Because it is Christmas Eve, we are going to keep this one short and light.  After all, there are still presents to be purchased, gifts to be wrapped, cards to be mailed, stockings to be stuffed, and pies to be baked. While we would strongly encourage you to take a minute out of the hustle and bustle to peruse the Drug and Device Law blog, this time of year we can’t help but recommend a few other yuletide/ year-end activities.  Whether you are caught up in the Christmas hoopla or simply in the everyday frenzy of life, Christmas Eve can be great night for a relaxing drink (warm tea, mulled wine, vodka martini – the choice is yours) and a good movie, TV show, or book.

For example, if, like some of us, the only time you get to the movies is to see the latest Disney animation (although Monsters University was good), you may still be able to find one of these playing somewhere:  Prisoners (Hugh Jackman as a desperate father trying to protect his family); Gravity (George Clooney and Sandra Bullock in space, meant to be seen on the big screen); Captain Phillips (Tom Hanks and the Somali pirates hijacking); Blackfish (documentary on orcas, very powerful); and The World’s End (latest Simon Pegg comedy, if you like “Shaun of the Dead” and “Hot Fuzz” this is a must see).  Or, there are the new releases.  We haven’t seen them but it seems like you could have a good time at:  American Hustle, Dallas Buyers Club, Anchorman 2, or Saving Mr. Banks.  And this doesn’t even include the movies opening Christmas Day.

Or, how about what you missed on TV this year.  You could take the day to catch up on Scandal (wow, Olivia’s parents).  We’ll watch just about anything with James Spader and Blacklist didn’t disappoint.  Did you see the finale of Breaking Bad? (both logically and emotionally satisfying)  And, don’t forget Netflix originals like Orange is the New Black or House of Cards.  Did you know Arrested Development is back too?

And, if movies and TV aren’t your thing, there’s still time to download a good book.  We know there are plenty out there to choose from, but the one’s we can recommend (won’t speak for what we haven’t read) are And the Mountains Echoed by Khaled Hosseini (author of the “Kite Runner” and “A Thousand Splendid Suns” – if you haven’t read those, start there); The Good Lord Bird (a slave boy must pass as a girl when joining John Brown’s antislavery crusade); Life After Life (an interesting tale of a women who is continually re-born); and Empty Mansions (a fascinating story of America in the 19th century and a modern battle over a staggering inheritance (non-fiction)).

We know there is more out there in all three genres – and we’re sure McConnell will have a few words especially about the movies and TV – but those lists should keep you busy through at least the New Year.  Before you tune us out for one of these entertainment choices, however, we do have a new case to tell you about:  In re Actos (Pioglitazone) Prods. Liab. Litig., 2013 WL 6328263 (W.D. La. Dec. 3, 2013).

First, we have to tell you that this decision involves a medical monitoring claim under New York law (anticipated costs if plaintiff’s bladder cancer recurs). At the time this decision was rendered, the court was applying Askey v. Occidental Chem. Corp., 102 A.D.2d 130 (4th Dept.1984).  But, as we recently reported, New York has now rejected claims for medical monitoring.  So, we aren’t interested in this case for its discussion of the underlying claim. Rather, what drew our attention was the court’s discussion of whether plaintiff’s experts’ opinions satisfied the federal standard for relevancy.

Most Daubert challenges that we post on are about the reliability of the expert’s methodologies and opinions, but Daubert and Federal Rule of Evidence 702 both also require the court to determine if an expert’s opinion is relevant.  To be relevant, the opinion must “help the trier of fact to understand the evidence or to determine a fact in issue.”  In every court we can think of, that means an expert’s opinion must be stated to a reasonable degree of certainty or probability.  There are slight variations, but in general, an expert has to be willing to say that he or she is more certain than not.

That was what the defendant was challenging in In re Actos.  Under New York federal law, to be relevant and therefore admissible, a physician’s opinion must be stated to a reasonable degree of medical certainty which has been defined as “a greater than 50% chance.”  In re Actos, 2013 WL  6328263 at *3. In this case, that meant a greater than 50% chance the plaintiff’s bladder cancer would recur, but the same standard would apply if the issue was whether product X caused plaintiff’s injury.

The court determined that plaintiff’s evidence didn’t meet this standard.  Plaintiff’s experts were willing to testify that plaintiff was at “a very high risk” of recurrence and when asked to quantify, they put the risk in the 8% to 35% range – well below the New York standard.  Id.  The court also found that plaintiff’s proffered opinion testimony should be excluded under Federal Rule of Evidence 104-403:

[N]either the experts who quantified the risk of a muscle-invasive bladder cancer, nor those experts who merely described that risk-included any indication that [plaintiff] will, to any acceptable degree of medical certainty, develop muscle-invasive bladder cancer within the next five years. Consequently, based upon the testimony presented, this Court would find on a F.R.E. 104–403 analysis the evidence of costs/damages for muscle-invasive bladder cancer to be too speculative, and whatever probative value it might have to be is substantially outweighed by unfair prejudice, confusion of the issues, and the potential to mislead the jury.

Id. at *4.

This isn’t a monumental or ground-breaking decision, but we found it noteworthy as the relevance side of Daubert challenges usually doesn’t get much attention.  So, it is another thing we remind you not to overlook – just like some of the best entertainment of 2013.  Merry Christmas!