1. 12 Angry Men v. The Agency:
Why Preemption Should Resolve This Conflict in Drug Labeling Litigation
Michelle L. Richards
Asst. Professor – Applied Legal Theory & Analysis
Detroit Mercy Law

2. Preemption Proposition
In drug warning label cases, federal preemption should apply in ALL cases for claims of failure to warn.
Congress should include an express preemption provision in FDCA for failure to warn claims.
Supreme Court should find conflict preemption
WHY?
Drug Labeling is & should be a matter of exclusive federal regulation.
The danger of state court juries.

3. How I got here… As a civil litigator:
The case I won and then lost.
As a legal writing professor & Moot Court Chair:
Wyeth v. Levine, 555 U.S. 555 (2009).
As a “new” legal scholar & Torts Professor:
PLIVA v. Mensing, 564 U.S. 604 (2011).
Proposed Rules, Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products, 78 Fed. Reg (2013).

4. Current state of affairs
Per Supreme Court
Name-brand or pioneer drug  No preemption
Generic drug  Preemption
FDA’s Proposed Regulation (Summer 2017)
Proposes to remove preemption protection for generic drugs.
Contrary to long-standing position of FDA
Violates the “sameness” requirement of Hatch Waxman Amendments to FDCA
Will result in mass exodus of generic drug manufacturers

5. FDA & Drug Labeling Regulation
1906 – Wiley Act
Gives agency power over product labeling
1911 – Hippolite Egg Co. v. United States
Affirms agency’s power under Commerce Clause
1920’s/1930’s
FDA could only regulate drug labels vs. food, cosmetics or medical devices
1938
FDCA created & given regulatory authority over labeling for drugs and biological products
1960’s
FDA takes over control over advertising of drugs and Fair Packaging and Labeling Act passes

6. Regulation of Drug Labels – How it works
FDCA – Purpose
Process of Approval
NDA – New Drug Application
FDA approval = “safe and effective”.
CBE – Changes Being Effected

7. Hatch Waxman Amendments
Simplified approval process for generic drugs
ANDA – Abbreviated New Drug Application
Requirement of “sameness”
Bioequivalence
Labeling
Result?
80% of all drugs dispensed in U.S. are generic
$200 billion saved by consumers and health care industry annually
Over $1.2 trillion between 2003 and 2012.

8. What does everyone think?
FDA?
Prior to 2013 – Preemption should apply
2013 – Proposed Regulation – removes preemption for generics
Supreme Court?
Preemption applies to generics only, not name brand
Has asked for guidance from the FDA
Should have found conflict preemption or agency preemption
Congress?
No express preemption
Clear delegation of power to FDA for more than 100 years
Removal of federal funding for proposed regulation

9. FDA & Preemption – Pre-2013
Lack of express preemption provision does not negate implied preemption.
Congress intended FDA to retain exclusive control over labeling approval process.
FDCA establishes floor and ceiling for drug labeling.
State law failure to warn actions “threaten FDA’s statutorily prescribed role as expert Federal agency responsible for evaluating and regulating drugs.”

10. Supreme Court & Preemption
Express or implied preemption
Did Congress expressly include preemption within law?
Do state tort claims upset regulatory balance struck by FDA?
What does agency think in light of the technical subject matter?
Non-Drug Warning Cases – High deference to agency
Geier v. American Honda Motor Company, Williamson v. Mazda Motor of America, Medtronic v. Lohr, Buckman Co. v. Plaintiff’s Legal Committee
Drug Warning Cases – Little to no deference to agency
Wyeth v. Levine (Name-brand Phenergan case)
PLIVA v. Mensing (Generic metoclopramide case)
Bartlett v. Mutual Pharmaceutical Co.

11. 2013 FDA Proposed Regulation
Requires generics to adhere to same obligations of name brand manufacturers
WHY?
Problems!!
Conflicts with federal law.
Contrary to long-standing position of Congress & FDA on exclusive authority of FDA over drug labeling.
Consumer Safety is adversely impacted.
More is not better!
Economic Dangers
Increase in lawsuits  generics leave market.
Contravention of Agency purpose

12. Danger of Juries
Juries should not be/are NOT in a position to question judgment of FDA.
WHY?
Evaluative considerations are not the same.
FDA – Asks whether label is safe & effective
Juries – Ask whether a “better” or “different” warning label could have prevented Plaintiff’s injury

13. The Court on Juries Problem with juries?
“[b]y their very nature, juries are ill-equipped to perform the FDA’s cost-benefit-balancing function…juries tend to focus on risk of a particular product’s design or warning label that arguably contributed to a particular plaintiff’s injury, not on the overall benefits of that design or label.”
Wyeth dissent
Product liability litigation is “less deserving of preservation” when FDA conducts the equivalent of a “federal safety review.”
Riegel majority
Inappropriate to allow a jury to ask whether an additional warning would have prevented plaintiff’s injury.
Ford Motor Credit Co. v. Milhollin

14. Conclusion Wyeth Court asked the FDA for guidance on preemption
“lawful specific regulations describing when labeling requirements serve as a ceiling as well as a floor.”
FDA’s proposed regulation is not the answer.
Answer?
Express Preemption – Congress
Conflict Preemption – Courts
Agency Preemption - Courts