Reevaluation of Phenylephrine: Unraveling the Credibility Crisis of 2018 FDA Guidelines
Several renowned companies, including the likes of Procter & Gamble, Walgreens, and Johnson & Johnson’s erstwhile consumer business, now known as Kenvue, are being entangled in legal accusations. These corporations are alleged to have perpetuated consumer deception related to over-the-counter cold medicines.
In 2018, the FDA released new guidelines that changed how symptoms related to nasal congestion are viewed. These guidelines suggested that the existing data supporting the effectiveness of phenylephrine were no longer trustworthy.
On September 14, 2023, the FDA clarified its position on the effectiveness of over-the-counter cough and cold products containing phenylephrine. The committee deliberated over fresh data concerning the efficacy of oral phenylephrine and reached a consensus that the existing scientific evidence does not validate the effectiveness of the suggested dose of orally taken phenylephrine as a nasal decongestant. Nonetheless, there were no concerns raised regarding the safety of utilizing oral phenylephrine at the advised dosage, by either the FDA or the committee.
A multitude of lawsuits have emerged, asserting that consumers were misled regarding the efficacy of decongestants containing phenylephrine, an ingredient, which, according to a unanimous panel of advisors to the U.S. Food and Drug Administration (FDA), does not outperform a placebo in relieving congestion. These legal actions emanated post the panel’s examination of various studies, concluding a widespread consensus on the inefficacy of phenylephrine as a decongestant. A staggering 242 million such products were purportedly sold last year, amassing revenue upwards of $1.76 billion and capturing a substantial majority of the oral decongestant market segment.
You may be able to receive monetary compensation if you’ve purchased any of the following over-the-counter decongestants between 2018 and today in NY, NJ, FL, CO, DC, MA, NC, or TX:
- Mucinex Sinus Max
- Tylenol Cold & Flu
- Benadryl Allergy Plus
- Walgreens-branded decongestants
The first product liability lawsuit was filed in a federal court in Pensacola, Florida, accusing both Johnson & Johnson Consumer and Procter & Gamble of consciously disseminating deceptive marketing assertions about the efficiency of their phenylephrine-infused products since 2018. The marketing narratives propagated by these corporations were discredited as “false and deceptive.”
Steve Audelo, the plaintiff and a resident of Florida, proclaimed that his purchase decisions for products like Sudafed PE, Benadryl Allergy Plus, and Vicks NyQuil were significantly influenced by the alleged deceptive claims posited by the implicated companies.
Numerous decongestant lawsuits are being filed against other pharmaceutical giants such as GSK, the maker of TheraFlu; Reckitt Benckiser, the manufacturer of Mucinex Sinus Max; and Walgreens, known for producing generic decongestants. Each of these companies is undergoing similar legal scrutiny for ostensibly misleading consumers through their marketing communications.
In response to the allegations, Johnson & Johnson issued a clarifying statement, emphasizing its non-involvement in the manufacture or sale of the decongestant cold medicines in question and outlining the separation between Johnson & Johnson and its consumer business, now operating under the name Kenvue. The latter, along with other implicated entities, refrained from commenting on the ongoing lawsuits or did not promptly address requests for comments.
How to Begin Your Claim
Have you or your loved ones been misled by deceptive marketing, or have you experienced adverse effects due to potentially misleading products? In a world where consumer rights are increasingly pivotal, it is crucial to assert your legal rights and seek the rightful compensation and justice you deserve. Parker Waichman LLP, a nationally recognized law firm that focuses its practice in product liability, is steadfastly committed to championing the rights of victims misled by unethical product representations or harmed by defective products.
Contact Parker Waichman LLP for your FREE consultation at 1-800-YOUR-LAWYER (1-800-968-7529).
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