Today we give you something rare from the Philadelphia Court of Common Pleas — a defense win on preemption. The Philadelphia CCP has been the source of some rather vexing decisions over the years and has certainly taken its share of criticism. Criticism that we think has been rather overstated. Don’t get us wrong, we’ve vehemently voiced our disapproval of several Philadelphia CCP decisions over the years. But there are plenty of times when Philadelphia judges get it right. That happened two weeks ago in Caltagirone v. Cephalon, Inc., 2017 WL 1135576 (Pa. CCP Mar. 23, 2017).

Plaintiff was prescribed an opioid medication to treat his migraines. The drug was approved for use to treat pain related to cancer, so the prescription was off-label. We use that term a lot, but it is worth stopping to remind ourselves what that really means. The FDA-approved labeling for the drug says its intended use is for treating pain in cancer patients. In other words, that was the patient population in which the drug was studied and the data presented to and examined by the FDA and therefore, the indication for which it was approved. Once a drug or device is on the market, however, doctors, who are not governed by the FDA, are free to use those products for any reason they find is medically necessary. Indeed, much of what we know today about drugs and devices comes from physicians using them in the field in ways that they were not originally intended (aspirin as a blood thinner being among the most well-known example). When you break it down like that, it is not surprising that doctors treating patients with migraines who have not been receptive to standard treatments would look to alternative pain medications, such as an opioid with proven success in alleviating pain in cancer patients. In this context, the drug is still being used to treat pain, just a different type of pain.

Back to Caltagirone. The opioid prescribed to plaintiff, in addition to being labeled for use with cancer patients, was also known to be highly addictive. Id. at *1 & 5. The drug was prescribed to plaintiff for 7 years during which time he was in and out of drug treatment programs due to opioid and other drug addictions. Plaintiff ultimately died from his drug addiction. Id. at *1.

Plaintiff’s claims were for negligence, fraud, misrepresentation, and violation of the UTPCPL. The basis for each claim was an allegation that defendants illegally promoted the drug for off-label uses, which was forbidden by the FDA. Id. at *2. The first thing the court does is negate plaintiff’s premise by holding that “generally off-label sales, promotions and prescriptions are proper.” Id. at *3. Further, at the motion to dismiss stage, the court had to accept as true the material facts pleaded by plaintiff. But a critical material fact was missing from plaintiff’s complaint – any allegation that any off-label promotion was false. A false or misleading statement or omission is a requirement for each of plaintiff’s claims under state law. However, plaintiff only alleges that defendants marketed the drug off-label, not that that off-label promotion was false in any way. Because there is no state-law duty to avoid off-label promotion, plaintiff’s claims “could not exist in the absence of federal laws and regulations.” Id. In other words, plaintiff is suing “because the conduct of promoting the drug for migraine headaches violates the FDCA,” not because defendant has breached any state-law duty. Therefore, plaintiff’s action is a private attempt to enforce the FDCA; the type of action that is barred by Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001).

While the court dismissed the case with prejudice as preempted, because defendants also asserted that it was barred by the learned intermediary doctrine, the court addressed that issue as well.

Plaintiff argued that the doctrine should not apply because plaintiff’s doctor was not learned because he was given “misinformation” by defendants. Id. at *4. The court saw that for the disingenuous argument that it was. Not only did the prescribing doctor have access to the risk and precaution information provided by defendants and his own medical training and judgment – in this case, the doctor had “actual knowledge” that his patient had become addicted and continued to prescribe the drug for many years. Id. at *5. The physician is the customer under the learned intermediary rule. Id. And it is the physician’s “duty to read and consider the materials from [other medical sources] and writings from the Defendant manufacturers.” Id. The fact that the prescriber may also have read or seen off-label promotion, didn’t change the fact that it was his duty to use all his training and experience, combined with his personal knowledge of the patient, which here included knowledge of addiction (the harm complained of), to treat the plaintiff. The court usefully also noted that the treater has a duty to know what other medications the patient is taking. Id. Keep in mind this strong statement of the learned intermediary’s duty the next time you are arguing this issue in Philadelphia.

Back in October we posted about the Eastern District of Pennsylvania decision McLaughlin v. Bayer Corp, 2016 U.S. Dist. LEXIS 37516 (EDPA Mar. 22, 2016) saying that while we liked the ultimate result – tossing out most of plaintiffs’ claims – some pieces of the decision weren’t as strong as we would have liked. Well, McLaughlin’s back and it’s still not a slam dunk, but plaintiffs’ don’t have too much left of their cases either.

As a reminder, this is actually a decision in 5 cases each alleging injury from plaintiffs’ use of a Class III, PMA contraceptive device, Essure. McLaughlin v. Bayer Corp., 2017 WL 697047, at *1 (E.D.Pa. Feb. 21, 2017). Several of plaintiffs’ original causes of action were dismissed with prejudice, but they were given an opportunity to amend to try to salvage their claims for negligent training, negligent risk management, breach of express warranty, fraudulent misrepresentation, and negligent manufacture. Negligent misrepresentation and failure to warn premised on failure to report survived the first motion to dismiss.

The decision methodically goes through each cause of action.

Negligent Training: In its first decision, the court opined it was possible to state a parallel claim for negligent training, but since plaintiffs failed to specify how defendant’s training deviated from federal training requirements or how those deviations caused plaintiffs injuries, the claim had to be dismissed as insufficiently pled. Id. at *3. In the amended complaint, plaintiffs alleged 6 such failures by defendant. As to 3, the court couldn’t find any federal directive that required defendant to do what plaintiffs alleged it failed to do. So, as to those 3 allegations, the claim was dismissed as expressly preempted. Id. at *4-5. As to the remaining 3 alleged violations, defendant challenged them on causation grounds but was unsuccessful. The court found the complaint sufficiently alleged that because defendant failed to properly train the doctors, the doctors in turn did not properly place the device causing it to migrate and cause plaintiffs’ injuries. Id. at *5. The complaint, however, lacked any specific allegations about the actual doctors who performed plaintiffs’ surgeries. The court didn’t find that fatal at the pleadings stage – that was for discovery. Id. at *6. But if you look at what the 3 bases for the failure train claim are, they appear to all be things plaintiffs could have asked their doctors about before filing these lawsuits. Did the doctor successfully complete 5 preceptorings? Did the doctor read and understand the training manual? Did the doctor successfully complete the simulator training? If the answers to those 3 questions are yes in each case – this claim is over.

Continue Reading PMA Preemption Revisited in Pennsylvania

It’s been two years since we applauded the downfall of Azzarello in Pennsylvania. Two years since the Pennsylvania Supreme Court ruling in Tincher v. Omega Flex, Inc., 104 A.3d 328 (Pa. 2014). Two years since we opined that we didn’t think Tincher changed Pennsylvania law applicable to prescription medical products much at all. After all, Hahn v. Richter, 673 A.2d 888 excluded prescription medical products entirely from Azzarello strict liability twenty years ago, so Tincher’s reworking of strict liability shouldn’t be of much consequence. And, our prediction has largely held true. We really haven’t mentioned Tincher much since here on the DDL blog, other than to point out the serious flaws in plaintiffs’ attempts to argue that Tincher somehow altered Pennsylvania’s negligence-only standard for prescription medical product litigation and that plaintiffs’ theory had been rejected by the first courts to consider it.

Now, two years later, we have to report that a Pennsylvania federal court used Tincher to allow a strict liability manufacturing defect claim to proceed in a medical device case – in what we view as a misconstruction of both Tincher specifically and Pennsylvania products liability law (especially post-Lance) generally.

The case is Wagner v. Kimberly-Clark Corp., slip op., No. 16-4209 (E.D. Pa. Dec. 1, 2016). During the installation of a feeding tube, a piece of the tube came off in plaintiff’s stomach and she had to undergo several procedures to have to have it removed. Wagner, slip op. at 2-3. Plaintiff’s complaint brings claims for negligence, strict liability, and breach of warranty. Defendant moved to dismiss the latter two claims. Id. at 1. Plaintiff did not oppose dismissal of the breach of warranty claim. Id. at 13. As for strict liability, the court dismissed strict liability design defect and failure to warn on the ground that neither is allowed under Pennsylvania law for prescription medical products. Id. at 6 n.3. But the court was unwilling to find the same was true as to plaintiff’s strict liability manufacturing defect claim.

Continue Reading Pennsylvania Federal Court Uses Tincher to Find Claim for Strict Liability Manufacturing Defect in Medical Device Case

Sometimes we take routine things for granted. We don’t appreciate the taste of our morning coffee, it’s just always there. We don’t appreciate the softness of our favorite college sweatshirt, it’s just always been that way. We don’t appreciate that while watching an episode of The Walking Dead and seeing a familiar face we can IMDB and find out we recognize the actor from a 3-episode storyline on Law & Order from the late 1990s. That last one hasn’t always been available, but it’s getting harder to recall what it was like to not have that answer until it woke you from a sound sleep at three in the morning.

In the legal world we take things for granted too. We talk about things like breach, duty, causation, and on this blog, preemption, so routinely, we do start to gloss over them a bit. TwIqbal, Daubert, Buckman. Routine, routine, routine. And for sure, learned intermediary fits into this category of things we know about, we like, but maybe take a bit for granted. For many of us, it’s been part of drug and device law our whole careers given that the term was first coined in 1966 by the Eighth Circuit in Sterling Drug Inc. v. Cornish, 370 F.2d 82, 85 (8th Cir. 1966). So sometimes, it’s good to be reminded just how important it is.

That is what today’s case is all about. In Bock v. Novartis Pharmaceuticals Corp., 2016 U.S. App. LEXIS 18042 at *1 (3d Cir. Oct. 5, 2016), decedent’s family alleged that the defendant failed to adequately warn decedent’s doctors that its drugs Aredia and Zometa contribute to the risk of developing osteonecrosis of the jaw (“ONJ”), which decedent developed following multiple tooth extractions and other dental procedures. The court’s decision starts out with a recitation of the warnings that accompanied the drugs as well as additional warnings distributed by the defendant via “Dear Doctor” letters. Those warnings, which pre-dated decedent’s prescription and use of the drugs, included information such as that ONJ had been reported in patients using the drugs, mostly associated with dental procedures like tooth extractions and that invasive dental procedures should be avoided. Id. at *2-3. We know we come at this from the skewed perspective of drug and device defense counsel, but the warning seems fairly clear to us.

Continue Reading Aredia/Zometa Plaintiff Can’t Avoid Learned Intermediaries

This post does not involve a drug/device case – or even a tort case − but counsel worried about potentially abusive litigation funding should take a look at WFIC, LLC v. Labarre, ___ A.3d ___, 2016 WL 4769436 (Pa. Super. Sept. 13, 2016), in which a statewide appellate court, in a precedential decision, invalidated a litigation funding agreement as “champertous.”

WFIC involved commercial litigation. The underlying litigation is not important, except for its being extensive and expensive, and that the result was a significant verdict (low eight figures) – but not the nine-figure whopper that the plaintiffs had been hoping for.  2016 WL 4769436, at *1.

After entry of judgment, to keep the litigation going during the appeal, the plaintiff’s lawyer rejiggered his own fee arrangement so that various litigation funders, who had previously advanced funds, would be paid out the lawyer’s contingent fee.  Id.  The funds from the eventual satisfaction of the affirmed judgment were insufficient to satisfy obligations to the various litigation funders, the expectations of the original plaintiff (WFIC was an assignee of the original plaintiff, id. at *3 n.10), and also provide counsel with a fee.  Id. at *2.  As a result, various parties sued various parties.  Id. at *3.  The appeal in question pitted plaintiffs’ counsel against the world over whose priorities (if any) in the remaining funds were superior to his under the litigation funding agreement.  Id.

The Superior Court didn’t decide the priority question.  Instead the three-judge panel unanimously declared the litigation funding agreement itself “champertous,” and therefore void and unenforceable by anyone.  WFIC, 2016 WL 4769436, at *5 (“we conclude that the 2008 Fee Agreement is champertous and, therefore, invalid”).  In Pennsylvania, “champerty” is defined as:

[T]he unlawful maintenance of a suit in consideration of some bargain to have a part of the thing in dispute or some profit out of the litigation. . . . An agreement by a stranger to defray the expenses of a suit in which he has no interest or to give substantial support and aid thereto in consideration of a share of the recovery or the proceeds thereof is condemned by the courts as champertous[.]

Id. (emphasis added) (discussion of “maintenance” – essentially the same thing without a written agreement – omitted).  “[T]he common law doctrine of champerty remains a viable defense in Pennsylvania.”  Id.

Continue Reading Litigation Funding Contract Invalidated as Champertous in Pennsylvania

The U.S. Supreme Court’s game-changing Bauman opinion in 2014 has us writing a lot on personal jurisdiction.  A while back we marveled over how quickly lower courts have responded to Bauman.  We had anticipated that it would take the passage of an entire generation of lawyers and judges steeped in International Shoe for Bauman’s more disciplined concept of general personal jurisdiction to take root.  The actual results have been better than we expected.  There have, however, been some bumps in the road.  There was the California Supreme Court’s aggressive take on specific personal jurisdiction in Bristol-Myers Squibb Co. v. Superior Court, where the court expanded this prong of personal jurisdiction beyond recognition.  The court essentially slapped the “specific jurisdiction” label on concepts of general jurisdiction that the U.S. Supreme Court overruled.  We discussed that case here.

Another open battlefield is jurisdiction by consent, and a district court in Pennsylvania recently entered an order favoring consent that again stretches personal jurisdiction beyond Constitutional limits.  The case is Bors v. Johnson & Johnson, No. 16-2866, 2016 U.S. Dist. LEXIS 128259 (E.D. Pa. Sept. 20., 2016), and the district court in Bors held that a foreign corporation consented to general personal jurisdiction in Pennsylvania merely by registering to do business in Pennsylvania. Id. at **1-12.  It was undisputed that the corporation had no other contacts with Pennsylvania and that the plaintiff’s action arose from commercial transactions that occurred outside that commonwealth.  In this district court’s view, the foreign corporation registration alone justified subjecting the corporation to general personal jurisdiction in Pennsylvania, i.e., personal jurisdiction over any dispute whatsoever, no matter the subject matter.

The district court was not writing on a clean slate. Since Bauman, several courts have considered consent to jurisdiction, and most have decided that registering to do business does not alone constitute consent to personal jurisdiction.  A notable example is Brown v. Lockheed-Martin Corp., 814 F.3d 619 (2d Cir. 2016), where the Second Circuit rejected “jurisdiction by consent” based on business registration and which prompted us to create our post-Bauman jurisdiction scorecard (including all consent cases), which you can find here.  The Second Circuit rejected general personal jurisdiction because allowing jurisdiction though “routine bureaucratic measures” would rob Bauman of any meaning by way of a “back door thief.”  814 F.3d at 640.  Nice.  In another major decision, the Delaware Supreme Court relied on Bauman to reverse its older decisions that had recognized jurisdiction by consent. See Genuine Parts Co. v. Cepec, 137 A.3d 123, 144-48 (Del. 2016).

For the district court in Bors, there was one fact that trumped everything else, including Bauman’s due process analysis:  Pennsylvania’s statute “specifically advis[ed] the [foreign corporation] registrant of its consent to personal jurisdiction through registration.” Id. at *2 (citing Pa. Consol. Stat. Ann. § 5301).  From this manifestation of “consent,” the district court found general personal jurisdiction and held that “general and specific jurisdiction principles applying to non-consensual personal jurisdiction do not apply.” Id.

Continue Reading Pennsylvania’s Long Arm Overreaches The Constitution And Bauman

We’ve blogged before about the long-running appeal in the Polett v. Public Communications litigation.  That’s the case where the plaintiff had knee implant surgery that was so successful she agreed to make a promotional video on behalf of the company – but allegedly reinjured her knee during the making of the video.  We pointed out, at the very beginning of our first post, that the plaintiff “frankly, wasn’t all that badly injured” but nonetheless received $27.6 million from a Philadelphia jury.

In the end, that was the reaction of the en banc Pennsylvania Superior Court as well. Last month, in Polett v. Public Communications, Inc., 2016 WL 3154155 (Pa. Super. June 6, 2016), the court (on remand from the Pennsylvania Supreme Court) threw out that whopping verdict because it was just too much money for not enough injury.  The court ordered remittitur in an unspecified amount. Id. at

First, a procedural note. Although the latest Polett opinion is from the en banc Superior Court, it is nonetheless unpublished, and thus non-precedential.  We’ve often thought that the Superior Court overuses unpublished, non-precedential decisions, but Polett takes things to new heights (or depths).  Now, even an en banc decision – which are ordinarily used to overrule prior Superior Court panel decisions – can be unpublished.  That’s a first, and we hope, a last.

Continue Reading It’s Just Too Much

Samples, samples, samples. We dare you to make it through your local supermarket or bulk supply store without finding at least one table set up asking you to sample the latest offerings from peanut butter to frozen breakfast sandwiches; from hummus to pre-made meatballs; and don’t forget the cheese. And it’s usually more than one. By the time you’re done shopping you can have eaten an entire meal – from salsa to cheesecake. Shopping alone, this doesn’t really present much of an obstacle. Shopping with children, however, and it adds a whole new dimension. Children want to try every sample. In sample size, children love almost everything they taste. So, you then get to listen to “please, please, please” for ten aisles. “I loved it.” “I promise I’ll eat every last frozen pierogi you buy.” In occasional moments of weakness, you say yes. To nobody’s surprise, however, you’re throwing away a nearly full bag of pierogis that you found wedge in the back corner of your freezer 10 months later. Because, what tasted so good in a sample size, simply didn’t have enough flavor to desire an entrée-sized portion.

That’s sort of how we feel about today’s decision, overall it tosses out most of plaintiffs’ claims – we like those samples. But, the decision is long and when you get down to digesting all of it – some of it is a bit hard to swallow.

The case is McLaughlin v. Bayer Corp, 2016 U.S. Dist. LEXIS 37516 (EDPA Mar. 22, 2016). It’s actually five cases with identical complaints all alleging injury from plaintiffs’ use of Bayer’s contraceptive device, Essure. The device is a Class III, PMA device, so Riegel express preemption and Buckman implied preemption are both viable defenses and both were raised by the defendant in response to each of plaintiffs’ twelve claims. That’s part of the problem. Plaintiffs raised novel claims to try to avoid preemption. In fact, none of the specific theories that were allowed to survive preemption have ever actually been recognized by Pennsylvania. So, we’re sure you’re expecting an Erie discussion – but Erie isn’t even mentioned in the decision. Fortunately, TwIqbal was also successfully used by the defense, so plaintiffs really do have to go back to the drawing board on their claims. We hope that after the claims are both stripped down and beefed up, the court will see it left some really indigestible morsels on the table. We’ll take the claims in the order the court did.

Continue Reading A Federal Pennsylvania Decision That We Like in Small Bites

Sometimes it takes an outsider to point out  something that should be blindly obvious.  In this case, that role was performed by a couple of our colleagues earlier this month at the annual ACI Drug and Medical Device Litigation Conference.  They both told us how useful they found the new – adopted in 2015 − Pennsylvania Suggested Standard (Civil) Jury Instructions (“Pa. SSJI Civ.”) on the learned intermediary rule in prescription drug and medical device litigation.  So we thought we’d introduce them to you.  Here they are:

23.00 (Civ) Duty to Warn − Reasonable Care

In the case of prescription [drugs] [medical devices], the manufacturer has an obligation to exercise reasonable care to inform the plaintiff’s prescribing physician about the risks of its product.  Such a manufacturer has a duty to warn about risks of its products that are not generally known, if the manufacturer knew or reasonably should have known about the risks of its product.

23.10 (Civ) Duty to Warn Physicians, Not Patients − Learned Intermediary Rule

A drug or medical device manufacturer only has a duty to warn the [prescribing] [implanting] physician about the dangers of its [drugs] [medical devices].

It does not have a duty to warn patients directly.

If you find that the defendant adequately warned the plaintiff’s [prescribing] [implanting] physician, even if the physician did not transmit that information to the plaintiff, you must find for the defendant on the failure-to-warn claim.

23.20 (Civ) Different Warning

The plaintiff has the burden of proving both of the following:

  1. that the defendant did not adequately warn the [prescribing] [implanting] physician about the risks of its [drug] [medical device], and
  2. that the [prescribing] [implanting] physician would not have [prescribed] [implanted] the [drug] [medical device] if a different warning had been provided.

23.30 (Civ) Physician’s Knowledge − Other Sources

A pharmaceutical or medical device manufacturer that fails to adequately warn the [prescribing] [implanting] physician about the risks of its [drug] [medical device] is not liable if the physician was aware of the risks from medical literature or other reliable sources.

If you find that the plaintiff’s [prescribing] [implanting] physician already knew about the risks of the defendant’s [drug] [medical device] when he or she decided to [prescribe] [implant] it [to] [in] the plaintiff, then you must find for the defendant on the negligent failure-to-warn claim.

Continue Reading Introducing the New Pennsylvania Learned Intermediary Jury Instructions

Warning:  You have heard all this before.

Still reading?  Okay.  But please don’t tell us later that our warning was inadequate and that you would have clicked over to Scotus or Grantland or TMZ if we had been more forthcoming.  As we have mentioned/kvetched what seems like 2814 times before (according to Blogger, that is how many posts we have put up — you’re welcome), most of the drug and device cases we encounter center around an allegation of failure to warn.  And most of those cases are weak and/or incoherent.  Yet most of those cases cost our clients a lot of money, if only because of the dysfunctional, asymmetrical meat-grinder called “discovery”.

Instead of ushering nuisance cases to the exit, too many courts are too inclined to find a purported issue of fact as to whether a warning is inadequate or whether a better warning would have made a difference.  Again, we’ve said it before and will doubtless say it again in the face of judicial obstinacy or lassitude, but courts should insist that plaintiffs state exactly what the warning should have been and show that such a warning would have prompted the doctor to make a different prescribing decision.

Continue Reading Lack of Warning Causation Dooms Aredia-Zometa Case