Happy New Year from all of us here at DDLaw! And happy old year, too. Was it a happy old year? In many ways it was, and it’s the purpose of this post, to list some of our top reasons why. So here are our choices for the best prescription medical product liability decisions of
Today we feature a case that exemplifies two principles that we routinely encounter in our practices, but rarely at the same time. First, there is no more sympathetic plaintiff than a disabled military veteran. We come across and write on cases involving sad facts with some regularity, which is an occupational hazard of our practice in the drug and medical device arena. The most compelling cases we see involve patients who have experienced actual injuries, a fact that we always bear in mind as we report on what the law is and what we believe the law should be. Moreover, while everyone has a point of view on what kinds of cases provoke the greatest sympathy, we have learned in our many years on Reed Smith’s Pro Bono Committee that disabled veterans garner the broadest imaginable support. Some people champion children’s issues; others promote immigration reform, or perhaps they favor housing rights. But everyone gets behind programs supporting disabled veterans. And rightfully so. Today’s veterans are young men and women who have completed their service and have their whole lives ahead of them, often with significant challenges.
The second principle that today’s case brings to mind is that civil litigation cannot and should not provide a remedy if the law and facts are not there to support one, no matter how sympathetic the plaintiff may be. The district court’s order granting summary judgment in Carnes v. Eli Lilly & Co., No. 0:13-591-CMC, 2013 U.S. Dist. LEXIS 176201 (D.S.C. Dec. 16, 2013), brings together these two principles by presenting a disabled Army veteran and physicians who prescribed prescription drugs with full knowledge of all the relevant risks. In Carnes, the plaintiff injured his spinal cord while attempting to rescue fellow soldiers in Iraq, and as a result he is wheelchair bound, has significant physical limitations, and suffers from chronic pain. Id. at *1. One physician prescribed Lyrica, an antiepileptic drug indicated for treating pain associated with spinal cord injury, but after about three years on the drug, the plaintiff asked to stop. Id. at *2. The doctor therefore prescribed Cymbalta, which is a serotonin and norepinephrine reuptake inhibitor that is also indicated for treatment of chronic pain. After a few months, the plaintiff changed doctors and asked to switch his medication again because he thought the drug was causing him to gain weight. Id. at *2. The new doctor therefore tapered the plaintiff off Cymbalta and restarted Lyrica. Id. at **2-3. According to the doctor, she tapered the plaintiff’s dose “to avoid potential side effects from stopping Cymbalta suddenly.” Id. at *3.
As the second doctor’s remarks suggest, discontinuing Cymbalta can result in withdrawal-like symptoms, which the doctor knew about and which the product’s label disclosed at all relevant times. Id. at **4-5. The physician who first prescribed the drug similarly was aware of the risk of withdrawal symptoms “having learned about them in medical school, during his residency, and from patients who experienced withdrawal symptoms.” Id. at *16. Alas, the plaintiff experienced post-discontinuation symptoms that he attributed to the drug, including sharp headaches, nightmares, anger, and shaking. He therefore sued the drug’s manufacturer, who moved for summary judgment under South Carolina’s learned intermediary doctrine.Continue Reading No Causation, No Claim
Back in March, we reported that a monstrous $27.6 million verdict had been tossed by the Pennsylvania Superior Court in Polett v. Public Communications Inc., No. 1865 EDA 2011, slip op., (Pa. Super. March 1, 2013), for no less than four separate reasons: (1) exclusion of a “tolling agreement” whereby the plaintiff agreed
Because it is Christmas Eve, we are going to keep this one short and light. After all, there are still presents to be purchased, gifts to be wrapped, cards to be mailed, stockings to be stuffed, and pies to be baked. While we would strongly encourage you to take a minute out of the hustle and bustle to peruse the Drug and Device Law blog, this time of year we can’t help but recommend a few other yuletide/ year-end activities. Whether you are caught up in the Christmas hoopla or simply in the everyday frenzy of life, Christmas Eve can be great night for a relaxing drink (warm tea, mulled wine, vodka martini – the choice is yours) and a good movie, TV show, or book.
For example, if, like some of us, the only time you get to the movies is to see the latest Disney animation (although Monsters University was good), you may still be able to find one of these playing somewhere: Prisoners (Hugh Jackman as a desperate father trying to protect his family); Gravity (George Clooney and Sandra Bullock in space, meant to be seen on the big screen); Captain Phillips (Tom Hanks and the Somali pirates hijacking); Blackfish (documentary on orcas, very powerful); and The World’s End (latest Simon Pegg comedy, if you like “Shaun of the Dead” and “Hot Fuzz” this is a must see). Or, there are the new releases. We haven’t seen them but it seems like you could have a good time at: American Hustle, Dallas Buyers Club, Anchorman 2, or Saving Mr. Banks. And this doesn’t even include the movies opening Christmas Day.
Or, how about what you missed on TV this year. You could take the day to catch up on Scandal (wow, Olivia’s parents). We’ll watch just about anything with James Spader and Blacklist didn’t disappoint. Did you see the finale of Breaking Bad? (both logically and emotionally satisfying) And, don’t forget Netflix originals like Orange is the New Black or House of Cards. Did you know Arrested Development is back too?
And, if movies and TV aren’t your thing, there’s still time to download a good book. We know there are plenty out there to choose from, but the one’s we can recommend (won’t speak for what we haven’t read) are And the Mountains Echoed by Khaled Hosseini (author of the “Kite Runner” and “A Thousand Splendid Suns” – if you haven’t read those, start there); The Good Lord Bird (a slave boy must pass as a girl when joining John Brown’s antislavery crusade); Life After Life (an interesting tale of a women who is continually re-born); and Empty Mansions (a fascinating story of America in the 19th century and a modern battle over a staggering inheritance (non-fiction)).
We know there is more out there in all three genres – and we’re sure McConnell will have a few words especially about the movies and TV – but those lists should keep you busy through at least the New Year. Before you tune us out for one of these entertainment choices, however, we do have a new case to tell you about: In re Actos (Pioglitazone) Prods. Liab. Litig., 2013 WL 6328263 (W.D. La. Dec. 3, 2013).
First, we have to tell you that this decision involves a medical monitoring claim under New York law (anticipated costs if plaintiff’s bladder cancer recurs). At the time this decision was rendered, the court was applying Askey v. Occidental Chem. Corp., 102 A.D.2d 130 (4th Dept.1984). But, as we recently reported, New York has now rejected claims for medical monitoring. So, we aren’t interested in this case for its discussion of the underlying claim. Rather, what drew our attention was the court’s discussion of whether plaintiff’s experts’ opinions satisfied the federal standard for relevancy.Continue Reading To A Reasonable Degree of Certainty, It Is Christmas Eve
Today’s post contains our annual list of those court decisions concerning prescription drugs and medical devices that are so bad and ugly that they leave us talking to ourselves – or even to the furniture. With the thirteenth year of the millennium drawing to a close, these opinions demonstrate that – yes, indeed –
Not to over-generalize, but older people have been known to break their hips. Based on anecdotal evidence, broken hips hurt more than stepping on a broken bottle or a sea urchin during a tropical vacation. Based on more than anecdotal evidence, product liability plaintiff lawyers prefer state courts over federal courts. This is because of various factors that, they think, make the state courts more likely to impose pain, and impose a lot of pain, on the defendants. We have posted on many cases discussing the strategies used by product liability plaintiffs to stay out of federal court. These cases often come up in the posture of a motion to remand by the plaintiff after the defendant has removed under 28 U.S.C. § 1446. If the case can be transferred to an MDL court—potentially well-versed in the anti-removal strategies—before a ruling on the motion to remand, then the chance of the case staying put tends to go up.
In Millman v. Biomet Ortho., Inc., No. 3:13-CV-77 RLM-CAN (N.D. Ind. Dec. 10, 2013), and Akin v. Stryker Corp., Civ. No. 13-1811 (DWF/FLN) (D. Minn. Dec. 12, 2013), we have decisions on motions to remand from two different MDL courts on two different cases involving two different hip replacement implantable medical devices. We also have two different results, although both are good.Continue Reading It’s Getting Icy Out, So Don’t Fall and Hurt Your (Non-Diverse Defendant in a) Hip (Replacement MDL)
This morning we posted about just how strong the preemption defense can be for pharmaceutical and device manufacturers.
And not to hide the light of preemption under a bushel, but there is the flip side. It’s sort of like an elementary school science project. You put a nice red, ripe tomato on the counter and wait to see how long it takes to spoil. It starts off aromatic, sweet, juicy. Very appealing. After a short time, it starts to shrivel, turn green, grow mold. And finally, it just really stinks. Well, that’s what Bausch v. Stryker Corp., 630 F.3d 546 (7th Cir. 2010) did for preemption in the Seventh Circuit. Smelled it up. (see posts here and here).
We get that courts in that circuit are bound by the decision and we lament new decisions that essentially reach the same conclusion as Bausch. But even applying its extraordinarily broad concept of a parallel violation claim, warning related claims in Bausch didn’t survive. So, we were more than a bit taken back by the recent decision in Comella v. Smith & Nephew, Inc., No. 13 C 1850, slip op. (N.D. Ill. Dec. 11, 2013) in which the court tumbles all the way down the Bausch slippery slope and allows what is effectively a fraud on the FDA claim to be a non-preempted parallel failure to warn claim.
This is going to leave a nasty taste in our mouth, but we’ll plow through it anyway. First, like Bausch, Comella is a hip replacement case. Following her hip replacement surgery, the plaintiff began experiencing hip pain and began hearing “squeaking” noises. Ultimately, the hip replacement device failed, resulting in another hip replacement surgery.Continue Reading Bausch Strikes Again
Contrary to popular belief – even among some lawyers – off-label use is not necessarily entirely off-label. That’s a good thing, too. One of the things we’ve harped on with this blog is that off-label use is legal, common, and in various fields can represent the prevailing medical standard of care.
One thing we’ve never argued on this blog is that off-label use (or any use) of prescription medical products is risk free. Thus, in cases of widespread off-label uses, by all means the FDA should have the ability to ensure (as is the case with labeled uses) that a product’s labeling informs prescribing doctors of relevant risks. The alternative view that we encountered back in the Bone Screw litigation (flirted with by the Kessler-era FDA), that warnings pertaining to off-label uses were somehow “promotion” and should be prohibited, always struck us as illogical and counterproductive.
It turns out that the FDA can indeed require warnings about off-label uses.
With prescription drugs, the Agency’s authority to order warnings about off-label uses is pretty well spelled out and straight-forward. The relevant regulations provide:
A specific warning relating to a use not provided for under the “Indications and Usage” section may be required by FDA in accordance with sections 201(n) and 502(a) of the act if the drug is commonly prescribed for a disease or condition and such usage is associated with a clinically significant risk or hazard.
21 C.F.R. §201.57(c)(6)(i) (emphasis added).
A specific warning relating to a use not provided for under the “Indications and Usage” section of the labeling may be required by the Food and Drug Administration if the drug is commonly prescribed for a disease or condition, and there is lack of substantial evidence of effectiveness for that disease or condition, and such usage is associated with serious risk or hazard.
21 C.F.R. §201.80(e) (emphasis added). The references in §201.57 to sections 201(n) (21 U.S.C. §321(n)) and 502(a) (21 U.S.C. §352(a)) of the FDCA are to general provisions relating to misbranding.Continue Reading The FDA, Preemption, And Warnings About Risks Of Off-Label Use
This blog has been up and running long enough such that certain themes have cropped up several times. Or to put it more bluntly, we occasionally repeat ourselves. Well, we hope it is not mere repetition. Call it elaboration. New things are continually developing with respect to TwIqbal, preemption, Daubert, and other rules,