We’ve been defending the ability of physicians to engage in off-label use ever since the Bone Screw litigation of the 1990s. Buckman Co. v. Plaintiffs Legal Committee, where the United States Supreme Court affirmed that “off-label use is generally accepted” and that under the law, “[p]hysicians may prescribe drugs and devices for off-label uses,” 531 U.S. 341, 351 & n.5 (2001), was one of our Bone Screw cases.  Thus, we follow medical malpractice decisions, like Doctors Co. v. Plummer, ___ So.3d___, 2017 WL 242577 (Fla. App. Jan. 20, 2017), which we discussed recently, for what they have to say about off-label use.  In malpractice cases, the dark side often attempts to equate “intended uses” listed in FDA-approved drug/device labeling with the medical standard of care.  As we mentioned in that post, arguments that FDA-approved product labeling equals the medical standard of care are really  attempts to turn off-label use itself into a tort.

The Doctors Co. decision prompted us to look back over our 9+ years of blogging output for where we addressed this issue previously.  Surprisingly, there was only one, a 2007 Bexis piece that (even more surprisingly) didn’t cite any caselaw.  We also found a 2009 law review article by our erstwhile co-founder, Mark Herrmann, which might have been prompted by the earlier blogpost.  But nothing was on the blog itself that could qualify as useful research.

We rectify that today.

Continue Reading FDA-Approved Labeling ≠ Medical Standard Of Care

Like most Americans, we like our doctor.  We like doctors in general.  We are not looking to start another song battle with our friends over at the Abnormal Use blog, like when we competed to name as many law songs as possible, but there are certainly many excellent doctor songs.  Listen to this top 10, and we guarantee you’ll feel better:

  • Doctor, Doctor (Thompson Twins)
  • Dr. Robert (Beatles)
  • Bad Case of Loving You (Robert Palmer)
  • Dr. Funkenstein (Parliament)
  • Calling Dr. Love (KISS)
  • Doctor My Eyes (Jackson Browne)
  • Good Lovin’ (The Rascals)
  • Doctor Wu (Steely Dan)
  • Dr. Feelgood (Motley Crue)
  • I Need a Doctor (Dr. Dre/Eminem)

Bexis proposes adding the following songs to our medical play-mix: Mother’s Little Helper (Rolling Stones), Go To The Mirror, Boy (Who), DOA (Bloodrock), and Comfortably Numb (Pink Floyd).  Yes, Bexis really does have a dark side.

In addition, we must admit that there have been many fine medical shows (Dr. Kildare, Ben Casey, Marcus Welby, St. Elsewhere, ER, Grey’s Anatomy, House), whereas legal shows usually disappoint.  It is possible that we nitpick at legal shows too much.  Our experience and knowledge make us overly-demanding and cranky.  Even so, we thoroughly enjoyed LA Law.   Every Thursday night we gathered around a 19 inch tv (remember them?) with fellow clueless, struggling associates to watch the adventures of the McKenzie Brackman law firm, which had an odd mix of practice areas we have yet to see replicated in real life:  M&A, divorce, criminal law (blue collar, not white collar), tax, and anything to do with sex.  Richard Dysart, who played the part of presiding partner at McKenzie Brackman, once was the guest speaker at a legal charity dinner in L.A.  He told the audience we could all consider him as our senior partner, and he actually gave out his home phone number in case we ever needed to call him for advice.  Years later, another tv program showed us our curmudgeonly, crazy future as the Danny Crane character on Boston Legal, memorably portrayed by William Shatner.  Many of his victories were celebrated with a cigar on an outside deck.  (We’d hate to think of what would happen if all law firms had outside decks.)  And, while we’re at it, we should blow a kiss at Goliath, a legal show currently running on Amazon.  It stars Billy Bob Thornton and was co-created and written by an old AUSA colleague, Jonathan Shapiro.  Give it a look.  It is a smart, smoky, surly show that grabs you by the briefs.

Doctors are often codefendants in our cases.  We try very hard to resist the temptation to point fingers in their direction.  In the last ten years of litigating physical injury cases, we can think of only one time when part of our defense was to suggest medical malpractice, and that was a case where the doctor had been the sole defendant initially, and then he claimed that the problem was with our client’s medical device.  So after we were added to the case as a defendant, we really had no option but to return fire.  Much more often, we find that the interests of the doctor are well-aligned with those of the device or drug manufacturer.  The characterization of the underlying reality that works for doctors usually also works for our clients.  The legal defenses that work for the doctors are usually consistent with the ones that work for our clients.  Indeed, it is not unusual for us to find a medical malpractice case that has things to say that can end up being important and helpful for our clients.  That is true with the recent case of Doctors Co., insurer, for itself and for Annabell Torres, M.D. v. Plummer, 2017 Fla. App. LEXIS 599 (Fla. 5th D. Ct. App. January 20, 2017).  Doctors Co. is a wrongful death medical malpractice case.  The Florida appellate court overturned a plaintiff jury verdict, and at least one of the reasons why it did so is noteworthy for our practice area.

Continue Reading Just What the Doctor Ordered: Package Insert Does not Establish Standard of Medical Care

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 haven’t digested it yet, so this isn’t a substantive post, but we wanted to make our readers aware that today the FDA made an announcement, which states in pertinent part:

We have also added a document to the docket for the public hearing titled “Memorandum: Public Health Interests and First Amendment Considerations Related to Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products,” which provides additional background on the issues the FDA is considering as part of our comprehensive review of our rules and policies relating to firm communications regarding unapproved uses of approved or cleared medical products, including a discussion of First Amendment considerations. We are requesting input on the Memorandum as it relates to the questions set forth in the initial notice of public hearing.

Thus, two days before a new administration takes office, the FDA has released an official document, albeit a “memorandum” with no particular regulatory significance, taking positions on the First Amendment protection (or more likely, lack of same) of truthful off-label speech by regulated entities – breaking literally years of silence.

Here is a link to the actual memorandum.  We haven’t read it yet, but we will – as certainly will many of you.  The timing suggests, rather blatantly, an attempt to put “agency” views on record before the change in administration potentially results in a much different approach.  Since we know from Wyeth v. Levine, 555 U.S. 555 (2009), that changes in FDA position adversely affects the scope of deference granted that position, the memorandum may also be a preemptive attempt to undercut that different approach in court.

We’ll have more to say later.

It is always nice to win a case, whether by motion or trial. But just in terms of pure exhilaration, it is hard to beat hearing the jury foreperson announce that, after a hard-fought trial, you win. But note that term “hard-fought.” Most trials really are hard. They really are expensive. They really are stressful. The road to even the most resoundingly wonderful verdict probably had a couple of nasty potholes. That was the case with Horrillo v. Cook Inc., 2016 U.S. App. LEXIS 21026 (11th Cir. Nov. 23, 2016). Prior to trial, there was at least one Daubert ruling that couldn’t have pleased the defense. Also, as reported by our friends in the Abnormal Use blog, there was a learned intermediary ruling that we do not like one bit. But all’s well that ends well, right?

In Horrillo, the plaintiff brought a product liability action on behalf of his deceased mother, who had undergone a surgery to clear her renal artery. The surgery went terribly wrong, as the patient sustained a stroke. The opinion also does not tell us whether the plaintiff ever sued the doctor. The surgeon used a stent manufactured by the defendant. That stent was designed for use in bile ducts, but the surgeon used it off-label in this case. That off-label use was apparently not all that uncommon. The plaintiff’s legal theories included negligence and negligent failure to warn, strict products liability and strict failure to warn, and breach of warranty. After a nearly four-week trial, the jury returned a verdict in favor of the defendant. The plaintiff then moved for a judgment notwithstanding the verdict, or, in the alternative, a new trial. The trial court denied those motions, and the plaintiff appealed to the 11th Circuit. Applying the appropriate standards of review, the 11th Circuit affirmed the trial court’s rulings and the defense verdict.

Continue Reading 11th Circuit Upholds Stent Defense Verdict

Today’s guest post is by Liz Minerd, a Reed Smith associate, who closely followed the online feed of  the recent FDA meeting that the Agency called to discuss what changes would be appropriate in its off-label promotion restrictions – although the official agenda steered away from both the terms “off-label” and “promotion”.  What follows is her summary of two days of testimony from over 60 speakers, some of whom thought that it was crazy that any damn fool can say whatever s/he wants about off-label uses, except for manufacturers, who can’t even tell the truth although knowing the most about them due to ongoing pharmacovigilance obligations, and other speakers who … do not.

As always, our guest poster deserves 100% of the credit (and any blame) for her post.  We’re only the piano-players.  Take it away Liz.

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Last Wednesday and Thursday (Nov. 9-10, 2016), the FDA conducted a public meeting on “Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products.”  The FDA’s notice of the meeting (available here) stated:

FDA is engaged in a comprehensive review of its regulations and policies governing firms’ communications about unapproved uses of approved/cleared medical products, and the input from this meeting will inform FDA’s policy development in this area.

What that means, stripped of regulatory jargon, is that the FDA public meeting involved potential updating of the FDA’s decades-old prohibition on truthful promotion of off-label uses by regulated manufacturers.

Continue Reading Guest Post – The FDA’s Two-Day Meeting on Manufacturer Off-Label Communications

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

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

If you’re even remotely interested in the topic of preemption in Pre-Market Approved (PMA) medical devices that were used in an off-label manner, simply search this blog for our Infuse cases. There are dozens and almost all are complete victories for the defense. What occasionally survives are fraud or misrepresentation claims, although they have a tough time meeting the heightened pleading standard of Rule 9(b), or failure to warn claims where a court recognizes failure to submit adverse events to the FDA as parallel to a state law duty to warn physicians. As you’ll easily see from our prior writings, we don’t understand that parallelism at all.

The most recent Infuse victory strikes a blow at each and every attempt by plaintiffs to circumvent, dodge, sidestep, and elude preemption and pleadings standards. And with each by-pass blocked, plaintiffs’ claims had nowhere to go.

As a quick refresher, Infuse is a medical device used to stimulate bone growth in spinal fusion surgeries. It is a multi-component device that received FDA PMA approval for use in single-level, anterior, lumbar surgeries. Aaron v. Medtronic, Inc., — F. Supp.3d –, 2016 WL 5242957, *1-2 (W.D. Ohio Sep. 22, 2016). Aaron is actually a consolidation of the claims of several hundred plaintiffs who alleged they were injured by their surgeon’s use of the Infuse device in an off-label manner. Specifically, they allege the device was either implanted without all of its component parts, implanted posteriorly, implanted at multiple levels, or implanted in their cervical or thoracic spines. Id. at *2. Plaintiffs’ causes of action are fraud/misrepresentation, strict liability failure to warn, strict liability design defect, negligence, and breach of express and implied warranties. Id. Defendants moved to dismiss all claims on several grounds, including most predominantly preemption.

Before getting to the substantive analysis, the court had to consider what pleadings standard to apply. Wait. Isn’t it TwIqbal? What’s the issue? The answer is the Seventh Circuit decision in Bausch v. Stryker. The Aaron plaintiffs alleged that they did not need to plead the specific federal law or regulations that defendant allegedly violated because medical device products liability cases should have a “more permissive” review standard. Id. at *3. Plaintiffs got that idea from Bausch which held that particularity in pleading the specific FDA regulations violated was not necessary due to much of the “critical information” being kept confidential. Id. at *3-4. Many courts disagree with Bausch, including the Sixth Circuit which held in a non-medical device case that a “natural imbalance of information” does not warrant lowering Rule 8’s pleading standards. Id. at *4. The discovery process cannot be used to find sufficient factual support for plaintiffs’ pleadings after the fact. So, Aaron applies TwIqbal, not some watered down version (although the court does state that some of plaintiffs’ claims might not have withstood application of that lesser standard).

Continue Reading Another Slam Dunk Infuse Win – Preemption and More

Tell us that that the feds prosecuted a doctor for using a medical device off-label, and the hairs on the back of our neck start to rise and do the samba.  After all, off-label use can be good medicine, even the best.  Then tell us that the same doctor also faced the music for using an “adulterated” device and our knees grow weak.  The word “adulterated” gets thrown around an awful lot in the FDA regulations.  You (and most jurors) might think of the old Upton Sinclair investigative journalism reports about fingers turning up in tubs of margarine, but “adulterated” can also refer to technical issues, such as labels that do not say quite enough.   The recent case of U.S.  v. Kaplan, 2016 WL 4709870  (9th Cir. Sept. 9, 2016), is arresting because it makes us wonder whether good facts (Bad facts?  Weird facts?) might make bad law.

The defendant in the Kaplan case was a medical doctor accused of conspiring to violate 18 USC section 331(k) – using an adulterated medical device held for sale.  Like the semi-adequate federal prosecutor we used to be, let’s start with the factual headline:  this doctor reused single use prostate biopsy needles.  Think for a moment about how prostate biopsy needles are used, then think about the impact of expert testimony to the effect that cleaning single use needles would not do the trick, and that the needles became discolored after use.  Yuck.  Then think about the effect of evidence that the doctor started reusing the single use needles for purely economic reasons, that he did not pass any savings along to the patients, and that other people in his medical practice told him to stop reusing the needles.

Continue Reading Has the Ninth Circuit Criminalized Malpractice, Adulteration, and Off-Label Use?