November 2013

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We’ve already blogged twice about the patently meritless U.S. ex rel. Watson v. King-Vassel False Claims Act case. In the first post, we pointed out that the apparent premise of King-Vassel lawsuit appeared to be that all prescriptions of drugs for off-label use was ipso facto a “false claim.” That was hardly surprising, since as the opinion we were discussing, United States v. King-Vassel, 2012 WL 5272486 (E.D. Wis. Oct. 23, 2012), pointed out that litigation was “solicit[ed] through the efforts of entities opposed to all use of what purported psychotropic drugs:

The relator .　.　. secured the cooperation of [a patient of the defendant’s] in bringing this suit after meeting an attorney through the International Society for Ethical Psychology and Psychiatry, and doing further research into bringing a qui tam claim through the website PsychRights.org. After researching qui tam false claims actions, [relator] placed an ad in a [local] newspaper soliciting minor Medicaid patients who had received certain medications.

Id. at *1. We were reasonably pleased at the dismissal of the suit, but not particularly impressed, since the dismissal wasn’t based on the suit’s erroneous equation of off-label prescription with “false claims,” but rather on the plaintiff not having a Medicaid legal expert.

Our second King-Vassel post discussed the Seventh Circuit reversing district court and holding that the district court’s expert-based rationale was improper because plaintiff hadn’t been given sufficient notice of it and in any event experts on issues of law aren’t required.  United States v. King-Vassel, 728 F.3d 708, 712-16 (7th Cir. 2013).   Because the District Court had gone off on a tangent, the Seventh Circuit let the suit’s improper legal foundation – that off-label use = a false claim – slide.   The court held that evidence of a physician’s knowledge that an off-label prescription would be reimbursed by Medicare was enough to support the complaint’s allegations of “knowing” conduct. Id. at 713.

That post pointed out that: (1) nothing in the Seventh Circuit opinion approved the suit’s false underlying legal premise, (2) the appellate court all but invited defendant to try again to dismiss the case, 728 F.3d at 717, and (3) the Seventh Circuit agreed with the District Court’s sanctions and condemnation of the manner in which this suit was initiated as “borderline fraudulent” except “we might remove the word ‘borderline.’” Id.Continue Reading King-Vassel, Round Three – Ridiculous Discovery

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Last Friday, we provided our readers with a “breaking news” (that is to say, quick and dirty) overview of the FDA’s just-released proposal to require manufacturers of generic drugs to use the “changes being effected” (“CBE”) process (also referred by the FDA as “CBE-0”) to update their labels in the same fashion as innovator/reference listed drug manufacturers.  That proposal appeared in the Federal Register on November 13, 2013 (pages 67985–67999), and here are links to it online and exactly as it appears in the hard copy of the Federal Register.  The 60-day comment period (unless extended) thus runs from 11/13.  Let’s see, 30 days hath November….  We think that the comment period ends on January 13 (the 12th is a Sunday), 2014.

Today we’re taking a closer look as a couple of places where we think the FDA’s proposal comes up short because it fails to address significant problems.  Those are:  (1) the Agency’s rather terse cost benefit analysis, and (2) the FDA’s failure to evaluate the relevant portion of Hatch/Waxman, 21 U.S.C. §355(j) – or indeed any part of Hatch/Waxman at all − in its analysis of its legal authority to make these changes without any Congressional amendments to the statute
itself.

As far as the merits of the proposal, we’ve already discussed what we think should be done to fix the inconsistent and backwards application of preemption to the FDCA under Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), Wyeth v. Levine, 555 U.S. 555 (2009), and PLIVA v. Mensing, 131 S. Ct. 2567 (2011), so we’re not going over that again.  The FDA didn’t go that route, nor did we expect it to.  Instead, it lunged for whatever it could devise to reduce preemption the most.  We’ll leave to others to comment on why that was the case, but we must admit that we’re disappointed.  For decades the FDA has taken the position that it does not tailor its regulations to affect civil liability:

  • “Tort liability cannot be a major consideration for FDA which must be guided by the basic principles and requirements of the act in its regulatory activities.”  63 Fed. Reg. 66378, 66383 (FDA Dec. 1, 1998).
  • “It is not the intent of FDA to influence the civil tort liability of the manufacturer or the physician.”  44 Fed. Reg. 37434, 37437 (FDA June 26, 1979).
  • “[W]hether particular labeling may alter a manufacturer’s liability in a given instance cannot be considered as a dispositive factor by the Commissioner in reaching a decision.”  42 Fed. Reg. 37636, 37637 (FDA July 22, 1977).

Now, the FDA has done a screeching four-wheel drift 180 and proposes to modify its regulations explicitly for the purpose of changing the scope of civil tort liability – in order to eliminate preemption of generic product liability warning (but not design) claims recognized by the Supreme Court under Hatch/Waxman in Mensing and recently reaffirmed in Mutual Pharmaceutical Co. v. Bartlett, 133 S. Ct. 2466 (2013).  See 78 Fed. Reg. 67985, 67988-89 (FDA Nov. 13, 2013) (discussing “recent court decisions”).Continue Reading A Closer Look At Some Aspects Of The FDA’s Generic Drug CBE Proposal

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California and Mississippi have little in common, but they  both apply the learned intermediary doctrine in prescription drug cases.  Prescription drug manufacturers have a duty to provide adequate warnings in connection with their products, but only to prescribing physicians – the learned intermediaries – and not directly to patients.  We write on the learned intermediary doctrine a lot because it comes up in so many of our cases, and also because it is a sound legal rule that should apply, and should apply consistently.  Toward that end, the Northern District of Ohio recently gave us twin opinions applying the learned intermediary doctrine under the laws of California and Mississippi, and the district court found that the defendants in both cases were entitled to summary judgment.

In Miller v. Ortho-McNeil Pharmaceutical, Inc., 2013 U.S. Dist. LEXIS 158302 (N.D. Ohio Nov. 5, 2013), the plaintiff used a prescription contraceptive patch and experienced a pulmonary embolism, which she attributed to her contraceptive use.  Every physician in the world knows that hormonal contraceptives of this type increase the risk of blood clots, and so did the nurse practitioner who first prescribed the plaintiff’s contraceptive patch.  In fact, the nurse practitioner knew that the product’s warnings “included the elevated risks of blood clot[s].”  Id. at *3.  A second nurse practitioner who prescribed to the plaintiff likewise “was aware that [the contraceptive product] exposed patients to a higher concentration of hormones than typical birth control pills, increasing the risk of thrombotic disease and pulmonary embolism.”  Id. at **3-4.  Even with this knowledge, both nurse practitioners believed the benefits of prescribing the product to the plaintiff outweighed the risks.  Id.

On these facts, the court had little difficulty granting summary judgment on a familiar two-prong basis.  First, the product warnings were adequate under Mississippi law because “Defendants specifically warned of the risk of blood clots.”  Id. at **10-11.  We are sometimes surprised when courts allow failure-to-warn claims to proceed even where the package inserts warn about the exact risk that allegedly befell the plaintiff.  But this court was on the ball and, in our view, came to the right conclusion on these facts.  Second, the court ruled that the plaintiff could not prove causation because “she has not shown that a different warning would have changed the prescribing decision.”  Id. at *12.  This is another refreshingly straightforward holding, and it follows Mississippi’s learned intermediary doctrine to a tee:  The manufacturer owes a duty to warn only the prescribing physician, so if an alleged inadequacy in the warnings had no impact on the prescribing decision, then proof on the essential element of warnings causation fails.  In Miller, both prescribing nurse practitioners knew about the clotting risk, and they prescribed the product anyway.  For her part, the plaintiff had no evidence that a different warning would have made any difference.  Summary judgment granted.Continue Reading Learned Intermediary Rule Applies, with No Exception for Contraception

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Here’s a preemption case that we’ll likely have an opportunity continue to follow.  A magistrate in North Carolina federal court recently issued a report recommending dismissal, on the basis of preemption, of product liability claims concerning the product Gelfoam.  Bradley v. Baxter Healthcare Corp., 2013 U.S. Dist. LEXIS 158935 (W.D.N.C. Oct. 18, 2013).  Gelfoam

…

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We haven’t done anything more than skim it, but we thought our readers would like to know that the FDA released its long-awaited proposal to allow generic drugmakers to use the CBE process to change their labels today – as it common, on a Friday afternoon.  Here’s a link to it.  This is just a preliminary draft that will open the proposal to a comment period.  Here’s the FDA’s description:

We are proposing to change our regulations to expressly provide that ANDA holders may distribute revised labeling that differs from the RLD upon submission of a CBE-0 supplement to FDA.  FDA’s proposed revisions to its regulations would create parity between NDA holders and ANDA holders with respect to submission of CBE-0 supplements for safety-related labeling changes based on newly acquired information.  This proposal is also intended to ensure that generic drug companies actively participate with FDA in ensuring the timeliness, accuracy, and completeness of drug safety labeling in accordance with current regulatory requirements.  If this proposed regulatory change is adopted, it may eliminate the preemption of certain failure-to-warn claims with respect to generic drugs.

FDA, “Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products,” at 16-17 (emphasis added).  Note that, this reference is limited to warning claims, and does not purport to reduce preemption with respect to design defect claims recognized in Bartlett.  Even so, it seems like a huge flip-flop from prior FDA statements in various contexts (some of which are discussed here) that it does not intend to affect civil litigation.  It sure intends to affect it now.
Continue Reading Breaking News – FDA Proposal for Generic CBE Label Changes Released

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We were walking through San Francisco’s Chinatown the other day, and above an otherwise nondescript storefront we saw a sign that said “Fortune Teller.  Tells Past Present and Future.”  We are not sure what is worse:  Someone who claims the clairvoyant power of telling the “past” and “present,” or the poor sap who pays for the privilege of learning where he is and what has already happened to him.  It seems that telling the present would get somewhat tedious and repetitive:  “You are sitting in a second floor apartment in Chinatown across from a woman who looks like Professor Sybill Trelawney from Harry Potter and the Prisoner of Azkaban.  That will be $100 please.”

Now, telling the future — that’s a keen trick, one that we would pay to see, and one that we attempt from time to time here at the Drug and Device Law Blog, such as when we predict (or encourage) the demise of judicial opinions that are particularly wrong headed and/or wrongly decided.  You might have already guessed that we are leading up to yet another post on Conte v. Wyeth, 158 Cal. App. 4th 89 (2008), the wrongly reasoned and wrongly decided opinion from the California Court of Appeal that took the “product” out of “product liability.”  For those not keeping score, Conte held that a drug innovator can be liable for inadequate warnings in connection with a competitor’s generic version of the drug.  That is to say, a drug manufacturer can be liable for injuries alleged caused by a product it did not make and did not sell.  Holy tarot cards!  The fortune teller nearly fell off her chair when she saw that in our past.

Fortunately, Conte appears to have a future no brighter than another notorious California opinion that bent product liability and expanded liability for questionable reasons — Sindell v. Abbott Laboratories, 26 Cal. 3d 588 (1980).  Sindell and its innovation known as market share liability was big news when it came out in 1980, and it was still making waves when we took Torts in law school in the early 1990s.  Today, 33 years after Sindell hit the books, we think it is safe to say that the opinion has had little lasting impact on the product liability landscape, and we doubt that it occupies any space in law school curricula other than as an interesting historical novelty.
Continue Reading New York Rejects “Innovator Liability”: The Future Of Conte Looks Dim

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Potentially the most important Pennsylvania product liability case in a generation was argued before the Pennsylvania Supreme Court on October 15, 2013.  That’s Tincher v. Omegaflex, No. 17 MAP 2013. As we mentioned before, the Pennsylvania high court took Tincher expressly to decide whether current Pennsylvania product liability law, based on Azzarello v. Black Brothers Co., 391 A.2d 1020 (Pa. 1978), and that court’s extremely strict form of strict liability under Restatement (Second) of Torts §402A (1965), should be maintained, or, alternatively, be replaced by the Third Restatement of Torts.  As we’ve also discussed, the Third Restatement’s largely (except manufacturing) negligence basis for product liability would eliminate a number of plaintiff-friendly evidentiary exclusions that have arisen under Azzarello’s progeny.  Tincher is a big deal – even by the standards of Biden-speak.

Bexis filed an amicus brief in Tincher for PLAC, but since the argument was in Pittsburgh, he didn’t attend the oral argument.  The argument, however, was eventually televised, and he has been able to obtain a CD of the proceedings.  We’d post it, but the CD came with a warning from the Pennsylvania Supreme Court that it was not for public use, so we’re not about to get crosswise with the justices.  You’ll just have to settle for our summary. We’re not starting at the beginning.  Rather, we’ll begin at 40:51 on the argument videotape, where counsel argued:

I would not be adverse to Azzarello being overruled; that I do believe that it’s caused headaches. [comment from Justice Saylor omitted]

It’s caused headaches for the Court.  It’s caused headaches for trial courts and I think the time has come for a modification or overruling of Azzarello and moving the courts of our state back to strict liability as it’s followed by other jurisdictions, without these kinds of problems; these kinds of headaches.

This quote wouldn’t be surprising if it had been uttered by counsel for defendant as appellant, seeking to change Pennsylvania law.  But that’s the point − it wasn’t.  The statement we just quoted was made by counsel for plaintiffs as appellee.  When even the plaintiffs’ side (albeit represented by a firm that is often on the right side of the “v.”) is running full tilt away from the Azzarello decision, it’s reasonable to think that “the time has come” for a new day in Pennsylvania product liability law.  It can’t come a moment too soon.

Continue Reading (Somewhat Belated) Report On Tincher Oral Argument

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Have you ever been sitting in a courtroom and wondered why you were there?  We don’t mean that in a metaphysical sense, though that probably happens sometimes, too.  No, we are thinking of the situation where you realize that neither the plaintiff nor the defendant are citizens/residents of the jurisdiction, and that the events in issue did not occur there either.  Why are we here?  This sort of thing happens to us a lot in courtrooms in New Jersey and Pennsylvania.  Of course, there is an answer to the question: that is where the plaintiff filed the lawsuit.  That choice of forum, so we are told by many authorities, is entitled to some respect.  Okay, but how much?  Forum-shopping is not one of the glories of American jurisprudence.  It is a form of lawsuit arbitrage that inflicts inappropriate costs on parties and court systems.  (Of course, some courts have unashamedly promoted themselves as litigation-tourist destinations.) When a plaintiff goes forum-shopping, what is being purchased?  It could be plaintiff-friendly judges, jurors, laws, or procedures.   It is ineluctably unseemly.  Plaintiffs, being plaintiffs, sometimes push things a bit far,  Forum shopping starts to look like forum-shoplifting.

If we had represented the defendant in the recent case of Kuennen v. Stryker Corp., 2013 U.S. Dist. LEXIS 1555571 (W.D. Va. Oct. 30, 2013), we would have wondered why we were in the place where the case was originally filed, the District of Columbia.  The plaintiff, a resident of Virginia, underwent arthroscopic shoulder surgery in Virginia.  The plaintiff received a pain pump made and sold by the defendants, to infuse a local anesthetic into the shoulder joint space.  Now the plaintiff was alleging that the pain pump caused her to lose cartilage in her right shoulder joint.  The defendants were both Stryker entities, which we will call “Corp.” and “Sales.”  Neither was a citizen of D.C.  The pain pump was not designed, manufactured, or sold in D.C. and the alleged injury occurred in Virginia.  The defendants did not simply wonder why they were being hauled into a D.C. court; they successfully moved under section 1404 to transfer the case to the place where it should have been filed, Virginia.  End of forum-shopping, right?

Maybe.  Yeah.  But not without a tussle.  The defendants moved for summary judgment based on the statute of limitations.   The defendants contended that the plaintiffs’ claims were barred by the Virginia two-year statute of limitations.  In opposition, the plaintiffs asserted that the D.C. statute of limitations should apply with its favorable discovery role as to the accrual of the cause of action. The parties agreed that if the Virginia statute of limitations applied, the case would be dismissed, and if the D.C. statute applied, the case would continue, at least for a while.  Why is it even an issue?  The case is in Virginia, right? Not so fast.  When an action is transferred under section 1404(a) from one district court to a district court in another state, the transferee court must apply the same law as the transferor court would have applied.  The forum-shopping effect lingers.Continue Reading No D.C. Personal Jurisdiction = No Loose D.C. Statute of Limitations = No Case

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As always, discussion of the pelvic mesh litigation comes from the non-Reed Smith side of the blog.

This summer we blogged about many pre-trial and in limine rulings in the Pelvic Mesh MDL. Most were quite favorable.  One of those decisions that we thought was pretty good was Cisson v. C.R. Bard, Inc., see post, which threw out a duty to test claim and applied a stringent state-of-the-art standard.  Back in July, we thought that ruling was helpful to the defendant and would serve it well at trial.  Well, we’re clearly not seers.  While we sometimes like to look into our crystal ball, our predictions are usually based on nothing more than wishful thinking (we like to think it’s more than that, but usually it’s not).  The Cisson case went to trial and the jury returned a verdict against the defendant awarding both compensatory and punitive damages.  Defendant moved for judgment as a matter of law during trial and the court deferred until post-verdict.  Unfortunately, the court upheld the verdict and in so doing made some not so great rulings.

A quick background of the case.  Plaintiff underwent implantation of defendant’s pelvic mesh device and began experiencing pain.  Two years later, she had surgery to remove the device, but the “arms” of the device could not be removed.  Plaintiff alleged that she continue to experience pain and evidence was presented that she suffered extrusion, erosion, excessive scarring, and inflammation. Cisson v. C.R. Bard, Inc., 2013 U.S. Dist. LEXIS 149976 at *3-4 (Oct. 18, 2013).  Plaintiff presented two claims to the jury – design defect and failure to warn.Continue Reading A Not So Peachy Decision Under Georgia Law

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