{"id":1587,"date":"2017-06-01T02:29:23","date_gmt":"2017-06-01T02:29:23","guid":{"rendered":"https:\/\/onpointlegalleads.com\/?p=1587"},"modified":"2025-05-01T17:12:56","modified_gmt":"2025-05-01T17:12:56","slug":"big-pharma-fraudulent-marketing-leads-mass-tort-claims","status":"publish","type":"post","link":"https:\/\/onpointlegalleads.com\/mass-tort-leads\/big-pharma-fraudulent-marketing-leads-mass-tort-claims\/","title":{"rendered":"How Big Pharma\u2019s Misleading and Fraudulent Marketing Leads to Mass Tort Claims"},"content":{"rendered":"[vc_row][vc_column][vc_empty_space][vc_column_text]\n

Profits vs. Lives in the War Against Defective Drugs and Defective Medical Devices<\/strong><\/span><\/p>\n[\/vc_column_text][\/vc_column][\/vc_row][vc_row][vc_column width=”1\/2″][vc_single_image image=”1608″ img_size=”400×300″ alignment=”center”][\/vc_column][vc_column width=”1\/2″][vc_single_image image=”1609″ img_size=”400×300″ alignment=”center”][\/vc_column][\/vc_row][vc_row][vc_column][vc_column_text]\n

I. Introduction to the Battle Against Defective Drugs and Medical Devices<\/strong><\/h3>\n[\/vc_column_text][vc_column_text]This article focuses on the inherent problems associated with drug and device manufacturers\u2019 misleading and fraudulent marketing practices.<\/p>\n

Unlike the past, Big Pharma\u2019s marketing now has less oversight over its promotional activities.<\/p>\n

Significantly, the current lack of oversight and forceful guidelines may have contributed to countless\u00a0mass tort cases and claims<\/a>, record-breaking civil and criminal fines, . . . and countless patients who have been seriously injured or died.<\/p>\n

Much of this article focuses on the risks and liabilities among three relationships: manufacturer-doctor; doctor-patient; and one relationship that is somewhat disconnected, which is manufacturer-patient.<\/p>\n

Generally, the source of strain within these relationships originates from the battle between the Food and Drug Administration (FDA)<\/a> and Big Pharma<\/a>. \u00a0The spring board for this tug-of-war stems from the FDA\u2019s policies regarding the safety and efficacy of drugs and medical devices versus manufacturers\u2019 desire to introduce products outside the scope of the FDA\u2019s original approval for those products.<\/p>\n

In other words, the safety and efficacy of patients\u2019 lives versus the mega-millions made by Big Pharma.<\/p>\n

Notably, Big Pharma pursues its right to market its wares to doctors by leveraging its freedom of speech.\u00a0 They say there is a need to provide free-flowing medical information.<\/p>\n

However, that argument likely is pretext for the underlying motivation, which is to line their pockets.<\/p>\n

Ultimately, this article will recommend that the FDA re-introduce a similar version of its prior prerequisites to manufacturers who promote off-label drugs and medical devices: the FDA should be required to review all off-label promotional materials intended to be submitted to prescribing physicians on a pre-approval or trial basis.<\/p>\n

Based upon current regulations, patients\u2019 rights to making an informed decision have been trumped by Big Pharma\u2019s right to free speech.<\/p>\n

Past FDA policies had the effect of a general rule that off-label materials sent to physicians was a violation, which was strongly imposed upon them. However, successful court battles by manufacturers asserting freedom of speech claims turned the tables in their favor.<\/p>\n

Today, one can contend that the exception is now the general rule, as manufacturers may send marketing materials on off-label products with significantly less restrictions. This is the \u201cnew normal.\u201d<\/p>\n

Record-setting criminal fines of more than $1 billion by one drug manufacturer may be demonstrative of a failed effort to fight fraudulent promotion and unsafe products, and that a new approach may be successful on many levels.<\/p>\n

Ultimately, a better approach could allow the agency to win the war against defective drugs and defective medical devices, and take advantage of the lost opportunities by the FDA to provide needed practical guidance.[\/vc_column_text][vc_single_image image=”1614″ img_size=”full” alignment=”center”][vc_column_text]\n

II. Off-Label Prescription and Promotion: A Background<\/strong><\/h3>\n[\/vc_column_text][\/vc_column][\/vc_row][vc_row][vc_column width=”1\/2″][vc_single_image image=”1617″ img_size=”400×300″ alignment=”center”][\/vc_column][vc_column width=”1\/2″][vc_single_image image=”1616″ img_size=”400×300″ alignment=”center”][\/vc_column][\/vc_row][vc_row][vc_column][vc_column_text]\n

Before drugs and devices are approved by the FDA for general use, they undergo through clinical trials (also called \u201cresearch studies\u201d) to determine how well they comport with safety and efficacy.1<\/a><\/sup> Specifically, the trials must prove that the drug: (1) works to treat a particular medical condition; (2) works the way in which it is expected; and; (3) is safe when used as instructed2<\/a><\/sup>.<\/p>\n

Originally, the FDA focused solely on safety; however, after realizing that even snake oil could be safe, the agency added efficacy to its threshold of approval.3<\/a><\/sup>Following approval for safety and efficacy, the FDA works with the drug or device manufacturer to develop the \u201clabel.\u201d4<\/a><\/sup>This \u201clabel\u201d does not refer to the \u201clabel\u201d on the side of a prescription bottle or medical device package5<\/a><\/sup> . Rather, it is a report that provides information about the drug or device, such as the conditions it is approved to treat (\u201cindications\u201d) and dosage amounts.6<\/a><\/sup><\/p>\n

Drugs and medical devices may be used for purposes that are not approved, provided they are approved for some type of treatment.7<\/a><\/sup> Those that are administered contrary to the FDA- approved label are called \u201coff-label.\u201d8<\/a><\/sup><\/p>\n

Types of off-label drug prescription include administering a drug for a different disease or a different manner of ingestion.9<\/a><\/sup> However, unbeknownst to many patients, physicians do not have strict legal limitations when prescribing off-label. In fact, doctors may prescribe FDA-approved drugs and medical devices in any manner they believe is medically suitable, and may do so without FDA oversight.10<\/a><\/sup> This is because the FDA lacks the authority to oversee doctors in this manner.<\/p>\n

In particular, the Federal Food, Drug and Cosmetic Act (FFDCA)<\/a> states, \u201cNothing in this Act shall be construed to limit or interfere with the authority of a healthcare practitioner to prescribe or administer any legally marketed device to a patient for any condition or disease within a legitimate healthcare practitioner-patient relationship.\u201d11<\/a><\/sup> In essence, off-label use \u201cis an accepted and necessary corollary of the FDA\u2019s mission to regulate in this area without directly interfering with the practice of medicine.\u201d12<\/a><\/sup><\/p>\n

This policy, which originates from the 1938 Food, Drug, and Cosmetic Act<\/a> and is known as the \u201cpractice-of-medicine exception,\u201d says that \u201conce a drug is approved for marketing, FDA does not generally regulate how, and for what uses, physicians prescribe that drug . . . [and a] physician may prescribe a drug for uses or in treatment regimens or patient populations that are not listed in the FDA-approved labeling.\u201d13<\/a><\/sup><\/p>\n

Off-label prescriptions are commonly pursued for non-experimental purposes, and the medical community is rife with examples that demonstrate their highly effective uses.14<\/a><\/sup> Arguably, the most notable off-label use of a prescription drug could be that of Pyrimethamine<\/a>, Famciclovir<\/a>, and Ganciclovir<\/a>, which are used for the treatment of AIDS, a condition which is treated with nearly 100% off-label prescriptions.15<\/a><\/sup><\/p>\n

This is a significant statistic that must be underscored. If an average of 40% of all prescriptions are off-label, it is not a great leap of logic to suggest that 40% of all revenues and profits come from off-label prescription. A figure which cannot be ignored by corporate executives reviewing cash flow and profit-and-loss statements\u2014especially when designing strategic approaches to market the medications they have developed.<\/p>\n

What may be more eye-opening is that doctors generally do not need to disclose that the drug or medical device has been prescribed for an off-label purpose during an informed consent discussion with the patient.16<\/a>\u00a0\u00a0<\/sup>Typically, a doctor is bound to discuss the potential complications associated with a drug or device.17<\/a><\/sup> Yet, that is not necessarily the case with off-labels.<\/p>\n

There are two approaches states apply to the question of whether a doctor should provide the patient with information about the potential side effects, complications, benefits, and history.18<\/a><\/sup> The majority rule is the \u201creasonable patient standard,\u201d which allows a jury to determine \u201cwhether a reasonable patient would have regarded the information as important.\u201d19<\/a><\/sup> Notably, expert testimony is not required here because there isn\u2019t an expert at being a reasonable patient; it is an illusory figure.20<\/a><\/sup> On the other hand, the minority approach applies an \u201cactual patient standard,\u201d which is a subjective approach that gives more weight to the actual patient.21<\/a><\/sup><\/p>\n

Notwithstanding, pharmaceutical companies\u00a0have a history of rigid restrictions when promoting off-label drugs and medical devices. For example, marketing drugs and medical devices for unapproved purposes<\/a> is forbidden in that it prohibits doctors and patients from making unbiased and informed decisions.22<\/a><\/sup> This is based upon the FDA\u2019s charge of regulatory oversight of protecting the general public from profit-focused pharmaceutical companies.23<\/a><\/sup><\/p>\n

If a non-FDA-approved use of a drug is included on a label, it is deemed \u201cmisbranded\u201d and the manufacturer faces potential criminal and civil penalties.24<\/a><\/sup> It is also a violation to release an \u201cadulterated\u201d product, one that is categorically problematic with respect to the product\u2019s degree or level of toxicity, cleanliness, or sterility, how well it conforms to its label in terms of composition of ingredients and strength, and any issues with manufacturing quality control.25<\/a><\/sup> Notably, a medical device may be deemed both adulterated and misbranded if promoted for a used not approved or cleared by the FDA.26<\/a><\/sup><\/p>\n

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