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Total Body Formula no Rx for health, sickens 197

Supplement recalled after hair falls out, kidneys fail, joints ache

By ALISON YOUNG

The Atlanta Journal-Constitution

Over the years, a Woodstock company’s fruit-flavored vitamin supplement gained a loyal following. Customers swore it made them healthier and their testimonials persuaded friends and family to take it, too.

They never imagined it would be the cause of bizarre and frightening symptoms that stumped their doctors.

At least 197 people in a dozen states — 53 of them in Georgia — were sickened earlier this year after taking the liquid supplement Total Body Formula. Their hair fell out in clumps, their fingernails fell off. They suffered nausea, vomiting and fatigue. Some had disabling joint pain, according to the Centers for Disease Control and Prevention and state health officials.

Doctors treating 21-year-old Felicia Blasingame of Acworth this spring first thought she had the flu, then tested her for everything from parasites to lupus to rheumatoid arthritis, trying to figure out what was causing her nausea, seizures, knee pain and hair loss, she said.

Edgar Gurley, 78, of Marietta said he went from being active and healthy to suddenly in January battling a cascading array of symptoms, including diarrhea, fatigue and confusion. Gurley said doctors struggled to explain why his blood chemistry and thyroid levels were out of whack, his kidneys were failing and his hair was falling out.

As their symptoms worsened, Blasingame and Gurley said they continued to take their daily 1-ounce dose of Total Body Formula, thinking it was critical to their health.

Yet several batches of Total Body Formula and Total Body Mega Formula contained hazardous amounts of the mineral selenium — up to 40,800 micrograms per serving, 200 times the amount listed on the product’s label, according to the U.S. Food and Drug Administration.

The FDA is still investigating how this happened, and state health officials are still tallying the human toll.

Because of several pending lawsuits, lawyers for three companies involved in the manufacture and sale of Total Body products declined to discuss what happened.

3 FDA Warnings

Total Body is one of more than two dozen dietary and herbal supplements that in the past year have been the subject of product recalls or FDA warnings because of various safety issues.

Officials at the Council for Responsible Nutrition, an industry group that represents major supplement companies, said problems such as those with Total Body Formula or recalls involving tainted products are rare.

“The overwhelming majority of dietary supplements on the market are safe and they do what they claim to do,” said Andrew Shao, the council’s vice president for scientific and regulatory affairs.

Problems with Total Body Formula products began in January as the first victims fell ill, but health officials were unaware for two more months. Alarm bells went off in early March after a Florida chiropractor notified state health officials about a cluster of patients with unusual hair loss, muscle cramps, nausea and diarrhea. All, it turned out, had used Total Body supplements.

“If he hadn’t said anything to anybody, we might not have known about it,” said Roberta Hammond, the Florida Department of Health’s food and waterborne disease coordinator.

On March 27, the FDA issued the first of three warnings, advising consumers not to use Total Body Formula in tropical orange and peach nectar flavors and Total Body Mega Formula in orange/tangerine flavor.

Tests by the FDA found the supplement contained high amounts of selenium as well as levels of chromium that were 17 times higher than recommended. Total Body recalled 1,484 bottles of the product from the market. The symptoms users experienced are signs of selenium toxicity, the FDA said.

“Some people have been pretty debilitated by this,” said Paul Melstrom, a CDC Epidemic Intelligence Service officer assigned to the Georgia Division of Public Health.

Severe joint pain and muscle cramps have caused people with physically demanding jobs to miss work. “That’s been a big issue with some folks,” Melstrom said. People who already had arthritis were particularly hard hit, he said. “A few found it very hard to even walk around.”

Others have been traumatized by going bald or losing their fingernails, he said.

State officials continue to track the progress of Georgia’s 53 known cases.

Melstrom is in the process this month of doing a third survey to follow up on checks made in April and June.

He has found that as time has passed and the product has left Total Body users’ systems, some symptoms have improved while others have worsened.

When he made his last round of calls in mid-June, the number of people who still suffered from nausea, vomiting and diarrhea had dropped dramatically since he first interviewed them in the spring. Fewer people had joint pain, but still more than half were affected.

The number of people reporting hair loss increased from 63 percent to 81 percent, he said. Those reporting fingernail discoloration or loss increased from 45 percent to 63 percent. These increases are to be expected because it takes longer for selenium to reach hair and nails, which have little blood flow, Melstrom said.

New Regulation

Nobody knows how many consumers are harmed each year by dietary supplements. A recent study of 275 calls to a California poison control center about dietary supplements concluded that most adverse reactions are likely minor. But the study found that moderate to severe reactions, even death, occur, especially involving products containing stimulants such as caffeine and yohimbe.

A new regulation that took effect late last year requires for the first time that supplement companies notify the FDA about customer illnesses. But they only have to report serious, life-threatening or deadly events. Still, in the first six months of this year, supplement firms have filed 368 of these mandatory reports, the FDA said.

Most of the symptoms experienced earlier this year by users of Total Body Formula supplements — hair loss, nausea, joint pain and the like — would not qualify as serious enough for mandatory reporting, FDA officials said.

Despite health alerts sent out by the FDA and the CDC, Blasingame and Gurley and their doctors remained unaware throughout the spring that federal officials had an explanation for the illnesses.

Gurley — who had been to numerous specialists and had met with a surgeon about removing his thyroid — said he didn’t learn of the Total Body recall until late April when he went back to a Marietta health food store to get another bottle before he ran out.

Blasingame didn’t know there was a problem with the product until May — after numerous doctors’ appointments, a trip to the hospital for seizures and invasive gastrointestinal tests. She was in the office of a new doctor, a dermatologist, seeking a second opinion about why her long hair was falling out by the handful. The doctor had seen the alerts and asked her whether she took the supplement.

“At first I was really relieved to know the reason for everything that was going on,” Blasingame said. “After that, I got really angry because this was something that could have been prevented.”

Blasingame and Gurley have sued Total Body Essential Nutrition, the supplement’s seller. They and consumers in several other states also have sued two other firms that manufactured the product for Total Body: TexAmerican Food Blending of Hot Springs, Ark., and Wright Enrichment of Crowley, La.

Total Body Essential Nutrition only markets and sells the product, said Rod Cate, an attorney for the company. “They have nothing to do with the manufacturing process. [Total Body] relies upon the manufacturers to do it correctly,” he said.

No Treatment

Wright Enrichment attorney Dino Gankendorff said the company denies any liability and stands behind its product. An attorney for TexAmerican declined to comment.

Jennifer Thomas, enforcement division director in the FDA’s Center for Food Safety and Applied Nutrition, said she can’t say what the agency’s investigation has found so far.

There’s no treatment for selenium or chromium poisoning, federal health officials said, and symptoms are expected to go away on their own over time. But recovery will vary depending on how much of the product a person consumed and their underlying health problems.

Blasingame says she’s no longer nauseated, her energy is returning and her hair is growing back. But she worries whether there’s been any long-term damage to her liver or kidneys.

Gurley said he continues to suffer serious health problems that he blames on the product.

“I am very close to having to go into dialysis,” said Gurley, whose doctor is checking his blood every two weeks. Kidney failure can be caused by excessive consumption of chromium.

Gurley said he’s lost the ability to drive and suffers from continued gastrointestinal problems that make it impossible to sleep or go to the American Legion hall to play cards with his buddies.

While he worries about his own future, he fears there may be others who are still taking the product. Each 32-ounce bottle contained enough doses for a month. “I’m sure there are people who still don’t know,” he said.

TOTAL BODY FORMULA RECALL

Products covered by the recall, announced in March:

• Total Body Tropical Orange — lot nos. 4016801, 4024801 and 4031801

• Total Body Peach Nectar — lot nos. 4016802 and 4031802

• Total Body Mega Orange/Tangerine — lot no. 4031803

Consumers should stop taking these products and consult a health professional if they’ve experienced adverse reactions.

To report an adverse reaction to a dietary supplement or drug:

FDA’s MedWatch program at 1-800-FDA-1088 or online at www.fda.gov/medwatch/how.htm

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Divorced parents – Who has standing to bring a wrongful-death action when their child is killed?

There is no question that divorced parents equally share in the distribution of any proceeds realized in a wrongful-death action arising out of the death of their minor child. Ala. Code § 6-5-391(c)(“Any damages recovered in an action under this section shall be distributed according to the laws of intestate succession.”). Thus, as to the distribution of the ultimate proceeds, which of the divorced parents commences the wrongful-death action is immaterial. At the same time, the divorced parent who commences the wrongful-death action chooses the attorney who handles the matter and acts as the quasi-fiduciary in the prosecution of the lawsuit. Unfortunately, presently, in some scenarios, there may be uncertainty as to whether both divorced parents have equal standing to commence the wrongful-death action.

By statute, there can be but one action for the wrongful death of a minor child. Ala. Code § 6-5-391(b)(“An action … for wrongful death of the minor shall be a bar to another action either under this section or under Section 6-5-410.”). A viable, first-filed wrongful-death action acts as a legal bar to any second-filed wrongful-death action. If both divorced parents have standing to commence a wrongful-death action, then, one divorced parent can retain legal representation and can “race to the courthouse” to be first to file a wrongful-death complaint. Therefore, when representing a divorced parent whose child has been killed due to the wrongful conduct of another, it must be first determined whether the client parent has standing to commence a wrongful-death action, because, if not, any representation is limited to ensuring that the client parent receives the correct distribution and will not include any attorney fees associated with the prosecution of the wrongful-death action.

Presently lacking is a firm determination as to when both divorced parents have equal authority to commence the wrongful-death action. The applicable statute reads: “When the death of a minor child is caused by the wrongful act, omission, or negligence of any person, persons, or corporation, or the servants or agents of either, the father[ ] or the mother as specified in Section 6-5-390 … may commence an action.” Ala. Code § 6-5-391(a). While § 6-5-390 is clear that parents “lawfully living together as husband and wife … have an equal right to commence” the wrongful-death action, the section’s language regarding divorced parents is far less certain, particularly if the divorce occurred after January 1, 1997. Section 6-5-390 states: “[H]owever, that in the event such mother and father are not lawfully living together as husband and wife, … the party having legal custody of such minor child shall have exclusive right to commence such action.” This statutory provision contains no definition of “legal custody.”

For divorces finalized prior to January 1, 1997, it was “settled” law that the custodial parent had an exclusive right to commence a wrongful-death action arising out of the death of divorced parents’ minor child. Carter v. Beaver, 577 So. 2d 448 (Ala. 1991); Miller v. Dismukes, 624 So. 2d 1038 (Ala. 1993); Gladhill v. Lamar County Commission, 698 So. 2d 113 (Ala. 1997). There was a bright-line rule that the parent with primary physical custody of the minor child had “legal custody” and, thus, had an exclusive right to commence the wrongful-death action. The non-custodial parent, typically, the father, had no standing to commence the wrongful-death action.

The enactment of Alabama’s Joint Custody Act, Ala. Code §§ 30-3-150 through -157, most likely, negated this bright-line rule. Pursuant to this Act, “[j]oint custody does not necessarily mean equal physical custody.” Ala. Code § 30-3-150. Divorced parents are “encourage[ed] … to share in the rights and responsibilities of rearing their children after the parents have separated or dissolved their marriage.” Id. In a divorce decree, the parents may be granted “joint custody” of their minor child or children, with “joint custody” defined as “[j]oint legal custody and joint physical custody.” Ala. Code § 30-3-151(1). Alternatively, one parent may be granted sole legal custody and/or physical custody. Most definitely, the Act differentiates legal custody from physical custody, with the former defined as follows: “Both parents have equal rights and responsibilities for major decisions concerning the child, including, but not limited to, the education of the child, health care, and religious training. The court may designate one parent to have sole power to make certain decisions while both parents retain equal rights and responsibilities for other decisions.” Ala. Code §30-3-151(2). In defining, “joint physical custody,” the legislature declared that “[j]oint physical custody does not necessarily mean physical custody of equal durations of time,” that is, one parent may have physical custody for the majority of time. Ala. Code § 30-3-151(3).

How now to determine “legal custody” for purposes of §§ 6-5-390 and -391 when deciding if one divorced parent has an exclusive right to bring a wrongful-death action has yet to be affirmatively decided by the Alabama Supreme Court and the Alabama Legislature has not resolve the issue through further legislation. Quite arguably, having primary physical custody of the deceased child is now immaterial. The salient question involves whether the divorced parents had joint custody or one parent had sole legal custody or whether, in the judgment of divorce, the court designated one parent has having the sole power or authority to bring a wrongful-death action. As to the latter question, while asking a court to make such a designation at the time of the divorce might be an unlikely event, such a designation is possible and the divorce documents should be examined for such a designation. Quite arguably, if the divorced parents were granted joint custody with no designation of a single parent with the power to bring a wrongful-death action, then, neither divorced parent has the exclusive right to commence a wrongful-death action and, instead, both divorced parents have standing to commence a wrongful-death action and, effectively, to “race each other to the courthouse.”

In Nix v. McElrath, 952 So. 2d 1107 (Ala. 2006), the Alabama Supreme Court was able to avoid answering the question of whether, after the enactment of the Joint Custody Act, a parent with primary physical custody had the exclusive authority or standing to commence a wrongful-death action. The parents of Magen were divorced in 2001 with the parents granted joint custody of Magen. The mother, who had primary custody, filed a wrongful-death action; later, the father sought to intervene as an indispensable party. The Supreme Court observed that “[b]oth the father and the mother persuasively argued at the trial level as to which of them, as divorced parents given ‘joint custody,’ have the right to maintain a wrongful-death action … and, secondarily, whether that right is exclusive.” 952 So. 2d at 1110. After noting the father’s concession that issue of the mother’s exclusive right to bring the wrongful-death action was now moot because the mother was the first to file a complaint and because the action was resolved, leaving open only the issue of distributing the recovery, the Supreme Court wrote:

The parties’ divorce was granted April 19, 2001, well after the legislature enacted Alabama’s Joint Custody Act, § 30-3-150, et seq., Ala. Code 1975. Although the terms “primary custody” and “secondary custody” are not defined in the act, the definitional section, § 30-3-151(1), defines “joint custody” as “joint legal custody and joint physical custody.” This terminology does not fit squarely with that portion of § 6-5-390 that provides that “the party having legal custody of such minor child shall have the exclusive right to commence such action.” …

952 So. 2d at 1111. In other words, the Nix Court appreciated the “problem” created by the Joint Custody Act in interpreting the phrase “legal custody” in § 6-5-390 but left the “problem” to be resolved in some future appeal.

In Nix, in its order, the trial court wrote: “It is well established under the Alabama law that the custodial parent of a minor is entitled to maintain a wrongful death action after the minor’s death …. There does not appear to be any Alabama case declaring the rights of the parents to maintain a wrongful death action when the parents were vested with joint legal custody of the minor.” 952 So. 2d at 1109. The trial court further wrote: “In view of the apparent lack of Alabama authority, the court is of the opinion that the better policy is to allow the action to be maintained by the parent who first files the action.” Id. This trial court concluded, without the benefit of any guidance from an Alabama appellate court, that, if joint legal custody was granted, both parents had authority or standing to commence the wrongful-death action and the parents could “race each other to the courthouse.”

Pittman Dutton attorneys have been involved in wrongful-death actions initially commenced by a divorced father where the mother has sought to be substituted as the named plaintiff and challenged the father’s authority or standing. To avoid an adverse ruling by the trial court and the cost of an appellate review, often, an agreement is crafted whereby both divorced parents join in the prosecution of the wrongful-death action with both parents’ counsel sharing in any attorney fees. This solution on the part of a divorced father who is the first to file a complaint begs the ultimate question but may be practical from the perceptive of the father’s attorneys. This solution is dependent on the parties and their respective counsel beginning amiable to cooperating with one another.

In Nix, the mother initially commenced the wrongful-death action and the Alabama Supreme Court found that she had standing to commence the wrongful-death action. While not expressly stated in the opinion, the language implicitly implies that, because the father had been granted joint custody, the father would also have standing to commence the wrongful-death action and the mother would not have had the exclusive right to commence the wrongful-death action and that, if the father had initially filed the complaint, the father could prosecute the action without intervention or interference from the mother. Yet, to date, the Alabama Supreme Court has not be compelled to make the implicit explicit. Likewise, the Alabama Legislature has chosen not to amend the applicable statutes so as to clarify when one parent “has the exclusive right to bring suit,” when the parents have been granted joint custody in a divorce proceeding.

Leigh King Forstman Selected as Preeminent Women Lawyers

Leigh King Forstman was selected for the 2011 Inaugural Edition of the Bar Register of Preeminent Women Lawyers in the field of Civil Trial Practice. The publication recognizes women lawyers who have achieved the “AV Preeminent(TM)” rating, the top ranking in the Martindale-Hubbell Law Directory. The “A” signifies the highest level of legal ability, while the “V” denotes “very high” adherence to the “Professional Code of Responsibility,” in conduct, ethics, reliability and diligence. This rating is the result of a structured peer review and is based upon the confidential opinions of practicing attorneys and members of the judiciary. Forstman was also inducted as a Charter Fellow of the Litigation Counsel of America, a national trial lawyer honorary society recognizing effectiveness and accomplishment in litigation and superior ethical reputation.

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