Innovator Liability Still Not Viable After Pliva v. Mensing - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

Innovator Liability Still Not Viable After Pliva v. Mensing
Recent legal decisions have further divided generic and brand manufacturer cases.


Pharmaceutical Technology
Volume 36, Issue 1, pp. 88-90

End result for the market

Mensing's pre-emption conclusion is completely irrelevant to the legal tenability of the innovator liability theory. The fact that one group of potential defendants is absolved of liability based on pre-emption does not mean that liability necessarily falls to another group. In fact, as stated above, both the majority and dissenting opinions in Mensing recognized that the net result of the decision on consumers of generic drugs was that they were now without a remedy for any claim of inadequate warnings, not that the improper defendants had been identified.

While this result may be unsatisfying to some, that is the legally correct byproduct of Mensing. Compared to judicially created innovator liability, the case also makes sound policy. Altering the long-held majority rule would be a knee-jerk reaction to a perceived unfairness without any basis in the law. As those types of decisions often do, it would likely result in a variety of unintended and harmful consequences that would throw off the balance created by Hatch–Waxman and threaten the objectives that underlie it. Branded companies would likely pull their drugs from the market once the patent had expired to reduce potential liability. This would result in less choice, less competition, and higher prices. Alternatively, branded companies could keep their products on the market, but at even higher prices for both their patented drugs and their drugs with generic competitors to compensate for the potential liability.

If Congress decides that Hatch– Waxman's tradeoff of drug access and affordability in exchange for the generic-drug manufacturers' immunity from state law failure to warn claims is untenable, then Congress can act to redress the situation. "But it is not Court's task to decide whether the statutory scheme established by Congress is unusual or even bizarre" (14). It is also not the job of the state or federal courts interpreting state tort law to torture the well-established statutory and common law schemes to rectify any perceived inequitable result.

References

1. 131 S.Ct. 2567 (2011).

2. 129 S.Ct. 1187 (2009).

3. Statement of Rep. Douglas Walgren, 130 Cong. Rec. H24456 (Sept. 6, 1984).

4. IMS Health, "Generic Medicines Saved US Health Care System $139.6 Billion in 2009; $824 Billion Saved over the Last Decade" (July 2010).

5. Mensing, 131 S.Ct. at 2581.

6. Id. at 2593. (J. Sotomayor, dissenting).

7. 29 F.3d 165 (4th Cir., 1994)

8. Id.

9. Id. at 171.

10. 168 Cal.App.4th 89 (Cal. Ct. App., 2008).

11. Colacicco v. Apotex, 432 F.Supp.2d. 514, 537–538, 543 (E.D. Pa. 2006).

12. F. 3d, 2011 WL 4389211 (C.A.6 (Ky.), Sept. 22, 2011.

13. Gross v. Pfizer, Civ. A. No. 10-cv-00110-AW, 2011 WL 4005266, *2 (D.Md.), Sept. 7, 2011; see also Morris v. Wyeth, Civ. A. No. 3:09-CV-854, 2011 WL 4975317, *2 (W.D. La.), Oct. 19, 2011.

14. Mensing, 131 S.Ct. at 2582.

Zach Hughes is a partner at Baker Botts,


ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
What role should the US government play in the current Ebola outbreak?
Finance development of drugs to treat/prevent disease.
Oversee medical treatment of patients in the US.
Provide treatment for patients globally.
All of the above.
No government involvement in patient treatment or drug development.
Finance development of drugs to treat/prevent disease.
23%
Oversee medical treatment of patients in the US.
14%
Provide treatment for patients globally.
7%
All of the above.
47%
No government involvement in patient treatment or drug development.
9%
Jim Miller Outsourcing Outlook Jim MillerOutside Looking In
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerAdvances in Large-Scale Heterocyclic Synthesis
Jill Wechsler Regulatory Watch Jill Wechsler New Era for Generic Drugs
Sean Milmo European Regulatory WatchSean MilmoTackling Drug Shortages
New Congress to Tackle Health Reform, Biomedical Innovation, Tax Policy
Combination Products Challenge Biopharma Manufacturers
Seven Steps to Solving Tabletting and Tooling ProblemsStep 1: Clean
Legislators Urge Added Incentives for Ebola Drug Development
FDA Reorganization to Promote Drug Quality
Source: Pharmaceutical Technology,
Click here