United States: Washington Blocks Attempt To Dodge Generic Preemption Rules

Last Updated: May 17 2019
Article by Michelle Yeary

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

This blogger is just returned from Ireland where we toured castles and abbeys, drove through amazing landscapes on tiny roads with hairpin turns (can't say enough about Connemara except that everyone should go), sang about Molly Malone and the Fields of Athenry, visited a pub or two, drank a Guinness or two, and learned the history and distilling process of Irish whiskey from beginning to end (maybe had a glass or two of that as well).  The Irish take their whiskey very seriously – including serious rules about what can be called Irish whiskey.  Irish whiskey can only have three ingredients – grain, water, and yeast.  It can be single grain, single malt, or a blend, but you can't add anything else.  And, Irish whiskey must be aged at least three years, not a day under.  And all of the aging must take place in the Republic of Ireland or Northern Ireland.  The result of strict adherence to the rules – a smooth, light flavor less sweet than American bourbon and less smoky than Scotch whisky.  What did our whiskey tour of Ireland teach us?  That we like rules.  That we like adherence to the rules.  That we like the result (a lot) when the rules are applied.  And the same can be said for drug and device law.

The first rule for generic drug cases – failure to warn claims are preempted.  PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011).  The second rule for generic drug cases – see rule number one.  That really should be it.  Take a look at our generic drug preemption scorecard – the rules are clear.  But some plaintiffs look for a way around the rules. Like a distiller trying to adding vanilla or caramel to Irish whiskey, it cannot be allowed (they call that liqueur in Ireland).  Fortunately, there also are causation rules, and learned intermediary rules, and general warning rules.  When you apply them all, you get Sherman v. Pfizer, Inc., No. 50914-8-11, slip op. (Wash. App. Ct. Apr. 30, 2019).

Plaintiff Sherman was prescribed the generic drug metoclopramide for treatment of gastroesophageal reflux (GERD) from 2004 to 2010.  In 2010, plaintiff developed tardive dyskinesia – a neurological disorder that causes involuntary movements.  Id. at 3.  Since 1985, the package insert for metoclopramide included a warning about tardive dyskinesia.  The manufacturers of Reglan, the brand version of metoclopramide, revised the package insert's warning regarding tardive dyskinesia in 2004 and again in 2009.  Id. at 3-4.

Presumably recognizing that a standard failure to warn to claim would be preempted – see rule number one – plaintiff tried to couch her claim in two different ways. The first we've seen numerous times – failure to update.  This post-Mensing contrived claim focuses exclusively on whether the generic label was the same as the brand label at all times as opposed to what a failure to warn claim is supposed to be about — whether a drug's labeling adequately warns of known and reasonably knowable risks.  Sameness and adequacy are not equal.  This is where causation and learned intermediary rules come into play.

Rule number three – "the plaintiff must show that the failure to warn was both the cause in fact and the legal cause of the harm."  Id. at 9.  Rule number 4 – in prescription drug cases, Washington applies the learned intermediary doctrine.  Id. at 8.  In Sherman, plaintiff's prescribing physician was adamant that he was aware of the risk of tardive dyskinesia at the time her prescribed metoclopramide to plaintiff and that he always monitored his patients for movement disorders.  More importantly, he testified that he does not read package inserts.  Id. at 5.  He doesn't read Dear Doctor letters, he didn't rely on the brand or generic package insert in deciding to prescribe metoclopramide to plaintiff, and no changes to the package insert influenced his prescribing decision.  Id. at 6.  "Instead, he relied on his clinical training and experience, the experience of his colleagues and associates, and his mentors and people in the academic world who he respected."  Id.

When you apply those facts to rules 3 and 4, you have one of this blog's recurring issues – when a physician fails to read the package insert it breaks the causal chain under the learned intermediary rule.  We even have a 50-state survey of favorable precedent on the issue.  Washington was a trail blazer on this issue.  Douglas v. Bussabarger was one of the first state high court decisions to rule favorably on this issue back in the 1960s.  438 P.2d 829 (Wash. 1968).  According to Douglas,

[E]ven if we assume [plaintiff's proposed] labeling should have taken place, [the prescriber] testified that he relied on his own knowledge of anesthetics and, in fact, did not read the labeling which was on the container.  Thus, if defendant-drug company was negligent in not labeling its container so as to warn of dangers, this negligence was not a proximate cause of plaintiff's disability.

Id. at 478.  With Douglas as the controlling law, plaintiff's failure to update claim fails for a lack of causation.  Sherman, at 12.

Plaintiff Sherman's second claim was that defendants breached their duty to warn by failing to communicate the drug's risks to plaintiff's prescriber and the medical community "in ways other than the package insert."  Id.  This failure to send Dear Doctor letters claim isn't completely novel either.  But, it's an interesting aspect of Washington product liability law that brings this claim down.  Rule number five – defendant's duty to warn does not extend beyond the warnings that accompany the product.

Under the Washington Products Liability Act (WPLA), a manufacturer can be liable for failure to warn "if the claimant's harm was proximately caused by the negligence of the manufacturer in that the product was . . . not reasonably safe because adequate warnings or instructions were not provided."  Id. at 13.  The WPLA goes on to provide

A product is not reasonably safe because adequate warnings or instructions were not provided with the product, if, at the time of manufacture, the likelihood that the product would cause the claimant's harm or similar harms, and the seriousness of those harms, rendered the warnings or instructions of the manufacturer inadequate and the manufacturer could have provided the warnings or instructions which the claimant alleges would have been adequate.

Id. at 14.  In other words, the WPLA limits the duty to warn to information "accompanying" the product.  The court noted that this is also consistent with comment k to Restatement (Second) of Torts §402A which states that "unavoidably unsafe products must be 'accompanied by proper directions and warning."  Id.  While plaintiff disagreed with this interpretation of the law, she offered no reason why the court should disregard the "provided with the product" language.  Since it is the package insert that accompanies prescription drugs, defendant's duty to warn stopped there.  The WPLA precludes any claim of failure to send "Dear Doctor" letters, or any of the other ways plaintiff argued defendants should have communicated with the medical community (advertising, reprints, CME).

The rules work.  When you stick to the rules, you get decisions like this one which we rank at about the level of the Teeling Small Batch.

This article is presented for informational purposes only and is not intended to constitute legal advice.

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