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.Continue Reading Two Out Of Three (Or Thereabouts) Ain’t Bad
We just did. Not only did we suffer through Stengel yesterday, but today we received Weeks – that is Wyeth, Inc. v. Weeks, No. 1101397, slip op. (Ala. Jan. 11, 2013). Alabama just recognized branded liability in a generic case – for fraud not AMELD, and assuming detrimental reliance by the physician. The key
However it’s our case, so the Reed Smith side can’t comment on it … period. Maybe the Dechert side will. All we can do at this time is provide our readers with a link to the opinion.
One of the many methods of aggregating litigation is an action filed by a governmental unit acting as “parens patriae.” See Principles of the Law of Aggregate Litigation §1.02 & Reporters notes to comment b(1)(B) (ALI 2010). Such actions, in which a “[g]overnmental actor” has “authority to speak for citizens on matters of
We call them like we see them – which of course is with a defendant’s eye. But nonetheless, excellent is how we view Solomon v. Bristol-Myers Squibb Co., 2013 U.S. Dist. LEXIS 534 (D.N.J. Jan. 3, 2013). And while the ruling was made by a New Jersey federal court judge, it is all about Texas learned intermediary law. It may have taken until late 2012 for Texas to join the ranks of states adopting the learned intermediary doctrine, but now that it has we get to enjoy decisions like this. It is so chock full of golden nuggets, we think it best to just walk you through the highlights. If you have a drug or device case pending in Texas, you’ll want to read the whole opinion more closely – and here’s why.
The case involves Plavix – an antiplatelet drug, more commonly thought of as a blood thinner typically prescribed to people who have had heart attacks, strokes, or other cardio- or vascular-related illnesses. Because its job is to inhibit the formation of clots, it carries a risk of increased bleeding. Its label sets forth that risk in great detail. Id. at *4-6. Plaintiff Solomon suffers from coronary artery disease and following stent placement post-heart attack, he was prescribed combination Plavix and aspirin therapy. After approximately 2 ½ years, plaintiff suffered chronic gastrointestinal bleeding requiring repeated blood transfusions and surgery. Id. at *6-7. Then he brought his lawsuit asserting several products liability claims under Texas law – all of which boil down to whether there was a failure to warn of the risk of bleeding. Id. at *8. And because there was no failure to warn – plaintiff has no claim.
Toward the end of a nice recitation of Texas’s learned intermediary law, id. at *11-16, we get our first highlight – no heeding presumption. The Texas Supreme Court hasn’t created such a presumption, the Fifth Circuit has predicted that they won’t, and there is no other authority to the contrary. Id. at *16-17. Short, sweet and to the point.Continue Reading Excellent Texas Learned Intermediary Decision