Like it or not--deny it or not--image is important to all of us. How we define ourselves is partly shaped by how we are perceived, or at least how we *think* we are perceived, by others.
One area that commands a great deal of attention during our normal routine is our hair. It's a vital element to many people's self-image; hair loss tends to be stigmatized in consumer culture as a sign of devaluation. It can be difficult and expensive to treat or hide hair loss, and as a big part of one's self-image, it can be a significant blow to permanently lose it.
Keeping this idea in mind, it's not surprising that consumers are currently seeking legal action against two companies that make products which can allegedly cause permanent hair loss--of which possibility the companies did not warn users. The products are certainly differently purposed; one, Taxotere, is a chemical agent used in chemotherapy treatments for aggressive forms of cancer. The other, Chaz Dean's WEN Hair Care product, is a hair treatment available for purchase through Home Shopping/QVC television shows and through his commercial website.
I understand and appreciate the importance of one's appearance toward confidence and overall well-being, and both products' manufacturers have apparently been negligent in the creation and promotion of their products. Despite their radically different uses, it seems as though both products' manufacturers have some answering to do.
Taxotere: The Case Against a Chemo Drug
Taxotere, the marketed brand name of the drug docetaxel, is a taxane-class drug manufactured by Sanofi-Aventis Pharmaceutical. It received FDA approval in 1996, and is used intravenously in combination with several other drugs (for the curious: capecitabine, cisplatin, fluorouracil, doxorubicin, cyclophosphamide) to treat breast, head/neck, prostate, lung, and stomach cancers.
Taxotere is at its core a synthetic distillation of a drug that already existed on the market called Taxol. Made by Bristol-Myers Squibb, Taxol is also used as a component of intravenous chemotherapy. Sanofi-Aventis sensed a chance to branch into a market with few competitors and synthesized Taxotere, which packs about twice the punch of a Taxol dose. It seems at first glance like a stronger medicine would be better; the company itself embraced this line of thinking, advertising for several years that Taxotere is safer and more effective than similar treatments, including Taxol. Of course, reality shakes this theory apart almost immediately. Chemotherapy unfortunately involves the injection of harmful chemicals--using one adverse element to conquer another. "Double the chemicals" does not equate to "twice the healing."
One of the unfortunate truths long known about cancer treatment is that it can involve a significant amount of hair loss. Chemotherapy targets mitotic (rapidly-dividing) cells in the body; while this is often an effective method of destroying cancer cells before they can propagate, it has the unfortunate side effect of targeting hair follicles, which also reproduce quickly. During the course of treatment, a cancer patient can lose hair all over his or her body, including eyebrows and eyelashes. However, if the cancer is successfully treated and the therapy concludes, many patients have a chance of gradually re-growing their lost hair, especially on the scalp, over a period of three to six months. Hair regrowth is regarded by many to be a vital psychological element of cancer survival, as it is a visual reminder of having overcome a tremendous obstacle, as well as a visual metaphor for the regaining of one's former health.
The primary focus of the Taxotere litigation is that its use seems to halt this hair regeneration, even after chemotherapy has concluded. The composition of synthetic docetaxel is alleged to cause permanent hair loss, called alopecia. Patients experience the hair loss differently, but a published study in the Annals of Oncology focused primarily on female patients who experienced permanent alopecia on their scalps after Taxotere's use during their therapy. The study was conclusive enough that it prompted the Food and Drug Administration (FDA) to publicly release information about the risk in December of 2015, to be included on Taxotere's future warning labels.
The specific wording of the approved FDA addition to the drug's label is:
"Cases of permanent alopecia have been reported."
No recall has been issued, but a formal federal acknowledgment of a previously-unknown issue is often an indication that the company breached its duty to its end-users, and that tends to be the opening shot of a negligence allegation against a drug manufacturer. Because permanent alopecia should have been announced by Sanofi-Aventis since day one, its absence from the label constituted grounds for action.
Pursuing Damages for Persistent Alopecia
What compounds this failure to warn is knowing that Sanofi-Aventis conducted studies in 2006 related this matter. Their findings suggested that approximately three percent of women developed alopecia after undergoing treatment with Taxotere. The same year, a follow-up study from the Rocky Mountain Cancer Centers showed the company's estimate to be off by as much as 100%. The study concluded that over six percent of women who were treated for breast cancer with Taxotere experienced the loss of at least half of their hair. The drugmaker took no action despite this knowledge, and continued to aggressively market the drug.
While it will likely be a few years before the claims filed against Sanofi-Aventis are successfully resolved (the litigation is fairly new, as the FDA warning will likely be considered the starting point for claims), many women are seeking the assistance of product liability attorneys. Many feel that their victory against cancer is marred by their inability to regrow their hair. Further knowledge that the company has been aware of this risk for over a decade with no interest in disclosing it does not speak well toward its defense.
The company might argue in its own defense that hair loss seems like a small price to pay to be rid of aggressive metastatic cancer--that the benefit outweighs the cost. Ironically, a cost/benefit analysis is most likely what sent them to court in the first place. Since they were aware of this matter since 2006, it is reasonable to assume that one or more meetings took place between the company's executives, in which they weighed the merits of recalling the product versus settling potential lawsuits if/when the public got wind of the problem. This exact debate happens all the time behind closed boardroom doors in corporate America, and far too often profit wins over pathos. Moreover, this argument is difficult to prop up given Taxotere has not been proven to be objectively better than its competitors, including Taxol and the other major taxane derivative, paclitaxel. Both of these drugs have similar success rates to Taxotere's and have not been shown to cause persistent alopecia.
WEN Hair Care: A Popular Shampoo with Some (Alleged) Problems
Beauty and wellness products have steadily increased in revenue over the last decade and beyond, from roughly $48 billion in 2006 to a projected $62.46 billion by the end of 2016. The ease of shopping at home and through the Internet saw enormous increases in sales in virtually every market, and wellness products are no exception.
"WEN by Chaz Dean Cleansing Conditioner" hair care products hit the market in 2008 and developed a strong following. Over ten million units of the supposed "single-step, five-in-one formula" have shipped to eager customers who pay dearly for its alleged formula of "special ingredients, including natural botanicals and herbs." With hair-care guru Chaz Dean as the public face of the product, the marketing firm Guthy Renker, LLC continues to aggressively market its product on informercials, shopping networks, and the Internet.
Accounts of hair loss due to these products have been trickling in since 2010, with a major surge in reports over the last couple of years. The FDA has awarded WEN the dubious honor of having "the largest number of [safety] reports ever associated with any cosmetic hair cleansing product." As of July's tally, 127 official "adverse event reports" were registered with the FDA, and over 21,000 complaints had been filed with the manufacturers themselves. Claimants suggest that using the product, regardless of which signature fragrance they chose, led to a variety of symptoms, including hair breakage and loss as well as skin irritation and scalp rashes. They have analyzed the complaints and determined that the product's Sweet Almond Mint fragrance appears to lead the pack in terms of adverse reports, but all three primary types of Cleansing Conditioner have racked up thousands of complaints between them. The federal agency has launched a formal investigation into the complaints, but as of yet has reached no specific conclusions. In a recent release answering some frequently-asked questions, a representative stated:
"We don't have enough information to determine the cause of these reactions...The law does not require cosmetic companies to share their safety data or consumer complaints with the FDA. The complaints that have come directly to the FDA have not provided enough information to determine why some consumers experienced reactions when they used these products."
Nobody is yet certain of the specific cause behind thousands of women's alarming photos of fistfuls of their brittle hair, lost during simple brushing. Even more heartbreaking are the parents who took to social media to share horror stories of their children's hair loss after using WEN conditioner. The hair products certainly seem to be a unifying thread among these depilatory horror stories, but official records so far don't contain indictments of Dean or Guthy-Renker. People speculate that perhaps a large "bad batch" was produced and shipped with an imbalance of ingredients, or perhaps that a secret "formula change" was green-lit without public disclosure. WEN has been offering refunds for the purposes of "customer satisfaction," but those involved on the supply-side have steadfastly denied any culpability in this matter, and is clear that the refunds are not to be construed as official admissions of wrongdoing.
Pursuing Damages for Hair Loss
Having personally spoken to dozens of women affected by this issue, I can attest that their hair loss cost them dearly on a personal, emotional level. Vacations were ruined, appointments cancelled, reputations and social lives destroyed. Worse, most of them seemed to be flabbergasted that a product with such a widespread and faithful following could have done such a thing to them, and had no idea how to go about restoring what had been taken away.
It doesn't look like Guthy-Renker has any interest in coming clean, so if the FDA investigation shows proof of wrongdoing, the case against WEN Hair Care will be a matter of a purely faulty product. It purports to clean and strengthen hair, but instead allegedly destroys it and causes it to fall out. It is in essence an allegedly bad product, and in its failure to perform as advertised, it is proof of negligence on the part of its manufacturers and marketers. Given that the hair loss may be permanent for many victims, compensation seems to be in order. As of December 2015, approximately 200 women from forty states have joined in a class-action lawsuit against Guthy-Renker, LLC and Chaz Dean, Inc. with this goal in mind.
Both companies so far vigorously defend their innocence:
"There is no scientific evidence to support any claim that our hair care products caused anyone to lose their hair. There are many reasons why individuals may lose their hair, all unrelated to Wen. We intend to vigorously contest the allegations made. We take great pride in the quality of our products and believe every product meets our high standards. We want all of our customers to have positive experiences with our products, and we encourage any customer with any questions to contact us."
The companies will no doubt do their utmost to avoid liability in court; it is the right of any company to defend itself against allegations, the same as individuals. Due process can't be selective, or the system falls apart. One argument that would likely see some effective use will be the discovery of confounders in a patient's history. Confounders are additional elements present in a plaintiff's history that conceivably could have been the source of her injury. If any of these elements can be found in a patient's medical history, a defendant can argue them as contributing factors, potentially canceling or at least lessening their responsibility to the plaintiff.
Many disparate elements have been shown via clinical studies to contribute to female hair loss. Women with histories of smoking, thyroid disorders, or hormonal disruption via hysterectomy or menopause are all at increased risk of hair loss. The defendant would argue the presence of these confounders are a mitigating factor, and their presence means that WEN cannot necessarily be pointed to as the proximate cause of the hair loss. This argument seems a little spurious, since wholesale hair loss may not have begun until after WEN was used, but unfortunately confounders often find a great deal of traction when defense argues its case.
What Both Cases Have in Common
While these two products are made for very-different purposes, they are alike in that--allegedly--they cause hair loss during their typical use. For one, this condition is to be reasonably expected, but is supposed to be reversed after its use is complete. For the other, applying the product should cause more or less the precise opposite of hair loss, being that it is a product to clean, moisturize, and strengthen hair.
Both products are being investigated for adverse events reported to the FDA, after they failed to perform in the manner they are meant to. In one case, there is documented proof that the adverse event occurs, and the responsible manufacturer has allegedly failed to do anything about the information for approximately a decade. In the other case, complaints have been occasionally filed since 2010, but the company has staunchly defended its innocence with relation to the reported problems.
In both scenarios, plaintiffs have lost their hair--perhaps permanently. Those suggesting that this is a superficial loss fail to take into account the psychological impact irreversible hair loss can have on an affected party. If the plaintiffs were not warned that such an effect could occur, it cannot be argued that they provided informed consent, in which they decided to make use of the product after being made fully aware of its risks. Naturally, some risks are inherent in chemotherapy that are not present in shampoo, but in neither situation was the end-user apprised of the possibility they might never regrow their hair. When robbed of the information necessary to provide informed consent, people have a right to pursue damages against the company that (allegedly) negligently provided the (allegedly) faulty product.
If I can wax idealistic for a moment, I don't believe there is any justification for putting profits before the needs of customers and clients; they are, after all, the reason those profits exist. To ignore potentially harmful information about a product because it might cost time, effort, and money to fix it is not acceptable. If a corporation fails to be proactive about preventing harm to its users, then those injured parties deserve their day in court. Be it medicine or shampoo, if harm is done then justice must be sought.