Allegations of False Claims and Misleading Information Regarding Lomaira and Fatal Lung Disease
The Lomaira lawsuit lawyers with Parker Waichman LLP commenced an investigation into claims that Lomaira manufacturer Avanthi, Inc. has misled the public. The deception perpetrated by Avanthi creates an extremely hazardous situation because Avanthi failed to warn physicians and consumers alike that taking Lomaira can cause a fatal lung disease in addition to potentially lethal interactions with other medications.
Parker Waichman LLP is a plaintiffs’ law firm with a national reputation for excellence in their mission to relentlessly pursue damages on behalf of their clients who have failed victim to large medical manufacturers like Avanthi, Inc. Medical manufacturers like Avanthi, Inc. are a money-making machine whose sole purpose is to generate revenue for stockholders. As evidenced by the allegations the U.S. Food and Drug Administration (FDA), made against Avanthi, it is clear that Avanthi is trying to take advantage of America’s fight to tackle obesity while endangering the people for whom Avanthi designed the drug to help.
Holding companies liable for their actions accountable for their actions which generate millions upon millions of dollars in revenue while victimizing others is the reason why Parker Waichman LLP exists. Parker Waichman LLP’s drug defect lawyers have developed the knowledge, training, and experience to recover over $2 billion in damages for their clients. Contact Parker Waichman LLP today and see for yourself how their drug defect attorneys can help you obtain a substantial financial award. Parker Waichman LLP will vigorously pursue compensation for your medical bills, future medical costs, lost wages, as well as pain and suffering, or recover for the wrongful death of your loved one caused by a drug manufacturer’s failure to warn their clients about the dangers of taking Lomaira or another drug marketed in the U.S.
FDA Alleges Avanthi Failed to Disclose Vital Information
Lomaira manufacturer Avanthi owes the public a duty to inform doctors, who in turn must counsel their patients, that taking Lomaira comes with risks. According to the FDA, Avanthi failed to do so. Instead, Avanthi openly marketed Lomaira, which is a medication designed to control a person’s weight, without disclosing that the drug has serious side effects which are potentially lethal as required by FDA regulations. The FDA requires that every piece of marketing material, from magazine ads to television spots, and even posters displayed at medical conventions to experts who should understand that every medicine has the potential of causing severe side effects, contain accurate information about the risks and limitations of the drug.
The generic name for Lomaira is phentermine hydrochloride (HCl) USP. Avanthi produced the medication in 8 mg tablets. Phentermine is one of the active ingredients in a pill more commonly known as “fen-phen.” Healthcare professionals linked fen-phen to a host of heart ailments and lethal interactions requiring drug manufacturers to pull the product from stores shelves in the late 1990s.
The FDA learned of Avanthi’s disregard for its duty to warn after a marketing Lomaira at medical conventions in March and April of 2017, respectively. The FDA alleges that Avanthi, and its partner in the United States, KVK Tech, Inc., specifically marketed its product to the conventioneers without informing them of the possible side effects that could appear while taking Lomaira.
Avanthi strategically placed an advertising billboard at the conventions to draw attendees’ attention to its new weight loss drug. The advertisement colorfully depicted Lomaira as a significant contributor to weight loss for people struggling with obesity. Avathi claimed that doctors should prescribe Lomaira as one part of the three-component plan to accelerate weight loss. Avanthi pointed out that diet, or caloric restriction, and exercise, or behavioral modification, along with Lomaira can help patients reduce weight. Avanthi implies the safety of the drug in its marketing materials. Furthermore, Avanthi’s marketing poster implied that the FDA approved of the claims Avanthi made about Lomaira.
Avanthi knew or should have known that its advertisement violated FDA regulations relating to the ethical marketing of Lomaira. Studies have consistently shown that long-term use of phentermine, the active ingredient of Lomaira, can cause severe, and possibly fatal, side effects. The results of these studies were widely publicized and existed long before March and Paril of 2017.
Phentermine uses can cause substantial health problems. Researchers connected phentermine to increased blood pressure, heart valve malfunction, palpitations, insomnia, among other complications. Phentermine can become addictive as well. Most notably, researchers indicate that phentermine can lead to “Primary Pulmonary Hypertension.” Doctors changed the name of the disease to “Pulmonary Arterial Hypertension” or PAH. PAH is an increase in blood pressure in the arteries of the lungs. PPH also affects the right side of the patient’s heart.
PAH has a variety of symptoms. Symptoms of PAH include:
- Shortness of breath,
- Heart palpitations which are an accelerated heartbeat that flutters,
- Loss of balance or a sense of feeling dizzy,
- Lips turning blue in appearance,
- The general feeling of fatigue, and
- Severe swelling in legs and ankles which is known as edema.
Any person experiencing these symptoms after taking Lomaira or any other medication containing phentermine must seek immediate medical help.
PAH is fatal in approximately 33% of all patients suffering from the malady. While the mortality rate remains exceptionally high, it is a drastic improvement from the 50% mortality rate which existed only a few years ago. There is hope in the medical community that new treatments will emerge with concerted effort and increase a person’s chance of survival.
The FDA Response to Avanthi
As a consequence of Avanthi’s blatant disregard for the safety and well-being of its consumers, the FDA sternly reprimanded the company in a letter addressed to Avanthi on December 19, 2017. The warning letter sent by the FDA to Avanthi unambiguously describes the nature of the allegations advanced by the FDA as to the irresponsible conduct of Avanthi. The letter demanded Avanthi “cease and desist” its current marketing campaign for Lomaira. The FDA also advised Avanthi that the agency will take legal action against Avanthi if the company refused or failed to correct the misrepresentations immediately.
In its letter, the FDA stated that Avanthi failed to post any information relating to the approved labeling and uses permitted by the FDA. For instance, Avanthi’s marketing material omitted any reference to the fact that the FDA approved Lomaira for short-term use that should last only a few weeks. Additionally, the FDA permits physicians to prescribe Lomaira to people who are morbidly obese. Without those limitations, the advertisement appears to be a long-term solution for weight loss that is safe for everyone to use as a means to control his or her weight. In actuality, however, the FDA approved Lomaira for use in relatively rare circumstances.
By virtue of the authority granted to the FDA, the agency demanded compliance with its regulations without delay. The FDA warned Avanthi that any refusal to comply with its demands would result in the FDA taking significant legal action including enjoining Avanthi from distributing Lomaira or seizing all of the medication.
Free Case Review With Our Lomaira Lawsuit Attorneys
Failing to warn is a severe violation of duty committed by any drug manufacturer. Parker Waichman LLP has held numerous drug companies liable for their actions which have caused injuries, illness, and death to people who took drugs without receiving a warning about the possible consequences. Call Parker Waichman LLP today at 1-800-YOURLAWYER (1-800-968-7529) or use our contact form to speak with experienced Lomaira lawsuit lawyers about your claim for damages.
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