July 2013

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We were perusing the recent GAO report on electronic drug labeling in our spare time (we’re weird like that).  We found a number of interesting points − such as what the FDA apparently told the GAO about its position on off-label promotion (“[a]ccording to FDA, if a drug manufacturer promotes a drug for off-label uses, such promotion may constitute evidence to support a violation of the [FDCA]”) (emphasis added).  But the most interesting aspect of the GAO study for some of us was its description of the non-labeling information available to purchasers of prescription drugs, mostly through pharmacies:

Patients can receive written drug information provided along with their prescription drugs in the form of CMI [“consumer medication information”].  Unlike prescribing information, Medication Guides, and [patient package inserts], CMI is not approved by FDA, and drug manufacturers do not produce this type of drug labeling.  Instead, it is produced by third parties and distributed to patients at the pharmacy when their drugs are dispensed.  CMI can include information from the prescribing information and can also include additional information not contained in FDA-approved labeling, such as off-label uses of certain drugs. According to officials from third parties that produce CMI, they also use other sources, such as peer-reviewed literature, to develop the information for their CMI.  FDA has not asserted the authority to require third parties to submit CMI for review by the agency before CMI is distributed,
according to agency officials.

GAO Report at 7.

This discussion started us thinking again about the novel – and we would add, reprehensible – assertion of product liability claims against some of the “third parties” mentioned in the GAO’s reports.  We discussed our overwhelmingly negative reaction to so-called “publisher liability” claims back in 2011.  Then, we pointed out that this sort of claim is almost always asserted by plaintiffs for ulterior motives (chiefly joining a non-diverse defendant to prevent removal to federal court), and that no state in the country has affirmatively permitted such a claim.
Continue Reading Revisiting Publisher (Non)Liability

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We talk a lot about the learned intermediary doctrine on this blog. Rightfully so. It is a powerful tool for drug and medical device defendants. In a nutshell, the learned intermediary doctrine says that pharmaceutical companies’ duty is to warn doctors, not patients, about the risks of prescription drugs.It is a recognition of the essential role the physician plays when it comes to prescription drugs and devices. And, while the doctrine inures to the benefit of defendants, it is not an affirmative defense. That is, the plaintiff still bears the burden to prove proximate causation. The plaintiff must prove that the doctor would have made a different prescribing decision if he had the information that plaintiff claims he should have had. And, as an essential element of plaintiff’s case, plaintiff must plead sufficient facts to support his claim that his physician would have acted differently.

That’s where plaintiff in today’s case ran into some trouble. Plaintiff brought a purported class action seeking a refund of what he spent on Avandia alleging that defendant violated Pennsylvania’s Unfair Trade Practices and Consumer Protection Law (“UTPCPL”). In re Avandia Marketing, Sales and Products Liab. Litig., MDL 1871 (Morgan v. Smithkline Beecham Corp.), 2013 U.S. Dist. LEXIS 96774 (E.D. Pa. Jul. 10, 2013). There was no personal injury alleged. Rather, the crux of plaintiff’s claim is that even though Avandia is effective in reducing blood-sugar, because it allegedly carries an increased risk for heart-related disease, the drug “has no health benefit.”Id. at *2-3. The court did not have to get into the substance of the claim, however, because plaintiff failed to allege any facts that would get him around the learned intermediary doctrine. The court also refused to recognize a direct-to-consumer exception to the learned intermediary doctrine. Once again, New Jersey remains a party of one on that issue.

It is worth noting that this was plaintiff’s second attempt to state his claim. The original complaint was dismissed because plaintiff failed to allege, among other things, “what materials or information his physician relied upon.”  Id. at *1.  Plaintiff tried to fix that deficiency by alleging that his physician reviewed defendant’s “marketing and statements.”  Id. at *2.  But that wasn’t enough to cure the fatal inadequacies of plaintiff’s pleading.  Fatal because this time, the court dismissed the case with prejudice.
Continue Reading Learned Intermediary Bars Consumer Protection Claims in Pennsylvania

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We just learned about Pinsonneault v. St. Jude Medical, Inc., No. 0:12-cv-01717-PJS-JSM, slip op. (D. Minn. June 13, 2013).  We think the court’s preemption analysis would be of interest to our readers, but since the defendant is a Reed Smith client (although not in the Pinsonneault case), our description is bare bones, with no…

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This post is from the Dechert side of the blog only. McBride v. Medtronic, Inc., 2013 U.S. Dist. LEXIS 96438 (W.D. La. July 10, 2013), is an opinion in a medical device case, and it is a joy for two reasons, one substantive and the other entirely stylistic. As to substance, it doesn’t allow plaintiffs to muse into existence a state law claim on which to base their parallel violation claims.  As to style, the opinion, written by Judge Trimble, is a smooth and enjoyable read because it doesn’t jam its paragraphs chock full of citations, italics, underlining, parentheticals and other distractions that are best placed elsewhere.

We’ll take the last point first.  Lawyers somehow pride themselves on being the only group of writers and readers who identify their sources in the text. Most professions, industries and for that matter schoolchildren know that a written piece with many sources should identify those sources in footnotes, not the text. Rather than turn paragraphs into a game of visual hopscotch, let the text be the text and identify citations at the bottom of the page where readers can easily find them when they want to.  A written piece – particularly one intended to persuade – should be a clean, crisp trip down the highway.  Not with lawyers.  With them, it’s a herky-jerky ride down Rt. 1 in New Jersey.  There’s a light at every intersection.  You’re forced to constantly be on the look-out for cars entering the road from every direction.  And you’ve got a congestion headache.  Lawyers seem to take pride in the pain they cause themselves, as if developing the skill to quickly read a page-long paragraph that has two actual sentences is something to be proud of.  Law students starting out on law journals seem to understand that this is not the way to do it.  They put citations in footnotes at the bottom of the page.  Then they graduate and become lawyers . . .
Continue Reading McBride v. Medtronic: Of Footnotes and Parallel Violations Claims That Have No Basis in State Law

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Last weekend saw the annual Blobfest celebration in Phoenixville, PA.  Blobfest commemorates the cheesy 1958 horror film The Blob, in which a very young Steve McQueen saves mankind from a growing, hungry goo.  The movie was set not far from our neck of the woods, including The Colonial Theater in Phoenixville, where the Blob…

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Things are not looking good for generic drug product liability plaintiffs after Bartlett.  In New Jersey, Judge Higbee – whom nobody would claim to be a pro-defense judge – has dismissed (on a motion to strike, which is a pleadings-based procedural posture) all claims against generic manufacturers of Isotretinoin (the generic form of Accutane). …

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Several years ago we vacationed in Toronto. Back then, the Drug and Device Law Son split his time between hockey and videogames. He was a goalie, so, like his dad, he was always on defense. We visited the Hockey Hall of Fame, tap-danced on the glass floor in the CN Tower, had dinner at Wayne Gretzky’s restaurant, took in a Maple Leafs game, and wandered around the huge underground mall. With the sort of weather that reigns in the True North, an underground mall (really an entire underground city) makes a lot of sense. We noticed that many of the stores had a slogan on the walls: “The World Needs More Canada.” It’s hard to argue with that. Canada has pretty much everything we like (a nice standard of living, cultural offerings, and poutine), and not so much of those things we don’t like (crime, arrogance, and crocodiles).   How can you not admire a country that has given us Joni Mitchell, Bobby Orr, and Pamela Anderson, as well as the inventors of the zipper, basketball, and Trivial Pursuit?  And we look back with fondness at a college road trip adventure, when we drifted across the border to empty the town of Magog of Molson Brador.  (Bexis points out that Canada is also responsible for the rock groups Rush and BTO.  Hmmmm.  That fact might prompt us to reconsider the whole premise of this paragraph.)

Every once in a while we have the opportunity to blog about drug and device developments north of the border, involving matters also being litigated in the USA. As we said above, there’s a lot to like about Canada.  But its class action law is usually something we don’t like so much.  Canada’s application of class action certification rules is considerably more liberal than the corresponding rules here — excepting, perhaps, certain rogue counties in Southern Illinois.  Nevertheless, we are pleased to relay some good news from the Canadian courts.  Our friends at Covington, specifically Michael Imbroscio, sent us a decision by the Quebec Superior Court rejecting certification (what they call “authorization” in Quebec) of a proposed class action alleging that Accutane (isotretinoin) caused inflammatory bowel disease (IBD), in Lebrasseur v. Hoffmann – La Roche Limitee, (Quebec Superior Court file no. 500-06-000512-109). The decision is in French, which we cannot read (though the Drug and Device Law Son says he can, and even has the grades to prove it), so we are trusting Covington’s summary.  But for those of you who claim the ability to read Proust and Moliere in the original, here is a copy of the Quebec court’s opinion.Continue Reading Quebec Court Denies Accutane Class Certification

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We have seen the news that FDA is preparing a proposed rule to change the regulations to permit generic drug manufacturers (ANDA holders) to update their labels based on post-approval information without waiting for the branded/NDA drug’s label to change.  This seems like a fairly obvious response to Mensing’s preemption of most generic drug labeling claims and the call to a legislative solution by various judges and commentators.

It is for another day whether FDA can actually offer a regulation that both undoes Mensing and makes enough sense within the statutory scheme that can it survive inevitable challenges.  In the meantime, we return to the gap in Mensing that some plaintiffs exploit.

As in many of the decisions on generic preemption and innovator liability over the last several years, Garza v. Wyeth LLC, No. 2:12-CV-00198, 2013 WL 329356 & 3293704 (S.D. Tex. June 28, 2013), involves allegations of “abnormal muscle movements” with long-term use of the generic prescription drug metoclopramide.  Like many of the decisions we have griped about, the plaintiff in Garza was permitted multiple amendments of her complaint, including one after the first set of motions to dismiss had been argued.  Those motions resulted in Garza v. Wyeth LLC, 2013 WL 878586 (S.D. Tex. March 7, 2013), where warning claims—the only type of claim permitted with a prescription drug under Texas law—against two generic manufacturers were preempted “as there are no allegations that their labels were inconsistent with the FDA-approved, name-brand drug labels.” Id. at *4.  The claims against two other generic manufacturers were not preempted because the current complaint alleged that they had failed to update their labels to match the branded labels.  Id.  The court also held that, to get past a motion to dismiss, the complaint need not allege the fraud-on-the-FDA exception to the statutory rebuttable presumption of adequacy for FDA-approved labels was met.  Id. at **4-5.  This followed from the fact that the complaint did not allege that the labels at issue had been approved; rather, it alleged that the same two generic manufacturers that ended up on the wrong side of the preemption decision had “failed to adhere to FDA label requirements.”  Setting aside whether plaintiffs would ever agree that approval of a drug’s label meant that the manufacturer had adhered to “FDA label requirements,” the March decision set the stage for the two in June.Continue Reading The Generic Preemption Door Stays Open, At Least Until The Facts Matter

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Since the unfortunate decision in Wyeth v. Levine, 555 U.S. 555 (2009), successful applications of preemption against warning claims asserted in litigation involving innovator (branded) drugs have been depressingly rare. We were aware of only two decisions since Levine that found sufficient regulatory evidence to conclude that the Levine “clear evidence” standard – apparently unique to FDA-approved drugs – has been satisfied. Those cases were: Robinson v. McNeil Consumer Healthcare, 615 F.3d 861 (7th Cir. 2010) (an OTC case where the FDA had rejected a directly on point citizen’s petition), and Dobbs v. Wyeth Pharmaceuticals, 797 F. Supp.2d 1264 (W.D. Okla. 2011) (where the FDA to this day has held on several occasions that insufficient scientific evidence exists to justify a warning). Now there are three.

Recently, the court in In re Fosamax Products Liability Litigation, ___ F. Supp.2d ___, 2013 WL 3270387 (D.N.J. June 27, 2013), found the “clear evidence” standard satisfied with respect to certain post-2009 warnings – given the relevant FDA regulatory history. The regulatory facts in Fosamax are both a testament to the intensity of the FDA’s review of that product and a caution that preemption standard set (we would say erroneously) by the Court in Levine remains dauntingly high. Post-Levine preemption motions remain a matter of utmost care and discretion, and require (as is the case in Fosamax) a powerful regulatory case.
Continue Reading A Preemption Win For An Innovator Drug

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A key to many drug or device law cases is the learned intermediary doctrine. It can powerful, and so we generally approach it with great care and from multiple angles.  We meticulously develop labeling histories to establish when the label first mentioned the alleged side effect and how and where it was discussed over time.  We do scientific research so that we can show the contemporaneous state of the science, when there was a signal to warn and, just as important, when there wasn’t, and we then match that to the contents of the label.  We lay out the company’s internal and regulatory history to show that it understood and advanced the science and included it, when appropriate, in the label.  And we take testimony of prescribers and treaters to show that they knew the potential side effects, were warned, and/or would’ve made the same decision even today.  When we do this well in discovery, we often feel that we should win summary judgment.

But despite a good discovery record on the learned intermediary doctrine courts sometimes seem unwilling to end a case before trial.  They gloss over which party has the burden of proof.  They can misconstrue the doctrine as an affirmative defense.  They can punt the decision on a seemingly adequate warning to the jury, or ask the jury to consider whether it should have been disseminated differently or better.  We’re sure that many of you have had similar experiences on summary judgment.

With that background, we want to discuss D’Agnese v. Novartis Pharmaceuticals Corp., 2013 U.S. Dist. LEXIS 92757 (D. Az. July 2,
2013).  It involves a plaintiff (and his wife suing for loss of consortium) who claimed to have suffered bisphosphonate-related osteonecrosis of the jaw as a result of using Aredia/Zometa.  While he brought a number of claims, they were all, at bottom, based on failure to warn. And the learned intermediary doctrine played a vital role. The defendant, Novartis, established its labeling history during discovery.  It had placed osteonecrosis in the Adverse Reactions section in September 2003 and revised the language in February 2004 to say that causality could not be determined but it was prudent to avoid dental surgery while on the drug.  In September 2004, Novartis added a three-paragraph discussion of osteonecrosis to the Precautions section.  It sent a Dear Doctor Letter to doctors attaching the revised label.  Id. at *15-18.As for plaintiff, his original prescriber prescribed him Aredia in 1996.  In March 2005 – after all these label changes were put into effect – a second prescriber informed plaintiff of the risk of osteonecrosis, plaintiff signed an informed consent form and, later that year, plaintiff made it clear that he wanted to continue on the drug. Plaintiff’s story was different in litigation.  He claimed no memory of the risk discussion or of signing the informed consent.  In 2005, Plaintiff was tentatively diagnosed with osteonecrosis of the jaw.  Finally, plaintiff’s second prescriber testified that he still prescribes Zometa today and even suggested that plaintiff restart it in 2010.  Id. at *18-19.These facts make this is one of those cases that we feel should be a defense win on summary judgment. But, as we mentioned, we’ve seen courts find the smallest of holes through which to push a trial.  Maybe the plaintiff’s different recollection about being told of the risk is enough for a jury to consider. . . . Or maybe a court could send it to a jury because there was no testimony from the original prescriber, like there was from the second prescriber, that he still prescribes Zometa and suggested that plaintiff restart it . . . . Or maybe there were some adverse events or animal studies that the doctor didn’t know about … Let a jury decide.
Continue Reading An Aredia/Zometa Win Thanks to the Learned Intermediary Doctrine

Drug & Device Resources

Bexis’ Book

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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