We’ve posted previously about the awful learned intermediary decision by the Arizona Court of Appeals in Watts v. Medicis Pharmaceutical Corp., 342 P.3d 847 (Ariz App. 2015). Well, that’s not the last word anymore. Today the Arizona Supreme Court granted the defendant’s petition for review in Watts. Here’s a copy of the court’s
It wasn’t a complete win, but the summary judgment outcome in Rheinfrank v. Abbott Laboratories, Inc., ___ F. Supp.3d ___, 2015 WL 4743056 (S.D. Ohio Aug. 10, 2015), has to put a spring in the step of the defendants as they approach trial. What’s left doesn’t strike us as a very good warnings case. Rheinfrank involved claims that the antiepileptic drug Depakote caused the minor plaintiff’s birth defects. Make no mistake about it, Depakote has a known association with such injuries. First approved in 1983, it’s been a Pregnancy Category D drug since 1988, meaning, according to FDA regulations, that:
there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but the potential benefits from the use of the drug in pregnant women may be acceptable despite its potential risks.
21 C.F.R. §201.57(c)(9)(i)(A)(4). Not only that, since 2003, this drug has carried a black box “teratogenicity” warning, as well as other quite explicit, and all-caps, language to the same effect. For details, see 2015 WL 4743056, at *2-3.
Plaintiff-mother had used Depakote for years, through four previous uneventful pregnancies. Id. at *1. On her fifth pregnancy, even though Depakote came with all these warnings, she continued to take it. Id. Her allegations did try to change the subject, however. In addition to claiming that the black box warning (more about that later) and all the other teratogenicity language were inadequate, she asserted that the defendants failed to warn altogether about “developmental delay.” Id. at *5.Continue Reading Preemption (and Other Things) Defanging Depakote Claims
This post is from the non-Reed Smith side of the blog.
Is anyone else watching the CW’s “Penn & Teller: Fool Us”? It is perfect summer TV – easy, funny and interesting. Each week aspiring, talented magicians perform to try to fool Penn & Teller. If at the end of the trick, the comedy-magic duo can’t figure out how the trick was performed, the magician gets to appear on Penn & Teller’s enormously popular Las Vegas show. Recorded on your DVR so you can skip commercials, it’s 45 minutes of stage performances, most of which are quite good and entertaining. And that’s where we like to see magic – on the stage. Who isn’t intrigued when a torn up playing card turns up tucked into a magician’s wallet whole again? Or when a dove appears where only an egg was before? Slight of hand, hidden compartments, mirrors, trap doors – all things designed to make an audience think they are seeing something more than they really are.
When magic is at work in legal opinions, we aren’t as enthusiastic. Especially, where the result is the conjuring of a case out of thin air. That is precisely what happened in Fields v. Eli Lilly and Co., slip op., Case No. 2:13-CV-35-WKW (M.D. Ala. Jul. 20, 2015). Plaintiff alleged that because she ingested Prozac in 1996 during the first 8 months of pregnancy, her son was born with a congenital heart defect. But she has NO proof of two of the most fundamental aspects of any prescription drug case – that she ingested the drug and that an alleged inadequate warning caused the injury. We would have thought that a complete lack of evidence on two key elements is enough for summary judgment, but plaintiffs managed to pull a rabbit out of a hat.
Let’s sum up all of the missing evidence. Plaintiff has no pharmacy records showing that a Prozac prescription was ever filled. She alleges her pharmacy no longer has those records. She has no financial records (bank statements, receipts, credit card statements) showing a purchase of Prozac. Id. at 9. Presumably she also doesn’t have insurance records reflecting a Prozac prescription. She has no medical records that Prozac was ever prescribed. Id. at 8. There isn’t a single reference in any of her medical records that confirms that Prozac was ever prescribed to plaintiff.Continue Reading Plaintiffs Allowed To Make a Case Out of Thin Air
We flew to Pittsburgh this week for depositions. From Philadelphia, it takes only about 40 minutes in the air to get to Pittsburgh. But there are only a few nonstops each day. With no other options, we booked a nonstop flight scheduled for a 7:55 a.m. departure, coordinated plans with colleagues, clients and witnesses, and went to sleep with our overnight bag packed and waiting at the door. All in order, right? Until our phone rang at 3:30 a.m. bearing the robotic message, “Your flight has been canceled.” No explanation. We called back to find that we had been “protected” – re-booked – on the next available flight, a couple of hours later. So far, so good. (Well, not really, but as good as it gets at that point.) But then we discovered that our colleague, scheduled to fly with us, was not “protected” on our flight, but had been bumped to a much later flight so he could continue to take advantage of the first class upgrade he had not requested in the first place. Good times. The next day, our flight for home departed right on schedule. We landed in Philadelphia, taxied to the gate, stood up, and remained standing in the aisle for the next 30 minutes, informed that the jetway would not move to the door of the plane and “a mechanic has been called.” Twice in one trip, the airline stopped just short of getting it right.
Recently, defendant Mentor Corp, moving for partial summary judgment in the Mentor ObTape Transobturator Sling Products MDL, similarly found itself at the mercy of a Court that laid the groundwork for a correct decision then stopped just short of getting it right. Twice.
Plaintiff had been implanted with an ObTape transobturator sling in 2004 to address her stress urinary incontinence. It was apparently undisputed that plaintiff “did not speak with anyone from Mentor or see any brochures, videos, product inserts, or other materials from Mentor before the procedure.” In re Mentor Corp. Obtape Transobturator Sling Prods. Liab. Litig., 2015 U.S. Dist. LEXIS 93001 at *5 (M.D. Ga. July 17, 2015). Plaintiff was happy with her implant until 2010, when she “began experiencing pain in her thighs.” Id. Initially, plaintiff was diagnosed with a groin strain; however, after several months of worsening symptoms, she was diagnosed with an abscess caused by erosion of the ObTape. She underwent excision surgery during which as much of the ObTape as possible was removed. Id. at *6-7.Continue Reading Almost, but Not Quite: No Summary Judgment for Mentor on Two of Plaintiff’s ObTape Claims
Happy birthday, Louise Fletcher, who won an Academy Award for her portrayal of the sadistic Nurse Ratched in One Flew Over the Cuckoo’s Nest (1975). Happy birthday also to Albert Brooks, writer/director/star of Modern Romance (1981), Lost in America (1985), Defending Your Life (1991), and a gaggle of other comedies. Brooks also did fine work as an actor in several non-comedies, such as Taxi Driver (1976), Broadcast News (1987), and Drive (2011). But for our money, his best performance is in Out of Sight (1998), where Brooks played a Michael Milken-esque financier-turned-prison-inmate. By the way, Brooks’ birth name was Albert Einstein. Brooks changed his name for obvious reasons. He cracked that the great physicist had changed his name to Albert Einstein simply to sound smart. Finally, happy birthday to Don Henley of The Eagles. Henley sang and co-wrote “Hotel California” (1977), an allegory about SoCal showbiz excess. The best line in the song is “We are all just prisoners here of our own device.”
Does that trio of birthdays suggest a theme? Indeed, it does: drugs and prisoners. Today’s case is Flowers v. Eli Lilly & Co., 2015 U.S. Dist. LEXIS (D. Nevada July 10, 2015), in which a pro se plaintiff prisoner claimed that Zyprexa gave him diabetes. The plaintiff had been prescribed Zyprexa at the beginning of his incarceration in 1997, went off it in 2003, and then back on it in 2009, continuing up through the filing of the lawsuit in 2014. The plaintiff was diagnosed with diabetes in November 2012. After learning of the diagnosis, the plaintiff requested that he be taken off Zyprexa. The request was denied. Remember, the plaintiff was a prisoner. Patient choice seldom matters from a legal point of view in these cases (because of the learned intermediary doctrine, discussed below), but in this case it really, really does not matter. Zyprexa is an antipsychotic drug that can be used to treat very serious conditions such as schizophrenia and bipolar disorder. The court’s opinion does not tell us why the prison wanted the plaintiff to be on an antipsychotic, but odds are there was a very good reason.Continue Reading Little Reprieve for Prisoner Zyprexa Suit
We admit it. We (and “we,” in this instance, should be read in the singular) are fans of certain social media, particularly the one that involves “posting” on a “wall” then sitting back and basking in the “likes.” We tend to eschew any intellectually-challenging material that may be available on this medium. Instead, when we are not ourselves posting pictures of the Drug and Device Law Rescue Pets, we most enjoy reading accounts of others’ rescues of doggies and kitties. (Don’t start – we know.) These stories always begin with horrific, heart-wrenching facts but generally wend their way to satisfying endings.
Today’s case, Taylor v. Intuitive Surgical, Inc., 2015 Wash. App. LEXIS 1442 (Ct. App. Wash. July 7, 2015), follows a similar formula, although the ending is happy only for “learned intermediary” jurisprudence, not for plaintiff’s unfortunate decedent. Taylor involved the da Vinci System, manufactured by defendant Intuitive Surgical, Inc. (“ISI”). The highly complex da Vinci system allows surgeons to perform minimally-invasive prostatectomies, remotely operating small instruments inserted through very small incisions in the patient’s body. Taylor, 2015 Wash. App. LEXIS at *3.
Apparently, ISI tightly controls physician access to its system. We are not sure how, but the opinion describes a specific credentialing process under which every surgeon is required to be credentialed, before using the da Vinci system, by the hospital where the procedure will be performed. Each hospital sets its own credentialing protocol. Surgeons must initially perform proctored cases – two, or a number set by hospital protocol. Id. at *4-5. Next, ISI requires surgeons to “choose simple cases for their first four to six unproctored procedures and to slowly progress in case complexity.” Id. at *5 (internal punctuation and citation omitted). During their early surgeries, “surgeons are advised to choose patients with . . . BMI of less than 30 and no prior history of lower abdominal surgery.” Id. Continue Reading No Duty for Device Manufacturer to Provide Separate Warnings to Hospital, According to Washington Court of Appeals
Those of us who live in Philadelphia are endlessly fond of rocking on our porches and reminiscing about the halcyon baseball season of 2008, when our beloved Phillies won the World Series. These days, we are resigned to a team that is, euphemistically speaking, “rebuilding.” In reality, all the team is building is a staggering
“We’ve seen this movie before.” That is something people say when they encounter something that seems simultaneously dreadful and predictable. That is how we felt upon reading the latest dismal opinion out of the Drake Botox litigation in Vermont federal court. We’ve blogged about this case several times before, bemoaning the blundering approach taken
This post comes only from the Cozen O’Connor side of the blog.
The Vioxx MDL is still alive. But not really kicking. The master settlement agreement ended the mass tort portion of this litigation, leaving behind a vastly smaller number of cases filed by plaintiffs who chose not to “opt in” to the settlement. The MDL court is still managing some of those cases. But, if Levitt v. Merck Sharp & Dohme Corp., 2015 U.S. Dist. LEXIS 52756 (E.D. La. Apr. 21, 2015), is any indication, it won’t be for much longer.
In Levitt, the MDL court denied Merck’s motion for summary judgment, instead ordering that discovery be reopened. While that might not sound like the decision of a court looking to end its involvement in the Vioxx litigation, remanding the case to the original transferor court for further proceedings sure does. And the MDL court did that too. Id. at * 30.Continue Reading Yes, There Is Still Vioxx Litigation
We’ve already discussed the peculiar decision in Watts v. Medicis Pharmaceutical Corp., 342 P.3d 847 (Ariz App. 2015), once, here. This time, we don’t care much about the peculiar facts, but rather we’re directing ourselves to the court’s odd reasoning that somehow there’s a conflict between the learned intermediary rule (adopted at some level now in every American jurisdiction – see our “headcount” post here − and the Uniform Contribution Among Tortfeasors Act (“UCATA”). Among the cases following the learned intermediary rule are four prior Arizona appellate decisions. Davis v. Cessna Aircraft Corp., 893 P.2d 26, 38 (Ariz. App. 1994) (non-medical product), review denied (Ariz. April 25, 1995); Piper v. Bear Medical Systems, Inc., 883 P.2d 407, 415 (Ariz. App. 1993), review denied (Ariz. Nov. 1, 1994); Gaston v. Hunter, 588 P.2d 326, 340 (Ariz. App. 1978), review denied (Ariz. Nov. 21, 1978); Dyer v. Best Pharmacal, 577 P.2d 1084, 1087 (Ariz. App. 1978), review denied (Ariz. May 2, 1978). In all four of these cases, the Arizona Supreme Court had the opportunity to evaluate the learned intermediary rule; all four times it passed and denied review.
Don’t be fooled by the 2007 date on our “headcount” post. We’ve kept updating it. Since we originally wrote that post in mid-2007, prompted by the terrible decision in State ex rel. Johnson & Johnson Corp. v. Karl, 647 S.E.2d 899 (W. Va. 2007), two more state supreme courts have adopted the learned intermediary rule for the first time: Centocor, Inc. v. Hamilton, 372 S.W.3d 140, 154-59 (Tex. 2012); Rohde v. Smiths Medical, 165 P.3d 433, 438 (Wyo. 2007). Two other state supreme courts have reaffirmed the learned intermediary rule since then, Wyeth, Inc. v. Weeks, ___ So.3d___, 2014 WL 4055813, at *19-20 (Ala. Aug. 15, 2014) (the only good thing about an otherwise awful opinion); Klasch v. Walgreen Co., 264 P.3d 1155, 1159 (Nev. 2011), as have two state intermediate courts of appeal. O’Connell v. Biomet, Inc., 250 P.3d 1278, 1281-82 (Colo. App. 2010), cert. denied, 2010 WL 4851480 (Colo. Nov. 30, 2010); Silva v. SmithKlineBeecham Corp., 2013 WL 4516160, at *2-3 (N.M. App. Feb. 7, 2013). In addition, federal courts have predicted the rule’s adoption in Rhode Island, where there used to be no law. Greaves v. Eli Lilly & Co., 503 F. Appx. 70, 71-72 (2d Cir. 2012); Hogan v. Novartis Pharmaceuticals Corp., 2011 WL 1533467, at *9-10 (E.D.N.Y. April 23, 2011), and in South Dakota, reconfirming earlier predictions. Schilf v. Eli Lilly & Co., 2010 WL 4024922 (D.S.D. Oct. 13, 2010). Finally, as we’ve blogged about before, West Virginia federal courts have recently cut back Karl to drug DTC advertising cases. See O’Bryan v. Synthes, Inc., 2015 WL 1220973, at *6-7 (S.D.W. Va. March 17, 2015); Wise v. C.R. Bard, Inc., 2015 WL 502010, at *4 (S.D.W. Va. Feb. 5, 2015); Tyree v. Boston Scientific Corp., ___ F. Supp.3d ___, 2014 WL 5431993, at *5-6 (S.D.W. Va. Oct. 23, 2014).
So even since Karl, the learned intermediary rule has been doing quite well for itself.Continue Reading Low Wattage Reasoning