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Removing Medical Device Preemption Impacts Jobs, Health Care Costs, Patient Access
Date:5/6/2009

ncreasingly practice defensive medicine to avoid litigation and expose patients to added risks of otherwise unnecessary procedures.
  • For those employed by the medical device industry, the increased manufacturers' costs would discourage investment in medical device development, reducing the R&D pipeline of innovative new products created and brought to market, and lead to layoffs of high-paying jobs.
  • Medical innovation would be affected, as decisions about health care products shift from expert, science-based regulators to untrained, non-expert juries, creating a duplicative, fragmented and inconsistent national framework administered by state and federal courts.
  • The government would experience increased costs, as Medicare and Medicaid spend more than they otherwise would due to fewer new product innovations, and government pays for increasing judicial system, tort and duplicative state regulatory costs.

    • "The question is not whether eliminating preemption will reduce innovation, but rather by how much and how rapidly," said co-author Mark Trusheim, Visiting Scientist at the MIT Sloan School of Management. "High levels of tort risk discourage investment in new technology. Eliminating preemption substantially alters the benefit/risk ratio of complex medical devices, increases the costs for all stakeholders, and negatively affects patients' future access to treatment options."

    "Given these findings, and current economic circumstances, Congress should carefully consider any change to current law as the ramifications could substantially harm patient choice and health," Trusheim concluded.

    The report was made possible by a grant from the Advanced Medical Technology Association. The views expressed are those of the authors only, and do not necessarily reflect views of the sponsor or MIT.


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    SOURCE Berndt Associates
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