PRODUCT LIABILITY:  REMOVE CURRENT

IMMUNITY FOR FDA-APPROVED DRUGS

House Bill 4044 as introduced

Sponsor:  Rep. Mike Simpson

House Bill 4045 as introduced

Sponsor:  Rep. Gary McDowell

House Bill 4046 as introduced

Sponsor:  Rep. Mary Valentine

Committee:  Judiciary

Complete to 2-21-07

A SUMMARY OF HOUSE BILLS 4044 - 4046 AS REPORTED FROM COMMITTEE

Together, the bills would eliminate the current immunity against product liability lawsuits that specifically applies to drugs approved by the federal Food and Drug Administration (FDA); create a three-year window in which claims could be filed for injuries attributable to FDA-approved drugs during the time the immunity was in place; and allow civil suits to be filed under the Consumer Protection Act if a business misrepresented risks associated with a drug, herb, dietary supplement, or botanical supplement.  Specifically, the bills would do the following:

House Bill 4044 would amend Section 2946 of the Revised Judicature Act (MCL 600.2946) to delete subsection (5).  Currently, Section 2946(5) says that a drug approved for safety and efficacy by the United States Food and Drug Administration (FDA) is not defective or unreasonably dangerous and the manufacturer or seller is not liable in a product liability action if the drug and its labeling were in compliance with the FDA's approval at the time the drug left the control of the manufacturer. 

The immunity from civil liability does not extend to a drug sold in the U.S. after the effective date of an FDA order removing the drug from the market or an order withdrawing FDA approval.  The civil immunity also does not extend to a defendant who, at any time before the event allegedly causing the injury, either bribed an official or FDA employee in order to secure or maintain approval of the drug or intentionally withheld from or misrepresented to the FDA information required to be submitted under the federal Food, Drug, and Cosmetic Act that, had the information been accurately submitted, the drug would not have been approved or the FDA would have withdrawn approval.

House Bill 4045 would amend Section 5805 of the Revised Judicature Act (MCL 600.5805) to establish a three-year period during which a cause of action could be filed based on drug product liability that had been barred by Section 2946(5).  This would apply to causes of action that otherwise could have been commenced on or after January 2, 1996 (the effective date of the legislation that created the ban) and before the effective date of House Bill 4044.  The three-year period would run after the effective date of House Bill 4044.  The bill is tie-barred to House Bill 4044.

House Bill 4046 would amend the Michigan Consumer Protection Act (MCL 445.902 and 445.903).  The act contains a list of actions that constitute unfair, unconscionable, or deceptive methods, acts, or practices in the conduct of trade or commerce, and that are unlawful.  House Bill 4046 would add to that list:

Failing to accurately represent the risks involved in the intended use of a prescription or over-the-counter drug or medication or an herbal product, dietary supplement, or botanical extract.

The bill also would define the term "goods" to include a legal pharmaceutical product.

(The act refers to "goods" and "services" throughout.  For example, the phrase "trade or commerce" is defined in the act as "the conduct of a business providing goods, property, or service primarily for personal, family, or household purposes and includes the advertising, solicitation, offering for sale or rent, sale, lease, or distribution of a service or property, tangible or intangible, real, personal, or mixed, or any other article, or a business opportunity.")

FISCAL IMPACT:

House Bills 4044 and 4045 would have an indeterminate fiscal impact on the judiciary; any fiscal impact would be related to increased caseload which would depend on the number and complexity of lawsuits that might be brought under these bills.  A fiscal analysis is in process for House Bill 4046.

POSITIONS:

Associations and organizations testifying in support of or indicating support for the bills on 2-14-07 were:

The DIME Coalition

The Michigan Citizen Action

Michigan Trial Lawyers Association

Michigan State AFL-CIO

International Union, UAW

Henry Greenspan, Ph.D., lecturer and founding member of Justice in Michigan (an organization of physicians and academics who teach at institutions of higher learning in Michigan)

Associations and organizations indicating, testifying, or submitting written testimony in opposition to the bills on 2-14-07 were:

Pfizer

PhARMA

MICHBIO

Michigan Lawsuit Abuse Watch (M-LAW)

Michigan Dental Association

Eli Lilly & Co.

Michigan Chamber of Commerce

Michigan Academy of Family Physicians

Wyeth

Michigan Retailers Association

Michigan Osteopathic Association

Grand Rapids Chamber of Commerce

Abbot Laboratories

GlaxoSmithKline

Sanofi-Aventis

Merck, Inc.

Michigan Association of Health Plans

Michigan Academy of Physicians Assistants

Michigan State Medical Society

Consumer Healthcare Products Association

Kalamazoo Regional Chamber of Commerce

Insurance Institute of Michigan

National Federation of Independent Business

Takeda Pharmaceuticals America, Inc.

Johnson & Johnson

Novartis Pharmaceuticals Corporation

Michigan Manufacturers Association

Schering-Plough Corporation

National Federation of Small Businesses

Detroit Regional Chamber

Michigan College of Emergency Physicians

                                                                                           Legislative Analyst:   Susan Stutzky

                                                                                                  Fiscal Analyst:   Viola Wild

                                                                                                                           Robin Risko

■ This analysis was prepared by nonpartisan House staff for use by House members in their deliberations, and does not constitute an official statement of legislative intent.