Removing Medical Device Preemption Impacts Jobs, Health Care Costs, Patient Access

Removing Medical Device Preemption Impacts Jobs, Health Care Costs, Patient
Access

BOSTON, May 6 /PRNewswire-USNewswire/ -- In a white paper released today by
Ernst Berndt and Mark Trusheim of the Massachusetts Institute of Technology,
research shows that eliminating FDA's preemption protection would decrease
patients' access to life-enhancing medical devices, increase health care costs
and reduce medical device industry employment.

The paper, "The Economic Impact of Eliminating Federal Preemption for Medical
Devices on Patients, Innovation and Jobs," comes as Congress considers
legislation that would remove Federal preemption of state rules and litigation
that exists for a small percentage of medical devices that undergoes the most
rigorous FDA review. The report highlights the damaging economic, health and
societal impacts the legislation would have on patients, medical device
industry innovation and employees, and the public health.

"As economic and health care researchers, we felt it was important to examine
how this regulatory change could harm innovation, and ultimately impact the
patients who rely on these treatments and the people who are employed by the
device industry" said co-author Ernst Berndt, Ph.D., Louis E. Seley Professor
in Applied Economics, MIT Sloan School of Management. "Congress should
carefully weigh any policies that could increase health care costs and reduce
high-paying jobs, particularly during an economic downturn."

The authors' research highlights the consequences to multiple stakeholders -
patients and the public health, medical device inventors and manufacturers,
their employees and the government - if medical device preemption were
eliminated. For example,

-- Patients' access to medical devices and the benefits they provide
would be reduced; as prices increase, products may be withdrawn, and
fewer new products will be developed.
-- Physicians will increasingly 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.

SOURCE Berndt Associates

Alina Piacentino, +1-202-778-1295, apiacentino@apcoworldwide.com, for Berndt
Associates