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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

Some time ago we were highly critical of a potentially dangerous expansion of liability for failure to warn to publishers of medical literature.

That’s right, publishers.

In our prior post we went after Slater v. Hoffman-La Roche, Inc., 771 F. Supp.2d 524 (E.D. Pa. 2011), for giving credence to a claim that a publisher of medical reference products could somehow be liable under Pennsylvania law for alleged errors and omissions in the content of materials written by others. Slater did not say that there was such a claim, mind you.  It only speculated (in the absence of any contrary precedent) that there could conceivably be such a claim.  Slater was an fraudulent joinder case.  The publisher defendant, Wolters Kluwer, had the misfortune of being headquartered in Pennsylvania.  That meant it was non-diverse, so if the plaintiffs could merely hang a “colorable” claim on it, the case would have to be remanded to the Philadelphia Court of Common Pleas – at the time the #1 ranked Judicial You-Know-What according to ATRA.

Philadelphia isn’t ranked #1 anymore.

The Philadelphia Court of Common Pleas Complex Litigation Center (home to Philly’s notorious mass tort programs) is under New management.

As in Judge Arnold New.

Judge New recently issued an opinion, A.B. vs. Ortho-McNeil-Janssen Pharmaceuticals, 2013 Phila. Com. Pl. Lexis 84 (Pa. C.P. Phila. Co. April 5, 2013), sticking a much deserved fork in the concept of publisher liability.  A.B. involved alleged injuries from certain atypical antipsychotic drugs.  In addition to the manufacturer of the drug, the plaintiffs sued two publishers of medical information, Excerpta Medica and Elsevier.  The publishers recently took the
bull***t by the horns and moved for summary judgment, on the ground that their role in “publishing scholarly books and journals” (Elsevier)  and “developing medical literature . . . including articles published in peer-reviewed journals and posters and abstracts presented at medical conferences” (EM), id.,  at *4-5, couldn’t possibly give rise to liability to the plaintiff.Continue Reading Publisher Liability Rejected By Philadelphia C.P. Court

            Today we look at a common topic – sales representatives – in a slightly different light.  We are all well-versed in the learned intermediary doctrine.  More and more often, plaintiffs’ failure to warn claims in pharmaceutical and medical device cases are thwarted by knowledgeable physicians who apply their independent medical judgment in deciding whether a

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When we began practicing law, we worked for a partner who believed in scorched-earth research. Every time we’d go to his office with our findings, he’d begin by asking what we had looked at: “Did you look at X? Did you look at Y? Did you look at Z?” As soon as we admitted we…

Not too long ago a case here in the Eastern District of Pennsylvania, Slater v. Hoffmann-LaRoche Inc., ___ F. Supp.2d ___, 2011 WL 1087240 (E.D. Pa. March 25, 2011), held that an inadequate warning claim against a “monograph publisher” survived the rather loose standard imposed upon fraudulent joinder.

A publisher?

That’s right, or at least that appears to be what this particular defendant, Wolters Kluwer Health, Inc., (“KWH”) does according to its website – it publishes textbooks (including Lippincott), reference products, journals, bibliographic and reference databases, drug information software, point-of-care tools, web-based information systems, online continuing education products, and electronic information.
A publisher can be liable in a product liability suit in Pennsylvania?

That’s a new one on us.

Let’s see how Slater purports to accomplish that feat.  First of all, it’s crystal clear under Pennsylvania law that a pharmacist dispensing drugs is not liable for failure to warn about a prescription drug.  Coyle v. Richardson–Merrell, Inc., 584 A.2d 1383, 1386-88 (1991); Makripodis v. Merrell–Dow Pharmaceuticals, Inc., 523 A.2d 374, 376-79 (Pa. Super. 1987); Ramirez v. Richardson–Merrell, Inc., 628 F. Supp. 85, 87-88 (E.D. Pa. 1985) (note: these are all Bendectin cases, and Bexis participated in their defense).  The only way a pharmacist can be liable is for independently screwing up, such as filling a prescription with the wrong drug.

So the plaintiff didn’t sue the pharmacist.

However, pharmacists now include fact sheets – “patient education monographs” about the drugs they dispense. As Slater recognizes, this isn’t something that tort law mandates.  In any event, somebody has to prepare and compile this information.  KWH is one of those entities.Continue Reading On Suing Publishers

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…

A couple of cases we’ve posted about recently started us thinking – a dangerous turn of events, we know. There was that Beaumont Hospital case involving allegations about delivery of an incorrect free sample of a device. If somebody – anybody – at the hospital had simply looked at the thing, either when it was…

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