Time travel is on our mind today. We should hasten to add that it is not a topic that usually absorbs us – otherwise we might squander what little credibility we have with our serious-minded readers. But a trio of things prompted us to think about time-travel. First, we will (soon, we promise) be discussing
This post is from the non-Reed Smith side of the blog.
It was the best of decisions (Scovil v. Medtronic, Inc., __ F. Supp.2d __, 2014 WL 502923 (D. Ariz. Feb. 7, 2014), it was the worst of decisions (Coleman v. Medtronic, Inc., No. B243609, slip op. (Cal. App. Jan. 27,
There are several reasons we recommend taking a look at last week’s decision in Ball v. Takeda Pharmaceuticals America, Inc., 2013 WL 4040395 (E.D. Va. Aug. 8, 2013). One is that the case involves Stevens Johnson Syndrome, a rare but devastating idiosyncratic reaction which has become something of a litigation flavor du jour, with plaintiffs claiming that a great number of drugs cause this condition. After showing considerable patience (plaintiff filed 5 motions to amend), the court ruled that plaintiff finally struck out.
Most significantly, Ball was super in dismissing the plaintiff’s warning claim. The court held that the defendant’s warning about SJS/TENS was adequate as a matter of law – and dismissed the case:
The [relevant] label clearly identifies Stevens-Johnsons syndrome as a potential “adverse reaction” that could result from use of the prescription drug. Under Virginia law, a manufacturer is obligated to give a reasonable warning, not the best possible one. Courts have routinely held warnings adequate as a matter of law when they alert a party to the very injury for which the plaintiff seeks relief. [Defendant] disclosed Stevens-Johnson syndrome as a possible adverse reaction to [the drug] prior to plaintiff’s ingesting the drug. . . . The failure to disclose this risk is the sine qua non of the plaintiff’s negligence and negligence per se claims to the extent they seek to hold [defendant] responsible for plaintiff’s Stevens-Johnson syndrome. Those claims are dismissed, with prejudice.
Ball, 2013 WL 4040395, at *5 (citations omitted). A finding of adequacy as a matter of law is powerful, since warning claims are at the heart of prescription drug litigation. That this determination was made at the motion to dismiss stage, with the court taking notice of the label, is obviously even better. “A manufacturer does not insure its product’s safety, and need not supply an accident-proof product,” Id. at *6 (citation and quotation marks omitted).Continue Reading On The Ball In The Old Dominion
Back in 2009, we posted that a recently enacted Oklahoma tort reform statute included a provision to eliminate most class action litigation under the notorious outlier case Ysbrand v. DaimlerChrysler Corp., 81 P.3d 618 (Okla. 2003), by forbidding nationwide classes to be brought under Oklahoma law. It seems to have worked. We haven’t heard of any Ysbrand shenanigans since then.
Well, the Oklahoma Supreme Court was plainly out of control in Ysbrand, and unfortunately it remains out of control to this day. Recently, in Douglas v. Cox Retirement Properties, Inc., ___ P.3d ___, 2013 WL 2407169 (Okla. June 4, 2013), the same court invalidated the entire tort reform statute, under the obscure (and rightly so) “single subject” rule for legislation. Funny how we never seem to see that invoked except when tort reform is at issue….
Douglas thus resurrects (at least potentially) the anything goes class action practice that existed under Ysbrand – as well as the raft of other litigation abuses that the Oklahoma legislature thought it had addressed in 2009. That’s bad news.
The silver lining is that, since practically the day Douglas was decided, legislators in Oklahoma, who passed the original bill by a substantial margins, have been quoted as saying that they would break up the original legislation into separate bills. Moreover, with Douglas reviving tort reform as an issue, additional “measures − to limit liability for gun manufacturers, adopt federal guidelines for expert witnesses and protect restaurants [from] obesity-related lawsuits” may also be on the agenda.
Umm … guys….Continue Reading Umm . . . While You’re At It
We were planning to write about the Bartlett oral argument today (we still might) when we learned about Howard v. Zimmer, Inc., ___ P.3d ___, 2013 WL 1130759 (Okla. March 19, 2013), in which the Supreme Court of one of the reddest states in the country, overruling prior precedent, held that, in general, violations of federal regulations suffice as a basis for negligence per se under Oklahoma law. Contrary to a stiff dissent, the court reached this result notwithstanding 21 U.S.C. §337(a) in which Congress expressed its intent that claimed violations of the FDCA only be enforced by the federal government. Id. at *6-7.
Prior Oklahoma precedent (rather like the law of Kentucky that we discussed earlier) had declined to permit state-law negligence per se to be brought on the basis of claimed violations of purely federal regulations. E.g., Claborn v. Plains Cotton Co-op. Ass’n, 211 P.3d 915 (Okla. App. 2009) (no negligence per se for claimed OSHA violations); Christian v. First Capital Bank, 147 P.3d 908 (Okla. App. 2006) (same; federal usury regulations on agricultural loans); Rosson v. Coburn, 876 P.2d 731 (Okla. App. 1994) (same; Medicaid abortion regulations).
Howard was, of course, a case where federal preemption had wiped out the usual product liability claims plaintiffs would normally bring against the defendant. A couple of years ago, in the same peripatetic case, the Sixth Circuit, in a non-precedential decision, allowed a “parallel claim” to escape preemption. Howard v. Sulzer Orthopedics, Inc., 382 Fed. Appx. 436 (6th Cir. 2010) (“Howard I”). Howard I, of course, did not purport to decide that such a parallel claim existed under state law. Id. at 442 (not reaching “whether Oklahoma law recognizes a negligence per se action based on violations of FDA
regulations”).
That was the Oklahoma Supreme Court’s job. Procedurally, at least, we think that the Tenth Circuit chose a better path in certifying the issue to that court.
Under Erie, certification was a proper avenue, although we have to wonder why the plaintiff didn’t do this during the prior appeal in the Sixth Circuit. Unlike Fulgenzi v. PLIVA, Inc., ___ F.3d ___, 2013 WL 949096 (6th Cir. March 13, 2013), at least, the Tenth Circuit respected the limited authority of federal courts in diversity actions and certified the negligence per se question rather than making up novel state law claims out of whole cloth. And “whole cloth” is the right description − there was nothing in prior Oklahoma law that remotely suggested what the happened next.
Make something up is exactly what Oklahoma Supreme Court did. Not only did it overrule all prior precedent barring federally based negligence per se as a general matter, it decided not to follow its own prior precedents precluding private allegations of alleged violations where a particular piece of legislation “indicate[es that] . . . the law-making body concerned itself specifically with the problem of who should be able to bring an action . . .and it then resolved not to confer a remedy on private individuals.” Holbert v. Echeverria, 744 P.2d 960, 965 (Okla. 1987); see also State ex rel. Oklahoma Bar Ass’n v. Mothershed, 264 P.3d 1197, 1227 (Okla. 2011) (where a statute “clearly places enforcement in the hands of governmental authorities the right of action is exclusively vested in such governmental authority”); Walls v. American Tobacco Co., 11 P.3d 626, 631 (Okla. 2000) (failure to make private cause of action retroactive was legislative intent not to permit earlier claims amounting to private enforcement).
Continue Reading Oklahoma Supreme Court OKs Federal Takeover of State Tort Law
Bexis is updating chapter 4 of his book, which includes a thorough discussion of negligence per se. Negligence per se in the context of the Food, Drug & Cosmetic Act (“FDCA”) has taken on increased salience, particularly in preemption cases where courts leave an “out” for parallel claims. Because there must be a pre-existing
Our first reaction upon reading Metz v. Wyeth, 2012 U.S. Dist. Lexis 42432 (M.D. Fla. March 28, 2012), is boy, this case has a little of everything! After it was over, the plaintiffs must have felt a little like the French after they went to war against the Prussians in 1870.
First, Metz
Every now and then there’s a piece of litigation that boldly goes where no court has gone before and opens up a host of new legal issues. Bone Screw was like that, with plaintiffs inventing new causes of action (fraud on the FDA and regulatory informed consent) and our side having to invent new defenses. We also felt that way while we were involved in the Fagan v. AmerisourceBergen litigation involving the then novel concept of liability of non-counterfeiters for injuries caused by counterfeit drugs.
We’ve just seen another opinion, Kapps v. Biosense Webster, Inc., ___ F. Supp.2d ___, 2011 WL 4470701, slip op. (D. Minn. Sept. 27, 2011), that makes us feel the same way. We can’t recall ever seeing an opinion previously that addressing liability issues in the context of a reprocessed medical device that allegedly failed due to defects introduced by the reprocessing.
Kapps involves something analogous to the aftermarket for automobile parts, only in the medical device field. The product, a heart catheter, was originally manufactured as a single-use product – expressly stated in the product’s original labeling. 2011 WL 4470701, at *3. Apparently the FDA has chosen not only to tolerate, but to affirmatively allow the particular type of off-label use: the reprocessing and reuse of products whose labeling is limited to single use. Id. at *5-6 (describing FDA regulation of reprocessing/reuse of single-use devices). After being completely relabeled and refurbished according to relevant FDA regulations, the heart catheter was reused and broke inside the plaintiff’s heart. Id. (refurbishing changed the device’s serial number, and replaced its labeling with its own). Plaintiff sued both the aftermarket and original equipment manufacturers.
The 68-page Kapps opinion raises, and in some cases decides for the first time, many fascinating issues.Continue Reading Twice Nice?
We just spotted Placencia v. I-Flow Corp., 2011 WL 1361562 (D. Ariz. April 11, 2011), a pain pump case, in which the court threw out the plaintiff’s latest attempt to keep non-manufacturer competitors in the case. Specifically they claimed that one pump company (DJO) conspired with another pain pump company (I-Flow) “acted as promoters of