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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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Bexis was away on vacation last week.  When he returned, he found four more reasons why we (on the defense side) should love TwIqbal. These four opinions have been duly added to our TwIqbal Cheat Sheet, but they deserve more mention than that:

Maybe An Advisory Opinion – But A Good One

In…

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Most of the opinion in Riley v. Medtronics [sic], Inc., C.A. No. 2:10-01071, slip op. (W.D. Pa. Aug. 8, 2011), is a fact-specific statute of limitations discussion – oddly occurring in the context of a motion to dismiss – about a less-than-diligent plaintiff who did next to nothing until the statute had almost expired…

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This post is largely about drug and medical device litigation “inside baseball.” Some of it’s going to be really technical. So if you’re looking for philosophical musings, or just a chuckle or two over the latest bizarre goings on in our neck of the woods, come back later.
But if you’ve ever had to worry…

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We’ve previously offered our collective four cents worth about tactical considerations that pharmaceutical defendants need to think about in deciding whether or not to bring preemption motions in particular cases. Given the importance of the issue, and (until 2008) the relative equipoise in the opposing positions, we strongly recommended the Hippocratic Oath – “First, do…

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Today we’re thinking about evidence – specifically FDA evidence. There’s a lot of different kinds. There are FDA approval letters, something we usually want to get in. There are FDA warning letters, Something that we always want to keep out. The same can be said for adverse drug and medical device reports, which we’ve already…