Levine

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

Today we laud an excellent prescription drug preemption ruling finding “clear evidence” that the FDA would not have permitted the warning of the sort plaintiff demanded – Cerveny v. Aventis, Inc., 2016 U.S. Dist. LEXIS 34182 (D. Utah Mar. 16, 2016).

At issue is the prescription drug Clomid. Clomid has been FDA approved and on the market since 1967. Id. at *2. It is prescribed to women to induce ovulation. The drug is taken for 5 consecutive days with ovulation typically occurring within 5 to 10 days. Id. at *5. Since the drug has been on the market it has carried a warning that Clomid should not be taken while pregnant due to the potential risk of harm to the fetus. Id. at *2-5. While the warnings have been modified over time, the risk of ingestion while pregnant has always been present, along with warnings about carefully monitoring ovulation so as to avoid becoming pregnant while taking the drug. Id.

Plaintiff used two rounds of Clomid in 1992. Following her second round she became pregnant. Her son was born with birth defects. Id. at *12-13. Plaintiff alleges that those defects were the result of the Clomid she took prior to becoming pregnant remaining present in her system during and after conception. And that therefore, defendant had a duty to warn of the risks of birth defects from Clomid taken prior to pregnancy. Id. at *13-14. Defendant filed a motion for summary judgment on the ground that plaintiff’s claims were barred by federal conflict preemption. Defendant argued that the FDA would not have allowed it to include the warning sought by plaintiff and therefore plaintiff’s state law tort claim conflicts with federal law and is preempted. Id. at *16-17. Under the standard announced in Wyeth v. Levine, 555 U.S. 555 (2009), defendant has to demonstrate the conflict between state and federal law by “clear evidence.” Since that decision, courts have been grappling with what “clear evidence” means. In this case, the court didn’t have to look too hard.Continue Reading More Clear Evidence of Conflict Preemption

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

Last week we posted about the decision in In re Incretin-Based Therapies Products Liability Litigation (S.D. Cal.) dismissing plaintiffs’ failure to warn claims as preempted based on the Wyeth v. Levine  “clear evidence” standard.  That is “clear evidence” that the FDA would have rejected the warning sought by plaintiffs, which leads to implied preemption based on impossibility.

At that time we had heard that the judge presiding over the consolidated incretin litigation in state court in California would be issuing a similar ruling.  That turned out to be correct.   Here is a link to the decision, In re: Byetta Cases, Case No. JCCP 4574 (Cal. Super. Nov. 13, 2015).  The ultimate conclusion is the same:  the evidence demonstrates that on multiple occasions the FDA considered and rejected a causal association between incretin and pancreatic cancer and likewise concluded that the drug’s labeling did not require revision.  In re: Byetta Cases, slip op. at 15-18.

We aren’t going to re-hash the impossibility preemption analysis again; we think the federal court decision handled the issue more than well enough.  But, we will point out a few interesting points made in the state court decision.Continue Reading Incretin Preemption Part II – California Tosses Failure to Warn Claims Too

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

It may be early November, but halls (more like malls) are being decked; trees are being trimmed; 24-7 Christmas carol radio stations are in full swing; and there’s some internet-created controversy over whether Starbucks’ cups will have snowflakes and reindeer on them???  Anyway, it’s hard not to start thinking about the holidays when the signs and symbols are everywhere you look.  One of this blogger’s favorite holiday traditions is to read Yes, Virginia.  For those who may be unfamiliar, it is the account of eight-year-old Virginia O’Hanlon’s letter to the editor of The Sun in 1897.  Little Virginia is dismayed by her friends’ lack of belief in Santa Claus.  Her father tells her to write to the The Sun because “if you see it in Sun, it’s so.”  So Virginia simply asks “is there a Santa Claus?”  The response was of course — Yes, Virginia.  He is real.  “He lives and he lives forever.  A thousand years from now, Virginia, nay, ten times ten thousand years from now, he will continue to make glad the heart of childhood.”

Well, we don’t know about a thousand years from now, but as for today and the foreseeable future – preemption makes glad the heart of defense lawyers.  We gave you the link to the decision in In re Incretin-Based Therapies Products Liability Litigation, slip op.  (S.D. Cal. Nov. 9, 2015) this morning. It’s a lot to read, but it’s worth it. The bottom line is the court granted defendants’ motion for summary judgement dismissing all failure to warn claims that had accrued as of October 15, 2015 based on clear evidence that the FDA would have rejected any change to the drugs’ labeling regarding the risk of pancreatic cancer.  Slip op. at 2.  Let’s get you to the highlights of this lengthy decision.Continue Reading Yes, Plaintiffs, There is Clear Evidence

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It wasn’t a complete win, but the summary judgment outcome in Rheinfrank v. Abbott Laboratories, Inc., ___ F. Supp.3d ___, 2015 WL 4743056 (S.D. Ohio Aug. 10, 2015), has to put a spring in the step of the defendants as they approach trial.  What’s left doesn’t strike us as a very good warnings case.  Rheinfrank involved claims that the antiepileptic drug Depakote caused the minor plaintiff’s birth defects.  Make no mistake about it, Depakote has a known association with such injuries.  First approved in 1983, it’s been a Pregnancy Category D drug since 1988, meaning, according to FDA regulations, that:

there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but the potential benefits from the use of the drug in pregnant women may be acceptable despite its potential risks.

21 C.F.R. §201.57(c)(9)(i)(A)(4).  Not only that, since 2003, this drug has carried a black box “teratogenicity” warning, as well as other quite explicit, and all-caps, language to the same effect.  For details, see 2015 WL 4743056, at *2-3.

Plaintiff-mother had used Depakote for years, through four previous uneventful pregnancies.  Id. at *1.  On her fifth pregnancy, even though Depakote came with all these warnings, she continued to take it.  Id.  Her allegations did try to change the subject, however.  In addition to claiming that the black box warning (more about that later) and all the other teratogenicity language were inadequate, she asserted that the defendants failed to warn altogether about “developmental delay.”  Id. at *5.Continue Reading Preemption (and Other Things) Defanging Depakote Claims

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Today we have a guest post (her second – she’s a glutton for punishment) from fellow Reed Smith associate Danielle Devens.  This one brings together recent precedent recognizing post-Levine preemption in cases involving non-generic prescription drugs (there are a couple our readers may not have seen before).  As always with our guest posts, the author gets all the credit, and any blame, for the contents of his/her work.

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As this blog has been explaining for a while, the rationale in Mensing – that “[t]he question for ‘impossibility’ is whether the private party could independently do under federal law what state law requires of it” –  could apply to innovator (brand-name) pharmaceutical manufacturers and not just to generics.  131 S. Ct. 2567, 2579 (2013).  About a year ago, this blog reported on cases in which defendants argued for the application of the impossibility preemption doctrine outside of the context of generic drugs.  Since that time, there have been several new decisions involving innovator pharmaceutical manufacturers arguing for the application of impossibility preemption principles.  It makes sense at this point to condense the available information into one post and assess the question “where are we now?”

First, the relevant statutes in a nutshell:  to obtain FDA approval for a new drug, an innovator manufacturer must prove the safety and efficacy of its product through lengthy clinical testing, while generic drugs can gain FDA approval by showing that the product is equivalent to a brand-name drug that has already been approved by the FDA.  21 U.S.C. §355(j)(2)(A).  (One caveat – there may be drugs legally marketed today that were not subject to these requirements, such as drugs evaluated prior to 1962 which were instead subject to the FDA’s Drug Efficacy Study Implementation program). This, of course, is not a complete description of the requirements, but you get the gist.  The generic drug application must also show that the safety and efficacy labeling proposed is the same as the labeling approved for the innovator drug.  21 U.S.C. §355(j)(2)(A)(v).Continue Reading Guest Post – Impossibility Preemption for Innovator Drug Manufacturers: Where Are We Now?

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The Third Circuit issued a whopper of a preemption opinion on Friday in Farina v. Nokia, Inc., ___ F.3d ___, 2010 WL 4138502 (3d Cir. Oct. 22, 2010), unanimously holding that state-law claims that cellphones emitted harmful radiation were preempted.  We’re not going to delve into Farina very much because:  (1) cell phones are…

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Judge Posner’s opinions are usually right and, even more usually, brilliant. It’s no surprise we’ve blogged about them so often. (For example, here, here, and here.) We could probably count the posts, but we’ll go with the “one, two, and many” formulation and acknowledge that today is the “many-th” time we’ve addressed a fan letter to Chicago. On Friday, we briefly posted on the case of Robinson v. McNeil Consumer Healthcare, No. 09-4011, Slip Op. (7th Cir. Aug. 11, 2010), where, in an opinion penned by Judge Posner, the Seventh Circuit held that the FDA’s decision not to add a warning to Children’s Motrin was preemptive. Because it’s a Posner opinion, it’s laden with other goodies.
Let’s begin with the facts, which are unspeakably sad. Mrs. Robinson bought Children’s Motrin for her child. Before she did so, she read the label, which said, among other things, “Stop and see a doctor if an allergic reaction occurs.” Several months later, Mrs. Robinson took the Children’s Motrin for her headache. When she awoke the next morning, she noticed a rash on her chest. That night, she took more of the Motrin. She did not reread the warnings. The next morning she went to her doctor, who gave her allergy medications. She told him she had taken Children’s Motrin; he did not react. The rash got worse, not better, sprouting blisters. That night, Mrs. Robinson took more of the Motrin, again without reading the warnings. The next morning, with “her condition deteriorating rapidly,” she went back to her doctor. Robinson, Slip Op. at 3. This time, her doctor diagnosed her with a severe form of Stevens-Johnson syndrome (specifically, “SJS/TEN”), a rare, life-threatening disease. Mrs. Robinson survived, “but sixty percent of her skin sloughed off, and she lost the vision in one eye and has only limited vision in the other … she is expected to go blind eventually.” Id. at 4.
Posner understates things when he says these are “unhappy facts.” Id. It would be hard to find anyone — including any juror — who wouldn’t feel enormous sympathy for Mrs. Robinson. At trial in a case like this, a defense lawyer needs to model for the jury how to express sympathy while still supporting a defense verdict. In fact, it seems that the defense counsel in this case managed to do exactly that, though one expression of sympathy created a thorny issue on appeal. More on that later.Continue Reading There’ll Always Be Posner — Part “Many”

Courts tend to overreact to Supreme Court decisions. The Supreme Court rules for a plaintiff on a specific ground and suddenly lower courts overwhelmingly rule for plaintiffs who bring even remotely similar claims. Eventually the right case works its way back to the Court, which holds that plaintiffs don’t always win, as anyone reading the…

Herrmann’s time-delayed comments about blogging reminded us of his practice of periodically surveying the law review literature for articles on our favorite topics. We did, and we found the exercise discouraging.
We first looked for recent scholarship on Wyeth v. Levine. We last reported on the scholarship on Levine in October. In days…

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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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