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When can patients sue drug companies?: supreme court finds that FDA approval does not stand in the way.
| Content Provider | Semantic Scholar |
|---|---|
| Author | Field, Robert I. |
| Copyright Year | 2009 |
| Abstract | Drugs go through rigorous testing before the FDA approves them. Drug manufacturers may spend as much as $1 billion and up to 12 years to gain permission to sell a new prescription product. Even when permission is granted, an approval still carries numerous limitations, including restrictions on promotional materials and requirements for specific warnings that must appear on the product’s labeling. After running this gauntlet, can manufacturers rest assured that they have met the legal standard for selling their drugs? Or, to put it another way, if a drug maker complies with FDA marketing and labeling restrictions, can an injured patient also sue the company for not making the product safe enough? In a closely watched case, the Supreme Court in early March said definitively “yes;” a company can be sued even after FDA approval. |
| File Format | PDF HTM / HTML |
| PubMed reference number | 19561869 |
| Journal | Medline |
| Volume Number | 34 |
| Issue Number | 5 |
| Alternate Webpage(s) | https://www.ptcommunity.com/system/files/pdf/ptj3405243.pdf |
| Journal | P & T : a peer-reviewed journal for formulary management |
| Language | English |
| Access Restriction | Open |
| Content Type | Text |
| Resource Type | Article |
