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Date: 10-22-2013

Case Style: United States of America v. Eric and Ryan Jensen

Case Number: 1:13-mj-01138-MEH

Judge:

Court: United States District Court for the District of Colorado (Denver County)

Plaintiff's Attorney: Jaime A. Pena

Defendant's Attorney: Richard J. Banta for Ryan Jensen

Forrest W. Lewis fpr Eric Jensen

Description: The United States of America charged Eric Jordan, age 37, and Ryan Jensen, age 33,six counts of introducing adulterated food into interstate commerce in a Listeria outbreak spread by cantaloupes. Cantalopes grown and sold by them
sickened hundreds and killed 33.

The Government alleged that the defendants introduced adulterated food into interstate commerce and aiding and abetting such in violation of 21 U.S.C. 331 which provides:

The following acts and the causing thereof are
prohibited:
(a) The introduction or delivery for introduction
into interstate commerce of any food, drug,
device, tobacco product, or cosmetic that is
adulterated or misbranded.
(b) The adulteration or misbranding of any
food, drug, device, tobacco product, or cosmetic
in interstate commerce.
(c) The receipt in interstate commerce of any
food, drug, device, tobacco product, or cosmetic
that is adulterated or misbranded, and the delivery
or proffered delivery thereof for pay or
otherwise.
(d) The introduction or delivery for introduction
into interstate commerce of any article in
violation of section 344, 350d, 355, or 360bbb–3 of
this title.
(e) The refusal to permit access to or copying
of any record as required by section 350a, 350c,
350f(j), 350e, 354, 360bbb–3, 373, 374(a), 379aa, or
379aa–1 of this title; or the failure to establish or
maintain any record, or make any report, required
under section 350a, 350c(b), 350f, 350e, 354,
355(i) or (k), 360b(a)(4)(C), 360b(j), (l) or (m),
360ccc–1(i), 360e(f), 360i, 360bbb–3, 379aa, 379aa–1,
387i, or 387t of this title or the refusal to permit
access to or verification or copying of any such
required record; or the violation of any recordkeeping
requirement under section 2223 1 of this
title (except when such violation is committed
by a farm).
(f) The refusal to permit entry or inspection as
authorized by section 374 of this title.
(g) The manufacture within any Territory of
any food, drug, device, tobacco product, or cosmetic
that is adulterated or misbranded.
(h) The giving of a guaranty or undertaking
referred to in section 333(c)(2) of this title, which
guaranty or undertaking is false, except by a
person who relied upon a guaranty or undertaking
to the same effect signed by, and containing
the name and address of, the person residing
in the United States from whom he received
in good faith the food, drug, device, tobacco
product, or cosmetic; or the giving of a
guaranty or undertaking referred to in section
333(c)(3) of this title, which guaranty or undertaking
is false.
(i)(1) Forging, counterfeiting, simulating, or
falsely representing, or without proper authority
using any mark, stamp, tag, label, or other
identification device authorized or required by
regulations promulgated under the provisions of
section 344 or 379e of this title.
(2) Making, selling, disposing of, or keeping in
possession, control, or custody, or concealing
any punch, die, plate, stone, or other thing designed
to print, imprint, or reproduce the trademark,
trade name, or other identifying mark,
imprint, or device of another or any likeness of
any of the foregoing upon any drug or container
or labeling thereof so as to render such drug a
counterfeit drug.
(3) The doing of any act which causes a drug to
be a counterfeit drug, or the sale or dispensing,
or the holding for sale or dispensing, of a counterfeit
drug.
(j) The using by any person to his own advantage,
or revealing, other than to the Secretary
or officers or employees of the Department, or
to the courts when relevant in any judicial proceeding
under this chapter, any information acquired
under authority of section 344, 348, 350a,
350c, 355, 360, 360b, 360c, 360d, 360e, 360f, 360h, 360i,
360j, 360ccc, 360ccc–1, 360ccc–2, 374, 379, 379e, 387d,
387e, 387f, 387g, 387h, 387i, or 387t(b) of this title
concerning any method or process which as a
trade secret is entitled to protection; or the violating
of section 346a(i)(2) of this title or any
regulation issued under that section..2 This
paragraph does not authorize the withholding of
information from either House of Congress or
from, to the extent of matter within its jurisdiction,
any committee or subcommittee of such
committee or any joint committee of Congress
or any subcommittee of such joint committee.
(k) The alteration, mutilation, destruction,
obliteration, or removal of the whole or any
part of the labeling of, or the doing of any other
act with respect to, a food, drug, device, tobacco
product, or cosmetic, if such act is done while
such article is held for sale (whether or not the
first sale) after shipment in interstate commerce
and results in such article being adulterated
or misbranded.
(l) Repealed. Pub. L. 105–115, title IV, § 421,
Nov. 21, 1997, 111 Stat. 2380.
(m) The sale or offering for sale of colored oleomargarine
or colored margarine, or the possession
or serving of colored oleomargarine or colored
margarine in violation of subsections (b) or
(c) of section 347 of this title.
(n) The using, in labeling, advertising or other
sales promotion of any reference to any report
or analysis furnished in compliance with section
374 of this title.
(o) In the case of a prescription drug distributed
or offered for sale in interstate commerce,
the failure of the manufacturer, packer, or distributor
thereof to maintain for transmittal, or
to transmit, to any practitioner licensed by applicable
State law to administer such drug who
makes written request for information as to
such drug, true and correct copies of all printed
matter which is required to be included in any
package in which that drug is distributed or
sold, or such other printed matter as is approved
by the Secretary. Nothing in this paragraph
shall be construed to exempt any person from
any labeling requirement imposed by or under
other provisions of this chapter.
(p) The failure to register in accordance with
section 360 or 387e of this title, the failure to
provide any information required by section
360(j), 360(k), 387e(i), or 387e(j) of this title, or
the failure to provide a notice required by section
360(j)(2) or 387e(i)(3) of this title.
(q)(1) The failure or refusal—
(A) to comply with any requirement prescribed
under section 360h, 360j(g), 387c(b),
387g, 387h, or 387o of this title;
(B) to furnish any notification or other material
or information required by or under section
360i, 360j(g), 387d, 387i, or 387t of this title;
or
(C) to comply with a requirement under section
360l or 387m of this title.
(2) With respect to any device or tobacco product,
the submission of any report that is required
by or under this chapter that is false or
misleading in any material respect.
(r) The movement of a device or tobacco product
in violation of an order under section 334(g)
of this title or the removal or alteration of any
mark or label required by the order to identify
the device or tobacco product as detained.
(s) The failure to provide the notice required
by section 350a(c) or 350a(e) of this title, the failure
to make the reports required by section
350a(f)(1)(B) of this title, the failure to retain
the records required by section 350a(b)(4) of this
title, or the failure to meet the requirements
prescribed under section 350a(f)(3) of this title.
(t) The importation of a drug in violation of
section 381(d)(1) of this title, the sale, purchase,
or trade of a drug or drug sample or the offer to
sell, purchase, or trade a drug or drug sample in
violation of section 353(c) of this title, the sale,
purchase, or trade of a coupon, the offer to sell,
purchase, or trade such a coupon, or the counterfeiting
of such a coupon in violation of section
353(c)(2) of this title, the distribution of a
drug sample in violation of section 353(d) of this
title or the failure to otherwise comply with the
requirements of section 353(d) of this title, or
the distribution of drugs in violation of section
353(e) of this title or the failure to otherwise
comply with the requirements of section 353(e)
of this title.
(u) The failure to comply with any requirements
of the provisions of, or any regulations or
orders of the Secretary, under section
360b(a)(4)(A), 360b(a)(4)(D), or 360b(a)(5) of this
title.
(v) The introduction or delivery for introduction
into interstate commerce of a dietary supplement
that is unsafe under section 350b of this
title.
(w) The making of a knowingly false statement
in any statement, certificate of analysis,
record, or report required or requested under
section 381(d)(3) of this title; the failure to submit
a certificate of analysis as required under
such section; the failure to maintain records or
to submit records or reports as required by such
section; the release into interstate commerce of
any article or portion thereof imported into the
United States under such section or any finished
product made from such article or portion, except
for export in accordance with section 381(e)
or 382 of this title, or with section 262(h) of title
42; or the failure to so export or to destroy such
an article or portions thereof, or such a finished
product.
(x) The falsification of a declaration of conformity
submitted under section 360d(c) of this
title or the failure or refusal to provide data or
information requested by the Secretary under
paragraph (3) of such section.
(y) In the case of a drug, device, or food—
(1) the submission of a report or recommendation
by a person accredited under section
360m of this title that is false or misleading
in any material respect;
(2) the disclosure by a person accredited
under section 360m of this title of confidential
commercial information or any trade secret
without the express written consent of the
person who submitted such information or secret
to such person; or
(3) the receipt by a person accredited under
section 360m of this title of a bribe in any
form or the doing of any corrupt act by such
person associated with a responsibility delegated
to such person under this chapter.
(z) Omitted.
(aa) The importation of a prescription drug in
violation of section 384 of this title, the falsification
of any record required to be maintained
or provided to the Secretary under such
section, or any other violation of regulations
under such section.
(bb) The transfer of an article of food in violation
of an order under section 334(h) of this title,
or the removal or alteration of any mark or
label required by the order to identify the article
as detained.
(cc) The importing or offering for import into
the United States of an article of food by, with
the assistance of, or at the direction of, a person
debarred under section 335a(b)(3) of this title.
(dd) The failure to register in accordance with
section 350d of this title.
(ee) The importing or offering for import into
the United States of an article of food in violation
of the requirements under section 381(m) of
this title.
(ff) The importing or offering for import into
the United States of a drug or device with respect
to which there is a failure to comply with
a request of the Secretary to submit to the Secretary
a statement under section 381(o) of this
title.
(gg) The knowing failure to comply with paragraph
(7)(E) of section 374(g) of this title; the
knowing inclusion by a person accredited under
paragraph (2) of such section of false information
in an inspection report under paragraph
(7)(A) of such section; or the knowing failure of
such a person to include material facts in such
a report.
(hh) The failure by a shipper, carrier by motor
vehicle or rail vehicle, receiver, or any other
person engaged in the transportation of food to
comply with the sanitary transportation practices
prescribed by the Secretary under section
350e of this title.
(ii) The falsification of a report of a serious
adverse event submitted to a responsible person
(as defined under section 379aa or 379aa–1 of this
title) or the falsification of a serious adverse
event report (as defined under section 379aa or
379aa–1 of this title) submitted to the Secretary.
(jj)(1) The failure to submit the certification
required by section 282(j)(5)(B) of title 42, or
knowingly submitting a false certification under
such section.
(2) The failure to submit clinical trial information
required under subsection (j) of section
282 of title 42.
(3) The submission of clinical trial information
under subsection (j) of section 282 of title 42
that is false or misleading in any particular
under paragraph (5)(D) of such subsection (j).
(kk) The dissemination of a television advertisement
without complying with section 353b of
this title.
(ll) The introduction or delivery for introduction
into interstate commerce of any food to
which has been added a drug approved under section
355 of this title, a biological product licensed
under section 262 of title 42, or a drug or
a biological product for which substantial clinical
investigations have been instituted and for
which the existence of such investigations has
been made public, unless—
(1) such drug or such biological product was
marketed in food before any approval of the
drug under section 355 of this title, before licensure
of the biological product under such
section 262 of title 42, and before any substantial
clinical investigations involving the drug
or the biological product have been instituted;
(2) the Secretary, in the Secretary’s discretion,
has issued a regulation, after notice and
comment, approving the use of such drug or
such biological product in the food;
(3) the use of the drug or the biological product
in the food is to enhance the safety of the
food to which the drug or the biological product
is added or applied and not to have independent
biological or therapeutic effects on
humans, and the use is in conformity with—
(A) a regulation issued under section 348 of
this title prescribing conditions of safe use
in food;
(B) a regulation listing or affirming conditions
under which the use of the drug or the
biological product in food is generally recognized
as safe;
(C) the conditions of use identified in a notification
to the Secretary of a claim of exemption
from the premarket approval requirements
for food additives based on the
notifier’s determination that the use of the
drug or the biological product in food is generally
recognized as safe, provided that the
Secretary has not questioned the general
recognition of safety determination in a letter
to the notifier;
(D) a food contact substance notification
that is effective under section 348(h) of this
title; or
(E) such drug or biological product had
been marketed for smoking cessation prior
to September 27, 2007; or
(4) the drug is a new animal drug whose use
is not unsafe under section 360b of this title.
(mm) The failure to submit a report or provide
a notification required under section 350f(d) of
this title.
(nn) The falsification of a report or notification
required under section 350f(d) of this title.
(oo) The sale of tobacco products in violation
of a no-tobacco-sale order issued under section
333(f) of this title.
(pp) The introduction or delivery for introduction
into interstate commerce of a tobacco product
in violation of section 387k of this title.
(qq)(1) Forging, counterfeiting, simulating, or
falsely representing, or without proper authority
using any mark, stamp (including tax
stamp), tag, label, or other identification device
upon any tobacco product or container or labeling
thereof so as to render such tobacco product
a counterfeit tobacco product.
(2) Making, selling, disposing of, or keeping in
possession, control, or custody, or concealing
any punch, die, plate, stone, or other item that
is designed to print, imprint, or reproduce the
trademark, trade name, or other identifying
mark, imprint, or device of another or any likeness
of any of the foregoing upon any tobacco
product or container or labeling thereof so as to
render such tobacco product a counterfeit tobacco
product.
(3) The doing of any act that causes a tobacco
product to be a counterfeit tobacco product, or
the sale or dispensing, or the holding for sale or
dispensing, of a counterfeit tobacco product.
(rr) The charitable distribution of tobacco
products.
(ss) The failure of a manufacturer or distributor
to notify the Attorney General and the Secretary
of the Treasury of their knowledge of tobacco
products used in illicit trade.
(tt) Making any express or implied statement
or representation directed to consumers with respect
to a tobacco product, in a label or labeling
or through the media or advertising, that either
conveys, or misleads or would mislead consumers
into believing, that—
(1) the product is approved by the Food and
Drug Administration;
(2) the Food and Drug Administration deems
the product to be safe for use by consumers;
(3) the product is endorsed by the Food and
Drug Administration for use by consumers; or
(4) the product is safe or less harmful by virtue
of—
(A) its regulation or inspection by the
Food and Drug Administration; or
(B) its compliance with regulatory requirements
set by the Food and Drug Administration;
including any such statement or representation
rendering the product misbranded under section
387c of this title.
(uu) The operation of a facility that manufactures,
processes, packs, or holds food for sale in
the United States if the owner, operator, or
agent in charge of such facility is not in compliance
with section 350g of this title.
(vv) The failure to comply with the requirements
under section 350h of this title.
(ww) The failure to comply with section 350i of
this title.
(xx) The refusal or failure to follow an order
under section 350l of this title.
(yy) The knowing and willful failure to comply
with the notification requirement under section
350f(h) of this title.
(zz) The importation or offering for importation
of a food if the importer (as defined in section
384a of this title) does not have in place a
foreign supplier verification program in compliance
with such section 384a of this title.

Outcome: Defendants pleaded guilty. The face up to 6 years in prison and fines totally $1.5 million.

Plaintiff's Experts:

Defendant's Experts:

Comments:



 
 
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