly legal, the off-label use itself remains off-label.  The FDA, however, can order a drug’s label to contain statements (usually warnings) about an off-label use.  21 C.F.R. §§201.57(c)(6)(i), 201.80(e) (both phrased in terms of “required by” the FDA).  That’s important because, as we discussed in more detail here, only the FDA can do this.  Drug companies are not allowed to discuss off-label uses in their labels whenever they want.  Without the FDA telling them to, that is a form of misbranding.Continue Reading What If We Win? Off-Label Promotion & Product Liability

Remember how Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), dismissed the §510k “substantially equivalence” medical device clearance as non-preemptive because it was supposedly “focused on equivalence, not safety”?  Id. at 493.  In the same vein:

“[S]ubstantial equivalence determinations provide little protection to the public. These determinations simply compare a post − 1976 device to a pre − 1976 device to ascertain whether the later device is no more dangerous and no less effective than the earlier device. If the earlier device poses a severe risk or is ineffective, then the later device may also be risky or ineffective.”

Id. (quoting from pro-plaintiff law review article).

Most of our readers know that this characterization, assuming it was true for the 1980s-era (implanted 1987) device that the Court considered in Lohr, was no longer true, even at the time Lohr was decided, and certainly hasn’t been the case since the FDAAA was passed a year after Lohr was decided.  Still, this anachronistic view of §510k has flourished for twenty years, affecting first preemption and now (thanks mostly to Mesh MDL rulings) admissibility of evidence.

That’s why we were interested in what the FDA had to say about today’s §510k clearance process in its recent memorandum entitled “Public Health Interests and First Amendment Considerations Related to Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products,” which is available here.  One of our guest bloggers, Liz Minerd, recently discussed the First Amendment aspects of that document, here.Continue Reading FDA Off-Label Promotion Memo Should Affect §510k Preemption & Evidence

This guest post is from Liz Minerd, an associate at Reed Smith.  She previously wrote the post on the FDA’s off-label promotion meeting last November, so when she indicated that she’d like to write about the FDA’s “Midnight Memo” on the same topic, we were only too happy to say “yes.”  So here is some in-depth analysis of the FDA’s rather unusual decision to, in effect, comment on its own meeting.  As always, our guest posters deserve all the credit, and any blame, for their efforts.

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As this blog reported here, last week—two days before the change in administrations—the FDA released a memorandum entitled “Public Health Interests and First Amendment Considerations Related to Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products” available here. The Agency characterizes this 12th hour memorandum as a follow up to the two-day public meeting it held on November 9-10 regarding off-label promotion (or what the Agency refers to as “communications regarding unapproved uses of approved/cleared medical products”).  In particular, the Agency claims that it is issuing this memorandum to provide “additional background” in response to frustrations expressed by certain speakers during the November meeting regarding the Agency’s failure to adequately address the First Amendment in the public hearing notice.

However, the real purpose of the memorandum appears to be to set forth the Agency’s justification for their current restrictions on off-label promotion before a new administration and a new FDA commissioner could have a chance to revisit them. Indeed, after briefly noting the First Amendment concerns raised at the November meeting, the Agency spends the first twenty pages of the memorandum detailing its oft-repeated policy justifications for its current restrictions before addressing any of the First Amendment jurisprudence that has called those restrictions into question.  Its attitude is reflected in the memorandum’s first case citation—to the dissent in United States v. Caronia, 703 F.3d 149 (2d Cir. 2012).  [Memorandum, at p. 2. fn. 3]  The Agency’s lengthy policy discussion demonstrates that the outgoing policymakers at the FDA find very little benefit in communications from manufacturers regarding off-label uses even, though it recites that off-label uses can be the standard of care in some circumstances.  This attitude, that only the Agency can keep the public sufficiently safe, is classic governmental paternalism of the sort that the United States Supreme Court has repeatedly condemned in its First Amendment decisions over the past several decades.

For example, the Agency asserts that it seeks to “motivate” the creation of “robust scientific data” about the safety and effectiveness of drugs. [Memorandum at 4-5]  However, the current prohibitions only do so prior to approval of a product.  After approval—a time period usually much longer than the approval process itself—the current prohibitions prevent the same manufacturers from providing the same sorts of scientific data to the same audience.  Thus, the Agency’s current prohibitions actually interfere with the continued creation of robust scientific data after approval.  For example, a manufacturer can be required to post clinical trial results concerning an off-label use [Memorandum at 17-18], but is prohibited from informing doctors that they can view the results on ClinicalTrials.gov and decide whether their patients might benefit from the studied use.Continue Reading Guest Post – Midnight Madness − The FDA Continues To Discount First Amendment Implications Of Restrictions On Off-Label Promotion

We have been following issues related to the interplay of off-label use, manufacturer statements about off-label use, the First Amendment, and FDA enforcement for a long time.  (Like here, here, and here, among many posts.)  The court battles that have garnered so much attention recently can be traced back to at least the 1990s, with the famed decision in Washington Legal Foundation v. Henney, 56 F. Supp.2d 81, 85 (D.D.C. 1999), vacated as moot by 202 F.3d 331 (D.C. Cir. 2000).  There can be lots of talk about what FDA’s policy is on what a manufacturer can and cannot say about unapproved uses for its drug or device.  Discussions about changing 21 C.F.R. § 201.128 (drugs) & 801.4 (devices) have dragged on for a while, even with the Amarin settlement and with other FDA statements suggesting that the regs do not reflect current policy.  FDA policy, of course, involves more than just a few sentences in a regulation or guidance document.  Particularly for a prohibition that has long been the crux of FDA enforcement—like warning letters and prosecutions—and has spawned or played a major role in subsidiary FCA, RICO, and product liability litigation, a decision to stop prohibiting truthful, non-misleading statements about unapproved uses for drugs and devices is not exactly the end of the story.  For one thing, criminal prosecutions that are based at least in part on manufacturer statements about unapproved uses are always on-going and U.S. cannot just hit the reset button in those cases.

We do not often post about decisions from, let alone briefs filed in, criminal cases brought pursuant to the FDCA.  That FDA enforcement sometimes results in prosecutions is something that comes up in our cases and posts, often in the context of preemption and primary jurisdiction—the FDA does not just have the authority to root out misbranded and adulterated medical products and fraud in connection with approval or post-approval reporting, but companies and individuals get prosecuted, so you should be comfortable respecting FDA’s authority, Your Honor.  It also comes up sometimes when there has been a prosecution that resulted in an indictment, plea, conviction, or sentencing memorandum that the plaintiffs want to use as evidence of something—or for issue preclusion—in a separate case.  When it comes to prosecutions based at least in part on manufacturers or their representative making statements about unapproved uses, we have an opportunity to see what FDA’s policy on off-label promotion really is these days and how it might affect behavior.  While we generally think manufacturers and their representatives try to follow applicable guidance documents, they definitely want to avoid being convicted.

Today, we take a look at two criminal prosecutions involving off-label promotion allegations, each of which has now been tried to a jury verdict.  In the first, the court denied all of the defendants’ motions in limine before the case proceeded to a defense verdict at trial. See U.S. v. Vascular Solutions, Inc., No. SA-14-CR-926-RCL, 2016 U.S. Dist. LEXIS 133717 (W.D. Tex. Jan. 27, 2016).  That opinion showed up in our searches recently, well after the acquittal of the device manufacturer and its CEO produced its own fall out, including a letter from Senator Grassley—hardly a known industry champion—to DOJ about prosecutorial misconduct.  The Vascular Solutions defendants were charged with misbranding (and conspiracy to misbrand) of its Vari-Lase device.  This device was cleared—the opinion says “approved”—for treatment of varicose veins, specifically, per the indictment’s allegations, superficial veins and not deeper perforator veins.  The U.S. contended that the company failed to seek an expanded indication and failed to provide revised labeling to account for the use of the device to treat perforator veins. Id. at *3.  Defendants filed various motions in limine based on the First Amendment and the definition of “intended use” in § 801.4.  We will discuss only two of them, particularly the government’s position.  The government announced that it would not “use promotional speech to doctors to prove the intended use of the devices for perforator vein ablation” to avoid the “possibility that the misbranding offenses criminalize promotional speech.” Id. at **6-7.  It planned, however, to use such promotional speech as an overt act in furtherance of a conspiracy.  The court agreed with the government that a lawful act, including constitutionally protected truthful commercial speech, could be used as an overt act. Id. at **7-8.Continue Reading Update on Prosecution for Truthful Off-Label Promotion

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

When we last talked about Shuker v. Smith & Nephew PLC, No. 13-6158 (E.D. Pa.), it was with high praise for the court’s decision tossing out almost all claims as preempted and any non-preempted claims for being inadequately pleaded. Our post on that decision is here. The court gave plaintiff a second chance to re-plead the non-preempted claims, which he did. Defendant again moved to dismiss and this time it was granted with prejudice. Shuker, 2016 WL 5461900 (E.D. Pa. Sep. 29, 2016).

Plaintiff underwent hip replacement surgery. For that surgery, plaintiff’s surgeon opted to use defendant’s R3 hip replacement system, but also used a component, the metal liner, from defendant’s BHR hip resurfacing system. Admittedly, an off-label use. Plaintiff suffered complications that required multiple revision surgeries. Id. at *3.

In its original decision, the court’s leave to amend went only to parallel claims based on allegations of off-label promotion. Id. at *1. Those claims were for “tortious misconduct based on off-label promotion” and fraud. Id. at *4. Plaintiff cites to a single press release to support his allegation that defendant “actively marketed” the metal liner as an option for the R3 system “in a way that led” doctors to believe the liner was a component of the R3 system and safe to use with the R3 system. Id.Continue Reading Hip Implant Off-Label Promotion Follow-Up