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Health: A Recall Is Not Necessarily A Recall

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October 8, 2007

The Testing Lab

 

http://www.nytimes.com/2007/10/08/washington/08consumer.html?_r=1 & th= & oref=slogi\

n & emc=th & pagewanted=print

Dangerous Sealer Stayed on Shelves After Recall By ERIC LIPTON

 

DENVILLE, N.J. — Walter E. Friedel's plans to waterproof the tile floors of

his hot tub room using Stand 'n Seal, a do-it-yourself product sold at his

local Home

Depot<http://topics.nytimes.com/top/news/business/companies/home_depot_inc/index\

..html?inline=nyt-org>,

promised to be a quick weekend project, one he could wrap up in time to

catch the Giants football game on a Sunday afternoon.

 

The product offered " a revolutionary fast way " to seal grout around tiles

and, its label boasted, any extra spray would " evaporate harmlessly. "

 

" It sounds like no big deal, " Dr. Friedel said, looking back.

 

But instead of watching football that afternoon, Dr. Friedel, a 63-year-old

physician, ended up being rushed to the hospital, where he would spend four

days in intensive care, gasping for air, his lungs chemically inflamed.

 

Dr. Friedel was the latest victim of a product whose dangers had become

known months earlier to the Consumer Product Safety

Commission<http://topics.nytimes.com/top/reference/timestopics/organizations/c/c\

onsumer_product_safety_commission/index.html?inline=nyt-org>and

the companies that made and sold it. Before Dr. Friedel bought Stand

'n

Seal, at least 80 people had been sickened using it, two of them fatally.

 

But even then, with the threat well-documented, the manufacturer, retailer

and the commission had failed to remove the hazard from the shelves.

 

The task of getting dangerous products out of consumers' reach is perhaps

the most pressing challenge the Consumer Product Safety Commission faces in

this era of surging recalls, particularly of products from China. It is an

essential part of the agency's mission, because premarket testing is not

required for consumer products in the United States.

 

Nancy A. Nord, the commission's acting chairwoman, said the agency was proud

of its record of moving rapidly and forcefully to pull hazardous products

off the market.

 

" The point is to get the recall out there, to get the consumer informed of

what's happening and then try to get the product out of consumers' hands, "

Ms. Nord said in testimony to a House panel in September. " I think a recall

process works very well. "

 

But the Stand 'n Seal case is a powerful illustration of the commission's

failure to fully live up to its mission.

 

Court documents show that, as the case unfolded, the product's maker, BRTT,

appeared at times to be more concerned with protecting its bottom line than

with taking steps to ensure that the hazard was removed. That meant that

hazardous cans of Stand 'n Seal remained on the shelves for more than a year

after the 2005 recall.

 

And the product that BRTT initially rushed to put in its place — and which

Dr. Friedel and others bought — contained the same chemical that had

apparently caused injuries in the first place, the company and Home Depot

now acknowledge.

 

Critics say the Stand 'n Seal case demonstrates how the Consumer Product

Safety Commission is too overwhelmed with reports of injuries and with new

hazards to comprehensively investigate or follow up on many complaints. The

agency's laboratory is also so antiquated it did not have the equipment

necessary to evaluate fully the remedy BRTT offered — leaving the agency to

rely largely on the company's promise that it would fix the problem.

 

And then, after receiving repeated complaints that the hazard persisted long

after the recall, the agency failed to follow up adequately, documents show.

 

Even if the slip-ups were a result of companies having concealed important

evidence, the commission still has a responsibility to use its enforcement

powers to investigate and, if appropriate, to issue fines. To date, more

than two years after the commission became aware of the problems with Stand

'n Seal, no fines have been issued.

 

" They did not get the job done that consumers expect, and people suffered as

a result, " said R. David Pittle, who served on the commission for a decade

after it was created in 1973, and later as technical director at Consumers

Union<http://topics.nytimes.com/top/reference/timestopics/organizations/c/consum\

ers_union/index.html?inline=nyt-org>,

which publishes Consumer Reports.

 

The problem is compounded because consumers often ignore warnings about

unsafe products, or simply never hear them, and continue to use flawed

products even after recalls have been issued.

 

A lawyer for BRTT, which was then known as the Roanoke Companies, declined

to comment. Home Depot issued a statement saying it never knowingly sold a

hazardous product.

 

" The Home Depot is working with Roanoke to make sure anyone injured from

this product is treated fairly, " the statement said.

 

The commission's own records show a growing list of products that have been

subject to " expanded " recalls, like Stand 'n Seal.

 

" A recall is not necessarily a recall, that is what it comes down to, " said

Stuart L. Goldenberg, a Minneapolis lawyer who represents a family whose

child was injured using an Easy-Bake toy oven. The maker, Hasbro, alerted

consumers about injuries to children's fingers from the ovens, first simply

offering a repair kit, but then expanding to a full-fledged recall after

dozens of additional injuries were reported.

 

And evidence is widespread of hazardous products — even after recalls —

being easy to find for sale, most notably imports from China that often are

sold at discount shops or on the Internet. In one instance, Baltimore health

officials found lead-contaminated toy rings in stores this year, three years

after they had supposedly been pulled from shelves.

 

A New Ingredient

 

Stand 'n Seal seemed like the perfect do-it-yourself product when it came on

the market in late 2003, for sale exclusively at Home Depot stores. Instead

of having to use a paintbrush to apply waterproofing sealant to tile grout,

customers could simply point the can and spray. A cardboard display at Home

Depot stores featured a photograph of a mock customer doing just that —

standing, with no mask, in front of a closed window, spraying the product

onto a bathroom floor.

 

In the spring of 2005, one of Roanoke's suppliers — Easy Care Products of

Scottsdale, Ariz. — switched the active ingredient from a chemical known as

Zonyl 225, made by

DuPont<http://topics.nytimes.com/top/news/business/companies/du_pont_de_nemours_\

and_company_e_i/index.html?inline=nyt-org>,

to a chemical called Flexipel S-22WS, made by a tiny Georgia company,

Innovative Chemical Technologies, according to company documents. Roanoke

executives were initially unaware of the switch, which was made for reasons

that remain unclear, corporate e-mail messages show.

 

But only a few weeks after those reformulated cans reached Home Depot

shelves, calls from customers, emergency rooms and doctors started to pour

in to poison control centers and, initially in smaller numbers, to the

Consumer Product Safety Commission's own hot line.

 

Terri Keenan of Kyle, Tex., was one of those callers. Ms. Keenan used the

spray in late May 2005 to seal tile in her kitchen and bathroom. Within an

hour or so, she began feeling dizzy, thirsty and short of breath. Minutes

later, she started foaming at the mouth; then she could not get up from the

ground. Her husband rushed her to the hospital, where she remained for five

days.

 

" I just could not understand what was happening, " Ms. Keenan said in an

interview. " It was a nightmare. "

 

In another case, an 11-year-old Colorado boy, Tyler Himmelman, had stopped

to speak to his father, who was using Stand 'n Seal on a bathroom shower,

when the boy began coughing, struggling to breathe and then vomiting. He,

too, ended up in the emergency room, where doctors said about 80 percent of

the surface area of his lungs had been damaged, said Sandie Himmelman, his

mother.

 

Roanoke's initial reaction to the reports was to try to manage their public

relations impact, documents show.

 

In early June, Richard F. Tripodi, Roanoke's chief executive, asked a staff

member fielding calls at a 24-hour emergency number not to tell customers

reporting illnesses that others had called with similar complaints,

documents show. Doing so " may cause unnecessary public concern, " the staff

member wrote in a case file.

 

Federal law requires manufacturers to notify the Consumer Product Safety

Commission within 24 hours after determining that a product defect might

present a health hazard. In this case, several weeks passed before that

report was made; it was not until mid-June 2005 that Roanoke notified the

agency, and only after a physician from the Rocky Mountain Poison and Drug

Center in Denver, which also had been getting calls from emergency room

doctors, told Roanoke that he planned to call the commission on his own.

 

Commission staff members quickly contacted Roanoke. But internal company and

agency documents, which have become public as a result of lawsuits, suggest

Roanoke tried to play down the hazard.

 

Roanoke explained that the revised Stand 'n Seal formula left it with a

" somewhat less chemically pungent " smell, and that, as a result, " some

customers tend to use the material in poorly ventilated or enclosed spaces. "

 

 

It did not mention that a safety data sheet published by the maker of

Flexipel S-22WS explicitly stated that it should not be used in aerosol form

because it could cause respiratory injury. Internal company documents show

that Roanoke knew that even with ventilation, the spray containing Flexipel

could cause a medical reaction. A Roanoke executive tested it in an office

bathroom, with the exhaust fan running.

 

" I actually forgot I was performing a test and found myself leaning over the

floor as I sprayed, " wrote the executive, Michelle Kascak, Roanoke vice

president for research, in an e-mail message to Mr. Tripodi, her boss,

before the recall. After the three-minute test, Ms. Kascak wrote that she

had a mild headache, dizziness and sinus irritation.

 

Mr. Tripodi's reply: " Please instruct us where to send the body when the

test is complete. "

 

Jokes aside, Mr. Tripodi made it clear that he wanted to ensure the product

remained on the market.

 

" We are doing everything to convince the Home Depot that there is no reason

to take these batches off the shelf, " said one e-mail message Mr. Tripodi

sent to a business associate in July 2005, as the company was negotiating

the recall.

 

Nearly three months passed between the time Roanoke first received a report

of an illness and the official recall by the Consumer Product Safety

Commission, a period during which dozens were sickened. They included

Phillip Willis III, 73, a retired Navy officer, from Pasco County, Fla., and

Thomas Kayser, 64, of Independence, Iowa, a retired John Deere machinist,

who soon died from their exposures, medical records show.

 

The agency sent investigators before the end of 2005 to the homes of two

victims, in Arizona and Iowa, and tested at least one can of Stand 'n Seal.

The tests give a basic indication of what was in the product: mostly butyle

acetate, an industrial solvent, and hydrocarbons, chemical compounds based

on crude oil.

 

But the agency's laboratory does not have the equipment needed to identify

the specific chemicals present, or what effect they might have on humans,

said Julie Vallese, a spokeswoman for the commission.

 

" There are a lot of things the agency should have, " Ms. Vallese said.

 

As a result of its limited testing capacity, the agency took Roanoke's word

that it had fixed the problem. But in fact, the company had not, and it

re-supplied Home Depot stores nationwide with 50,000 cans of Stand 'n Seal

that still contained the chemical implicated in the earlier illnesses. The

only change was an additive to give the spray a stronger odor to signal to

consumers that they should use the product in a ventilated area.

 

The Consumer Product Safety Commission has never publicly acknowledged that

the threat remained. Its recall notice said that any can bought after June

2005 was safe.

 

Similar Problems

 

Dr. Friedel, a veteran physician, has a jovial air about him that quickly

turns to agitation, then anger, when he discusses Stand 'n Seal. He knew

nothing about the earlier trouble with the product when he went to the Home

Depot.

 

" At least there should have been a sign, " Dr. Friedel said of his Home Depot

store in East Hanover, N.J., referring to the initial recall. " Without it,

the consumer has no idea what they are getting into. "

 

Dr. Jack Goldshlack, a pulmonologist who is still treating Dr. Friedel, said

tests conducted after Dr. Friedel showed up at the hospital showed abnormal

lung inflammation that limited his ability to get oxygen into his blood

stream. After his release from the hospital, Dr. Friedel spent months taking

oxygen-tank breaks in his office, as his lungs slowly recovered.

 

Interviews with a dozen other people turned up stories that are strikingly

similar.

 

Andrew Lamer, a 24-year-old home contractor from Zeeland, Mich., who like

Dr. Friedel bought one of those 50,000 cans used to restock the shelves,

said he ended up in a hospital intensive care unit after using a can of

Stand 'n Seal he bought in November 2005, four months after the recall.

 

Amy Paddock, 45, of Fridley, Minn., said she passed out in her car, after

having felt ill and pulling to the side of the road, shortly after using the

product in April 2006, and was also hospitalized.

 

Moreno, 50, an office manager from Fullerton, Calf., went to the

hospital on Thanksgiving Day in 2006 — more than a year after the recall —

after using Stand 'n Seal in her home. " I just couldn't breathe, I could not

even move, " Ms. Moreno said in a recent interview.

 

Her can had a lot number that showed it had been among the original batches

that were recalled in August 2005 — but it remained on the shelf at Home

Depot, as the retailer and Roanoke, which shared responsibility to remove

these cans, had not completed the job.

 

Growing Evidence

 

The Consumer Product Safety Commission received several notices that the

hazard associated with Stand 'n Seal continued, even after the recall.

 

Sandra Himmelman, whose son was injured before the recall, called the agency

after she was startled to find one of the " recalled " cans still for sale at

her local Home Depot, agency records show. " How could it still be for sale? "

she said she asked.

 

Rick Ericksen, 59, a Mississippi state geologist, called the agency to

report " uncontrollable shivering spasms that convulsed my entire body " after

using Stand 'n Seal, as well as a " tremendous headache, nausea and a dry

cough that wouldn't stop, " agency records how.

 

An agency official, reviewing the complaint, noted in the report that the

lot number on the can Mr. Ericksen had used in September 2005 " was not on

the list of recalled cans. "

 

But Mr. Ericksen, Ms. Himmelman and others with similar complaints said they

never received a response from the commission.

 

Roanoke had growing evidence that the problem persisted, documents show,

including continued reports that went to the emergency call center about

illnesses and a growing list of lawsuits based on injuries, many of them

filed by consumers who used cans that were not among those recalled.

 

But it was not until March 2007, 18 months after the original recall, that

Home Depot and Roanoke acknowledged the apparent source of the continuing

problem.

 

The 50,000 cans used to restock the shelves in 2005, the companies conceded,

" have been identified as containing the same potentially harmful formulation

as the recalled batches, " a Home Depot statement said.

 

The hazard was finally eliminated this spring, as Home Depot removed Stand

'n Seal from the market entirely and posted a notice on its corporate Web

site offering a refund to anyone who, after the recall, had bought one of

the 50,000 cans.

 

The commission blames misinformation provided by the Stand 'n Seal suppliers

for much of the breakdown. But at the same time, it acknowledges that it is

the agency's responsibility to detect and respond to bad information, and

that it had failed to do so quickly in this case.

 

" Through investigations, the agency should be able to determine the accuracy

of information being provided, " said Ms. Vallese, the commission

spokeswoman. " Hindsight is really a great thing. "

Copyright 2007 The New York Times Company

 

 

 

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