Generic Drugs

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On May 18, the FDA extended the comment period for its proposed generic drug labeling rule until April 2017 – that is, until after the next presidential election.  We believe that, for all practical purposes, this means that the proposed rule is dead.  Here’s why we think that.

As we have maintained from the beginning, the statute, which requires generic labeling to be the “same” as innovator labeling, simply does not support the FDA proposal to allow CBE labeling changes that would result in generic labeling that is not the “same.”  The FDA can do a lot of things, but it can’t do that – the opposite of what its organic statute specifically requires.  The generic drug industry knows this, too, and from day one has vowed an administrative challenge to any rule that violates statutorily-mandated sameness.

As we have also maintained almost from the beginning, the FDA’s proposed rule has been driven by the desire of the political FDA leadership (who broke the rules regarding impartial communication with outside groups) to overturn the generic preemption decisions, PLIVA v. Mensing, 131 S. Ct. 2567 (2011), and Mutual Pharmaceutical Co. v. Bartlett, 133 S. Ct. 2466 (2013).  They are doing this as affirmative political payback to satisfy the plaintiffs’ trial bar, for whom they broke the aforesaid rules.  The plaintiffs’ trial bar have, of course, been major political supporters of the current administration, and as long as they tell the FDA’s political leadership to jump, during this administration the response will be “how high.”Continue Reading Stick a Fork in It – FDA Anti-Generic Drug Preemption Proposal Postponed Until After the Presidential Election

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In terms of the legal gyrations plaintiffs try to avoid preemption, we’ve already expressed our opinion that so-called “failure to update” claims take the booby prize. There are good reasons, discussed in these prior posts, why plaintiffs not faced with preemption never bring claims for failure to update a warning – they’re simply lousy claims. The latest example of this fact is Woods v. Wyeth, LLC, 2016 WL 1719550 (N.D. Ala. April 29, 2016).

Woods is yet another metoclopramide case – that’s the generic drug that produced PLIVA v. Mensing, 131 S. Ct. 2567 (2011). Stuck between a rock and a hard place, the plaintiff:

Argue[d] that her claims are not preempted because they are based on the generic defendants’ “failure to update” their labels to be consistent with the brand name labeling.

Woods, 2016 WL 1719550, at *1. Woods, after examining various non-binding precedents, concluded that plaintiff “has set out a narrow claim that falls outside the scope of federal preemption” – the failure to update claim involving no more than the FDA-approved labeling. Id. at *8.

OK, so take generic preemption out of the mix entirely – what happens with Woods?

Same ultimate result as if the claim had been preempted; that is to say, judgment on the pleadings for the generic defendants.Continue Reading Yet Another Failure-To-Update Claim Bites the Dust

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It is not often that we get the opportunity to discuss an opinion from a panel of judges including two former professors from our law school.  Diane Wood is the Chief Judge of the 7th Circuit and taught us Civil Procedure at the University of Chicago Law School a long time ago.  Richard Posner is the reason we took a course in Law and Economics, and it is hard for us to think about economics, M&A, securities, or even – wait for it – tort causation without recalling some of his graphs, equations, and, most importantly, insights.  The fact that Wood and Posner were both brilliant members of the same remarkable faculty does not mean they always agree.  For instance, there was quite a judicial kerfuffle not too long ago when Wood took Posner to task for conducting his own outside-the-record experiment to determine how long it really would take a worker to change in and out of special clothing.

But Wood and Posner, along with Judge Bauer, did agree in Houston v. United States, 2016 WL 403310 (7th Cir. Feb. 3, 2016), where the court held that failure to warn and design defect claims against a generic manufacturer were preempted. No outside-the-record experiments were required.  The plaintiff claimed that he had been permanently disfigured by Stevens-Johnson Syndrome caused by ingestion of allopurinol. Allopurinol is a generic version of Zyloprim.  It is used to treat gout by reducing uric acid in the body.  The plaintiff took the generic version and sued the manufacturer of the generic.  The plaintiff also sued various health care providers for medical malpractice. Those health care providers were federal employees under the Public Health Service Act, which explains why the lead defendant was the United States.  The claims against the federal employees were dismissed for failure to exhaust administrative remedies.Continue Reading Seventh Circuit Knocks Out Claims Against Generic Manufacturer on Preemption Grounds

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A couple of years ago the one–two punch was all the rage in prescription drug cases.  “One-two punch” has been our moniker for decisions where plaintiffs ingested only generic drugs, but tried to hedge their bets, given the threat of generic drug preemption, by also suing branded drug manufacturers on innovator liability theories alleging that innovators’ purportedly inadequate labeling could make them liable to people who never used their products.  The new one-two held the generic drug claims preempted while at the same time ruling that the state in question (see our 50-state compilation) did not recognize inadequate warning claims against companies that neither sold nor profited from the sale of the drug that purportedly injured the plaintiff.  A one-two punch decision required us to update both our generic preemption and our innovator liability scorecards.

More recently, these cases sort of tailed off.  We assumed this was due to a litigation version of chronic traumatic encephalopathy − the plaintiffs had grown weary (and financially wary) of losing, and had stopped suing these defendants on theories that had been so widely rejected in the courts.  Apparently, though, the plaintiff in Tsavaris v. Pfizer, Inc., ___ F. Supp.3d ___, 2016 WL 80221 (S.D. Fla. Jan. 7, 2016), didn’t get the memo.  The result is another excellent one-two punch decision.Continue Reading The New One-Two Is Back

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We knew that Star Wars had overtaken Christmas in pop culture when we heard a junior high school band play a Jingle Bells/Star Wars mashup.  We were not surprised that this cross-cultural amalgamation received the largest and most immediate ovation of the program.  A couple of things did, however, come as unexpected.  The first surprise was that sleigh bells integrate very nicely into the Star Wars Cantina theme.  The second was that people of all ages and from all walks of life have embraced Star Wars in a way that we could not have foreseen when sitting on the edge of our seats in 1977 as Luke descended into the Death Star trench.

Star Wars has become a unifying Force.  Sure, it’s crassly commercial – we will not be giving our loved ones Darth Vader pendants from the Star Wars collection at Kay Jewelers this holiday season.  We also have read the columns on the Internet written by people who say Star Wars is all too much, that it was just a campy sci-fi pirate tale, that the three “prequels” in the early 2000s were forgettable, and so on.

To those people, we offer the intergalactic version of “Bah, humbug.”  You see, today is December 25, 2015.  Christmas Day.  A day off of work for many people, and a time that we hope you are spending with people you like, doing things you enjoy, perhaps even seeing a movie.  We spend most of our time finding reasons to disagree, and even though many do not celebrate this holiday, we will take one day off to celebrate something that people can find in common, even if that thing is a grossly overachieving motion picture.  People love it.  So if you are reading this, and we will forgive you if you do not, May the Force be with you.  And happy holidays.

So why the title of this blog post (A Long Time Ago . . .)?  Well, the District of Kentucky just put an end to a case that has kicked around the federal courts for five years when it should have lasted less than five days.  The problem was the wrong-headed plaintiffs’ lawyers who insisted on suing branded drug manufacturers when their client took only generic drugs.  We call it innovator liability, and it is wrong.Continue Reading A Long Time Ago . . .

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The rumblings began shortly after the industry First Amendment victory over the FDA in Amarin Pharma, Inc. v. FDA, ___ F. Supp.3d ___, 2015 WL 4720039 (S.D.N.Y. Aug. 7, 2015).  A couple of anonymous, obviously plaintiff-side, comments to our “breaking news” Amarin post suggested that the Amarin First Amendment victory for truthful off-label promotion might have a downside.  Both comments raised the same issue:  what happens to “impossibility” preemption in the drug warning context once First Amendment protection is extended to truthful pharmaceutical promotion?

One response would be that, if such speech is fully protected, as the Supreme Court indicated in Sorrell v. IMS Health, Inc. – “[s]peech in aid of pharmaceutical marketing, however, is a form of expression protected by the Free Speech Clause of the First Amendment” − 131 S. Ct. 2653, 2660 (2011), then it’s game over.  The same First Amendment protection equally precludes private suits under New York Times Co. v. Sullivan, 376 U.S. 254 (1964).  “What a State may not constitutionally bring about by means of a criminal statute is likewise beyond the reach of its civil law.”  Id. at 277.  See also In re Asbestos School Litigation, 46 F.3d 1284, 1294-96 (3d Cir. 1994) (First Amendment precluded product liability action).  Sullivan also roundly rejected the “commercial” overtones of otherwise fully protected speech as a basis for suppressing it through tort litigation:

The publication here was not a ‘commercial’ advertisement. . . .  That the [defendant] was paid for publishing the advertisement is as immaterial in this connection as is the fact that newspapers and books are sold. . . .  To avoid placing such a handicap upon the freedoms of expression, we hold that if the allegedly [tortious] statements would otherwise be constitutionally protected from the present judgment, they do not forfeit that protection because they were published in the form of a paid advertisement.

376 U.S. at 266 (citations and quotation marks omitted).Continue Reading When They Don’t Have Anything, They’ll Try Anything

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We just read on 360 this morning that the FDA has again postponed its schedule for finalizing the generic drug labeling changes (the so-called “Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products” rule) it proposed two years ago in order to overturn Supreme Court precedent recognizing preemption in generic drug product liability…

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In case you haven’t noticed, we like preemption.  We’ve even called ourselves “obsessed” with it.  And with good reason.  Preemption, where it’s available, is the most powerful defense around – capable of wiping out an entire MDL with a single motion to dismiss.  Preemption is not dependent on the strength of a plaintiff’s underlying case.  It doesn’t matter how solid medical causation might be, or how much the prescribing physician has (or has not) been suborned during ex parte chats with the other side.  If preemption applies, than it’s bye-bye claim, and often bye-bye plaintiff.  No discovery necessary.

Thus, it’s not surprising that plaintiffs’ lawyers fight preemption tooth and nail.  That’s their job.  They are just as ethically bound to represent their clients zealously within the boundaries of the law as we are.  Thus they pick every preemption nit they can find.

That’s what we’re on about today.  We’re discussing some recent decisions that address some lesser-known – but equally deadly − preemption arguments.Continue Reading Preemption 201 – Recent Cases Raising Specialized Issues

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With claims related to warnings, design, and recall all preempted, plaintiffs seeking to sue makers of generic drugs don’t have many options.  After all, as we’ve discussed before, if state common law can’t require changing a defendant’s warnings, changing the design, or making the defendant stopping selling the product altogether, there’s not much left for a plaintiff to allege.

So, who ya gonna call?

One straw that generic drug plaintiffs have grasped at is the footnote in Mutual Pharmaceutical Co. v. Bartlett, 133 S. Ct. 2466 (2013), “not address[ing]” the issue of “parallel claims” – facially dictum about something not raised in Bartlett:

We do not address state design-defect claims that parallel the federal misbranding statute.  The misbranding statute requires a manufacturer to pull even an FDA-approved drug from the market when it is “dangerous to health” even if “used in the dosage or manner, or with the frequency or duration prescribed, recommended, or suggested in the labeling thereof.” 21 U.S.C. § 352(j).  The parties and the Government appear to agree that a drug is misbranded under federal law only when liability is based on new and scientifically significant information that was not before the FDA.

Because the jury was not asked to find whether new evidence concerning [the drug] that had not been made available to the FDA rendered [it] so dangerous as to be misbranded under the federal misbranding statute, the misbranding provision is not applicable here.

Id. at 2477 n.4 (other citations omitted).Continue Reading Ghostbusters – Phantom “Parallel Claim” Exorcized by Generic Drug Preemption

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What?  You were expecting another of our insensitive blogpost headlines?

Nope, we’re playing this one straight down the middle.  In In re Testosterone Replacement Therapy Products Liability Litigation, 2015 WL 6859286 (N.D. Ill. Nov. 9, 2015) (“TRT”), the court ruled that all claims against all makers of generic testosterone replacement drugs were preempted.  Indeed, except for those generic manufacturers who were also designated by the FDA as “reference listed drugs,” the plaintiffs did not even contest dismissal.  Id. at *1.

Maybe the word is getting through to the other side that the Supreme Court meant what it said in PLIVA v. Mensing, 131 S. Ct. 2567 (2011), and Mutual Pharmaceutical Co. v. Bartlett, 133 S. Ct. 2466 (2013).

The main issue in TRT was whether a generic manufacturer somehow lost the protection of impossibility preemption because the FDA designated that manufacturer’s product as a “reference listed drug” (“RLD”) after the original branded drug left the market.  This issue has been out there for some time, and we discussed in detail in our post on the aberrant Pennsylvania Superior Court metoclopramide-related decisions.  Indeed, we noted that that the FDA had confirmed – on the very day that we wrote that post – that designated generic RLDs remained generic drug manufacturers and were unable to use the preemption-destroying “changes being effected” process to modify their labels.  Id. (citing and quoting “FDA, Guidance for Industry, Safety Labeling Changes − Implementation of Section 505(o)(4) of the FD&C Act, at 7 n.10 (FDA July 30, 2013)).Continue Reading Generic Preemption Prevails in Testosterone MDL

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FDA-regulated products now account for an estimated one-fifth of overall economic activity in the U.S. They have also been the focus of a litigation explosion. This timely guide covers all aspects of litigation involving drugs, medical devices, vaccines and other FDA-regulated prescription products.
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