Access To Justice

The Consumer Product Safety Commission (CPSC) is seeking comment on a petition asking that cadmium – a substance often found in children’s jewelry and products – be declared a hazardous substance. The Sierra Club petition argues that unless a safe level can be established for the metal, cadmium should banned under the same rules applied to lead.

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Around 30,000 Nap Nanny portable baby recliners are being recalled by Baby Matters LLC after an infant died in one that was being used in a crib. The Consumer Product Safety Commission (CPSC) is investigating the report and says it has received reports of 22 other incidents in which infants have fallen over the recliner’s side despite being strapped into its harness.

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Johnson & Johnson faces five potential class-action suits from consumers who have sued the drugmaker in federal court over its plan to offer refund coupons for its recalled children’s cold and allergy medicines, according to Bloomberg News.

The suits, which accuse the company of racketeering and fraud, claim the coupons are “worthless” because the medicines are not currently being made.  Also, consumers who have tossed the drugs and don’t have a receipt wouldn’t be eligible to receive the coupons. Bloomberg reports the suits instead seek a cash refund.

In April, J&J’s McNeil Consumer Care unit issued a product recall for more than 40 kinds of children’s cold and allergy drugs (including liquid Tylenol and Benadryl) for problems with quality and potency, according to Bloomberg.

California’s children may soon be protected from BPA (Bisphenol-A) under legislation that is now moving through state government there.

The Los Angeles Times reported that the California Assembly last week passed a bill banning BPA from baby bottles and other uses related to infants and toddlers. BPA, a plastic additive used in food packaging and consumer products, has been linked to health risks in humans, including asthma, autism, and hyperactivity.

If passed, the Toxin-Free Toddlers and Babies Act, or SB 797, would ban the chemical from bottles, cups, jars, and the linings of infant formula cans by 2012, according to the LA Times. The bill now moves to the state Senate, which will vote on in August.

Federal regulators today announced the recall of some 2 million potentially unsafe drop-side cribs made by seven companies, including Child Craft, Delta Enterprise, Evenflo, Jardine Enterprises, LaJobi, Million Dollar Baby, and Simmons Juvenile Products.

The U.S. Consumer Product Safety Commission (CPSC) said that the cribs were recalled due to worries that infants and toddlers might fall out or get trapped if the drop side detached or malfunctioned, leading the children to strangle, suffocate, or sustain injuries. The recalled cribs were cited in 250 incidents and 16 infant entrapments reported to the CPSC, according to the Associated Press.

Just last month the CPSC issued a warning about the potential hazards of drop-side cribs. The agency says they tend to be less structurally sound than cribs with four fixed sides, although some fixed-side cribs by Child Craft and Delta are named in the current recall. Over the last five years, approximately 9 million drop-side cribs have been recalled, including last fall’s recall of 2.1 million Stork Craft cribs.

The CPSC called the current recall voluntary and said the manufacturers would supply consumers with free repair kits to immobilize the drop sides. The CSPC urged parents to stop using the affected cribs and to find a safe alternative sleeping arrangement for their young children.

Contact us if you or someone you know has been injured by these products.

Some 12 million Shrek glasses potentially tainted by the toxic metal cadmium are being recalled by McDonald’s, which sold them as part of a sales tie-in to the move “Shrek Forever After,” according to the Consumer Product Safety Commission (CSPC).

The CSPC says that the designs on the glasses, which feature movie characters Shrek, Fiona, Puss n’ Boots, and Donkey, were found to contain cadmium. Long-term exposure to cadmium can cause serious health effects. We’ve blogged here before about the dangers of cadmium in children’s products.

Consumers should stop using the glasses immediately and return them to McDonald’s for a refund, according to the CSPC.

Interestingly, the Los Angeles Times reports that the recall was spurred by an anonymous tip to Rep. Jackie Speier (D-Calif.), who alerted the commission. Federal regulators then tested the glasses and confirmed there was cadmium in the paint. Speier, who is pushing legislation banning cadmium in children’s jewelry, told the LA Times: “We need stronger testing standards to ensure that all children’s products are proven safe before they hit the shelves.”

Johnson & Johnson (J&J) is on the hot seat today.

Congressional leaders will grill the company at a hearing held by the House Committee on Oversight and Government Reform over its recall of Tylenol and other children’s medicines made by J&J subsidiary McNeil Pharmaceuticals. But the J&J’s woes don’t end there. The Food and Drug Administration (FDA) will testify at the hearing that it is looking at additional enforcement actions against the company, including possible criminal penalties.

Manufacturing problems at the McNeill plant that makes infant and children’s Tylenol, Motrin, Zyrtec and Benadryl spurred J&J to recall a total of 6 million bottles from over 40 different types of medications last month.  According to Reuters, a report released by the committee says the FDA is investigating more than 700 reports of problems – including 30 deaths — with the recalled medications but has failed to find a direct tie so far. The FDA will continue its investigations but officials still say that the risk posed to the public by the recalled products remains remote.

In its testimony before the committee, J&J will outline the steps McNeill will take “to bring its operation back to a level of quality” including improving manufacturing processes and employee training, leadership changes, and comprehensive action plan on quality improvements.

News developments that we’ll be watching at Sokolove Law:

Bayer, the maker of YAZ, quietly recalled the popular woman’s contraceptive drug last November, according to BNET’s Pharma Analysis blog. The notice was never published to the recall section of the Food and Drug Administration’s website; it was tucked into an FDA “Enforcement Report” instead. The blog reports that 32,856 boxes of YAZ as well as 122,208 of Ocella, a generic version of the birth control drug Yasmin, were recalled for “specifications for the dosage of drospirenone” in the drugs. Last August, the FDA sent Bayer a warning letter over a similar issue, according to our YazTalk.com website. Oral contraceptives have been linked to the risk of serious injuries such as blood clots, strokes, and heart attacks.

A Queens woman who allegedly developed “popcorn lung” from a daily habit eating the tasty kernels is suing ConAgra, according to the New York Daily News.  Popcorn lung (also known as bronchiolitis obliterans) is a rare lung disease that can occur through exposure to diacetyl, a flavoring chemical used to make popcorn taste buttery. Agnes Mercado, the plaintiff, claims she ate ConAgra’s Act II popcorn at daily for 16 years, according to the Daily News. Mercado was diagnosed last month with bronchiolitis obliterans; she now uses an oxygen tank and may ultimately need a lung transplant.  The Courthouse News Service reports that Givaudan Flavors, which make the butter flavoring, is also named in the lawsuit.

Congress will investigate the recent recall of children’s cold medicines made by a subsidiary of Johnson & Johnson. Law 360 (subscription required) reports that the House Committee on Oversight and Government Reform will schedule a hearing on the recent voluntary recall involving Children’s and Infant’s Tylenol, Motrin, Zyrtec and Benadryl made by McNeill Consumer Healthcare.  The hearings will look into conflicting accounts by the FDA and McNeill about what sparked the recall and the extent of the problems, according to the report.

Following a systemwide review, the Veterans Affairs Department is limiting the kinds of surgeries some of its hospitals can perform. The Associated Press reports that surgical deaths at the VA’s hospital in southern Illinois prompted the decision to institute a “surgical complexity” level for its facilities nationwide. Based on the new system, less complicated surgeries will now be performed in VA hospitals in Alexandria, La.; Beckley, W. Va.; Fayetteville, N.C.; Danville, Ill.; and Spokane, Wash. Inpatient surgeries remain on hold at the hospital in Marion., Ill., where investigators found evidence that substandard or questionable care led to as many as nineteen deaths between October 2006 and March 2007, according to the AP.

Keep those you love protected from harm. At Sokolove Law, we’re here to help.

News developments that we’ll be watching at Sokolove Law:

Americans are being harmed by exposure to widespread environmental toxins and the government needs to do more to protect them, according to a new report from the President’s Cancer Panel, which reports to President Barack Obama. The report says the government has “grossly underestimated” the problem of environmentally induced cancer and notes that there are nearly 80,000 chemicals in the market in the US that are both understudied and largely unregulated.  The report offers a series of recommendations the government can take to reduce cancer risks related to environmental contaminants including stronger regulation, a comprehensive policy agenda, and safer alternatives to many chemicals now in use.

Add a new worry to those already spawned by the 2010 Gulf Coast oil spill: What are the potential health risks faced by those living nearby or working to clean it up? USAToday reports that the experts are divided over the possible human health hazards from the disaster.  However, the article notes that there were more than 6,700 cases of upper-respiratory illness among workers who helped clean up the Exxon Valdez spill.  USAToday also writes that individuals exposed to oil by the 2007 sinking of the Hebei Spirit oil tanker off Korea experienced greater risks of headache, nausea, itchy skin, fatigue and shortness of breath, among other symptoms.

Pampers with Dry Max have come under scrutiny by the Consumer Product Safety Commission following reports the disposable diapers allegedly caused chemical burns and rashes on some children. Reuters reports that the claims from parents surfaced after Procter & Gamble updated its Pampers Swaddlers and Cruisers diapers with a new absorption technology. P&G said it stands by the products and has shared its safety data with CPSC.

Crib recall: About 170,000 drop-side cribs distributed by C&T International/Sorelle are being voluntarily recalled due to potential strangulation and suffocation hazards. The Consumer Product Safety Commission (CPSC)  says the cribs’ drop-side hardware can disengage from the tracks and cause the drop side to detach from crib, which creates a space between the mattress and the drop side where an infant can become trapped and possibly suffocate or strangle. Complete detachment of the drop sides can also lead to falls from the crib. In addition, slats can detach from the cribs. Infants and toddlers can then become entrapped, strangle or fall out of the crib.

The CPSC says it has received reports of 104 incidents of drop-side and slat detachments involving the cribs, including six reports of injuries.

News developments that we’ll be watching at Sokolove Law:

The Food and Drug Administration (FDA) now says that the manufacturing problems that led to McNeill Healthcare’s recall of its Tylenol products for children and infants are more serious than first reported. The Wall Street Journal (subscription required)  writes that during a recent FDA inspection bacterial contamination was found in raw materials used to manufacture some of the product lots that were withdrawn last weekend.  The FDA called the findings “serious” but said it could not yet determine “whether further action by the FDA is warranted,” reports WSJ. The company’s own testing of finished products did not turn up evidence of contamination. The FDA still says the risk of harm from the products is remote but it still urges parents not to use the products (pediatric versions of Tylenol, Motrin, Zyrtec and Benadryl) as a precaution. McNeill is a business unit of Johnson & Johnson.

A preliminary study finds that expectant mothers who use a proton pump inhibitor (PPI) to ease symptoms of pregnancy-related acid reflux may increase their child’s risk of cardiac birth defects. MedPage Today reports that use of a PPI in the first three months of pregnancy was associated with twice the risk of such defects. However, the study noted that congenital heart deformations remain rare. Many women develop gastroesophageal reflux disorder (GERD) during pregnancy. Some are treated with PPIs, although the safety of the therapy in pregnancy is unclear, according to MedPage.

Abbott Laboratories HIV drug Kaletra is being investigated for potential risk of liver toxicity by the FDA, according to Reuters. The FDA mentioned Kaletra in its quarterly list of safety probes, which was released yesterday. The agency is also looking at breast cancer in male patients using Avodart, baldness drug Propecia, and Proscar, a prostate drug. The FDA notes that being on the list doesn’t mean that the agency has concluded that a drug causes a specific risk.

As always, do not change medications without consulting your doctor.