Sir as you are aware the recent deaths caused by the negligence of Robins and Robins has caused a stir in the area. The families are after the company and want to sue them to get compensated for the loss of loved ones they had to bear. In this chain of event FDA is also being dragged since FDA did not pass the Original Tracking Bar rule. A lot of people are saying that FDA is responsible for these, although it is clear that FDA does not have any liability towards the these victims.
Robins and Robins has caused this problem and they were one of the most active members who opposed this regulation and even bribed companies to be against it. they went ahead and they convinced the addicts to support them. Robins and Robins lobbied against this rule and got the rule stopped during the public comments period. Even after Robins and Robins was aware of the problem caused by their medicine they did not make a justified effort to recall their product. It could never be a 100% recall since there is no tracking methodology that can be used.
As far as the role played by FDA is concerned they did the right thing in stopping this bar code rule. They could not pass it without public’s consent and majority of them had voted against it. They thought it would violate their privacy rights. And also doing this would have increased the price of the medicine which was a big concern. As it is hard for people to afford medication as is and with this the price increase would have been tremendous. It was not only Robins and robins that lobbied against it but there were certain public interest groups involved as well.
The death and illness have been caused because of the negligence of Robins and Robins and not the FDA. In response to the concerns of public interest groups the FDA has stopped the rule.

The defense that FDA has is that the rule was created by FDA itself. However, the imposition of the rule was set aside because of protests from public interest groups. Further, Section 402 (a) applies to food and not to medicine. Even if it does apply to medicine it clearly indicates that anyone who sells any product in a defective condition is subject to liability.
Since, Robins and Robins was the strongest opponent to the rule requiring tracking code, the negligence claim should be against Robins and Robins and not against the FDA. It is clear that had Robins and Robins not lobbied the lives of the children could have been saved.

In this case another defense that FDA has is the General Negligence that Plaintiff(consumers) had showed in this situation. They had been against this law for bar codes with out being aware of the implications. It was a negligence on their part and not FDA
References:
www.fda.gov/ www.fda.gov/Food/default.htm http://biotech.law.lsu.edu/cases/products/402a-b.htm www.accessdata.fda.gov/scripts/cder/drugsatfda/ www.fda.com/ - www.fdanews.com/