HOUSE AMENDMENT

    hbd-06                                        Bill No. HB 3871

    Amendment No.     (for drafter's use only)

                            CHAMBER ACTION
              Senate                               House
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 5                                           ORIGINAL STAMP BELOW

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11  Representative(s) Ritter offered the following:

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13         Amendment 

14         On page 3, lines 4-18,

15  remove from the bill:  all of said lines

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17  and insert in lieu thereof:

18         (2)  In a product liability action against a

19  manufacturer or seller, it shall be an affirmative defense

20  that a product that is a drug as defined in Section 201(g)(1)

21  of the Federal Food, Drug and Cosmetics Act, 21 U.S.C.

22  321(g)(1), or a medical device as defined in Section 201(h) of

23  the Federal Food, Drug and Cosmetics Act, 21 U.S.C. 321 (h),

24  is not defective or unreasonably dangerous if the drug or

25  device was approved for safety and efficacy by the United

26  States Food and Drug Administration and the drug or medical

27  device and its labeling were in compliance with the United

28  States Food and Drug Administration's approval at the time the

29  drug or medical device left the control of the manufacturer or

30  seller. However, this subsection does not apply to a drug or

31  medical device that is sold in the United States after the

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    File original & 9 copies    03/05/98
    hbd0016                     03:19 pm         03871-0096-891065




                                                   HOUSE AMENDMENT

    hbd-06                                        Bill No. HB 3871

    Amendment No.     (for drafter's use only)





 1  effective date of an order of the United States food and Drug

 2  Administration to remove the product from the market or to

 3  withdraw its approval. This subsection does not apply if the

 4  defendant at any time before the event that allegedly caused

 5  the injury does any of the following.

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    File original & 9 copies    03/05/98
    hbd0016                     03:19 pm         03871-0096-891065