Will Medical Device Companies Finally Stand Behind Their Implants With A Warranty?
I criticized Consumer Reports’ hospital ranking methodology not too long ago, but, as I wrote then, I think they do good work and I support their mission. Last week, they yet again stepped in to protect consumer safety with a new initiative at the Safe Patient Project demanding that a variety of medical device manufacturers offer real warranties with their products. More details available at the Consumerist blog (which they own).
To understand why such a basic consumer promise is a big deal requires a bit of background.
The new iPhone comes out this week, and if there’s one thing we know for sure, it’s this: it’ll be largely disposable. Apple provides a one-year limited warranty on iPhones, which covers “defects in materials and workmanship when used normally in accordance with Apple’s published guidelines … [which] include but are not limited to information contained in technical specifications, user manuals and service communications.” It’s annoying and feels cheap, but it’s hard to complain about it; sure, an iPhone is expensive, but it’s also rarely necessary, it’s just one of dozens of viable options for consumers, and the limitations and problems with the phone are generally disclosed upfront. By and large, iPhones work, but they don’t work for years on end, and when it inevitably breaks or stops working, you’ll need to buy a new phone. C’est la vie.
Medical implants, however, are another story. They’re incredibly expensive and their risks are completely unknown to patients. More importantly, when your medical device fails, you don’t just buy a new one, you suffer a host of complications until you can find a doctor willing to explant the device and implant a new one, which you hope will bring you at least back to the condition you were in. That’s the best case scenario; many times, medical device failures bring with them a host of horrendous complications. More than a few of my hip implant clients had their broken hip removed, had a new hip implanted, had to get that removed when it got infected, had to sit around for a while with the dreaded “spacer,” then got another hip implant that leaves them with severely limited mobility and chronic pain.
So what’s the typical warranty on a medical device implant?
There isn’t one. Typically, a medical device manufacturer is not responsible at all for promises it makes on the label, nor responsible for even making a product “fit for ordinary purposes.” Thus, when their devices fail, the patients bear the harm and losses with no recourse, and we as a society shoulder a financial cost that should be paid wholly by the manufacturers. (Morgan & Morgan’s blog has a bit more on the typical cost of hip failures.)
Consider Cornett v. Johnson & Johnson, in which the plaintiff was implanted with a Cypher heart stent, a Class III medical device, for the treatment of coronary heart disease. He had diabetes, so the use was considered “off-label” — as in, unapproved by the FDA — and, five months after surgery, he suffered a subacute stent thrombosis in the area where the Cypher® stent was placed. In their complaint, the “plaintiffs allege[d] defendants breached express warranties by manufacturing, marketing, packaging, labeling and selling the Cypher® stent while misstating the risks of injury, without providing warnings of the misstatements in the labeling or packaging, and without modifying or excluding any express warranties.” Cornett v. Johnson & Johnson, 211 N.J. 362, 391–392, 48 A.3d 1041, 1058 (2012).
Sounds simple enough, right? Surely a manufacturer can be held responsible for the written promises it makes on its packaging. Alas, no: “these claims would require a change of an approved design or a change of an approved label, which would require further FDA review and approval, and are tantamount to imposition of greater or different requirements than the FDA imposed [premarket approval] requirements.” Id. The claims were thus preempted under Riegel v. Medtronic, Inc., 552 U.S. 312 (2008). See also Walker v. Medtronic, Inc., 670 F.3d 569, 574 (4th Cir. 2012)(implanted medicine pump failed to “maintain[ ] the delivery accuracy of +/-15%” as required by FDA approval and as listed on the packaging, causing patient to die from overdose of medication; breach of warranty claims preempted anyway). Indeed, as the defense lawyers at Drug & Device Law have been cheering, many courts don’t even hold manufacturers to the promises made by their sales representatives before the surgery and in the operating room!
Defenders of the medical device industry rationalize these decisions in light of the FDA’s “premarket approval” process. Sure, the system in real life works about as well as most self-certifying systems — which is to say, it’s wholly dependent on how motivated the medical device company is to ferret out and disclose medical data and research against its own financial interests — but, they claim, at least in theory, the FDA premarket approval process ensures that medical devices are thoroughly reviewed before they’re sold.
But this argument makes no sense: even in theory, the FDA premarket approval process doesn’t ensure that a medical device works exactly as promised. It’s simply the FDA agreeing that the device’s benefits outweigh its risks. There’s no reason to jump from that minimal safety standard to the point of granting the medical manufacturers wholesale immunity when their devices don’t work as promised. FDA premarket approval is no different from the NHTSA’s crash testing program ensuring that new cars meet minimal safety standards — it’s just an indication the product meets the minimum safety requirements, not a government stamp of approval for every last promise made about the product. A car company would be held liable if it claimed no passengers would be hurt in accidents at less than 35 mph; medical device companies, too, should be liable when their products don’t live up to the descriptions that come with them.
The situation is a little better when it comes to “Class II” medical devices — i.e., the ones that medical device manufacturers sneak onto the market through a dangerous regulatory loophole the Institute of Medicine wants to close — but not a whole lot better. Breach of warranty claims against Class II manufacturers aren’t inherently preempted by federal law, but the problem is that (a) express warranty claims usually fail because the medical device company usually doesn’t promise anything and (b) implied warranty claims typically fail because of a illogical legal doctrine that holds “the very nature of prescription medical products which are considered unavoidably unsafe products precludes the imposition of a warranty of fitness for ordinary purposes.” Schiff v. Hurwitz, 2012 U.S. Dist. LEXIS 70039 *16 (W.D. Pa. 2012).
And that’s where the Safe Patient Project’s initiative would come in. As Cornett described, “to the extent the breach of express warranty claim is based on voluntary statements, i.e., statements not approved by the FDA or mandated by the FDA about the use or effectiveness of the product for on-label or off-label uses, a breach of express warranty claim may proceed because federal law requires any warranty statement to be truthful and accurate.” Cornett, 48 A.3d at 1058. The manufacturers could make real promises about their products, they just choose to hide behind the FDA labeling they’re not obligated to honor and behind consumer expectations that medical implants have an implied warranty of fitness for ordinary purposes, just like the majority of consumer products.