January 2012

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This is the Drug and Device Law blog, but sometimes we discuss cases that do not involve drugs or medical devices. We do so when the cases offer some sort of principle or object lesson that might prove useful. Such is the case with Kidd v. Conagra Foods, Inc., 2012 U.S. Dist. LEXIS 2725 (N.D. Ga. Jan. 9, 2012). It is from the peanut butter MDL.
Truth be told, we’ve always loved peanut butter. It’s a yummy source of protein. It also carries a whiff of nostalgia. It seemed to the Drug and Device Law Toddler that a peanut butter and jelly sandwich was an absolutely unimproveable lunch item, especially with the chunky version of peanut butter. Our dietary proclivities have acquired more sophistication over the years, but old habits and tastes die hard. Once we were defending a criminal case and the prosecutor proposed to resolve the case by giving us a PBJ. Wow – not only would our client avoid jail time, but we’d get a scrumptious snack out of the deal. Turns out we were right about no jail time, but wrong about the culinary component — PBJ meant “probation before judgment.” Like peanut butter itself, the outcome seemed bittersweet.
Peanut butter is more complicated now. The peanut allergy is far and away the most common serious adverse food reaction. About one percent of kids are allergic to peanuts, and today the use of peanuts and peanut butter in schools is subject to all sorts of restrictions. The Drug and Device Law Daughter told us that there’s either one peanut-butter-friendly table or one no-peanut-butter table at her school cafeteria — we cannot remember which it is. Either way, it’s nothing like our simple peanut butter days (definitely not salad days) munching PBJs en masse during the Johnson administration. Who knew that peanut butter would become the stuff of product liability?
The Kidd case is not about an allergy. Instead, it is a personal injury action where the plaintiff alleged that he contracted salmonella from peanut butter. (And not just any salmonella — Salmonella Tennessee. Query whether a state wants a disease strain named after it. This is hardly Chamber of Commerce stuff.) The defendants filed a motion for summary judgment, which was denied because the testimony of the plaintiff doctor expert “created an issue of fact as to the cause of the Plaintiff’s illness.” 2012 U.S. Dist. LEXIS 2725 at *20. The court then ordered that the allegedly contaminated peanut butter be tested. Guess what? It tested negative for salmonella. That should end the case, right? Would you be surprised to learn that the plaintiff expert explicitly based his opinion “on the assumption that the Plaintiff’s peanut butter was contaminated”? Id. at *21. Would you be surprised to learn that the plaintiff expert testified that if the peanut butter in question “tested negative for salmonella, he would change his opinion.”? Id. at *22.Continue Reading When an Expert Spreads it on Too Thick

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We’ve been blogging now, with one lineup or another, since November of 2006 – over five years.  As we’ve said on a number of occasions, such as here, our philosophy has always been that a rising tide lifts all boats.  It’s the nature of stare decisis (that earlier court decisions are the precedent on which later decisions rest) that defense wins anywhere tend to help other defendants everywhere.  We thus strive to keep the pharmaceutical/medical device defense community abreast of new decisions, new arguments, and (when we’re lucky) new strategies that can help win cases.
We’re big firm lawyers.  We have big firm clients and big firm resources.  Not everybody is or does.  But cases not involving big/big/big can be every bit as important as those that do.  For instance, the two major product liability cases that established the (we’d say unfortunate) course of strict liability here in Pennsylvania are Azzarello v. Black Brothers Co., 480 Pa. 547, 391 A.2d 1020 (1978), and Berkebile v. Brantly Helicopter Corp., 462 Pa. 83, 337 A.2d 893 (1975).  Everyone who’s heard of the Black Brothers Co. or the Brantly Helicopter Corp. other than in connection with these cases raise your hands.
We thought so.
Those cases handled for those clients have screwed up the law in Pennsylvania since before some of us started practicing it.  We don’t think Pennsylvania’s unique.  The Fortune 500 and the AmLaw 100 aren’t anywhere near all that matters.
Thus, as much as we want to reach – and be thought well of by – our big firm colleagues around the country (and globe), we believe it’s probably even more important to reach the folks in the regional firms, and defending the smaller companies, who are involved in prescription medical product liability litigation.  Because those folks, and their clients, might not have the resources to do the kind of comprehensive research that we’re used to, we try to make what we do on this blog as helpful as possible, and we have even taken research requests on occasion.  That’s probably the chief reason we keep our scorecards and cheat sheets.  These concern important or current subjects, and provide (we hope) comprehensive and up-to-date legal research that anybody can use and craft to their particular cases.Continue Reading Who Are We/What Can We Do?

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Because of Dechert’s involvement in Reglan litigation, we can’t say as much as we’d like to (or used to) about so-called “Conte” liability – that is theories by which plaintiffs who only took generic drugs attempt to impose liability on the manufacturer of a branded bioequivalent that they neither bought nor consumed.  As

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As we’ve mentioned before, the supposed “parallel violation claim” exception to medical device preemption has been frustratingly vague.  That’s because it originated in a complaint’s vague language that Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996) – decided on a motion to dismiss – speculated might have stated such a claim.  A single paragraph

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            When last we left Boles v Merck, the case had been tried twice and the trial court had certified for appeal its decision denying defendant’s motion for judgment as a matter of law or in the alternative for a new trial.  In denying the defense motion, the court saw fit to reduce the

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For this one, we go to the wisdom of Homer:
(Lisa)      “I’m going to become a vegetarian”
(Homer)  “Are you saying you’re never going to eat any animal again? What about bacon?”
(Lisa)      “No”
(Homer)  “Ham?”
(Lisa)      “No.”
(Homer)  “Pork Chops?”
(Lisa)      “Dad, those all come from the same animal.”
(Homer)

Photo of Stephen McConnell

In football the referees will occasionally change bad calls. Maybe it takes a videotape with unambiguous ocular evidence, but errors can get fixed. By contrast, it’s beastly hard to get judges to change their minds. We recall one instance so clearly because it stands out in our experience. When we were clerking on the U.S. Court of Appeals one of our jobs was to review petitions for reconsideration. They seldom detained us very long. The petitions merely rehashed losing arguments and supplied no real reason to revisit the court’s ruling. But one time one of the judges took an interest, convened a conference call of all three judges plus their clerks, and announced that “we’ve blown it.” The court ended up changing its mind. That judge, by the way, is now on the U.S. Supreme Court, and it is more than a little comforting to know that at least one of the Justices is so devoid of ego and dogma and is truly open-minded and conscientious.
That sort of thing is agonizingly rare.
We’ve been keeping a Mensing scorecard, watching what lower courts have done with generic plaintiffs’ efforts to circumvent preemption. One of the early cases we covered was Fisher v. Pelstring, C.A. No. 4:09-cv-00252-TLW (D.S.C. Sept. 30, 2011). The district court declined to dismiss the complaint, holding Mensing preemption inapplicable because the plaintiff argued that the generic defendant did not timely incorporate in its metoclopramide label certain FDA-approved warnings that were added to the brand label. We blogged about Fisher here. Subsequently, the plaintiff filed an amended complaint. Defendant, PLIVA USA, then filed a motion to dismiss the First Amended Complaint and, in the alternative, requested the court to reconsider its September 30, 2011 order. Dear reader, we have some involvement in metoclopramide litigation, so we must confine ourselves to reporting what happened. We will do so with clenched teeth and pounded keyboard. A copy of the Fisher court’s new order can be found here.
First, the good news. The court did change its mind on one point and dismissed the claim for manufacturing defect. In its earlier ruling refusing to dismiss that cause of action, the court had “reasoned that the evidence of record supported a finding there was an issue of fact as to whether an error in the manufacturing process caused the 2003 or 2004 changes to the Reglan labeling to not be included on PLIVA’s metoclopramide labels.” Slip op. at 13. That was then and this is now. In its new motion, PLIVA observed that “the plaintiffs’ allegations in the First Amended Complaint focus on the product, not the product labeling. For their manufacturing defect cause of action, the plaintiffs allege that ‘defects in the products were caused by the way the products were manufactured.’” Id. (emphasis in original). That point seems unanswerable. And, indeed, the plaintiffs did not respond to it. Additionally, “the plaintiffs provided no evidence showing that the metoclopramide Mr. Fisher ingested deviated in some way from its design specifications or that it was rendered unsafe by an error in the manufacturing process.” Id. at 14. It is not clear why that was not perfectly obvious back in September. Oh well — better late than never.Continue Reading After Further (Careful) Review

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Because it applied implied preemption, the decision in PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011) is powerful.  We’ve previously mentioned how we think Mensing’s principles might be invoked in some claims against non-PMA medical devices, where express preemption is precluded by Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996).

We