This post is from the non-Reed Smith side of the blog.
August 25th. How can that be? Some of us are still using the red, white and blue napkins we purchased for the Fourth of July. Jersey corn is sweet and the tomatoes are juicy. The shore is still packed with sun and surf lovers. The commute attests to a lack of school of buses and plenty of people still on vacation. But there is only about one week until the unofficial end of summer. Labor Day is late this year, but as soon as that calendar flips to September everyone starts thinking about falling leaves over blooming impatiens; pumpkin spice over piña colada; sweaters over tank tops. And for lovers of flip-flops, barbecue, pool floats, and sand – it means a case of the end of summer blahs. The blahs are something less than the blues. After all, it’s likely to still be 85 degrees for most of September (at least in the mid-Atlantic). The blahs are more about glancing up to see that it’s getting dark at 8:00 pm again. Or when a friend on Facebook starts a Countdown to Christmas clock. Or you realize that none of your children’s shoes fit and barefoot isn’t an option for school. It’s not that we don’t enjoy the change in season and aren’t ready for some crisp fall air. It’s more about realizing just how fast another summer sped by. So, you’re not blue – you’re just blah.
And that’s sort of how the case we are talking about today makes us feel – blah. We like it in part, but there’s just enough not to like too. The case is Williams v. Smith & Nephew, Inc., 2015 U.S. Dist. LEXIS 108670 (D. Md. Aug. 18, 2015). Plaintiff alleges that his hip implant led to cobalt and chromium poisoning. Id. at *6. He filed a four count complaint – negligence, strict liability, breach of express and implied warranty, and loss of consortium. Id. at *7-10. Because the hip implant was a Class III, Pre-Market Approved medical device, defendant moved to dismiss on the grounds of preemption. Usually a smart decision in a PMA case – and it was here as well. The court didn’t agree completely on all counts, but some of the claims were knocked out.
The first thing we noticed is that the allegations in this case seem to be more carefully pleaded; at least more artfully tailored to establish parallelism. For example, plaintiff alleged that his negligence claim was “based solely on [defendant’s] failure to comply with the PMA approval order” and that they seek damages “only to the extent that they run parallel to the federal conditions and requirements.” Id. at *9. But that kind of qualifying language only goes so far – the claim itself has to be a traditional state law claim premised on a violation of a specific federal requirement.
Design defect is usually an easy win in PMA cases – you can’t argue that defendant should have used a different design than then the one approved by the FDA. Id. at *17. That would be imposing “a more demanding standard that that of the FDA, rather than a parallel one.” Id.
As for breach of implied warranty, under Maryland law, you can have an implied warranty that the product is fit for its ordinary purpose or a particular purpose. The court found that because the FDA through the PMA had defined the scope of the device’s intended use and the representations defendant is obligated to make regarding the device, any ruling under Maryland law that defendant breached an implied warranty would impose an obligation beyond that of the FDA. Right result, wrong reasoning. The following will come as no surprise to our readers: The FDA approves devices not uses. PMA requirements are device specific. The FDA does not and cannot regulate how devices are used by surgeons. So, we’ll have to disagree with the court that the PMA defines the scope of use. Blah.
We also feel blah about the court’s failure to warn decision (maybe slightly more than just blah). Here plaintiff hung his hat on failure to provide post-marketing reports to the FDA and the court said OK. Id. at *18. There is no dispute that Maryland law recognizes a claim for failure to warn. We take issue with distorting that claim into a failure to warn the FDA claim. But even where courts decide to recognize this as a legitimate state law claim, this is where we think express preemption yields to implied preemption or Buckman preemption. Unfortunately, the court didn’t agree, finding that none of plaintiff’s claims resemble fraud-on-the-FDA. Id. at *27. But failure to report events to the FDA is simply a way of saying fraud-on-the-FDA without using those words. The argument is the same – defendant misled the FDA into either taking some action or not taking some action by failing to provide complete information as required under the law. The Supreme Court has already held that that is a matter for the FDA to police – not private litigants. Calling it failure to warn doesn’t change the underlying analysis.
Even narrowly interpreting Buckman, the court had to acknowledge that not all of plaintiff’s claims thread the gap between express preemption and implied preemption. Where plaintiff’s negligence claim is based on a violation of federal duties that are not actionable under state law, those claims were dismissed as impliedly preempted. Id. at *29. They include such claims as duty to train physicians, duty to conduct studies and duty to recall. Id. at *19n.8.
The court took a middle of the road approach on express warranty. To the extent the claim is based on warranties in FDA-approved labeling – it is preempted. To the extent it is based on “voluntary communications” with doctors – it is not. Id. at *21. This is not an unfamiliar approach. The part of the decision that gives the blahs here is the ruling that plaintiff sufficiently pleaded the claim. The court concedes that the complaint does not identify the sales representatives who allegedly made the representations or when they were made, but said that because it identified the product literature at issue, that was good enough. Id. at *32-33. Without even a passing connection to plaintiff’s surgeon, we again must disagree.
Somewhat out of the norm, plaintiff also brought a manufacturing defect claim alleging that the defendant deviated from the manufacturing requirements of the FDA. Id. at *20. This is probably the cleanest example of a parallel claim. But, this claim was dismissed under TwIqbal. Without specific allegations of how plaintiff’s hip implant deviated from the FDA approved design, the court found the claim too speculative. Id. at *30-31.
We don’t like feeling blah. So we aren’t going to dwell on this decision and instead grab some SPF 30 and a cold drink and get out and enjoy the last few days of summer.