Happy birthday to Eric Idle, one of the funniest members of the Monty Python troupe.  In addition to writing bizarre, hilarious comedy skits, Idle also wrote songs.  When he proposed a song for The Life of Brian,  he ran into resistance.  The song seemed insufficiently catchy.  That song was “Always Look on the Bright Side of Life,” one for the ages.  It manages to be simultaneously profound and absurd.   In honor of Idle, we decided today to discuss a case that is similarly profound and absurd.   The case is New York v. Richard Z., 20 I 7 N. Y. Misc. LEXIS 9 I 8; 20 I 7 N Y Slip Op 30498(U) (Oneida Cty March 9, 2017), and has nothing to do with product liability.  Or does it?

 

Our clients get vilified anytime there is a hint of off label use.  Never mind that off label use can be enormously beneficial for patients.  It can even be the standard of care.  We’ve said that several times and the point is made in Bexis’s book.   But now we have the ultimate proof: in Richard Z, a court ordered prison doctors to make off-label use of a medicine available to a prisoner.  The facts are weird and icky, but the point is nonetheless unmistakable.  The prisoner was apparently in prison for some sort of sexual assault.  The opinion supplies no details, but since the prisoner had been in civil confinement for over nine years, and in prison for 30 years before that, we are guessing he had done something(s) really bad.  It is well known that sexual assaulters have a very high rate of recidivism.  That probably accounts for all those years of civil confinement.      

 

The prisoner wanted to get out of stir, and requested a particular chemical therapy.  That therapy involved an antiandrogen that would substantially reduce his sexual urges, and that has been proven in scientific tests to assist in the reduction of recidivism to less than 3%.  A couple of outside experts supported the chemical treatment, opining that such treatment would likely place the prisoner “at a low risk for future sexual offense recidivism and violent recidivism to the point that he could be released to the community on strict supervision”.   But a prison doctor opposed administering the particular requested/recommended therapy, the use of which for these particular purposes would have been off label.  The prison scheduled an “informed consent” conference relative to the chemical treatment of the prisoner.  The prison doctor elicited responses that suggested the prisoner would be taking the drug under compulsion and that “he would not have chosen to take this medication by himself” and “that he knew he had other choices.”  But to the court it was “abundantly clear” that these responses were “coaxed” from the prisoner via  “a carefully guided inquiry” by the prison doctor in an effort to dissuade the prisoner from taking the off label treatment.  The doctor “was acting according to her own subjective views and beliefs thereby substituting those views and opinions” for the prisoner’s .  It was also clear to the court that the prisoner was intelligent, educated, and engaged, and that he “clearly understands the off-label use of this prescription and its risk.”

 

The court concluded that the prison doctor lacked “experience and training in this area,” had misinterpreted her duties in this case, and that she and the prison were attempting “to avoid compliance with the clear and unequivocal expert opinions.”  The court relied on “many studies that show that antiandrogens greatly assist in repressing sexual urges and allow release of sex offenders safely into the community.”  The prison doctor had “substituted her subjective opinion” for the prisoner’s informed consent, and was “both inexperienced in the field of treating sexual offenders and has not kept current with medical advancements and evolving scientific understanding.”  That evolving scientific understanding supported the off label use of the drug, and denying that off label use to the prisoner would be “precluding him from attaining his liberty.”

 

Off label use was not only permissible, it was ordered. 

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

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