Subsequent Remedial Measures

It is always nice to win a case, whether by motion or trial. But just in terms of pure exhilaration, it is hard to beat hearing the jury foreperson announce that, after a hard-fought trial, you win. But note that term “hard-fought.” Most trials really are hard. They really are expensive. They really are stressful. The road to even the most resoundingly wonderful verdict probably had a couple of nasty potholes. That was the case with Horrillo v. Cook Inc., 2016 U.S. App. LEXIS 21026 (11th Cir. Nov. 23, 2016). Prior to trial, there was at least one Daubert ruling that couldn’t have pleased the defense. Also, as reported by our friends in the Abnormal Use blog, there was a learned intermediary ruling that we do not like one bit. But all’s well that ends well, right?

In Horrillo, the plaintiff brought a product liability action on behalf of his deceased mother, who had undergone a surgery to clear her renal artery. The surgery went terribly wrong, as the patient sustained a stroke. The opinion also does not tell us whether the plaintiff ever sued the doctor. The surgeon used a stent manufactured by the defendant. That stent was designed for use in bile ducts, but the surgeon used it off-label in this case. That off-label use was apparently not all that uncommon. The plaintiff’s legal theories included negligence and negligent failure to warn, strict products liability and strict failure to warn, and breach of warranty. After a nearly four-week trial, the jury returned a verdict in favor of the defendant. The plaintiff then moved for a judgment notwithstanding the verdict, or, in the alternative, a new trial. The trial court denied those motions, and the plaintiff appealed to the 11th Circuit. Applying the appropriate standards of review, the 11th Circuit affirmed the trial court’s rulings and the defense verdict.


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If you read the decision in Rossitto v. Hoffmann-LaRoche Inc., 2016 N.J. Super. Unpub. LEXIS 1714 (N.J. App. Div. Jul 22, 2016), we think you’ll agree with our calling it “strong” criticism of two trial rulings that the appellate court firmly believed led to undue prejudice of the defendant.  The $18 million verdict awarded to two of four plaintiffs in a joint trial was vacated and the case is being remanded for a new trial.  This is not the first Accutane plaintiff’s verdict to be vacated by New Jersey’s appellate division, but rather another notch in the demise of this litigation which has seen a turn in favor of defendant since coming under new management.  Indeed, a quick search of the DDL blog for Accutane will show how the tide has turned.

The Accutane litigation is primarily comprised of claims alleging that the manufacturer failed to adequately warn about the risk of inflammatory bowel disease (“IBD”).  Therefore, the drug’s label takes center stage.  Here, the plaintiffs both used the drug with its 1984 label that included a warning that “Accutane has been temporally associated with IBD.”  Id. at *8.  In May 2000, after plaintiffs had stopped using Accutane, the label was revised to remove the word “temporally” and to add information about persistent IBD symptoms.  Id. at *18.

Although only one of the plaintiffs was a New Jersey resident, the parties agreed that New Jersey law would apply to both.  Id. at *34.  So, New Jersey’s “super-presumption” applies – that is if the warning given has been approved by the FDA, there is a rebuttable presumption of adequacy.  Id. at *37.  Called a “super-presumption” because it is “virtually dispositive” on failure to warn, it can be overcome with evidence of intentional concealment of a known risk or “substantial evidence of economically-driven manipulation of the post-market regulatory process.”  Id. at *37-38.  Plaintiffs got to trial in these cases because the New Jersey courts have found that as to the 1984 label plaintiffs have put forth enough evidence from which a reasonable jury could conclude they had rebutted the presumption.  Id.  at *55-56 (citing prior Accutane decisions addressing this issue).   But it’s a strong presumption so we decided to take the time to remind you about it.


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Last weekend, we celebrated Mother’s Day.  As we contemplated the text message and the Tufts University mug we received from the Drug and Device Rock Climber, it occurred to us that we could hardly remember a time before that mercurial force of nature punched our admission ticket to this holiday.  There is only “after.”  And “after” – specifically, “after what?” – was the issue facing the United States District Court for the District of New Jersey in Brady v. Zimmer, Inc., 2015 WL 2092850 (D.N.J. May 4, 2015), a decision on a motion in limine filed by defendant Zimmer.

Brady involved a Durom Cup hip implant.  Plaintiff received the implant in a total hip replacement in August 2006.  About six months later, she “began experiencing a gradual increase in pain.” Brady, 2015 WL 2092850 at *1.  In 2007, Zimmer began receiving complaints that the Durom Cup was loosening after implantation.  It conducted an investigation from December 2007 to July 2008, then it suspended the sale of the Durom Cup for a month while it revised its training of surgeons.  Id.  In August 2008, after taking x-rays, Plaintiff’s physician concluded that plaintiff’s symptoms were due to loosening of her Durom Cup.  Plaintiff underwent revision surgery in December 2008 and received a replacement implant in April 2009.  Id.  She filed her Complaint in the Eastern District of Texas on March 8, 2010, and the case was subsequently transferred to the MDL pending in the District of New Jersey.  Id.


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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:  negligenceGood 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.


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This discussion of an opinion in the Pelvic Mesh litigation once again comes only from the Dechert side of the blog. The MDL court in the pelvic mesh litigation issued rulings on motions in limine last week.  In re: Bard, Inc. Pelvic Repair Sys. Prods. Liab. Litig., MDL No. 2187, 2:11-cv-00195, 2:11-cv-00012, 2:10-cv-01224, 2:11-cv-00114, 2013 U.S. Dist. LEXIS 90210 (S.D.W.V. June 27, 2013).  In previous pretrial rulings, the defense made out well, winning summary judgment on a number of plaintiffs’ claims, including a failure to warn claim in one case (see here and here), and winning a number of key Daubert motions (here).  Things didn’t go as well with the in limine motions.  It was more of a mixed bag.  Here are a few of the issues addressed by the court.

FDA 510(k) Clearance 

This was plaintiffs’ motion.  They wanted to exclude evidence related to the FDA’s clearance of the Avaulta products through its 510(k) process.  Id. at *4-6.  Seems pretty relevant, doesn’t it?  It’s the process established by the industry’s primary regulator as to what the industry must do and how it must do it in order to be able to bring its product to market.  Yet the court granted plaintiffs’ motion.

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One of the remand courts in the Aredia/Zometa litigation recently issued a decision on various motions in limine.  See Brown v. Novartis Pharmaceuticals Corp., 2012 U.S. Dist. LEXIS 104985 (E.D.N.C. July 27, 2012).  Here’s the rundown of the “good,” the “not-so-good,” and the “it depends.”
The good:
·                     Post-injury label changes: The court

With our focus on prescription drug and medical device product liability litigation, we sometimes overlook developments that occur outside the boundaries of our own little sandbox.  While that’s necessary to restrict the blog’s scope to something manageable, nonetheless it’s somewhat artificial.  Drug and device law doesn’t exist in some kind of vacuum, cut off from the rest of tort law.  What we do here sometimes affects other types of cases, and what goes on in other types of cases certainly can have significant impact on our clients.

One of the other things that Bexis does around here to make himself useful is to prepare monthly memoranda that summarize newly decided cases involving Pennsylvania tort and product liability law generally (he’s a glutton for punishment).  In that capacity, he came across Pennsylvania Trust Co. v. Dorel Juvenile Group, Inc., 2011 WL 3740472 (E.D. Pa. Aug. 25, 2011), which on its face has nothing to do with prescription drugs or devices.  Instead, it has to do with injury allegedly suffered from a child car seat.

The accident apparently happened when, for unknown reasons, the child’s mother plowed her minivan headlong into a tree.  The father originally brought the suit, but also for unknown reasons – possibly due to the parents’ questionable actions – a bank ended up as guardian ad litem.  See Pennsylvania Trust Co. v. Dorel Juvenile Group, Inc., 2011 WL 2789336 (E.D. Pa. July 18, 2011) (parents sanctioned for recklessly spoliating the product); Waltman v. Dorel Juvenile Group, Inc., 2009 WL 2877153 (E.D. Pa. Aug. 28, 2009) (parents entered into secret release, and then hid it during discovery).

The Dorel opinion at No. 3740472 addressed with a plethora of “in limine” (that means evidentiary matters presented before trial) motions.  We’re old enough to remember when in limine motions were thought of as unusual; but they’ve propagated faster than rabbits since we’ve been practicing – but back to the point.


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We included “Getting Better” among our allusions to Beatles songs in one of last week’s posts. It’s a light ditty from the Sergeant Pepper album and is an interesting example of a Lennon-McCartney song (on some early albums — er, LPs, er CDs — the writing credit for their songs was listed as “McCartney-Lennon”) because the optimistic McCartney-esque “it’s getting better” is counterbalanced by Lennon’s murmuring of “it couldn’t get much worse.” We side with McCartney on this issue and, indeed, on most issues. In the movie Vanilla Sky, the Kurt Russell character describes himself as a guy whose favorite Beatle used to be Lennon but, now that he’s the father of kids and has seen a few things, his favorite Beatle was now McCartney. We agree. Life is tough enough, and we need silly love songs more than primal screams.

One doesn’t have to believe in the myth of human perfectibility to have a healthy respect for progress. In this society, in this culture, at this time, things mostly are getting better. One might not have said that in Europe in 1100 or 1939. We hear a lot of grousing now about how our kids might grow up in a tougher world than ours. But improvements are all around us. Just look at dentistry. And American beer. Probably not preemption law.

Anyway, we should all support efforts to improve on things. Which brings us to the rule against admitting evidence of subsequent remedial measures. In one sense, it’s easy to see why subsequent remedial measures might be relevant to a claim of product defect. If the issue is whether a product should have been safer, does the manufacturer admit as much by making the product safer? A reflexive affirmative answer to that question is facile and foolish. The competitive marketplace is reason enough for manufacturers to try to improve their products. Further, at any given time, there is a state of the art. It’s simply unfair to suggest that a subsequent improvement proves that the earlier version was defective.


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Usually, when we’ve had occasion on this blog to touch on the Erie doctrine, it has been in the context of castigating one federal court or another for adopting an expansive view of state tort law in the absence of state court authority for that interpretation.

But there’s more to Erie than that, and