Here is another post by Reed Smith’s Eric Alexander, quasi-member of our blog.  At this point, we think he’s only holding off becoming a full blogger because as long as he doesn’t have his own blogger account, somebody else (like Bexis) has to take the time to input his posts.
We welcome ourselves back after our hiatus.  Not that blogging/blawging is not real work, but we sometimes have clients pay for our quips—and, perhaps, occasional legal insights.  Plus, the product liability decisions have been fairly slim, particularly after more venerable—they would say venerated—posters call “dibs.”  So, we wade into the wonderful world of the False Claims Act (FCA).  We products lawyers might say that we sometimes view FCA cases as red headed stepchildren if we were not a little afraid of retribution from the soulless GLA (Ginger Liberation Army).  Since we will not say such a thing, we will say that FCA cases do not involve plaintiffs with real or trumped-up physical injuries or state court judges and juries.  They do involve issues of compliance with FDA regulations, some Latin phrases, and often a “U.S.” on the other side of the v.  That makes them relevant to what we do and what this ABA-nominated blog does.  (Non-products lawyers can vote too.  There is no hair color or prevalence requirement.  That comes from a footnote in the Harper v. Virginia Board of Elections on poll taxes.  Bexis says it is precedential; McConnell says it is only dicta because it does not use a form of the words “hold” or “find.”)
U.S. ex rel. Polansky v. Pfizer, Inc., No. 04 Civ. 0704 (BMC), 2012 U.S. Dist. LEXIS 163557 (E.D.N.Y. Nov. 15, 2012), is the final dismissal of a FCA case filed in 2004 that was on its Fifth Amended Complaint at the end.  Setting aside why it took eight years and six complaints to get rid of what was ultimately not a cognizable claim, this is a nice decision.  We cannot quite set aside that the U.S. chose to intervene in this case and the chance that its intervention increased the lifespan and defense costs of the case.  The basic claim was that the defendant promoted its product (Lipitor) off-label, allowing for Medicare and Medicaid to pay for prescriptions written and filled for patients who were not within the approved indication for the product.  That part is pretty standard.

Continue Reading FCA, FDA, What’s The Difference?

The Orthopedic Bone Screw litigation would never have occurred – and Bexis might never have found his way to prescription medical product liability litigation – if not for the Kessler-era FDA’s ill-considered salami slicing of the “intended use” of that product.  In that instance, the FDA had limited its cleared “intended use” to disc spaces

We’re tired – Tired of blatant lying about COVID-19 and the vaccines that can stop it.  Tired of miserable, selfish people who won’t take basic, proven health precautions to combat COVID-19, endangering not only themselves, but everyone else as well.  We’re tired of obstructionist politicians who cynically seek to prolong the pandemic for political ends. 

The defense response to so many plaintiff allegations amounts to: so what? What difference did the complained of conduct make? Think of medical causation. Or think of warning causation in the context of a learned intermediary. In securities cases or, closer to our DDL hearts, False Claims Act cases, the ‘so what’ arrives dressed in

We’ve already provided two “reports from the front” about how the federal government is faring in False Claims Act cases where it has moved to dismiss actions over the objections of the relators supposedly pursuing recovery in the government’s name.  Here’s a third one, about Polansky v. Executive Health Resources, Inc., ___ F.4th ___,

The recent appellate False Claims Act (“FCA”) decision in Dan Abrams Co. LLC v. Medtronic Inc., ___ F. Appx. ___, 2021 WL 1235845 (9th Cir. April 2, 2021), has us scratching our heads.  It’s like riding a legal roller coaster.  Some parts are really high, and others are really low.

Bexis first ran across

Not long ago we brought you a report from the False Claims Act (“FCA”) front on how the government was doing with its attempts to prune back some of the worst abuses of FCA litigation – particularly the advent of “professional relators.”  In that earlier post, we discussed the two major approaches that courts