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JAMES M. BECK is Counsel resident in the Philadelphia office of ReedSmith. He is the author of, among other things, Drug and Medical Device Product Liability Handbook (2004) (with Anthony Vale). He wrote the seminal law review article on off-label use cited by the Supreme Court in Buckman v. Plaintiffs Legal Committee. He has written more amicus briefs for the Product Liability Advisory Council than anyone else in the history of the organization, and in 2011 won PLAC's highest honor, the John P. Raleigh award. He has been a member of the American Law Institute (ALI) since 2005. He is the long-time editor of the newsletter of the ABA's Mass Torts Committee.  He is vice chair of the Class Actions and Multi-Plaintiff Litigation SLG of DRI's Drug and Device Committee.  He can be reached at jmbeck@reedsmith.com.  His LiinkedIn page is here.

That’s Engle v. Liggett Group, Inc., 945 So. 2d 1246 (Fla. 2006), the most bizarre use of res judicata that we’ve ever seen – giving preclusive effect to a class action verdict despite also finding that the class was not certifiable.  Anyway, continuing in the tradition of unusual, pro-plaintiff results from the Florida Supreme Court (but not necessarily the district courts of appeals), we have two more to discuss.

First, since we blogged about the preemption result in Charles v. Southern Baptist Hospital, Inc., 178 So.3d 102 (Fla. App. 2015), we feel we ought to warn you that the favorable preemption decision was reversed late last month by the Florida Supreme Court.  Charles v. Southern Baptist Hospital, Inc., ___ So.3d ___, 2017 WL 411333 (Fla. Jan. 31, 2017).  Basically, the court held that the provisions of the federal Patient Safety and Quality Improvement Act (“PSQI”), didn’t preempt (expressly or impliedly) an unusual Florida constitutional provision (called “Amendment 7”) granting patients (read:  plaintiff lawyers) access to “adverse medical incidents” – even though these incidents were compiled and provided to PSQI evaluation committees in accordance with the statute.  Anything that had been initially created for any other purpose couldn’t qualify as protected “patient safety work product” under the PSQI.  2017 WL 411333, at *8.  The statute provided:

Notwithstanding any other provision of Federal, State, or local law, and subject to subsection (c) of this section, patient safety work product shall be confidential and shall not be disclosed.

42 U.S.C. §299b-22(a)-(b).  Tort litigation was not mentioned in subsection (c), but the court in Charles grabbed a “rule of construction” from elsewhere in the statute, and used that to create an exception to confidentiality that Congress has not seen fit to create in subsection (c).  Charles has a lot of mumbo-jumbo about not reading statutes in “isolation” and giving “every portion” meaning, 2017 WL 411333, at *4-5, but none of that can hide that the decision ignored the “notwithstanding any other provision” language and used something other than “subsection (c)’ to create a huge hole in confidentiality that Congress did not authorize.

That’s one.

In In re Amendments To Florida Evidence Code, ___ So.3d ___, 2017 WL 633770 (Fla. Feb. 16, 2017), the same court showed the same lack of respect for the state legislature that Charles had shown to the United States Congress.  In 2013, the legislature passed a statute to replace the prior Frye-based analysis of expert testimony with that of Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993).  2017 WL 633770, at *2-3.  In re Amendments refused to amend the Florida Rules of Evidence to comply with this legislative directive.  This result followed a narrow 16-14 vote to that effect by a rules committee (no doubt packed, like Pennsylvania’s, with plaintiff-side members).  Id. at *1.

The reason for refusing to follow the Legislature’s directive was as bizarre as Engle – that Daubert may well be unconstitutional:

[T]he Committee and commenters who support the recommendation raised what we consider “grave constitutional concerns.”  Those concerns include undermining the right to a jury trial and denying access to the courts.  While the Court does not address the constitutionality of a statute or proposed rule within the context of a rules case, the fact that there may be “grave concerns about the constitutionality of the amendment” has been a basis previously for the Court not adopting an amendment to the Evidence Code. . . .  [W]e decline to adopt the Daubert Amendment to the extent that it is procedural, due to the constitutional concerns raised, which must be left for a proper case or controversy.

In re Amendments, 2017 WL 633770, at *3.  The court cited no precedent at all for this jaw-dropping proposition.  Daubert – a United States Supreme Court decision – has been around, now, since 1993.  The Federal Rules of Evidence (Rule 702) have been amended to conform to Daubert.  As the dissent points out, no court anywhere has ever declared Daubert unconstitutional before:

[T]he United States Supreme Court decided Daubert in 1993, and the standard has been routinely applied in federal courts ever since.  The clear majority of state jurisdictions also adhere to the Daubert standard.  In fact, there are 36 states that have rejected Frye in favor of Daubert to some extent.  Has the entire federal court system for the last 23 years as well as 36 states denied parties’ rights to a jury trial and access to courts?  Do only Florida and a few other states have a constitutionally sound standard for the admissibility of expert testimony?  Of course not.

In re Amendments, 2017 WL 633770, at *6 (dissenting opinion).  The dissent cited two cases directly rejecting this sort of constitutional challenge to Daubert. Id. (citing Junk v. Terminix International Co., 628 F.3d 439, 450 (8th Cir. 2010), and E.I. du Pont de Nemours & Co. v. Robinson, 923 S.W.2d 549, 558 (Tex. 1995)).  That’s two more cases than the majority cited.  It’s also probably the tip of the iceberg.  The relevant West keynote for Junk is #24, and for Robinson is #8.  According to Westlaw, these two keynotes, between them, have been cited by 97 other cases.

We agree with the dissent in In re Amendments – the proposition that, after a quarter century, Daubert is unconstitutional is absurd.

Not only absurd, but utterly unsupported by precedent.

Fish rot from the head, and there is currently something very rotten in the State of Florida.

One of us was asked a question the other day that we couldn’t answer immediately.  “Does the learned intermediary rule apply to a physician’s assistant?”  We didn’t remember any cases actually deciding that issue.  So we did what we usually do in that situation and looked at Bexis’ book.  The book has a section (§2.03[2]) titled “Who Is the Learned Intermediary,” which looked like it would cover this subject.  It did, but while it had cases discussing nurses:

Yes: Ellis v. C.R. Bard, Inc., 311 F.3d 1272, 1281 (11th Cir. 2002) (applying Georgia law); Walker v. Merck & Co., 648 F. Supp. 931, 934 (M.D. Ga. 1986), aff’d without op., 831 F.2d 1069 (11th Cir. 1987); Wyeth-Ayerst Laboratories Co. v. Medrano, 28 S.W.3d 87, 93 (Tex. App. 2000); Holley v. Burroughs Wellcome Co., 330 S.E.2d 228, 235-36 (N.C. App. 1985), aff’d, 348 S.E.2d 772 (N.C. 1986); Singleton v. Airco, Inc., 314 S.E.2d 680, 682 (Ga. App. 1984); In re NuvaRing Litigation, 2013 WL 1874321, at *28 (N.J. Super. L.D. April 18, 2013) (applying California law).  No: Mazur v. Merck & Co., 964 F.2d 1348, 1357 (3d Cir. 1992) (a nurse “not authorized to prescribe drugs”) (applying Pennsylvania law); Reyes v. Wyeth Laboratories, 498 F.2d 1264, 1277 (5th Cir. 1974) (applying Texas law).

Cases discussing optometrists:

No: Prager v. Allergan, Inc., 1990 WL 70875, at *4 (N.D. Ill. May 2, 1990); Bukowski v. CooperVision Inc., 592 N.Y.S.2d 807, 809 (N.Y.A.D. 1993);

Cases discussing pharmacists:

No: Coyle v. Richardson-Merrell, Inc., 584 A.2d 1383, 1387 (Pa. 1991); Makripodis v. Merrell-Dow Pharmaceuticals, Inc., 523 A.2d 374, 378 (Pa. Super. 1987);

A case discussing veterinarians:

Yes: Haste v. American Home Products Corp., 577 F.2d 1122, 1124 (10th Cir. 1978) (applying Wyoming law);

A case discussing physical therapists:

Yes: Seifried v. The Hygenic Corp., 410 S.W.3d 427, 433 (Tex. App. 2013); and

A case discussing medical societies:

No: Davis v. Wyeth Laboratories, 399 F.2d 121, 130 (9th Cir. 1968) (applying Montana law) . . . .

There were no cases specifically addressing P.A. prescriptions and the learned intermediary rule in Bexis’ book.

As an aside, we note that, while the weird case we discussed last week from Washington State, Taylor v. Intuitive Surgical, Inc., ___ P.3d ___, 2017 WL 532497 (Wash. Feb. 9, 2017), wasn’t phrased in such terms, it is effectively a ruling that a hospital can be a learned intermediary.

The only specific mention of physician’s assistants in Bexis’ book was quoting dictum in Perez v. Wyeth Laboratories, Inc., 713 A.2d 520 (N.J. Super. A.D. 1998), that although limited to “physicians” by statute, the learned intermediary rule might also apply to “dentists, optometrists, podiatrists, nurse practitioners, home health care service firms, physician’s assistants, or others similarly permitted to prescribe or administer drugs on a limited basis.” Id. at 522-23 (statutory citations omitted).  That decision was, of course, famously reversed in Perez v. Wyeth Laboratories Inc., 734 A.2d 1245 (N.J. 1999), another weird decision that created a “direct to consumer” exception to the learned intermediary rule (since rejected by every other state to consider it), and thus never had to reach the “who is” question.

The next thing we did was to run a ridiculously broad Westlaw search – looking for “learned intermediary” anywhere in the same case as “physician’s assistant”?

Not too bad, this time. Less than 25 cases, including the two Perez decisions.

The most significant case on P.A.s and the learned intermediary rule is Stevens v. Novartis Pharmaceuticals Corp., 247 P.3d 244 (Mont. 2010).  As we discussed here and here, while Stevens is not overall a favorable decision for defendants, it did reaffirm the learned intermediary rule and extend it to a P.A.-prescribed drug.  Stevens first mentioned the Third Restatement’s version of the learned intermediary rule, Restatement (Third) of Torts, Products Liability §6(d)(1), which describes the rule in terms of warnings “provided to . . . prescribing and other health-care providers.”  247 P.3d at 492 (emphasis added).  The court then discussed the “evolution” of the rule “away from limiting the doctrine’s applicability to the prescribing physician alone.” Id. A P.A. could thus be a “learned intermediary” when fulfilling the “traditional” role of a physician:

The modern healthcare system, however, places far less emphasis on these traditional relationships, and patients today often receive the majority of their care from nurses, nurse practitioners, physicians’ assistants, and physicians other than the prescribing physician.  Appropriately, in situations where the underlying rationale of the doctrine − the traditional doctor-patient relationship − is no longer present, the doctrine has adapted to fit the realities of the situation.

*          *          *          *

[T]he evolution of the doctrine [has been] through an expansion of the possible class of learned intermediaries. This development, likewise spurred by the fact that the medical professionals with whom patients most commonly interact are often no longer primary physicians, has led courts and secondary sources such as the Restatement to suggest that a variety of different healthcare providers may be considered learned intermediaries, depending on the unique facts of the patients’ treatment scenario.

*          *          *          *

We concur with authorities who consider the learned intermediary to be the healthcare professional actually responsible for making decisions related to the patient’s care. . . . [Plaintiff] received much of her treatment from nurses, treating physicians, and nurse practitioners.

Stevens, 247 P.3d at 492-95 (footnote citing many of the cases in Bexis’ book omitted).

Another case applying the learned intermediary rule to a physician’s assistant is Luke v. Family Care & Urgent Medical Clinics, 246 F. Appx. 421 (9th Cir. 2007) (applying Washington law).  The drug in question in Luke was prescribed by a P.A., id. at 423, and but the learned intermediary rule still applied:

[T]he district court properly decided that the [risk at issue] was not material and that the physician’s assistant had no duty to warn [plaintiff] of the danger.  Under Washington law, it would be contradictory to require a pharmacist to warn of the same danger when the “learned intermediary” had no duty to warn.

Id. at 425.

The learned intermediary rule also applied to a physician’s assistant in Yates v. Ortho-McNeil-Janssen Pharmaceuticals, Inc., 808 F.3d 281 (6th Cir. 2015) (applying Ohio law) – a case we usually cite for its preemption holdings.  In Yates the prescriber (“Smith”) was a P.A.  Id. at 288.  Without a lot of discussion of Smith’s P.A. status, Yates found the learned intermediary rule applicable:

Smith testified that it is her custom to use her independent medical judgment when prescribing birth control products to patients, and she specifically testified that she discussed the risks and benefits of several different forms of birth control with [plaintiff].  The mere fact that Smith gave [plaintiff] options and a voice in determining which method of birth control would best fit her needs and lifestyle does not remove Smith from her status as a learned intermediary.

Id. at 293.  Without any separate discussion of P.A. status, Czimmer v. Janssen Pharmaceuticals, Inc., 122 A.3d 1043, 1056-58 (Pa. Super. 2015), treated a prescribing P.A. as a learned intermediary.  See also Canady v. Ortho McNeil Pharmaceutical, Inc., 2014 WL 1653349, at *4 (N.D. Ohio April 24, 2014) (applying learned intermediary rule in negligence action over drug prescribed by a P.A.; not applying learned intermediary rule to strict liability, due to peculiar Oregon statute); Woodhouse v. Sanofi-Aventis U.S. LLC, 2011 WL 3666595, at *2-3 (W.D. Tex. June 23, 2011) (applying learned intermediary rule to prescribing P.A. without regard to P.A. status).

As Stevens in particular demonstrates, expanding the learned intermediary rule to non-physicians such as P.A.s is something of a double-edged sword.  On one hand, recognizing non-physicians who prescribe drugs or devices as learned intermediaries precludes plaintiffs from arguing for direct-to-patient warnings.  On the other hand, the rule requires that adequate warnings be given to the learned intermediary – whoever that might be.  Thus, expanding the categories of medical practitioners who qualify as “learned intermediaries” also expands the scope of a defendant’s warning obligations to such practitioners, although not to plaintiffs themselves.  Given the choice between a plaintiff coached to say whatever is necessary to obtain recovery, and a P.A. who usually won’t be in the plaintiff’s back pocket, we’ll take our chances with the P.A.

We’re serious – we’re not planning to give a flip answer like “an extortion racket.”  No, it’s more like law school, where a first-year contracts professor began with the question “What is Chicken?”  (Hint – that’s discussed in Frigaliment Importing Co., Ltd. v. BNS International Sales Corp., 190 F. Supp. 116 (S.D.N.Y. 1960)).  The question of “what is product liability” is of interest to us primarily, but not exclusively, because of 21 U.S.C. §379r(e), which creates an exception for “product liability law” to what is otherwise a rather broad preemption provision governing over-the-counter (also called “monograph”) drugs.

We wrote a post in the early days of the blog – 2008 – about that particular provision, entitled “Preemption Without a Prescription,” where we discussed cases that, up to that time, had addressed the scope of §379r(e)’s saving clause.  That boundary of that clause, as we explained it then, was that “suits for purely economic loss – primarily, but not exclusively, brought under state consumer protection statutes – are not ‘product liability’ actions.”

That’s still true.

We’re not repeating the 2008 post, but we will update it.  Here is a list of cases not discussed in that post, which likewise hold that preemption defeats OTC drug litigation that does not involve personal injury claims:  Wiltz v. Chattem, Inc., 2015 WL 3862368, at *1-2 (C.D. Cal. May 8, 2015); Bowling v. Johnson & Johnson, 65 F. Supp.3d 371, 376-77 (S.D.N.Y. 2014); Gisvold v. Merck & Co., 62 F. Supp.3d 1198, 1202-03 (S.D. Cal. 2014); Crozier v. Johnson & Johnson Consumer Cos., 901 F. Supp.2d 494, 503-05 (D.N.J. 2012) (discussing scope of §379r(e)); Delarosa v. Boiron, Inc., 818 F. Supp.2d 1177, 1188 n.7 (C.D. Cal. 2011) (discussing scope of §379r(e)); Eckler v. Neutrogena Corp., 189 Cal. Rptr.3d 339, 357-61 (Cal. App. 2015) (discussing scope of §379r(e)).

Thanks to this recent blogpost, however, we’ve become aware of another way that the definition of “product liability” is important.  Down in Texas, they have a unique indemnification statute, Tex. Civ. Prac. & Rem. C. §82.002(a) that provides:

A manufacturer shall indemnify and hold harmless a seller against loss arising out of a products liability action, except for any loss caused by the seller’s negligence, intentional misconduct, or other act or omission. . . .

We’d vaguely heard of this statute before, in connection with a case, Hadley v. Wyeth Laboratories, Inc., 287 S.W.3d 847, 849 (Tex. App. 2009), which we liked because it held that prescribing physicians weren’t “sellers” of the drugs they prescribed, which means they can’t be sued for strict liability.

But §82.002(a) also means that, in Texas, the ability of an intermediate seller to recover indemnity (including counsel fees) requires that the underlying action to be one for “products liability.”  That’s where the blogpost comes in.  It discussed a recent case, vRide, Inc. v. Ford Motor Co., 2017 WL 462348 (Tex. App. Feb. 2, 2017), that also addressed the definition of “product liability.” vRide involved an indemnity claim brought by a lessor of a motor vehicle from the defendant, which manufactured the vehicle.  The underlying claim had not been for strict liability, but rather for misrepresentation – that the vehicle did not have the attributes that the original defendant (the lessor) claimed that it did.

The court in vRide held that a misrepresentation claim did not fall within the meaning of “product liability”:

The [plaintiffs’ complaint] did not allege that the [product] was unreasonably dangerous, was defective by manufacture or design, was rendered defective because it lacked certain safety features, or was otherwise defective. Instead, the petition alleged that [defendant] represented [that the product] had certain safety features when in actuality [they] did not have those safety features. . . .  In short, the [complaint] did not contain allegations that the damages arose out of personal injury, death, or property damage allegedly caused by a defective product.

2017 WL 462348, at *7. We can imagine situations in which this definition could come in useful in litigation involving OTC preemption, since it excludes from “product liability” even some actions involving (as did vRide) personal injury.

The most significant hypothetical involves a situation where the plaintiff’s injuries were caused by a generic OTC drug. In that situation, given the broad scope of preemption available in generic drug cases, one could expect plaintiffs to attempt to assert innovator liability against the branded drug manufacturer.  But innovator liability is based (like vRide) on the (we believe phony) proposition that “misrepresentation” is not “product liability” and thus can extend to non-manufacturers.  But if misrepresentation is not “product liability,” then the savings clause in §379r(e) would not apply, and innovator liability claims would be expressly preempted whether or not they involved personal injury. vRide would thus be precedent in favor of preemption.

That would be a good thing.  And so is cross-fertilization – where a definition in a completely unrelated statute can be utilized in support of preemption.

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

We can’t stand “cy pres” distributions of class action settlement funds to non-litigants.  We’ve blogged about this benighted doctrine many times.  We fought against cy pres at in the ALI, and we’ve been fighting against it through Lawyers for Civil Justice in the context of federal rules amendments.

Sure, cy pres can be useful in resolving this or that class action once our clients are unfortunate enough to have become embroiled.  But we firmly believe in the “build it and they will come” theory – that making class actions easier to settle make them easier to bring, because 99% of all class actions (at least those seeking $$$) are brought as strike suits to settle, rather than to litigate.  A cy pres award is a sure-fire indicator of litigation that should never have been brought – because even after settlement, without any opposition from the defendant(s), a cy pres request is an admission that the plaintiffs still can’t prove damages and causation with respect to the absent class members.  They can’t even win a walkover.  Outside the class action area, that would mean “case dismissed” (and maybe sanctions).  As a class action, it means “write a check.”

There is no basis for cy pres in substantive law (outside of a couple oddball statutes), and there’s nothing more “substantive” than taking money supposedly owed to absent class members and giving it to non-litigant charities. Since it’s substantive, there’s also no possible basis for it in Fed. R. Civ. P. 23, since court rules can’t change substantive law.  Cy pres a racket – designed primarily to inflate attorney fee awards − and while the charities might do good work, call us the Grinch, because we don’t think the litigation industry should be funding charities with other people’s money extorted through litigation threats.

Here’s the latest example of cy pres abuse occurring in the context of bogus litigation that should never have been brought, Koby v. ARS National Services, Inc., ___ F.3d ___, 2017 WL 359670 (9th Cir. Jan. 25, 2017).  This isn’t a drug/device case.  Thankfully, between the FDCA no private right of action rule (which, regrettably has a food loophole) and the rejection of personal injury class actions, we don’t encounter all that many of them anymore against drug/device clients.  Instead, Koby is a Fair Debt Collection Practices (“FDCP”) action, and as you might expect from the introduction, a bottom-feeding FDCP action at that.

Supposedly the defendant violated the FDCP at some point a decade or so ago when its employees left messages that did not fully identify themselves. This issue was later fixed, but the class action supposedly includes “some four million people nationwide.”  Koby, 2017 WL 359670, at *1.  Predictably, nobody in the class was actually harmed by what appears to have been a technical FDCP violation (quickly fixed), so only statutory damages were sought.  Theoretically that could have been a lot (4M x $1000), but because ARS was a small company, the 1% of net worth statutory cap limited recovery to $35,000. Id. at *1-2.

You do the math.

Continue Reading More Cy Pres Abuse in California Class Action Litigation

When we heard about Judge Neil Gorsuch being nominated for the United States Supreme Court, our first move was to enter his name in Westlaw along with the term “preemption.” That’s the constitutional doctrine most important to our medical device, generic drug, and (unfortunately to a lesser extent) innovator drug clients.  It’s also a doctrine more likely to get less attention in what promises to be the upcoming brouhaha.

By far the most important Gorsuch preemption decision is Caplinger v. Medtronic, Inc., 784 F.3d 1335 (10th Cir. 2015), cert. denied, 136 S. Ct. 796 (2016), the very favorable PMA medical device preemption decision that we discussed previously here and named as our #2 best case of the year for 2015.  We’re not reprising those posts here.  Rather, we’re examining Caplinger for what it might tell us about Judge Gorsuch’s broader views of FDCA preemption.  His dissatisfaction with the Supreme Court’s tortured approach to express preemption in medical device product liability cases is very clear.

Caplinger begins with the strong statement that, in enacting the Medical Device Amendments, Congress “[e]xercis[ed] its authority under the Supremacy Clause” in enacting 21 U.S.C. §360k(a). 784 F.3d at 1336.  Before looking at relevant Supreme Court authority, Caplinger comments:

At first glance the answer to this appeal might appear easy enough.  Section 360k(a) preempts “any requirement” imposed by states on manufacturers that differs from or adds to those found in the FDCA.  Given this expansive language one might be forgiven for thinking all private state law tort suits are foreclosed.  After all, a “requirement” usually means a request, need, want, or demand.  And an adverse tort judgment seems to involve just that: a demand that a defendant appear to answer for its conduct and pay damages for failing some state law duty.

Id. at 1337 (dictionary citation omitted).  A string citation about the lower courts’ “struggles” to make sense of medical device preemption followed.  Id. at 1337-38.

The problem was, when the Supreme Court got involved, rather than interpreting Congress’ “expansive” preemptive language according to its terms, the Court “issued a number of opinions that embody ‘divergent views’ about the proper role of the MDA’s preemption provision, a fact that has yielded considerable ‘uncertainty’ among the lower courts.”  Id. (citation omitted).

Continue Reading Gorsuch Looks Pretty Good On Preemption

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

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

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

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

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

Continue Reading FDA Off-Label Promotion Memo Should Affect §510k Preemption & Evidence

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

*********

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

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

For well over a year, now Reed Smith has been engaged in an “initiative” concerning the innovative technology, “3D printing,” also known as “additive manufacturing.”  We’ve tried to stay on the forefront of the legal implications of 3D printing, particularly the product liability implications, as we have posted about it here, here, here and here.

Blogging is a quick way to disseminate information, but it’s not the only way.  That’s why Bexis, sometimes guest poster Matt Jacobson, and a number of their Reed Smith colleagues have explored the legal ramifications of 3D printing in a more in-depth and traditional fashion.

Most recently, Bexis and Matt have authored the most comprehensive law review article to date on the product liability implications of 3D printing.  The article is called, “3D Printing:  What Could Happen to Products Liability When Users (and Everyone Else in Between) Become Manufacturers,” and it will appear in the Minnesota Journal of Law, Science & Technology at 18 Minn. J.L. Sci. & Tech. 143 (2017).  If there is anything better out there on this subject, we have not seen it.  It’s now on the law review’s site, and you can download directly a PDF of the article for free at this link.

The first part of this comprehensive article covers the nature of 3D printing and how this new technology works.  There follows an overview of traditional tort liability concepts, and of the gray area that occurs when a potentially revolutionary new technology that allows anyone to become a manufacturer meets legal doctrines, like strict liability and warranty, that turn on concepts like “manufacturer” and “seller” from a prior era.  The second part of the article focuses specifically on 3D printing’s impact on medical devices and health care and the product liability considerations that are specific to these highly technical and potentially life-saving products.

As 3D printing appears to be the next great chapter in the industrial revolution, with the technology often moving more rapidly than the law, this article is significant in that it comprehensively analyzes the current state of products liability law and the legal issues that arise from this body of law when 3D printing is involved.

Second, Reed Smith, again with Bexis and Matt co-authoring the tort liability chapter, has now released a second edition of its “white paper” on 3D printing legal issues:  “3D Printing of Manufactured Goods: An Updated Analysis.”  The paper includes chapters on the following topics:  (1) Constitutional Issues (regarding 3D printed guns); (2) Commercial Litigation; (3) Product Liability, (4) 3D Printing/Component Parts/Raw Materials, (5) Insurance Issues, (6) Intellectual Property Issues, (7) Data Privacy, and (8) Environmental Safety.

The second edition of the Reed Smith 3D printing white paper is available here. And for those who missed the first edition, it can be found here.

We on the Reed Smith side are committed to exploring this novel technology and the legal issues that come with it, especially when those issues involve products liability.  We will continue to post any new updates as products liability law changes (or does not change) as 3D printed products become more and more commonplace.

Our weekly search for new drug/medical device cases for 1/13/17 turned up something unusual – not of particular substantive significance, but unusual. Two of the opinions included citations to Wikipedia.

Wikipedia?  You mean the comprehensive online encyclopedia that is crowd-sourced, so that anybody – even us – can edit/alter the information contained on the entries (at least, most of them)?  That’s it.  Since the provenance of the information on Wikipedia is unknown, as lawyers we’ve been taught never, ever to cite to it as authoritative in filed papers (we often cite to it on the blog).  After all, given the high stakes of most of our litigation, an attorney citing to Wikipedia could have just added the information to which s/he is citing.

[I]f Wikipedia were regarded as an authoritative source, an unscrupulous lawyer (or client) could edit the Web site entry to frame the facts in a light favorable to the client’s cause. Likewise, an opposing lawyer critical of the Wikipedia reference could edit the entry, reframing the facts and creating the appearance that the first lawyer was misrepresenting or falsifying the source’s content.

Peoples, “The Citation of Wikipedia in Judicial Opinions,” 12 Yale J. L. & Tech. 1, 24 (2010) (quoting Richards, “Courting Wikipedia,” Trial, at  (April 2008)).  Obviously, that kind of bootstrapping oneself into authority isn’t allowed.  If lawyers want to cite ourselves, we should at least have to write law review articles.

So we thought it would be fun to see what we could find in the way of Wikipedia references in judicial opinions involving product liability litigation or prescription medical products, and even both. This post details what we found.

First, courts (or masters) have gotten in trouble for excessive reliance on Wikipedia.  In a Vaccine Act case, a special master declined to hold a hearing, and instead relied on internet sources such as Wikipedia.  That produced a reversal.  As to Wikipedia, the court stated:

[T]he exhibit introduced by the Special Master indicates that its information was drawn from Wikipedia.com, a website that allows virtually anyone to upload an article into what is essentially a free, online encyclopedia. A review of the Wikipedia website reveals a pervasive and, for our purposes, disturbing series of disclaimers, among them, that:  (i) any given Wikipedia article “may be, at any given moment, in a bad state: for example it could be in the middle of a large edit or it could have been recently vandalized;” (ii) Wikipedia articles are “also subject to remarkable oversights and omissions;” (iii) “Wikipedia articles (or series of related articles) are liable to be incomplete in ways that would be less usual in a more tightly controlled reference work;” (iv) “[a]nother problem with a lot of content on Wikipedia is that many contributors do not cite their sources, something that makes it hard for the reader to judge the credibility of what is written;” and (v) “many articles commence their lives as partisan drafts” and may be “caught up in a heavily unbalanced viewpoint.”

Campbell v. Sec’y HHS, 69 Fed. Cl. 775, 781 (2006). But see Keeler v. Colvin, 2014 WL 4394467, at *3 (D. Colo. Sept. 4, 2014) (allowing administrative law judge to cite Wikipedia in vaccine case; “[t]his Court finds no per se prohibition on citing Wikipedia in judicial opinions”).

Continue Reading Pitfalls Of Judges, Lawyers, And Experts Citing Wikipedia