Medical Device False Branding Whistleblower Lawyer Handles Medical Device Misbranding Whistleblower Lawsuits, Medical Device False Label Whistleblower Lawsuits, Medical Device False Marketing Lawsuits, Defective Medical Device Kickback Lawsuits, and Medical Device Marketing Fraud Lawsuits by Medical Device False Marketing Lawyer, Medical Device Misbranding Lawyer, & Medical Device False Branding Whistleblower Lawyer Jason S. Coomer  

Medical doctors, physicians, neurologists, health care administrators, medical device sales representatives, pharmacists, medical device executives, nurses, and other medical professionals are needed to blow the whistle on medical device misbranding fraud and drug misbranding fraud.  If you are aware of medical device false branding, fraudulent marketing practices, illegal kickbacks, drug misbranding, or medical device misbranding, please feel free to contact Medical Device False Branding, Medical Device Marketing Fraud, and Misbranding Whistleblower Lawyer Jason Coomer via e-mail message or use our submission form about a potential medical device marketing fraud whistleblower lawsuit, medical device misbranding fraud lawsuit, medical device false branding kickback fraud lawsuit, drug misbranding fraud lawsuit, or other marketing fraud whistleblower qui tam lawsuit. 

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The Department of Justice is going after large medical device manufacturing firms and pharmaceutical firms for fraudulently misbranding products including knowingly misrepresenting product information in labeling and marketing materials, even if FDA is not actively investigating the matter.  In the Quest case, Quest agreed to pay $300 million to settle false labeling and marketing materials.

Quest Diagnostics to Pay U.S. $302 Million to Resolve Allegations That a Subsidiary Sold Misbranded Test Kits
  Quest Subsidiary, Nichols Institute Diagnostics, Pleads Guilty to Felony Misbranding

WASHINGTON – Quest Diagnostics Incorporated and its subsidiary, Nichols Institute Diagnostics (NID), have entered into a global settlement with the United States to resolve criminal and civil claims concerning various types of diagnostic test kits that NID manufactured, marketed and sold to laboratories throughout the country until 2006, the Justice Department announced today. The payment of $302 million will resolve these allegations and represents one of the largest recoveries ever in a case involving a medical device.

As part of the criminal resolution, NID pleaded guilty today before U.S. District Judge Sterling Johnson Jr. in Brooklyn to a felony misbranding charge in violation of the Food, Drug and Cosmetic Act relating to NID’s Nichols Advantage Chemiluminescence Intact Parathyroid Hormone Immunoassay, a test that was used by laboratories throughout the country to measure parathyroid hormone (PTH) levels in patients. As part of the plea, NID will pay a criminal fine of $40 million. Quest has also entered into a non-prosecution agreement with the United States.

As part of the civil settlement, Quest and NID will pay the United States $262 million plus interest to resolve False Claims Act allegations relating to the Advantage Intact PTH assay and four other assays manufactured by NID that allegedly provided inaccurate and unreliable results. Quest has agreed to pay various state Medicaid programs approximately $6.2 million to resolve similar civil claims. The company has also entered into a Corporate Integrity Agreement with the Office of Inspector General of the U.S. Department of Health and Human Services.

The United States commenced its civil and criminal investigation after the filing of a qui tam or whistleblower suit brought by Thomas Cantor. As a result of today’s settlement, Mr. Cantor will share in the proceeds of the False Claims Act recovery and will receive approximately $45 million.

The criminal resolution focuses solely on the Advantage Intact PTH Assay. As alleged in the information, there were periods of time in which the Advantage Intact PTH Assay provided elevated results. The marketing materials that NID distributed regarding the Advantage Intact PTH Assay described that product as having "excellent correlation" to the IRMA Assay. Additionally, the directional insert for the Intact PTH Assay, in a section entitled "Accuracy," described a study in which the IRMA Assay and the Advantage Intact PTH Assay produced nearly identical results when used to test PTH levels in samples of human blood. Contrary to the claims in NID’s directional inserts and marketing materials, however, in about May 2000, and at various times thereafter, NID was aware that the Advantage Intact PTH Assay was not consistently providing results that were equivalent to those of the IRMA Assay.

Additionally, during some of the periods of time after May 2000, NID was also aware that the Advantage Intact PTH Assay provided elevated PTH results. Nonetheless, NID continued to indicate, in its directional inserts and marketing materials, that the Advantage Intact PTH Assay and the IRMA Assay provided nearly identical results. As part of the guilty plea, NID admitted that in or about May 2000 and at various times thereafter, the company knowingly, intentionally and with intent to mislead, introduced into interstate commerce, and caused the introduction into interstate commerce of the Advantage Intact PTH Assay, that was misbranded.

The civil settlement resolves allegations that NID manufactured, marketed and sold the Intact PTH and Bio-Intact PTH test kits, despite knowing that between May 1, 2000, and April 30, 2006, some of these kits produced results that were materially inaccurate and unreliable, thereby causing: (a) some clinical laboratories that purchased and used the Intact PTH and Bio-Intact PTH test kits to submit false claims for reimbursement to federal health programs; and (b) some medical providers to submit false claims for reimbursement to federal health programs for unnecessary treatments.

The civil settlement also resolves allegations that NID manufactured, marketed and sold test kits, some of which produced results that were materially inaccurate and unreliable, thereby causing some clinical laboratories that purchased and used these test kits to submit false claims for reimbursement to federal health programs.

"This settlement provides further evidence that the Department will vigorously prosecute cases involving violations of the Food, Drug, and Cosmetic Act, and will pursue recovery of taxpayer dollars resulting from fraudulent marketing campaigns by medical device manufacturers," said Michael F. Hertz, Acting Assistant Attorney General for the Civil Division. "Pursuing this case was particularly important in light of the potential for adverse health consequences to beneficiaries of federal healthcare programs."

"The American public has the right to expect medical device manufacturers to make accurate claims in their labeling, especially when the failure to meet those claims could indicate that the performance of the device is suspect," stated U.S. Attorney Benton J. Campbell. "In order to safeguard public health, and when appropriate, to recover taxpayer dollars, the government will vigorously investigate allegations that a manufacturer knowingly sold medical devices, such as test kits, that were materially unreliable or provided significantly inaccurate results."

Besides the Justice Department’s Civil Division and the U.S. Attorney’s Office for the Eastern District of New York, the Department of Health and Human Services Office of Inspector General; FBI: U.S. Postal Inspection Service; and the Food and Drug Administration, Office of Criminal Investigations assisted in the matter.

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Department of Justice and Misbranding Whistleblowers Allege Johnson & Johnson's Scios Unit Misbranded  their Heart Drug, Natrecor

Johnson & Johnson’s Scios unit was charged by United States prosecutors with misbranding the heart drug, Natrecor.  The allegations state that the heart drug's labeling lacked adequate directions for use and was fraudulently misbranded. According to the charges filed on July 7 in federal court in San Francisco, Johnson & Johnson's Scios Inc. distributed misbranded Natrecor from Kansas throughout the U.S. from August 2001 to June 2005.   The charge carries a maximum fine of $200,000 or twice the gain or loss resulting from the illegal conduct and unspecified restitution, according to the charging document.  The Department of Justice joined two whistleblower lawsuits accusing Scios of marketing Natrecor for unauthorized uses. The Department of Justice alleged that the misbranding and marketing fraud cost the government-run health insurance program Medicare substantial amounts of money.   Johnson & Johnson and Scios denied engaging in off-label marketing of the drug or intentional misbranding.

Pharmaceutical Quality Assurance Whistleblower Lawsuits, Drug Safety Whistleblower Lawsuits, Adulterated Drug Whistleblower Lawsuit, Contaminated Drug Whistleblower Lawsuits, and Pharmaceutical Drug Calibration Whistleblower  Qui Tam Lawsuits (Drug Quality, Contaminated Drug, Adulterated Drug, and Pharmaceutical Quality Assurance Whistleblower False Claims Act Lawyer)

Pharmaceutical Quality Assurance Managers, Drug Calibration Specialists, and other Drug Safety Whistleblowers are stepping forward to blow the whistle on adulterated drugs, contaminated drugs, and poorly calibrated drugs that threaten the health and lives of children, women, and men that are taking the drugs.  Because of the danger of giving defective drugs to the sick and injured, it is extremely important that pharmaceutical whistleblowers continue to step forward to blow the whistle on drugs that threaten the health and safety of the people taking these drugs.  It is clear that the government will not tolerate any lapses in safety standards for pharmaceutical manufacturers.  Further, it is clear that pharmaceutical whistleblowers that blow the whistle on defective and dangerous drugs, may receive a large amount of money for properly reporting fraudulent disregard for safety standards.   

If you are a pharmaceutical quality assurance manager, drug calibration specialist, or other pharmaceutical safety or quality control specialist that is aware of adulterated drug fraud, misbranding of drugs, illegal drug kickbacks, or other pharmaceutical manufacturing fraud or marketing fraud, please feel free to send an e-mail message to or go to the following Drug Quality Fraud Lawsuit, Contaminated Drug Lawsuit, Adulterated Drug Lawsuit, and Pharmaceutical Quality Assurance Whistleblower False Claims Act Lawsuit Information Page.

Medical Device Misbranding Whistleblower Lawyer, Medical Device False Branding Whistleblower Lawyer, Medical Device Marketing Fraud Whistleblower Lawyer, Misbranding Drug Whistleblower Lawyer, Medical Device Kickback Lawyer, and Medical Device Marketing Fraud Lawyer

Cases against individuals or firms involved in the manufacture or distribution of medical devices are usually rooted in allegations that the devices are "adulterated" or "misbranded" under the Federal Food, Drug, and Cosmetic Act (the "FDCA"). A device may be adulterated or misbranded for a number of reasons. A device may be adulterated, for example, if it was not manufactured in accordance with the required manufacturing standards ("good manufacturing practice"), FDCA § 501(h), 21 U.S.C. § 351(h); FDCA § 520(f), 21 U.S.C. § 360j(f); 21 C.F.R. part 820, or if it does not have the quality that it purports to possess, FDCA § 501(c), 21 U.S.C. § 351(c). Examples of causes of misbranding of a device include that its labeling is false or misleading, FDCA § 502(a), 21 U.S.C. § 352(a), or that it is an over-the-counter (i.e., non-prescription) device that does not bear adequate directions for the consumer to be able to use it, FDCA § 502(f), 21 U.S.C. § 352(f); 21 C.F.R. § 801.109. A device may also be adulterated or misbranded because it lacks requisite FDA clearance or approval. See FDCA §§ 501(f), 502(o), 21 U.S.C. §§ 351(f), 352(o).

The FDCA prohibits the doing of a number of acts with respect to a medical device that is adulterated or misbranded, such as introducing it into interstate commerce, see FDCA § 301(a), 21 U.S.C. § 331(a), or holding the device for sale after shipment of the device itself or a component of the device in interstate commerce, see FDCA § 301(k), 21 U.S.C. § 331(k); see also FDCA § 303, 21 U.S.C. § 333 (penalties); FDCA § 709, 21 U.S.C. § 379a (presumption of interstate commerce for medical devices).

The definition of medical device includes everything from toothbrushes to x-ray cameras. A medical device is:

an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is -

(1) recognized in the official National Formulary, or the United States Pharmacopeia, or any supplement to them,

(2) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease in man or other animals, or

(3) intended to affect the structure or any function of the body of man or other animals, and

which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes.

FDCA § 201(h), 21 U.S.C. § 321(h).

Note that the definition of "device" is quite similar to the definition of "drug." The key distinction is that devices do not work primarily through chemical action or by being metabolized.

Device Clearances or Approvals:

As explained below, it is not always necessary to get FDA's permission before marketing a medical device. But, if FDA's permission is needed, it is acquired through one of two possible mechanisms - a 510(k) or a Premarket Approval Application ("PMA").

510(k)s - A 510(k) (named for the relevant provision of the FDCA, FDCA § 510(k), 21 U.S.C. § 360(k), and also known as a premarket notification or PMN) is by far the more common of the two mechanisms. As compared to PMAs, 510(k)s are generally much shorter, reviewed more quickly, and, unlike PMAs, do not usually contain clinical data. Increasingly, however, 510(k)s are becoming lengthier, more complex submissions, and at times are including clinical data.

In "clearing" a 510(k), FDA makes a finding that the new device is "substantially equivalent" to a "predicate" device.

A "predicate" is a device that was legally marketed before May 28, 1976 (the effective date of the Medical Device Amendments of 1976) and that is not required to have a PMA, a device that has been classified into Class I or Class II (see below), or any device that is covered by a cleared 510(k). See FDCA § 513(f)(1), 21 U.S.C. § 360c(f)(1).

"Substantially equivalent" means that the new device has the same intended use and the same technological characteristics as the predicate device, or it has the same intended use and different technological characteristics, but the information submitted in the 510(k) demonstrates that the new device is as safe and effective as the predicate and does not raise different questions regarding safety and effectiveness than the predicate. FDCA § 513(i)(1)(A), 21 U.S.C. § 360c(i)(1)(A); see also 21 C.F.R. § 807.100(b).

PMAs - A PMA is analogous to an NDA for a new drug. PMAs are far more complex than 510(k)s, because in order to obtain FDA approval of a PMA the sponsor must provide FDA with a reasonable assurance that the device is safe and effective for its intended use. FDCA § 515(d)(2), 21 U.S.C. § 360e(d)(2); see generally 21 C.F.R. part 814. A PMA will usually include the results of extensive clinical studies, and may be in the FDA review process for a period of years.

In approving a PMA, FDA can (and often does) impose conditions on a device or its manufacturer. FDCA § 515(d)(1)(B)(ii), 21 U.S.C. § 360e(d)(1)(B)(ii); see also 21 C.F.R. § 814.82(a). For example, FDA may require that a device be restricted to prescription use. See FDCA §§ 515(d)(1)(B)(ii), 520(e), 21 U.S.C. §§ 360e(d)(1)(B)(ii), 360j(e). (Note that FDA can also impose restrictions on devices by means of a regulation. See FDCA § 520(e), 21 U.S.C. § 360j(e).)

Lack of Necessary Clearance or Approval - The failure to submit a required 510(k) is a prohibited act, and the lack of a necessary 510(k) renders a device misbranded. See FDCA §§ 301(p), 502(o), 21 U.S.C. §§ 331(p), 352(o). A device that lacks a necessary PMA is adulterated. FDCA § 501(f), 21 U.S.C. § 351(f). Note, however, that every new device that lacks a necessary 510(k) is considered by operation of law to be a Class III device that needs a PMA, and therefore until that device has a 510(k), it is also adulterated. See FDCA §§ 513(f)(1), 501(f)(1)(B)(i), 21 U.S.C. §§ 360c(f)(1), 351(f)(1)(B)(i).

Modifications of Already Cleared or Approved Devices:

For "510(k)ed" devices, a new 510(k) is required if the device is "about to be significantly changed or modified in design, components, method of manufacture, or intended use." 21 C.F.R. § 807.81(a)(3). The regulations specify the following as significant changes or modifications that require a 510(k): (1) a change or modification of the device that could significantly affect the safety or effectiveness of the device; or (2) a major change or modification in the intended use of the device. Id.

For "PMAed" devices, the manufacturer is required to submit a supplement to its PMA before making a change "affecting the safety or effectiveness" of the device. 21 C.F.R. § 814.39(a).

The consequences of a failure to submit a necessary 510(k) or a necessary PMA supplement for a change to a device are the same as those for failing to make any necessary 510(k) or PMA submission (see above).

General Device-Related Obligations:

Registration and Listing - With certain exceptions, an owner or operator of an establishment engaged in the manufacture, preparation, propagation, compounding, assembly, or processing of a medical device is required to register with FDA and to "list" its products with FDA by providing certain information about those products. See FDCA §§ 510(a)-(j), 21 U.S.C. §§ 360(a)-(j); see also 21 C.F.R. part 807. A device that was manufactured, prepared, etc. in an establishment that is not duly registered, or that is not listed as required by 510(j), is misbranded. FDCA § 502(o), 21 U.S.C. § 352(o). In addition, the failure to register or to list is a prohibited act. FDCA § 301(p), 21 U.S.C. § 331(p).

Good Manufacturing Practices - Devices must be manufactured in accordance with Good Manufacturing Practices ("GMPs"). FDCA § 520(f), 21 U.S.C. § 360j(f). The device GMP regulations are broadly drawn, and cover such things as equipment, production and process controls, and recordkeeping. See 21 C.F.R. part 820. A device that was manufactured, packed, stored, etc. in conditions that do not meet applicable GMP requirements is adulterated. FDCA § 501(h), 21 U.S.C. § 351(h). Filth, or insanitary manufacturing conditions which could render the device injurious to health, are also potential, but less common, grounds for device adulteration. See FDCA § 501(a), 21 U.S.C. § 351(a).

Labeling - A device is misbranded if its labeling is false or misleading in any particular. FDCA § 502(a), 21 U.S.C. § 352(a). There are also certain formal requirements applicable to device labeling (e.g., the label must bear the name and place of business of the manufacturer, packer, or distributor), and a failure to comply with any of those requirements renders the device misbranded. See FDCA §§ 502(b), 502(c), 502(e)(2), 21 U.S.C. §§ 352(b), 352(c), 352(e)(2); see also 21 C.F.R. §§ 801.1-801.6. In addition, a device is misbranded if it is dangerous to health when used as directed in its labeling. FDCA § 502(j), 21 U.S.C. § 352(j). Finally, over the counter devices (i.e., non-prescription devices) are misbranded if their labeling does not bear adequate directions for use. FDCA § 502(f), 21 U.S.C. § 352(f); see also 21 C.F.R. § 801.109.

Advertising - Jurisdiction over medical device advertising is split between FDA and the FTC. See FDCA § 502(r), 21 U.S.C. § 352(r). When FDA does have jurisdiction, there are certain formal requirements that apply (e.g., the advertisements must contain a brief statement of the intended uses of the device and relevant warnings, precautions, side effects, and contraindications), and the device is misbranded if its advertising does not comply with any of the formalities or if the advertising is false or misleading in any particular. FDCA §§ 502(q)(1), 502(r), 21 U.S.C. §§ 352(q)(1), 352(r). Even when FDA does not have jurisdiction over a device's advertising, however, the agency can use that advertising as a means of showing the intended use of the device (to demonstrate, for example, that the manufacturer intends the device for an unapproved use). See 21 C.F.R. § 801.4.

Reporting Requirements:

Medical Device Reporting ("MDRs") - A device manufacturer or importer is required, within specified time periods, to submit reports to FDA whenever the manufacturer or importer receives or otherwise becomes aware of information that reasonably suggests that one of its marketed devices: (1) may have caused or contributed to a death or serious injury; or (2) has malfunctioned, and that the device or a similar device marketed by the manufacturer or importer would be likely to cause or contribute to a death or serious injury if the malfunction were to recur. FDCA § 519(a), 21 U.S.C. § 360i(a); see also 21 C.F.R. part 803.

Distributor Reporting - Device distributors (including, for some purposes, importers) are required to report similar types of incidents involving devices distributed by them to FDA and/or the manufacturer of the device. FDCA § 519(a), 21 U.S.C. § 360i(a); see also 21 C.F.R. part 804.

User Reporting - Device user facilities are under a statutory obligation to report deaths, serious injuries, and serious illnesses associated with medical devices to FDA and/or the device manufacturer. FDCA § 519(b), 21 U.S.C. § 360i(b).

Failures to Report - The failure or refusal to comply with any of the above reporting requirements is a prohibited act, and renders the device misbranded. FDCA §§ 301(q)(1), 502(t), 21 U.S.C. §§ 331(q)(1), 352(t); see also FDCA § 301(e), 21 U.S.C. § 331(e).

New Rules - Effective July 31, 1996, medical device user facilities and manufacturers are required to report adverse events related to medical devices under a uniform reporting system. The new rules, which will be codified at 21 C.F.R. part 803, replace the manufacturer reporting requirements discussed above and implement the user facility reporting obligation. Under the new rules, device user facilities and manufacturers must, among other things, report deaths and serious injuries which a device has or may have caused or contributed to, and establish and maintain adverse event files. See 61 Fed. Reg. 16043 (Apr. 11, 1996); 60 Fed. Reg. 63578 (Dec. 11, 1995).

Classification of Devices:

Whether a device is required to have a 510(k), or a PMA, or neither, and how all of the other above requirements apply to any particular device, depend on that device's "Class." The FDCA requires FDA to divide medical devices into three classes based on the potential risks and benefits of each kind of device. FDCA § 513(b)(1), 21 U.S.C. § 360c(b)(1); see also 21 C.F.R. part 860.

Class I Devices - Class I devices are those devices, such as doctors' rubber gloves for patient exams, which FDA deems to be in need of the least regulatory oversight. See FDCA § 513(a)(1)(A), 21 U.S.C. § 360c(a)(1)(A); 21 C.F.R. § 880.6250. Class I devices are usually subject to the FDCA's "general controls" for devices, including 510(k), registration, listing, reporting requirements, GMPs, and the prohibitions against adulteration and misbranding. FDCA § 513(a)(1)(A), 21 U.S.C. § 360c(a)(1)(A).

However, FDA can, and does, exempt Class I devices from certain of the general controls, including registration, listing, GMPs, recordkeeping and reporting requirements, and 510(k). FDCA § 513(d)(2)(A), 21 U.S.C. § 360c(d)(2)(A). For example, the agency recently issued a final rule exempting 122 generic types of Class I devices (including dental floss and therapeutic massagers) from 510(k). See 61 Fed. Reg. 1117 (Jan. 16, 1996).

Class II Devices - For Class II devices, the general controls applicable to Class I devices are insufficient to provide a reasonable assurance of safety and effectiveness. Therefore, in addition to general controls, FDA can establish "special controls," such as performance standards and postmarket surveillance, for Class II devices. FDCA § 513(a)(1)(B), 21 U.S.C. § 360c(a)(1)(B); see also FDCA § 514, 21 U.S.C. § 360d (establishment of, and allowable provisions for, performance standards); FDCA § 501(e), 21 U.S.C. § 351(e) (failure to comply with an applicable performance standard renders a device adulterated); FDCA § 502(s), 21 U.S.C. § 352(s) (a device that does not bear the labeling required by a performance standard is misbranded). An example of a Class II device is a CAT scan system. See 21 C.F.R. § 892.1750.

Class III Devices - Class III devices are subjected to the highest level of regulation. Class III devices are those: (1) for which general controls and special controls would not provide a reasonable assurance of safety and effectiveness; and (2) which are either for a use in supporting or sustaining human life, or for a use which is of substantial importance in preventing impairment of human health, or which present a potential unreasonable risk of illness or injury. FDCA § 513(a)(1)(C), 21 U.S.C. § 360c(a)(1)(C). In addition to being subject to general controls, Class III devices must have a PMA. Id. An example of a Class III device is an intraocular lens (a lens implanted to replace the natural lens of the eye). See 21 C.F.R. § 886.3600.

Unfortunately, knowing the class of a device and the applicable requirements is not always a simple matter. In general terms, the rules are as follows:

Classification of "Old" Devices - Most preamendments devices (defined here as devices that were on the market before May 28, 1976) have been classified by FDA. See 21 C.F.R. parts 862-892. If a manufacturer had a device on the market before May 28, 1976, that device is grandfathered and that manufacturer does not need FDA clearance or approval for its device, unless FDA has classified that device as Class III or some aspect of the device, such as in its intended use, has been changed. See FDCA § 510(k), 21 U.S.C. § 360(k). If FDA has classified a preamendments device into Class III, and the agency has issued a regulation calling for the submission of PMAs for that device, every manufacturer of that device will be required to submit a PMA not less than 30 months after the promulgation of a final classification regulation or 90 days after the promulgation of a final regulation calling for the submission of PMAs, whichever is later. FDCA §§ 515(b), 501(f)(1)(A), 501(f)(2)(A), 21 U.S.C. §§ 360e(b), 351(f)(1)(A), 351(f)(2)(A). An important exception, however, is that preamendments devices that were regulated as drugs before May 28, 1976 - devices known as "transitional devices" - are, by statute, automatically Class III and automatically require a PMA, unless FDA reclassifies them. FDCA §§ 520(l), 501(f)(1)(C), 21 U.S.C. §§ 360j(l), 351(f)(1)(C).

Classification of "New" Devices - A new device (i.e., one first introduced or delivered for introduction into interstate commerce on or after May 28, 1976) that may qualify as substantially equivalent to a Class I device that is not exempt from 510(k), to a Class II device, or to a Class III device for which FDA has not called for PMAs, may escape the requirement of a PMA with a cleared 510(k), and once cleared is considered to be the same class as its predicate. See FDCA § 510(k), 21 U.S.C. § 360(k). A new device that is substantially equivalent to a Class I 510(k)-exempt device, is Class I and exempt from 510(k). See FDCA § 513(d)(2)(A), 21 U.S.C. § 360c(d)(2)(A). A new device that is not exempt from 510(k) and does not have a cleared 510(k) is Class III and must have an approved PMA. FDCA §§ 513(f)(1), 501(f)(1)(B), 21 U.S.C. §§ 360c(f)(1), 351(f)(1)(B).

Clinical Investigations of Medical Devices:

A clinical investigation of a medical device will generally be conducted under an Investigational Device Exemption (IDE). An IDE, like its counterpart for drugs, the IND, functions as an exemption from other provisions of the FDCA. See FDCA §§ 520(g), 505(i), 21 U.S.C. §§ 360j(g), 355(i). If a device clinical investigation is being conducted in accordance with the IDE regulations, that device is exempted from, among other things, misbranding, registration, listing, 510(k), performance standards, PMA, certain recordkeeping and reporting requirements, and GMPs. FDCA § 520(g), 21 U.S.C. § 360j(g); see also 21 C.F.R. part 812.

Among other things, the IDE regulations dictate various responsibilities for IDE sponsors and investigators, contain recordkeeping and reporting requirements, and prohibit promotion and sale of the investigational device. See 21 C.F.R. part 812. The failure or refusal to comply with any IDE requirement, or to furnish any information required by the IDE regulations, is a prohibited act. FDCA § 301(q)(1), 21 U.S.C. § 331(q)(1). In addition, if a device is under an IDE, and the IDE sponsor or investigator fails to comply with a requirement of the IDE regulations, the device is adulterated. FDCA § 501(i), 21 U.S.C. § 351(i).

Imports and Exports of Medical Devices:

Imports - The rules for device imports are essentially the same as the rules for drug imports. FDA can refuse admission of a device if the device appears, among other things: (1) to be adulterated or misbranded; or (2) to be forbidden or restricted in sale in the country in which it was produced or from which it was exported. FDCA § 801(a), 21 U.S.C. § 381(a). In some cases, FDA may first give the owner or consignee of the device a chance to re-condition the device, in order to bring it into compliance with the FDCA. FDCA § 801(b), 21 U.S.C. § 381(b).

Exemption for Imports of Certain Components - Effective April 26, 1996, a company can import a component part or accessory of a device, which is ready or suitable for use for health-related purposes, if: (1) the importer submits a statement to FDA at the time of initial importation, reporting that the imported article is intended to be incorporated into a device that will be lawfully exported; (2) the initial owner or consignee of the article keeps records and, if requested makes a report to FDA, regarding the use or disposition of the imported article; and (3) the owner or consignee destroys or exports any component part or accessory that is not incorporated. FDCA § 381(d)(3), 21 U.S.C. § 381(d)(3). The making of a knowingly false statement in any of these required records or reports, the failure to maintain or submit any of the required records or reports, the release into interstate commerce of any of these imported articles or any finished product made from those articles, and the failure to destroy or export any component part or accessory that is not incorporated, are prohibited acts. FDCA § 301(w), 21 U.S.C. § 331(w).

Exports before April 26, 1996 - Devices that complied with all applicable requirements of the FDCA could be exported freely. See FDCA § 801(e), 21 U.S.C. § 381(e). FDA approval was necessary for export of investigational devices, devices that lacked a necessary PMA or did not comply with an applicable performance standard, and banned devices. FDCA § 801(e)(2), 21 U.S.C. § 381(e)(2). Any other device that was adulterated or misbranded could be exported without FDA's permission if it: (1) accorded to the specifications of the foreign purchaser; (2) was not in conflict with the laws of the country to which it was intended for export; (3) was in a shipping package labeled for export; and (4) was not sold or offered for sale in domestic commerce. FDCA § 801(e)(1), 21 U.S.C. § 381(e)(1). Because fulfilling the export requirements exempted the device from adulteration and misbranding, a failure to fulfill any of the requirements rendered the device adulterated and/or misbranded. See FDCA § 801(e), 21 U.S.C. § 381(e).

Exports on or after April 26, 1996 - Devices that comply with all applicable requirements of the FDCA can be exported freely. See FDCA § 801(e), 21 U.S.C. § 381(e).

An investigational device, a device that lacks a necessary PMA or does not comply with an applicable performance standard, and a banned device can be exported with FDA approval, or it can be exported without FDA approval if, among other conditions, it: (1) has marketing authorization in one of certain specified countries; (2) complies with the laws of the country to which it is being exported; (3) accords to the specifications of the foreign purchaser; (4) is in a shipping package labeled for export; (5) is not sold or offered for sale in domestic commerce; and (6) complies with certain manufacturing, labeling, and promotional requirements. FDCA §§ 801(e)(2), 802(a)-(b), 802(f), 21 U.S.C. §§ 381(e)(2), 382(a)-(b), 382(f). The exporter of a device under this latter procedure is required to notify FDA when the exporter first begins to export the device. FDCA § 802(g), 21 U.S.C. § 382(g).

A device that is intended for further processing in anticipation of market authorization in one of the specified countries or for investigational use in one of those countries may be exported in accordance with the laws of that country if, among other things, the device satisfies conditions 3-6 in the previous paragraph. FDCA §§ 802(c)-(d), 802(f), 21 U.S.C. §§ 382(c)-(d), 382(f).

A device that cannot otherwise be lawfully exported and is intended to be used for a disease that is not of significant prevalence in the U.S. can be exported with FDA approval, subject to certain conditions, including conditions 2-6 above. FDCA §§ 802(e)-(f), 21 U.S.C. §§ 382(e)-(f).

Any other device that is adulterated or misbranded can be exported without FDA's permission if it: (1) accords to the specifications of the foreign purchaser; (2) is not in conflict with the laws of the country to which it is intended for export; (3) is in a shipping package labeled for export; and (4) is not sold or offered for sale in domestic commerce. FDCA § 801(e)(1), 21 U.S.C. § 381(e)(1).

Because fulfilling the export requirements exempts the device from adulteration and misbranding, a failure to fulfill any of the requirements renders the device adulterated and/or misbranded. See FDCA § 801(e), 21 U.S.C. § 381(e).

Certain recordkeeping requirements also apply to device exporters. FDCA § 802(g), 21 U.S.C. § 382(g).

Enforcement-Related Notes:

Most of the device-related enforcement provisions, and the prohibited acts applicable to devices, are the same as those for food, drugs, and cosmetics. See, e.g., FDCA §§ 301(a)-(c), 21 U.S.C. §§ 331 (a)-(c). There are, however, a few distinct aspects of device-related enforcement:

False Reports - It is a prohibited act to submit any device-related report required under the FDCA that is false or misleading in any material respect. FDCA § 301(q)(2), 21 U.S.C. § 331(q)(2).

Presumption of Interstate Commerce - For medical devices, interstate commerce is presumed. FDCA § 709, 21 U.S.C. § 379a ("In any action to enforce the requirements of this Act respecting a device the connection with interstate commerce required for jurisdiction in such action shall be presumed to exist.").

Seizure - An adulterated or misbranded device, like a counterfeit drug, can be seized at any time, without regard to whether the device is, or has been, in interstate commerce. FDCA § 304(a)(2), 21 U.S.C. § 334(a)(2).

Detention - If, during an inspection, FDA finds devices that it has "reason to believe" are adulterated or misbranded, the agency can order those devices temporarily detained. FDCA § 304(g), 21 U.S.C. § 334(g). The movement of a device in violation of that detention order, or the removal or alteration of a mark required by the order to identify the device as detained, is a prohibited act. FDCA § 301(r), 21 U.S.C. § 331(r).

Civil Penalties - FDA has the authority to impose civil penalties for violations of many device-related provisions of the FDCA. FDCA § 303(f), 21 U.S.C. § 333(f). FDA can impose penalties up to $15,000 for each violation, totaling up to $1,000,000 in each proceeding. Unpaid civil penalties can be collected by the Justice Department in an action in any appropriate federal district court. Id.

Drug Company Influence on Standards of Care and Hospital Formularies Through Marketing Fraud, Fraudulent Research, and Manipulation

Many health care professionals have become aware of the strong influence that drug companies and medical device companies now have in determining community standards of care for medication use and medical device use in patients.  These drug companies push drug samples into many hospitals and often use powerful forms of manipulation including biased research, influencing key medical doctors, and kickbacks to get their drugs placed on hospital formularies.  Likewise medical device companies commonly push their medical devices for use in hospitals regardless of truth or effectiveness.

Because of the immense power and influence of drug companies and medical device companies, it is becoming common to have drug marketing executives, medical device marketing representatives, medical device executives, and drug sales representatives to be able to influence what drugs and medical devices are used in whole communities.  In many situations the drug companies and medical device companies are more powerful than individual doctors that are forced to follow hospital formularies.  This drug company manipulation and medical device company manipulation of the medical community can be extremely dangerous because it takes important medical decisions out of the hands of individual medical doctors and allows the drug companies to push potentially dangerous drugs for off-label drug uses and in inappropriate situations as well as medical device companies to push ineffective or dangerous medical devices for unintended uses. 

The drug and medical device industries' main goal is to make a profit.  Each drug company and medical device company is trying to sell as much of their drug or medical device as they can regardless of the potential danger to patients or if there are cheaper more effective alternatives available.  If the marketing executives and sales representatives can get their drug placed on a hospital formulary or make the medical device the standard of care in a community, they are able to make lots of money.  Once this is accomplished there are economic incentives to keep expanding the use of the drug or medical device to new off-label uses. 

Recently several large drug companies and medical device companies have been caught fraudulently marketing drugs and medical devices for off-label purposes.  These drug companies and medical device companies have had to pay Billions of dollars for Medicare Marketing Fraud Off-Label Lawsuits, Medicaid Marketing Fraud Off-Label Lawsuits, and other health care fraud lawsuits.   Despite these large fines, Drug Companies and Medical Device Companies have continued this practice because they are making profits of Hundreds of Billions of Dollars.

"WASHINGTON (AP) -- Federal prosecutors hit Pfizer Inc. with a record-breaking $2.3 billion in fines Wednesday and called the world's largest drug maker a repeating corporate cheat for illegal drug promotions that plied doctors with free golf, massages, and resort junkets." Pfizer to pay record $2.3B penalty over promotions Repeat offender Pfizer paying record $2.3B settlement for illegal drug promotions By Devlin Barrett, Associated Press Writer On Wednesday September 2, 2009, 3:47 pm EDT

The Department of Justice has announced that this penalty is a warning to all drug manufacturers that criminal and civil prosecution of fraudulent drug marketing, fraudulent off label marketing, illegal kickbacks, and other fraud schemes.  They have also announced that there are several new Medicare Fraud and Medicaid Fraud Law Enforcement Teams that are cracking down on Medicare Fraud and Medicaid Fraud Schemes.  These teams will be investigating and prosecuting people that have profited from these scheme and people that knew about the fraudulent scheme, but failed to report them.

Pharmaceutical Marketing Representatives and Medical Device Marketing Representatives often Combine Free Gifts, Lunches, Dinners, and Drinks with Biased and/or Fraudulent Research to Encourage Medicare Off-label Drug Use, Changes in Standards of Care, and Over Prescribing of Medical Devices or Drugs

Marketing fraud including medical device marketing fraud and drug company marketing fraud has increased over the past decade as medical device marketing executives, pharmaceutical marketing executives, and other health care executives are using advanced marketing schemes to manipulate doctors, surgeons, pharmacists, and other health care providers.  These advanced marketing schemes are often fraudulent and designed to increase drug profits through off label marketing and over use of unsafe medical devices and drugs.   

Pharmaceutical representatives, medical device marketing representatives, and marketing executives that use illegal kickbacks and fraud to sell more drugs and medical equipment may be subject to criminal and civil liability for their actions.  If you are aware of and have evidence of these illegal kickbacks or fraud schemes, it is important to step up and blow the whistle, not only to avoid potential liability or to potentially collect a large reward for properly reporting the fraud, but because without whistleblowers Billions of dollars are continuing to be stolen each year from Medicare, Medicaid, and taxpayers.

From providing false information to using young attractive and charismatic drug representatives and free gifts, drug companies and medical device companies are using advanced drug marketing schemes and techniques to push physicians to use new drugs and products to obtain as much Medicare money as possible.  When these marketing techniques are used fraudulently to push a dangerous drug or to push a drug or medical device for off-label purposes, it can be dangerous for the patient's health as well as can be the basis for a qui tam lawsuit or other lawsuit if the Medicare Marketing Fraud can be documented.

Free gifts, lunches, dinners, and drug samples from drug companies are common place in the World of the successful physician.  Sales people and marketing representatives commonly seek to use free meals, drinks, marketing giveaways, and drug samples, to obtain the attention of a medical doctor and these free gifts can often influence a physician to use a new, more expensive, and less safe drug.  A recent article, Prescribing Under the Influence By E. Haavi Morreim, thoughtfully discusses the potential influence direct or indirect that free meals and gifts from drug representatives and medical device representatives can have on physicians.  These freebies combined with false marketing materials on a drug or medical device can often manipulate a medical doctor into prescribing drugs for off-label purposes, using an inferior or unsafe produce, or over prescribing a drug or medical device.

When this occurs, it can be difficult to determine who all was involved in the fraud and if the physician should have known about the false research materials and fraudulent representation about the drug or received some type of kickback.  It is extremely important for physicians to be careful what gifts that take from drug companies, to verify materials given to them by drug companies, and to report fraudulent activities where a drug company is committing fraud or using illegal kickbacks to sell more drugs.  It is also vital that physicians report drugs that adverse effects and that are dangerous.

Pharmaceutical Marketing Executives and Medical Device Marketing Executives often use Attractive and Charismatic Marketing Representatives with Advanced Fraudulent Marketing Scripts to Encourage Medicare Fraud Including Off-label Drug Use and Over Prescribing of Medical Devices

Another technique that drug companies use to push their new drugs and implants include hiring attractive and charismatic drug representatives to push physicians through an advanced script that falsely presents a new medication or medical device as better and more safe than it actually is.  The drug representatives are usually highly articulate and are able to use the skewed research from the drug marketing departments combined with befriending or flirting with the physician to push the doctor to use their company's new product regardless of safety or expense.

These advanced fraudulent scripts are often presented as well accepted scientific research including cites or references from authentic sounding publications.  They are also often well thought out by drug marketing executives and medical device marketing executives then given to and rehearsed by the  attractive and charismatic drug representatives or medical device representative for the sole purpose of manipulating the medical doctor into prescribing more of the drug for off-label purposes or the medical device.

It is important that drug representatives, hospital administrators, and physicians that are aware drug companies using fraudulent research and fraudulent scripts to sell drugs to report these fraudulent marketing schemes.

Pharmaceutical Marketing Executives and Medical Device Marketing Executives often use Medical Doctor Profiling to Manipulate Physicians into Prescribing Off-label Drug Use and Over Prescribing of Unsafe Medical Devices for Medicare Patients

Through experience the drug marketing departments have also devised Medical Doctor Profiling schemes that they can use to determine what best motivates a particular physician and use this information combined with advanced marketing techniques to manipulate the physician without the medical doctor even realizing that they are being manipulated.  These techniques include understanding that some medical doctors are research oriented while others are politically motivated, financially motivated, career motivated, or relationally motivated.  By understanding a medical doctor's predispositions, interests, and motivations, a drug marketing department or medical device marketing department can use or manipulate a medical doctor based on their profiled information.  Examples of these drug marketing department and medical device marketing department profiling and manipulations include

Research Motivated Medical Doctor - The Marketing Departments will often create research with skewed data from the drug company to push the research motivated physician that relies strongly on science and research to make their decisions.  The marketing representatives will also often invite the research motivated physician to publish in selected publications or to speak at sponsored medical conferences.     

Politically and Career Motivated Medical Doctor - Marketing Departments will often create professional and social events, activities, and opportunities to advance the physician's ability to expand their political activities and career. 

Relationally Motivated Medical Doctor - Drug marketing departments will not only find marketing representatives that are attractive and charismatic, but will also find drug representative with similar interests as well as hire family members or friends of the relationally motivated physician.

The above techniques and many more are all methods that drug marketing departments and medical device marketing executives use to gain the attention of and influence on medical doctors.  These marketing techniques combined with fraudulent marketing research and other fraudulent practices can often work to manipulate a medical doctor into prescribing drugs for off label purposes as well as using unsafe medical devices or over using medical devices.

Drug Representative Off Label Drug Marketing Medicare Fraud Lawyer, Pharmaceutical Representative Medicare Marketing Fraud Lawyer, and Pharmaceutical Representative Whistleblower Qui Tam Lawyer (Off Label Marketing and Pharmaceutical Whistleblower False Claims Act Law Suits)

Through Drug Company Marketing Fraud Whistleblower Lawsuits, Off Label Medicare Marketing Fraud Qui Tam Lawsuits, Illegal Kickback Lawsuits, and other Medicare Health Care Fraud Lawsuits, hundreds of billions of dollars have been recovered from dishonest pharmaceutical companies, medical device companies, health insurance companies, health providers, individuals and organizations that have committed Medicare health care fraud and stolen large amounts of money from the government.

It is extremely important that Whistle Blowers continue to expose fraudulent marketing practices, billing practices and unnecessary treatments that cost hundreds of billions of dollars.   Off Label Drug Marketing Fraud Lawyer Jason Coomer works on Off Label Pharmaceutical False Claims Act Lawsuits and commonly works with other Pharmaceutical Medicare Marketing Fraud Whistleblower Lawyers, Medicare Medical Product Marketing Fraud Qui Tam Whistleblower Lawyers, and Medicare Health Care Fraud Whistleblower Lawyers. 

Health Care Fraud  and Pharmaceutical Off Label Fraud Law Suits (Fraud Costs Tax Payers and Consumers Hundreds of Billions of Dollars)

Health Care Expenses in the United States have increased to be over Two Trillion and a Half ($2,500,000,000,000.00) Dollars each year.  This amount continues to rise as pharmaceutical companies continue to make large profits.  One of the reasons that the pharmaceutical companies are making such large profits is that they are using aggressive marketing campaigns that not only promote drugs for the medication's intended purpose, but aggressively push doctors to prescribe drugs for off label purposes.  From a taxpayer stand point, health care fraud costs taxpayers between $60 billion and $100 billion each year.  This cost increases dramatically when you include other forms of health care fraud including insurance fraud and fraud on patients. 

Drug Marketing Fraud Law Suits, Price Fixing Qui Tam Lawsuits, Kickback Marketing Scam Lawsuits, Pharmaceutical Marketing Fraud Lawsuits, and Pharmaceutical Whistleblower Qui Tam Law Suits

Taketa-Abbott Pharmaceutical Pharmaceutical Products Inc. -- $559,483,560 under the False Claims Act In October 2001, TAP Pharmaceutical Products Inc. agreed to pay $875 million to resolve criminal charges and civil liabilities in connection with fraudulent drug pricing and marketing of Lupron, a drug sold for the treatment of prostate cancer. Of this amount, $559,483,560 was recovered under the False Claims Act. In addition, TAP pled guilty to a conspiracy to violate the Prescription Drug Marketing Act and paid a $290 million criminal fine, the largest criminal fine ever in a health care fraud prosecution. Under the Lupron scheme, TAP gave doctors kickbacks by providing free samples with the knowledge that the physicians would bill Medicare and Medicaid $500 per dose. At the time the Lupron fraud was discovered, Lupron accounted for 10% of the money spent on prescription drugs under Medicare Part-A. As part of the settlement, TAP entered into what prosecutors called a "sweeping" corporate integrity agreement.

Schering Plough -- $255,000,000 under the False Claims Act In August of 2008, Schering-Plough agreed to pay a total of $435 million to resolve criminal charges and civil liabilities in connection with illegal sales and marketing programs for brain tumor medication Temodar, and Intron-A which is used in the treatment of bladder cancer and hepatitis C. The Schering settlement also covers best price violations related to Claritin RediTabs (an antihistamine), and K-Dur, which is used in the treatment of ulcers.

Serono-- $567,000,000 under the False Claims Act In October of 2005, Serono agreed to pay $704 million to settle a fraud case involving Serostim, a human growth hormone product used to fight AIDS-related wasting. The charges involved kickbacks to doctors for prescribing Serostim, kickbacks to specialist pharmacies for recommending Serostim, illegal off-label marketing of the drug, and non-FDA approved diagnosis equipment designed to spur more Serostim prescriptions. Serostim cost as much as $20,000 for a three-month regime. Of the total $704 million settlement, $567 million is earmarked to settle federal and state civil claims ($305 million federal), with $136.9 million paid as a related criminal fine.

Off Label Drug Marketing Fraud Qui Tam Claim Lawyer, Pharmaceutical Marketing Fraud Qui Tam Claim Lawyer, and Pharmaceutical Whistleblower Qui Tam Lawyer (Off Label Marketing and Pharmaceutical Whistleblower False Claims Act Law Suits)

Through Whistle Blower Lawsuits, Qui Tam Lawsuits, and other Health Care Fraud Lawsuits, Billions of dollars have been recovered from dishonest pharmaceutical companies, health insurance companies, health providers, individuals and organizations that have committed health care fraud and stolen large amounts of money from the government.  It is extremely important that Whistle Blowers continue to expose fraudulent marketing practices, billing practices and unnecessary treatments that cost hundreds of billions of dollars.   Off Label Drug Marketing Fraud Lawyer Jason Coomer works on Off Label Pharmaceutical False Claims Act Lawsuits and commonly works with other Drug Company Whistleblower Lawyers, Qui Tam Whistleblower Lawyers, and Health Care Fraud Whistleblower Lawyers. 

If you are a pharmaceutical misbranding whistleblower that is aware of fraudulent marketing practices by a pharmaceutical marketing department, feel free to contact Pharmaceutical Misbranding Off Label Drug Marketing Fraud Whistleblower Lawyer Jason Coomer via e-mail message or our submission form about a potential pharmaceutical misbranding whistleblower lawsuit, off label pharmaceutical marketing fraud lawsuit, or other pharmaceutical false label whistleblower qui tam lawsuit. 

Medical Device Misbranding Whistleblower Lawyer, Medical Device False Branding Whistleblower Lawyer, Medical Device Marketing Fraud Whistleblower Lawyer, Misbranding Drug Whistleblower Lawyer, Medical Device Kickback Lawyer, and Medical Device Marketing Fraud Lawyer

If you are aware of a large health care company or individual that is defrauding the United States Government out of millions or billions of dollars, contact Medical Device Misbranding Lawyer and Drug Misbranding Lawyer, Jason Coomer.  As a Texas Drug and Medical Device Marketing Fraud Lawyer, he works with other powerful misbranding qui tam lawyers that handle large fraudulent branding whistleblower cases.  He works with San Antonio Medical Device Misbranding Lawyers, Dallas Medical Device Misbranding Lawyers, Houston Medical Device Misbranding Fraud Lawyers, and other Texas Drug and Medical Device Marketing Fraud Lawyers as well as with Medical Device Misbranding Qui Tam Lawyers throughout the nation to blow the whistle on fraud that hurts the United States. 

If you are a medical device misbranding whistleblower or drug misbranding whistleblower that is aware of fraudulent marketing practices, drug misbranding, medical device misbrand, drug price fixing, drug kickbacks, or other pharmaceutical or medical device fraud, please feel free to contact Medical Device False Branding, Medical Device Marketing Fraud, and Misbranding Whistleblower Lawyer Jason Coomer via e-mail message or use our submission form about a potential medical device marketing fraud whistleblower lawsuit, medical device misbranding fraud lawsuit, medical device false branding kickback fraud lawsuit, drug misbranding fraud lawsuit, or other marketing fraud whistleblower qui tam lawsuit.