But sometimes the plaintiff side's offerings to the press find their way to us - as bloggers.
Thought you should be aware that a qui tam lawsuit against device maker, Medtronic was recently unsealed by the U.S. District Court in Boston. The key takeaway in this particular case is that lawsuit suggests that Medtronic knowingly made a mockery of the FDA and its 501(k) process. . . .The email went on to make various other allegations along the same lines.
- Any qui tam action filed in the District of Massachusetts (“U.S. District Court in Boston”) should be automatically suspect. If ATRA ever did a hellhole jurisdiction analysis of qui tam actions, that district would rank number one. It’s notorious for letting plaintiffs get away with cases that would be thrown out of court elsewhere.
- The allegation “knowingly made a mockery of the FDA and its 501(k) process” is hauntingly familiar to us. That sounds almost exactly like the claim made against the defendants in the Bone Screw litigation – and which, when presented as a state-law claim, was unanimously held preempted in Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001).
In the FDCA, Congress said explicitly that the FDA and only the FDA (all right, technically the Department of Justice) has the right to take enforcement action against violators of the Act. See 21 U.S.C. §337(a). We did a long post recently, called “What To Do With Unpreempted Fraud On The FDA Claims,” detailing just how Buckman’s policy arguments concerning preemption are equally valid in the context of private parties (such as qui tam plaintiffs) purporting to use other federal statutes to pursue FDCA violations. In short, private federal fraud on the FDA suits are just as meritless as state-law ones - we just can’t use the word “preemption.”
- (1) Do the devices work (part one of did the government get good stuff)? We think so. There’s nothing at all in on the plaintiff’s website claiming that these stents aren’t effective for whatever off-label uses to which they’ve been put. If there’s even a slim argument that they didn’t do the job, we’d expect plaintiffs to shout that from the rooftops. They don’t, so we assume they work.
- (2) Are the devices safe (part two of did the government get good stuff)? The plaintiffs mention various risks and call the devices “high risk.” But remember these are implantable stents. All implants have risks and failure rates. We don’t see any claim that these devices were less safe than any alternatives, and again if that argument could be made any competent plaintiff’s side lawyer would make it – loudly. So our strong suspicion is that this off-label use isn’t any less safe than available alternatives.
- (3) Did the government get overcharged? Funny, there’s nothing at all about pricing in the plaintiff’s propaganda. What’s that Sherlock Holmes said about it being “curious” that some dog didn’t bark? It’s equally curious that there’s no hint of an overcharge claim here. Frankly, an overcharge seems implausible (yes, we mean that in the Twombly/Iqbal sense) to us. To the contrary, we suspect that the government got a bargain. There’s only one reason to go the “substantially equivalent”/§510(k) route rather than seek FDA pre-market approval. That’s because the first way is a lot easier and cheaper. In product liability, it’s much better to have a PMA device, because then there’s preemption. Remember Riegel v. Medtronic, Inc., 552 U.S. 312 (2008)? So a defendant using §510(k) would probably pass some of the cost savings on to its customers. In other words, if the defendant had done what plaintiffs’ claim it should have, the government probably would have paid more than it did.
Supposedly, an “increased” number of MDRs (“medical device reports” of adverse events) happened. Complaint ¶¶38, 126, 138. Again, consider the source. An increase in reports is to be expected if more doctors believe the devices work and choose to use them more often. More use = more reports. As we’ve discussed, among other places such as here, the FDA itself says that adverse event reports can’t establish causation. And jeez, we don’t think these plaintiffs can do math very well – they actually allege that an off-label use representing “90%” of product use produces “81%” of malfunction reports and “87.9%” of all adverse events that are reported. Complaint ¶137. On a per-use basis, that indicates (as much as anecdotal reports indicate anything) that the off-label uses are safer than the labeled uses.
Second, the allegations don’t establish lack of safety either. If anything the off-label uses seem to be relatively less productive of adverse events than these stents’ on-label uses. There’s no allegation that other products were significantly safer. In short, the government bought and paid for good stuff.
The social value of the product at issue in this litigation is also noteworthy. . . . [Defendant] has created a product with substantial benefits that even now-after many years of litigation, research, testing, and controversy-is still favored by many physicians and patients. . . . [T]his lawsuit is an effort. . .to obtain a windfall: to recoup money  spent covering a prescription drug for Medicaid beneficiaries even though it does not claim that the drug injured them or that it failed to work. . . .
If allowed to proceed in their entirety, [these] claims could result in serious harm or bankruptcy for this defendant and the pharmaceutical industry generally. For the legal system to be used for this slash-and-burn-style of litigation would arguably constitute an abuse of the legal process. Constitutional, statutory, and common law rights of those injured to seek relief from the courts must be recognized. But courts cannot be used as an engine of an industry’s destruction.