Hon. Michael G. Oxley: “I rise to offer the bipartisan FDA defense amendment, along with my colleagues Mr. Coburn, Mr. Burr, Mr. Tauzin, Mr.…”

“I rise to offer the bipartisan FDA defense amendment, along with my colleagues Mr. Coburn, Mr. Burr, Mr. Tauzin, Mr. Brewster, and Mr. Stenholm. Mr. Chairman, the amendment states simply that when the manufacturer of a drug or medical device receives pre-market approval from the FDA and complies with all post-approval reporting requirements, the manufacturer will not be liable for punitive damages in a civil suit. The amendment protects the rights of plaintiffs to receive full compensatory damages, including pain and suffering. Punitive damages are not compensatory. They are intended to punish malicious conduct. To bring a drug from the laboratory to the marketplace takes on average 9½ years and costs manufacturers $350 million. The sponsors and supporters of this amendment believe that compliance with the process, and post-approval reporting requirements, clearly demonstrate a lack of malice. Punitive damages are quasi-criminal in nature, and careful adherence to an expensive 10-year process is certainly not criminal.”