August 2015

[Drug and Device Law] Guest Post - Game of Thrones, the FDA Under Attack, An In-House View of Amarin

Posted by Law

Today's guest post is a first for this blog in two ways, first, our guest poster is anonymous. Second, our guest post is from an in-house source. The two are, of course, related. While it is important to us as lawyers that our clients not be charged with anything we say on our blog, that goes double (or triple) for someone actually working in-house. So you won't know exactly who to credit, or blame, for what follows.

What follows is our in-house source's thoughts on the recent Amarin First Amendment victory over the FDA.

************

We are witnessing a strange chapter in the hegemony of FDA control over drug promotion. For while the OIG and DOJ continue to make good use of their Swiss army knife of an Anti-Kickback Statute, the FDA has been taking body blows from First Amendment litigators. First, the Supreme Court’s Sorrell decision, Sorrell v. IMS Health Inc., 131 S. Ct. 2653 (2011), protecting promotional communications as commercial speech; next, the Second Circuit in United States v. Caronia, 703 F.3d 149 (2d Cir. 2012), vacating a misbranding conviction on First Amendment grounds; and finally, the Southern District of New York in Amarin Pharma, Inc. v. FDA, ___ F. Supp.3d ___, 2015 WL 4720039 (S.D.N.Y. Aug. 7, 2015), declaring that a manufacturer may legally engage in off-label promotional communications.

Any doubts that this may indeed be a watershed event should be assuaged by the FDA’s public relations campaign to marginalize Caronia and the agency’s anxious efforts to moot the Amarin case or controversy before decision.

After all, the attack here is not a flanking maneuver. It is aimed straight at the FDA’s weakened center and threatens to scatter the spoils of decades of doctrinal toil spent erecting the divide between on- and off-label communications, an article of faith in the industry. And, to add insult to injury, and in marked contrast to the restraint shown in Caronia, the opinion in Amarin deliberately sabotages a key justification for FDA’s land grab on this subject − that the FDA must be allowed to regulate truthful, non-misleading speech to protect the integrity of the drug approval process – by reasoning that the regulatory scheme “predates modern First Amendment law respecting commercial speech” and is thus vulnerable to “frontal assault” from manufacturers. 2015 WL 4720039, at *25.

Of course the victory is not conquest, and needs to be tempered by the acknowledgement that Caronia and Amarin reflect Second Circuit jurisprudence with limited precedential value outside of New York, Connecticut and Vermont. The decision is also not a blanket license to promote off-label. Different facts, and in particular different safety risks or less reliable scientific evidence, may result in a different balancing and warrant greater restrictions to protect the public health. And there is the court’s admonition that the First Amendment protects speech, not conduct, 2015 WL 4720039, at *27, so promotional tactics designed to increase off-label use may still receive the full treatment from OIG and DOJ. That being said, manufacturers are ahead of the FDA 3-0 in cases where the federal courts have applied Central Hudson’s commercial speech balancing test (see Central Hudson Gas & Electric Corp. v. Public Service Communication, 447 U.S. 557 (1980)). to drug promotion (4-0 if you include the venerable Washington Legal Foundation decision, WLF v. Friedman, 13 F. Supp.2d 51 (D.D.C. 1998)).

Given these caveats, the end game is difficult to handicap at this point in time. Interested observers, and forward thinking advisors, might nevertheless be well-advised to consider what this new world order would look like if this view from Manhattan were fully realized, at least for the sake of discussion. For one thing, the heretofore binary world, divided between scientific exchange (unregulated) and promotion (heavily regulated), turns into a tripartite world, with a third category one could label “protected speech”:

So while the distinction in 21 C.F.R. § 312.7, cordoning off communications that are made outside of “a promotional context,” still applies to emancipate scientific exchange, promotional speech would now be separated into communications subject to traditional FDA controls and a new category of truthful and non-misleading promotion that is neither necessarily on-label nor based upon “substantial evidence.” In effect, the dichotomy between on- and off-label communications disappears, since none of these three categories relies on the distinction as a criterion.

Most importantly, the authority for what is “truthful and not misleading” is not inevitably the FDA − which, if asked, is likely to take the position that the standard is coterminous with the existing substantial evidence requirements. Put another way, the Second Circuit decisions stand for the proposition that “truthful and not misleading” data does not need to meet the FDA’s heightened standard, or require FDA approval, before it can be communicated to healthcare providers.

This change, should it take hold, would be significant, but probably not as momentous as the hysterics among us would have you think. For one thing, one would expect that the drill for updating safety information would remain unchanged, since the interests of industry and the FDA are closely aligned on this issue. There is every incentive for manufacturers to continue to work through the existing FDA processes to bring about label revisions to ensure that accurate and up-to-date contraindications, adverse reactions and interactions are reflected in the label (and failure to warn defenses in product liability cases preserved). There is also much that remains on the FDA’s plate in terms of policing efficacy claims, even if the new standard is changed to truthful and not misleading. If anything, the change should presage more, rather than less work for FDA staffers, now stripped of the thick armor provided by a blanket off-label prohibition.

Would this be a good thing for patient health? It is hard to see how it would not be. Manufacturers have always been the best source for detailed scientific information about their products and have clamored for many years against seemingly arbitrary restrictions on their ability to communicate this information. Earlier efforts to fix the problem have fallen victim to what appeared to be kneejerk conservatism from the FDA – a condition that got the agency into this battle in the first place.

--
Posted By Bexis to Drug and Device Law at 8/31/2015 04:30:00 PM

--
You received this message because you are subscribed to the Google Groups "Drug and Device Law" group.
To post to this group, send email to drug-and-device-law@googlegroups.com
To unsubscribe from this group, send email to drug-and-device-law-unsubscribe@googlegroups.com
For more options, visit this group at http://groups.google.com/group/drug-and-device-law?hl=en
---
You received this message because you are subscribed to the Google Groups "Drug and Device Law" group.
To unsubscribe from this group and stop receiving emails from it, send an email to drug-and-device-law+unsubscribe@googlegroups.com.
For more options, visit https://groups.google.com/d/optout.

[Drug and Device Law] Ask But Don't Tell: Kentucky Allows Defendant to Seek Ex Parte Interviews of Plaintiff's Treating Physicians

Posted by Law

We walked into the Drug and Device Law Rock Climber’s room last night to find her packing for her return to college while the ignored TV blared in the background. Onscreen was a popular cable reality franchise involving wealthy denizens of a gated community in Southern California. The heated argument du jour involved one resident’s decision to speak privately to another about a third, during which exchange B-to-C confidences may or may not have been disclosed to A. The original confider was adamant that the information was hers alone to control, insisting that the private conversation should not have occurred. Much perfectly-coiffed shrieking ensued.

We were reminded of this spectacle as we read the decision of the Kentucky Supreme Court in Caldwell v. Chauvin, -- S.W. 3d. --, 2015 WL 3653447 (Ky. June 11, 2015). In Caldwell, the underlying medical malpractice action involved plaintiff’s claim that her spinal surgery was unnecessary and negligently performed and caused her permanent injuries. In the course of discovery, defendant moved for a qualified protective order permitting him to make ex parte contacts with plaintiff’s healthcare providers. The court entered an order permitting such contacts but expressly declining to authorize disclosure of plaintiff’s health information. The order “also explicitly stated it was [not] requiring any physician to speak with [defendant] . . . , noting [that] the treating physicians [were] free to accept of decline counsel’s request as they [saw] fit.” Id. at *2 (internal punctuation omitted). Plaintiff sought a writ of prohibition from the Court of Appeals. The Court of Appeals declined to issue the writ, holding: 1) no Kentucky law prohibits the trial court from authorizing ex parte communications with non-expert treating physicians; and 2) the order did not violate any privacy right plaintiff might have because it did not compel the disclosure of any information. Id.

On further appeal, the Supreme Court first considered whether HIPAA prohibits ex parte contacts with treating physicians. The Court noted that HIPAA provides for mandatory disclosure of protected health information by a covered entity, such as a healthcare provider, only when: 1) an individual requests her own health information; or 2) the Secretary of HHS requests it to investigate HIPAA compliance. Id. at *6 (citation to HIPAA omitted). “Permissible disclosures” under HIPAA include the “litigation exception,” which “permits disclosure of protected health information in the course of any judicial or administrative proceeding, either in response to an order of court or administrative tribunal or in response to a subpoena, discovery request or other lawful process, so long as additional safeguards are met” to protect the disclosed information. Id. (internal punctuation and citation omitted).

“Noticeably absent from the sea of HIPAA privacy regulations,” the Court pointed out, “is any mention of ex parte communications between counsel and a covered entity. In fact, the privacy rule does not purport explicitly to regulate the permissibility of ex parte communications or interviews as an informal discovery tool.” Id. at *7. However, “[b]ecause HIPAA, by its terms, applies to the oral disclosure of health information, it has routinely been held that the disclosure of protected health information in ex parte interviews falls within the ambit of HIPAA. “ Id. While plaintiff argued that that the so-called “judicial exception” is inapplicable to ex parte discovery because such discovery falls “outside the course of any judicial or administrative proceeding,” the Court agreed with defendant that HIPAA “does not prohibit ex parte interviews with treating physicians” but “merely superimposes procedural prerequisites to authorize disclosure of protected health information.” Id. The Court emphasized that protected health information may be disclosed in the course of such an interview only when ordered by a court or administrative tribunal. Id.

Preemption

The Court next considered the issue of HIPAA preemption, noting that “HIPAA contains a preemption clause whereby any ‘contrary’ provision of state law is preempted absent the application of any enumerated exception.” Id. at *10. But, “if a ‘contrary’ law requires a more stringent standard of privacy, HIPAA’s preemption provisions are inapplicable and state law controls.” Id. at *10. Thus, the Court analyzed Kentucky law to determine what law controlled the dispute.

First, the Court rejected plaintiff’s arguments that a patient- physician privilege protected her communications with her treating physicians, or, in the alternative, that the Court should treat those communications as privileged even if no privilege existed.. The Court commented that plaintiff’s argument was “disingenuous at best,” as, “[f]or better or worse, [Kentucky] jurisprudence has been unwavering in [its] rejection of the patient-physician privilege.” Id. at *11. The Court concluded, with evident impatience, “It is high time litigants abandon this tired argument. Our disinclination to recognize a physician-patient privilege or to apply the faux privilege that [plaintiff] argues for in the alternative is well documented,” to be altered only by changes to the rules of evidence or by legislative enactment. Id.

Next, the Court rejected plaintiff’s argument that the American Medical Association’s Code of Medical Ethics rendered ex parte contacts with treating physicians impermissible. The Court noted that, while the relevant provisions “created a professional duty that requires healthcare providers to maintain the confidentiality of patient information,” the Code lacked the force of law and did not “create an all-encompassing right to confidentiality by patients.” Id. at *12. The Court concluded,

A physician’s ethical duty of confidentiality, even if promulgated by a professional body under statutory authority, does not carry the weight of law to limit a litigant’s ability to engage in ex parte interviews with physicians. Admittedly, the ethical duty may restraint he physician’s willingness to agree to such an interview, but it in no way prohibits a party to litigation from requesting one.

Id. at *13.

Finally, commenting that, “[a]s with her previous state-law arguments, [plaintiff] again overstates the scope of the law she cites,” the Court concluded that nothing in Kentucky case law “limits a litigant’s ability to conduct informal ex parte interviews when the fact witness interviewed is a treating physician. They are like any other fact witness in the eyes of the law.” Thus, Kentucky law contains neither prohibition against such interviews nor entitlement to them. Id. at *14. As such, “Kentucky law cannot be contrary to HIPAA as pertaining to ex parte interviews with treating physicians . . . ,” and preemption doesn’t come into play.

The Court concluded that, while the challenged trial court order was not HIPAA-compliant and could not operate to authorize the disclosure of the plaintiff’s protected health information, it did not seek to provide such authorization. In fact, it expressly declined to compel disclosure of protected information. As such, the trial court’s order did “nothing more than maintain the status quo. It . . .effectively, and correctly, stated the status of the law currently: defense counsel may seek an ex parte interview with [plaintiff’s] treating physicians, but those physicians may not disclose her protected health information without facing HIPAA sanctions.” Decision affirmed, no writ issued.

We like this opinion. We enjoy good writing and appreciate a prickly, impatient judge (when we are not the targets). And if nothing really happened – if all of the holdings were already inevitable under Kentucky law and HIPAA – it was a good show. Like our favorite reality screamfests. Tune in tomorrow.

--
Posted By Rachel B. Weil to Drug and Device Law at 8/31/2015 08:00:00 AM

[DK GreenRoots] WA State Open Thread - Environmental Award given

Posted by Law

Hi all,

When I saw this in my e-mail box this last week I immediately knew what I had to post about this week.

Washington State Open Thread - An Award Well Deserved Goes to Representative Joe Fitzgibbon (D-34)

--
You received this message because you are subscribed to the Google Groups "DK GreenRoots" group.
To unsubscribe from this group and stop receiving emails from it, send an email to dk-greenroots+unsubscribe@googlegroups.com.
To post to this group, send email to dk-greenroots@googlegroups.com.
Visit this group at http://groups.google.com/group/dk-greenroots.
For more options, visit https://groups.google.com/d/optout.

[Drug and Device Law] Breaking News - Ohio Sets Class Actions Right.

Posted by Law

One of the most basic prerequisites to having court rules is that the rules aren’t supposed to change substantive law. With class action rules, like Fed. R. Civ. P. 23 and its state-law analogs, courts seem to have a hard time remembering that. No substantive effect means that, if a plaintiff couldn’t bring the claim individually, that same claim can’t be brought on behalf of that same plaintiff via a class action.

One of the most basic attributes of almost any cause of action is injury. That’s why we’re bringing you news of the recent Ohio Supreme Court decision in Felix v. Ganley Chevrolet, Inc., No. 2013-1746 slip op. (Ohio Aug. 27, 2015), even though it’s not a drug and device case.

It’s a consumer fraud statute case brought under the Ohio version of Rule 23, and we think all defense attorneys who confront this kind of thing ought to know about it. It’s that good. Some choice quotes:

Plaintiffs bringing OCSPA [the Ohio statute] class-action suits must allege and prove that actual damages were proximately caused by the defendant’s conduct.

Felix ¶31.

Plaintiffs in class-action suits must demonstrate that they can prove, through common evidence, that all class members were in fact injured by the defendant’s actions.

Id. ¶33. Note the word “all.”

The inquiry into whether there is damage-in-fact is distinct from the inquiry into actual damages: fact of damage pertains to the existence of injury, as a predicate to liability.

Id. ¶34 (citation and quotation marks omitted).

If the class plaintiff fails to establish that all of the class members were damaged (notwithstanding questions regarding the individual damages calculations for each class members), there is no showing of predominance.

Id. ¶35. Again, note the word “all.”

Perhaps the most basic requirement to bringing a lawsuit is that the plaintiff suffer some injury. Apart from a showing of wrongful conduct and causation, proof of actual harm to the plaintiff has been an indispensable part of civil actions. We agree, and we hold that all members of a class in class action litigation alleging violations of the OCSPA must have suffered injury as a result of the conduct challenged in the suit.

Id. ¶36 (emphasis added).

Here, here! This is the only way that a class action rule can be read so that it does not improperly change the underlying substantive law, and plaintiffs get away with herding uninjured persons into class actions – indeed, bringing class actions where nobody at all has been injured − all the time.

Not in Ohio, anymore. We thought you’d like to know.

--
Posted By Bexis to Drug and Device Law at 8/28/2015 04:30:00 PM

[Drug and Device Law] Lack of Proximate Cause for Failure to Warn Nets a Directed Verdict

Posted by Law

A week ago, in a post-script to a post on Daubert decisions, we reported that the trial court in Hexum v. Eli Lilly & Co., No. 2:13-cv-02701-SVM-MAN, 2015 U.S. Dist. LEXIS 109737 (C.D. Cal. Aug. 18, 2015), had granted directed verdict at the end of plaintiffs’ case. Our readers may have noticed that we (in both the singularly singular and common plural sense of the word) have a thing for proximate cause for failure to warn, which was why the defendant won in Hexum. So, we decided to somewhat deeper dive on why the defendant drug manufacturer won and whether there are lessons to be learned.

We start with two caveats and one somewhat rhetorical question. First, plaintiffs rested their case on the second day of trial. How much evidence they could have presented was no doubt limited by the Daubert rulings and other evidentiary rulings, but they seem to have taken a pretty narrow view of the evidence they needed to present for their four remaining claims—negligent failure to warn, strict liability failure to warn, negligent misrepresentation, and fraud—all grounded in failure to warn the learned intermediary. For instance, they chose not to present evidence from the physician who directed plaintiff (the one on the drug) to taper down and stop the drug. Second, from the testimony presented in the order—which we assume is the most relevant—it does not look like plaintiffs pushed hard to get the “magic words” that most plaintiffs try to get from prescribing physicians. The result was testimony that was more “fuzzy” on some key issues than we normally see in prescription drug product liability cases, even though this testimony was from the trial. Assuming plaintiffs did not do any better with the prescribing physician in deposition than they did at trial—and one would expect they would have impeached him with inconsistent deposition testimony—then why did this case get past summary judgment?

But it did, so on to the directed verdict order. The basic allegation was that the label was inadequate in how it warned about the risk of various (mostly transient central nervous system) symptoms upon discontinuation of the drug and the need to taper the drug down. The plaintiff who took the drug—her husband also sued—experienced some of these a year after starting the drug when she moved away and talked to a new doctor about stopping the drug so that she could get pregnant. The symptoms resolved without lasting effect, she had a successful pregnancy, and she managed the condition for which she had been prescribed the drug by switching to non-pharmaceutical therapies. Id. at **13-15. We suppose that we should mention that the drug was a selective serotonin and norepinephrine reuptake inhibitor and she was taking it for fibromyalgia, which was not an approved indication (and she knew it). It apparently worked while she took it, so we have a hard time seeing why a suit was brought at all. Plaintiffs also had no real theory that we can discern for what was allegedly lacking from the fairly thorough discussion in the label about discontinuation symptoms—at least after their expert case was gutted. If the plaintiffs cannot articulate through admissible evidence some reason why the label’s actual warnings in the label about the very risk at issue were inadequate, then they should lose before they get to trial. Such a shortcoming also makes the proximate cause analysis unduly abstract: the question should be whether the “stronger warning” urged by plaintiffs would have changed the prescribing physician’s behavior and avoided the injury not whether an unspecified “stronger warning” would have done the same.

While the lack of evidence of what the warnings should have been instead of what they were should have been another ground for directed verdict (or summary judgment), there is one basic fact pattern that gets to a defense win without even considering what the label did say or allegedly should have said—when the prescribing physician did not read the label. That is what happened here and is the focus of the order. We have posted many times about how warnings claims should fail unless the prescribing physician actually read the label that plaintiff contends should have provided additional warnings about whatever harm eventually (and allegedly) befell her. What Hexum did was cut through less than clear testimony and hold plaintiffs to their burden. The prescribing physician here did not recall reading the label before prescribing the drug to plaintiff, did not typically read labels “cover to cover,” and only recalled reviewing a third-party publication called Up To Date before prescribing the drug to plaintiff. Id. at **8-9. He acknowledged that labels came with the drug samples he received and that he would have reviewed the label if a sales representative asked him to do so, but plaintiffs did not close the loop on whether that happened with this drug before plaintiff’s prescription. Id. at **9-11. Some courts might have determined that all of this created a jury issue, but this court saw that “there is no proof beyond speculation that Wollaston read Cymbalta’s label before prescribing it to Hexum.” Id. at *24. Nor could it be inferred from the testimony about the doctor and patient’s discussion of discontinuation risk—yes, the patient admits that she was also warned, but more on that later—that the doctor had read the drug’s label before prescribing it to plaintiff. Id. at **24-25. Under the applicable and pretty good California law, this was a clear break in the causal chain for every claim that plaintiffs asserted.

In so holding, the court distinguished cases using a heeding presumption—which California does not have—to allow failure to warn claims to survive even when the prescriber did not read the label. Id. at *21 n.4. In our compilation on this issue, we do discuss the role heeding presumptions have played in cases from around the country. To us, in addition to the heeding presumption being inapplicable to all prescription drug cases except those with warnings that remove all judgment by urging something like “don’t use the drug in someone exactly like this plaintiff,” it does not make sense that a heeding presumption would link up the broken causal chain from a doctor not reading the label. You can’t heed what you don’t read. Maybe this really requires a reading presumption, but that presumption would be rebutted by the doctor’s actual practice of having not read the label.

After concluding that plaintiffs lost because they did not establish that the prescribing physician read the drug’s label, the court considered plaintiff’s failure of proof on two possible alternative methods to prove causation that we do not think would have worked under the law anyway. Plaintiffs often try to backdoor proximate cause by suggesting that a doctor who would have prescribed the drug anyway would have discussed the risk with the plaintiff (in some unspecified way compared to the actual discussion of the risk that occurred) and the plaintiff, blessed with the power of hindsight and a secondary profit motive, would have declined to take the drug (or been a more responsible patient in avoiding or minimizing the risk). The plaintiff here, who admitted she had actually read the label’s discussion of discontinuation risk before taking the drug, testified that “I can’t guess and speculate what I would have done” if told the risk of discontinuation symptoms were higher than 1-2%—a purported contrast to the standard discussion in the label of clinical trial events occurring at 1% or greater and at a significantly higher rate than in placebo patients. Id. at *29. She also offered a lukewarm “I imagine not” when posed with the leading and admittedly speculative question about what she would have done if her doctor had told her the risks were “more than 44 to 78 percent.” Id. at **29-30. On top of the lack of predicate evidence about what her doctor would have told her (and maybe if anybody ever said the label should have included such percentages), this was “too ambiguous and speculative to allow a jury to find that if given stronger warnings Hexum would never have taken Cymbalta.” Id. at *30. This is all pretty far afield when the prescriber did not read the label, but we have a hard time seeing this sort of chain ever being sufficient to satisfy proximate cause. At a minimum, there would need to be clear testimony from the prescribing physician on how the discussion with the plaintiff would have differed if presented with the specific alternative label and the plaintiff would have to answer questions tied to that testimony, not to generalities about a “stronger warning.” The court also slammed plaintiffs for failing to present testimony from “the tapering physician” as a way to make a failure to warn claim. Id. at **32-33. But the prescription drug manufacturer does not owe a duty to warn every physician in any specialty who may later treat a patient on its drug. It owes a duty to the physicians who prescribe its drug. A breach of a non-existent duty cannot create liability.

Like we said, we have a thing when it comes to proximate cause for failure to warn. Hexum was a nice win and may help some other court reject the sort of cobbled together speculation that some plaintiffs offer as proof of proximate cause for failure to warn with prescription medical products. We would take that.

--
Posted By Eric Alexander to Drug and Device Law at 8/28/2015 01:00:00 PM

[Drug and Device Law] Batting Down Generic Plaintiffs' Amarin Hail Mary Pass

Posted by Law

We received a couple of odd anonymous comments to our “breaking news” post about the Amarin First Amendment victory for truthful off-label promotion. Both of them raised the same suggestion: “Does the logic of this opinion permit a generic manufacturer to include truthful warnings about the risks of a drug on its labeling when such truthful warnings do not appear on the labeling of the bra

Not much later, we saw the same point raised by a plaintiff-side lawyer in this story in 360:

“I think this decision has huge implications for the preemption doctrine,” Lou Bograd of the Center for Constitutional Litigation PC said.

“If it's the case that drug companies have the First Amendment right to make truthful statements about off-label uses, and the FDA cannot prohibit them, then it follows that they would have the First Amendment right to truthfully communicate the risks of their products even if that information isn't on the label of the brand-name products,” he said.

Needless to say, we don’t think that’s true. Moreover, if plaintiffs try for what amounts to an Amarin-based Hail Mary pass, it may even create a jurisdictional advantage for our side.

There may be others, but right now we see two reasons why the FDA’s speech-based prohibition on truthful off-label promotion is not the First Amendment equivalent of the FDA’s sameness-based requirement that generic drug manufacturers to receive prior Agency approval for all substantive label changes.

First reason: The first FDA scheme (off-label promotion) is a flat ban – a prior restraint − backed by criminal penalties, fines, and the threat of False Claims Act civil actions. That’s all discussed in the Amarin decision. See Amarin Pharma, Inc. v. FDA, ___ F. Supp.3d ___, 2015 WL 4720039, at *5-6 (S.D.N.Y. Aug. 7, 2015). The second FDA scheme (generic label changes) is a reasonable time, place, and manner restriction that simply requires the submission of all would-be warning changes to the FDA so that it can see that the statute’s non-speech-related sameness requirements are met. The statutory sameness requirements have nothing to do with the substance of the warning changes, and everything to so with the basic bioequivalence requirement that is at the core of the Hatch-Waxman Act. Unless they’re the “same,” generics simply aren’t generics. Nor does the FDA ban label changes for generic products; it simply requires agency review before they happen, rather than afterwards (as is the case with its CBE process).

So we don’t think, in First Amendment terms, that the off-label promotion ban is in the slightest bit equivalent to how the Agency chooses to time review of generic label changes. The demise of the first says nothing about the validity of the second.

Second reason: Remember what procedure the manufacturer followed with respect to its proposed truthful off-label promotion in Amarin:

The FDA does, however, encourage manufacturers to request advisory comments . . . with respect to promotional materials aimed at healthcare professionals. . . . The FDA’s Office of Prescription Drug Promotion (the “OPDP”) reviews such materials to ensure, inter alia, that they are not false or misleading; it provides written comments on proposed materials, reviews complaints of alleged violations, and initiates enforcement actions as to materials it finds false or misleading.

2015 WL 4720039, at *6 (footnotes omitted). Amarin thus approached the FDA and asked it to bless its promotional materials, and the FDA refused:

The FDA also refused to approve Amarin’s request to include the ANCHOR results in the Vascepa label. It “reserve[d] comment” until the application is otherwise adequate. In the penultimate sentence of the [rejection letter], the FDA stated: “This product may be considered to be misbranded under the [FDCA] if it is marketed with this change before approval of this supplemental application.”

Id. at *12.

Thus, Amarin approached the FDA ahead of time and sought, if not approval, at least Agency acquiescence in its truthful off-label promotion. That’s all well and good, but it’s not something that can defeat preemption. Rather, it’s a variant of the less-than-formal-submission “take steps” approach that the FDA proposed, and the Supreme Court rejected, in PLIVA v. Mensing, 131 S.Ct. 2567 (2011), as a ground for defeating preemption:

[T]he agency asserts that a different avenue existed for changing generic drug labels. According to the FDA, the Manufacturers could have proposed − indeed, were required to propose − stronger warning labels to the agency if they believed such warnings were needed. If the FDA had agreed that a label change was necessary, it would have worked with the brand-name manufacturer to create a new label for both the brand-name and generic drug.

Id. at 2576 (citations omitted). Going to the FDA (as Amarin did in the First Amendment context), and seeking its agreement to a label change doesn’t make simultaneous compliance with state and federal duties “possible” under Mensing:

The federal duty to ask the FDA for help in strengthening the corresponding brand-name label, assuming such a duty exists, does not change this analysis. Although requesting FDA assistance would have satisfied the Manufacturers’ federal duty, it would not have satisfied their state tort-law duty to provide adequate labeling. State law demanded a safer label; it did not instruct the Manufacturers to communicate with the FDA about the possibility of a safer label.

Id. at 2578. What Amarin did is precisely what the Supreme Court held in Mensing does not ameliorate the “impossibility” of simultaneous compliance with both federal and state duties.

There may be more, but those are two reasons that come to mind why generic plaintiffs should get nowhere with a last gasp “truthful speech” argument (assuming truth, which may also be disputed) against Mensing/Bartlett preemption.

But there’s somewhere else that plaintiffs might get with such an argument – into federal court.

We’ve blogged before about the availability of federal question jurisdiction in certain types of prescription medical product liability litigation under Grable & Sons Metal Products, Inc. v. Darue Engineering & Manufacturing, 545 U.S. 308 (2005). Successful invocations of Grable-based federal question jurisdiction have been few and far between. The Supreme Court’s latest iteration of the test for such jurisdiction is found in Gunn v. Minton, 133 S.Ct. 1059 (2013).

[F]ederal jurisdiction over a state law claim will lie if a federal issue is: (1) necessarily raised, (2) actually disputed, (3) substantial, and (4) capable of resolution in federal court without disrupting the federal-state balance approved by Congress.

Id. at 1065.

Most Grable-based attempts to remove cases to federal court have foundered on prong three – substantiality. With few exceptions, device-specific claims of “parallel-claim” FDCA violations, tied causally to the timing of a particular plaintiff’s medical history haven’t been able to overcome the substantiality requirement. A few other cases have, however. Take, for example NASDAQ OMX Grooup, Inc. v. UBS Securities, LLC, 770 F.3d 1010 (2d Cir. 2014), where it wasn’t just the removing defendant claiming substantiality, but also the relevant government agency. Specifically, the Securities & Exchange Commission made a statement about the federal interests involved in NASDAQ OMX that “strongly signal[ed] the substantial importance of the[] federal issues” at stake in the litigation. Id. at 1025.

The same thing could be said about the FDA’s position on First Amendment protection for truthful off-label promotion. In Amarin, for example, the Agency characterized the company’s position as “a frontal assault . . . on the framework for new drug approval that Congress created in 1962” with “the potential to eviscerate [the] FDA drug approval regime.” 2015 WL 4720039, at *25. In a prior Amarin post we mentioned another statement by the Agency that:

In discharging its regulatory responsibilities, however, FDA has reviewed other alternatives − including all of those identified in Caronia, 703 F.3d at 168 − but has found them all inadequate to meet public health needs, and therefore not viable less restrictive alternatives to the regulatory approach adopted by FDA.

Quoting FDA brief at 38.

We don’t think that First Amendment protection of truthful promotional speech about drugs, on- or off label, means that the sky is falling, but the FDA certainly does. Remember the Agency’s explosive rhetoric in the Solis case? We blogged about it here. The FDA claimed that recognizing free speech rights to off-label promotion would mean that “vast areas of federal and state law would be invalidated.” Since one of the prongs of the commercial speech test in Central Hudson Gas & Electric Corp. v. Public Service Commission, is a “a substantial interest to be achieved by restrictions on commercial speech,” 447 U.S. 557, 564 (1980), we’re certain that mining the government’s briefs in prior First Amendment litigation such as United States v. Caronia, 703 F.3d 149 (2d Cir. 2012), will yield numerous governmental statements at least as full-throated as the one that established the Gunn/Grable substantiality in NASDAQ OMX.

The final factor of the Gunn/Grable federal jurisdiction test, that the federal dispute be “capable of resolution in federal court without disrupting the federal-state balance approved by Congress,” would also seem easily satisfied in a generic preemption case where the plaintiffs are raising the First Amendment. Given the broad scope of generic preemption, there’s unlikely to be many other, confounding arguments. Amarin shows the ability of federal courts to address such First Amendment issues. Finally, given the FDA’s prior position that the ban is necessary to protect the “substantial’ interest in encouraging submission of new uses for drugs to the Agency, it and any generic defendant are likely to find some common ground on what exactly does, or does not, “disrupt” the “federal-state balance.”

So if generic plaintiffs want to join us in driving a First Amendment stake through the heart of the FDA’s ban on truthful off-label promotion, be our guest. We think that there’s a world of difference between that absolute prohibition and FDA regulations regarding how and when generic labels are updated, but we’ll happily pocket the other side’s signing on to the initial proposition found in Amarin - that pharmaceutical detailing is accorded free speech protection when truthful. First Amendment-related arguments of this sort by plaintiff lawyers can only help innovator drug and medical device defendants in product liability litigation involving off-label promotion allegations. Nor do we think – for the reasons stated − that such arguments will ultimately have much effect on generic preemption, except for ensuring that the venue in which they are heard is federal.

--
Posted By Bexis to Drug and Device Law at 8/27/2015 08:00:00 AM

[Drug and Device Law] SDNY Dismisses Manufacturing and Fraud Claims in Fertility Drug Case, But Conflates and Confuses the Rest

Posted by Law

By all rights, it should be Sullivan writing about the Sullivan case. But John is taking a well-deserved vacation. We do not know if Sullivan’s travels more closely approximate a Bexis expedition, which involves long hikes where one must dodge rattlesnakes and gila monsters, or if Sullivan is more like today’s correspondent, who is content to plop down in a BeNeLuxian cafe and down a couple of Chimays before staggering past museum walls adorned with Brueghel and van Ruisdael masterpieces.

Sullivan v. Aventis, Inc., 2015 WL 4879112 (S.D.N.Y. Aug. 13, 2015), is no masterpiece. It offers a crabbed reading of Bartlett to support its stubborn refusal to expand that case’s generic preemption to brandeds, it conflates design defect and warning theories, and its reasoning often seems incomplete or incoherent. We’re not saying that the Sullivan case is a complete train-wreck, but it is not exactly pleasant beach reading either.

The Sullivan case was brought by a woman who claimed that she suffered birth defects because her mother had taken an allegedly defective fertility drug. She alleged that the drug’s half-life was too long and that the manufacturer had failed to supply the requisite warnings. The legal claims included design defect, manufacturing defect, failure to warn, misrepresentation, breach of express and implied warranties, and unjust enrichment. New York law controlled.

Before we get to the standard product liability issues, we must first dawdle over an interesting argument raised by the defendant: that the Sullivan case was an impermissible claim of “wrongful life.” Our law school moot court topic was on wrongful life, and the philosophical perplexities of that issue do not seem to have been resolved over the intervening decades. New York law does not smile upon claims that boil down to an assertion that had things not gone wrong, a baby would not have been born, because the pregnancy would never have happened or because the parents would have terminated the pregnancy if they learned of the birth defects. Any “injury” suffered by the children “would require resolving the philosophical or theological ‘mystery’ of whether ’nonexistence’ is preferable to existence.” Sullivan, 2015 WL 4879112 at *2. This line of reasoning is called the “nonexistence problem.” Id. The Sullivan court ultimately held that this case was a prenatal tort, rather than a wrongful life case, because the plaintiff’s design defect theory was that the drug could have been designed in a way that would have permitted the plaintiff to be born without the birth defects. The problem with the court’s reasoning is that there really was no reason to know whether such a drug could have been designed and approved. There is still a “nonexistence problem” - the nonexistence of a safer alternative. In any event, it really is hard to see how the plaintiff’s failure to warn claim survives the ban on wrongful life claims. The failure to warn claim must be premised on the position that the plaintiff’s mother would not have taken the drug if she or her doctor had been warned. But then the plaintiff would not exist, right? Not so, says the court. The plaintiff might have been born anyway. Really? This same plaintiff? Who is engaging in theology now?

Let’s retreat from the spiritual issues and head back to hum-drum tort law. Not to put too fine a point on it, the Sullivan court’s discussion of preemption and design defect leaves us praying for clarity. The defendant correctly argued that the logic of the SCOTUS opinion in Bartlett means that design defect claims against even branded drugs must fail, because any alternative design could not be implemented absent action by the FDA. That is the impossibility theory logic behind the Bartlett decision. The Sullivan court escapes this logic the same way a squid escapes danger: by emitting a lot of confusing ink. The Sullivan court discussed New York’s risk-utility test for design defect, and then pointed out that manufacturers can avoid liability by strengthening the product’s warning label. Okay, so now we have bounced from design defect to failure to warn. Does the court understand that those are separate issues? We would say we are baffled and disappointed by the court’s conflation of the issues, but if it means that there really is no true design defect claim in the case, then we suppose that would not be so bad. Unfortunately, we are not sure we understand what the court thinks it understands.

Moreover, according to the Sullivan court, the defendant could have submitted a design for a safer product before obtaining FDA approval. The plaintiff was essentially suggesting that the defendant should not have submitted the drug design that the FDA approved as safe and effective. How is that not different from the stop-selling theory that the SCOTUS rejected in Bartlett? We cannot know that any such redesign is possible. Talk about a nonexistence problem! And then, to get around that little problem, the court says that even if a redesign was not possible, nothing stopped the company from submitting a stronger warning. Thus, again, the court conflates design and warning theories. The Sullivan court wishes away Bartlett and applies Levine without any sense of its nuances (would a Changes Being Effected have been permissible?).

The court’s discussion of comment K is similarly garbled. The clear terms of comment K should preclude a design defect claim, but the Sullivan court says that the design defect claim can proceed because the plaintiff “had adequately pleaded a failure to warn claim.” Sullivan, 2015 WL 4879112 at *7. Aaargh. When we see the usual panoply of product liability claims, we like to knock out as many as possible because we worry that a jury might be confused by the multiplicity and variety of the claims. Frankly, we do not expect that it is the court that will be confused by such multiplicity and variety. And now there is the Sullivan decision to remind us that such confusion is not confined to the jury room.

The defendant took a shot at getting rid of the design defect claim on the ground that the complaint did not come close to stating how a safer design (presumably with a shorter half life) could be possible. Here is what the court said, in rejecting the defense argument: “Defendant argues that the Iqbal-Twombly standard demands more detail concerning how the design should have been altered and why it was feasible. Imposing such a standard would require the plaintiff to possess technical or scientific knowledge about the inner workings of the product, which would contravene the notice pleading requirement….” Id. at *7. Not true. Rather, such a standard would require a plaintiff actually to know some facts supporting the claims before filing them. Why not do a little of that “technical or scientific” work before filing a complaint?

The Sullivan court did dismiss the manufacturing defect claim, because the plaintiff had simply failed to allege facts supporting such a theory. But even here, the court’s reasoning was unnecessarily muddy. The court says that the plaintiff did not allege “that the dose(s) administered to Plaintiffs mother deviated from other doses in anyway.” Id. at *8. Whatever. Dose-schmose. The plaintiff simply did not allege that the product consumed had deviated from its specs in any way, and that is the end of any manufacturing claim.

The Sullivan court gave short shrift to the defendant’s challenge to the failure to warn claim. In fact, we’d say that the court’s discussion is so empty and conclusory as to flunk the Iqbal and Twombly tests. All we get is that the defendant failed to warn doctors of the “purported dangers,” and “proximate cause may be inferred from alleged circumstances.” Id. What circumstances? We can only guess.

The court declined to dismiss the breach of warranty claims. That is annoying in itself. But it is interesting how, in also refusing to dismiss the negligent misrepresentation claim, the court discussed the issue of privity. Normally we see some sort of privity discussion with respect to warranty claims, as well. Not here. Why? Dunno. Further, the court dismissed the unjust enrichment claim because it duplicative. That is nice. But isn’t it clear from the court’s own discussion that every single theory in this case is duplicative except the failure to warn claim?

Let’s end on a happy note. The court dismissed the fraud claim because it was not pleaded with particularity under Fed. R. Civ. P. 9(b). Yay. The complaint did not allege any particular statements, advertisements, or anything else that the plaintiffs' mother saw. Nor did the complaint allege that the mother relied on any such statements, even if they were specifically identified. And the court did not believe that it could “infer reliance in these circumstances.” Id. at *9. Once again, we do not know what these "circumstances” are, but we agree. We also think that "these circumstances” should not permit a court to infer proximate causation for the failure to warn claim, and since the court seems to treat all the claims as one vast mess of a tort, the different conclusions are a bit confusing. But that is characteristic of the Sullivan decision. Some bits are okay, some are quite bad, and all of it is confusing.

We’d rather stare at a Brueghel. There is usually a lot going on his paintings, and they can seem a little chaotic. But it turns out that there is an underlying unity and beauty. We will stare some more at the Sullivan decision, but so far any unity or beauty elude our poor powers of perception. Come to think of it, the Sullivan decision reminds us of another Northern European painter: Hieronymus Bosch.

--
Posted By Steve McConnell to Drug and Device Law at 8/26/2015 07:30:00 AM

[Drug and Device Law] A Case of the End of Summer Blahs

Posted by Law

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

August 25th. How can that be? Some of us are still using the red, white and blue napkins we purchased for the Fourth of July. Jersey corn is sweet and the tomatoes are juicy. The shore is still packed with sun and surf lovers. The commute attests to a lack of school of buses and plenty of people still on vacation. But there is only about one week until the unofficial end of summer. Labor Day is late this year, but as soon as that calendar flips to September everyone starts thinking about falling leaves over blooming impatiens; pumpkin spice over piña colada; sweaters over tank tops. And for lovers of flip-flops, barbecue, pool floats, and sand – it means a case of the end of summer blahs. The blahs are something less than the blues. After all, it’s likely to still be 85 degrees for most of September (at least in the mid-Atlantic). The blahs are more about glancing up to see that it’s getting dark at 8:00 pm again. Or when a friend on Facebook starts a Countdown to Christmas clock. Or you realize that none of your children’s shoes fit and barefoot isn’t an option for school. It’s not that we don’t enjoy the change in season and aren’t ready for some crisp fall air. It’s more about realizing just how fast another summer sped by. So, you’re not blue – you’re just blah.

And that’s sort of how the case we are talking about today makes us feel – blah. We like it in part, but there’s just enough not to like too. The case is Williams v. Smith & Nephew, Inc., 2015 U.S. Dist. LEXIS 108670 (D. Md. Aug. 18, 2015). Plaintiff alleges that his hip implant led to cobalt and chromium poisoning. Id. at *6. He filed a four count complaint – negligence, strict liability, breach of express and implied warranty, and loss of consortium. Id. at *7-10. Because the hip implant was a Class III, Pre-Market Approved medical device, defendant moved to dismiss on the grounds of preemption. Usually a smart decision in a PMA case – and it was here as well. The court didn’t agree completely on all counts, but some of the claims were knocked out.

The first thing we noticed is that the allegations in this case seem to be more carefully pleaded; at least more artfully tailored to establish parallelism. For example, plaintiff alleged that his negligence claim was “based solely on [defendant’s] failure to comply with the PMA approval order” and that they seek damages “only to the extent that they run parallel to the federal conditions and requirements.” Id. at *9. But that kind of qualifying language only goes so far – the claim itself has to be a traditional state law claim premised on a violation of a specific federal requirement.

Design defect is usually an easy win in PMA cases – you can’t argue that defendant should have used a different design than then the one approved by the FDA. Id. at *17. That would be imposing “a more demanding standard that that of the FDA, rather than a parallel one.” Id.

As for breach of implied warranty, under Maryland law, you can have an implied warranty that the product is fit for its ordinary purpose or a particular purpose. The court found that because the FDA through the PMA had defined the scope of the device’s intended use and the representations defendant is obligated to make regarding the device, any ruling under Maryland law that defendant breached an implied warranty would impose an obligation beyond that of the FDA. Right result, wrong reasoning. The following will come as no surprise to our readers: The FDA approves devices not uses. PMA requirements are device specific. The FDA does not and cannot regulate how devices are used by surgeons. So, we’ll have to disagree with the court that the PMA defines the scope of use. Blah.

We also feel blah about the court’s failure to warn decision (maybe slightly more than just blah). Here plaintiff hung his hat on failure to provide post-marketing reports to the FDA and the court said OK. Id. at *18. There is no dispute that Maryland law recognizes a claim for failure to warn. We take issue with distorting that claim into a failure to warn the FDA claim. But even where courts decide to recognize this as a legitimate state law claim, this is where we think express preemption yields to implied preemption or Buckman preemption. Unfortunately, the court didn’t agree, finding that none of plaintiff’s claims resemble fraud-on-the-FDA. Id. at *27. But failure to report events to the FDA is simply a way of saying fraud-on-the-FDA without using those words. The argument is the same – defendant misled the FDA into either taking some action or not taking some action by failing to provide complete information as required under the law. The Supreme Court has already held that that is a matter for the FDA to police – not private litigants. Calling it failure to warn doesn’t change the underlying analysis.

Even narrowly interpreting Buckman, the court had to acknowledge that not all of plaintiff’s claims thread the gap between express preemption and implied preemption. Where plaintiff’s negligence claim is based on a violation of federal duties that are not actionable under state law, those claims were dismissed as impliedly preempted. Id. at *29. They include such claims as duty to train physicians, duty to conduct studies and duty to recall. Id. at *19n.8.

The court took a middle of the road approach on express warranty. To the extent the claim is based on warranties in FDA-approved labeling – it is preempted. To the extent it is based on “voluntary communications” with doctors – it is not. Id. at *21. This is not an unfamiliar approach. The part of the decision that gives the blahs here is the ruling that plaintiff sufficiently pleaded the claim. The court concedes that the complaint does not identify the sales representatives who allegedly made the representations or when they were made, but said that because it identified the product literature at issue, that was good enough. Id. at *32-33. Without even a passing connection to plaintiff’s surgeon, we again must disagree.

Somewhat out of the norm, plaintiff also brought a manufacturing defect claim alleging that the defendant deviated from the manufacturing requirements of the FDA. Id. at *20. This is probably the cleanest example of a parallel claim. But, this claim was dismissed under TwIqbal. Without specific allegations of how plaintiff’s hip implant deviated from the FDA approved design, the court found the claim too speculative. Id. at *30-31.

We don’t like feeling blah. So we aren’t going to dwell on this decision and instead grab some SPV 30 and a cold drink and get out and enjoy the last few days of summer.

--
Posted By Michelle Yeary to Drug and Device Law at 8/25/2015 03:37:00 PM

Law

Pages

[Drug and Device Law] Guest Post - Game of Thrones, the FDA Under Attack, An In-House View of Amarin

[Drug and Device Law] Ask But Don't Tell: Kentucky Allows Defendant to Seek Ex Parte Interviews of Plaintiff's Treating Physicians

[DK GreenRoots] WA State Open Thread - Environmental Award given

Washington State Open Thread - An Award Well Deserved Goes to Representative Joe Fitzgibbon (D-34)

[Drug and Device Law] Breaking News - Ohio Sets Class Actions Right.

[Drug and Device Law] Lack of Proximate Cause for Failure to Warn Nets a Directed Verdict

[Drug and Device Law] Batting Down Generic Plaintiffs' Amarin Hail Mary Pass

[Drug and Device Law] SDNY Dismisses Manufacturing and Fraud Claims in Fertility Drug Case, But Conflates and Confuses the Rest

[Drug and Device Law] A Case of the End of Summer Blahs

Blog Archive