Some states have statutes that we find very helpful.  Louisiana has the Louisiana Product Liability Act, with its strong exclusivity clause; New Jersey’s PLA provides some very helpful presumptions, including a presumption of adequacy for FDA-compliant drug labeling.  We have often cited the Texas statute that creates a presumption that pharmaceutical manufacturers and sellers are not liable for allegedly inadequate warnings if the labeling was approved, unless the plaintiffs can rebut the presumption in specific ways.  Michigan has a good statute too, which we will get to in a moment.

We like these statutes because they are one step closer to the high-regulation, low-litigation model of product liability that we favor.  We say that not just because we represent drug companies and medical device manufacturers, but also because it is the best approach for the consistent and effective regulation of medical products. Regular readers are familiar with the conundrum created when drug and medical device labeling is regulated through civil litigation.  As we recently wrote in connection with primary jurisdiction, when the FDA determines what drug labeling should and should not say, it applies its expertise to a balanced view of the product’s risks and benefits. When regulating that same labeling through civil litigation, the jury sees only the one plaintiff who has experienced an alleged injury.  It is a skewed and incomplete depiction of the product’s true risk profile and, by extension, the adequacy of the labeling that accompanies it.  A balanced view ensures that life-saving and life-improving products will remain available to patients in need and that doctors will have the information regarding risks and benefits necessary to make informed treatment decisions.

Because we feel this way, we lament the fact that state product liability statutes often deal with drugs, but not medical devices.  Texas and Michigan are both that way, and we don’t know why that should be.  All drugs have risks and cannot be made one-hundred percent risk free.  Same with medical devices.  That’s why a doctor’s prescription is required.  Drugs are regulated by federal law administered by the FDA.  So are medical devices.  Drugs are accompanied by approved written information stating their indications and setting forth their risks in a regimented way.  Medical devices?  Check.  Ditto the common law.  Courts overwhelmingly apply both the learned intermediary rule and comment k in the same fashion to drugs and medical devices.  The same policy considerations apply, and urge the application of those laws in medical device cases when we have the opportunities.  If bills were introduced to expressly extend those states’ laws to medical devices, we would vote for them.

Imagine then our disappointment when we read Miller v. Mylan, Inc., No. 12-2502, 2013 U.S. App. LEXIS 1077 (6th Cir. Jan. 21, 2014), where the Sixth Circuit actually narrowed the application of Michigan’s statute (we told you we would get back to Michigan’s statute) and expanded the role of litigation in regulating a drug.  In Miller, the patient used an analgesic skin patch and sadly died, which resulted in a lawsuit against the product’s manufacturer.  The manufacturer moved to dismiss the complaint under Michigan’s statute, which states that

a drug is not defective or unreasonably dangerous, and the manufacturer or seller is not liable if the drug was approved for safety and efficacy by the [FDA], and the drug and its labeling were in compliance with [FDA’s] approval at the time the drug left the control of the manufacturer or seller.

Id. at *3 (quoting Mich. Comp. Laws § 600.2946(5)).  The manufacturer argued that it was entitled to the statute’s protection, and the district court agreed and dismissed the complaint.  This was the correct result.  The Michigan statute does not “immunize” drug manufacturers like they are diplomats who freely ignore parking laws.  It cuts off civil liability if the manufacturer fully complies with the federal regulatory regime set up to ensure the safety and efficacy of prescription drugs.  That’s what we were talking about before—high regulation, low litigation.

The case went off the rails in the Sixth Circuit, where two judges took a look at the product and decided that maybe it was not a drug after all.  Maybe it was a “combination product,” which is an FDA term of art.  And if that’s the case, then a Michigan statute “that immunizes manufacturers of ‘drugs’ from suit” would not apply.  Id. at **1-2.  Oddly, the plaintiffs made this argument neither in the district court nor in the Court of Appeals, and the term “combination product” did not appear in the parties’ briefs until after the Sixth Circuit sua sponte requested supplemental briefs on whether the product was a “combination product” and whether the statute would apply to such a product.  Appellate clerks have a term for this:  It’s called a “rescue mission,” which is when an appellate court really wants to reverse a judgment and does its own research to re-craft the appellant’s argument to enable that result.

We feel sympathy for the decedent too, but the Sixth Circuit’s mission took Michigan law in the wrong direction.  To be clear, the analgesic skin patch was a drug.  How do we know that?  Well, the plaintiff (the decedent’s successor) alleged it was a drug in her initial complaint, and when given the opportunity to amend her complaint she again alleged it was a drug.  Id. at *17.  The manufacturer said the product was a drug; the FDA regulated the product as a drug; and the district court based its ruling on the fact that the product was a drug.  The analgesic patch achieved its primary intended purpose through metabolization of its active ingredient, which is what “drugs” do.  (Compare, for example, a combination product such as antibiotic-coated surgical mesh, which fights infection and mechanically repairs a body structure.)  When everyone agreed that the analgesic patch was a drug, including the relevant federal regulator, we scratch our heads wondering what piqued the interest of these two Circuit Judges.  They should have deferred to the FDA’s determination; and even if the court thought that the FDA’s treatment of the product was somehow ambiguous, it should have deferred to the FDA’s primary jurisdiction and allowed the FDA the first opportunity to take a clear position.

The Sixth Circuit therefore took a clear state statutory provision with bright-line rules that, if anything, should be expanded to include other FDA-regulated products and made them less clear and more narrow.  As we’ve said time and time again (and so has the Sixth Circuit when it’s not determined to rescue a plaintiff), it’s not the role of a federal court sitting in diversity to expand liability under state law where the state courts have not done so.

The concurring opinion adds insult to injury by stating that rather than deferring to the FDA’s regulatory determination, a product’s identity as a drug is a factual issue subject to discovery.  The manufacturer had requested judicial notice of FDA documents to establish that the analgesic patch was a drug, which was a perfectly appropriate request to make.  The concurring opinion took exception with that, noting that the only document it reviewed as relevant “is not central to plaintiff’s claim” and “seems central to the defense.”  Id. at *13 (emphasis in original).  According to the concurring judge, such a document should be introduced in support of a motion for summary judgment, which “would of course be made after plaintiff had an opportunity for discovery about all the exchanges between [the manufacturer] and the FDA with regard to the patch.”  Id. at **13-14.

For one thing, we do not see how it matters whether a request for judicial notice aids the plaintiffs or the defense.  More importantly, the principal benefit of statutes that defer to regulatory systems and expertise, such as Michigan’s, is that drug manufacturers who comply with the rules do not have to endure civil litigation, including and especially expensive discovery.  The concurring opinion stood this point on its head by reading the statute to permit, or even require, more litigation to get to a result.  This is exactly the sort of case that should have been determined on the pleadings, and the district court had it right in the first instance under Michigan law.