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Gathering Clouds and
Legislative Change
by
Mark A. Heller
MassMedic
13th Annual Conference
May 5, 2009
ALLEGATIONS
• Media Criticism (510(k) Process)
 N.Y. Times (January 16, 2009) –
 “Most medical devices have never been shown to be safe
or effective, and for the riskiest devices this must change,
Congressional investigators concluded in a report released
Thursday.”
 “Most medical devices are given quick approvals with
minimal testing because manufacturers tell the FDA that the
products operate just like older devices that had already
been approved.”
 WSJ (March 6, 2009) –
 “[The device] was approved under fast-track rules that don’t
require clinical trials needed under a full review.”
 “Dr. von Eschenbach, . . ., is calling for an overhaul of the
way the $200 billion-a-year medical device business is
regulated. The fast-track system ‘has gotten out of control,’
he said.”
(Cont’d)
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• The Media and Preemption
 N.Y. Times (March 15, 2009 - Editorial)
 “Now that the Supreme Court has ruled that
patients can sue drug companies in state
courts for harm caused by medicines
approved by the Food and Drug
Administration, Congress ought to give
patients the same right to sue makers of
medical devices.”
 “Suits in state courts reinforce federal
regulations. Patients who have been hurt by
faulty medical devices should have the right
to seek redress there.”
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• Employee Letters
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May 31, 2008 – Commissioner von Eschenbach
October 14, 2008 – Congressman Dingell
January 7, 2009 – John T. Podesta, Transition Team
April 2, 2009 – President Obama & Senator Grassley
 Allegations
o Managerial Misconduct
o “Corruption” of the premarket review process
o Management’s lack of scientific/clinical expertise
o Hostile work environment/retaliation
o Conduct endangering the Public Health
(Cont’d)
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 Letters’ Flavor
o “Rather than recall, re-evaluate or otherwise deal with
potentially unsafe or ineffective devices that are
already on the market, these managers at CDRH
continue to approve more devices of the same kind in a
non-transparent and non-scientific manner. This is
especially true of the 510(k) program but also applies
to the PMA Program as well as the advice and
guidance given to manufacturers before they make
regulatory submissions.” Oct. 14 Letter at 3.
o “Since May 2008, the FDA Commissioner has been
provided with irrefutable evidence that managers at
CDRH have placed the nation at risk by corrupting and
distorting the scientific evaluation of medical devices,
and by interfering with our responsibility to ensure the
safety and effectiveness of medical devices before they
are used on the American public.” Jan. 7 Letter at 1.
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Legislative Change
?
6
Premarket Notification/510(k): What is it?
•
Medical Device Amendments of 1976
 Premarket Regulation
 Class I Devices – General Controls
 Class II Devices – Performance Standards
 Class III Devices - PMA
 Preamendments Devices
 Classification by Rulemaking
 Class II Standards by Rulemaking
 Class III PMAs by Rulemaking
 Classification of Post-Amendments devices
 Automatic classification/PMA
 SE
 NSE
 NOT AN APPROVAL
 Implementation Led to Regulatory Gap
 No standards
 Few PMA regulations
 510(k) became the only premarket review for class IIs and preamendments class
IIIs
(CONT’D)
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• “Medical Device Regulation: The FDA’s Neglected Child”
Report by Subcommittee on Oversight and Investigations,
Committee on Energy and Commerce, May 1983
 “Although generally not discussed as a general control, the
requirement in section 510(k) for a manufacturer to notify FDA
at least 90 days before first introducing a device into the market
has proven to be one of the most important provisions in
the device amendments. . . . Congress may well have
anticipated a large volume of these premarket notifications, . . .,
but it did not envision the importance these submissions
would play in resolving a high volume of significant
regulatory decisions by the agency.” Report at 8 (Emphasis
added).
 “The three-tiered regulatory system created by Congress
has been collapsed by FDA inaction into a system that
treats the most hazardous device virtually as if it were the
least hazardous —that virtually treats coronary bypass blood
oxygenators as if they were no more hazardous than tongue
depressors. . . . [Congress] clearly did not intend all
devices to be subject to the same set of regulatory
controls—the minimum controls at that.” Report at 34
(Emphasis added).
(CONT’D)
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 “Given that the 510(k) process—by default—has become
a more important regulatory tool than Congress
envisioned, two conclusions are apparent. First, until
the agency has taken serious steps to implement the
statutorily mandated three-tiered regulatory system
created to assure that marketed devices are safe and
effective, any attempt to weaken the 510(k) process—
especially to facilitate the entry of class II and class
III substantially equivalent devices into the market—
should be resisted. This conclusion is by no means an
endorsement of the use of the 510(k) process as a
substitute for class II and III regulatory controls. It simply
recognizes that no matter how desirable or necessary,
these controls cannot be fully implemented to provide
protection immediately. Something must continue to
fill the gap while the agency begins to put the
mandated controls in place.” Report at 35 (Emphasis
added).
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• Safe Medical Devices Act of 1990
 Codified FDA’s 510(k) program
 “The Committee believes that it is important to codify the
[FDA’s] interpretation of the terms ‘substantial
equivalence’ and ‘substantially equivalent.’” Senate
Report at 28.
 “The bill modifies the statutory authority for the FDA to
consider the safety and effectiveness of a device when
determining whether such a device is substantially
equivalent to a predicate device.” House Report at 24
(Emphasis added).
 "The Committee recognizes that the FDA does not
always need clinical data to make a finding of
substantial equivalence. . . . The Committee believes that
it is appropriate for the FDA to request such information
when necessary. It is not the intent of the Committee to
make such data a necessary element of every substantial
equivalence determination.” House Report at 25 (Emphasis
added).
(CONT’D)
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 Required Transparency for SE decisions
 Summaries of Substantial Equivalence, or
 Statements
 For Preamendment Class III Devices not subject to PMAs —
Require certification of a “reasonable search of all information
known or otherwise available to the manufacturer” regarding the
510(k) device and its predicates
 Increased postmarket controls for FDA: PMS, reports of
removals and corrections, device tracking, mandatory recalls,
and civil penalty authority
 Class II and Preamendment Class III Devices
 Class II
o Abandoned Standards
o Created Special Controls
 Class III
o Request Information
o By regulation, reclassify or maintain in Class III by 12/1/95
o No later than 12 months after regulations retaining
devices in class III, set timetable to request PMA data
(CONT’D)
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 “Less Than the Sum of Its Parts” Report by
Subcommittee on Oversight and Investigations
Committee of Energy and Commerce, May 1993
 “The basis for the SMDA was the recognition that:
--over 80 percent of the riskiest devices (class III)
was being allowed market entry under FDA’s
510(k) process. This process did not require FDA to
determine that any of these devices were safe and
effective. . . .” Report at 13 (Emphasis added).
 “The question that needs to be answered is whether a
more streamlined approach can be crafted
consistent with present statutory mandates.”
Report at 64 (Emphasis added).
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• Food and Drug Administration Modernization Act
of 1997
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Class I and II Exemptions
Third Party Review
“Least Burdensome”
Recognition of Standards
Risk Based/De Novo Classification
• Medical Device User Fee and Modernization Act of 2002
 510(k)s
 PMAs
• Food and Drug Administration Amendments Act of 2007
 Extension of user fees
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510(k) Conclusions
•
•
•
•
•
•
510(k) as a classification tool is effective, efficient and
necessary
Ultimately the real concern with the 510(k) process is its
use as a surrogate for PMAs and performance
standards/now special controls, i.e., an implementation not
a legal authority or program structure concern
Currently, FDA is addressing the preamendments PMA issue to
ensure either the reclassification or the submission of PMAs for
preamendments Class IIIs
Reclassified preamendments Class III devices will have
special controls to qualify for Class II regulation
For higher risk Class IIs, FDA could selectively reopen
classification regulations and include special controls for
each such type of device that requires them to provide
reasonable assurance of safety and effectiveness
In sum, effective implementation of FDA’s authority can
address the alleged major deficiencies of the 510(k)
process; amendments to the FDCA will not achieve much
or advance the public health
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Preemption
• SEC. 521. [21 USC 360k ] State and local
requirements respecting devices
(a) General Rule. Except as provided in
subsection (b), no State or political subdivision
of a State may establish or continue in effect
with respect to a device intended for human
use any requirement—
(1) which is different from, or in addition to,
any requirement applicable under this Act to the
device, and
(2) which relates to the safety or effectiveness
of the device or to any other matter included in
a requirement applicable to the device under
this Act.
(Cont’d)
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Supreme Court Cases
• Medtronic v. Lohr, 518 U.S. 470 (1996) –
design, manufacturing and labeling
claims
 510(k) does not preempt tort claims because a
substantial equivalence determination does not
amount to a specific, federally enforceable
requirement applicable to a particular device.
 Rejects position that section 521 preempts all
common law cases, and deferred on whether
section 521 never preempts common law
claims
(Cont’d)
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• Riegel v. Medtronic, 522 U.S. __; 128 S.
Ct. 999 (2008)
 Common law claims of negligence and strict
liability impose requirements within the ordinary
meaning of that term
 PMA approvals preempt state common law
claims challenging safety and effectiveness if
the device is in the form that was approved by
FDA, and the claim is not based upon a theory
the defendant violated federal law
 Thorough safety and effectiveness review
 Each approval creates a set of requirements
 Need approval for changes
 Authority to withdraw approval
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• Wyeth v. Levine, 555 U.S. __ (March 4, 2009)
 Failure to warn claim related to NDA approved drug
 Although warnings on the specific cause of the plaintiff’s
injury, Court held stronger warnings could have been
included that would have satisfied federal and state
requirements
 Wyeth’s claim that it would be impossible to
accommodate state and federal law was rejected by the
Court because Wyeth could have altered its label under
the Changes Being Effected regulation without first
receiving FDA’s approval
 Congress chose not to authorize preemption for drugs
 Where Congress has not authorized preemption, the
Court will assess the weight accorded an agency’s
explanation of a state law’s impact on the federal
regulatory scheme
 “Although we recognize that some state-law claims might
frustrate the achievement of congressional objective, this
is not such a case.”
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Draft Device Preemption
Legislation
• Introduced Bills (March 5, 2009)
 H.R. 1346 – Sponsor: Rep. Frank Pallone, Jr.; 78 Cosponsors
 S. 540 – Sponsor: Sen. Edward Kennedy; 20 Cosponsors
• Each Bill entitled “Medical Device Safety Act of
2009”
• Identical Bills
 Added language to the end of section 521 to negate
device preemption as it applies to tort suits
 Effective date: May 28, 1976 to “apply to any civil action
pending or filed on or after the date of enactment of this
Act.”
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Now a Matter of Policy and
Not Law
• Distinction between the device and drug
industries?
• Effect on small companies and
innovation?
• Effect on patient costs in response to
increased litigation costs?
• Public health implications of losing
preemption?
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