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

Modglin v. DJO Global Inc., 2015 U.S. Dist. LEXIS 60812 (C.D. Cal. May 8, 2015) is one of those cases that has so much good stuff going on, we just want to dive right in.  It is the complete dismissal with prejudice of an attempt to state a False Claims Act (“FCA”) case against the manufacturers of Pre-Market Approved (“PMA”) bone-growth stimulators based on allegations that the manufacturers were aware their products were being used off-label – a fact they failed to disclose to Medicare and other federal healthcare plans when submitting claims for reimbursement.  We’ve got allegations of fraud, connected to off-label promotion, surrounding a PMA medical device and all tied up in a dismissal with prejudice.  It’s like package wrapped in shiny paper with a big red bow on top.  As pretty as the trappings are, we’re still going to rip them off to see what’s inside. And we don’t think you’ll be disappointed.

Relators’ specific allegations are that defendants requested reimbursement for stimulators approved for lumbar spine use when they knew that the stimulators were being used with the cervical spine – an off-label use – which they claim is not allowed.  Id. at *25.  So, what is allowed?  Under the Medicare Act, to be reimbursed, the device must be “reasonable and necessary” for diagnosis or treatment.  Id. at *13.  The Department of Health and Human Services (“HHS”) has decided that PMA devices generally can be reimbursed.  Id. at *15.  So far so good for stimulators.Continue Reading California Federal Court Gets Tough on Off-Label Promotion FCA Claims

Back in February, we hosted a guest post about United States ex rel. Rostholder v. Omnicare, Inc., 745 F.3d 694 (4th Cir. 2014), an extremely important False Claims Act (“FCA”) decision for the defense-side’s effort to prevent the FCA from being converted into an improper private enforcement mechanism for the FDCA.

We’ve got more news.  Certiorari has been denied.

Here’s a much briefer guest post (see our original one for details of the original decision) from Reed Smith partner Colin Wrabley (a member of the victorious team), putting this latest development in context.  As always our guest posters get all the credit (and any blame) for their work.Continue Reading Another Guest Post on Rostholder FCA Developments

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.
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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?

In stark contrast to the “MDL treatment” that the Valsartan plaintiffs received earlier this year, the decision in Post v. Amerisourcebergen Corp., 2023 WL 5602084 (N.D.W. Va. Aug. 29, 2023), was more mainstream.  Class certification was denied for a variety of good reasons.

Unlike the result, the Post class action allegations, were relatively unusual.  The members of the class were all patients of the same physician.  Plaintiffs alleged that “defendants” “unlawfully made payments to [the physician] to induce him to misdiagnose” them so that they were eligible for the product at issue.  Id. at *1 We’re not 100% sure, but only one of these “defendants” apparently was the product’s manufacturer.  Plaintiffs sought “the return of every payment made from every source” for this treatment – essentially, they wanted after-the-fact (Post-hoc?) free medical care.  Id.  In addition, they demanded various damages for “invasion of privacy” and “negligence,” as well as punitive damages.  Id.

And they wanted this all as a class action.

The Post reaction?  No way.Continue Reading Post-Out Sticky Notes

We have been reporting on third party payer/payor (“TPP”) litigation for a long time.  This category covers a range of causes of action and allegations but boils down to boils down to insurance companies or other entities trying to recover amounts they paid for patients to receive medical products because the manufacturers or sellers…

A little while ago, Bexis attended a Lawyers for Civil Justice semi-annual meeting, at which he received that organization’s “Outstanding Contributor Award” (in full disclosure, so did a half dozen other members).  With the soon-to-be-adopted amendments to Fed. R. Evid. 702 having now been approved by the Supreme Court (with only the unlikely step of a congressional veto remaining), the question was what happens next.

These amendments expressly enshrine the expert “gatekeeper” function in the text of Rule 702.  The next step is whether they can be duplicated – or paralleled − in state rules of evidence.  We think that they can, and for a state (like Pennsylvania and a number of others) that still follows the “Frye” standard looking to the “general acceptance” of expert testimony as the touchstone to admissibility, a Rule 702 state-law equivalent might look something like this:Continue Reading 50-State Survey of State Court Decisions Supporting Expert-Related Judicial Gatekeeping

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. …

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