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On November 18, 2008, a panel of independent advisers urged the FDA to revise the labeling of cosmetic facial fillers to include the possibility of long lasting reactions such as bumps under the skin, blotches and scars.

“It is almost a no-brainer,” said Dr. Michael Bigby, a Harvard Medical School dermatologist. “The current label is not adequate.” The gel-like fillers, which have become hugely popular in the last few years, are injected into the face to smooth away wrinkles.

Manufacturers and plastic surgeons say fillers have an excellent safety record. But this recent FDA hearing raised questions about unapproved uses, untrained technicians giving injections, and a lack of long-term safety data. The hearing was a first step as the FDA considers whether to regulate fillers more closely.

Plastic surgeons pledged to help the government track safety, improve training and provide clearer information to consumers. Women, and even some men, are drawn to skin fillers by the promise of youthful good looks at far less cost and trouble than a face lift. A touchup two or three times a year can boost deflated middle-age egos. Unfortunately, for some patients, the result can be blotchy skin, bumps on the face and worse.

Different from Botox, which is derived from a toxin that acts on facial muscles, wrinkle fillers are like the biological equivalent of a bit of spackle, except they’re injected into the face. They include such products as Juvederm, made by Allergan, Inc., and Restylane, from Medicis Aesthetics Holdings.

FDA officials are concerned that fillers are being used for purposes they were never tested and approved for, such as plumping the lips, which are extremely sensitive.

There are also questions about a lack of clinical evidence on how darker-skinned patients fare with the beauty treatments. More African American, Latino and Asian patients are trying plastic surgery, and some information suggests they may be susceptible to unsightly blotches and other complications from fillers.

“The trouble is that once this material is in the hands of physicians, there’s really not much control over how it’s used and where it’s placed,” said Dr. Scott Spear, a Washington plastic surgeon. “That creates the potential for a certain amount of mischief.

“But the good news is that, by and large, these are very safe materials,” Spear added. “They have a very healthy risk profile.”

FDA scientists will present the advisory panel with data on 823 patients who suffered serious reactions after treatment with fillers between 2003 and this September. The overwhelming majority were women, and the most common age group was 50- to 60-year-olds. Plastic surgeons performed some 1.5 million cosmetic surgery procedures with fillers last year alone.

Although no deaths were reported to the FDA, the complications were troublesome enough that 638 of the patients required follow-up medical treatment.

Most reactions involved minor swelling and redness, complications that could be expected. But the FDA said it also received reports of “serious and unexpected” problems, including facial, lip and eye paralysis, disfigurement, vision complications and some severe allergic reactions.

A small number of patients, 19 went to the emergency room with life-threatening allergic reactions, such as difficulty breathing. Twelve developed infections that required hospitalization.

“The FDA has been rushing these products to market as if they were lifesaving medical products,” said consumer activist Diana Zuckerman, president of the National Research Center for Women & Families. “They should be requiring better studies since these products have only cosmetic benefits but potentially lethal risks.”

Some problems reported to the FDA may be due to unapproved or “off-label” use of fillers. For example, the FDA does not recommend them for plumping the lips, but some doctors see no problem with that.

Another challenge is the sheer variety of fillers. Most are eventually absorbed into the body, but one type contains tiny, round, smooth plastic particles that the body does not absorb. Some are made from natural substances and others are not. That means they may react differently in the body.

On October 9, 2008, Health Canada announced that the agency began investigating the deaths of five people who had been injected with Botox, and serious reactions in another eight cases. All the deaths involved people who were treated for such medical conditions as neck and muscle spasms.

Two of the deaths occurred in children with cerebral palsy, including a nine-year-old boy given Botox for drooling, a condition for which the drug hasn’t been approved.

The reactions suggest the botulinum toxin may have spread to other parts of the body beyond where it was injected, according to Health Canada. Only one of the 13 reports Health Canada had received as of March 28 involved using Botox for wrinkles, and none was medically confirmed as “distant toxin spread,” according to the agency’s most recent adverse reaction newsletter.

However, “10 of the 13 cases were deemed to be serious owing to life-threatening reaction (one case), hospitalization (three cases), ongoing disability (one case) or fatal outcome (five cases).”

Adverse reactions included throat swelling, respiratory arrest, difficulty swallowing and aspiration pneumonia, and infection that takes place when food or liquids are inhaled into the respiratory tract and lungs.

The reports are based on suspicion only and could be due to an underlying illness or some other factor, Health Canada says.

Allergan Inc., the makers of Botox, says reported adverse reactions are rare and don’t prove cause-and-effect.

“If you look at its entire 18-year history that the product has been on the market in Canada, and 20 years worldwide, serious adverse event reports have been rare with this product,” said spokeswoman Caroline Van Hove. More than 14 million Botox vials for medical use have been distributed worldwide since the product was approved in 1989; another four million vials have been distributed for cosmetic use.

Health Canada announced an ongoing safety review of Botox in February following reports from the U.S. linking Botox and a similar drug, Myobloc, to adverse reactions, including respiratory failure and death.

The Canadian deaths included three women in their 60s, all of whom had underlying medical conditions such as Parkinson’s or cerebral palsy. A 13-year-old boy with cerebral palsy and severe seizure disorder died after receiving Botox for muscle spasms.

Allergan is updating its product information to note rare reports of muscle weakness and other serious adverse events in children and adults, Van Hove said.

She said people treated with Botox for medical conditions such as muscle contractions receive far higher doses than a healthy adult would for wrinkling.

Consumer advocacy group Public Citizen has petitioned the U.S. Food and Drug Administration to issue warnings to doctors about the use of botulinum toxin products available in the U.S. as Botox and Myobloc  including hospitalizations and deaths. The group wants a “black box” added to product labels and an information pamphlet given to patients when the drug is injected.

In Canada, Botox is approved for medical conditions such as uncontrollable muscle contractions, crossed eyes and excessive underarm sweating. Botox Cosmetic is approved for glabellar lines, the vertical lines between the eyebrows, forehead wrinkles and crow’s feet.

But “nobody knows what happens when you go to another part of the body,” said Dr. Sydney Wolfe, director of Public Citizen’s Health Research Group. His group worries about the uses of Botox for unapproved applications, and at higher than approved doses.

Health Canada is asking doctors to report any adverse reactions suspected of being associated with Botox or Botox Cosmetic.

Mark & Associates, P.C. and McGinnis, Lochridge, Kilgore, L.L.P., have filed a civil lawsuit on July 10, 2008 against Botox-maker Allergan, Inc. (NYSE: AGN) for negligent failures in the design, manufacturing and marketing of the popular anti-wrinkle drug that has caused patient deaths and injuries. The suit, filed in the Superior Court of California, Orange County, (Case No. 00180033) on behalf of 15 plaintiffs from across the nation, seeks unspecified compensatory and punitive damages. Allergan is based in Irvine, California. A copy of the complaint is available at www.BotoxLegalRights.com.

In addition to alleging design and manufacturing flaws, the suit claims that Allergan continues to promote “off label” uses of Botox for treating patients with cerebral palsy and other uses that have not been approved by the Food and Drug Administration. Allergan also fails to properly warn Botox users of the possibility of fatal and life-threatening injuries from Botox injections and fails to inform physicians and health care providers about all known risks of the drug, including death.

Ray Chester, lead counsel in the Botox litigation from McGinnis, Lochridge, Kilgore, L.L.P., and Jason Mark from Mark & Associates, P.C., continue to evaluate cases involving Botox deaths and injuries on behalf of patients who used the drug for cosmetic and therapeutic purposes. Free case consultations are available by calling 1-866-50-RIGHTS (1-866-507-4448) or by completing an inquiry on www.BotoxLegalRights.com.

Select Plaintiff Profiles

• A seven-year-old girl from Amarillo, Texas who died in 2007 after receiving Botox injections intended to treat her limp spasticity, caused by cerebral palsy. The girl developed pneumonia after undergoing Botox treatments and died. The suit is being brought on behalf of the girl’s mother who is suing for damages from the death of her daughter.
• A four-year-old boy from Maryland who died in 2007 after undergoing Botox treatments. His parents have filed suit on behalf of their deceased son.
• A sixty-nine-year-old woman who died in March 2008 after undergoing Botox treatments. The victim, a registered nurse, received Botox injections in 2007 in an attempt to lessen neck and shoulder pain. Following a series of Botox treatments, she developed severe dysphasia, lost about 50 pounds, and died of aspiration and malnutrition. Her children are suing for the death of their mother.
• A New Jersey man who died in April, 2008 as a result of Botox injections. The man’s brother has filed suit on behalf of his deceased brother.

What is Botox?

The active ingredient in Botox is Botulinum Toxin A, a purified and diluted form of botulism, which causes muscle paralysis. By temporarily stopping muscle movement, Botox can be effective in reducing the appearance of wrinkles in the skin, particularly around the eyes, nose and mouth. Botox is approved for cosmetic uses and select medical indications, including: Cervical dystonia, Blepharospasm, Strabismus, and excessive underarm sweating.

FDA Has Warned of Botox Dangers

In February 2008, the Food and Drug Administration issued a public health warning to consumers and health care providers after receiving reports of deaths, breathing problems, and other adverse reactions caused by Botox. Many of the deaths and injuries involved unapproved, “off label” uses of Botox in cerebral palsy patients suffering from muscle spasms. “Botulinum toxin is one of the most potent neurotoxins known, and injecting it at high doses is simply inviting catastrophe. The manufacturer’s promotion of that practice without properly informing patients and the medical community of the potential consequences is outrageous,” commented Jason Mark, the founding partner of Mark & Associates.

About Mark & Associates, P.C.

Mark & Associates, P.C. has offices in Boston, Massachusetts and Long Island, New York. The firm aggressively represents victims of securities and investment fraud, insurance bad faith, defective products, dangerous pharmaceuticals and medical devices and serious accidents. More information on Mark & Associates, P.C. is available at www.youhaverights.com.

About McGinnis, Lochridge, Kilgore, L.L.P.

McGinnis, Lochridge, Kilgore, L.L.P. is a multi-practice Texas law firm with offices in Austin and Houston. The firm has earned a prominent reputation for professional excellence by guiding its clients to pragmatic solutions in lawsuits, business, and government. For over 75 years, clients have relied on the firm’s talent, experience, and strength to achieve their goals and protect their interests.