House Bill Would Eliminate Learned Intermediary Doctrine In Pharmaceutical AND N

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House Bill Would Eliminate Learned Intermediary Doctrine In Pharmaceutical AND Non-Pharmaceutical Products Cases

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Posted by Mike Laszlo on February 12, 2011

Congressman Bob Filner (D-CA) has introduced the Consumer Protection Act of 2011, H.R. 542, which would "...eliminate the learned intermediary defense to tort claims based on product liability, and for other purposes."

The legislation would repeal the Learned Intermediary Doctrine, a legal doctrine well established in many jurisdictions that provides a defense for pharmaceutical and medical device manufacturers in failure to warn claims. The Learned Intermediary Doctrine is an exception to the general rule that a product manufacturer has a duty to warn the consumer of the risks associated with the use of its product. Under the Learned Intermediary Doctrine a manufacturer raises the defense that it had only a duty to adequately warn the "learned intermediary" (who stands between the manufacturer and consumer) of the risk associated with the use of its product. The theory of the doctrine being that the "learned intermediary" is in the best position to understand and warn the end consumer of the product's risks. Over the years however, several exceptions have eroded the application of the doctrine: vaccinations, contraceptives, drugs withdrawn from the market, and direct to consumer advertising.

When the medicine that was supposed to heal us, instead harms us, we should be able to hold drug manufacturers responsible," "This legislation puts the power back in the hands of the consumer and makes drug companies accountable for their products.

- Congressman Bob Filner.

While the Learned Intermediary Doctrine is generally understood to apply only in pharmaceutical related actions and to involve a manufacturer-doctor-patient relationship chain, H.R. 542 is so broadly worded that it has the potential to include any product whether a pharmaceutical or a tractor trailer. In its apparent simplicity, the Bill could effectively shut the door on any defense that includes a "sophisticated intermediary." Further, H.R. 542 raises significant preemption issues as it would encompass "...any tort claim in any court in the United States..."

H.R. 542 was introduced on February 8, 2011 and has no co-sponsors. It has been referred to Committee. H.R. 542 is in the first step in the legislative process and will first go to committee where it will deliberated, investigated, and revised it before it would go to general debate. The majority of bills and resolutions never make it out of committee. The full text of the Bill is below.

112th CONGRESS

1st Session

H. R. 542

To eliminate the learned intermediary defense to tort claims based on product liability, and for other purposes.

IN THE HOUSE OF REPRESENTATIVES

February 8, 2011

Mr. FILNER introduced the following bill; which was referred to the Committee on the Judiciary

A BILL

To eliminate the learned intermediary defense to tort claims based on product liability, and for other purposes.

Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

This Act may be cited as the `Consumer Protection Act of 2011'.

SEC. 2. LEARNED INTERMEDIARY DEFENSE.

(a) In General- It shall not be a defense to any tort claim in any court in the United States that a manufacture of a product has fulfilled that manufacturer's duty of care when the manufacturer provides all of the necessary information to a learned intermediary who then interacts with the consumer of the product.

( Definition- In this section--

(1) the term `learned intermediary' means a person, licenced under applicable State or Federal law, to advise a consumer whether or not to use the product in question; and

(2) the term `State' includes the District of Columbia, Puerto Rico, and any other commonwealth, possession, or territory of the United States.