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We have today another False Claims Act case in which the plaintiff—or, we should say, “Relator”—alleges that reimbursement claims made to the government for drugs purchased for off-label uses are false claims.  United States v. Solvay S.A., 2015 U.S. Dist. LEXIS 166639 (S.D. Tex. Dec. 14, 2015).  That’s nothing new.  But “Relator” did something to make it a little more interesting.  He couldn’t argue that Medicaid hadn’t authorized reimbursement for the off-label uses at issue in this litigation.  It had.  Medicaid authorizes reimbursement for off-label uses of a drug if a qualified compendium cites clinical studies supporting that use for that drug.  And a qualified compendium had done so here.

But “Relator” didn’t accept that.  He attacked the validity of the inclusion of the studies in the compendium.  He alleged that the pharmaceutical company tricked and cajoled the compendium company into listing those articles, pointing to all the types of evidence that we have seen over the years in product liability cases:  Suppressing bad studies.  Manipulating data.  Ghostwriting articles.  Obscuring bad results by hiding the true number of dropouts from studies.  Publishing articles in non-peer-reviewed supplements.  “Relator” claimed that these improper tactics by the pharmaceutical company created misinformation and misleading studies that the compendium was tricked or wooed into citing.  And, on that basis, “Relator” asserted an FCA claim against the pharmaceutical company.

Continue Reading Happy Holidays to “Relator”

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Sometimes it takes an outsider to point out  something that should be blindly obvious.  In this case, that role was performed by a couple of our colleagues earlier this month at the annual ACI Drug and Medical Device Litigation Conference.  They both told us how useful they found the new – adopted in 2015 − Pennsylvania Suggested Standard (Civil) Jury Instructions (“Pa. SSJI Civ.”) on the learned intermediary rule in prescription drug and medical device litigation.  So we thought we’d introduce them to you.  Here they are:

23.00 (Civ) Duty to Warn − Reasonable Care

In the case of prescription [drugs] [medical devices], the manufacturer has an obligation to exercise reasonable care to inform the plaintiff’s prescribing physician about the risks of its product.  Such a manufacturer has a duty to warn about risks of its products that are not generally known, if the manufacturer knew or reasonably should have known about the risks of its product.

23.10 (Civ) Duty to Warn Physicians, Not Patients − Learned Intermediary Rule

A drug or medical device manufacturer only has a duty to warn the [prescribing] [implanting] physician about the dangers of its [drugs] [medical devices].

It does not have a duty to warn patients directly.

If you find that the defendant adequately warned the plaintiff’s [prescribing] [implanting] physician, even if the physician did not transmit that information to the plaintiff, you must find for the defendant on the failure-to-warn claim.

23.20 (Civ) Different Warning

The plaintiff has the burden of proving both of the following:

  1. that the defendant did not adequately warn the [prescribing] [implanting] physician about the risks of its [drug] [medical device], and
  2. that the [prescribing] [implanting] physician would not have [prescribed] [implanted] the [drug] [medical device] if a different warning had been provided.

23.30 (Civ) Physician’s Knowledge − Other Sources

A pharmaceutical or medical device manufacturer that fails to adequately warn the [prescribing] [implanting] physician about the risks of its [drug] [medical device] is not liable if the physician was aware of the risks from medical literature or other reliable sources.

If you find that the plaintiff’s [prescribing] [implanting] physician already knew about the risks of the defendant’s [drug] [medical device] when he or she decided to [prescribe] [implant] it [to] [in] the plaintiff, then you must find for the defendant on the negligent failure-to-warn claim.

Continue Reading Introducing the New Pennsylvania Learned Intermediary Jury Instructions

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Discovery was so much easier when we prosecuted federal criminal cases.  We got no discovery from the criminal defendant.  That is not to say we were not entitled to any; we simply did not get it.  Never mind.  We’ll convict you, anyway.  In the other direction, we pretty much produced our whole file.  If there were things in the file that could not help the defendant, why not turn it over?  And if it could conceivably help the defendant, then the the SCOTUS Brady decision says we are required to turn it over.  So, aside from redacting personal information regarding our CI (that is, confidential informant – we weren’t keen on disclosing home addresses to the cartels), we handed everything to the other side, usually with a smirk.

But civil discovery is an entirely different deal.   The cases are not the one-sided gimmes that they are in the criminal system, and discovery, courtesy of the ESI scourge, is extraordinarily burdensome.  Lines must be drawn.   The problem arises when courts adopt the attitude that anything goes and that overreaching plaintiffs deserve whatever they want.

Continue Reading N.D. Mississippi Says “Bah, Humbug!” to Discovery on Devices Not Used

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Have you ever seen a superbly qualified expert give an opinion that is utterly unsupported? That is what happened last week in In re Lipitor (Hempstead v. Pfizer), No. 2:14-cv-1879, 2015 WL 9165589 (D.S.C. Dec. 11, 2015), and the district court did an admirably methodical job putting the kibosh on it. The expert was a former Rhodes Scholar, trained at top universities, and was the director of the endocrinology and metabolism division at a prestigious teaching hospital on the west coast. Yet, she seemingly allowed plaintiffs’ lawyers to lure her into placing her reputation at jeopardy by giving a medical causation opinion that was obviously wrong and boiled down to little more than “because I said so.”

Of course, we are oversimplifying, but not by much. The product was Lipitor, a statin, which is one of the most useful and health-promoting drugs in history. Even Consumer Reports, which is run by consumer advocates, has said that statins reduces the risk of heart attack, heart disease, and death and that statins are quite safe overall. But Lipitor is also one of the best selling drugs in history, which has attracted reams of litigation. The allegation du jour against Lipitor is that it causes Type-2 diabetes, which is curious since adult weight gain is a major risk factor both for Type-2 diabetes and high cholesterol. Do you think maybe people taking statins also show an increased prevalence of Type-2 diabetes because they are overweight or obese? Hmm.

Anyway, back to our wayward expert, Dr. Elizabeth Murphy. The plaintiff in Hempstead took Lipitor off and on starting in 1999 and was diagnosed with new-onset diabetes five years later. 2015 WL 9165589, § II (the order was just posted to Westlaw, so there is no star pagination yet.) Naturally, she sued Lipitor’s manufacturer and had the good fortune of being selected as a “bellwether” case.

Continue Reading Lipitor MDL Judge Dissects Plaintiff’s Expert

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April might be the cruelest month according to T.S. Eliot, but the last month hasn’t been very kind to plaintiffs’ expert Nicholas Jewell, Ph.D.  As we posted recently, at the beginning of December, Prof. Jewell was booted from the Zoloft MDL.  See generally In re Zoloft (Sertraline Hydrocloride) Products Liability Litigation, 2015 WL 7776911 (E.D. Pa. Dec. 2, 2015).  Only two weeks earlier, however, he was also given the bum’s rush in In re Lipitor (Atorvastatin Calcium) Marketing, Sales Practices & Products Liability Litigation, ___ F. Supp.3d ___, 2015 WL 7422613 (D.S.C. Nov. 20, 2015).  His being shown the door in two MDLs in two weeks is pretty impressive defense work.  Anybody out there in a position to turn this brace into a hat trick?

Prof. Jewell is a statistician, not a medical doctor.  Lipitor, 2015 WL 7422613, at *14 (“Prof. Jewell is a statistician, not a medical doctor or medical professional.  He has no expertise in diabetes, has never treated participants of any kind, and is not a clinician.”).  As in Zoloft, the Lipitor plaintiffs called him in to second-guess the statistical bona fides of studies involving the drug and condition (diabetes) in question.  As we discussed in detail in the Zoloft post, Prof. Jewell started with the “a priori opinion” needed by his plaintiff-side paymasters and “t[ook] a results-driven approach . . ., molding his methodology and selectively relying upon data so as to confirm his preconceived opinion.”  Zoloft, 2015 WL 7776911, at *16.  Thus, it’s no surprise at all that he committed the same statistical sins in Lipitor:

The Court finds that Prof. Jewell’s analysis of the [statistical] data was results driven, that Prof. Jewell’s methodology and selection of relevant evidence changed based on the results they produced, and that Prof. Jewell chose to ignore and exclude from his report his own analyses that did not support his ultimate opinions.  It is apparent to the Court that rather than conducting statistical analyses of the data and then drawing a conclusion from these various analyses, Prof. Jewell formed an opinion first, sought statistical evidence that would support his opinion and ignored his own analyses and methods that produced contrary results.

Lipitor, 2015 WL 7422613, at *18.

Continue Reading Bookends – Prof. Jewell’s Opinions Also Excluded in Lipitor MDL, and More

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We do not have a case to blog about this week.  Things in the DDL world are slow.  Well, that is not exactly right.  In fact, maybe it is exactly wrong.  There is plenty going on, but virtually all the bloggable (that is, interesting and not yet already well-publicized) DDL cases involve our firm, Reed Smith, in some way, and blogging about such cases is like running through a gauntlet and minefield.  It is probably a good problem to have – unless you are staring at an empty computer screen and Bexis is clamoring for content.  So where does that leave us?

Usually we run into these doldrums during the Summer, when courts plunge into a blissful torpor.  The first time we completely discarded the DDL script and blogged about no case  was the Summer of 2011, when we went fully self-indulgent (or, at least, more self-indulgent than usual) and told a story about a deposition against a plaintiff lawyer who claimed to be the provocation behind Star Wars.  In truth, it is probably the single best blog post that emerged from our clumsily pecking fingers.  The folks at Abnormal Use recently linked to that post, so the number of views spiked.  Our cheap immortality grows yet again.

So now comes our Return of the Nerdy.  Put plainly, we are embarrassingly excited about the release of The Force Awakens later this week.  Our childish enthusiasm is marred only a little by the grim undercurrent mantra of “Please Please Don’t Suck”.  The prequel trilogy left psychological and aesthetic scars.  From what we hear, this new entry is set 30 years after Return of the Jedi.  And, in fact, it is about 30 years since Return of the Jedi.  JH Abrams has taken the helm from George Lucas, which is almost certainly a Very Good Thing.  Abrams did a nice job with the Star Trek reboot.  And let’s not forget that Lucas did not direct the best Star Wars film, The Empire Strikes Back, while he did oversee the excrescence called The Phantom Menace.  (The Simpsons episode where Bart watches in disbelief how that film centered on a tariff dispute is absolutely precious).  The great Lawrence Kasdan wrote The Force Awakens screenplay.  John Williams composed the score.   We are weak-kneed with anticipation.

Continue Reading “You are unwise to lower your defenses!”

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

The remake is a Hollywood staple.  From Annie to Planet of the Apes.  From The Thomas Crown Affair to Willard (couldn’t come up with a “Z” remake) – everything old is new again.  Sometimes a remake turns out better than the original – True Grit, The Fly, You’ve Got Mail, and maybe Ocean’s 11 (feel free to disagree).  More often than not, remakes do not live up to our expectations.  Why, oh why, did Steve Martin even attempt to remake The Pink Panther?  Sorry Billy Bob, but your Bad News Bears is not even in the same league as Walter Matthau’s.  Russell Brand and Jennifer Garner don’t even come close to Dudley Moore and Liza Minnelli’s magic in Arthur.  And while Patrick Swayze’s Point Break and Road House may not be of the same caliber as the aforementioned originals – do they both need to be remade? (With all due respect to Rhonda Rousey who we are quite certain would make an extremely effective bouncer in real life).

Remakes are apparently inevitable and not limited to the movies.  Lawyers on both sides of the v. are often looking to “remake” the law.  But when it comes to PMA preemption, we defense counsel say leave it alone.  That’s just what the court did in today’s case – Pearsall v. Medtronics, Inc., 2015 U.S. Dist. LEXIS 164199 (E.D.N.Y. Dec. 7, 2015).  At issue was the same cardiac defibrillator and lead that was the subject of the In re Medtronic, Inc. Sprint Fidelis Leads Products Liability Litigation (D. Minn.) in which the Eighth Circuit affirmed dismissal of plaintiffs’ claims as preempted.  The blog is peppered with mentions of Sprint Fidelis as it was probably the first major post-Riegel PMA preemption battle and victory.  So plaintiff had a bit of an uphill fight on his hands.  His approach:  draw attention away from Sprint Fidelis by focusing on Hughes and Stengel.  The blog also is loaded with references to these cases, only they aren’t as flattering.  The court didn’t fall for the old switcheroo.

Continue Reading Plaintiff Seeking to Remake Sprint Fidelis Gets Shut Down

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Earlier this month the United States Supreme Court agreed to hear Universal Health Services, Inc. v. United States ex rel. Escobar (No. 15-7), in which the Court will decide whether a False Claims Act claim can succeed under the so-called “implied certification” theory, and if so whether that theory goes beyond situations where compliance is an express precondition to payment.  We’re not FCA lawyers, but other folks at Reed Smith are, so rather than sorting through all this ourselves, we’re linking (a first for us) to a Reed Smith client alert that has what we think is a good explanation of why this case – and this FCA theory – is important to our clients and to our readers generally.

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We learned about it yesterday from a reporter, but were sworn to secrecy until today.  Pacira Pharmaceuticals and the FDA settled their litigation with Pacira getting essentially everything it wanted – what the company calls “favorable resolution.”  Pursuant to the settlement agreement, the FDA is formally rescinding its unfortunate warning letter that attempted a retroactive reduction in the scope of the indications of Exparel’s (the drug at issue) approval.  That kind of retraction by the Agency is very rare, if not unprecedented.  FDA is also giving the OK to labeling for the drug that reflects the original broad surgical indication.  In return, Pacira will drop the litigation before any ruling on its First Amendment-related request for an injunction against the FDA.

So this one is over.

Now, however, everybody in the industry, and in the Agency, knows the drill with respect to truthful off-label promotion.  If an FDA-regulated entity is convinced that:  (1) the off-label use is safe, (2) the product is effective for the use; and (3) it has valid science (not necessarily meeting FDA’s “substantial evidence” standard) supporting items 1 and 2; then it can submit a truthful off-label promotion proposal to FDA.  If FDA rejects the proposal, then the threat of FDA prosecution of the entity creates sufficient First Amendment “chilling effect” to give the entity standing to take the FDA to court and prove the truth of items 1-3 to a presumably unbiased federal judge.  As the plaintiff, the entity can choose the forum in which to sue, and given the Caronia v. United States, 703 F.3d 149 (2d Cir. 2012), precedent, that forum will be in the Second Circuit, probably in New York City.

This First Amendment process doesn’t change the off-label warning impossibility argument that we’ve discussed, because not only is prior FDA review still required, but also a prior (perhaps lengthy) litigation process before any change to labeling (or promotion) can legally occur.

We’ll be watching for the next case.

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The preemption clause in the Nutrition Labeling and Education Act of 1990 is clear and direct.  It prohibits states from imposing nutritional labeling requirements that are not “identical to” federal requirements.  21 U.S.C §343-1(a).  If they’re not identical, they’re preempted.

This came squarely into play last week in Dougherty v. Source Natural, Inc., 2015  U.S. Dist. LEXIS 164117 (E.D. Mo. Dec. 8, 2015).  A putative class action plaintiff claimed that a multivitamin distributed by defendant Source Natural, Inc. contained actual nutrient levels for six of its vitamins and minerals that were less than the labeled amount.  Id. at *1-2.  She requested a refund for her and everyone else in the class. Id. at *2.  But she ran into a problem, a big one.  Her expert (really, the expert hired by her lawyer) calculated the nutrient levels of the multivitamin using a testing methodology that was different from the FDA’s methodology.  Uh-oh.

The FDA’s methodology is laid out in the Code of Federal Regulations.  It involves, among other things, sampling from 12 different product cases:

[T]he FDA has enacted regulations pertaining to expressed nutrient content claims.  Under 21 C.F.R. § 101.13, “[a] claim that expressly or implicitly characterizes the level of a nutrient of the type required to be in nutrition labeling under §101.9 or under § 101.36 (that is, nutrient content claim) may not be made on the label or in labeling of foods unless the claim is made in accordance with this regulation.”  21 C.F.R. § 101.13(b).  Whether the requirements or nutrient content claims comply with the regulations are determined by using the methodology provided in § 101.9. 21 C.F.R. § 101.13(o).  Under § 101.9(g), “[t]he sample for nutrient analysis shall consist of a composite of 12 subsamples (consumer units), taken 1 from each of 12 randomly chosen shipping cases, to be representative of a lot.”  21 C.F.R. § 101.9(g)(2).

Id. at *5-6.  Plaintiff’s test didn’t use 12 cases, or even 12 bottles.  It used one bottle.  That’s a “different” test from the FDA’s.  Allowing a plaintiff to hold a manufacturer liable for not meeting that “different” test would impose a requirement on the manufacturer that is different from the FDA’s requirement.  And, so, Plaintiff’s claim was preempted:

Because Plaintiff has failed to allege she followed FDA testing protocols, her state law claims that rely on a different methodology to demonstrate such labeling violations are inconsistent with the FDCA and are thus preempted.

Id. at *11.  That’s certainly a quick and neat preemption win.

Continue Reading Court Dismisses Nutritional Labeling Class Action on the Basis of Preemption

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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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