Direct To Consumer Advertising

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

Last week we mentioned the decision in Watts v. Medicis Pharmaceutical Corp., 2015 Ariz. App. LEXIS 12 (Ariz. Ct. App. Jan. 29, 2015) in a breaking news post when it first hit the wires and promised more detail would follow.  Well that day has come.

We take a lot of abuse here in New Jersey:  waste dumps, wise guys, Jersey Shore; Chris Christie.  But as drug and device products liability lawyers in New Jersey, we bear another burden — Perez v. Wyeth Laboratories, Inc., 734 A.2d 1245 (N.J. 1999) – the decision that makes New Jersey the only state to adopt a direct-to-consumer (“DTC”) exception to the learned intermediary rule (putting aside West Virginia’s use of DTC as an excuse for rejecting the rule altogether).  But it is a burden we are more than happy to bear on our own.  Texans managed to dodge a bullet and avoided joining our ranks in 2012.  And the DTC issue has been rather quiet in our world in the last few years.

Unfortunately, in Watts an Arizona intermediate appellate court has decided to see whether it wants to keep New Jersey company.  Arizona is one of the relatively few states where the highest court has never passed on the learned intermediary rule.  But heretofore, its appellate courts have gotten it right – adopting and applying the doctrine.  That is, until now.


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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.
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It seems like litigation over TNF inhibitors (used to treat auto-immune conditions) consistently presents extremely interesting legal issues.  After all, it was a TNF inhibitor (Remicaid) case that produced our #1 2012 decision, Centocor, Inc. v. Hamilton, 372 S.W.3d 140 (Tex. 2012).  Another TNF inhibitor, Humira, also produced a couple of very bloggable recent opinions.

Now we’ve found another one, DiBartolo v. Abbott Laboratories, 2012 WL 6681704 (S.D.N.Y. Dec. 21, 2012). While not complete a win as the previous three, DiBartolo did get the big things right.  DiBartolo presents the standard medical profile of TNF inhibitor litigation.  Plaintiff is prescribed a TNF inhibitor to treat an auto-immune disease (here, severe psoriasis) and is later diagnosed with a form of cancer (here, non-melanoma skin cancer – on the tongue).  That’s because “TNF” stands for “tumor necrosis factor” – meaning a substance that kills (necrosis) tumors. If you “inhibit” that (which also reduces the inflammation characteristic of autoimmunity), you inhibit something that the body uses to fight cancer.  Do that, and the risk of cancer goes up.

If even we can explain the science in a couple of sentences, then you can bet that the risk is well-known and warned about.  DiBartolo, 2012 WL 6681704, at *2 (detailing extensive “malignancy” warnings – specifically including non-melanoma skin cancer).  Indeed, with respect to psoriasis, the FDA even imposed a requirement that the defendant manufacturer “publish a Medication Guide to inform patients directly of Humira’s risks.”  Id. at *3.  This booklet also warned specifically about non-melanoma skin cancer.  Id.

However, this particular plaintiff, who had “struggled with psoriasis periodically throughout her life,” only took Humira after trying several other therapies – including something called “PUVA” (which involves UV light).  As anybody who’s ever had a sunburn knows, UV exposure can kill skin cells (for those fortunate enough to have avoided the annoying “heartbreak of psoriasis” commercials of yesteryear, it’s a skin disease).  DiBartolo, 2012 WL 6681704, at *1.

Despite both physician- and patient-directed warnings about the precise type of cancer the plaintiff suffered, plaintiff sued anyway.  New York law applied in DiBartolo.  Id. at *5. The defendant moved to dismiss, hoping to blow the entire complaint right out of the box.  Eight theories of liability were at issue: negligent and strict liability variants of warning, design and misrepresentation claims (3 x 2 = 6), and express and implied warranty.  Id. at *6.


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In his role as amicus curiae for the Product Liability Advisory Council (“PLAC”) Bexis is now two for two since moving to Reed Smith – of course that also means that somebody else is doing the really heavy lifting, in this case Randy Roach of Roach & Newton and Gene Williams and Manuel Lopez of Shook Hardy.  Today the Texas Supreme Court, in a landmark (there goes Bexis breaking his arm patting himself on the back again) 55-page unanimous decision, the Texas Supreme Court held the following:

(1) the learned intermediary doctrine generally applies within the context of the physician-patient relationship, and a prescription drug manufacturer fulfills its duty to warn its product’s end users by providing an adequate warning to the prescribing physician; (2) the [lower court] erred by adopting a DTC advertising exception to the doctrine; (3) the learned intermediary doctrine is not a common-law affirmative defense, but a common-law rule and its applicability was not waived by [defendant]; (4) [a] non-prescribing, treating physician, owed no duty to warn [plaintiffs] of the risks associated with [the drug] beyond the risks directly attributable to the infusion process; (5) because all of [plaintiff’s] claims are premised on [defendant’s] alleged failure to warn, the learned intermediary doctrine applies to all of their claims; and (6) [plaintiffs] failed to introduce any evidence that the allegedly inadequate warning was the producing cause of [plaintiffs’] purported injuries.

Centocor, Inc. v. Hamilton, No. 10-0223, slip op. at 55 (Tex. June 8, 2012).


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We blogged about the highly suspect decision in Centocor, Inc. v. Hamilton, 310 S.W.3d 476 (Tex. App. 2010), and last month awarded it the dubious honor of our #4 worst drug/device decision of all 2010.

Well, that isn’t all we’ve done. We (well, Bexis) submitted an amicus brief in Hamilton in the Texas Supreme Court earlier this week.  Doing that required us to sit down and think about the supposed (except in New Jersey) “DTC (direct to consumer) exception” to the learned intermediary rule – more than we had before (which was relatively little). And it just so happened, that when we exercised our brains, we came up with more thoughts.

As we mentioned in the earlier post, the first problem with Hamilton was that it wasn’t even a DTC advertising case.  Instead, it was a situation where the defendant provided patient-friendly material (a videotape) to the doctors and those doctors had the final say in whether the plaintiff ever saw the material.

Our gut reaction then was that this sort of professionally-mediated information wasn’t what anybody really considered DTC advertising.  Now, having looked at that question further, we know we’re right.  Why?  Well, for one thing the FDA says so.  The Agency itself doesn’t consider a videotape (or anything else) provided to a physician for the physician use with patients (or otherwise) to be DTC advertising – or “advertising” at all.

Nope.


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Not too long ago the FDA unveiled a proposed rule that would revise the way in which DTC (direct-to-consumer) drug advertising would have to deal with contraindication and side effect information.  We thought our readers would like to know (if they didn’t already).  But because we’re lazy – and it’s late on a Friday afternoon 

We spoke recently to an in-house lawyer at a generic drug company.

(Aw, c’mon, innovator clients! You can’t fire us for that! Surely we’re allowed to talk to the guys, even if we can’t represent ’em.)

The generic guy was outraged that Representative Waxman wants Congress to pass a bill barring direct-to-consumer advertising for