Kiranas LLC d/b/a Jake’s 3 / Exxon, DAB TB7636 (2024)

INITIAL DECISION AND DEFAULT JUDGMENT

Found:

1) Respondent violated 21 U.S.C. § 331, specifically section 906(d)(5) of the Federal Food, Drug, and Cosmetic Act (Act) (21 U.S.C. § 387f(d)(5)), and 21 C.F.R. § 1140.14(a)(2)(i) as modified by the Act, as charged in the Complaint;
2) Respondent violated 21 U.S.C. § 331, specifically section 906(d)(5) of the Act, and 21 C.F.R. § 1140.14(a)(2)(i) as modified by the Act, as charged in the prior Complaint;
3) Respondent committed at least five violations in a 36-month period as set forth hereinabove; and
4) Respondent is hereby assessed a civil penalty in the amount of $6,397.

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Glossary:

I. JURISDICTION

I have jurisdiction to hear this case pursuant to my appointment by the Secretary of Health and Human Services and my authority under the Administrative Procedure Act (5 U.S.C. §§ 554-556), 5 U.S.C.A. § 3106, 21 U.S.C. § 333(f)(5), 5 C.F.R. §§ 930.201 et seq. and 21 C.F.R. Part 17.²

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II. PROCEDURAL BACKGROUND

The Center for Tobacco Products (CTP or Complainant) filed a Complaint on August 8, 2023, against Kiranas LLC d/b/a Jake’s 3 / Exxon (Jake’s 3 / Exxon or Respondent), located at 1703 East Hubbard Street, Mineral Wells, Texas 76067, alleging that FDA documented at least five violations within a 36-month period.

Respondent Jake’s 3 / Exxon was served with process on August 7, 2023, by United Parcel Service (UPS).  Docket (Dkt.) Entry Nos. 1b, 2.  Respondent timely filed its Answer on September 5, 2023.  Dkt. Entry Nos. 4, 4a.  On September 8, 2023, I issued a Pre-Hearing Order (PHO) setting a schedule for the parties’ exchanges of evidence and the procedures in preparation for a hearing.  Dkt. Entry No. 5.

On October 27, 2023, CTP filed a Motion to Compel Discovery with two exhibits consisting of its Request for Production of Documents (RFP) and the UPS Delivery Notification (DN).  Dkt. Entry Nos. 7, 7a-7b.  CTP’s RFP was delivered to Respondent on September 22, 2023, Dkt. Entry No. 7b, and Respondent had 30 days after receiving the CTP’s request to produce any responsive documents.  PHO ¶ 3 (citing 21 C.F.R. § 17.23(a)).  CTP stated it has not received a response to its RFP.  Dkt. Entry No. 7 at 1.  To date, Respondent has not filed a response to CTP’s Motion to Compel Discovery.

Because Respondent failed to comply with procedural rules and directives established in my Pre-Hearing Order, and pursuant to the regulations at 21 C.F.R. part 17, I construed CTP’s Motion to Compel Discovery as a request for an order to show cause.  On November 3, 2023, I issued an Order to Compel Discovery and Order to Show Cause

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to Respondent (OSCR).  In the OSCR, Respondent was directed to comply with CTP’s RFP by November 14, 2023.  I warned Respondent:

Failure to comply will result in sanctions, which may include issuance of an Initial Decision and Default Judgment finding Respondent liable for the violations listed in the Complaint and imposing a civil money penalty.

November 3rd OSCR at 2 (citing 21 C.F.R. § 17.35, emphasis added).

Further, I ordered Respondent to show cause by November 14, 2023, why default judgment should not be entered against it for failing to comply with the procedural rules.  I also extended the parties’ prehearing exchange deadline if Respondent was able to show cause.  Id.  Respondent did not show cause or otherwise respond to my November 3rd OSCR.

On November 17, 2023, CTP filed a Status Report and Motion to Impose Sanctions stating, “Respondent has not produced documents to CTP in response to its RFP,” and “Respondent failed to respond to the ALJ’s November 3, 2023, Order requiring it to comply with CTP’s Request for Production of Documents.”  Dkt. Entry No. 9 at 1-2.  CTP asserted that sanctions against Respondent are appropriate, and a reasonable sanction for Respondent’s non-compliance is to strike Respondent’s Answer.  Id. at 2.

On November 30, 2023, I issued another Order to Show Cause to Respondent (OSC).  In my OSC, I noted Respondent Jake’s 3 / Exxon’s failure to comply with the procedural rules in 21 C.F.R. Part 17, that CTP’s Motion to Impose Sanctions was construed as a request for an order to show cause, and so I directed Jake’s 3 / Exxon to either comply with CTP’s RFP or to show cause why default judgment should not be

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entered against it for failing to comply with the procedural rules by December 18, 2023.  I again warned Respondent:

Failure to comply will result in sanctions, which may include issuance of an Initial Decision and Default Judgment finding Respondent liable for the violations listed in the Complaint and imposing a civil money penalty.

November 30th OSC at 1 (citing 21 C.F.R. § 17.35, emphasis added).  I extended again the parties’ prehearing exchange deadline if Respondent was able to show cause.  Id. at 2.

On December 1, 2023, Respondent filed a one-page document captioned “Request to Dismiss Default Judgment.”  Dkt. Entry No. 11.  Respondent’s submission does not address its failure to produce documents responsive to CTP’s RFP, that is, documents to support, refute, or mitigate CTP’s allegations.  Also, Respondent’s submission neither addresses its failure to comply with my November 30th OSC nor shows cause as to why default judgment should not be entered against it for failure to comply with the procedural rules.  See id.  While Respondent’s December 1st request does not provide a response to CTP’s RFP, or to my respective Orders to Show Cause, I infer Respondent may be attempting to seek dismissal of the case presently before me.  Therefore, as Respondent’s filing might be construed as a “motion to dismiss,” I will consider it briefly herein.

III. PRELIMINARY MATTER

As discussed above, Respondent filed a December 1st request which might be construed as a motion to dismiss.  Dkt. Entry No. 11.  In its one-page motion, Respondent denied the allegations “regarding the illegal sale of Tobacco products to a minor as the

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citation issued [wa]s lacking ample evidence of the sale . . . .”  Id.  Respondent also “request[ed] further evidence (Sales Receipt) of the alleged sale on 8:56 AM May 13, 2023.”  Id.

In addressing a motion to dismiss, I must first consider whether I have regulatory authority to dismiss a complaint on the basis alleged.³  The regulations at 21 C.F.R. § 17.19 identify the general authority of the presiding officer.  A review of that section does not provide any authority to dismiss a complaint under any circumstances.  Section 17.19(b)(17) does, however, allow the presiding officer to waive, suspend, or modify any rule in the governing regulations if the presiding officer determines that no party would be prejudiced.  Changing a procedural rule and granting a dismissal of the complaint would certainly result in prejudice to CTP.

The only provision specifically authorizing the ALJ to issue a dismissal is contained in 21 C.F.R. § 17.35(e), which provides that the presiding officer may dismiss the action if a party fails to prosecute or defend an action after service of a notice of hearing.  No notice of hearing has been served yet, so the conditions have not been met in this case.  These provisions do not provide me with the authority to grant Respondent’s request.  Accordingly, as I do not have regulatory authority to dismiss the complaint on the basis alleged by Respondent, the motion to dismiss is DENIED.

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IV. STRIKING RESPONDENT’S ANSWER

I may sanction a person, including any party or counsel for:

(1) Failing to comply with an order, subpoena, rule, or procedure governing the proceeding;
(2) Failing to prosecute or defend an action; or
(3) Engaging in other misconduct that interferes with the speedy, orderly, or fair conduct of the hearing.

21 C.F.R. § 17.35(a).  The harshness of the sanctions I impose must relate to the nature and severity of the misconduct or failure to comply.  21 C.F.R. § 17.35(b).

Here, Respondent failed to comply with multiple judicial orders and directives.  Specifically, Respondent has not complied with:

• the regulation at 21 C.F.R. § 17.23(a) and paragraph 3 of the September 8th PHO by failing to respond to CTP’s Request for Production of Documents within 30 days;
• my November 3rd OSCR by failing to submit documents responsive to CTP’s Request for Production of Documents by November 14, 2023; and
• my November 30th OSC by failing to submit documents responsive to CTP’s Request for Production of Documents by December 18, 2023.

Additionally, Respondent failed to defend this action.  21 C.F.R. § 17.35(a)(2).  Specifically:

• Respondent did not file a response to CTP’s Motion to Compel Discovery, as permitted by the regulations, or file a response to my November 3rd OSCR giving Respondent until November 14, 2023, to show cause why default judgment should not be entered against it; and
• Respondent did not file a response to CTP’s Motion to Impose Sanctions, as permitted by the regulations, or file a response to my November 30th OSC giving Respondent until December 18, 2023, to show cause why default judgment should not be entered against it.

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Even though Respondent did file a response immediately after issuance of my November 30th OSC, I found the December 1st request insufficient to demonstrate or show cause as to its failure to comply with CTP’s RFP.  I even considered whether the December 1st request was intended to serve as a motion to dismiss this case as opposed to a responsive filing to my PHO or multiple orders and directives.  See Section III.

In the absence of any explanation from Respondent, I find Respondent failed to comply with orders and procedures governing these proceedings, failed to defend this action, and as a result, has interfered with the speedy, orderly, or fair conduct of this proceeding.  I also find and conclude that sanctions are appropriate in this proceeding and that striking Respondent’s September 5th Answer is an appropriate sanction.  21 C.F.R. §§ 17.35(b), (c)(3).  Striking Respondent’s Answer leaves CTP’s Complaint unanswered.  Therefore, I am required to issue an initial decision by default, provided the Complaint is sufficient to justify a penalty.  See 21 C.F.R. § 17.11(a).  Accordingly, I must determine whether the allegations in the Complaint establish violations of the Act.

V. BURDEN OF PROOF

CTP as the petitioning party has the burden of proof.  21 C.F.R. § 17.33.

VI. LAW

21 U.S.C. § 331, specifically section 906(d)(5) of the Act, and 21 C.F.R. § 1140.14(a)(2)(i) as modified by the Act.⁴

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VII. ISSUE

Did Respondent violate 21 U.S.C. § 331, specifically section 906(d)(5) of the Act, and 21 C.F.R. § 1140.14(a)(2)(i) as modified by the Act, as alleged in the Complaint?

VIII. DEFAULT

I find Respondent was served and is subject to the jurisdiction of this forum, as established by the Notice of Filing filed by CTP on August 9, 2023.

It is Respondent’s right to participate in the legal process.

It is Respondent’s right to request a hearing or to waive a hearing.

I find Respondent waived its right to a hearing pursuant to 21 C.F.R. § 17.11(b).

IX. ALLEGATIONS

A. Agency’s recitation of facts

CTP alleged that Respondent owns an establishment, doing business under the name Jake’s 3 / Exxon, located at 1703 East Hubbard Street, Mineral Wells, Texas

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76067.  Respondent’s establishment receives tobacco products in interstate commerce and holds them for sale after shipment in interstate commerce.

CTP’s Complaint alleged that during an inspection of Jake’s 3 / Exxon conducted on May 13, 2023, an FDA-commissioned inspector documented the following violations:

1. Selling regulated tobacco products to a person under 21 years of age, in violation of section 906(d)(5) of the Act.  Specifically, a person younger than 21 years of age was able to purchase a package of Camel Crush cigarettes on May 13, 2023, at approximately 8:56 AM; and
2. Failing to verify the age of a person purchasing covered tobacco products by means of photographic identification containing the bearer’s date of birth, as required by 21 C.F.R. § 1140.14(a)(2)(i).  Specifically, the underage purchaser’s age was not verified before the sale, as detailed above, on May 13, 2023, at approximately 8:56 AM.

B. Respondent’s recitation of facts

As the result of being sanctioned for failing to comply with my orders and the procedures governing this proceeding, Respondent’s Answer was stricken from the record.  Since Respondent filed no responsive pleadings that I may consider, I must assume those allegations set forth in the Complaint to be true.  21 C.F.R. § 17.11(a).

X. PRIOR VIOLATIONS

On February 24, 2023, CTP initiated a previous CMP action, CRD Docket Number T-23-1159, FDA Docket Number FDA-2023-H-0595, against Respondent for at

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least three ⁵ violations within the 36‑month period relevant to the current Complaint.  CTP alleged those violations to have occurred at Respondent’s business establishment on February 19, 2022, and November 19, 2022.

The previous action concluded when Respondent admitted the allegations contained in the Complaint issued by CTP and agreed to pay a monetary penalty in settlement of that claim.  Further, “Respondent expressly waived its right to contest such violations in subsequent actions.”

I find and conclude Respondent committed five violations of 21 U.S.C. § 331, specifically section 906(d)(5) of the Act, and 21 C.F.R. § 1140.14(a)(2)(i) as modified by the Act, within a 36-month period as set forth in the Complaint.

XI. FAMILY SMOKING PREVENTION AND TOBACCO CONTROL ACT

The “relevant statute” in this case is actually a combination of statutes and regulations:  The Family Smoking Prevention and Tobacco Control Act, Pub. L. No. 111‑31, 123 Stat. 1776 (2009) (TCA), amended the Food, Drug, and Cosmetic Act (21 U.S.C.A. Chap. 9) (FDCA) and created a new subchapter that dealt exclusively with tobacco products, (21 U.S.C. §§ 387-387u), and it also modified other parts of the FDCA explicitly to include tobacco products among the regulated products whose misbranding can give rise to civil, and in some cases criminal, liability.  The 2009 amendments to the FDCA contained within the TCA also charged the Secretary of Health and Human

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Services with, among other things, creating regulations to govern tobacco sales.  The Secretary’s regulations on tobacco products appear in Part 1140 of Title 21, Code of Federal Regulations.

Under the FDCA, “[a] tobacco product shall be deemed to be misbranded if, in the case of any tobacco product sold or offered for sale in any State, it is sold or distributed in violation of regulations prescribed under section 387f(d).”  21 U.S.C. § 387c(a)(7)(B) (2012).  Section 387a‑1 directed FDA to re-issue, with some modifications, regulations previously passed in 1996.  21 U.S.C. § 387 a-1(a) (2012).  These regulations were passed pursuant to section 387f(d), which authorizes FDA to promulgate regulations on the sale and distribution of tobacco products; 75 Fed. Reg. 13,225 (Mar. 19, 2010), codified at 21 C.F.R. Part 1140 (2015); 21 U.S.C. § 387f(d)(1) (2012).  Accordingly, 21 C.F.R. § 1140.1(b) provides “failure to comply with any applicable provision in this part in the sale, distribution, and use of cigarettes and smokeless tobacco renders the product misbranded under the act.”

Under 21 U.S.C. § 331(k), “[t]he 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” is a prohibited act under 21 U.S.C. § 331.  Thus, when a retailer such as Respondent misbrands a tobacco product by violating a requirement of 21 C.F.R. Part 1140, that misbranding in turn violates the FDCA, specifically 21 U.S.C. § 331(k).  FDA may seek a civil money

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penalty from “any person who violates a requirement of this chapter which relates to tobacco products.”  21 U.S.C. § 333(f)(9)(A) (2012).  Penalties are set by 21 U.S.C. § 333 note and 21 C.F.R. § 17.2.  Under current FDA policy, the first time FDA finds violations of 21 C.F.R. Part 1140 at an establishment FDA only counts one violation regardless of the number of specific regulatory requirements violated, but if FDA finds violations on subsequent occasions, it will count violations of specific regulatory requirements individually in computing any civil money penalty sought.  This policy is set forth in detail, with examples to illustrate, at U.S. Food & Drug Admin., Guidance for Industry and FDA Staff, Civil Money Penalties and No-Tobacco-Sale Orders for Tobacco Retailers, Responses to Frequently Asked Questions , (Revised) (2016), available at http://www.fda.gov/downloads/TobaccoProducts/Labeling/RulesRegulationsGuidance/UCM447310.pdf, at 13-14.  So, for instance, if a retailer sells a tobacco product on a particular occasion to an underage purchaser without checking for photographic identification, in violation of section 906(d)(5) of the Act, and subpart B of part 1140 of title 21, Code of Federal Regulations, this will count as two separate violations for purposes of computing the civil money penalty, unless it is the first time violations were observed at that particular establishment.  This policy of counting violations has been determined by the HHS Departmental Appeals Board to be consistent with the language of the FDCA and its implementing regulations.  See Orton Motor Co. d/b/a Orton’s Bagley v. HHS,884 F.3d 1205 (D.C. Cir. 2018).

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XII. LIABILITY

When a retailer such as Respondent is found to have “misbranded” a tobacco product in interstate commerce, it can be liable to pay a CMP.  21 U.S.C. §§ 331, 333.  A retailer facing such a penalty has the right, set out in statute, to a hearing under the Administrative Procedure Act.  21 U.S.C. § 333(f)(5)(A).  A retailer can forfeit its rights under the statute and regulations by failing to participate in the process, a failure known as a “default.”  21 C.F.R. § 17.11.

As set forth above, it is Respondent’s right to decide whether to participate in the legal process.  It is Respondent’s right to decide to request a hearing and it is Respondent’s right to waive a hearing.

I find Respondent, by failing to respond, waived its right to a hearing.

XIII. IMPACT OF RESPONDENT’S DEFAULT

When a Respondent defaults by failing to answer the complaint, or respond to a OSC, an ALJ must assume as true all factual allegations in the complaint and issue an initial decision within thirty (30) days of the answer’s due date, imposing “the maximum amount of penalties provided for by law for the violations alleged” or “the amount asked for in the complaint, whichever is smaller” if “liability under the relevant statute” is established.  21 C.F.R. § 17.11(a)(1) and (2).  But see 21 C.F.R. § 17.45 (initial decision must state the “appropriate penalty” and consider aggravating and mitigating circumstances).

Two aspects of Rule 17.11 are important in default cases.

First, the Complainant benefits from a regulatory presumption (the ALJ shall

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assume that the facts alleged in the complaint are true) which relieves it from having to put on evidence.

The presumption affords a party, for whose benefit the presumption runs, the luxury of not having to produce specific evidence to establish the point at issue.  When the predicate evidence is established that triggers the presumption, the further evidentiary gap is filled by the presumption.  See 1 Weinstein’s Federal Evidence § 301.02[1], at 301‑7 (2d ed.1997); 2 McCormick on Evidence § 342, at 450 (John W. Strong ed., 4th ed. 1992); Routen v. West, 142 F.3d 1434, 1440 (Fed. Cir. 1998).⁶

Second, as far as the penalty is concerned, my discretion is limited by the language of the regulation.  I may not tailor the penalty to address any extenuation or mitigation, for example, nor, because of notice concerns, may I increase the penalty beyond the smaller of (a) the Complainant’s request or (b) the maximum penalty authorized by law.

XIV. LIABILITY UNDER THE RELEVANT STATUTE

Taking the CTP’s allegations as set forth in the Complaint as true, the next step is whether the allegations make out “liability under the relevant statute.”  21 C.F.R.

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§ 17.11(a).

Based on Respondent’s failure to answer I assume all the allegations in the Complaint to be true.

I find and conclude that the evidentiary facts, by a preponderance of the evidence standard, support a finding that Respondent violated 21 U.S.C. § 331, specifically section 906(d)(5) of the Act, in that a person younger than 21 years of age was able to purchase regulated tobacco products on February 19, 2022, November 19, 2022, and May 13, 2023.

I find and conclude that the evidentiary facts, by a preponderance of the evidence standard, support a finding that Respondent violated 21 U.S.C. § 331, specifically 21 C.F.R. § 1140.14(a)(2)(i) as modified by section 906(d)(5) of the Act, on those same dates in that Respondent also violated the requirement that retailers verify, by means of photo identification containing a purchaser’s date of birth, that no regulated tobacco product purchasers are younger than 21 years of age.

The conduct set forth above on February 19, 2022, November 19, 2022, and May 13, 2023, counts as five violations for purposes of computing the civil money penalty.

XV. PENALTY

There being liability under the relevant statute, I must now determine the amount of penalty to impose.  My discretion regarding a penalty is constrained by regulation.  I must impose either the maximum amount permitted by law, or the amount requested by the Center, whichever is lower.  21 C.F.R. § 17.11(a)(1), (a)(2).

In terms of specific punishments available, the legislation that provides the basis

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for assessing civil monetary penalties divides retailers into two categories:  those that have “an approved training program” and those that do not.  Retailers with an approved program face no more than a warning letter for their first violation; retailers without such a program begin paying monetary penalties with their first.  TCA § 103(q)(2), 123 Stat. 1839, codified at 21 U.S.C. § 333 note.  See 21 C.F.R. § 17.2.  The FDA has informed the regulated public that “at this time, and until FDA issues regulations setting the standards for an approved training program, all applicable CMPs will proceed under the reduced penalty schedule.”  FDA Regulatory Enforcement Manual, Aug. 2015, ¶ 5‑8‑1.  Because of this reasonable exercise of discretion, the starting point for punishments and the rate at which they mount are clear – the lower and slower schedules.

XVI. MITIGATION

It is incumbent upon Respondent to present any factors that could result in mitigation of CTP’s proposed penalty.  Specifically, it is Respondent’s burden to provide mitigating evidence.  In a default, Respondent has failed to participate and has failed to present any evidence regarding potential mitigation.  Accordingly, I have no reason to mitigate the penalty.

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XVII. CONCLUSION

Respondent committed at least five violations in a 36‑month period and so, Respondent is liable for a civil money penalty of $6,397.  See 21 C.F.R. § 17.2.

WHEREFORE, evidence having read and considered it be and is hereby ORDERED as follows:

1. I find Respondent has been served with process herein and is subject to this forum.
2. I DENY Respondent’s Request to Dismiss Default Judgment (motion to dismiss) as I have no authority to dismiss this action on the basis asserted by Respondent.
3. I find Respondent failed to comply with my PHO, my November 3rd and November 30th Orders to Show Cause.
4. I find Respondent’s misconduct warrants striking its answer as a sanction.  21 C.F.R. § 17.35(c).
5. I find striking Respondent’s answer leaves the Complaint unanswered.  21 C.F.R. § 17.11.
6. I find Respondent is in default.
7. I assume the facts alleged in the Complaint to be true.  21 C.F.R. § 17.11.
8. I find the facts set forth in the Complaint establish liability under the relevant statute.
9. I assess a monetary penalty in the amount of $6,397.

Endnotes

¹ See 5 C.F.R. § 930.204.

² See also Butz v. Economou, 438 U.S. 478, 513 (1978); Marshall v. Jerrico, Inc., 446 U.S. 238 (1980); Federal Maritime Com’n v. South Carolina State Ports Authority, 535 U.S. 743, 744 (2002).

³ I note under 21 C.F.R. § 17.32(a) motions must state the relief sought as well as the authority relied upon in making the motion.  Respondent has not cited to any such authority in its request to dismiss.  I would also note that although CTP has not filed a response to Respondent’s request to dismiss, the regulations at 21 C.F.R. § 17.32(d) provide, in part, that a presiding officer “may overrule or deny such motion without awaiting [CTP’s] response.”

⁴ On December 20, 2019, the Act was amended by the Further Consolidated Appropriations Act, 2020, Pub. L. No. 116–94, § 603(a)-(b), to raise the federal minimum age for sale of tobacco products to 21, and directed the Secretary of the U.S. Department of Health and Human Services to “update all references to persons younger than 18 years of age in subpart B of part 1140 of title 21, Code of Federal Regulations, and to update the relevant age verification requirements under such part 1140 to require age verification for individuals under the age of 30.”  21 U.S.C. § 387f (note).  Prior to December 20, 2019, the sale of regulated tobacco products was only prohibited to any person younger than 18 years of age, 21 C.F.R. § 1140.14(a)(1), (b)(1), and retailers were only required to verify, by means of photographic identification containing a purchaser’s date of birth, that no regulated tobacco product purchasers were younger than 18 years of age, 21 C.F.R. § 1140.14(a)(2)(i), (b)(2)(i).

⁵ Two violations were documented on February 19, 2022, and two on November 19, 2022.  In accordance with customary practice, CTP counted the violations at the initial inspection as a single violation, and all subsequent violations as separate individual violations.

⁶ However, when the opposing party puts in proof to the contrary of that provided by the presumption, and that proof meets the requisite level, the presumption disappears.  See Texas Dept. of Community Affairs v. Burdine, 450 U.S. 248, 254–55, 101 S.Ct. 1089, 1094–95, 67 L.Ed.2d 207 (1981); A.C. Aukerman, 960 F.2d at 1037 (“[A] presumption ... completely vanishes upon the introduction of evidence sufficient to support a finding of the nonexistence of the presumed fact.”); see also Weinstein’s Federal Evidence § 301App.100, at 301App.–13 (explaining that in the “bursting bubble” theory once the presumption is overcome, then it disappears from the case); 9 Wigmore on Evidence § 2487, at 295–96 (Chadbourn rev.1981).  See generally Charles V. Laughlin, In Support of the Thayer Theory of Presumptions, 52 Mich. L.Rev. 195 (1953); Routen v. West, 142 F.3d 1434, 1440 (Fed. Cir. 1998).