Medtronic raises death estimate tied to heart device wires

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Posted on 13th March 2009 by Gordon Johnson in Uncategorized

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Date: 3/13/2009

By MATTHEW PERRONE
AP Business Writer

WASHINGTON (AP) — Medtronic, the world’s largest medical device maker, said Friday that 13 patients may have died as a result of problems with its heart device wires that were first disclosed in 2007.

The Minneapolis-based company pulled its Sprint Fidelis defibrillator leads off the market in October 2007 after identifying five patient deaths that may have been caused by the cracked wires.

In a letter sent to physicians Friday, Medtronic raised the number of estimated deaths to 13. The company notes that four of those deaths occurred when physicians tried to extract the wires. Medtronic has recommended patients leave the devices in because the risk of surgery may outweigh the risk of a device malfunction.

“This is likely to be the best choice for the majority of patients,” the company advised physicians.

Defibrillator leads connect patients’ hearts to implanted defibrillators that send an electrical shock if it senses a life-threatening abnormal heart rhythm. A fractured lead can prevent the device from sending a lifesaving shock or cause painful, unnecessary shocks.

Roughly 268,000 of the Fidelis leads have been implanted in patients worldwide, according to the company.

The Food and Drug Administration has received 107 reports of patient deaths where the devices may have played a role. Most of those reports were not filed by physicians, Medtronic notes, but “by family members or attorneys with minimal supporting data.”

After reviewing 89 of those reports, an outside group of physicians assembled by Medtronic judged that 13 deaths may have been caused by problems with the wires.

In recent months, federal judges have thrown out thousands of patient lawsuits against Medtronic, ruling that federal regulations shield the company from lawsuits filed at the state level. Those decisions were based on a Supreme Court decision last year that the federal FDA is the final arbiter of medical device safety.

Democrats in Congress are currently working to pass legislation to overturn that decision.

Shares of Medtronic fell $1.03, or 3.6 percent, to $27.55 in after-hours trading.

Copyright 2009 The Associated Press.

Hong Kong drug firm suspended over expiration dates

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Posted on 13th March 2009 by Gordon Johnson in Uncategorized

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Date: 3/13/2009

By DIKKY SINN
Associated Press Writer

HONG KONG (AP) — Hong Kong police have arrested four employees of a drug manufacturer for allegedly lying about the expiration dates on more than 200 over-the-counter medicines, officials said Friday.

Marching Pharmaceutical Ltd. has had its license suspended for one month while authorities look into claims the company was selling medicines with expiration dates that went beyond a product’s shelf life, a Health Department spokesman said on condition of anonymity, citing internal policy.

Authorities have also ordered the company to recall 216 products — including dozens of cough syrups and antifungal creams, he said.

The spokesman said the products being recalled are low-risk drugs and that there was no immediate risk to human health.

Police arrested four employees Thursday in connection with the case. They have been released on bail pending further investigation, police spokesman T.K. Ng said.

Nobody has fallen ill from using the company’s products, but the Health Department spokesman said “some of the documents provided by this company are not consistent, so we’ve asked police to step in and investigate.”

Repeated calls to MPL rang unanswered Friday.

Copyright 2009 The Associated Press.

–According to http://www.news.gov.hk

Department of Health Chief Pharmacist Anthony Chan stressed that the case only involved product stability – not safety of the products which were low-risk drugs.

The recalled products are low-risk drugs. Most are non-prescription products including vitamins, minerals and cough and cold preparations. Others are prescription topical preparations such as skin creams.

The manufacturer has set up a hotline, 2781 6320, to answer questions.

Traces of Lead in Dishes and Cookware

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Posted on 6th March 2009 by Gordon Johnson in Uncategorized

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Date: 3/6/2009

By The Associated Press

With so much concern paid to toys made in China that contain lead paint, how are we to know that dishes and cookware also made in China are free from lead? Is this dangerous for us?
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Lead in cookware and dishware has been found in ceramics from China, Mexico and India. The lead comes from varnish or glaze that gives the product a shiny finish. If the temperatures used to “cure” or “seal” the varnish are high enough, the cookware will be safe and the metal will not leach into food or liquids.

The U.S. Food and Drug Administration says it tests imported ceramicware to measure whether lead might leach into food. And the FDA has put out alerts warning about excessive lead in ceramicware from China, among other countries.

China has set safety standards on how much lead and other potential toxins are allowed in products. However, with large numbers of small, often loosely run operations in the country focused on cost-cutting and profits as they manufacture everything from ceramics to food, it’s hard to police every step of the process.

The FDA is also involved, but as seen in recent problems with lead paint in toys and other tainted imports, American government agencies lack the manpower to inspect all shipments.

In the absence of firm controls either in China or the U.S., a consumer may be better off buying from large, reputable retailers, which usually do a better job making sure their suppliers observe quality and safety standards.

“More reputable stores would install a tighter quality control system to screen out defective products,” said Chen Shih-Fen, a professor at the University of Western Ontario who specializes in outsourcing interactions between Western buyers and Chinese subcontractors.

In short, there is no sure way to guarantee that the products you are using are completely safe, unless you have them tested. Here are a few home test kits that have been reviewed by Consumers Union, the nonprofit publisher of Consumer Reports: http://sn.im/d81p1. Additionally, here is a page from the National Institutes of Health that outlines the symptoms of lead poisoning and offers resources on what to do if you think you’ve been poisoned: http://sn.im/d81ry.

Audra Ang

Associated Press Writer

Beijing

Copyright 2009 The Associated Press.

Inspector failed to flag salmonella-linked plant

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Posted on 5th March 2009 by Gordon Johnson in Uncategorized

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Date: 3/5/2009

By DANNY ROBBINS
Associated Press Writer

DALLAS (AP) — A Texas agriculture inspector failed to note that a peanut plant at the center of a national salmonella outbreak was operating without a state health department license despite at least three visits in the years before hundreds of people got sick, according to interviews and documents obtained by The Associated Press.

The inspector responsible for certifying the plant to process organic products noted after each visit that the plant had such a license when it didn’t. Health officials said problems at the plant operated by Peanut Corp. of America might have been flagged years ago had the inspector, who has since been fired, reported the plant’s failure to obtain the required license.

When the plant was finally inspected earlier this year, Texas health officials found dead rodents, rodent excrement and bird feathers in a crawl space above a production area, leading them to order a recall of all products the plant had shipped since 2005.

Tests have since shown that ground peanuts at the Plainview plant were contaminated with the same strain of salmonella that sickened more than 650 people, is suspected of causing at least nine deaths, and led to one of the largest product recalls in U.S. history. Salmonella has also been detected in peanut samples from a Georgia plant operated by Peanut Corp., which has filed for bankruptcy amid fallout from the outbreak.

Texas Department of Agriculture spokesman Bryan Black said if the lack of a license had been properly noted, the department would have denied it organic certification and notified the Department of State Health Services. The inspector, Gaylon Amonett, was fired on Feb. 13, the day after state health officials ordered the recall.

“We trust our inspectors to do their jobs,” Black said. “Any time they do not follow the protocol, it is inexcusable.”

Because the Plainview plant was not licensed, state health officials have said they had no record it existed and never sent their own inspectors to the facility to check for possible food safety problems. All food manufacturers in the state are required to obtain a license from the state health department.

Amonett, a 22-year TDA employee who worked out of the agency’s Lubbock office, acknowledged that he checked “yes” to the question of whether the Plainview plant had records showing it was in compliance with health codes on worksheets he completed for inspections in 2005, 2006 and 2008.

The reason he checked “yes” the first time, he said, was because a plant manager told him an application for state health department licensing had been completed and was in the hands of Peanut Corp. officials at the company’s headquarters. He said he continued to check “yes” in succeeding years because he assumed that the license was granted.

Amonett said the matter was his “only mistake” in his years as an inspector. Agriculture department records show that he received a merit raise on Jan. 1.

“It’s an inadvertent mistake, and I’m sorry for it,” he said.

Jack McCasland, environmental inspector for the Plainview-Hale County Health Department, said plant officials led him to believe the licensing process was under way when he visited the facility before it opened.

“To be honest, I never really thought to follow up on it,” McCasland said. “It just never occurred to me that they wouldn’t be (licensed).”

Organic certification allows companies to market products as organically grown or produced. Processors must meet standards set by the U.S. Department of Agriculture and are monitored by a USDA-accredited entity. The Texas Department of Agriculture has served as a certifying agency since 2002.

In a memo about the Plainview matter, TDA assistant general counsel Jim Pollard wrote that Amonett was trained as an organic inspector in 2004. Under agency rules, inspectors are required to make sure a company’s licenses and other records are complete and current. The memo, obtained by the AP through a request under the Texas Public Information Act, cited the three inspections by Amonett.

TDA declined to release the inspection reports, contending that they are exempt from disclosure under the information act.

Although food safety is technically not part of the organic certification process, the salmonella outbreak has prompted the USDA to direct organic certifying entities to report any health or safety violations to the appropriate government officials.

“While we do not expect organic inspectors to be able to detect salmonella or other pathogens, their potential sources should be obvious from such evidence as bird, rodent and other animal feces or other pest infestations,” the directive stated.

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Associated Press writer Betsy Blaney contributed to this report from Lubbock, Texas.

Copyright 2009 The Associated Press.

Warning: Don't wear medication patches during MRI

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Posted on 5th March 2009 by Gordon Johnson in Uncategorized

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Date: 3/5/2009

By LAURAN NEERGAARD
AP Medical Writer

WASHINGTON (AP) — Need an MRI scan? Tell the doctor if you use a nicotine patch or any other medication patch — or you’ll risk a burn during the MRI.

Patches that ooze medication slowly through the skin are becoming more popular, from over-the-counter nicotine patches to prescription patches that deliver estrogen, pain medication, Alzheimer’s or Parkinson’s drugs, even an anti-nausea drug for chemotherapy recipients.

But the Food and Drug Administration just discovered that some are missing a key safety warning about MRI compatibility.

More than a quarter of the 60 different drug patches sold contain traces of aluminum or other metals in their backing, the part that makes them stick to the skin, estimated Dr. Sandra Kweder, the FDA’s deputy drug director.

You can’t see the metal; the patch even may appear completely clear. But affected patches contain just enough metal to conduct electricity, meaning a patch worn during an MRI scan can overheat and cause a skin burn similar to a bad sunburn.

The FDA recently learned of a few patients who suffered patch burns, none severe. In January, tracking the source of one burn, officials found that Teva Pharmaceuticals’ fentanyl painkiller patch lacked the MRI warning. The FDA then found a variety of other drug patches also lacked the warning.

On Thursday, the FDA issued a public health advisory: Tell your doctor about any medication patches, so the professional can decide which should be removed before an MRI, how soon before the scan, and when it can be reapplied.

“If there’s any uncertainty, just don’t wear it in the machine,” Kweder said. “It’s just the smart thing to do.”

As for patch makers, FDA is reviewing every product’s label to be sure ones that are supposed to carry the safety warning do. Some may be missing because a patch was reformulated to add metal after its label was written; other times FDA acknowledged it just didn’t ensure the warning was present in the first place.

Now the agency is considering having an MRI warning somehow be put on the individual patch, not just the box it comes in.

“We have to look at the different configurations of these patches and what’s going to be practical to allow for this,” Kweder said.

Copyright 2009 The Associated Press.

Dems move to overturn shield for device makers

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Posted on 5th March 2009 by Gordon Johnson in Uncategorized

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Date: 3/5/2009

By MATTHEW PERRONE
AP Business Writer

WASHINGTON (AP) — A day after the Supreme Court decided that federal rules do not protect drugmakers from state lawsuits, Democrats in Congress moved to overturn a decision that has shielded medical device companies from similar legal action.

On Wednesday the court turned away Wyeth’s claim that it could not be sued in state courts for its drug Phenegran, because it had already been approved by the federal Food and Drug Administration. The ruling upheld a $6.7 million award to a Vermont woman who lost her arm after she was improperly injected with the company’s nausea medication.

Seizing on the decision, Democrats on Thursday reintroduced a bill that would allow similar lawsuits against companies that make heart devices, catheters, hip replacements and other devices.

“Yesterday the Supreme Court rightfully upheld a patient’s right to legal recourse after sustaining an injury from a pharmaceutical product,” said Rep. Frank Pallone, D-N.J. “Today, we introduce legislation that gives patients that same right when injured by a medical device.”

The idea that corporations are shielded from state liability claims by federal rules is relatively new and was pushed aggressively under the Bush administration.

Last year, the Supreme Court agreed with the pre-emption policy in a case involving medical devices, ruling a patient injured by a catheter from Medtronic could not sue under state laws. That case turned on a provision of federal law prohibiting states from imposing their own requirements on the devices. There’s no similar provision for drugs.

Since then thousands of lawsuits against Medtronic and other device companies have been dismissed by lower courts, citing the Supreme Court’s decision.

But Pallone and other Democrats said Thursday that decision ignored decades of precedent, in which lawsuits brought by patients in state courts helped bolster safety regulation at the federal level. The bill to restore liability claims against device makers is co-sponsored by Rep. Henry Waxman, who chairs the Energy and Commerce Committee. He is expected to hold hearings on the issue in coming weeks.

The device industry’s chief lobbying group quickly slammed the effort, saying it will “produce a chilling effect on medical innovation, create more lawsuits and ultimately result in higher health care costs for all Americans.”

The Advanced Medical Technology Association, or AdvaMed, said the legislation would allow state courts to second-guess medical experts at the FDA and create a “patchwork of inconsistent and confusing guidance.”

Despite opposition from industry, the Medical Device Safety Act enjoys support from a broad range of interest groups, including consumer advocates, trial lawyers and AARP. With companion legislation introduced by U.S. Sen. Ted Kennedy, D-Mass., many analysts have already predicted the measure will become law.

Earlier in the day AdvaMed rolled out its first-ever advertising guidelines for companies like Medtronic Inc., Johnson & Johnson and Boston Scientific Corp. Among other things, the guidelines urge companies to state the risks of their implants clearly and concisely when advertising them to consumers.

The device industry has begun attracting new scrutiny from lawmakers as companies increasingly pitch their implants to consumers via TV and magazine advertisements.

Copyright 2009 The Associated Press.

INSIDE WASHINGTON: Is the FDA a broken agency?

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Posted on 3rd March 2009 by Gordon Johnson in Uncategorized

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Date: 3/3/2009

EDITOR’S NOTE — An occasional look at how Washington works — or doesn’t.
By RICARDO ALONSO-ZALDIVAR and MIKE BAKER
Associated Press Writers

WASHINGTON (AP) — Tainted peanuts. Unsterilized syringes. Salmonella in Mexican chili peppers. A contaminated blood thinner from China that sent patients into life-threatening shock.

Every few months, the Food and Drug Administration goes into fire-brigade mode, rushing to get control over another safety crisis. The agency that regulates products worth 25 cents of every dollar spent by U.S. consumers seems overwhelmed by its own mission.

Some say the FDA is broken, and others want to break it up — by moving food safety to a new office.

“You’ve got an agency that quite frankly is either non-functional, or dysfunctional, or maybe all of the above,” said Rep. John Dingell, D-Mich., who as the longest serving member of Congress has investigated many agencies, including the FDA.

“Bet yourself a new hat or a fine dinner that you are going to have a scandal a month,” Dingell added. “They are running around like a lot of headless chickens.”

Others, even some critics, see tentative improvements. Many defenders acknowledge the FDA is struggling.

“‘Broken’ is the kind of word that’s sort of a fighting word,” said Dr. Frank Torti, the cancer researcher serving as acting FDA commissioner. “We have recognized for a long time that more is needed. Because of a lack of (legal) authorities and inadequate resources, it’s really hard to do the job.”

Restoring the FDA’s reputation will be a major challenge for an Obama administration that strode into town promising competent government.

The decline didn’t happen overnight. There’s no single, simple cause. In 2007, an independent group of science advisers concluded that the FDA was in danger of failing in its mission. “American lives are at risk,” said their report. It wasn’t the first alarm.

As the pharmaceutical and food industries went global in recent years, the FDA fell behind on inspections. Its legal powers failed to keep up with fast-changing industries. Its own scientists said it grew too cozy with drug companies and tuned out signals of safety problems.

Money for research grew scarce. The agency struggled to answer such seemingly simple questions as how far from a cow pasture a farmer should plant his spinach patch to keep out bad germs. Internal computer systems were allowed to decay, although they are essential to monitoring drug safety trends or blocking shady imports.

The FDA drifted. During the Bush administration, it went long periods without a permanent commissioner who could be an advocate before Congress. Lawmakers piled new responsibilities on the agency, often without the funds to carry them out.

This past year’s safety problems — homegrown and imported — illustrate the FDA’s weakness.

Summer brought a salmonella outbreak blamed first on tomatoes, and later on hot peppers as well.

This winter, it was salmonella again, in peanut products. A small company’s apparent disregard for basic sanitation led to the recall of more than 2,800 foods that used its ingredients.

More than 2,100 people were sickened in these incidents. At least nine deaths have been blamed on tainted peanuts alone.

Last week, another problem surfaced. Federal prosecutors in North Carolina obtained guilty pleas from two employees of AM2PAT, a company that manufactured syringes in unsterile conditions and covered it up with phony paperwork.

Prosecutors say hundreds of patients were sickened and five died. The FBI is looking for the company’s owner, who may have fled the country.

Different products were involved in the incidents, but some of the same FDA shortcomings: inspections, legal authority and technology.

It was unclear how many foreign drug facilities fall under the FDA’s jurisdiction because one government database lists about 7,000 and another, 3,000.

Sending inspectors to China used to involve first waiting for permission from the Chinese government. The situation has improved, under a U.S.-China agreement that led to the opening of FDA offices there.

The tomato outbreak last summer underscored other kinds of gaps. Produce companies are not required to have a food safety plan. And the FDA lacks legal authority to require a system for tracing foods back to the farm. Investigators had to sift through piles of paper records as losses mounted for tomato growers. Dingell said the FDA looked like the Keystone Kops.

In the peanut butter outbreak, the FDA has been slowed because of the length of time it takes to identify positively a strain of salmonella. The agency wants to replace current lab tests that can take a week or more with technology that cuts the wait to a day or two.

FDA inspectors quickly descended on the small Georgia facility at the center of the peanut outbreak. But they didn’t get the whole story immediately. The FDA had to invoke bioterror laws to get lab reports that ultimately showed the company shipped tainted peanuts. Meantime, the agency had no authority to order a food recall.

“The FDA has been trying to do so much with so little for so long that they really have lost the vision of what would make an effective food safety program,” said Caroline Smith DeWaal, food safety director for the Center for Science in the Public Interest, which wants to set up a separate food agency.

Congress has been pumping more money into the FDA the last couple of years. And the Obama administration seems willing to consider big changes, especially on food safety.

The two leading candidates for FDA commissioner are physicians from outside the agency. One is Baltimore health commissioner Joshua Sharfstein, a pediatrician who has taken on the FDA over risks in children’s cough and cold drugs. The other is Margaret Hamburg, a bioterrorism expert who served in the Clinton administration and as New York’s health commissioner.

“One area where we could see bipartisan cooperation might be the strengthening of the FDA,” said Dr. Paul Stolley, a former department head at the University of Maryland medical center who had a stint as a visiting scientist at the FDA. “I don’t think ideological differences should interfere.”

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Baker reported from Raleigh, N.C.

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On the Net:

FDA Science Board report — http://tinyurl.com/yvnk28

Copyright 2009 The Associated Press.

NC body parts supplier's alleged fraud detailed

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Posted on 3rd March 2009 by Gordon Johnson in Uncategorized

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Date: 3/3/2009

By MIKE BAKER
Associated Press Writer

RALEIGH, N.C. (AP) — When a North Carolina company that collected human body parts for transplants and other medical procedures was shut down in 2006, federal regulators cited inaccurate paperwork and poor record-keeping.

But new court documents illuminate a more malicious story line: Federal prosecutors contend the company’s owner falsified medical histories, identities and blood samples of harvested cadavers to ensure the risky tissue could be sold.

Court papers accuse Philip Guyett Jr. of forging the age and cause of death of cadavers he gathered from North Carolina funeral homes because tissues can be rejected for a number of reasons to protect the health of transplant recipients. Prosecutors claim Guyett’s Donor Referral Services Inc. hid instances of disease or drug use and say that if Guyett knew a blood sample would be rejected, he would submit one from a different cadaver donor.

Guyett faces three counts of fraud. He has not been formally indicted, but the “criminal information” documents from prosecutors can only be filed with the defendant’s consent and typically signal a plea deal is forthcoming.

Guyett has previously denied any wrongdoing. His attorney declined to comment.

An arraignment is scheduled for Monday.

The new details renew concerns raised a couple of years ago after Guyett’s facility was shut down and in a separate case, a New Jersey company was accused of plundering corpses for body parts.

In the wake of those cases, thousands of Americans who had routine procedures like knee and back operations were urged to get tested for HIV and hepatitis. More than 1.3 million procedures each year use tissue from donated cadavers in what has become a billion-dollar industry.

The Food and Drug Administration said in 2007 it rushed inspections on all 153 companies that recover cadaver parts and found no major problems. Regulators oversee some 2,000 business that handle tissues and generally only inspect a few hundred each year. The agency declined this week to say whether transplants linked to Guyett led to illnesses, saying that information could only be released through a Freedom of Information Act request, which is pending.

Industry officials said no transplant recipients were affected, but worry there is still not enough federal regulation.

“The part that concerns myself and other state licensing boards is the idea that (the tissue recovery business) is still not regulated like transplantable organs are regulated,” said Paul Harris, executive director of the North Carolina Board of Funeral Service. “And I haven’t seen anything to indicate that it’s headed toward regulation.”

Transplantable organs are tested and regulated under a more rigorous system.

Robert Rigney, head of the American Association of Tissue Banks, said his group regulates member companies separate from the FDA, requiring onsite inspections and reviewing operating procedures. Companies voluntarily join the association, and while Rigney said the most transplantable tissues firms are members, Guyett’s business was not.

Rigney said he doesn’t think the FDA inspects new businesses soon enough, but said tissue transplant procedures are among the safest in medicine and that there hasn’t been a transmission of disease since 2002. He thinks the chances of another case like Guyett’s are minimal.

“What these people are accused of doing violates everything that we stand for,” Rigney said.

FDA spokeswoman Susan Cruzan said a 2007 report found no major deficiencies in the industry and a 2005 report found low risks for disease transmission in tissue transplants.

Guyett has been in trouble with authorities before. He was sentenced a decade ago to community service and probation after police accused him of pocketing cash from the sale of a cadaver. And while working in Las Vegas, Missouri police discovered human limbs in a leaky FedEx container Guyett’s company had shipped.

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On the Net:

American Association of Tissue Banks: http://www.aatb.org/

North Carolina Board of Funeral Service: http://www.ncbfs.org/

Copyright 2009 The Associated Press.

In switch, China courts accept tainted milk suits

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Posted on 3rd March 2009 by Gordon Johnson in Uncategorized

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Date: 3/3/2009

By ANITA CHANG
Associated Press Writer

BEIJING (AP) — For months, courts across China refused to accept the lawsuits from families whose children were killed or sickened in a tainted milk scandal. Now, in a turnaround, hundreds of families are planning to file suit after the country’s highest court this week said cases would be accepted.

The move signals a change in the way Beijing is handling fallout from the scandal, which killed at least six babies and sickened nearly 300,000 with kidney stones and kidney failure. A government-sanctioned compensation plan had been expected to ease public anger, but instead it gave embittered, outspoken parents across China a common cause.

“There will be lawsuits against all 22 dairy companies,” said Zhao Lianhai, who has rallied victims’ parents through a Web site he created.

He said Tuesday the 600-plus families involved want compensation for emotional harm as well as medical and other expenses — demands that go beyond the government’s one-time payouts.

But it was not clear how the government planned to handle the cases. One lawyer who filed a lawsuit this week on behalf of dozens of families said he was told the court was supposed to guide him toward the existing compensation plan.

Infant formula contaminated with the industrial chemical melamine was blamed in the scandal that was exposed last September. Unscrupulous middlemen are accused of adding melamine, which is high in nitrogen, to watered-down milk to fool quality tests for protein content.

The crisis highlighted the need for major overhauls to China’s food safety system, culminating in a law passed over the weekend that consolidates hundreds of regulations covering the country’s 500,000 food processing companies.

On Monday, Shen Deyong, executive vice president of China’s highest court, said courts will accept compensation cases in the scandal.

“The courts have done the preparation work and will accept the compensation cases at any time, ” Shen said in an online interview with the official People’s Daily Newspaper.

Already, Beijing attorney Li Jinglin said he filed an 8 million yuan ($1.2 million) lawsuit Monday in northern China’s Qingdao Intermediate People’s Court on behalf of 54 families. Their children became sick after drinking Shengyuan brand milk, whose parent company is based in Qingdao.

Li said he expected a response from the court this week. But he said a court official told him: “We have the responsibility of guiding you toward accepting the compensation plan from the companies involved … According to our situation, we are prepared to give the same amount of compensation as the dairies.”

A man in the propaganda department at the Qingdao court said he was not aware of the case.

Under the payout plan organized by the dairies, families whose children died received 200,000 yuan ($29,000), while others received 30,000 yuan ($4,380) for serious cases of kidney stones and 2,000 yuan ($290) for less severe cases.

More than 95 percent of victims’ families had accepted the money, Shen said in the interview.

Since the scandal broke, victims’ parents tried several times to file lawsuits, but courts refused to take their documents. Chinese courts often turn down class-action suits, preferring to deal with cases one by one to avoid running afoul of Communist Party officials, who ultimately control the judiciary.

At least 100 families who have already accepted compensation money plan to file lawsuits, lawyer Xu Zhiyong said, conceding that some could be rejected.

“Strictly speaking, after you sign the agreement accepting the compensation, you can’t file a case. But if you can prove that you were forced to accept the money, then you can sue,” he said.

One parent who took the money said it wasn’t enough, but he didn’t plan to fight on.

Luo Ming, whose 2-year-old daughter was diagnosed with kidney stones but apparently has recovered, said he spent 40,000 yuan ($5,850) in medical fees and travel costs and was forced to take six weeks of unpaid leave from his job as a machine designer in central Hunan province.

In January, local health authorities told him 2,000 ($290) in compensation was the best the family could expect.

It wasn’t enough, Luo said. But “my job has been affected, and the government hasn’t helped me. So I’m just going to give up.”

___

Associated Press researcher Xi Yue in Beijing contributed to this report.

Copyright 2009 The Associated Press.

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