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The Massachusetts Supreme Judicial Court recently addressed the
question of what pleading standard is required in Massachusetts to
allege parallel state law claims involving medical devices to avoid
preemption under the federal law regulating medical devices.
The Court s decision sheds light on the lack of consensus among
state and federal courts on this issue, which may impact the time
and resources that litigants and the courts expend on claims that
may later prove to be meritless.
To read the full text of this post by Duane Morris
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On March 3, 2021, FDA issued a statement acknowledging that certain
entities produce certificates of registration for medical device
manufacturers and clarifying that the agency does not issue such
certificates. The agency also announced that it sent letters to 25
entities demanding that they stop producing these false and
misleading certificates because some device manufacturers and
distributors are using them to claim that the devices they produce
or sell are cleared, approved, or otherwise authorized by FDA. It
is important to add that FDA likewise does not issue certificates
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This time out of Massachusetts. And in an opinion authored
by a female judge. This isn t something we would normally
take the time to point out, but as we embark on the 39
th
Women s History Month, the combination of Massachusetts and a
female judge stood out to us. Afterall, Massachusetts was
home to Abigail Adams, one of her husband s closest
advisors. It was Abigail who implored John Adams in 1776 to Remember the ladies and be more generous and favorable to
them than your ancestors. While that may be her most
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Sunday, February 28, 2021, was Rare Disease Day. With so much
focus on COVID-19 throughout 2020, it s important to recognize
the continued work done in rare disease drug development by
sponsors and FDA throughout 2020. In addition, a number of policies
implemented in response to COVID-19 are expected to have a positive
impact on rare disease drug development going forward. Yet, the
lasting nature of these policies, post-pandemic, remains uncertain,
creating an opportunity for rare disease drug sponsors to be
proactive in engaging with regulatory authorities and the patient