CACI No. 1205

[Name of plaintiff] claims that the [product] lacked sufficient [instructions]

[or] [warning of potential [risks/side effects/allergic reactions]]. To

establish this claim, [name of plaintiff] must prove all of the following:

1. That [name of defendant] [manufactured/distributed/sold] the

[product];

2. That the [product] had potential [risks/side effects/allergic

reactions] that were [known/ [or] knowable in light of the

[scientific/ [and] medical] knowledge that was generally accepted

in the scientific community] at the time of

[manufacture/distribution/sale];

3. That the potential [risks/side effects/allergic reactions] presented a

substantial danger when the [product] is used or misused in an

intended or reasonably foreseeable way;

4. That ordinary consumers would not have recognized the potential

[risks/side effects/allergic reactions];

5. That [name of defendant] failed to adequately warn [or instruct] of

the potential [risks/side effects/allergic reactions];

6. That [name of plaintiff] was harmed; and

7. That the lack of sufficient [instructions] [or] [warnings] was a

substantial factor in causing [name of plaintiff]’s harm.

[The warning must be given to the prescribing physician and must

include the potential risks, side effects, or allergic reactions that may

follow the foreseeable use of the product. [Name of defendant] had a

continuing duty to warn physicians as long as the product was in use.]

New September 2003; Revised April 2009, December 2009, June 2011, December

2011, May 2020