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

Looking back at our posts on innovator liability, it’s becoming more and more difficult to title them. According to the DDL blog, innovator liability has been rejected, abolished, denied, refused, disallowed. You get the idea. With the news from earlier this summer that the California Supreme Court is going to consider the issue – which will hopefully spell the demise of Conte – we may be nearing the end of the chapter on innovator liability. In the meantime, we’ll keep bringing you the wins as they stack up.

Today’s case was actually decided right around the time the California Supreme Court decided to take on the issue. Gillette v. Boehringer Ingelheim Pharm., Inc., 2016 WL 4217758 (Mag. D. Minn. Jun. 16, 2016). The decision didn’t come to our attention, however, until the magistrate’s report and recommendation was adopted last week. See 2016 WL 4203422 (D. Minn. Aug. 9, 2016).

The Gillette decision comes out of the Mirapex MDL and involves the application of Indiana law. Indiana products liability claims are governed by the Indiana Products Liability Act (“IPLA”) which provides a single cause of action subsuming all common law strict liability and negligence claims, as well as tort based warranty claims. Gillette, 2016 WL 4217758 at *3-4, *6. So, plaintiff in this case had one cause of action based on her allegations that her use of Mirapex caused her to gamble compulsively.

But was it Mirapex that plaintiff was taking at the time she suffered her injuries? According to her pharmacy records, plaintiff was prescribed Mirapex from 2001 until 2015. Id. at *1-2. It appears that from 2001 until April 2010, plaintiff’s pharmacy filled her prescriptions with brand name Mirapex. In April 2010, when her prescribing physician increased plaintiff’s dosage, her pharmacy began filling her Mirapex prescriptions with its generic equivalent – pramipexole dihydrochloride. Id. at *1. From April 2010 until late 2015, plaintiff received the generic version of the drug manufactured by a succession of four different generic drug manufacturers. Id. at *1-2.Continue Reading Brand Defendants Thwart Another Innovator Liability Claim

Recently, we noted that one of the first decisions we wrote a post about had been affirmed by the Second Circuit.  Of the district court decision, we had penned “It is nice to see a judge with a proper understanding of how drug labels, FDA, and cockamamie theories about off-label marketing should fit together.  We would like to see more of the judges handling product liability cases with similar issues follow the lead of the judges handling FCA cases and dismiss complaints premised on nonsensical interpretations of labels and regulations.”  In discussing U.S. ex rel. Polansky v. Pfizer, Inc., No. 14-4774,  2016 U.S. App. Lexis 8974 (2d Cir. May 17, 2016), we could be lazy and swap in “a panel” for “a judge” in the preceding quote.  That would be true, but it would be incomplete.  A few weeks after the district court’s decision in Polansky, the Second Circuit decided U.S. v. Caronia, 703 F.3d 149 (2d Cir. 2012), where it vacated the conviction (conspiracy to sell a misbranded drug under 21 U.S.C. §§ 331(a) and 333(a)(1)) of a sales representative for promoting a prescription drug for off-label use.  Then, a few months before the Polansky appeal was argued, the Southern District of New York enjoined the FDA from prohibiting a manufacturer’s truthful off-label promotion concerning a (generic) prescription drug.  Next, a few months later, FDA reached a well-publicized settlement with that manufacturer, preserving that “Amarin may engage in truthful and non-misleading speech promoting the off-label use” of its drug without risking prosecution for misbranding.  While there are still decisions like Neurontin out there and many cases still seek to impose liability under the FCA or other statutes for truthful off-label promotion, the off-label landscape has clearly changed.

With that in mind, we turn back to Polansky.  For eight years and through multiple amended complaints, the plaintiff pursued a FCA claim that Pfizer’s promotion of Lipitor for use within the approved indications was actually off-label—and therefore allegedly led to false claims for Medicare and Medicaid reimbursement—because of references in the label to the National Cholesterol Education Program Guidelines.  We will be blunt—shocking to our readers, we know—this was always a dubious claim because any common sense reading of the label does not come close to supporting the contention that the Guidelines narrowed what was “on-label” compared to the five indications that were approved and described in the label.

The NCEP Guidelines, which came out of NIH and were expressly not intended to trump clinical judgment, set out an algorithm for  recommendations for the general type of treatment (e.g., just lifestyle modifications) depending on risk categories derived from lab results and clinical history.  2016 U.S. App. Lexis 8974, **7-9.  The Indications section in the pre-Physician Labeling Rule label referenced the Guidelines in conjunction with stating that lipid-altering agents should be used only when response to diet and other lifestyle modifications “has been inadequate” and included a summary of the Guidelines. Id. at **10-11.  When PLR changes went into effect in 2009, the reference and summary were omitted, which suggested something about the relative importance of these references. Id. at *9.  Both before and after PLR, the Dosage section of the label had a cite to the Guidelines when stating, for one subcategory of patients, that “The starting does and maintenance doses of Lipitor should be individualized according to patient characteristics such as goal of therapy and response.” Id. at *11.Continue Reading A Blow Against False Claims Act Liability For Off-Label Promotion

This is a quick-hit post as we head into the Independence Day holiday weekend.  The Southern District of West Virginia’s order this week in McNair v. Johnson & Johnson, No. 2:14-17463, 2015 WL 3935787 (S.D. W. Va. June 26, 2015), dismissed claims against the seller of an innovator drug for precisely the right reason: The defendant neither made nor sold the generic drug that the plaintiff ingested.  That is to say, there is no Conte-style “innovator liability” in West Virginia.

It seems obvious, doesn’t it?  It has been seven years since the California Court of Appeal issued its wrongly reasoned and wrongly decided opinion in Conte v. Wyeth, where the court held that a plaintiff who used a generic drug could sue the manufacturer of the listed version.  As we like to say, the court took the “product” out of product liability and held a company potentially liable for injuries allegedly caused by a product that it did not make and did not sell.  The late Roger Traynor and his colleagues on the California Supreme Court, who presaged strict product liability way back in 1944 in Escola v. Coca-Cola Bottling Co., must have rolled in their graves.

The Conte opinion has predictably become an outlier, and courts have rejected the opinion and its reasoning many times over, often expressly. (Check out our Innovator Liability Scorecard here and our survey of innovator liability here.)  As we reported here, the Alabama legislature abolished innovator liability just a few months ago, and we believe the California Supreme Court overruled Conte in Crane v. O’Neill, 53 Cal. 4th 335 (2011), where it held that a manufacturer has no duty to warn of hazards in another manufacturer’s product due to “foreseeability.”Continue Reading No Innovator Liability: National Drug Code Saves the Day

We are sometime not sure what to make of pharmacy monographs.  You know what we mean.  Those sheets that pharmacists print out and give us with our prescriptions.  They are not drug labeling, and they are not medication guides.  They are summaries intended for patient perusal, with information taken from the labeling, but digested in a fashion intended for the lay reader.  Notably, the FDA has not asserted any prerogative to review and approve pharmacy monographs, leaving publishers essentially self-regulated under an FDA action plan.

From time to time, we are surprised when a plaintiff produces a pharmacy monograph in discovery, one that he or she received from the pharmacy and has saved.  (We have not seen the data, but we expect that people who save pharmacy monographs are the same people who have their utility bills from the mid 1990s and who know where the instructions and warranties are for all their household appliances.)  But even when this happens, we are unsure how the monographs help us.  The parties we represent – drug manufacturers – do not publish these things, and they generally don’t have any duty to warn patients anyway.
In a way, pharmacy monographs are more useful to the other side because they give plaintiffs someone else to sue – the monograph publishers.  We have commented on this before (here and here) and noted that lawsuits against publishers have met with virtually no success, and for good reason.  Publishers do not make prescription drugs; they do not sell or dispense prescription drugs; and they have no relationship or contact with the plaintiffs.  That is to say, they owe plaintiffs no duty of care, which is and should be enough to stop litigation.

Continue Reading Pharmacy Monographs and an Illusory Duty of Care

This is a guest post by Reed Smith partner Larry Sher, who was part of a team successfully representing Omnicare on a civil False Claims Act case before the United States District Court for the District of Maryland and the Fourth Circuit.  The rest of the defense team included Eric Dubelier, Katherine Seikaly, James Martin and Colin Wrabley.  As we have noted previously, there has been increasing overlap between the issues presented in cases under the False Claims Act (and state law mimics) and the sort of product liability cases we usually talk about here.

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Over the last few years, counsel for defendants in civil False Claims Act (“FCA”) cases have increasingly seen relators (the FCA version of plaintiffs) pushing the limits of the FCA to attempt to pressure defendants into costly settlements based on allegations that the defendant violated some regulation that really has nothing to do with the submission of any claim for money from the government, false or otherwise.  Last week the United States Court of Appeals for the Fourth Circuit confirmed that the FCA is meant to combat fraud and is not a “sweeping” catch-all mechanism to address all regulatory violations in the absence of actual fraud.

In United States ex rel. Rostholder v. Omnicare, Inc., No. 12-2431, the Fourth Circuit affirmed the dismissal of a relator’s FCA complaint (and denied leave to amend) under Fed. R. Civ. P. 12(b)(6) in a case that may have a significant impact on the future of healthcare related FCA actions in the Fourth Circuit and maybe elsewhere.  The Rostholder court held that because compliance with the Food and Drug Administration’s (FDA) Current Good Manufacturing Practices (cGMP) regulations is not a precondition for reimbursement under Medicare and Medicaid, violations of the cGMP regulations by themselves cannot form the basis for False Claims FCA claims.  No. 12-2431, slip op. (4th Cir. Feb. 21, 2014).Continue Reading Guest Post — The Fourth Circuit Weighs In: False Claims Act Liability Under Medicare and Medicaid Cannot be Based Merely on Regulatory Violations

We were perusing the recent GAO report on electronic drug labeling in our spare time (we’re weird like that).  We found a number of interesting points − such as what the FDA apparently told the GAO about its position on off-label promotion (“[a]ccording to FDA, if a drug manufacturer promotes a drug for off-label uses, such promotion may constitute evidence to support a violation of the [FDCA]”) (emphasis added).  But the most interesting aspect of the GAO study for some of us was its description of the non-labeling information available to purchasers of prescription drugs, mostly through pharmacies:

Patients can receive written drug information provided along with their prescription drugs in the form of CMI [“consumer medication information”].  Unlike prescribing information, Medication Guides, and [patient package inserts], CMI is not approved by FDA, and drug manufacturers do not produce this type of drug labeling.  Instead, it is produced by third parties and distributed to patients at the pharmacy when their drugs are dispensed.  CMI can include information from the prescribing information and can also include additional information not contained in FDA-approved labeling, such as off-label uses of certain drugs. According to officials from third parties that produce CMI, they also use other sources, such as peer-reviewed literature, to develop the information for their CMI.  FDA has not asserted the authority to require third parties to submit CMI for review by the agency before CMI is distributed,
according to agency officials.

GAO Report at 7.

This discussion started us thinking again about the novel – and we would add, reprehensible – assertion of product liability claims against some of the “third parties” mentioned in the GAO’s reports.  We discussed our overwhelmingly negative reaction to so-called “publisher liability” claims back in 2011.  Then, we pointed out that this sort of claim is almost always asserted by plaintiffs for ulterior motives (chiefly joining a non-diverse defendant to prevent removal to federal court), and that no state in the country has affirmatively permitted such a claim.
Continue Reading Revisiting Publisher (Non)Liability

While it may not be immediately obvious, the dismissal of pharmacy defendants from drug cases is almost always a good thing. 
The dismissals are often based on the learned intermediary doctrine, which says that a drug manufacturer’s obligation to warn about risks of its prescription medications runs to the doctors, not patients.  The doctrine recognizes

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Regular blog readers know how we feel about Conte v. Wyeth, Inc., 85 Cal. Rptr.3d 299 (Cal. App. 2008), review denied (Cal. Jan. 21, 2009) – the case that held an innovator drug manufacturer potentially liable for “misrepresentations” even though it did not manufacture the drug that allegedly harmed the plaintiff. We criticized virtually…

Our learned intermediary rule “head count” lists Oklahoma as solidly in support of the doctrine:

Oklahoma: Edwards v. Basel Pharmaceuticals, 933 P.2d 298, 300-01 (Okla. 1997); Tansy v. Dacomed Corp., 890 P.2d 881, 886 (Okla. 1994); McKee v. Moore, 648 P.2d 21, 24 (Okla. 1982); Cunningham v. Charles Pfizer & Co., 532 P.2d 1377, 1381 (Okla. 1974).

The “head count” lists every state supreme court decision to follow the learned intermediary rule, and the Oklahoma Supreme Court’s four decisions applying the doctrine are exceeded only by Ohio’s six (plus a statute) and Kansas’ five opinions.

Oklahoma courts had never applied the rule to pharmacists, however. As we’ve discussed before, the learned intermediary rule helps pharmacy defendants by precluding claims that pharmacies, as intermediate sellers of prescription drugs, should have some sort of independent duty to warn patients. Just as the rule recognizes physicians as learned intermediaries in passing along relevant warnings from prescription medical product manufacturers to their patients, learned intermediary principles also preserve the physician-patient relationship by precluding imposition of independent warning duties on other possible interlopers – such as pharmacies – who otherwise might be legally required to confuse patients by providing information that conflicts with what prescribing physicians tell their patients. Back in 2011, on occasion of the Arkansas decision Kowalski v. Rose Drugs, Inc., 378 S.W.3d 109 (Ark. 2011), we did a 50-state survey post on this issue, and Oklahoma was missing in action.

Not any longer. In Carista v. Valuck, ___ P.3d ___, 2016 WL 6237855 (Okla. App. Oct. 20, 2016), the court applied the learned intermediary rule to pharmacy-related claims in essentially the same fashion as the previous cases in our survey post. Carista involved a plaintiff (or more precisely, a plaintiff’s decedent) who took too many painkillers – it appears, from the opinion, illegally − overdosed, and then attempted to blame someone else, in this case the pharmacy where the prescriptions were allegedly filled. The case was dismissed, and the plaintiff appealed. Recognizing the issue as one of first impression, the court followed what it concluded, rightly, was the majority rule:

Many other states appear, however, to have adopted the [learned intermediary] doctrine, with limited exceptions, to shield pharmacists from being required to “second guess” a physician’s medical decisions embodied in an otherwise authorized and legally made prescription.

Continue Reading Oklahoma Becomes the Latest State To Apply Learned Intermediary Principles To Pharmacies

The Texas Supreme Court answered yes in its recent decision Randol Mill Pharmacy v. Miller, 2015 WL 1870058 (Tex. Apr. 24, 2015).  And while the decision is full of statutory interpretation of the Texas Medical Liability Act, which wouldn’t normally draw our interest, when we read this one we saw some implications for pharmacy liability we didn’t like.  That’s bad for pharmacies.  It is also bad for manufacturers who look to get pharmacy defendants who may create a bar to federal removal dismissed as fraudulently joined.

The facts are fairly straightforward.  Plaintiff’s physician prescribed and administered weekly injections of lipoic acid to treat plaintiff’s hepatitis C.  Plaintiff suffered an adverse reaction to one injection and alleges she has been left blind as a result.  Id. at *1.  Plaintiff sued both the pharmacy who compounded the lipoic acid and several of its pharmacists.  The pharmacy and pharmacists moved to dismiss for plaintiff’s failure to serve an expert report within 120 days of filing as required by the Medical Liability Act.  Plaintiff argued that her claims against the pharmacy/pharmacists were products liability claims, not healthcare liability claims and therefore the statute did not apply.  Both the trial and intermediate appellate courts agreed with plaintiff concluding that the pharmacists were not healthcare providers. Id.

Plaintiff’s allegations against the pharmacy defendants include:

  • negligence in manufacture, design and warning;
  • breach of implied warranties in the design, manufacture, inspection, marketing, and/or distribution;
  • and what essentially sounds like strict liability manufacturing, design and warning claims (“inappropriate warnings and instructions for use,” the produce “was defective, ineffective and unreasonably dangerous.”   Id.

Continue Reading Are Compounding Pharmacists Healthcare Providers?

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