Pharmacy Liability

Subscribe to Pharmacy Liability
Photo of Bexis

It was the last blank space on the legal map – the only state with no precedent whatsoever.  As we mentioned earlier in the week, Rhode Island has now fallen.  There now remains no state in the country totally without precedent concerning the learned intermediary rule.  Granted, for now it’s only an oral ruling in a transcript, but a federal judge has predicted that Rhode Island would join the overwhelming consensus of jurisdictions and follow the learned intermediary rule:

First of all, after the learned intermediary doctrine, that has been adopted by over two dozen jurisdictions and, I think, Rhode Island would adopt it as well.
I see nothing in Rhode Island case law, including the Castrugnano [sic, should be Castrignano] case, to suggest that Rhode Island would require direct patient warning in pharmaceutical drug cases.  Just because 4024 A [sic, should be 402A] of the second restatement says nothing about the learned intermediary doctrine doesn’t bother me.  There are a lot of states that adopted both.
If Rhode Island doesn’t accept the doctrine in the way that most courts have, then it’s likely it’s going to look to the third restatement, which requires direct warnings when the manufacturer has reason to know that the health care provider will not be in a position to reduce the risk to the patient.
Unlike the mass inoculation vaccine scenario that the restatement mention in one of its comments, Zometa is a very serious therapy that is commenced after consultation with doctors. . . . As intended there Zometa is a type of drug learned intermediary doctrine encourages a doctor-patient dialogue.
Zometa does not fall within the exception of the restatement and I, therefore, find a direct warning to Mr. Hogan was not required.

Hogan v. Novartis Pharmaceuticals Corp., 06 CV 260, Trial Tr. (5/23/11), at 387-88 (E.D.N.Y.).  The same court had discussed the learned intermediary rule with approval, but avoided a direct ruling, in Hogan v. Novartis Pharmaceuticals Corp., 2011 WL 1533467, at *9 (E.D.N.Y. April 24, 2011).Continue Reading The Closing Of The Learned Intermediary Frontier

Photo of Bexis

We’ve remarked before about the odd, detrimental position that the Southern District of Illinois has taken towards removal, fraudulent joinder, and diversity jurisdiction in cases claiming that pharmacies should be liable for prescription drugs just like any other intermediate product seller.  The Illinois Supreme Court, as a substantive matter, has rejected pharmacy liability repeatedly as a consequence of the learned intermediary rule.  See Happel v. Wal-Mart Stores, Inc., 766 N.E.2d 1118, 1127 (Ill. 2002); Frye v. Medicare-Glaser Corp., 605 N.E.2d 557, 559-61 (Ill. 1992); Kirk v. Michael Reese Hospital & Medical Center, 513 N.E.2d 387, 392 (Ill. 1987).  Yet plaintiffs in the South Illinois “hellhole” counties, Madison, St. Clair, etc., kept alleging pharmacy liability, and numerous Southern District of Illinois decisions let them get away with it – remanding the cases based upon a combination of a “presumption” in favor of remand, and something called the “common defense” exception.  Funny, but that didn’t stop federal district courts in other parts of the country from finding fraudulent joinder where (as in most states) pharmacy liability was similarly barred under the relevant state’s law.
Well, we think that’s come to an end.  As we also discussed before, with the Yazmin/Yaz litigation, the S.D. Ill. got its own MDL.  Where a judge stands apparently depends somewhat on where s/he sits, and in that litigation, the court broke ranks and – rather than tolerate a large number of similar state-court suits trenching on the MDL – held that, contrary to a lot of other S.D. Ill. precedent – pharmacy liability claims constituted fraudulent joinder, and denied remand.
MDLs are a little different from individual litigation in other ways, too.  For one thing, plaintiffs lawyers have lots and lots of “clients” and are not adverse to using them as cannon fodder when they want to make a legal point – or at least try to.  That’s what happened in Yazmin/Yaz.  Counsel for one of the non-remanded plaintiffs, named Walton, decided to risk tanking the client’s claim in order to appeal the failure to remand.  So poor Ms. Walton defaulted on discovery obligations, the MDL court dismissed her case with prejudice as a sanction, and the plaintiff’s lawyer challenged the dismissal for lack of federal subject matter litigation.
Yeah, a plaintiff can do that.
But the plaintiff had better be right, because if s/he loses the appeal – no more case.Continue Reading Seventh Circuit Shoves the S.D.Ill. Back Into Line On Removal

Photo of Bexis

As our readers certainly know, the learned intermediary rule holds that prescription medical product warnings are to be directed to prescribing physicians rather than to end user patients.  We’ve discussed the policy reasons for the rule before, and at length, most notably here and here.  Briefly, courts have adopted the learned intermediary rule because:

  • Warnings go to physicians because they are the only people who know both a particular patient’s medical history as well as the risk/benefit profile of the drug/device being prescribed.
  • Limiting warning duties to physicians makes the common law consistent with warning duties imposed by the FDA.
  • Routing prescription drug/device information through the doctor preserves the physician/patient relationship from outside interference.
  • The complicated medical terminology necessary to explain the risk/benefit profile of prescription drugs/devices is difficult for ordinary patients to understand.
  • Practical difficulties often preclude drug/device companies from direct communication with patients.

But plaintiffs don’t make direct-to-patient warning claims only against drug/device companies.  They’ll also tried to get around the learned intermediary rule by claiming that other entities in the drug/device (but mostly drug) distribution chain should have warned patients directly.  Such claims have most frequently been made against pharmacies.  Sometimes the plaintiffs are really serious about pharmacy warning claims, but more often pharmacies are sued on failure to warn theories for tactical reasons – such as adding a non-diverse (that’s a resident of the plaintiff’s home state, for you non-lawyers) defendant to prevent the case from being removed from state to federal court.
In either case, representing manufacturer defendants, we’d usually not have a pharmacist around complicating the case.  A recent decision, Kowalski v. Rose Drugs of Dardanelle, Inc., slip op.,  ___ S.W.3d ___, 2011 WL 478601 (Ark. Feb. 9, 2011), says we we’re right about that, at least in Arkansas.  Interestingly, at least from the caption, it appears that Kowalski wasn’t a product liability suit at all, but a simple negligence action.  The parties were a doctor, who prescribed a veritable cornucopia of drugs to the decedent, and the pharmacy.  Evidently, the decedent took a bunch of these drugs all at once and died from what the court called “mixed drug intoxication.”  Slip op. 2 (ordinarily we’d use the Westlaw pagination, but for some bizarre reason WL doesn’t provide any for Arkansas slips).  There’s no indication in the opinion whether the decedent made an honest mistake or was trying to get high (as we’ll see, several of these drugs were controlled substances).
Anyway, the claim against the doctor wasn’t involved in the Kowalski appeal.  The claim against the pharmacy alleged that – even though every one of the prescriptions was regular and proper on its face – the pharmacy had a duty not to fill them because, taken together, the drugs could be fatal.  The Arkansas Supreme Court, joining a substantial majority of other jurisdictions, said no.  A pharmacist has no duty to inquire behind a facially regular prescription.Continue Reading Pharmacists And The Learned Intermediary Rule

Photo of Bexis

With a lot of you on the way out the door for Labor Day, here are a couple of new (at least to us) cases, that while not important enough to merit lengthy discussion, which contain something interesting (to us defense drug and device lawyers, that is).
Cheatham v. Teva Pharmaceuticals, 2010 U.S. Dist.…

Photo of Bexis

Appropriately – since here in Philadelphia we’re being snowed in (again) – today’s post concerns Winters v. Alza Corp., 2010 WL 446451, slip op. (S.D.N.Y. Feb. 4, 2010).  Winters is an example of how remand motions should be decided – when federal courts don’t elevate docket control uber alles.
Winters is was originally filed…

Drug & Device Resources

Bexis’ Book

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.
Learn More About This Book