80 FR 12013 - Steven M. Lynch; Denial of Hearing; Final Debarment Order
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 43 (March 5, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 43 (March 5, 2015)
| Page Range | 12013-12016 | |
| FR Document | 2015-05044 |
[Federal Register Volume 80, Number 43 (Thursday, March 5, 2015)] [Notices] [Pages 12013-12016] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-05044] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0301] Steven M. Lynch; Denial of Hearing; Final Debarment Order AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- [[Page 12014]] SUMMARY: The Food and Drug Administration (FDA) is denying a request for a hearing submitted by Dr. Steven M. Lynch, and is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Dr. Lynch for 2 years from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on a finding that Dr. Lynch was convicted of a misdemeanor under Federal law for conduct relating to the regulation of a drug product under the FD&C Act and that the type of conduct underlying the conviction undermines the process for the regulation of drugs. In determining the appropriateness and period of Dr. Lynch's debarment, FDA has considered the relevant factors listed in the FD&C Act. Dr. Lynch has failed to file with the Agency information and analyses sufficient to create a basis for a hearing concerning this action. DATES: The order is effective March 5, 2015. ADDRESSES: Submit applications for termination of debarment to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Nathan Doty, Office of Scientific Integrity, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 301-796-8556. SUPPLEMENTARY INFORMATION: I. Background On August 11, 2009, in the U.S. District Court for the Northern District of New York, Dr. Lynch, a physician, pled guilty to a misdemeanor under the FD&C Act, namely misbranding a drug in violation of sections 301(k), 502(i)(3) and 303(a)(1) of the FD&C Act (21 U.S.C. 331(k), 352(i)(3), 333(a)(1)) and 18 U.S.C. 2. The basis for this conviction was conduct surrounding his injection of patients seeking treatment with BOTOX/BOTOX Cosmetic (BOTOX) with a product, TRI-toxin, distributed by Toxin Research International, Inc. BOTOX is a biological product derived from Botulinum Toxin Type A that is manufactured by Allergan, Inc., and was approved by FDA for use on humans for the treatment of facial wrinkles in 1991. According to the records of the criminal proceedings, Dr. Lynch's colleague in the same medical practice, The Plastic Surgery Group (TPSG), directed a nurse to obtain 31 vials of TRI-toxin, an unapproved drug product, which was represented by its distributor as ``Botulinum Toxin Type A.'' Dr. Lynch then proceeded to inject approximately 18 patients, who believed they were being injected with BOTOX, with TRI-toxin as a substitute. Dr. Lynch is subject to debarment based on a finding, under section 306(b)(2)(B)(i)(I) of the FD&C Act (21 U.S.C. 335a(b)(2)(B)(i)(I)): (1) That he was convicted of a misdemeanor under Federal law relating to the regulation of a drug product under the FD&C Act and (2) that the type of conduct underlying the conviction undermines the process for the regulation of drugs. By notice to Dr. Lynch dated November 30, 2010, FDA's Office of Regulatory Affairs (ORA) proposed to debar him for 4 years from providing services in any capacity to a person having an approved or pending drug product application. In a letter dated December 30, 2010, through counsel, Dr. Lynch requested a hearing on the proposal. In his request for a hearing, Dr. Lynch acknowledges his conviction under Federal law, as alleged by FDA. By letter dated February 4, 2011, Dr. Lynch submitted materials and arguments in support of his request. Dr. Lynch acknowledges that he was convicted of a Federal misdemeanor, as found in the proposal to debar, but argues that he should not be debarred for reasons related to the factual basis set forth in the proposal to debar. In particular, with respect to the considerations for determining the appropriateness and period of debarment under section 306(c)(3) of the FD&C Act, he argues that there are genuine and substantial issues of fact for resolution at a hearing, namely factual issues bearing on whether he participated in or even knew of certain conduct that resulted in his violation of the FD&C Act. Hearings are granted only if there is a genuine and substantial issue of fact. Hearings will not be granted on issues of policy or law, on mere allegations, denials, or general descriptions of positions and contentions, or on data and information insufficient to justify the factual determination urged or the action requested (see 21 CFR 12.24(b)). The Chief Scientist has considered Dr. Lynch's arguments, as well as the proposal to debar itself, and concludes that, although Dr. Lynch has failed to raise a genuine and substantial issue of fact requiring a hearing, the appropriate period of debarment is 2 years. II. Arguments In support of his hearing request, Dr. Lynch first asserts that he is not subject to debarment under section 306(b)(2)(B)(i)(I) of the FD&C Act. He contends that he pled guilty to a misdemeanor violation of the FD&C Act (see section 303(a)(1)), which is a strict liability offense, and that thus there was no demonstration or admission of criminal intent or knowledge underlying the conviction. Dr. Lynch concludes, therefore, that the conduct underlying his conviction did not undermine the process for the regulation of drugs. Section 306(b)(2)(B)(i)(I) of the FD&C Act specifically provides for the debarment of individuals convicted of Federal misdemeanors related to the regulation of drug products under the FD&C Act. Given that misdemeanor violations of the FD&C Act themselves are strict liability offenses, it stands to reason that criminal intent is not a critical component to debar an individual under section 306(b)(2)(B)(i)(I). During his criminal proceedings, Dr. Lynch pled guilty to misbranding and causing the misbranding of a drug in violation of sections 301(k), 502(i)(3) and 303(a)(1) of the FD&C Act by offering an unapproved drug, TRI-toxin, for sale as an approved drug product, BOTOX. Dr. Lynch's conduct undermined the process for the regulation of drugs in that it permitted an unapproved drug to be substituted for an approved drug without the knowledge of the patient. As a result, Dr. Lynch is, in fact, subject to debarment under section 306(b)(2)(B)(i)(I) of the FD&C Act. Dr. Lynch next challenges the manner in which ORA applied the considerations under section 306(c)(3) of the FD&C Act in determining the appropriateness and period of his debarment. In the proposal to debar Dr. Lynch, ORA stated that there are four applicable considerations under section 306(c)(3) of the FD&C Act: (1) The nature and seriousness of his offense under section 306(c)(3)(A); (2) the nature and extent of management participation in the offense under section 306(c)(3)(B); (3) the nature and extent of voluntary steps taken to mitigate the impact on the public under section 306(c)(3)(C); and (4) prior convictions involving matters within the jurisdiction of FDA under section 306(c)(3)(F). ORA found with respect to Dr. Lynch that the first two considerations weigh in favor of debarment and noted that the third and fourth considerations would be treated as favorable factors for him. In making all of its findings under section 306(c)(3) of the FD&C Act, ORA characterized Dr. Lynch's conduct based on records from his criminal proceedings. Under section 306(c)(3)(A) of the FD&C Act, in determining the appropriateness and period of [[Page 12015]] debarment, FDA considers ``the nature and seriousness of the offense involved.'' In the proposal to debar, ORA relied on the criminal information to which Dr. Lynch pled guilty to find that the conduct underlying his convictions: created a risk of injury to consumers due to the use of an unapproved drug, undermined [FDA's] oversight of an approved drug product by representing that [he] used the approved drug while actually substituting an unapproved drug in its place, and seriously undermined the integrity of [FDA's] regulation of drug products. Under section 306(c)(3)(B), ORA also considered the ``nature and extent of [Dr. Lynch's] management participation in the offense'' and specifically found that he was a corporate principal who ``pleaded guilty to misbranding TRI-toxin'' and ``participated in the [TPSG's] unlawful conduct of administering [an] unapproved drug on multiple occasions to patients.'' ORA concluded, therefore, that the nature and seriousness of Lynch's offenses and the nature and extent of management participation were unfavorable factors with respect to him. Dr. Lynch counters ORA's findings with respect to those two considerations in section 306(c)(3) of the FD&C Act with the following arguments: (1) That he did not admit any criminal intent or intentional wrongdoing when he pled guilty to a misdemeanor offense under the FD&C Act; (2) that, in fact, another physician at TPSG took unilateral action in ordering the TRI-toxin and directing a nurse to substitute it for BOTOX; (3) that the TRI-toxin vials that they used for injecting patients with TRI-toxin were identical to the vials he used for BOTOX before the substitution; and (4) that since the conviction for the underlying misdemeanor was of an individual, that there was no management participation and that, thus, the nature and extent of management participation is inapplicable as a factor in determining appropriateness and period of debarment. Dr. Lynch concedes that he pled guilty to the misdemeanor offense because he was, in fact, guilty of offering TRI-toxin for sale to their patients as BOTOX. He argues, however, that the criminal records do not establish any intent or knowledge on his part and that thus the conduct underlying his conviction does not warrant debarment in light of the considerations in section 306(c)(3) of the FD&C Act. As noted previously, ORA relied on the records of Dr. Lynch's criminal proceedings for its findings in the proposal to debar. There is nothing definitive in the criminal records before FDA to contradict Dr. Lynch's assertions with respect to the nature of his involvement in the misdemeanor offense to which he pled guilty. The criminal information to which Dr. Lynch pled guilty alleges that TPSG, as opposed to Dr. Lynch, began ordering TRI-toxin for use in the medical practice, and there are no allegations that Dr. Lynch took part in the ordering process. Indeed, the proposal to debar states that, as claimed by Dr. Lynch, another physician in the practice, William F. DeLuca, Jr., was responsible for authorizing a nurse to substitute TRI-toxin for BOTOX, not Dr. Lynch. At Dr. Lynch's sentencing hearing, at which six other codefendants, including DeLuca, were also sentenced, the presiding judge also made clear that he believed DeLuca was the physician responsible for making the ``mistake'' that led to the other physician's offenses. In addressing DeLuca, the court stated: And we're here because of your actions and inactions. As I said, your mistakes were different in kind and degree from those of your colleagues. It was you who brought this drug into the practice, and it was your conduct and your failure to check out either the company or the drug that you were ordering, as you should have done, your negligence in doing that that has brought us here today in the end. In addressing one of the other three physicians who pled guilty under circumstances similar to Dr. Lynch's, the court further stated: ``There have been disputes on how in the past over who knew what and at what point in time. It is clear from the facts in this case that you had no knowledge that the substance was anything other than [BOTOX] until your discovery of it in November of 2004.'' In short, consistent with the proposal to debar Dr. Lynch for 4 years, the records of his criminal proceedings establish that the misdemeanor convictions for the physicians in TPSG other than DeLuca were not based on any affirmative involvement in ordering the TRI-toxin or substituting the TRI-toxin for BOTOX. Furthermore, in proposing to debar Dr. Lynch for 4 years, ORA did not rely on any findings with respect to Dr. Lynch's intent or knowledge. Rather, citing the records of Dr. Lynch's criminal proceedings, the proposal to debar simply rests on Dr. Lynch's position of authority within TPSG and his conduct in misbranding TRI-toxin by administering it to patients who believed they were receiving BOTOX. As a result, under Sec. 12.24(b), there is no genuine and substantial issue of fact raised by Dr. Lynch's arguments for resolution at a hearing. As set forth in the proposal to debar and summarized above, Dr. Lynch pled guilty to a misdemeanor under the FD&C Act for his role in offering a drug under the name of another. Based on the undisputed record before the Agency, the consideration in section 306(c)(3)(A) of the FD&C Act with respect to the nature and seriousness of the offense involved is a favorable factor. As reflected in the records of the criminal proceedings, Dr. Lynch's offense did not rest on any intent or knowledge of wrongdoing on his part, nor may such intent or knowledge be inferred from the circumstances of his offense or the findings in the proposal to debar. Although, as a practicing physician, Dr. Lynch should be expected to take the appropriate steps to avoid administering an unapproved new drug to patients or misrepresenting the drug being administered, his failure to do so over a 10-month period does not warrant considering the nature and seriousness of his offense as an unfavorable factor, relative to the range of conduct that might underlie a Federal misdemeanor conviction. On the other hand, because of Dr. Lynch's position of authority within TPSG and, thus, presumed ability to prevent the series of events that resulted in the offense underlying his misdemeanor conviction, the nature and extent of management participation in the offense is an unfavorable factor, for the purposes of the consideration under 306(c)(3)(B) of the FD&C Act. Dr. Lynch asserts that there was no management participation, and that, thus, this factor is inapplicable because the underlying conviction was of an individual. However, the criminal information to which Dr. Lynch pled guilty alleges that TPSG began ordering TRI-toxin for use in the medical practice. It is undisputed that Dr. Lynch is a principal in TPSG, and this is the basis for considering the nature and extent of management participation as a factor in determining the appropriateness and period of debarment. FDA has relied on this factor in other debarment cases where the underlying conviction was of an individual (see 78 FR 68455 (November 14, 2013); 77 FR 27236 (May 9, 2012)). The limited scope of his direct actions in committing the underlying misdemeanor offense does not mitigate the extent of his management participation, as established during his criminal proceedings and as set out in the proposal to debar. It is true that nothing in the criminal proceedings or the proposal to debar reflects any involvement by him in the decision to [[Page 12016]] order the TRI-toxin and substitute it for BOTOX, and the proposal to debar specifically finds that another physician authorized a nurse to place that order. However, Dr. Lynch, as a principal of TPSG, was responsible for failing to ensure that there were controls and procedures in place to prevent other physicians or a nurse from ordering unapproved drugs for administration to patients. His own admitted inaction on that front warrants treating his management participation as an unfavorable factor.\1\ --------------------------------------------------------------------------- \1\ See United States v. Park, 421 U.S. 658, 673-74 (1975) (holding that a high-level manager within a business entity bears a responsibility to prevent and correct violations of the FD&C Act). --------------------------------------------------------------------------- Consistent with the proposal to debar, the record establishes that the medical practice of which Dr. Lynch was a part ultimately took voluntary steps to mitigate the effect on the public health from its unlawful conduct (see section 306(c)(3)(C) of the FD&C Act). Furthermore, it is undisputed that Dr. Lynch had no previous criminal convictions related to matters within the jurisdiction of FDA (see section 306(c)(3)(F) of the FD&C Act). Therefore, these will be treated as favorable factors. In light of the foregoing four considerations, one of which weighs against Dr. Lynch, debarment for 2 years is appropriate. III. Findings and Order Therefore, the Chief Scientist, under section 306(b)(2)(B)(i)(I) of the FD&C Act and under authority delegated to him, finds that Dr. Lynch has been convicted of a misdemeanor under Federal law for conduct relating to the development or approval of a drug product or otherwise relating to the regulation of a drug product under the FD&C Act and that the conduct underlying the conviction undermines the regulation of drugs. FDA has considered the relevant factors listed in section 306(c)(3) of the FD&C Act and determined that a debarment of 2 years is appropriate. As a result of the foregoing findings, Dr. Lynch is debarred for 2 years from providing services in any capacity to a person with an approved or pending drug product application under section 505, 512, or 802 of the FD&C Act (21 U.S.C. 355, 360b, or 382), or under section 351 of the Public Health Service Act (42 U.S.C. 262), effective (see DATES) (see 21 U.S.C. 335a(c)(1)(B) and (c)(2)(A)(iii) and 21 U.S.C. 321(dd)). Any person with an approved, or pending, drug product application, who knowingly uses the services of Dr. Lynch, in any capacity during his period of debarment, will be subject to civil money penalties. If Dr. Lynch, during his period of debarment, provides services in any capacity to a person with an approved or pending drug product application he will be subject to civil money penalties. In addition, FDA will not accept or review any abbreviated new drug applications submitted by or with the assistance of Dr. Lynch during his period of debarment. Any application by Dr. Lynch for termination of debarment under section 306(d) of the FD&C Act should be identified with Docket No. FDA-2010-N-0301 and sent to the Division of Dockets Management (see ADDRESSES). All such submissions are to be filed in four copies. The public availability of information in these submissions is governed by 21 CFR 10.20(j). Publicly available submissions may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Persons with access to the Internet may obtain documents in the Docket at http://www.regulations.gov/. Dated: February 24, 2015. Stephen Ostroff, Director, Office of the Chief Scientist. [FR Doc. 2015-05044 Filed 3-4-15; 8:45 am] BILLING CODE 4164-01P
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legislative history in order to ascertain unpersuasive. Accordingly, the Chief considered the relevant factors listed in
the statute’s meaning. (Chamber of Scientist denies Dr. DeLuca’s request for section 306(c)(3) of the FD&C Act and
Commerce of United States v. Whiting, a hearing. determined that a debarment of 5 years
131 S. Ct. 1968 (2011).) Dr. DeLuca’s As set forth in the proposal to debar is appropriate.
conduct in misbranding Tri-toxin by and summarized in this document, Dr. As a result of the foregoing findings,
holding it for sale and administering it DeLuca pled guilty to a misdemeanor Dr. DeLuca is debarred for 5 years from
to patients as the approved drug BOTOX under the FD&C Act for his role in providing services in any capacity to a
clearly relates to FDA’s regulation of offering a drug under the name of person with an approved or pending
approved drugs. Likewise, his argument another. Based on the undisputed drug product application under section
that section 306(b)(2)(B)(i) of the FD&C record before the Agency, the 505, 512, or 802 of the FD&C Act (21
Act could not have been intended to consideration in section 306(c)(3)(A) U.S.C. 355, 360b, or 382), or under
cover him because he did not work for and (B) of the FD&C Act with respect to section 351 of the Public Health Service
a person with a pending or approved the nature and seriousness of the offense Act (42 U.S.C. 262), effective (see
drug product application when he was and extent in management participation DATES) (see 21 U.S.C. 335a(c)(1)(B) and
convicted or that section 306(b)(2)(B)(i) involved are unfavorable in light of Dr. (c)(2)(A)(iii) and 21 U.S.C. 321(dd)).
applies to only individuals who DeLuca’s conduct in bringing the Any person with an approved or
manufacture and distribute drugs unapproved drug into the medical pending drug product application who
ignores both the plain language of the practice and his management position knowingly uses the services of Dr.
statute and the remedial purpose of the in The Plastic Surgery Group. At Dr. DeLuca, in any capacity during his
Agency’s debarment authority. DeLuca’s sentencing hearing, at which period of debarment, will be subject to
Furthermore, Dr. DeLuca’s argument six other codefendants were also civil money penalties. If Dr. DeLuca,
that Bhutani v. U.S. Food and Drug sentenced, the presiding judge in during his period of debarment,
Administration, 161 Fed. Appx. 589, addressing Dr. DeLuca stated: provides services in any capacity to a
591 (7th Cir. 2006), and FDA’s And we’re here because of your actions and person with an approved or pending
debarment order for Premchand inactions. As I said, your mistakes were drug product application he will be
Girdhari (65 FR 3454) evidence the different in kind and degree from those of subject to civil money penalties. In
court’s and FDA’s view that the statute your colleagues. It was you who brought this addition, FDA will not accept or review
is to be interpreted to exclude him is drug into the practice, and it was your any abbreviated new drug applications
without merit. Both the court decision conduct and your failure to check out either submitted by or with the assistance of
and FDA’s debarment order address the the company or the drug that you were
ordering, as you should have done, your Dr. DeLuca during his period of
specific fact situations at issue. Both debarment.
negligence in doing that that has brought us
situations involved persons who Any application by Dr. DeLuca for
here today in the end.
manufactured and distributed drugs. termination of debarment under section
The decision and order did not purport Consistent with the proposal to debar,
306(d) of the FD&C Act should be
to define the full scope of section the record established that the medical
identified with Docket No. FDA–2010–
306(b)(2)(B)(i) of the FD&C Act or hold practice of which Dr. DeLuca was a part
N–0303 and sent to the Division of
that conduct such as Dr. DeLuca’s was ultimately took voluntary steps to
Dockets Management (see ADDRESSES).
not within the scope of the statutory mitigate the effect on the public health
All such submissions are to be filed in
provision. from its unlawful conduct and that Dr.
four copies. The public availability of
Finally, Dr. DeLuca argues that FDA DeLuca had no previous criminal
information in these submissions is
does not typically debar physicians for convictions related to matters within
governed by 21 CFR 10.20(j).
criminal violations of the FD&C Act. FDA’s jurisdictions. As such, the
Publicly available submissions may
FDA has, however, debarred several considerations in sections 306(c)(3)(C)
be seen in the Division of Dockets
other physicians under section and (F) of the FD&C Act will be treated
Management between 9 a.m. and 4 p.m.,
306(b)(2)(B)(i)(I) of the FD&C Act for as favorable factors.
In light of the totality of the Monday through Friday. Persons with
convictions under the FD&C Act on the
circumstances underlying the foregoing access to the Internet may obtain
basis of similar conduct. (See, e.g., 77
four considerations, the seriousness of documents in the Docket at http://
FR 27235, May 9, 2012; 76 FR 69272,
the offense and Dr. DeLuca’s www.regulations.gov/.
November 8, 2011; 76 FR 30947, May
27, 2011; 76 FR 21910, April 19, 2011; management participation make Dated: February 24, 2015.
76 FR 13192, March 10, 2011; 76 FR debarment for 5 years, consistent with Stephen Ostroff,
11789, March 3, 2011 (debarring the proposal to debar, appropriate in Director, Office of the Chief Scientist.
physicians for felony violations of the spite of the favorable factors under [FR Doc. 2015–05043 Filed 3–4–15; 8:45 am]
FD&C Act for substituting TRI-toxin for 306(c)(3)(C) and (F) of the FD&C Act. BILLING CODE 4164–01P
BOTOX); 77 FR 27236, May 9, 2012; 76
III. Findings and Order
FR 66072, October 25, 2011; 76 FR
48168, August 8, 2011; 76 FR 37126, Therefore, the Chief Scientist, under DEPARTMENT OF HEALTH AND
June 24, 2011; 76 FR 30946, May 27, section 306(b)(2)(B)(i)(I) of the FD&C HUMAN SERVICES
2011; 76 FR 18556, April 4, 2011; 76 FR Act and under authority delegated to
18557, April 4, 2011; 76 FR 12971, him by the Commissioner of Food and Food and Drug Administration
March 9, 2011 (debarring physicians for Drugs, finds: (1) That Dr. DeLuca has
mstockstill on DSK4VPTVN1PROD with NOTICES
a misdemeanor violations of the FD&C been convicted of a misdemeanor under [Docket No. FDA–2010–N–0301]
Act for substituting TRI-toxin for Federal law for conduct relating to the
BOTOX). development or approval of a drug Steven M. Lynch; Denial of Hearing;
Dr. DeLuca’s arguments do not raise product or otherwise relating to the Final Debarment Order
any genuine and substantial issue of fact regulation of a drug product under the AGENCY: Food and Drug Administration,
for a hearing. Furthermore, Dr. DeLuca’s FD&C Act and (2) that the conduct HHS.
legal arguments do not create a basis for underlying the conviction undermines
ACTION: Notice.
a hearing and, in any event, are the regulation of drugs. FDA has
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debarment, FDA considers ‘‘the nature definitive in the criminal records before of fact raised by Dr. Lynch’s arguments
and seriousness of the offense FDA to contradict Dr. Lynch’s assertions for resolution at a hearing.
involved.’’ In the proposal to debar, with respect to the nature of his As set forth in the proposal to debar
ORA relied on the criminal information involvement in the misdemeanor and summarized above, Dr. Lynch pled
to which Dr. Lynch pled guilty to find offense to which he pled guilty. The guilty to a misdemeanor under the
that the conduct underlying his criminal information to which Dr. FD&C Act for his role in offering a drug
convictions: Lynch pled guilty alleges that TPSG, as under the name of another. Based on the
created a risk of injury to consumers due to opposed to Dr. Lynch, began ordering undisputed record before the Agency,
the use of an unapproved drug, undermined TRI-toxin for use in the medical the consideration in section 306(c)(3)(A)
[FDA’s] oversight of an approved drug practice, and there are no allegations of the FD&C Act with respect to the
product by representing that [he] used the that Dr. Lynch took part in the ordering nature and seriousness of the offense
approved drug while actually substituting an process. Indeed, the proposal to debar involved is a favorable factor. As
unapproved drug in its place, and seriously states that, as claimed by Dr. Lynch, reflected in the records of the criminal
undermined the integrity of [FDA’s] proceedings, Dr. Lynch’s offense did not
regulation of drug products. another physician in the practice,
William F. DeLuca, Jr., was responsible rest on any intent or knowledge of
Under section 306(c)(3)(B), ORA also wrongdoing on his part, nor may such
for authorizing a nurse to substitute TRI-
considered the ‘‘nature and extent of intent or knowledge be inferred from the
toxin for BOTOX, not Dr. Lynch. At Dr.
[Dr. Lynch’s] management participation circumstances of his offense or the
Lynch’s sentencing hearing, at which
in the offense’’ and specifically found findings in the proposal to debar.
six other codefendants, including
that he was a corporate principal who Although, as a practicing physician, Dr.
DeLuca, were also sentenced, the
‘‘pleaded guilty to misbranding TRI- Lynch should be expected to take the
toxin’’ and ‘‘participated in the [TPSG’s] presiding judge also made clear that he
believed DeLuca was the physician appropriate steps to avoid administering
unlawful conduct of administering [an] an unapproved new drug to patients or
unapproved drug on multiple occasions responsible for making the ‘‘mistake’’
that led to the other physician’s misrepresenting the drug being
to patients.’’ ORA concluded, therefore, administered, his failure to do so over
that the nature and seriousness of offenses. In addressing DeLuca, the
court stated: a 10-month period does not warrant
Lynch’s offenses and the nature and considering the nature and seriousness
extent of management participation And we’re here because of your actions and of his offense as an unfavorable factor,
were unfavorable factors with respect to inactions. As I said, your mistakes were
relative to the range of conduct that
him. different in kind and degree from those of
your colleagues. It was you who brought this might underlie a Federal misdemeanor
Dr. Lynch counters ORA’s findings conviction.
with respect to those two considerations drug into the practice, and it was your
conduct and your failure to check out either On the other hand, because of Dr.
in section 306(c)(3) of the FD&C Act the company or the drug that you were Lynch’s position of authority within
with the following arguments: (1) That ordering, as you should have done, your TPSG and, thus, presumed ability to
he did not admit any criminal intent or negligence in doing that that has brought us prevent the series of events that resulted
intentional wrongdoing when he pled here today in the end. in the offense underlying his
guilty to a misdemeanor offense under misdemeanor conviction, the nature and
the FD&C Act; (2) that, in fact, another In addressing one of the other three
physicians who pled guilty under extent of management participation in
physician at TPSG took unilateral action the offense is an unfavorable factor, for
in ordering the TRI-toxin and directing circumstances similar to Dr. Lynch’s,
the court further stated: ‘‘There have the purposes of the consideration under
a nurse to substitute it for BOTOX; (3) 306(c)(3)(B) of the FD&C Act. Dr. Lynch
that the TRI-toxin vials that they used been disputes on how in the past over
asserts that there was no management
for injecting patients with TRI-toxin who knew what and at what point in
participation, and that, thus, this factor
were identical to the vials he used for time. It is clear from the facts in this
is inapplicable because the underlying
BOTOX before the substitution; and (4) case that you had no knowledge that the
conviction was of an individual.
that since the conviction for the substance was anything other than
However, the criminal information to
underlying misdemeanor was of an [BOTOX] until your discovery of it in
which Dr. Lynch pled guilty alleges that
individual, that there was no November of 2004.’’
TPSG began ordering TRI-toxin for use
management participation and that, In short, consistent with the proposal in the medical practice. It is undisputed
thus, the nature and extent of to debar Dr. Lynch for 4 years, the that Dr. Lynch is a principal in TPSG,
management participation is records of his criminal proceedings and this is the basis for considering the
inapplicable as a factor in determining establish that the misdemeanor nature and extent of management
appropriateness and period of convictions for the physicians in TPSG participation as a factor in determining
debarment. Dr. Lynch concedes that he other than DeLuca were not based on the appropriateness and period of
pled guilty to the misdemeanor offense any affirmative involvement in ordering debarment. FDA has relied on this factor
because he was, in fact, guilty of the TRI-toxin or substituting the TRI- in other debarment cases where the
offering TRI-toxin for sale to their toxin for BOTOX. Furthermore, in underlying conviction was of an
patients as BOTOX. He argues, however, proposing to debar Dr. Lynch for 4 individual (see 78 FR 68455 (November
that the criminal records do not years, ORA did not rely on any findings 14, 2013); 77 FR 27236 (May 9, 2012)).
establish any intent or knowledge on his with respect to Dr. Lynch’s intent or The limited scope of his direct actions
part and that thus the conduct knowledge. Rather, citing the records of in committing the underlying
mstockstill on DSK4VPTVN1PROD with NOTICES
underlying his conviction does not Dr. Lynch’s criminal proceedings, the misdemeanor offense does not mitigate
warrant debarment in light of the proposal to debar simply rests on Dr. the extent of his management
considerations in section 306(c)(3) of Lynch’s position of authority within participation, as established during his
the FD&C Act. TPSG and his conduct in misbranding criminal proceedings and as set out in
As noted previously, ORA relied on TRI-toxin by administering it to patients the proposal to debar. It is true that
the records of Dr. Lynch’s criminal who believed they were receiving nothing in the criminal proceedings or
proceedings for its findings in the BOTOX. As a result, under § 12.24(b), the proposal to debar reflects any
proposal to debar. There is nothing there is no genuine and substantial issue involvement by him in the decision to
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![12016 Federal Register / Vol. 80, No. 43 / Thursday, March 5, 2015 / Notices
order the TRI-toxin and substitute it for period of debarment, will be subject to Court of Federal Claims, 717 Madison
BOTOX, and the proposal to debar civil money penalties. If Dr. Lynch, Place NW., Washington, DC 20005,
specifically finds that another physician during his period of debarment, (202) 357–6400. For information on
authorized a nurse to place that order. provides services in any capacity to a HRSA’s role in the Program, contact the
However, Dr. Lynch, as a principal of person with an approved or pending Director, National Vaccine Injury
TPSG, was responsible for failing to drug product application he will be Compensation Program, 5600 Fishers
ensure that there were controls and subject to civil money penalties. In Lane, Room 11C–26, Rockville, MD
procedures in place to prevent other addition, FDA will not accept or review 20857; (301) 443–6593.
physicians or a nurse from ordering any abbreviated new drug applications
unapproved drugs for administration to submitted by or with the assistance of SUPPLEMENTARY INFORMATION: The
patients. His own admitted inaction on Dr. Lynch during his period of Program provides a system of no-fault
that front warrants treating his debarment. compensation for certain individuals
management participation as an Any application by Dr. Lynch for who have been injured by specified
unfavorable factor.1 termination of debarment under section childhood vaccines. Subtitle 2 of Title
Consistent with the proposal to debar, 306(d) of the FD&C Act should be XXI of the PHS Act, 42 U.S.C. 300aa–
the record establishes that the medical identified with Docket No. FDA–2010– 10 et seq., provides that those seeking
practice of which Dr. Lynch was a part N–0301 and sent to the Division of compensation are to file a petition with
ultimately took voluntary steps to Dockets Management (see ADDRESSES). the U.S. Court of Federal Claims and to
mitigate the effect on the public health All such submissions are to be filed in serve a copy of the petition on the
from its unlawful conduct (see section four copies. The public availability of Secretary of Health and Human
306(c)(3)(C) of the FD&C Act). information in these submissions is Services, who is named as the
Furthermore, it is undisputed that Dr. governed by 21 CFR 10.20(j). Publicly respondent in each proceeding. The
Lynch had no previous criminal available submissions may be seen in Secretary has delegated this
convictions related to matters within the the Division of Dockets Management responsibility under the Program to
jurisdiction of FDA (see section between 9 a.m. and 4 p.m., Monday HRSA. The Court is directed by statute
306(c)(3)(F) of the FD&C Act). Therefore, through Friday. Persons with access to to appoint special masters who take
these will be treated as favorable factors. the Internet may obtain documents in evidence, conduct hearings as
In light of the foregoing four the Docket at http:// appropriate, and make initial decisions
considerations, one of which weighs www.regulations.gov/. as to eligibility for, and amount of,
against Dr. Lynch, debarment for 2 years compensation.
Dated: February 24, 2015.
is appropriate. Stephen Ostroff, A petition may be filed with respect
Director, Office of the Chief Scientist. to injuries, disabilities, illnesses,
III. Findings and Order conditions, and deaths resulting from
[FR Doc. 2015–05044 Filed 3–4–15; 8:45 am]
Therefore, the Chief Scientist, under vaccines described in the Vaccine Injury
BILLING CODE 4164–01P
section 306(b)(2)(B)(i)(I) of the FD&C Table (the Table) set forth at Section
Act and under authority delegated to 2114 of the PHS Act or as set forth at
him, finds that Dr. Lynch has been DEPARTMENT OF HEALTH AND 42 CFR 100.3, as applicable. This Table
convicted of a misdemeanor under HUMAN SERVICES lists for each covered childhood vaccine
Federal law for conduct relating to the the conditions which may lead to
development or approval of a drug Health Resources and Services compensation and, for each condition,
product or otherwise relating to the Administration the time period for occurrence of the
regulation of a drug product under the first symptom or manifestation of onset
FD&C Act and that the conduct National Vaccine Injury Compensation or of significant aggravation after
underlying the conviction undermines Program; List of Petitions Received vaccine administration. Compensation
the regulation of drugs. FDA has may also be awarded for conditions not
AGENCY: Health Resources and Services
considered the relevant factors listed in listed in the Table and for conditions
Administration, HHS.
section 306(c)(3) of the FD&C Act and that are manifested outside the time
ACTION: Notice.
determined that a debarment of 2 years periods specified in the Table, but only
is appropriate. SUMMARY: The Health Resources and if the petitioner shows that the
As a result of the foregoing findings, Services Administration (HRSA) is condition was caused by one of the
Dr. Lynch is debarred for 2 years from publishing this notice of petitions listed vaccines.
providing services in any capacity to a received under the National Vaccine Section 2112(b)(2) of the PHS Act, 42
person with an approved or pending Injury Compensation Program (the U.S.C. 300aa–12(b)(2), requires that
drug product application under section Program), as required by Section ‘‘[w]ithin 30 days after the Secretary
505, 512, or 802 of the FD&C Act (21 2112(b)(2) of the Public Health Service receives service of any petition filed
U.S.C. 355, 360b, or 382), or under (PHS) Act, as amended. While the under section 2111 the Secretary shall
section 351 of the Public Health Service Secretary of Health and Human Services publish notice of such petition in the
Act (42 U.S.C. 262), effective (see is named as the respondent in all Federal Register.’’ Set forth below is a
DATES) (see 21 U.S.C. 335a(c)(1)(B) and proceedings brought by the filing of list of petitions received by HRSA on
(c)(2)(A)(iii) and 21 U.S.C. 321(dd)). petitions for compensation under the January 1, 2015, through January 31,
Any person with an approved, or Program, the United States Court of
mstockstill on DSK4VPTVN1PROD with NOTICES
2015. This list provides the name of
pending, drug product application, who Federal Claims is charged by statute petitioner, city and state of vaccination
knowingly uses the services of Dr. with responsibility for considering and (if unknown then city and state of
Lynch, in any capacity during his acting upon the petitions. person or attorney filing claim), and
1 See United States v. Park, 421 U.S. 658, 673–
FOR FURTHER INFORMATION CONTACT: For case number. In cases where the Court
74 (1975) (holding that a high-level manager within
information about requirements for has redacted the name of a petitioner
a business entity bears a responsibility to prevent filing petitions, and the Program in and/or the case number, the list reflects
and correct violations of the FD&C Act). general, contact the Clerk, United States such redaction.
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Document Created: 2015-12-18 12:09:32
Document Modified: 2015-12-18 12:09:32
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | The order is effective March 5, 2015. | |
| Contact | Nathan Doty, Office of Scientific Integrity, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 301-796-8556. | |
| FR Citation | 80 FR 12013 |
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