Not too long ago we commented on the President of the United States promoting the unproven off-label use of a prescription drug, hydroxychloroquine, for treatment of COVID-19, on nationwide TV, in the presence of the Commissioner of the FDA, no less. As we pointed out in the prior post, this drug has serious potential side
Ponder the following: A man attends an exercise class at a facility run by a local religious institution. Assume that he belonged to this facility, wanted to attend an exercise class because his fitness was less than optimal, and was informed of the need to get medical advice before starting a new and potentially demanding exercise program. He had a heart attack and collapsed right after leaving the class. Assume that the heart attack was not a total surprise given his health, but that he had not had a heart attack before and had not informed the people running the class of any particular risk. The class instructor rushed to the man’s aid while others called 911. The instructor was certified in cardiopulmonary resuscitation (“CPR”) and did her best to help the man. When paramedics arrived, they assumed care of the man, but he died despite their best efforts.
Based on these facts and assumptions, answer this question:
Who should the man’s estate sue over his death?
A) Nobody. B) The class instructor. C) The religious institution. D) The entities that operate the 911/EMT system.
If you answered other than “A,” then you might need to examine your propensity to blame others.
Add in the following to the scenario presented above: The class instructor tending to the man did not utilize an automated external defibrillator (“AED”) that she knew was present and was certified in using. She brought the AED to the man’s side, but elected not to use it because, in her judgment, he was having a seizure and not a heart attack.
Based on these additional facts, answer these questions:
1. Who should the man’s estate sue over his death?
A) Nobody. B) The class instructor. C) The religious institution. D) The entities that operate the 911/EMT system. E) The company that sold the AED and offered training to purchasers.
2. If the man’s estate already sued the religious institution over his death, who should the defendant bring in via third-party complaint?
A) Nobody. B) The class instructor. C) The entities that operate the 911/EMT system. D) The company that sold the AED and offered training to purchasers.
In Wallis v. Brainerd Baptist Church, No. E2015-01827-SC-R11-CV, 2016 Tenn. LEXIS 920 (Tenn. Dec. 22, 2016), the estate sued the church that ran the gym and then both turned their attention to the seller of the medical device that was not used. It is often said that bad cases make bad law, but sometimes egregiously over-reaching cases can make good law. Ultimately, Wallis fits into the latter category. A contrary result, which would have allowed a negligence or contract claim against the seller of a device that was not used with the decedent, would have been bad, maybe bad enough to have been mentioned in our bottom ten post last week.
Anyone who has checked our post-Levine innovator drug & vaccine cheat sheet lately has no doubt noticed our two most recent entries, Gentile v. Biogen Idec, Inc., 2016 WL 4128159 (Mass. Super. July 25, 2016), and Christison v. Biogen Idec Inc., No. 2:11-CV-01140-DN-DBP, slip op. (D. Utah Aug. 5, 2016). With respect to preemption and innovator drug warnings, these cases provide further support to an emerging, common-sense bright line in the otherwise all-too-murky world of “clear evidence” – that a warning change rejected by the FDA for lack of scientific evidence must be “clear evidence” that this change would have also been rejected at any earlier date. The logic is inescapable that, if there was insufficient scientific evidence at moment X, there is no more, and usually less, evidence on the same issue at any time before X.
Looking at our cheat sheet, the first case to so hold appears to be In re Fosamax (Alendronate Sodium) Products Liability Litigation, 951 F. Supp.2d 695 (D.N.J. 2013). Fosamax involved the FDA’s partial rejection of a prior approval supplement after the date of the plaintiff’s injury. Id. at 703 (FDA rejection occurred “approximately one month after” plaintiff’s injury). The label change failed because “the data that FDA has reviewed have not shown a clear connection” between the drug and the risk at issue. Id. at 699.
[C]lear evidence exists that the FDA would not have approved a label change to the Precautions section of the [drug] label prior to [plaintiff’s] fracture because Defendant submitted a label change and the FDA rejected it, and the FDA never required Defendant to submit new language or change the label, which demonstrates that the FDA did not think that the label should have been changed at that time.
Id. at 703-04. See In re Fosamax Alendronate Sodium Products Liability Litigation, 2014 WL 1266994, at *11 (D.N.J. March 26, 2014) (applying this ruling “to those Plaintiffs’ whose injuries occurred prior to [the FDA rejection date], without allowing additional discovery”).
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.
This post is from the non-Reed Smith side of the blog.
This is the official week in the United States for giving thanks. Counting your blessings. Welcoming family and friends to your home. Christmas might get top billing, but Thanksgiving is all about feeling warm and fuzzy. And here at the Drug and Device Law Blog, we’ll get to what we are thankful for tomorrow. Today is a different story. Today we feel more cold and hard. And who is the unfortunate recipient of our negativity at this otherwise festive and lighthearted time – California.
And why is that we don’t want to share our turkey and pumpkin pie with California? Three reasons: negligence, Good Samaritan, and subsequent remedial measures.
Plaintiff Christine Scott sued manufacturer C.R. Bard, Inc. alleging injuries resulting from implantation of that company’s pelvic mesh device. The case went to trial and the jury found the manufacturer negligent and awarded damages (reduced based on finding that surgeon was 40% at fault). Scott v. C.R. Bard, Inc., 2014 Cal. App. LEXIS 1049, at *1 (Cal. App. Ct. Nov. 19, 2014). On appeal, the defendant argued, among other things, that the trial court erroneously submitted the negligence theories of liability to the jury, including negligent training and erroneously admitted evidence of post-surgery events. Id. at *1-2. The court denied the appeal in its entirety. We are blogging about this case because it demonstrates the potholes created by California’s recognition of negligence claims in pharma and medical device cases.
Those of us whose childhood had low tech play options and at least a touch of OCD recall playing with dominoes. Not whatever the game is where the number of dots on a tile matters, which we understand exists from witnessing it in screen classics like “Boyz n the Hood.” No, we mean the activity where you line up a series of dominoes in a sequence where tipping over the first one will cause a chain reaction where many or all fall over. If you were really motivated or bored, then the arrangement of dominoes might have included the construction of elaborate stairs, towers, or catapults or tiles falling off of tables to start new chains. There is probably some app for this now.
The decision in Grabowski v. Smith & Nephew, Inc., No. 14-433, 2014 La. App. LEXIS 2367 (La. Ct. App. Oct. 1, 2014), reminds us of dominoes. (We do try to have our non-legal introductions have something to do with our purported point.) The case was really a detour from what looked like a medical malpractice action against a surgeon who performed a knee replacement with an insert that was too small for the tray he used. The details of the two part implant system are not terribly important here, but the sizing of the insert and tray should match up. The surgeon blamed the sizing error on the sales rep present at the implant after learning about it from another rep at a revision surgery three months later. Skipping over some procedural parts and a whole section of the decision about a motion to recuse the judge—arrangements of dominoes sometimes have dead ends on purpose—plaintiff sued the original rep, the distributor with whom he had a contract at the time of the implant surgery, and the manufacturer of the implant with whom he used to have a contract. The defendants eventually moved for and were granted summary judgment.
The basic idea was the rep was not liable for negligence because the duty of providing medical care to the patient—including using the right size of any medical device—rested solely with the surgeon. In addition, the distributor was not liable for acts or omissions of someone who was its independent contractor and the manufacturer was not liable for someone with whom it had no direct contractual relationship. On appeal, all the tiles fell to bring the deep pockets back into the case. (We cannot tell what happened in terms of litigation between the plaintiff and the surgeon.)
Not too long ago a case here in the Eastern District of Pennsylvania, Slater v. Hoffmann-LaRoche Inc., ___ F. Supp.2d ___, 2011 WL 1087240 (E.D. Pa. March 25, 2011), held that an inadequate warning claim against a “monograph publisher” survived the rather loose standard imposed upon fraudulent joinder.
That’s right, or at least that appears to be what this particular defendant, Wolters Kluwer Health, Inc., (“KWH”) does according to its website – it publishes textbooks (including Lippincott), reference products, journals, bibliographic and reference databases, drug information software, point-of-care tools, web-based information systems, online continuing education products, and electronic information.
A publisher can be liable in a product liability suit in Pennsylvania?
That’s a new one on us.
Let’s see how Slater purports to accomplish that feat. First of all, it’s crystal clear under Pennsylvania law that a pharmacist dispensing drugs is not liable for failure to warn about a prescription drug. Coyle v. Richardson–Merrell, Inc., 584 A.2d 1383, 1386-88 (1991); Makripodis v. Merrell–Dow Pharmaceuticals, Inc., 523 A.2d 374, 376-79 (Pa. Super. 1987); Ramirez v. Richardson–Merrell, Inc., 628 F. Supp. 85, 87-88 (E.D. Pa. 1985) (note: these are all Bendectin cases, and Bexis participated in their defense). The only way a pharmacist can be liable is for independently screwing up, such as filling a prescription with the wrong drug.
So the plaintiff didn’t sue the pharmacist.
However, pharmacists now include fact sheets – “patient education monographs” about the drugs they dispense. As Slater recognizes, this isn’t something that tort law mandates. In any event, somebody has to prepare and compile this information. KWH is one of those entities.