Pharmacy Liability

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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.

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Continue Reading Are Compounding Pharmacists Healthcare Providers?

On Friday, we posted about a Florida court that allowed negligence claims against a pharmacy that did nothing more than fill prescriptions as they were written (Oleckna).  As you can imagine, we had some reservations about the ruling.  Well, those reservations were driven home when we happened upon another recent pharmacy liability case, this one in Indiana – Kadambi v. Express Scripts, 2015 U.S. Dist. LEXIS 13607 (N.D. Ind. Feb. 5, 2015).

If we call Oleckna a “damned if you don’t” case, then Kadambi is the example of “damned if you do.”  Which leaves the question – what is a pharmacy to do?

Plaintiffs in Kadambi are an endocrinologist, Dr. Kadambi, and 8 of his patients for whom he prescribed human growth hormone (HIGH).  While plaintiffs allege that the prescriptions were medically necessary, the defendant pharmacies refused to fill HIGH prescriptions from Dr. Kadambi because they believe the prescriptions might violate federal law making it a “crime to knowingly distribute HIGH” for improper purposes.  Id. at *3.  Defendants alleged that they had a good faith belief that Dr. Kadambi was prescribing HIGH for non-medically acceptable reasons and/or that he was affiliated with organizations that advocate
off-label use of HIGH.  Id. at *4.

Plaintiffs advanced essentially two causes of action against the pharmacies – violation of Indiana’s statute governing pharmacies and defamation.   While the court dismissed the statutory claim, it allowed the defamation action.  We’ll go through the court’s ruling, but our real interest lies in the fact that both Kadambi and Oleckna are moving forward.

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Continue Reading The Flip Side of Pharmacy Liability

A pharmacy case from Florida caught our eye this week.  We still have fresh in our minds the survey that Bexis posted a few days ago of state laws limiting the liability of non-manufacturing sellers of prescription medical products.  It was an impressive collection, as Bexis-prepared surveys tend to be, and it covered the potential liability (or lack thereof) of distributors, suppliers, pharmacies, etc.  You know, anyone in the chain who did not manufacture the drug or device and who typically would have no role in developing the product or its warnings. It comes up a lot for us in the context of removal jurisdiction, where plaintiffs fraudulently join local or non-diverse defendants in an attempt to prevent removal to federal court.  The plaintiffs never—and we mean never—actually pursue claims against the local defendants, and we routinely resist their motions to remand cases to state court with arguments that there are no viable claims against mere pass-through sellers of pharmaceutical products and medical devices.

In this regard, the result in Oleckna v. Daytona Discount Pharmacy, No. 5D13-3057, 2015 WL 477841 (Fla. Dist. Ct. App. Feb. 6, 2015), is not helpful because it allows negligence claims against a pharmacy that did nothing more than fill prescriptions as they were written.  In Oleckna, the patient was being treated for stress, and his doctor prescribed Xanax and narcotic pain medication over a period of two years.  Id. at *1.  The patient, sadly, died allegedly “due to combined drug intoxication” of the prescribed medications, and his estate sued the physician who wrote the prescriptions and a pharmacy who filled many of them—allegedly more than 30 prescriptions.  Id. 

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Continue Reading Florida Court Races to Questionable Conclusion on Pharmacy Liability

Today the World Cup takes another day off before it starts its semifinals to determine who will play for the Trophy on Sunday.  I know this only because other people have told me.  Left to my own predilections, I’d know none of it.  But other people’s interest and intense enthusiasm for these games has swept

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This blog has been up and running long enough such that certain themes have cropped up several times.  Or to put it more bluntly, we occasionally repeat ourselves.  Well, we hope it is not mere repetition.  Call it elaboration.  New things are continually developing with respect to TwIqbal, preemption, Daubert, and other rules,…

We read rulings under the Federal Tort Claim Act about as often as we read bench trial rulings or rulings from the District of Montana.  Or rulings where a judge says he is retiring in two days.  That is, with a frequency somewhat below what our diminishing memory can recall.  In Holtshouser v. United States…

We read the Law 360 piece yesterday (subscription required) on the now-commenced congressional hearings concerning the FDA’s oversight of compounding pharmacies in the wake of the New England Compounding Center/meningitis controversy.  We’ve seen some reports about the testimony.  We can’t say a whole lot about this because of client concerns, but we can say this

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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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Sometimes we feel just like Phil Connors when he said:  “I told you. I wake up every day, right here, right in Punxsutawney, and it’s always February 2nd, and there’s nothing I can do about it.”   That about sums up our feelings about the Yasmin/Yaz MDL – We wake up, right here in Southern District of Illinois, and it’s always pharmacist liability and fraudulent joinder, and there’s nothing we can do about it.  We thought the Seventh Circuit had put this issue to bed in Walton v. Bayer Corp., 643 F.3d 994 (7th Cir. 2011).  But, here we are one year later – and plaintiffs continue to file claims against pharmacies/pharmacists in the Yasmin/Yaz MDL in the hopes of beating diversity and having their cases remain in the South Illinois judicial hellholes (St. Clair County in this case).  Like Phil Connors, plaintiffs seem determined to re-live the same issue over and over again.  Like Phil Connors, plaintiffs make small changes to their argument each time in hope that the result will turn out differently.  But, unlike Phil Connors, we don’t see plaintiffs breaking out of this loop – the issue has been decided and it’s time to move on.

The most recent case on pharmacy/pharmacist liability and fraudulent joinder is Martin v. Moody’s Pharmacy, 2012 U.S. Dist. LEXIS 80863 (S.D. Ill. Jun. 12, 2012).  And, since this is a repeat performance by plaintiffs, it is somewhat of a repeat performance for us as well.  You can see our prior posts on Walton and pharmacy liability in the Yasmin/Yaz MDL here and here.  In fact, it’s only been a few weeks since the last Yasmin/Yaz pharmacy liability/fraudulent joinder decision.  So we’ll dispose of the basic issues quickly.

Plaintiff’s failure to warn claim is premised on the allegation that defendants failed to warn about the risks of taking YAZ for someone suffering from arteriovenous malformation (AVM) (a vascular condition which includes a heightened risk of hemorrhage).  Id. at *4.  In addition to suing the manufacturer, plaintiff sued her non-diverse pharmacy and pharmacists.  On that claim, plaintiff Martin, like plaintiffs in the prior cases, tried to rely on a narrow exception to pharmacy non-liability in Illinois where the pharmacist has actual, subjective knowledge of a reason why a particular drug is contraindicated in a particular patient.  Happel v. Wal-Mart Stores, Inc., 766 N.E.2d 1118 (Ill. 2002) See Martin, 2012 U.S. Dist. LEXIS at *18-20 (discussing Happel).  In deciding plaintiff’s motion to remand and the pharmacy defendants’ motion to dismiss, the court found that plaintiff missed the mark on the “actual knowledge” requirement:

the allegations of this most artfully crafted complaint do not specify that [the pharmacy] or The Pharmacist defendants had actual knowledge of the decedent’s AVM condition. There is no allegation that anyone had specifically advised the non-diverse defendants of the decedent’s condition, or that the pharmacy had previously filled prescriptions related to the decedent’s AVM condition, or that the pharmacy had asked about any complicating factors. All that is alleged is that the non-diverse defendants should have known of the risks inherent in YAZ for a person with AVM.

Id. at *10.  And, that’s not enough.

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Continue Reading Groundhog Day in Illinois in June

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).

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Continue Reading The Closing Of The Learned Intermediary Frontier