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Not too long ago we were asked what we thought about warning claims involving medication guides.   Our off-the-cuff reaction was that such suits have been occasionally filed over the years, but were largely unsuccessful in achieving the plaintiffs’ primary goal, which almost always was to avoid the learned intermediary rule.

That was our gut reaction, but since we also have to feed the blog, we decided that the question warranted a closer look.

First, a little on the current regulatory status of medication guides, which are also sometimes referred to as “patient package inserts,” or “patient brochures.”  They are “FDA-approved patient labeling conforming to the [Agency’s] specifications.” 21 C.F.R. §208.3(h).  Such guides were authorized by the FDA in 1998 under 21 C.F.R. §208.1, which states:

(a) This part sets forth requirements for patient labeling for human prescription drug products, including biological products, that the Food and Drug Administration (FDA) determines pose a serious and significant public health concern requiring distribution of FDA-approved patient information. . .

(b) The purpose of patient labeling for human prescription drug products required under this part is to provide information when the FDA determines in writing that it is necessary to patients’ safe and effective use of drug products.

(c) Patient labeling will be required if the FDA determines that one or more of the following circumstances exists:

(1) The drug product is one for which patient labeling could help prevent serious adverse effects.

(2) The drug product is one that has serious risk(s) (relative to benefits) of which patients should be made aware because information concerning the risk(s) could affect patients’ decision to use, or to continue to use, the product.

(3) The drug product is important to health and patient adherence to directions for use is crucial to the drug’s effectiveness.

Emphasis added.  See also 21 C.F.R. §208.24(a) (“The manufacturer of a drug product for which a Medication Guide is required under this part shall obtain FDA approval of the Medication Guide before the Medication Guide may be distributed”) (emphasis added); 21 C.F.R. § 201.57(c)(18) (requiring all “FDA-approved patient labeling” to appear in the “Patient counseling information” section of drug labeling).

We added all this emphasis to underscore the point that requiring a medication guide – as distinguished from what it might say − is another of those decisions that requires FDA pre-approval.  See Bartlett v. Mutual Pharmaceutical Co., 2010 WL 3659789, at *5 (D.N.H. Sept. 14, 2010) (“FDA may require that a drug be accompanied by a medication guide”) (citing §208.1).  As we’ve explained elsewhere, a mandate for FDA pre-approval such as this calls into play the Mensing/Bartlett impossibility preemption rationale, since a hypothetical state immediate tort duty to include a medication guide would conflict with the federal agency preapproval requirement.  Bowdrie v. Sun Pharmaceutical Industries Ltd., 909 F. Supp. 2d 179, 186 (E.D.N.Y. 2012) (finding preemption because “a specific FDA directive, is a necessary predicate to . . . any medication guide”).

Continue Reading A Guide To Medication Guides

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…

Several of us (the Reed Smith side, obviously) recently attended the firm partners’ retreat. All our brainstorming about how to improve client service started us thinking about the blog.  In some ways, legal blogging’s not that much different than other legal services – we just don’t get paid for it, at least not directly.  Our intended readership follows us, to the extent they do, with the expectation (realistic, we hope) of learning things that they can use to help defeat drug/device product liability litigation.  That brings value to the industry (and indirectly to various clients), since a win anywhere helps defendants everywhere.

So where can we bring, or at least preserve, value to the industry/our clients through the blog? We thought about MDLs.  Defendants spend a great deal of money slogging their way through MDLs, and where possible we’d like to preserve whatever good we get out of them.  Depending on judicial predilection (Judge Bechtle didn’t; Judge Weinstein does), MDLs often include summary judgment and (less frequently) other dispositive motions concerning individuals or groups of plaintiffs.  Some of the motions are based on Daubert, but if not, they’re usually based on state law – learned intermediary, statute of limitations, other issues.

So what?

Here’s what. State-law-based rulings in MDLs involve judges in one jurisdiction, like Judge Weinstein in New York in Zyprexa, deciding issues presented by other states’ laws – say whether a failure to warn was causal under Louisiana law.  That’s fine for the MDL, but what about the rest of us?  Also, what about anybody after an MDL is (at long last) concluded?  What legal researcher would think to look in New York for a case possibly presenting a relevant fact pattern for a Louisiana motion?

Not too many.

We speak from experience.  When we’re putting together a summary judgment motion in some other case, whether one-off or a different MDL, where do we look for supportive precedent?  Why we look in the logical place, of course – the decisions of that particular state’s courts and federal decisions in the district and appellate courts responsible for that state.  That’s where we get the most bang for our research bucks. That’s doing our clients’ work in the most efficient manner.

So we don’t look in Florida, or New York, or Pennsylvania if we’re working on a case under Texas law.  It’s simply not cost effective, given the number of other jurisdictions and the relatively low likelihood of success.  Sometimes we run across something significant through checking lists of citations (colloquially known as “Shepardizing”) to relevant cases, but we’re not systematic.

But just because it’s not worthwhile in a given case to conduct such broader searches doesn’t mean that what’s out there isn’t worth knowing about.  In Zyprexa alone, Judge Weinstein granted dozens of summary judgments applying the law of at least half the states of the union. Those cases are useful precedent – if defense counsel can locate them in a way that doesn’t waste the client’s money.

That’s where we come in.  We’re bloggers.  We’re not getting paid for this.  We don’t have to be cost effective in the narrow sense that lawyers working for client X or client Y have to be.  We just have to do the research – and we have.

What follows will be incredibly boring to many of you, but we hope equally useful.  We’ve collected individual summary judgment decisions (unless we specify a different procedural posture) in various MDLs – no matter what jurisdiction they were in.  We’ve organized them by state, omitting decisions made by MDL courts applying their own forum’s law, since those cases would be found by searching “the usual suspects.” That means, if you’re researching Mississippi law, just look under “Mississippi law cases” in the list below, and there are the cases, no matter what MDL court decided them.

Caveat #1: As we’ve said many times, we don’t do the other side’s research for them.  These lists include only cases where the defendant won everything (or almost everything) under a particular state’s law.  As far as adverse MDL precedent is concerned, we make no representations whatsoever.  Yeah, we saw some bad cases while doing this research.  We’ve intentionally omitted them.

Caveat #2. We expect this list is under-inclusive. Why? To keep the searches manageable, we reviewed only cases where “product liability” appeared in the name of the case (the usual way that MDLs are named), and “[insert state name] law” appeared somewhere in the body of the opinion.  That means we searched “Alabama law,” not just “Alabama.”  Otherwise, we’d have gotten hits for every MDL case where one of the (often scores) of attorneys was from Alabama.  Still, we think our results are a lot better than nothing. We’re not aware of this kind of list having been compiled anywhere – at least anywhere that’s public.

Caveat #3. We’ve only included issues that we could see possibly arising in drug and device product liability litigation. If an MDL decision was favorable to the defendant only on, say, asbestos exposure product identification (the most common example by far), we have not included it.

Caveat #4. We have not included decisions that were driven by federal issues, such as Daubert or preemption.  Federal issues involve different research considerations, so that decisions from MDLs in different circuits are less useful.

So here goes. For the first time anywhere, pro-defense product liability MDL decisions organized by the jurisdiction of the law being applied.Continue Reading MDL Precedent Rescue – Big List

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.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).Continue Reading The Closing Of The Learned Intermediary Frontier

Yesterday we brought you some welcome news on the pharmacy front in the never-ending struggle against fraudulent joinders.  But outside of certain parts of Illinois, we’ve generally done OK where the fraudulently joined party is a pharmacy.
Today, we feature a rarer bird – a court’s decision that a claim brought against a local distributor…

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

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

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…

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