For the second time in three years the Pennsylvania legislature has proven itself entirely unable to carry out its most basic function, which is to pass a budget – any budget – which is balanced and otherwise meets constitutional requirements. Instead, it seems bent on distracting the public from its abject failures with empty gestures.
Thus, we saw in Law 360 the other day that the legislature has passed, and the governor has agreed to sign, "right to try" legislation. As we've discussed before, right to try legislation purports to make it easier for terminally ill patients to obtain access to drugs (and other FDA-regulated products) that have not completed the FDA's long and arduous approval process. In fact, we have seen no evidence that such legislation has ever actually helped anyone. State right to try legislation has been ineffective chiefly for three reasons: (1) it is federally preempted by the FDA's compassionate use program, (2) manufacturers are unlikely to opt into these purely voluntary programs because any adverse events involving what would be a very sick patient population would have to be reported to the FDA and thus could jeopardize eventual approval, and (3) the legislation does not adequately protect manufacturers from potential liability for allowing the use of unapproved drugs. Why do we care? Because we worry about terminally ill patients suing manufacturers to force them to provide investigational drugs, which has been unsuccessfully tried in the past, and might be tried again in the future.
Obviously, no state legislation can do anything about problems #1 or 2, because those are matters governed by federal law that would require a federal statute. As for problem #3, states have immunized manufacturers from state-law liability to a greater or lesser extent, so what about Pennsylvania?
Here's a link to the text (as amended) of the current bill, HB45.
While there's a section devoted to "health care provider immunity" (§5(a)), the potential liability of the entities that actually manufacture the investigational drugs (and other products) in question is only addressed in the section (§6) involving "construction" of the statute. That section provides – with unnecessary verbosity removed for clarity:
Nothing in this act may be construed as creating a private cause of action against a manufacturer of an investigational drug, biological product or medical device . . . for any injury suffered by the eligible patient resulting from the investigational drug, biological product or medical device, as long as the manufacturer . . . acted in accordance with this act, except when the injury results from a failure to exercise reasonable care.
(Emphasis added).
Pathetic. Probably worse than nothing. This section says zilch about liability under existing common-law theories – only about "creating" a new "private cause of action." Nor does it even preclude a new, private statutory cause of action. To the contrary, it allows one, only it must be based on negligence ("failure to exercise reasonable care"). As we've pointed out before, negligence is already the existing basis for Pennsylvania product liability for prescription medical products. See, e.g., Hahn v. Richter, 673 A.2d 888, 889 (Pa. 1996) (another case Bexis worked on way back when). Thus, the Pennsylvania Right To Try legislation provides no additional protection to participating manufacturers at all – even those who complied with the statute – instead it appears to allow an additional, redundant negligence-based private statutory cause of action.
That being the case, there is no incentive whatsoever for any FDA regulated manufacturer to participate in the putative Pennsylvania Right To Try program, and every reason for them to refrain from doing so. Rather, it's an empty gesture – intended to distract the public from the legislature's inability to perform its most basic constitutional duties.
This article is presented for informational purposes only and is not intended to constitute legal advice.
