We’ve been interested in the issue of what is sometimes referred to “compassionate use” of unapproved products still in the pipeline ever since the we blogged on the Abigail Alliance litigation back in 2007. For those of you not reading us then, we praised the D.C. Circuit’s rejection of any constitutional right for terminally–ill patients to demand access to investigational drugs. Abigail Alliance for Better Access to Developmental Drugs v. von Eschenbach, 495 F.3d 695, 710-11 (D.C. Cir. 2007).
We did that because the next step, after establishing such a constitutional right as against the FDA, would have been to file suit against our clients (the government usually doesn’t have the drugs, the manufacturers do) to “enforce” that right by demanding that drug companies supply them with the unapproved drugs they sought. Sure enough, that’s happened, too, even without the purported constitutional right. We discussed a number of such cases (all, thankfully unsuccessful) here.
The “Right To Try” statutes seek to accomplish much the same thing, albeit with more consideration given to the rights of manufacturers (the earlier lawsuits mostly tried to get investigational drugs for free) and reasonable procedural steps included for health care providers as well. One key feature of these statutes – we’ll pick the Arizona statute for no reason other than alphabetical order, but all the statutes are the same on this – is that participation by drug companies is voluntary:
A manufacturer of an investigational drug, biological product or device may make available the manufacturer's investigational drug, biological product or device to eligible patients pursuant to this article. This article does not require that a manufacturer make available an investigational drug, biological product or device to an eligible patient.
Ariz. R.S.A. §36-1312(A).
Right to Try statutes also typically include robust informed consent requirements (more on that in a minute), id. §1311(1)(d-e), see Colo. R.S.A. §25-45-103(4) (very detailed informed consent provision); Mich. C.L.A. §26451(d) (same), as well as provisions for payment of whatever the owner of the investigational product chooses to charge. Ariz. R.S.A. §§36-1312(B)(2). Nor are these statutes the equivalent of those infamous “Laetrile bills” that underwent a brief efflorescence in the late 1970s. Those sought to legalize quackery. These statutes are limited to investigational drugs that have successfully passed FDA Phase I trials. Id. §1311(2). In Phase I, investigational new drugs are tested on a few dozen human subjects (20-80) “to determine the metabolism and pharmacologic actions of the drug in humans, the side effects associated with increasing doses, and, if possible, to gain early evidence on effectiveness.” 21 C.F.R. §312.21(a).
Still, we don’t think these statutes are going to accomplish much, let alone achieve their purpose of making investigational drugs generally available to terminally ill patients having no other choices. For one thing, there’s the FDA. States can pass all the laws they want, but unless the FDA gives its okay to programs more expansive than its compassionate use (“expanded access”) program, nothing’s going to happen. It's called "preemption." You may have read a bit about that on this blog.
But putting the FDA to one side, even if states could start their own compassionate use programs, these statutes aren’t likely to help much.
The reason, as is the case for so many things these days, is the threat of liability. Nothing in any Right to Try statute allows companies to insist upon ironclad releases of liability as a condition of their participation, and absent that state courts (which tend to read releases parsimoniously) could well hold such releases invalid as coercive. “If you don’t sign this release, you’re sure to die” isn’t exactly a situation calling for the unfettered exercise of equal bargaining power. A Right to Try statute could override other law in this limited circumstance by expressly allowing such releases, but none of them do.
The other way to eliminate the liability disincentive to the provision of drugs/devices of unknown safety and effectiveness (for any use) to desperately ill people is through statutory preclusion of liability. Once again the Right to Try statutes come up short. Some of these statutes have no limitations on tort liability at all (at least as to manufacturers, we’re not discussing doctors and other health care providers). Arizona’s doesn’t. Neither does Louisiana. In fact Louisiana is worse, since it's statute provides blanket tort immunity to any “physician who prescribes an investigational drug, biological product, or device to an eligible patient pursuant to the provisions of this Part.” La. R.S. §1300.385. The practical result of such immunity would be that, should anyone in Louisiana sue for injuries caused by the unknown risks of an “investigational” drug, the manufacturer would stand alone in the cross-hairs, without even the right to join the physician that made the prescribing decision, no matter how negligent that decision might have been. You won't induce a manufacturer to participate in a voluntary program by painting a target on its back.
The Colorado and Michigan statutes provide that the Right to Try law itself doesn’t “create a private cause of action.” Sort of:
This article does not create a private cause of action against a manufacturer of an investigational drug, biological product, or device or against any other person or entity involved in the care of an eligible patient using the investigational drug, biological product, or device, for any harm done to the eligible patient resulting from the investigational drug, biological product, or device, so long as the manufacturer or other person or entity is complying in good faith with the terms of this part 1, unless there was a failure to exercise reasonable care.
Colo. R.S.A.§ 25-45-107 (emphasis added); see Mich. C.L.A. §26457 (identical language). Let’s break that down. There’s not a private cause of action created under the Colorado or Michigan Right to Try statutes unless: (1) the defendant doesn’t act in “good faith,” whatever that is, or (2) “fail[s] to exercise reasonable care,” in other words, is negligent.
So not only do the Colorado and Michigan statutes fail to give any relief to a participating manufacturer from any pre-existing common-law tort liability, but they create new statutory causes of action for “bad faith” and negligence (with no statute of limitations stated) against any participating manufacturer. That’s a particular drawback in Michigan, which otherwise has a statute (blogged about here) that precludes ordinary negligence (let alone bad faith) liability against makers of FDA-approved drugs. Historically, negligence is already quite capacious in what “reasonable care” encompasses, and the experience of the insurance industry is that “bad faith” can mean just about anything. Any rational economic actor would think long and hard about distributing a product having – by definition – an unknown risk/benefit profile under these conditions.
The Missouri statute is better. It does not purport to create a private statutory cause of action under any circumstances, although it doesn’t expressly preclude such new liability either (as you may have guessed, it’s silent). Even more importantly, it does eliminate some common-law liability:
Except in the case of gross negligence or willful misconduct, any person who manufactures, imports, distributes, prescribes, dispenses, or administers an investigational drug or device to an eligible patient with a terminal illness in accordance with this section shall not be liable in any action under state law for any loss, damage, or injury arising out of, relating to, or resulting from:
(1) The design, development, clinical testing and investigation, manufacturing, labeling, distribution, sale, purchase, donation, dispensing, prescription, administration, or use of the drug or device; or
(2) The safety or effectiveness of the drug or device.
V.A. Mo. S. §191.480.8 (emphasis added). In other words a participating manufacturer can still be liable to any plaintiff who can plead gross negligence or wilful conduct under Missouri’s ostensible fact pleading rules. That’s better than any other extant Right to Try statute, but is still dependent on how strictly pleading requirements are enforced.
On the other hand, Missouri uniquely requires the manufacturer of an investigational drug – not just the prescribing physician – “notify the patient” directly in the event that the drug’s “clinical trial is closed due to lack of efficacy or toxicity.” V.A. Mo. S. §191.480.7. Where that fits into the partial immunity from suit provided by §191.480.8 is unclear, but a plaintiff’s lawyer could certainly be expected to argue that if this direct-to-patient notice were not given, then the manufacturer was not acting “in accordance with this section” as required by the immunity provision. If such an interpretation were accepted, such plaintiffs could further argue that the statutory requirement of direct-to-patient notice vitiates the learned intermediary rule, also not a happy situation for a defendant.
In fairness, it must also be acknowledged that proving causation would not be easy in any civil action concerning investigational products dispensed under Right to Try statutes, given their augmented informed consent requirements. Nor would such cases otherwise be attractive to our opponents, since the damages that could be recovered on behalf of persons by definition already in terminal condition are not likely to be very large.
Conversely, it must also be kept in mind that Right to Try statutes are seeking to get manufacturers to take actions – voluntarily, since no statute requires an participation at all – that they don’t ordinarily do, and that are well outside their comfort zone. They are not allowed by the FDA to “promote” such products for any use, so even providing routine information to those outside of FDA-regulated clinical trials is fraught with difficulty. What warning could a manufacturer give, anyway? “CAUTION: This drug may not be safe or effective for any use and has unknown risks, that may include death or serious injury of any sort.” What good would that do?
Right to Try statutes seek to induce manufacturers to make available to desperate persons products with no track record and that have not had their safety or effectiveness established for any purpose, and indeed that have not been studied adequately so that their risk/benefit profile is known to anyone, even to the manufacturer. Manufacturers are not heartless, regardless of what our opponents might say, but they are usually rational economic actors. They are not going to go out of their way unless assured that, at least, they are not going to get sued for their trouble. The five statutes enacted to date do not provide that assurance. The Colorado, Louisiana, and Michigan statutes would leave participating manufacturers in a worse position than the plain common law (much worse than under Michigan’s statutory presumption of non-defectiveness). Arizona doesn’t address the common-law at all. While Missouri’s statute does, it leaves a significant hole in its protections – and creates a potentially scary exception to the learned intermediary rule for participants. Thus, we doubt that Right to Try statutes are going to be any more effective than previous litigation in making investigational drugs available to terminally ill patients who are willing to try them.
In closing, we should mention that we do find one possible benefit to Right to Try statutes – especially those like Colorado and Michigan that have very detailed informed consent prerequisites to participation. Such informed consent provisions demonstrate that a legislature knows how to impose detailed informed consent requirements when it wants to. Since we still see occasional common-law attempts to create novel informed consent duties concerning FDA regulatory status in cases involving off-label use, statutes like these Right to Try laws are useful to defendants. They demonstrate that expansion of informed consent should be left to the legislature, and further that lawmakers are quite capable of strengthening informed consent standards if and when they see fit.
But in terms of achieving their intended purpose, we don’t think that Right to Try statutes, as currently drafted, are going to save any lives. That's unfortunate.