July 2015

Photo of Michelle Yeary

This post is from the non-Reed Smith side of the blog only.

That’s an admonition that plaintiffs in Cales v. Medtronic, Inc. should have heeded. Last November, they became another of the many InFuse plaintiffs to have the bulk of their claims dismissed with prejudice on the grounds of preemption, with non-preempted claims dismissed without prejudice for failure to plead with sufficient particularity. See Cales v. Medtronic, Inc., 2014 WL 6600018 (Ky. Cir. Ct. Nov. 21, 2014).  Rather than spending their time drafting a well-pleaded amended complaint for their remaining causes of action, plaintiffs moved for reconsideration.  Cales v. Medtronic, Inc., No. 14-CI-1774, slip op. (Ky. Cir. Ct. Jul. 1, 2015).  Not only was their motion denied — the court found a few other things that had slipped through the cracks that should have been dismissed as well.  In other words, plaintiffs aren’t any better off for their motion; in fact, their worse.

The crux of plaintiffs’ motion for reconsideration is that the court applied the federal TwIqbal standard of pleading rather than Kentucky’s “notice” pleading standard. It turns out that plaintiffs’ complaint was so poorly crafted that the error was harmless – plaintiffs’ complaint failed even the less-demanding requirements.

But plaintiffs’ complaint wasn’t the only thing poorly crafted.  So too were plaintiffs’ arguments on reconsideration.  The court spends pages of its decision admonishing plaintiffs for “selectively cherry-pick[ing] quotes from a number of unpublished appellate decisions and out-of-context dictum to support their argument that merely pleading bald, legal conclusions satisfies Kentucky’s liberal pleading standard.”  Cales, slip op. at 5.  Challenging plaintiffs’ “Frankenstein-esque construction of notice pleading,” id. at 7, the court is clear that notice pleading does not “relieve [plaintiffs] of a responsibility to produce some factual basis to support the elements of their various claims.”  Id.Continue Reading Be Careful What You Ask For

Photo of John Sullivan

The briefing is complete on Amarin’s motion for preliminary injunction.  The parties and several amici have all weighed in, and the court will hear oral argument tomorrow.

To this point, there has been significant back and forth between the FDA and Amarin.  Here is some of it.  The FDA argued that it mooted much of Amarin’s preliminary injunction request by sending its June 5 letter to Amarin.  We all saw that argument coming. Even though Amarin never asked for an FDA response to its proposed off-label promotion, it got one anyway.  In the June 5 letter, the FDA said that it “does not have concerns with much of the information [that Amarin] proposed to communicate.”  The FDA’s decision to send this unsolicited response appeared litigation driven and, unsurprisingly, it led off the FDA’s response brief:

The June 5 Letter makes clear that FDA does not object to Amarin’s distribution of summaries and reprints of the ANCHOR trial and journal article reprints, if Amarin takes the reasonable steps outlined in the Letter and ensures that such dissemination is truthful and non-misleading. June 5 Letter at 10.  Assuming Amarin takes those steps, then for all but one of the communications proposed in the Complaint, FDA would not rely on such communications in an enforcement action against Amarin.

(FDA Br. at 15.)Continue Reading The Court Will Hear Oral Argument Tomorrow Morning on Amarin’s First Amendment Challenge to FDA Off-Label Regulation

Photo of Steven Boranian

This is a quick-hit post as we head into the Independence Day holiday weekend.  The Southern District of West Virginia’s order this week in McNair v. Johnson & Johnson, No. 2:14-17463, 2015 WL 3935787 (S.D. W. Va. June 26, 2015), dismissed claims against the seller of an innovator drug for precisely the right reason: The defendant neither made nor sold the generic drug that the plaintiff ingested.  That is to say, there is no Conte-style “innovator liability” in West Virginia.

It seems obvious, doesn’t it?  It has been seven years since the California Court of Appeal issued its wrongly reasoned and wrongly decided opinion in Conte v. Wyeth, where the court held that a plaintiff who used a generic drug could sue the manufacturer of the listed version.  As we like to say, the court took the “product” out of product liability and held a company potentially liable for injuries allegedly caused by a product that it did not make and did not sell.  The late Roger Traynor and his colleagues on the California Supreme Court, who presaged strict product liability way back in 1944 in Escola v. Coca-Cola Bottling Co., must have rolled in their graves.

The Conte opinion has predictably become an outlier, and courts have rejected the opinion and its reasoning many times over, often expressly. (Check out our Innovator Liability Scorecard here and our survey of innovator liability here.)  As we reported here, the Alabama legislature abolished innovator liability just a few months ago, and we believe the California Supreme Court overruled Conte in Crane v. O’Neill, 53 Cal. 4th 335 (2011), where it held that a manufacturer has no duty to warn of hazards in another manufacturer’s product due to “foreseeability.”Continue Reading No Innovator Liability: National Drug Code Saves the Day

Photo of Stephen McConnell

On this date in 1896 the Dutch completed the harbor at IJmuiden.  (That capital J is not a mistake.  The I and J go together as a digraph, and they form a ligature that effectively makes up a single letter in the Dutch language.)  The IJmuiden harbor has an interesting history.  It connects Amsterdam to the North Sea via canals.  After the Germans invaded the Netherlands in 1940, the Dutch Royal family left the country from IJmuiden.  The Germans then used the IJmuiden harbor to house their torpedo boats and midget submarines.  After D-Day, the Allies bombed IJmuiden.  The American Air Force employed various weapons to penetrate the German concrete bunkers, including rocket-powered Disney bombs.  The bombs were named after war propaganda efforts by the Disney Studio.  Today IJmuiden harbor welcomes cruise ships.  It is a safe harbor.

(Yes, that is a rather long and pointless windup to get to our safe harbor case, but we are busily planning our Benelux Summer vacation, so you’ll have to excuse the travelogue/history.)

In the past we have had several opportunities to discuss state consumer protection laws containing “safe harbor” provisions that bar suits over conduct that was authorized, approved, or permitted by governmental agencies. Applying these safe harbor provisions, courts have dismissed consumer protection claims that attacked FDA-approved actions (usually labeling) after finding that the challenged conduct had the imprimatur of an agency.  One example was the DePriest case in the Arkansas Supreme Court.  The plaintiff in that case claimed that the defendant fraudulently marketed Nexium as better than older drugs that – allegedly – did essentially the same thing. The case was styled as an economic-loss-only class action.  The Arkansas Supreme Court threw the case out and we blogged about it here in 2009.Continue Reading Consumer Food Fraud Claim Sinks in Arkansas Safe Harbor

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