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

It seems that we have posted hundreds of times about attempts to impose liability on the manufacturer of a PMA device that a doctor chose to use off-label.  Recently, a bunch of those have involved Infuse.  Cales v. Baptist Healthcare Sys., Inc., No. 2015-CA-001103-MR, 2017 Ky. App. LEXIS 10 (Ky. Ct. App. Jan. 13, 2017), involves claims against a hospital over alleged off-label use of Infuse by a doctor there.  (The decision gives no indication of a specific alleged injury from the use.)  Why sue the hospital?  Maybe to keep the case against the manufacturer in state court.  Maybe to pursue someone else when the claims against the manufacturer are preempted.  The problem for the plaintiff is that she needs a viable claim against the hospital, at least something that can get by a motion to dismiss.  She offered three claims (two product liability and one medical negligence) premised on the hospital’s alleged knowledge of the possibility of off-label use, and the trial court dismissed them all.

Unfortunately for the hospital, the Kentucky Court of Appeals reversed as to one of the claims.  Product liability claims against the manufacturer of this PMA device have, as the court noted, “been mostly unsuccessful based on federal pre-emption.” Id. at *10.  Plaintiff claimed that preemption does not apply to such claims when made against a healthcare provider.  “This distinction is of no avail.” Id. at *11.  As the court analyzed it, consistent with the majority position, express preemption for PMA devices is based on the device, not how it is used or who uses it.  It stands to reason that strict liability product liability claims about the design and warnings of a PMA device are expressly preempted too.  This may seem obvious, but we think it is the first ruling of its kind in favor of a hospital.  That may be because strict liability claims against hospitals are generally unavailable.

Framing those claims as negligence does not help under the Kentucky Product Liability Act.  Among other things, a distributor or “middleman” is not liable simply based on knowing that there may be off-label use, which is not the same thing as knowing the product is in a defective condition.  Id. at **12-13.

Medical negligence predicated on the hospital not telling the plaintiff that her doctor planned to use the device off-label is neither preempted by the MDA—FDA does not regulate the practice of medicine—nor covered by the Kentucky Product Liability Act.  Kentucky law imposes a duty on hospitals to obtain informed consent from patients in connection with procedures to be performed.  Id. at **15-16.  In essence, the consent process is supposed to inform the patient of the “procedure[,] acceptable alternative procedures or treatments and substantial risks and hazards inherent in the proposed treatment or procedures.”  Id. at *15.  In the context of a motion to dismiss, the Cales appellate court viewed that whether there was a need to inform a patient of off-label us was a question of fact to be addressed as the case progresses and resurrected the medical negligence claim.  Id. at *17.  Not having the complaint in front of us, it is hard to say if there was any allegation of failing to inform the plaintiff of inherent substantial risks and hazards, it is hard to say whether this was a correct result.  We can say, however, as the court acknowledged in its discussion of the product liability claims, that off-label use does not necessarily involve excess risks compared to on-label use.  It may be possible to meet the state law requirements for proper consent without ever mentioning the loaded term “off-label.”  That is why other courts have held that there is no duty to warn that a planned treatment is off-label.

An inter-agency taskforce is proposing a comprehensive overhaul of “Federal Policy for the Protection of Human Subjects” in today’s issue of the Federal Register (comments close on 12/7/2015).  See 80 Fed. Reg. 53933 (Sept. 8, 2015). The proposal is 130 pages long, but most of it won’t have much relevance to product liability, except insofar as a plaintiff might have been injured during the course of a clinical trial.  In the past we’ve been interested in clinical trial regulations primarily for three reasons: (1) if they allow plaintiffs to argue that entities other than treating physicians (usually hospitals) have informed consent obligations; (2) if they clearly distinguish between off-label and “investigational” use of prescription medical products, and (3) preemption.

With that in mind we’ve looked through the new proposal.

Informed Consent:

We don’t see much in the new rule expanding who is required actually to obtain informed consent – only that the informed consent requirement would be extended to a lot more types of research, such as that involving “biospecimens” lacking individualized identifying information.  That seems like a lot more work in situations without additional risk of physical injury to research subjects, id. at 54028, but precisely because of the low risk of harm inherent in most biospecimen situations, we doubt it will have much impact on product liability.  It could increase other kinds of litigation, however, such a privacy (won’t keeping all these informed consent forms effectively re-identify the specimens?) and intellectual property (identifiable research subjects are more likely to want a piece of the economic “pie” created through research using their specimens).

Continue Reading Anything in the New Clinical Trial Rules of Interest to Product Liability? Not Really.

Any time you find yourself drawing an analogy to asbestos lawsuits, you know you’re in trouble.   We have too often heard plaintiff lawyers or, worse, judges advocate for borrowing procedures from asbestos litigation.  Almost always those procedures would make it easier for plaintiffs to ‘prove’ little things like product identification, and would abridge defendants’ rights to seek certain discovery or file motions.  If the symbol for the legal system is a scale, the symbol for the asbestos docket should be a meat-grinder.  We had the experience earlier in our career of representing a tertiary asbestos defendant that really and truly had nothing to do with any harm inflicted on any asbestos plaintiff.  It should never have been sued.  But after the actual asbestos manufacturers went bankrupt, enterprising plaintiff lawyers sued any and every entity in sight so as to keep the asbestos gravy train rolling.  Instead of winding down to extinction or at least to something with narrowly circumscribed limits, asbestos litigation entered second and third waves of opportunistic litigation. It is like what Hannah Arendt said about totalitarian regimes, how they constantly need to find new enemies and scapegoats.  Asbestos litigation became a bizarre, parallel legal system, more characterized by (bad) social engineering than coherent rules and procedures.  Our encounter with the asbestos maw was relatively brief.  We represented a company that made components for automobile brakes.  Mind you, the company did not use or touch asbestos at all.  After the products entirely left our clients’ hands, somebody else would add the asbestos.  When we pointed out that fact to the plaintiff lawyers, they still insisted that we must pay a nuisance exit fee.  When we sought to file a motion with the court, we were advised that the asbestos docket permitted no such motions until the eve of trial.   Good system, huh?

We do not know a whole lot of the facts behind the New England Compounding Pharmacy MDL, but the first opinion we have seen from it (there will doubtless be many more) gave us an ugly asbestos flashback.  The MDL stems from allegations that the New England Compounding Center (NECC) produced a contaminated medicine that caused people to suffer from fungal meningitis.  NECC recalled the medicine.  It then surrendered its pharmacy license, ceased production of all medical products, and filed for bankruptcy.  The plaintiffs steering committee filed actions against NECC, naturally enough, and also filed actions against affiliated entities and individuals.  The plaintiffs also filed complaints against not-so-affiliated entities and persons, including hospitals, clinics, and doctors.  This is where we started thinking about asbestos cases.  If there must be a remedy for every wrong, does that mean the remedy can be collected from someone who did nothing wrong?   The NECC opinion we are looking at today, In re New England Compounding Pharmacy, Inc. Products Liability Litigation, MDL No. 13-02419-RWZ (D. Mass. Jan. 13, 2015), provides an interesting snapshot.  This particular opinion relates to actions where plaintiffs alleged that Illinois medical providers played a role in administering the contaminated NECC medicine, thereby causing injuries.  The claims were for medical negligence, violation of the Illinois Consumer Fraud and Deceptive Business Practices Act, failure to warn, strict product liability, and punitive damages.  

The good news for the defendants was that the court dismissed the strict liability claim, because that theory could apply only if the defendants were predominantly providing a product rather than a service.  The court, quite sensibly, concluded that the medical providers were predominantly providing a service rather than a product.  But the rest of the opinion was bad news for the defendants.  The defendants made an argument that rings true to our admittedly biased ears: that physicians have no duty to regulate pharmacies and drug manufacturers.  But the court concluded that the master complaint passed muster because it alleged that the defendants had a duty to exercise reasonable care to ensure that the drugs they administered  to patients were procured from drug companies that complied with pharmaceutical laws, made safe and effective drugs, and utilized proper quality control, safety, and sterility measures.  Wow.  The plaintiffs also alleged that physicians must take care that the drugs administered were not contaminated, and must inform plaintiffs of the sources of drugs (especially if there was “an unaccredited, mass producing, out of state, compounding pharmacy, unregulated by the FDA … and the dangers associated therewith”).  That is a fairly breathtaking litany of duties for doctors.  The complaint also alleged that the defendants “deceptively concealed” information about the source of the medicine and failed to inform patients that they were being administered “an unsafe, unreasonably dangerous drug compounded by NECC.”    Those allegations were deemed enough to make out claims for negligence, consumer fraud, and failure to warn.  Moreover, because the complaint said that the defendants went beyond mere inadvertence and, instead, demonstrated such utter disregard for the rights of others as to amount to “complete neglect for the safety of patients,” and that the defendants “willfully and knowingly failed to abide by consumer safety regulations and withheld important safety information from patients,” the claims for punitive damages could go forward.

The court did cite TwIqbal, but certainly did not appear to apply the standard with any rigor.  As a result, the plaintiffs have gotten away with very vague, very broad allegations that rip large holes in the duty envelope.  It will be interesting to see what sort of proof the plaintiffs have that the doctors actually knew what was going on at the compounder.  Are these defendants now on the hook because they really were negligent, or merely because they were next?

Since the beginning of 2014, five states that we know of have enacted what is called “Right to Try” statutes.  See Ariz. R.S.A. §36-1311 to -1314; Colo. R.S.A. §§25-45-101 to -108; La. R.S. §1300.381-386; Mich. C.L.A. §§16221, 26451; V.A. Mo. S. §191.480.  “Right to Try” (a play on right to die) legislation addresses a serious subject as to which there is no easy answer.  There are still a lot of incurable diseases out there.  When somebody is afflicted with such a disease, all established treatments have failed, and that person is facing certain death, can that person have access to unapproved drugs – those that are still “investigational”  in FDA parlance – on the theory that s/he has nothing to lose?

We’ve been interested in the issue of what is sometimes referred to “compassionate use” of unapproved products still in the pipeline ever since the we blogged on the Abigail Alliance litigation back in 2007.  For those of you not reading us then, we praised the D.C. Circuit’s rejection of any constitutional right for terminally–ill patients to demand access to investigational drugs.  Abigail Alliance for Better Access to Developmental Drugs v. von Eschenbach, 495 F.3d 695, 710-11 (D.C. Cir. 2007).

We did that because the next step, after establishing such a constitutional right as against the FDA, would have been to file suit against our clients (the government usually doesn’t have the drugs, the manufacturers do) to “enforce” that right by demanding that drug companies supply them with the unapproved drugs they sought.  Sure enough, that’s happened, too, even without the purported constitutional right.  We discussed a number of such cases (all, thankfully unsuccessful) here.

Continue Reading On “Right To Try” Legislation

We’ve blogged a number of times about the illogical, and often downright counterproductive, nature of the FDA’s position that regulated manufacturers are generally banned from providing the medical community (or the public) with truthful information about the off-label uses of their products.  Even information about the risks of off-label uses cannot be included on a product’s labeling unless the FDA requires it.

A new draft FDA guidance demonstrates how strange these results can be.  This draft guidance, entitled “Informed Consent Information Sheet, Guidance for IRBs, Clinical Investigators, and Sponsors,” is located here on the FDA’s website.  It came out in July.  Like the title says, it concerns the informed consent obligations of persons involved in FDA-regulated clinical trials.  As with most other medical practice, the attending physician (in clinical trials, the “investigator”) has primary responsibility for providing patients (“subjects” in trials) with the information necessary to obtain their informed consent.  The Draft Guidance discusses this information in detail.

The interesting part, from our perspective, has to do with “alternative procedures or treatments.”  Here the FDA advises “consent forms must disclose appropriate alternatives to entering the clinical investigation, if any, that might be advantageous to the subject.”  Part III(B)(4) (sorry about this, but the FDA’s online documents aren’t paginated). That’s pretty standard.  Viable alternative treatments are part of most, if not all, states’ informed consent common law.  When discussing alternatives, “a description of any reasonably foreseeable risks or discomforts and potential benefits associated with these alternatives must be disclosed.”  Id.

According to the FDA, the informed consent disclosure “must include a description of the current medically recognized standard of care.”  Id.  We’ve pointed out in the past that, in many instances, the medical standard of care includes off-label use.  Notably, in the new draft guidance, the FDA recognizes this fact as well:

Standard of care may include uses or treatment regimens that are not included in a product’s approved labeling (or, in the case of a medical device cleared under the 510(k) process, in the product’s statement of intended uses).

Id. For this proposition, the draft guidance cites an earlier finalized guidance:

As FDA has recognized in prior guidance, “[O]ff-label uses or treatment regimens may be important and may even constitute medically recognized standard of care.”  FDA Guidance, “Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices.”

That earlier guidance is available here, and we blogged about it here.

So the FDA recognizes that investigators in regulated clinical trials have to provide informed consent information to trial subjects about off-label use where that treatment represents the medical standard of care.  Trouble is, what’s the most logical source for this information? The manufacturer of the product being used off label.  After all, the manufacturer is the primary entity with the obligation under the FDA’s regulatory scheme to report adverse events, and the FDA’s adverse event reporting regulations don’t really distinguish between on- and off-label uses – manufacturers report about both.  After a fashion, the FDA also recognizes that logic.  In discussing the informed consent role of manufacturers (“sponsors,” in clinical-trial-speak), the new draft guidance observes:

Sponsors often provide clinical investigators with a model consent form that may be adapted by the clinical investigator to meet local needs.  When the consent form is submitted to FDA for review, FDA’s comments are generally directed to the sponsor. . . .  [T]he sponsor should work closely with the clinical investigator to make certain the modified consent form is reviewed and approved.

Draft Guidance at Part III(C).

But in the case of a standard-of-care off-label use one of two things has to happen:  (1) the off-label use is of the sponsor/manufacturer’s own product, or (2) the off-label use is of a different, competing manufacturer’s product.  It’s either one or the other.  If the first option is applicable – as will be the case when the sponsor is attempting to bring the off-label use onto the label (something FDA encourages) – then the sponsor/manufacturer could be in trouble.  Providing the investigator/physicians with proposed informed consent forms accurately describing off-label use is what the FDA calls, in other contexts, “promotion” of off-label use.  The FDA claims that’s illegal.  So do all these plaintiffs we write about frequently seeking to follow in the FDA’s footsteps.

The draft guidance, of course, recites that it doesn’t “establish legally enforceable responsibilities.”  Id. at Part I.  That means that, if it wants, the FDA might come along and try to prosecute manufacturer/sponsors for providing physician/investigators with the very information that this draft guidance states should be provided. Or private plaintiffs might improperly purport to enforce the FDCA concerning off-label promotion.

Don’t laugh. It’s already happened.  We’ve already seen plaintiffs allege that clinical trials are merely ruses for off-label promotion.

And if option two – the standard-of-care off-label use is of a competing product − is applicable, then the results verge on the downright perverse.  The FDA’s regulations don’t prohibit the off-label promotion of a competing product.  After all, in the jerry-rigged regulatory scheme by which the FDA professes to ban manufacturer dissemination of truthful information about off-label uses, the manufacturer is only obligated to provide “adequate directions for use” about its own product, not somebody else’s.  So a manufacturer can “promote” the off-label use of a different company’s product.

What’s the incentive for it to do so?  Is there anything in the FDCA that requires a manufacturer to provide “fair balance” about a product it doesn’t make?  Why would it want to present the off-label use of a competing product as the “standard of care” at all?  Beyond that, what information is a manufacturer going to have about the risk profile of competing products’ off-label uses.  A manufacturer doesn’t receive adverse event reports about products it doesn’t make.  Even if it received one by accident, the FDA’s reporting requirements relate only to products for which it is the NDA/ANDA/PMA/§510k holder.

So the practical result of the new informed consent draft guidance is that sponsors are expected to help investigators with informed consent forms, and investigators are required to provide patients with information about off-label uses when they are the standard of care.  Owing to the FDA’s outdated off-label promotion positions, however, a sponsor is open to persecution/prosecution for off-label promotion when it does what this draft guidance envisions with respect to the products it knows most about – those being its own.  It has no incentive, and is likely to be providing incomplete information, to the extent that this guidance relates to off-label uses of competing products.

The FDA is tying itself in knots with respect to its increasingly untenable position about truthful off-label promotion.  We suppose it will continue to do so until the First Amendment finally forcibly ejects the Agency from those positions.

In our opinion, that can’t happen soon enough.

Our first reaction to Zeman v. Williams, 2014 U.S. Dist. LEXIS 91501 (D. Mass. July 7, 2014), wasn’t related to the fact that it involved a federal court recognizing a cause of action previously unrecognized by Massachusetts state courts.  Our first reaction was that the case shouldn’t be complicated.  The plaintiff participated in a clinical trial involving a bilateral gene transfer, which is a new procedure intended to treat Young-Onset Parkinson’s Disease.  Id. at *3.  As the “bilateral” in its name implies, a bilateral gene transfer consists of two injections of genes into the brain, one into the right side and one into the left.  Id. at *3-4.  But (plaintiff alleged) the surgeon gave both injections to the left side.  Id. at *4.

It seems fairly easy to identify the problem here.  If an engineer designs a twin-engine plane, and the mechanics put both engines on the left side, you’ve got a good idea who made the mistake.  If the Doublemint gum company told its casting director to hire blond twins for its commercial, and the casting director hired some guy named Roy, you can be pretty sure who made that mistake too.  So whom did the Zeman plaintiffs sue over the improper procedure?  The manufacturer and the Institutional Review Board (“IRB”), of course.

Continue Reading Federal Court Finds a Duty With Regard to Consent Forms in Clinical Trials That the State Court Had Not Previously Recognized

The last opinion available on Lexis or Westlaw for Seavey v. Globus Medical, Inc., is from early 2012, when the manufacturer defendant failed to get the plaintiff’s express warranty claim thrown out on the pleadings. See 2012 WL 253116 and/or 2012 U.S. Dist. Lexis 9435. Fortunately, all the defendants did better on summary judgment – much better, since all claims against all of them were recently dismissed.  See In Seavey v. Globus Medical, Inc., Civ. No. No. 11-2240 (RBK/JS), slip op. (D.N.J. March 11, 2014).

First, to satisfy your (or at least our) curiosity, how did the express warranty claim that the court had allowed previously fare?  The way almost all such claims do when facts finally replace allegations:  “Plaintiff has now indicated that he does not oppose summary judgment on the manufacturing defect and express warranty claims.”  Slip op. at 34.  Forget TwIqbal, we wish courts would enforce Rule 11 as to express warranty, since any such warranty would be in a plaintiff’s possession, and should be pleaded truthfully.

Now, on to the fun stuff.

Seavey is an off-label use case involving a “spinal fixation device.”  Slip op. at 2.  See Seavey, 2012 WL 253116, at *1 (employing the unusual term “off brand”). Sound familiar?  To us Bone Screw veterans it does.  Not only does the plaintiff bring product liability claims against medical device manufacturer, but also “informed consent” claims against his surgeon.  We’ve got you covered there.  See Blazoski v. Cook, 787 A.2d 910 (N.J. Super. A.D. 2002) (bone screw case). Anyway, plaintiff appears to have been treated quite conservatively for intractable back pain caused by two-level degenerative disc disease (L4-S1 – the most common locations) including both herniation and a “large extruded disc fragment,” and complicated by something called “Normokalemic Periodic Paralysis.”  Slip op. at 2-3.  He was treated nonsurgically for six years, had uninstrumented surgery, which didn’t resolve his pain, and the instrumented procedure that is the subject of suit was only performed three years after the first, unsuccessful surgery (and with a diagnosis of “complete collapse” at L5-S1).  Id. at 2-4.

The off-label use involved the manufacturer defendant’s device being used in a “dynamic stabilization technique”:

Prior to Plaintiff’s surgery, [the surgeon defendant] had used several dynamic stabilization devices that were not manufactured by [the manufacturer defendant].   He attended lectures by doctors who were utilizing the dynamic stabilization technique with a semi-rigid fixation device in their practices, with the disclaimer made by those doctors that such use was “off-label.”  Subsequently, [the surgeon defendant] began using dynamic stabilization with semi-rigid devices in a manner not approved by the FDA.

Slip op. at 6 (citations omitted).  That surgery helped plaintiff’s pain for a while, but in less than a year he was “explor[ing] other options regarding pain relief.”  Id. at 6-7.

And yes, pedicle screws (“screws that run through the pedicles”) were used.  Id. at 5.  Despite failure of fusion, id. at 6, 8, the instrumentation remained “intact” for almost two years.  Id. at 8.  Then, one of the screws at L4 – the “dynamic stabilization” level of plaintiff’s surgery – broke.  Id. Despite multiple revision surgeries, other hardware, and pain medication pumps, plaintiff remained in pain.  Id. at 8-9.  In short, Seavey sounds like a bog standard bone screw case.

Ditto for the device.  It also sounds pretty standard − cleared by the FDA, as all such devices are, pursuant to non-preemptive (thanks to Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996)) §510k clearance.  Slip op. at 7.  There is one significant difference from the cases we dealt with 15-20 years ago.  Pursuant to the Agency’s authority that we previously discussed here, the FDA required a warning specifically about off-label use:

The safety and effectiveness of this device has not been established for the intended use of spinal stabilization without fusion.  This device is only intended to be used when fusion with autogenous bone graft is being performed at all instrumented levels.

Id.  The manufacturer complied with the FDA’s requirement and included this warning every place it was supposed to.  Id. at 8

Plaintiff had the surgery in question in New Jersey, so that state’s law applied. That means the New Jersey product liability statute, including its presumption of adequacy for warnings “approved or prescribed” by the FDA.  Slip op. at 11 (quoting N.J.S.A. 2A:58C-4).  While this §510k device might not have been “approved,” its warnings were certainly “prescribed” by the FDA:

Here [the device] underwent a federal regulatory evaluation process, which ultimately resulted in the FDA’s grant of permission for [the manufacturer defendant] to place the device on the market, provided that a warning prescribed by the FDA was given.  The approval includes the label and other instructions that are included with a device that the FDA permits to proceed into the marketplace.

Seavey, slip op. at 11-12.  Thus, Seavey is useful precedent for applying the New Jersey presumption of warning adequacy to §510k medical devices.

Nor was the presumption rebutted.  The FDA specifically considered off-label use and required a warning.  Defendant gave it.  Defendant “also warned of the risks of screw breakage, hardware failure, and non-union.”  Slip op. at 12.  Plaintiff claimed that the defendant’s sales representative knew that the defendant surgeon was going to use the device off-label.  Id. at 12-13.  So what? Off-label use is legal, and manufacturers have no duty to try to prevent it:

Plaintiff has no evidence that any [sales representative] encouraged [defendant surgeon] to use the [device] off-label.  At most, he has produced evidence suggesting that [defendant’s representative] may have known that [the surgeon] planned to do so and did not prevent this from occurring.  Plaintiff has cited no law indicating that a device manufacturer has any duty to prevent off-label use of its products.  The FDA does not regulate the use of medical devices by doctors, and does not purport to control how doctors use a given device. Nor can the FDA intrude upon the practice of medicine, through its regulation of the marketing and sale of medical devices.  Thus, it follows that a manufacturer has no affirmative duty to intervene in order to prevent off-label use of its product by a surgeon. Plaintiff’s claim that [defendant’s] representative allowed the misuse of the product through calculated silence is insufficient to create an issue of material fact for trial as to failure to warn.

Slip op. at 15-16 (citations and quotations from Blazoski omitted) (emphasis added).  While Seavey cites only Blazoski, this result is actually in accord with considerable other precedent.  See Carson v. Depuy Spine, Inc., 365 Fed. Appx. 812, 815 (9th Cir. 2010) (applying California law); Haley v. I-Flow, LLC, 853 F. Supp.2d 868, 881 (D. Minn. 2012); Wolicki-Gables v. Arrow International, Inc., 641 F. Supp.2d 1270, 1292 (M.D. Fla. 2009), aff’d, 634 F.3d 1296 (11th Cir. 2011); Rohlik v. I Flow Corp., 2011 WL 2669302, at *3 (E.D.N.C. July 7, 2011); Davenport v. Medtronic, Inc., 302 F. Supp.2d 419, 439-40 (E.D. Pa. 2004); Little v. Depuy Motech, Inc., 2000 WL 1519962, at *9 (S.D. Cal. June 13, 2000); Cox v. Depuy Motech, Inc., 2000 WL 1160486, at *8-9 (S.D. Cal. March 29, 2000).

Nor would off-label promotion – alleged but not proven in Seavey – defeat the New Jersey presumption:

Plaintiff has produced no evidence showing that [defendant manufacturer] marketed the device for use in an off-label manner, and has cited no law indicating that “calculated silence” that fails to prevent a doctor from using a device off-label, is the equivalent of off-label marketing.  Further, even if [its] representatives had encouraged off-label use of their devices − which has not been demonstrated − this conduct would not support a product defect case for inadequate warning. . . .  While such action, if true, might be actionable, it would not result in a viable products liability action under a failure to warn theory.

Slip op. at 16 (emphasis added).  As a federal court sitting in diversity, Seavey refused to create a judicial exception to the New Jersey presumption for off-label promotion.  Id. at 16-17.  That is for either the FDA (which prescribed an off-label warning) or the New Jersey legislature (which enacted the statute).  Id.  We’ve been pushing Erie-based conservatism since this blog started. It’s gratifying to see it properly applied.

Nor was a court applying state law in position to question product “testing” that the FDA had found sufficient:

Plaintiff has asserted that he was not warned that the device did not undergo certain tests. . . .  The FDA ultimately viewed the testing done on the [device] as adequate, as it approved the marketing of the device pursuant to its 510(k) approval process, provided that certain warnings were included. . . .  [I]t is not this Court’s place to challenge the adequacy of the FDA’s regulatory process in a warning context, particularly in light of the New Jersey Legislature’s decision to enact the presumption of adequacy standard.

Seavey, slip op. at 17 n.9 (citations omitted).  We point out, although Seavey did not reach the issue, that there is no viable claim for failure to test in New Jersey in any event.  For cases, see our duty to test cheat sheet (which includes three New Jersey decisions).

As an alternative holding, Seavey also invoked the learned intermediary rule. The manufacturer defendant’s warning was “clearly” adequate.  The implanting surgeon “knew”:  he was engaging in off-label use, the risks of the off-label procedure he selected, and that the medical community viewed this off-label use as “safe.”  Slip op. at 18.  The surgeon also knew he had the right to pursue off-label use where, in “his medical judgment,” he believed it would be of therapeutic benefit to his patient:

[H]is decision was based upon Plaintiff’s individual condition and needs, and because he knew that the FDA does not prohibit a surgeon’s use of any device off-label, he concluded that such a course was the best possible treatment for his patient.

Id. Thus, the manufacturer defendant adequately warned the physician under the learned intermediary rule and “cannot be held liable for failing to prevent [the surgeon defendant] from using the device in an off-label fashion.”  Id. at 19.  For all these reasons, the manufacturer defendant received summary judgment against plaintiff’s warning claims.

Plaintiff’s design claim also failed.  Plaintiff was required by New Jersey law to come forward with a safer alternative design, and failed to do so.  Slip op. at 19-21.  “It is insufficient to merely recite that such an alternative design exists. Rather, a plaintiff must demonstrate the reasonableness and feasibility of the alternative design.”  Id. at 21.  Plaintiff offered neither an alternative nor proof that “an alternatively designed product would have prevented the harm to Plaintiff.”  Id.  It is not a design defect that the surgeon “used the device incorrectly.”  Id. at 22.  That argument is “a medical malpractice claim under the guise of a design defect claim.”  Id. at 22 n.12.  Summary judgment for the right side of the “v.” on design defect.

The implanting surgeon also received summary judgment.  We’re not as interested in those claims, but we do care about informed consent.  Plaintiff predictably claimed that his surgeon “did not inform him of the FDA status of the device.”  Slip op. at 23.  We’ve been fighting that battle since Bone Screw, and the precedent from that litigation once again (as we recently discussed here) stood the test of time:

[W]hen a surgeon uses a medical device in an “off-label” manner, a failure to disclose that information to the patient is, alone, insufficient to support a claim that the physician failed to meet the applicable disclosure standard.  A physician must disclose all material information that a ‘prudent patient’ might find significant for a determination whether to undergo the proposed therapy. However, the FDA regulatory status does not speak directly to the medical issues surrounding a particular surgery.  This is the case because the FDA’s concern is to regulate the marketing and labelling of medical devices, not to intrude upon the practice of medicine or redefine the doctrine of informed consent.  Doctors may use medical devices for off-label purposes that are not FDA approved, provided that the FDA has approved the device for some other purpose.  Thus, the law is established in New Jersey that the fact that a device is being used in a manner unapproved by the FDA does not fall under the umbrella of information that a “prudent patient” would find significant.  Doctors routinely use devices for purposes that are not approved by the FDA.

Seavey, slip op. at 23-24 (numerous Blazoski citations and quotation marks omitted) (emphasis added).  An off-label use is not a use that was “rejected” by the FDA, and in any event that doesn’t matter because “the FDA cannot, and does not attempt to, prevent the use of an approved device in an unapproved or ‘rejected’ manner by a physician.”  Id. at 25.

Nor could informed consent liability be justified because a device is “experimental.”  The FDA simply doesn’t govern medical practices:

Plaintiff has also not shown that the FDA makes any distinction between experimental and prohibited devices with respect to the general marketplace for a device.  The FDA can only regulate the marketing and labelling of devices.  It cannot regulate what physicians do with the devices with respect to their patients.  Plaintiff has cited nothing indicating that the FDA indicated anywhere that physicians were “prohibited” from using the device for any purpose . . . .  [T]he FDA either gives its approval for a device manufacturer to market a device for a particular purpose or it does not.  If it does not issue approval, the manufacturer may not market the device. . . .  The FDA Clearance letter that Plaintiff cites . . . does not indicate any such rejections with respect to physicians.

Seavey, slip op. at 27 (more Blazoski citations omitted).  We’ve seen these same tired informed consent arguments used over and over in off-label use cases.  We’re happy to report on yet another rejection.

Of course, if the underlying medical risks of off-label use are material, then they have to be disclosed to the patient – regardless of a product’s FDA status.  Seavey, slip op. at 28.  That, however, requires expert testimony, which the plaintiff did not produce.  Therefore summary judgment. Id. at 28-31.

Finally, plaintiff also asserted product liability claims against the defendant physician. You can’t do that in New Jersey, as in most places, unless the physician leaves his/her role as a doctor and engages in manufacturing activities – which did not happen here.  Id. at 31-33.

Plaintiff’s products liability claim against [defendant physician] constitutes an attempt to shoehorn a medical malpractice or informed consent claim into a products liability cause of action by attempting to characterize off-label use and the risks associated with such use as a “defect.”  Plaintiff has cited no law, and the Court is aware of none, suggesting that he can use a products liability claim as a second attempt at a negligence claim against a physician, without having to demonstrate the standard of care.

Seavey, slip op. at 33.

Seavey demonstrates that bone screw cases are no more meritorious today than they were the first time around.  Some things don’t change. Thanks to Terry Henry at Blank Rome for passing along Seavey to us.  Sometimes word of mouth is faster than Lexis or Westlaw.

We’ve blogged several times about the nearly unanimously accepted proposition that FDA regulatory status – that is, the bare fact that a drug or medical device is used off-label – is not a medical risk, benefit, or alternative about which physicians must tell patients under the law of informed consent.  Bexis in particular is emphatic on this point because he played a big part in creating that law in the Bone Screw litigation.

Recently, in a case we didn’t blog about – because we didn’t want to tip off the other side – a Maryland intermediate appellate decision had gone the other way. We’re now pleased to inform everyone, however, that the Maryland Court of Appeals (that state’s highest court) has reversed that bad decision on precisely the grounds we hoped it would (yes, Bexis was in touch with the appellant physician’s counsel in that case). Here’s the money quote:

Information pertaining to an “off-label” use provides the patient with no information about the treatment itself.  As the Pennsylvania court recognized in Southard [a case Bexis briefed], “‘[t]he mere fact that the FDA has not cleared a product for a particular use does not mean that the product is not in fact suitable for that purpose; it simply means that the FDA has not cleared it.’” Southard, 781 A.2d at 107.  Because it provides no information regarding the medical treatment, it cannot, therefore, be considered material information to an informed consent discussion.  We note, finally, with respect to this issue, that the FDA-approval status does not provide any information regarding the materiality of the risks of the administration of [the drug]; it does not inform the fact-finder of the likelihood or severity of any risk.

Shannon v. Fusco, 2014 Md. Lexis 275 (Md. April 24, 2014) (citation and footnote omitted) (emphasis added).

This discussion of an opinion in the Pelvic Mesh litigation once again comes only from the Dechert side of the blog. The MDL court in the pelvic mesh litigation issued rulings on motions in limine last week.  In re: Bard, Inc. Pelvic Repair Sys. Prods. Liab. Litig., MDL No. 2187, 2:11-cv-00195, 2:11-cv-00012, 2:10-cv-01224, 2:11-cv-00114, 2013 U.S. Dist. LEXIS 90210 (S.D.W.V. June 27, 2013).  In previous pretrial rulings, the defense made out well, winning summary judgment on a number of plaintiffs’ claims, including a failure to warn claim in one case (see here and here), and winning a number of key Daubert motions (here).  Things didn’t go as well with the in limine motions.  It was more of a mixed bag.  Here are a few of the issues addressed by the court.

FDA 510(k) Clearance
This was plaintiffs’ motion.  They wanted to exclude evidence related to the FDA’s clearance of the Avaulta products through its 510(k) process.  Id. at *4-6.  Seems pretty relevant, doesn’t it?  It’s the process established by the industry’s primary regulator as to what the industry must do and how it must do it in order to be able to bring its product to market.  Yet the court granted plaintiffs’ motion.

Continue Reading Pelvic Mesh Litigation: In Limine Rulings