Photo of Steven Boranian

The district court’s express preemption ruling in Simoneau v. Stryker, Corp., No. 3:13-CV-1200, 2014 U.S. Dist. LEXIS 43137 (D. Conn. Mar. 31, 2014), reminds us of the piano we learned to play on as a child. It was a nice old piano, maybe even an antique, and it remains to this day in the Drug and Device Law Family. The problem was that there were a few keys that just would not stay in tune.  Just a few.  There we were, tearing off a killer Minuet in G, and then “clunk,” we hit the offending keys. Or maybe it was “clank.”  Either way, it was just one or two notes, but it was enough to dampen our spirit over an entire song.

And so is the small but significant part of Simoneau that permitted manufacturing defect claims to go forward in a case involving PMA-approved hip replacement devices.  We harken to the piano analogy because the rest of the Simoneau order is music to our ears, so let’s start with the good parts:  In Simoneau, the plaintiff was treated with a PMA-approved hip implant device in 2003 and had to undergo revision surgery in 2012. Id. at **3-4.  In the meantime, the FDA issued two warning letters in 2007 relating to the defendant’s manufacturing facilities, and two recalls followed in 2009—one recall of a hip replacement component and another of a bone screw.  Id. at **8-9, 17.

The plaintiff sued the manufacturer and alleged several product liability theories under the Connecticut Product Liability Act, including design defect, manufacturing defect, and failure to warn.  We note first that the court’s order is one of the most carefully crafted orders we’ve seen in a long time, including a long description of the regulatory framework for medical devices and an accurate recitation of the general rules governing express preemption:  “First the court must find that the federal government has imposed requirements on the medical device at issue.  If so then the court must determine whether plaintiff’s claims are based on state requirements that are ‘”different from or in additional to” the federal ones, and that related to safety and effectiveness.’”  Id. at **13-14 (citing Riegel).

Applying this rule, the court concluded correctly that federal law preempted the plaintiff’s design claims and warnings claims, which sounded both in strict liability and negligence.  On design, the court played a short and sweet tune:

With respect to a Class III medical device, which is subject to the rigorous PMA process, state law claims for defective design cast doubt on the FDA’s findings concerning the safety of that device’s design and, thus, are categorically preempted by the MDA.

Id. at *27.  We’ve written a lot about express preemption over design related claims, and we don’t see how a court could come to any different result.  Fortunately this court saw it the same way.

On the warnings-related claims, the court took somewhat longer, but reached the same result.  The plaintiff argued that her state-law warnings claims were based on violations of FDA regulations and thus were “parallel” claims.  Id. at **28-30.  But the court rejected that argument because the plaintiff had not linked her alleged injuries to any such violation.  Id. at **30-31.  Nor could the plaintiff claim that her state law claims were based on the “misbranding” of the devices because misbranding claims “necessarily impose requirements different from or additional to the FDA’s requirements.”  Id. at *31.  This last point should be obvious because FDA-approved warnings cannot be “misbranded” unless you hold that the labeling should have been different, which is the definition of express preemption.

Finally, the plaintiff argued that the defendant failed to advise her of the recalls or to report adverse events to the FDA.  The latter argument regrettably gained traction in one of the worst opinions of 2013Stengel v. Medtronic, Inc., 704 F.3d 1224 (9th Cir. 2013).  This court, however, rejected these arguments on the concise and reasoned bases that there is no state-law duty to warn patients about recalls of prescription products and also no state-law duty to warn the FDA.  Id. at **32-33.  (If only the Ninth Circuit had seen it so clearly).

Finely tuned on design, and finely tuned on warnings.  Which leads to the “clunk”—manufacturing defect.  On this theory, the court regrettably took its cue from one of the worst decisions of 2010 (although we reported it in 2011 because it was published so late in the year)—Bausch v. Stryker Corp., 630 F.3d 546 (7th Cir. 2010).  Because the plaintiff alleged that the recall-related manufacturing issues were directly related to the manufacture of the products she received in 2003, the court basically held that she had alleged violations of federal regulations that were also breaches of state-law duties, i.e., “parallel” claims.  Id. at **17-24.  When stated this way (which is generous to the court’s reasoning), it does not sound so bad.  We have always acknowledged the possibility that if a violation of FDA manufacturing regulations actually results in a product that does not meet manufacturing standards, there could be a parallel claim if that nonconforming aspect of the product causes an injury.

What then is the problem? The district court (like the Seventh Circuit in Bausch) gave the plaintiff a pass on TwIqbal pleading standards. Sure, the plaintiff alleged that the  2009 recalls “directly relate to the manufacture of the [hip implant] she received in 2003,” but she needed to allege facts showing a plausible basis for that alleged relationship, plus more.  How exactly did her product deviate from what the manufacturer intended and how was it in a defective condition unreasonably dangerous as a result?  If she did not plead a plausible state-law manufacturing defect claim, she should not get even to square one.  On express preemption, how exactly did a 2009 recall impact manufacturing in 2003?  Did manufacturing issues actually result in a product that did not meet the manufacturer’s specifications?  Did that nonconforming aspect of the product result in plaintiff’s injury?  The court brushed off TwIqbal in a footnote and excused plaintiff from pleading plausible claims.  Why? Because “’much of the critical information . . . is kept confidential as a matter of federal law’ and will, therefore, be unavailable to a plaintiff without discovery.”  Id. at *19.  So discovery solves all woes.  Clank.

The district court also accepted that a parallel claim can be based on violations of generally applicable cGMPs, rather than device-specific requirements.  Id. at **20-22.  As in Bausch, the court seemed disinclined to examine too closely the actual basis for the plaintiff’s “parallel” claim, again because “policing that limitation at the pleadings stage would work especial hardship for plaintiffs in this context.”  Id. at *22.

We don’t want to work especial hardship on anyone, but we do know that hardship is not an element of the express preemption analysis.  Preemption is powerful because it eliminates entire complaint in deference to federal regulation.  It embodies the high regulation, low litigation model that we favor, and while Simoneau plays a sweet melody on many issues, its tune on manufacturing defect is decidedly off key.