2014

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Today’s post would normally come from our artsiest contributor.  We expect that such a post would compare some decision to the movies for which awards were handed out at Sunday’s “Golden Globes,” possibly with a comment about how the Oscars are more important.  We did not see the “Golden Globes,” are unlikely to see the Oscars, and saw few of the movies/performances nominated for the major awards.  All that we can go off of at this point are the lists of winners and nominees.  Whether we agree with the decisions on the merits cannot be determined at this time. The most we can say is that we would respect the process.

This brings us to a tidy Missouri state court summary judgment decision in McDonald v. Cox, No. 1231-CV02646 (Mo. Cir. Ct. Jan. 2, 2014), which comes to us from Mike Carroll at Shook.  While a defense win on preemption from Missouri—not exactly our favorite jurisdiction of late—is of interest to us, we can only say so much.  We can see that the process was followed as it should have been—not always a foregone conclusion when the process results in judgment for device manufacturer defendant—but not enough to judge the merits.  This is because, proving the adage that a (wo)man who is his/her own lawyer has a fool for a client, the pro se plaintiff failed to respond to a well-supported motion for summary judgment based on preemption.  As we know, pro se plaintiffs can get a little extra leeway despite law, like cited in McDonald, stating that the same standards apply to them. Perhaps because the plaintiff was an “inactive attorney,” he suffered consequences of failing to respond that a lay pro se plaintiff might have avoided.  (Or, perhaps, this sort of diligence is why plaintiff was not an active attorney.) Regardless, we feel a little bit cheated out of what could have been a more interesting read—and a more significant win—if plaintiff had put up the kind of fight presaged by amending his complaint and filing motions for default.Continue Reading Class III Walkover in Missouri

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This just in. The Supreme Court decided two important cases today. In Mississippi v. Hood, No. 12-1036, the Court held that state attorney general actions do not qualify under CAFA for removal to federal court under that statute’s minimal diversity standards for “mass actions.”   The decision was unanimous, and it primarily turned on…

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Last year (that is 2012), we named Pom Wonderful LLC, v. Coca-Cola Co., 679 F.3d 1170 (9th Cir. 2012), as number eight in our top ten decisions.  Here’s how we summarized the case:

Pom Wonderful LLC, v. Coca-Cola Co., 679 F.3d 1170 (9th Cir. 2012). This is another case that suffers a bit…

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We don’t get to write much about the Federal Circuit.  It is unique in our federal court system in that it has nationwide jurisdiction over specialized subjects, most notably patent and trademark.  We are guessing the Federal Circuit sees a lot of drug and medical device cases as companies dispute intellectual property rights of one kind or another, and we picture the judges and clerks reading densely packed briefs written by engineers-turned-lawyers who are able to explain how one thing “teaches from” another, or how this thing “reads onto” that.  Patent lawyers and the judges they practice before have their own language, which makes us admire them all the more.

We are also guessing that the Federal Circuit does not see a lot of the FDCA.  A quick search of published Federal Circuit opinions found that the Federal Circuit cited the FDCA just once in all of 2013.  Did you think that we at the Drug and Device Law Blog would miss such a momentous event?  Certainly not, and we are doubly excited to report that the case at hand involved federal preemption of a state unfair competition statute, even though the opinion came out the wrong way.

The case is Allergan, Inc. v. Athena Cosmetics, Inc., No. 2013-1286, 2013 U.S. App. LEXIS 25746 (Fed. Cir. Dec. 30, 2013), which started unsurprisingly as a patent dispute.  The plaintiff Allergan sells a product called Latisse, a prostaglandin derivative and FDA-approved prescription drug indicated for eyelash growth.  Readers might recall the commercials for Latisse that ran a few years ago featuring Brooke Shields, the forty-something actress whose accomplishment-to-notoriety ratio is shockingly low.  But we digress.  The defendant Athena Cosmetics also sells a prostaglandin derivative for eyelash growth, but it does so without the FDA’s approval.  It seems the cosmetic manufacturer defendant considered the product to be the same as mascara and fingernail polish, which do not require approval through new drug applications (“NDAs”) if they affect only a person’s appearance.Continue Reading Federal Circuit Bats An Eye At FDCA Preemption

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We’ve covered a lot of topics since we started DDLaw in late 2006.  One that we haven’t addressed in any real fashion is overwarning – except for an unusual allegation made by a plaintiff that a defendant was “hiding” a warning among too many other warnings.  Cf. Kendall v. Hoffmann-La Roche, Inc., 2010 WL 3034453, at *22 (N.J. Super. App. Div. Aug. 5, 2010) (plaintiff complained that a drug’s warnings focused “predominantly” on birth defects and suicide but only “alluded to” about her condition (“abdominal and bowel problems”) in a “less conspicuous or pointed manner”).

We remedy that today.

Usually, the concept of overwarning is asserted by a defendant – that the plaintiff is threatening the usefulness of warnings about serious, relatively frequent risks by demanding that a defendant include a plethora of warnings about less serious and/or less frequent risks, or otherwise seeks to clutter up the defendant’s warnings with details of one sort or another.  As the Supreme Court observed, albeit not in the product liability context, “[m]eaningful disclosure does not mean more disclosure.  Rather, it describes a balance between competing considerations of complete disclosure and the need to avoid informational overload.”  Ford Motor Credit Co. v. Milhollin, 444 U.S. 555, 568 (1980) (citation and quotation marks omitted).  A typical critique of the problem of overwarning in the general (non-drug/device) product liability context occurred in Liriano v Hobart Corp., in consideration of the “open and obvious” limitation on the duty to warn:

[W]hen a warning would have added nothing to the user’s appreciation of the danger, no duty to warn exists as no benefit would be gained by requiring a warning. . . .  This is particularly important because requiring a manufacturer to warn against obvious dangers could greatly increase the number of warnings accompanying certain products. . . .  Requiring too many warnings trivializes and undermines the entire purpose of the rule, drowning out cautions against latent dangers of which a user might not otherwise be aware.  Such a requirement would neutralize the effectiveness of warnings as an inexpensive way to allow consumers to adjust their behavior based on knowledge of a product’s inherent dangers.

700 N.E.2d 303, 308 (N.Y. 1998) (citation omitted) (emphasis added).  Here’s another:

[T]he proliferation of label detail threatens to undermine the effectiveness of warnings altogether.  As manufacturers append line after line onto product labels in the quest for the best possible warning, it is easy to lose sight of the label’s communicative value as a whole.  Well-meaning attempts to warn of every possible accident lead over time to voluminous yet impenetrable labels-too prolix to read and too technical to understand.Continue Reading On Overwarning

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So, in case you’ve missed every national news report over the last 24 hours – it’s cold outside.  Really cold.  The media is calling it Polar Vortex 2014 – because it’s nothing without a catchy name and graphic.  Weather reporters are demonstrating how long it takes anything from a wet t-shirt to a hamburger to freeze outside.  To the reporter who was stunned that her water froze this morning, I suggest you re-acquaint yourself with what happens in your freezer every day.  Social media sites were over loaded with Canadians sending tips to their southern neighbors on how to beat the cold.    All this hype over cold weather also prompts anyone over the age of 40 (which means us too) to seem to recall whole winters where the temperature never went above 20 degrees.

The bottom line – it’s winter.  Those of us above the Mason-Dixon Line should have the necessary gear to make it through a few days of real cold.  For those of you who aren’t used to it dipping below 65 – gloves, scarves, extra socks and let your car warm up for at least 10 minutes before heading out.  That about covers it.  Cold weather in January just doesn’t seem like something that warrants this much excitement.  After all, it’s not like a blogworthy pharmaceutical case out of Idaho.  Now that’s news.

The case is Wilson v. Amneal Pharmaceuticals, L.L.C., 2013 U.S. Dist. LEXIS 181953 (D. Idaho Dec. 31, 2013).  Plaintiff alleged he developed Stevens-Johnson Syndrome (a severe skin condition) as a result of taking the generic version of the prescription antibiotic Bactrim, manufactured by the defendant.  Attached to its answer to the complaint, Defendant included the first FDA approval of Generic Bactrim, the FDA’s acknowledgement of transfer of ownership of the ANDA to the defendant, and three versions of the label for Generic Bactrim.  Id. at *4-5.  When the defendant moved to dismiss the complaint, it asked the court to take judicial notice of those documents as well as the FDA approval letter for brand name Bactrim and two FDA approvals of label changes for the brand name drug.  Id. at *6.  Plaintiff objected to the judicial notice request, arguing that defendant’s motion should be converted to a motion for summary judgment and that in turn plaintiff be afforded an opportunity to conduct discovery before the motion was ruled on.Continue Reading Idaho Says No to Generic Liability and Yes to Judicial Notice

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FDA-regulated products now account for an estimated one-fifth of overall economic activity in the U.S. They have also been the focus of a litigation explosion. This timely guide covers all aspects of litigation involving drugs, medical devices, vaccines and other FDA-regulated prescription products.
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