Sometimes we discus broad issues, like TwIqbal; sometimes we don’t. Today we’re not.
While we don’t claim to know much about the specifics, we’re aware that the FDA is going (or maybe already has) to lower the classification of percutaneous transluminal coronary angioplasty (that mouthful is thankfully abbreviated “PTCA”) catheters from Class III to Class II. For you packrat types, you can read the FDA’s proposal at 75 Fed. Reg. 54493 (FDA Sept. 8, 2010). When the FDA does that kind of thing – reclassifies a medical device so as to reduce its risk profile – the jargon for that is “downclassification.”
One of the things that a downclassification of that sort means is that the device is no longer subject to the FDA’s pre-market approval (“PMA”) process for either initial approval of new devices of that description or for modifications to existing devices. Over here at Drug and Device Law, when we hear “PMA,” we think Riegel preemption. It’s instinctive, like when Pavlov’s dogs heard that bell. We try not to drool to much.
So our thought was, what does a downclassification do to a manufacturer’s preemption defense in a product liability suit? After all, two days after announcing the downclassification, the FDA also announced a recall of some PTCA catheters.
Well, it turns out there’s some, but not a lot, law on that subject. We looked through our device preemption scorecard and found one case, Colombini v. Westchester County Health Care Corp., 2009 WL 2170230 (N.Y. Sup. July 6, 2009) (unpublished, in table at 899 N.Y.S.2d 58). Then we dug a little deeper and found a pre-Riegel preemption case presenting more or less the same scenario. Rousseau v. Depuy Orthopaedics, Inc., 2006 WL 3716061 (W.D. La. Dec. 13, 2006).
Colombini involved an MRI machine. The “M” stands for “magnetic,” and those devices certainly are. In Colombini a patient being examined in the machine was killed when struck by a stray piece of metal (an oxygen tank) that somebody left in the room to be drawn in by the magnetism the machine generated while in use.
How that kind of error would make the machine’s manufacturer liable we don’t know – and fortunately we don’t have to worry about that, because MRI machines are Class III devices to which Riegel preemption applies.
Except they’re not – not anymore.
Here’s the deal. In Colombini, the MRI machine was downclassified from Class III to Class II before the plaintiff’s decedent was killed. The timeline:
1983 – MRIs receive Class III designation
1985 – Defendant receives FDA PMA to manufacture MRI device
1986 – Defendant sells MRI device involved in accident
1988 – FDA downclassifies MRIs to Class II
1997 – MRI device involved in accident overhauled
2001 – Accident leading to suit occurs
The plaintiff argued that the downclassification eliminated the product’s prior PMA status and that preemption was thereby “revoked.” 2009 WL 2170230, at *3. The defendant, not surprisingly disagreed. The court, we’re pleased to report, agreed with the defendant.
The court held that, once a device was PMAed by the FDA, subsequent changes in the device’s classification that made approval easier for other products made by other manufacturers didn’t change what the manufacturer of the PMA device had to go through at the FDA to get its own device to market:
[T]he fact of having gone through the “rigorous” premarket approval process is determinative. Once a device has undergone premarket approval, it is already in an approved form that the FDA has determined provides a reasonable assurance of safety and effectiveness. . . . [I]t is not the present classification of the device at issue that is the primary factor in determining whether claims are preempted under the MDA, but “the process the product underwent in order to obtain FDA approval.
2009 WL 2170230, at *3 (citations and quotation marks omitted).
Rousseau involved bone cement – a medical device with a regulatory history so complicated that it more properly belongs in the FDA law blog. Bone cement predated the passage of the Medical Device Amendments in 1976, and thus passed through the FDA’s “transitional device” protocols. Still later it was downclassified to Class II. Here’s the Rosseau timeline:
1971 – Defendant’s bone cement approved by FDA as a “new drug”
1976 – MDAs passed by Congress, establishing medical device regulatory scheme
1976 – Defendant’s bone cement automatically classified as Class III PMA as a “transitional device” previously approved via New Drug Application
2002 – Bone cement downclassified as Class II
2004 – Plaintiff receives defendant’s bone cement as part of unsuccessful knee replacement surgery
Rosseau was pre-Riegel, but the Fifth Circuit (where Louisiana is located) had anticipated the Supreme Court and recognized PMA preemption. The question was whether an FDA downclassification – in Rosseau two years before the product was used – divested the defendant of its preemption defense. The court held that the initial PMA/Class III status prevailed, although the downclassification happened before the cement used in the plaintiff’s operation was sold. Rosseau first analyzed the transitional device process, finding the initial NDA to be the “equivalent” of a PMA:
[The product] was approved through the NDA process before the passage of the MDA and the establishment of the PMA process. However, the MDA provides that such devices are deemed to have completed the PMA process. Since [the product] is deemed to have been approved through the PMA process, this court will analyze the claims accordingly.
2006 WL 3716061, at *8 (citation omitted).
Turning to the downclassification, the court held that “the process the product underwent in order to obtain FDA approval” was the important factor in determining preemption. Id. Because that process (equivalent to a PMA) “is key to the preemption analysis . . . the reclassification . . . did not cause [the product] to automatically lose the protection from suit it earned when granted approval through the PMA process.” Id. That the downclassification occurred prior to the device’s sale, did not matter because nothing relevant had changed in the interim:
Since [the product] was reclassified in 2002, no changes have been made to [it], the manufacturing process, or the labeling. Therefore, every aspect of the package of [the product] used in [plaintiff’s] surgery had been approved by the FDA, just as it would have been had [the product] remained in Class III. . . . Accordingly, the preemption analysis for the [the product] used in [plaintiff’s] surgery should be the same as for other devices approved through the PMA process, regardless of the fact that [the product] was reclassified.
Id. Cf. Brooks v. Howmedica, Inc., 273 F.3d 785, 789 n.5 (8th Cir. 2001) (post-use downclassification of same product at issue in Rosseau did not affect Class III status, and therefore preemption; no analysis); Scott v. Pfizer Inc., 249 F.R.D. 248, 254 n.8 (E.D. Tex. 2008) (same).
The first case to address the regulatory status of a downclassified device for litigation purposes, however, did not do so in a preemption context. In Southard v. Temple University Hospital, 781 A.2d 101 (Pa. 2001), the plaintiff claimed injury from (drum roll please) orthopedic bone screws and brought a malpractice suit against the surgeons who implanted the device. After the plaintiff’s surgery, the bone screws were downclassified. The parties disputed the proper classification of the device, and the court held that the original (Class III) classification controlled:
The parties dispute the appropriate classification of the device at issue. . . . [W]hen the screws were used in the pedicles of the portion of the spine at issue here, they were designated as a Class III device. This, for purposes of this opinion, we will refer to the bone screws as a Class III device. Parenthetically, we note that . . . after [plaintiff’s] surgery, the FDA classified certain previously unclassified pedicle screw spinal systems into Class II and reclassified other pedicle screw systems from Class III to Class II for certain intended uses.
781 A.2d at 104 n.3.
Another case of note is the Mississippi Supreme Court’s recent decision in Sanders v. Advanced Neuromodulation Systems, Inc., ___ So.3d ___, 2010 WL 3785302 (Miss. Sept. 30, 2010), although it’s one step removed. Saunders affirmed a preemption-based summary judgment against an argument that the defendant’s Class III device should be considered Class II (and unpreempted) because the defendant had unsuccessfully sought downclassification. The court held that the actual classification of the device, and not the lower classification the defendant had unsuccessfully sought, controlled for preemption purposes:
We find that the trial court did not err by finding that the [product] was a class III medical device, and as such, [plaintiff’s] claims were barred, because the claims were subject to federal preemption. . . . The [product], pursuant to the MDA, was classified as a class III device. In an attempt to have the [product] reclassified from a class III device to a class II device, [defendant] petitioned the FDA in 1999. The record contains the FDA’s denial of [defendant’s] request at reclassification. In its 2001 denial letter, the FDA unequivocally stated that the stimulator was “automatically classified into class III.
2010 WL 3785302, at *8. Cf. Busch v. Ansell Perry, Inc., 2005 WL 877805, at *4 (W.D. Ky. March 8, 2005) (unadopted FDA proposal for upward reclassification of medical device likewise has no preemptive effect).
On a related note, we’ve also noticed that the PMA status of a medical device system has also controlled where it is alleged that one of the components used to have a lower classification before the entire system was submitted for premarket review. That’s sort of a reclassification, although the classification change is accomplished in another manner. Courts have held that where a medical device system has actually gone through PMA, then the prior regulatory status of its individual components is irrelevant to preemption. Lewkut v. Stryker Corp., ___ F. Supp.2d ___, 2010 WL 1544275, at *4 (S.D. Tex. April 16, 2010); Bass v. Stryker Corp., 2010 WL 3431637, at *4 (N.D. Tex. Aug. 31, 2010); Phillips v. Stryker Corp., 2010 WL 2270683, at *5 (E.D. Tenn. June 3, 2010); Hayes v. Howmedica Osteonics Corp., 2009 WL 6841859, at *7 (D.N.J. Dec. 15, 2009).
Looking at all of the reclassification cases, we think we can safely say that a device downclassification will not adversely affect the manufacturer’s entitlement to preemption in most circumstances. Intervening downclassifications, whether before or after use of the device in a particular plaintiff’s treatment, have not divested devices of their original Class III – and therefore preemption protected – status. By contrast, an intervening upward reclassification, whereby a device actually undergoes PMA by the FDA, will trump a prior lower classification and support preemption, as long as plaintiff got the reclassified device.
It might be more problematic if, after a downclassification, a device modification not governed by the PMA process occurred that was in some way causal of the plaintiff’s alleged injuries. So far, however, we have not seen any cases addressing that scenario.