Class Six/Discuss
From Cyberlaw
1. Should companies be required to advise patients of all known risks prior to implantation? Or are there some risks that are so improbable that it’s better, therapeutically, for the patient not to know? (3)
2. Can you compare financial conflicts of interest in drug development to medical device development? (2)
3. Should consumers be expected to sacrifice some degree of long-term product safety, perhaps in the form of restricted legal recourse, in exchange for expedited premarket device approval? (2)
- Or, alternatively, should consumers be allowed early access to devices (or to drugs) that are still in the testing phase if they agree to waive liability on the part of the manufacturer, provider, care-giver, etc.? Is this a type of risk acceptance that we will ever allow individuals to undertake? To me this returns to the discussion at the end of yesterday's class: What role do we foresee for individuals as elephant-keepers? DVorhaus 14:47, 14 March 2006 (EST)
- Note: I added a brief post in my journal describing in more detail an alternative conceptualization for the individual as a medical decision-maker (I'm getting tired of the 'individual as elephant-keeper' simile...) DVorhaus 15:01, 14 March 2006 (EST)
4. To what degree is partnering between small startups and large corporations seen in the medical device industry (0)
5. Can these slides be made available on the wiki? (0)
- Dustin: Yes! I talked to Doctor Lorell before class and she agreed to let us post them (with some small changes) here [1]
6. Is it possible for the knowledge/reporting of a device or drug defect to increase the rate of incidence? (0)
- Just to expand upon this - what I meant was whether it was possible for the very act of reporting a device failure, even a very rare one, to increase the likelihood of a failure? I'm curious if there has been any research done on this, as I know it's an ongoing issue with respect to adverse effects in drugs, and I could see it being an issue for certain medical devices (especially those that are implicated in stress responses). DVorhaus 14:47, 14 March 2006 (EST)
