Breaking News – Consumer Expectations Test Preempted

By Bexis on March 4, 2014

This breaking news post is from the non-Dechert bloggers, because it discusses a metoclopramide case.

Like the Drager case we told you about earlier, another case has held that, in the context of generic drug preemption, labeling a design defect claim a “risk/utility” or “consumer expectations” is a distinction without a difference – and both are preempted. This time it’s a federal court in Arkansas on remand from the Eighth Circuit’s Fullington decision. See Fullington v. Pfizer, Inc., 720 F.3d 739 (8th Cir. 2013). The new case is Fullington v. Pfizer, Inc., No. 4:10CV00236 JLH, slip op. (E.D. Ark. Feb. 28, 2014). As you might expect Fullington relied heavily on the Fourth Circuit’s reasoning in Drager. But more that, Fullington got it right because, right from the start, the court asked the right question: “[T]he Court directed [plaintiff] to explain what the Generic Defendants could have done to comply with [state] law without violating federal law.” Slip op. at 5. The correct answer was – as we’ve been saying since our “bullseye” post – nothing. Generic manufacturers cannot change their warnings without prior FDA approval. No drug (or device) manufacturer can change its design without prior FDA approval. Finally, plaintiffs cannot avoid preemption by claiming that the manufacturer of an FDA-approved drug had some state-law duty to take it off the market. Slip op. at 5.

The only other thing the plaintiff in Fullington could think of was “post-marketing surveillance.” Id.

[Plaintiff] does not explain how a failure to conduct post-marketing surveillance constitutes a design defect or breaches one of the implied warranties, nor does she explain how the defendants could have avoided liability on her design defect and implied warranty claims by conducting post-marketing surveillance.

Id.

We’ve said it before, and we’ll say it again. For preemption purposes there is no distinction between theories of design defect. What must the defendant actually do? As long as any theory would require a change in design, it’s preempted because that requires prior FDA approval.

A Twitch of Life for Learned Intermediary Doctrine in West Virginia

By Michelle Yeary on March 4, 2014

Don’t get too excited. When we say a twitch, we mean it in its smallest sense. A shudder, a tremor. One blip followed by a long flat line. We aren’t talking about resuscitation at this point. But, just maybe West Virginia hasn’t signed a DNR order quite yet.

Ever since the West Virginia Supreme Court of Appeals refused to adopt the learned intermediary doctrine in State of West Virginia ex rel. Johnson & Johnson Corp. v. Hon. Mark A Karl, 220 W. Va. 463 (W. Va. 2007), we haven’t been shy about telling you all the ways that decision simply got it wrong (see here and here). But, ever the optimists, we sift and pan through West Virginia decisions like 19th century gold miners – looking for those little nuggets we can use to breathe life back into the learned intermediary doctrine.

We got one of those nuggets back in 2010 when the West Virginia Supreme Court of Appeals decided that there is no private cause of action under the West Virginia Consumer Credit and Protection Act (“CCPA”) for prescription drugs. White v. Wyeth, 705 S.E. 2d 828 (W. Va. 2010). Nowhere in that decision will you find the words “learned intermediary.” However, what that court did say was that when a plaintiff alleges affirmative misrepresentations, he must prove reliance and because for prescription drugs “the consumer cannot and does not decide what product to purchase”, id. at 838, plaintiffs can’t establish a causal connection. If we were playing charades, we’d be making the “sounds like” gesture. The court even went so far as to say that it is the physician who must “exercise[] judgment whether or not to prescribe a particular medication.” Id. So close.

Continue Reading A Twitch of Life for Learned Intermediary Doctrine in West Virginia

More Food Litigation in California: Attack of the Sunflower Seeds

By John Sullivan on March 3, 2014

More and more we find ourselves at parties on Oscar night. Lately they’ve become red carpet parties. Jeez. We have no idea how that happened, but that’s where things are. There’s an upside though: the alcohol. Oh, and the snide comments. The alcohol and the snide comments make for fun. A couple of years ago, we stood watching yet another actor wrapped in suspect confidence and dazzling designer fabric standing in front of a microphone on the red carpet talking about [insert far away country] and how uninformed we are about its dire circumstances and how this actor was now going to inform us. Yummy. A guy holding a beer next to this particular DDL blogger summed things up: “Actors. What would we do without them?”

That’s pretty funny. But watch out. Lawyers may be worse. At those same parties others seem to think that you as a lawyer mysteriously have the answers to all sorts of difficult questions because your daily work-life is filled with complicated, intellectual problems that you approach in complicated, intellectual ways. But then you leave the party, go to work the next day and deal with crazy stupid stuff.

A Ninth Circuit panel seems to have faced this same feeling 11 days ago when it wrote this opening paragraph:

Some days we are called upon to consider such profound issues as eleventh-hour death penalty appeals, catastrophic threats to the environment, intense and existential questions of civil and human rights, and the most complicated, controversial problems in civil, criminal and administrative law. Today we consider the coating on sunflower seeds.

Lilly v. ConAgra Foods, Inc., 2014 U.S. App. LEXIS 3159, at *2 (9th Cir. Feb. 20, 2014).

Continue Reading More Food Litigation in California: Attack of the Sunflower Seeds

Another One-Two Punch Landed in the Fifth Circuit

By Steven Boranian on February 28, 2014

Of all the catch phrases that we have coined or popularized (see Twiqbal), one of our favorites is the “one-two punch,” our affectionate label for post-Mensing cases holding that (1) a plaintiff can bring product liability claims only against the maker of the drug that he or she actually took and (2) that claims against generic manufacturers are preempted. We like these cases a lot and write on them every chance we get because they make so much sense. A court should not have to say out loud that a plaintiff cannot bring product liability claims against a defendant that did not make or sell the product. That is why it is called “product” liability. We also agree wholeheartedly with generic preemption, which is the only solution to the “damned if you do, damned if you don’t” position that generic manufacturers would otherwise find themselves in, i.e., unable to comply with state-law claims because federal law prohibits it. We like one-two punch cases also because they give us the opportunity to criticize the wrongly reasoned and wrongly decided Conte case from the California Court of Appeal. (Have we mentioned that we do not think very much of Conte?). The so-called “innovator liability” that Conte attempted to pioneer based on “common sense” and “the general rule of duty” has floated like a lead balloon, probably because it made no “sense” and because “general rule of duty” was code for “based on no body of law that we can specifically identify.”

The Fifth Circuit has just given us another clear-minded one-two punch in yet another case involving generic metoclopramide. The case is Lashley v. Pfizer, Inc., No. 12-60861, 2014 WL 661058 (5th Cir. Feb. 21, 2014), and our only regret is that it is not published, because the holding and its reasoning are right on the money. The two plaintiffs in this consolidated appeal—one alleging claims under Texas law and the other under Mississippi law—used generic metoclopramide and allegedly developed tardive dyskinesia and akathisia, so they sued not only the manufacturers of the generic drugs they actually took, but also the manufacturers of branded Reglan. Id. at *1.

The court disposed first of the claims against the generic manufacturers, against whom the plaintiffs alleged the usual laundry list of claims: Negligence, gross negligence, strict liability, breach of numerous warranties, misrepresentation, fraud, suppression of evidence, and deceptive trade practices. In the end, however, the court correctly saw all of the claims for what they were—variations on failure-to-warn—and from there it was a short step to preemption: “At their core, all [of the plaintiffs’] claims against the generic manufacturers turn on the adequacy of the labeling and related information, and can thus be construed as failure-to-warn claims. As such we find them to be preempted under Mensing.” Id. at *2.

The plaintiffs tried to argue their way around Mensing in a few ways. They first argued that generic manufacturers could have made consumers aware of the risks in ways that did not differ from the content in the warnings, but the court through that: As was said in Cool Hand Luke, “what we have here is a failure to communicate.” Thus Lashley held that Mensing forecloses all claims based on allegedly inadequate communication, no matter what means of transmission. Id. at **2-3. The plaintiffs also argued that not all of their claims were based on a failure-to-warn, but the court shot that down, too. To begin with, we can’t really tell from the opinion how the plaintiffs thought that any of their claims were based on anything other than an alleged failure to provide adequate warnings. Maybe the court could not tell either, but regardless, the court held that “non-failure-to-warn claims” were preempted in light of Bartlett because “assuming distribution of the drug was acceptable in the first place, any useful action (of lack thereof) for which the companies could be held responsible would necessarily involve some form of warning.” Id. at *3.

Finally, the plaintiffs argued that some of their state-law claims were “parallel” to federal law and thus not preempted. This is our favorite, because the plaintiffs were so clearly trying to pull a fast one. So-called “parallel claims” can exist only within the express preemption context, where the relevant question is whether state law is imposing a requirement “different from or in addition to” federal requirements. Although we don’t like it, courts have allowed state-law claims to proceed where they “parallel” federal claims, i.e., where the state requirement neither adds to nor is different from federal requirements.

The concept becomes utter nonsense when imported into implied preemption, which is the only kind of preemption that was at issue in Lashley. The Fifth Circuit was not fooled, and it rejected the plaintiffs’ parallel claim argument because:

Medtronic and Hughes [cited by the plaintiffs] concern express preemption; in those cases, “parallel” state law claims against manufacturers of medical equipment were allowed to proceed because there was no express preemption found in the applicable statute. In Mensing, as here, the Supremacy Clause—not a statute—made it impossible for the generic defendant to do what state law required of it and, therefore, the state law claim was preempted. In these types of cases, the inquiry is not whether there is a “parallel” claim where one looks for absence of conflict with the statute; the inquiry is whether the state law claim is impliedly preempted.

Id. at *4 (emphasis added). We like this quote. It is a correct statement of the law (although we still think the parallel claim doctrine does not hold water), and it maintains a conceptual distinction between express preemption and implied preemption that is necessary to prevent confused and unfair results. The opinion thus affirmed the district court’s order dismissing claims against the generic manufactures. This was blow number one.

The court’s second blow affirmed summary judgment in favor of the innovator manufacturers on the basis that they did not make or sell the products that these plaintiffs used. Id. at **4-5. The court did not cite Conte, but it understood what the Conte court did not—that the innovator manufacturers owed the plaintiffs no duty because the plaintiffs “did not ingest the . . . brand defendants’ products.” Id. at *4. The court applied Mississippi law to one plaintiff and Texas law to the other, but we would have courts come to this conclusion under any state’s law because it is so clearly the correct result. It comforts us to know that we are not the only people who feel that way, including nearly every court to consider the issue. Add the Fifth Circuit to the list and hope that the next time they file an opinion like Lashley they deem it worthy of publication.

Guest Post — The Fourth Circuit Weighs In: False Claims Act Liability Under Medicare and Medicaid Cannot be Based Merely on Regulatory Violations

By Eric Alexander on February 27, 2014

This is a guest post by Reed Smith partner Larry Sher, who was part of a team successfully representing Omnicare on a civil False Claims Act case before the United States District Court for the District of Maryland and the Fourth Circuit. The rest of the defense team included Eric Dubelier, Katherine Seikaly, James Martin and Colin Wrabley. As we have noted previously, there has been increasing overlap between the issues presented in cases under the False Claims Act (and state law mimics) and the sort of product liability cases we usually talk about here.

* * *

Over the last few years, counsel for defendants in civil False Claims Act (“FCA”) cases have increasingly seen relators (the FCA version of plaintiffs) pushing the limits of the FCA to attempt to pressure defendants into costly settlements based on allegations that the defendant violated some regulation that really has nothing to do with the submission of any claim for money from the government, false or otherwise. Last week the United States Court of Appeals for the Fourth Circuit confirmed that the FCA is meant to combat fraud and is not a “sweeping” catch-all mechanism to address all regulatory violations in the absence of actual fraud.

In United States ex rel. Rostholder v. Omnicare, Inc., No. 12-2431, the Fourth Circuit affirmed the dismissal of a relator’s FCA complaint (and denied leave to amend) under Fed. R. Civ. P. 12(b)(6) in a case that may have a significant impact on the future of healthcare related FCA actions in the Fourth Circuit and maybe elsewhere. The Rostholder court held that because compliance with the Food and Drug Administration’s (FDA) Current Good Manufacturing Practices (cGMP) regulations is not a precondition for reimbursement under Medicare and Medicaid, violations of the cGMP regulations by themselves cannot form the basis for False Claims FCA claims. No. 12-2431, slip op. (4th Cir. Feb. 21, 2014).

Continue Reading Guest Post — The Fourth Circuit Weighs In: False Claims Act Liability Under Medicare and Medicaid Cannot be Based Merely on Regulatory Violations

Understanding the “Intermediary” Part of The Learned Intermediary Doctrine

By Eric Alexander on February 27, 2014

We watched some of the recently concluded Winter Olympics. When the temperature at the Black Sea-side resort exceeded the temperature of Washington, D.C., by 20° Fahrenheit (or 11.1° Celsius), we questioned the “Winter” part of the event’s title in a way we never expected. Of course, we watched some action from familiar sports, like the hockey showdowns with our once-archrival and our northern neighbor. We also watched some of the biathlon, a fascinating sport that involves cross country skiing with a rifle on your back and stopping periodically to shoot at targets. Our initial thoughts on that sport ran like this: “This is not a sport that people do casually. Maybe this is to echo the Winter War. Maybe they could make it a more militaristic triathlon by adding a phase where an edged weapon is used to decapitate a snowman while skiing. These tortilla chips are making me thirsty.” This being a blog on drug and device law—as its title hints—and our thirst having been quenched, it occurs to us that our experience with the cases we write about is like watching the biathlon. (We may have quenched our thirst with a nice winter ale and/or a little Russian water, but we are sober as we write.) We do not hear much about the exhausting cross-country grind of discovery. We do not follow all the ups and downs of trial argument and evidence. We check in, periodically, when the litigants have paused long enough to shoot (at each other, unlike in the Olympic version of the biathlon) and the court issues some ruling explaining the targets, hits, and misses. Even then, we typically pay attention to the results of the shooting only when the decision is published (or sent to us by a participant) and it seems interesting. Occasionally, we notice multiple decisions from a single case as it proceeds past discovery, dispositive motions, and pretrial motions, and through trial. These may not be the highest stakes or most groundbreaking cases, though. This is somewhat like watching NBC focus on the battle for 15th place in the Men’s Relay, just because the U.S. team was battling. (Bulgaria, you are the ancestral homeland of the mighty Spartacus. Need you grab more glory by 0.7 seconds?)

The Guenther case is one of many Aredia/Zometa cases involving allegations about osteonecrosis of the jaw (ONJ) whose decisions have been discussed in our posts. Guenther, however, has achieved special puffy coat status due to its recurring role in six prior posts. Over the last year, we have posted on decisions on case consolidation, summary judgment, punitive damages, limiting Dr. Parisian (as part of a compilation), motions in limine, and more motions in limine. Yet, we know that there were other decisions and developments in the case that shaped its course. We know from Guenther v. Novartis Pharm. Corp., No. 6:08-cv-456, 2014 U.S. Dist. LEXIS 21182 (Feb. 20, 2014), that its course took the case all the way to trial, where the plaintiff won on strict liability and negligent warnings causes of action and was awarded $1.3 million in compensatory damages, leading defendant to move for judgment notwithstanding the verdict, a new trial, and/or remittitur. All we know about the trial evidence from the plaintiff, prescribing physicians, other treating physicians, and the experts comes from the decision itself, as the court identifies and characterizes the evidence it wants as it explains its particular findings. See, this is just like watching biathlon. No need to analyze the parallels any further.

Continue Reading Understanding the “Intermediary” Part of The Learned Intermediary Doctrine

Ninth Circuit Toes the Line on Learned Intermediary and Warning Causation

By Stephen McConnell on February 26, 2014

Any U.S. Circuit Court clerkship should add some sparkle to a resume, but we used to take endless grief about the Ninth Circuit’s reputation for liberalism and for Supreme Court reversals. Noted pharmaceutical expert and exponent of judicial (though not gastronomic) restraint Rush Limbaugh calls it the “Ninth Circus.” We clerked for William Norris, a brilliant and fair-minded jurist. He was considered a liberal and, indeed, he penned many prominent opinions that earned that label. Way ahead of his time, Judge Norris in the 1980’s authored the Watkins decision, which upheld the right of a gay man to serve in the military. But Judge Norris looked positively antediluvian compared to colleagues such as Judges Pregerson and Reinhardt. Every couple of years Congressmen from Idaho or Montana beg to split up the Ninth Circuit, complaining that their jurisprudence has been polluted by the wackos in California. The funny thing is that when conservative jurists assume leadership in the Ninth Circuit (such as Judges Wallace and Kozinski), they inevitably oppose such a split and discover the virtues of the country’s biggest circuit court. Splitting the Ninth Circuit would do nothing of value; it would merely lead to more circuit splits. Maybe it is because of economies of scale, but the Ninth Circuit is productive in terms of caseloads and opinions. Plus those judges and clerks in Billings and Boise should want to keep open the possibility of a calendar sitting in Hawaii. And how can you dislike a court whose Chief manages to insert 215 movie titles into an opinion (Syufy) and who was once upon a time the winner on The Dating Game? (Don’t believe us? Look here.)

The Ninth Circuit still is at or near the top in the league tables when it comes to Supreme Court reversals (by some measures the Sixth Circuit is ahead), though at times that can feel like a badge of honor. We remember Judge Pregerson (a wonderful man who welcomed other clerks to his chambers and liked to point out from a window in his chambers down at the LA post office annex where his dad worked many years ago) once mentioning at an oral argument how he had written an opinion on the same subject several years before, only to be reversed by the Supremes. But, he said, he was subsequently vindicated by “a higher authority”: the Harvard Law Review. In reality, the reputation ‘enjoyed’ by the Ninth Circuit is much ado about nothing. Most decisions are unanimous, even when the panel is shared by people perceived to be ideological opposites. We remember an oral argument we made as an AUSA seeking an upward departure in a criminal sentence because the defendant had slashed a woman’s face to ribbons. The defendant committed this mayhem on the grounds of a VA Hospital, thus making it a federal crime. On the panel were Judges Wallace and Reinhardt – the leading conservative and liberal on the court, respectively. There was a third judge, of course, but he barely got a word in edgewise on this very hot panel. The court unanimously upheld the upward departure, but Judge Reinhardt used the oral argument as an opportunity to bemoan the paucity of downward departures for deserving crooks. Nothing in there for us. We let Wallace and Reinhardt go at it, and collected the affirmance.

Continue Reading Ninth Circuit Toes the Line on Learned Intermediary and Warning Causation

A Removal Win With a Word of Caution

By Michelle Yeary on February 25, 2014

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

We embrace all defense wins on this blog. From the small and routine to the precedent-setting. From discovery violations to appeals and everything in between. And we are certainly no strangers to talking about removal issues. So, of course we want to share with our readers H.R. ex rel. Reuter v. Medtronic, Inc., 2014 WL 554454 (S.D. Ohio Feb. 13, 2014), and more specifically, the court’s decision that defendant properly removed the case in light of “substantial federal issues” within the meaning of Grable & Sons Metal Products, Inc. v. Darue Engineering & Manufacturing, 545 U.S. 308 (2005). But, don’t go filing your removal papers quite yet. Anything involving Grable is hardly a one size fits all argument, and we caution everyone to look closely at all aspects of your case (especially the jurisdiction) before attempting to squeeze anything into this slender and contorted federal question category.

The Grable argument isn’t new. We’ve pondered it before because the restriction of theories via PMA preemption to “parallel” claims involving FDA violations does seem to push that type of case towards Grable. But frankly, our idea hasn’t had much success. Which also isn’t surprising. The general principle is to use the presence of an issue implicating federal law – but something less than a federal cause of action – as a basis of obtaining subject matter jurisdiction in federal court. Removal is appropriate where a state court claim “necessarily raise[s] a stated federal issue [that is] actually disputed and substantial, which a federal forum may entertain without disturbing any congressionally approved balance of federal and state judicial responsibilities.” Grable, 545 U.S. at 312. That last part, about “balance,” means that by definition Grable doesn’t apply to anything involving large numbers of cases. So look elsewhere for jurisdictional panaceas.

H.R. is an InFuse case. If you haven’t been following our other InFuse posts, InFuse is a PMA, Class III medical device. In almost all of the InFuse cases, including H.R., plaintiffs’ claims are based on alleged off-label promotion of the device which they claim violates the FDCA. The combination of a PMA device and plaintiff’s extensive, and nearly exclusive, reliance on detailed FDCA-related allegations involving off-label promotion are what made H.R. a particularly strong vehicle for advancing the Grable substantial federal question argument.

Continue Reading A Removal Win With a Word of Caution

Favorable Preemption Decision from the Eastern District of Pennsylvania

By John Sullivan on February 24, 2014

Starks v. Coloplast Corp., 2014 U.S. Dist. LEXIS 19611 (E.D. Pa. Feb. 18, 2014), brings us another favorable preemption ruling. This is not a mass tort. It appears to be a one-off complaint filed in Pennsylvania state court and, since Coloplast is a Minnesota company, removed to federal court where Coloplast’s preemption motion might be better received. It was.

The product was the Titan OTR Inflatable Penile Implant. It had been implanted in the plaintiff and failed, requiring revision surgery and resulting in the type of difficulties that often come with that. The Titan is a Class III medical device, however, so that brought Riegel preemption into play.

And from there, it was relatively simple. Plaintiff’s negligence, strict liability and implied warranty claims were all preempted – and rather ordinarily. But there are two interesting notes. First, the plaintiff tried to concoct a claim by simply regurgitating (roughly) the standard to be met to state a parallel violation claim: the company failed to satisfy “state duties equal to, or substantially identical to, federal requirements.” Id. at *15. Nice try, but a whole lot more is required. The complaint must identify the actual standard that was not met and a state law that enforces the same standard. Plaintiff did neither. Two, while the court on a number of occasions underscored plaintiff’s failure to identify an FDA regulation or statute that the defendant failed to satisfy, id. at *15-18, we want to highlight once again that even doing so wouldn’t have been enough. Plaintiffs do not have the authority to bring a private right of action for violating FDA regulations. The FDCA explicitly disallows it. Plaintiff must instead identify a state law that independently allows private plaintiffs to sue based on the conduct that resulted in those violations. Nothing in the court’s opinion indicates that plaintiff did so.

Not all of plaintiff’s claims were preempted. He also brought breach of express warranty and breach of contract claims. The court held that such claims, if properly pleaded, can survive preemption. Id. at *18-22. But plaintiff hadn’t pleaded facts to support the existence of an express warranty or a contract. Plaintiff relied, for the most part, on statements made about the product in a brochure. The brochure, however, was given to plaintiff’s doctor, not plaintiff. Alleging the existence of an undated brochure given to a third party doesn’t state a contract or warranty claim, particularly given the lack of factual allegations surrounding an offer or acceptance of a contract or warranty. Id. at *21-22. So the court dismissed these claims, but without prejudice.

Finally, this is another case in which the court accepted and considered publicly available FDA documents without converting the motion to dismiss into a summary judgment motion. Id. at *2-3. This is becoming more and more common and is, we believe, proper. Considering such documents allows the defense to inject a dose of reality into a motion that is based on a complaint that might be trying to tiptoe around it.

A Guide To Medication Guides

By Bexis on February 21, 2014

Not too long ago we were asked what we thought about warning claims involving medication guides. Our off-the-cuff reaction was that such suits have been occasionally filed over the years, but were largely unsuccessful in achieving the plaintiffs’ primary goal, which almost always was to avoid the learned intermediary rule.

That was our gut reaction, but since we also have to feed the blog, we decided that the question warranted a closer look.

First, a little on the current regulatory status of medication guides, which are also sometimes referred to as “patient package inserts,” or “patient brochures.” They are “FDA-approved patient labeling conforming to the [Agency’s] specifications.” 21 C.F.R. §208.3(h). Such guides were authorized by the FDA in 1998 under 21 C.F.R. §208.1, which states:

(a) This part sets forth requirements for patient labeling for human prescription drug products, including biological products, that the Food and Drug Administration (FDA) determines pose a serious and significant public health concern requiring distribution of FDA-approved patient information. . .

(b) The purpose of patient labeling for human prescription drug products required under this part is to provide information when the FDA determines in writing that it is necessary to patients’ safe and effective use of drug products.

(1) The drug product is one for which patient labeling could help prevent serious adverse effects.

(2) The drug product is one that has serious risk(s) (relative to benefits) of which patients should be made aware because information concerning the risk(s) could affect patients’ decision to use, or to continue to use, the product.

(3) The drug product is important to health and patient adherence to directions for use is crucial to the drug’s effectiveness.

Emphasis added. See also 21 C.F.R. §208.24(a) (“The manufacturer of a drug product for which a Medication Guide is required under this part shall obtain FDA approval of the Medication Guide before the Medication Guide may be distributed”) (emphasis added); 21 C.F.R. § 201.57(c)(18) (requiring all “FDA-approved patient labeling” to appear in the “Patient counseling information” section of drug labeling).

We added all this emphasis to underscore the point that requiring a medication guide – as distinguished from what it might say − is another of those decisions that requires FDA pre-approval. See Bartlett v. Mutual Pharmaceutical Co., 2010 WL 3659789, at *5 (D.N.H. Sept. 14, 2010) (“FDA may require that a drug be accompanied by a medication guide”) (citing §208.1). As we’ve explained elsewhere, a mandate for FDA pre-approval such as this calls into play the Mensing/Bartlett impossibility preemption rationale, since a hypothetical state immediate tort duty to include a medication guide would conflict with the federal agency preapproval requirement. Bowdrie v. Sun Pharmaceutical Industries Ltd., 909 F. Supp. 2d 179, 186 (E.D.N.Y. 2012) (finding preemption because “a specific FDA directive, is a necessary predicate to . . . any medication guide”).

Continue Reading A Guide To Medication Guides

Drug & Device Law