Adverse Event Reporting

As we blogged at the time, we believe that the Ninth Circuit made a historic error in Stengel v. Medtronic Inc., 704 F.3d 1224 (9th Cir., 2013) (en banc), when it equated routine product liability inadequate warning claims with indirect third-party warning claims where the third party is a governmental agency – that is, the FDA.  Validating such allegations could have much broader implications – on everything from statements made to insurance regulators to child abuse reporting requirements – but, even limited to the FDA, it creates precisely the same perverse incentive “to submit a deluge of information that the [FDA] neither wants nor needs” that supported preemption of other tort claims challenging the accuracy/completeness of FDA submissions in Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341, 351 (2001). But the Supreme Court denied certiorari in Stengel, so life goes on.

To the extent that Stengel had any redeeming feature, it is found in the 7-judge concurrence (a majority opinion, really, since 11 judges were sitting for the en banc decision), which recognizes that causation is particularly problematic where a federal agency with preemptive power is a middle-man in state-law litigation:

Because they predicate their claim on [defendant’s] reporting duty to the FDA, as they must to avoid express preemption, [plaintiffs] face a causation hurdle that would not otherwise exist.  To prevail, they will ultimately have to prove that if [defendant] had properly reported the adverse events to the FDA as required under federal law, that information would have reached [the prescribing] doctors in time to prevent [plaintiffs’] injuries. But at this juncture − a request for leave to amend their complaint – [plaintiffs’] allegations of causation are adequate.

Stengel, 704 F.3d at 1234-35 (concurring opinion). Stengel cited to the causation theory described in Hughes v. Boston Scientific Corp., 631 F.3d 762 (5th Cir. 2011):

[Plaintiff’s] primary causation theory is that if [defendant] had reported the true number of injuries and malfunctions related to [the risk] caused by the [device], this information would have appeared on the FDA’s MAUDE internet database [of adverse events reported about medical devices] and in medical journals, and with this information [the prescriber] would not have recommended the [device] to [plaintiff] for treatment.

Id. at 776.

Continue Reading Causation Issues in Failure-To-Report Cases – Post-Stengel Precedent

Desperate to get around preemption, in PM medical device and generic drug cases, plaintiffs have been pushing disguised fraud on the FDA claims under the rubric of “negligent failure to report.”  Even though such claims facially challenge the adequacy of information that a regulated party submits to the FDA (a Buckman no-no), some courts have

A couple of weeks ago, we talked about Westminster Kennel Club Dog Show.  We were eagerly anticipating the Best in Show competition, which was slated to feature a Standard Poodle – the breed of our heart – along with a Portuguese Water Dog whose record of wins was unprecedented in dog show history.  Based on this past record, the “PWD” was heavily favored to “take the Garden.” The Best in Show judge (few assignments in dogdom carry more prestige) built the tension in the sold-out stadium to a fever pitch.  The dogs submitted to painstaking “hands on” examinations, they “free-stacked,” they gaited.   And they gaited again.  Finally, the judge, flanked by AKC officials, strode purposefully to the table to “sign the book,” then returned to the center of the ring, microphone turned on, purple and gold rosette and trophy in hand.   He made a moving speech about the history of the event, and he praised the lineup of seven gorgeous group winners.   Pausing one more time for effect, he announced, “Best in Show at the 139th Westminster Kennel Club Dog Show is . . .  the Beagle!”  The Beagle? Make no mistake – “Miss P” is a spectacular show dog, with many Best in Show wins to her credit.  She is a striking example of her breed.  And she is very, very cute.   But it just wasn’t what we expected.

We also thought we knew what to expect when we began reading the recent decision of the Superior Court of New Jersey – Atlantic County — in the Accutane Multicounty Litigation. This litigation, in which plaintiffs allege that Isotretinoin (Accutane’s chemical name) causes Inflammatory Bowel Disease (“IBD”) and Crohn’s Disease (“CD”), has been pending since 2003, and we have been troubled, at times, about an apparent plaintiff bias. Appellate courts have agreed with us, overturning a number of plaintiffs’ verdicts. (See here and here, for example.)  But we were most pleasantly surprised this time.

In In re Accutane Litigation, 2015 WL 753674 (N. J. Super. Law. Feb. 20, 2015), the Court considered defendant’s motion to exclude plaintiffs’ general causation and biostatistics experts.  The Court explained that New Jersey applies a standard less stringent than Frye’s “general acceptance” standard, in determining whether expert testimony is admissible.  Under the guiding Rubanick decision of the New Jersey Supreme Court (125 N.J. 421 (1991)), “if the methodology by which the expert reached a conclusion is sound, the conclusion may be introduced into evidence.”  Accutane, 2015 WL 753674 at *4 (citation to Rubanick omitted).  Later, in Kemp v. The State of New Jersey,  174 N.J. 412 (2002), the Supreme Court held that the trial court was obligated to conduct an evidentiary hearing “any time an expert’s theory has not attained ‘general acceptance,’” and that the failure to do so is “plain error.” Accutane, 2015 WL 753674 at *6 (citations to Kemp omitted).  Hence the moniker “Kemp hearing” to describe hearings such as the one that was the subject of the Court’s decision.

Continue Reading A Pleasant Surprise from the Accutane MCL

We saw the movie “Whiplash” last weekend.  In this Oscar contender, a drum student at a prestigious music conservatory seeks the approval of a harsh and punishing conductor, as well as a berth in the conductor’s competition jazz band.  The film is so tense and so consistently painful to watch that it would not be accurate to say that we “enjoyed” it, but we wouldn’t have missed it for the world.

Early in the movie, the conductor demands that the student play several measures over and over and over again in a relentless and seemingly futile attempt to find the correct tempo. In today’s decision out of the Denture Cream MDL pending in the Southern District of Florida (thanks to David Walz at Carlton Fields for sending it to us)  Plaintiffs are back, beating the same drum, in a repeat attempt to surmount defendant Procter & Gamble’s (“P & G’s”) Daubert challenges to their general causation experts.  In re Denture Cream Prods. Liab. Litig., No. 09-2051-MD-Altonaga, 2015 U.S. Dist. LEXIS 9653 (S.D. Fla. Jan.. 28, 2015).  In these cases, Plaintiffs allege that, with long-term use of Fixodent denture adhesive, the zinc in the product causes copper deficiency and, ultimately, a neurological condition known as copper deficiency myeloneuropathy (“CDM”).  In 2011, the court granted P & G’s Daubert motions to exclude Plaintiffs’ general causation experts. See In re Denture Cream Prods. Liab. Litig. (Chapman, et al. v. Procter & Gamble Distributing, LLC), 795 F. Supp. 2d 1345 (S.D. Fla. 2011), aff’d, 766 F.3d 1296 (11th Cir. 2014) (“Chapman’).  As we discussed at the time, the Court held, “[Plaintiffs’] theory is not ridiculous, but neither is it necessarily true; it is ripe for testing.  . . . [T]aking everything together, there is enough data in the scientific literature to hypothesize causation, but not to infer it.”  795 F. Supp. 2d at 1367 (emphasis in original).  This past September, as we reported here, the Eleventh Circuit affirmed the District Court’ Chapman decision.

Continue Reading Rule 702 Decision Bites Denture Cream Plaintiffs Again

It takes time and effort to keep all our scorecards and cheat sheets up to date.  So we fell all over ourselves when a Reed Smith associate, Kevin Hara, offered to update our cheat sheet on adverse event reports.  The result is this guest post.  As you might guess, Kevin works out of the RS San Francisco office.  As with all guest posts, Kevin is due all the credit (and blame, if any) for what follows.  The AER cheat sheet has been simultaneously updated to include the case descriptions in Kevin’s post.


As the San Francisco Giants completed their biennial foray deep into the playoffs, on their way to a third World Series title in the last five seasons, it makes us think of Adverse Event Reports (“AERs”) and Medical Device Reports.  How exactly do we relate baseball to AERs?  The Giants have managed to advance to the World Series with a seemingly rhythmic frequency, in 2010, 2012, and again this year.  Baseball fans even joke that because 2014 is an even numbered year, that was why the Giants won.  Are the two things related?  Do people really believe that the digits on the calendar determine the fate of the Bay Area baseball franchise?  Or is it simply a coincidence, and not a cause and effect relationship? Is it not more likely that consistently good pitching, defense, and timely hitting along with good management are reason that the Giants are winning, and it just happens to fall on even numbered years (although until last night the Kansas City Royals of course disagreed)?  Although Kevin Costner’s soliloquy in Bull Durham captures the idea that baseball players in general take superstition to the extreme, and might argue that the Giants’ success is as simple as the calendar year, the answer of course, is yes, there is much more to the analysis.

A similar analogy can be drawn between using AERs as evidence of causation in pharmaceutical drug and medical device litigation.  There are numerous other potential explanations that may be more likely and one simply cannot draw a conclusion that a drug or device caused an adverse event based on AER data.  The publicly available FDA Adverse Event Reporting System “FAERS,” launched on September 10, 2012, clearly cautions that “[t]he appearance of a drug on this list does not mean that FDA has concluded that the drug has the listed risk.  It means that FDA has identified a potential safety issue, but it does not mean that FDA has identified a causal relationship between the drug and the listed risk.”

However, when required to submit evidence establishing medical causation of their injuries, plaintiffs in drug and device cases frequently attempt to submit expert opinions that rely heavily on AERs. As this blog has reported before, here, and here, AERs, often referred to as case reports, are not reliable indicia of causation.  A recent decision, Wendell v. Johnson & Johnson, which the blog covered here, underscored the fact that anecdotal evidence is not a reliable source of medical causation.  2014 WL 2943572, at *3-5 (N.D. Cal. June 30, 2014).  Although the experts in Wendell “cite[d] a handful of studies and case reports discussing possible causes of HSTCL, none of these purports to show that the specific combination of drugs prescribed to [plaintiff] actually causes HSTCL.”  Id. at *5 (emphasis added).  This straightforward application of the law of medical causation is elegant in its simplicity – if the plaintiff cannot show that the medicine, or in this case – combination of medicines – is even capable of causing the alleged injury, the defendant (rightly so)

Continue Reading Guest Post on Adverse Event Reports & Updating Cheat Sheet

Bad news arrives in all sorts of vehicles, not just product  liability suits.  For example, in a medical malpractice case, the E.D. of Tenn recently issued a ruling that admitted an FDA Alert into evidence.  Guthrie v. Ball,  2014 U.S. Dist. LEXIS 148900 (E.D. Tenn. October 17, 2014).  That ruling displeased us, but since to be forewarned is to be forearmed, we share it with you in an effort to get all of the week’s nasty rulings behind us before we are halfway through hump day.

In Guthrie, the plaintiff’s counsel sought to use an FDA Alert sent to physicians regarding the risks of fentanyl patches.  Specifically, the plaintiff’s counsel used the FDA Alert during depositions of expert witnesses.  It appeared that the plaintiff’s counsel was attempting to use the FDA Alert to establish the standard of care.  The doctor defendant filed a motion in limine to exclude the FDA Alert on the ground that it was inadmissible hearsay to which no exception applied, including the 803(8) hearsay exception.  Among other things, the defendant argued that the FDA Alert did not contain a statement identifying the office responsible for the alert or reflect the FDA’s activities, did not indicate whether it pertained to a matter observed under a legal duty to report, and did not appear to reflect actual findings from a legally authorized investigation.  Rule 803(8) creates an exception to the hearsay bar for “[a] record or statement of a public officer if: (A) it sets out: (i) the office’s activities; (ii) a matter observed while under a legal duty to report …; or (iii) in a civil case …. factual findings from a legally authorized investigation; and (B) the opponent does not show that the source of information or other circumstances indicate a lack of truthworthiness.”  Fed.R.Evid. 803(8).

Continue Reading FDA Alert based on Adverse Event Reports Admitted in Med-Mal Case

Our recent post on the outcome of the plaintiffs’ in limine motions in the Guenther Aredia/Zometa case prompted a volcanic retort from one of the plaintiffs’ counsel (who will remain anonymous) that “all was not beer and skittles” (yech – not an appetizing combination) for the defense, specifically listing the court’s rejection of a defense “paper storm” and “preemption based in limines.” Attached to counsel’s emails were an order striking an original set of defense in limines as too darn long and a second order resolving a choice of law dispute in favor of Florida, rather than Georgia, law.  Why a plaintiff would prefer Florida law in prescription drug product liability litigation case escapes us; some of us remember the excellent Florida law on causation and the learned intermediary rule that led to huge defense wins in the Seroquel litigation.

At about the same time as that email, one of our automatic searches pulled up the opinion on the Guenther defense in limines, which counsel had referenced but did not attach.  See Guenther v. Novartis Pharmaceutical Corp., 2013 WL 4648449 (M.D. Fla. Aug. 29, 2013).  Because (as counsel noted) we are interested in preemption issues – even hard ones for our side, which certainly includes preemption in innovator drug cases post-Wyeth v. Levine, 555 U.S. 555 (2009) – we took a look. Hmmmm.

For a post-Levine decision, we actually don’t think the rulings are all that bad.  In fact, since the opinion provides a road map for possible future preemption inroads, we think this Guenther decision is worthy of comment.

Continue Reading More On Aredia/Zometa – Innovator Drug Preemption

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

We’ve been reading the Keith Richards autobiography, Life, and it made us think about the past. The Rolling Stones were formed 50 years ago, in April 1962. We were Beatles fans in the 1960’s. (Still are). When the Rolling Stones showed up on The Ed Sullivan Show they seemed sort of terrifying. (Still are.)

A topic of repeated interest for us is how courts treat evidence of adverse event reports.  And we haven’t been shy about how we feel — AER’s should not be used in a civil trial.  AER’s are voluntary, biased (sometimes litigation-generated), and should not be used to calculate incidences of drug risk. AER’s are not the stuff of good science.  We’ve even put together an Adverse Event Report Cheat Sheet  filled with cases laying out compelling reasons for excluding AER’s.

So, why are we re-hashing this already well trod ground?  Well because in railing against the use of AERs in the courtroom, we’ve often distinguished the FDA’s reliance on AERs on the basis that the FDA can act in the public interest on a lower quantum of evidence than is necessary to establish causation in a products liability suit.  A recent report by the FDA, however, has left us wondering just how helpful AERs are to even the FDA.  The purpose of the report, entitled Understanding Barriers to Medical Device Quality was “to assess and understand gaps in medical device quality.”  FDA Report at 3.  While the FDA didn’t rely exclusively on AERs, they were a driving factor in the FDA’s apparent conclusion that medical device quality has significantly lagged behind medical device technology.  While we will leave a more thorough discussion of the four corners of the report to our friends at the FDA Law Blog, we thought it worthwhile to point out how even the FDA’s use of voluntary AERs can lead to false conclusions.

Continue Reading More Reasons to Discount Adverse Event Reports