Dry dog food contaminated with salmonella has been sickening human beings. The pheonomenon, which began in 2006, has continued as 8 more people have been identified with sickness related to salmonella linked to the dry dog food. As of the end of October, 79 cases have been reported in 21 states of the country. Most of the cases involve very young children, typically 2 years of age or younger.
“We have been following an outbreak of illness due to a specific strain of salmonella. And in 2007, we linked those human illnesses with contaminated pet food produced at one Pennsylvania pet food plant,” said report co-author Dr. Casey Barton Behravesh, a CDC epidemiologist. “In 2008, we have identified eight additional cases.”
The salmonella contamination has been linked with a specific brand of dog food coming from a Mars Petcare U.S. plant in Everson, Pa. The plant has since been closed and the company has recalled more than 23,000 tons of dry dog food sold under over 100 different brand names.
“The issue is that since dry pet food has a one-year shelf life, it is possible that contaminated products from even our 2007 recall could still be in the homes of ill persons and could lead to additional illness,” said Barton Behravesh, a CDC epidemiologist.
According to the CDC, the best way to minimize the risk of infection is to take the following steps:
1)refrain from feeding pets in the kitchen
2)thoroughly clean pet feeding bowls
3)wash your hands after handling pet foods
4)avoid any cross-contamination of the pet foods with human food or areas in which human food is prepared or consumed.
According to the CDC, most infected people develop diarrhea, fever, and abdominal cramps within 12 to 72 hours. The illness typically lasts four to seven days, and most people recover without treatment. But, for some, the diarrhea may be so severe that they need to be hospitalized. In these patients, the infection can spread from the intestines to the bloodstream, and then to other parts of the body, leading to death unless antibiotics are administered promptly. The elderly, infants, and those with impaired immune systems are more likely to have a severe illness.

Months after the heparin contamination scare, US Marshalls seized lots of heparin from an Ohio plant. Federal marshalls seized 11 lots from Celsus Laboratories located in Cincinnati Ohio. Five of the lots seized Thursday were heparin sodium active pharmaceutical ingredient, used in finished drug products. Six were heparin lithium, used in medical devices, the agency said.
The contaminated heparin has been linked to counterfeited heparin manufactured in China. The lots were contaminated with over-sulfated chondroitin sulfate (OSCS), a substance that mimics heparin’s anti-clotting activity. The contaminated heparin caused serious adverse effects earlier this year including nausea, vomiting, shortness of breath, a severe drop in blood pressure, and in some cases, death.
Celsus Laboratories had quarantined the suspected heparin product since learning of the contamination on March 8th but the FDA remained concerned that Celsus practices were insufficient to protect the general public from being exposed to the contaminated heparin.

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FDA Seizes Contaminated Heparin from a Cincinnati Manufacturer
As part of the U.S. Food and Drug Administration’s ongoing efforts to ensure that heparin for patients remains safe, the government today seized 11 lots of heparin from Celsus Laboratories Inc. in Cincinnati, Ohio.
The five lots of Heparin Sodium Active Pharmaceutical Ingredient (API) and six lots of Heparin Lithium were seized at the FDA’s request by U.S. Marshals. These products, which were manufactured from material imported from China, had been found by the agency to be contaminated with over-sulfated chondroitin sulfate (OSCS), a substance that mimics heparin’s anticoagulant activity.
“This action will help prevent this contaminated heparin from finding its way into the marketplace,” said Mike Chappell, acting associate commissioner for regulatory affairs, FDA.
Contaminated Heparin Recall Side Effects Lawsuit Attorney Page
Heparin is a blood-thinning drug. An API is a substance or mixture of substances that, when delivered in a finished drug product, directly affects the structure or function of the body. Heparin Sodium USP is an API that may be incorporated into finished drug products. Heparin Lithium is used in certain medical devices including vacutainer blood collection tubes, some in vitro diagnostic assays, and as a coating for capillary tubes. Celsus has distributed Heparin Sodium USP and Heparin Lithium to manufacturers in both the United States and abroad.
OSCS contaminant in injectable drug products containing heparin has been linked to multiple adverse events and deaths initially reported to the FDA in January 2008. Since then, the FDA has put in place a comprehensive inspection and import controls program and has acted to remove from the market heparin materials and products contaminated with OSCS. The seized Celsus heparin – which had entered the United States before the establishment of import controls for the drug – was tested for the presence of OSCS as part of this FDA effort.
To date, the agency has initiated 13 recalls of multiple contaminated medical products containing heparin from several companies.
The FDA informed Celsus Laboratories during an April 2008 inspection and again in a May 8, 2008, letter that the company’s actions to notify customers about a contaminant in its heparin were insufficient to assure an effective recall. The agency advises manufacturers who may have purchased heparin from Celsus to contact the company to make certain they are not using any heparin from the seized lots because the product does not meet acceptable quality standards.
Class Action Lawsuit Against FDA Recalled Heparin
The FDA has notified Japanese, Canadian, Australian, European Union, and other international authorities of shipments of contaminated heparin from Celsus.
Heparin Death Attorney

Insulin syringes sold at WalMart and Sam’s Club have been recalled by the FDA. The manufacturer of the syringes, Covidien Ltd. is recalling 471,000 ReliOn disposable syringes because of a mislabeling error that could cause patients to receive 2.5 times the intended dosage.
According to the FDA, “the recall applies to the following lot number and product information:
— Lot Number 813900
— ReliOn 1cc, 31-gauge, 100 units for use with U-100 insulin
Only ReliOn syringes from this lot number and labeled as 100 units for use with U-100 insulin are the subject of the recall.”
During the packaging process for this lot, some syringes labeled for use with U-40 insulin were mixed with syringes labeled for use with U-100 insulin, then all packaged individually and in boxes as 100 units for use with U-100 insulin.
The manufacturer has distributed 4,710 boxes in the recalled lot, which equals 471,000 individual syringes. Wal-Mart sold the syringes at Wal-Mart stores and Sam’s Clubs from Aug. 1, 2008, until Oct. 8, 2008.

A scientific panel assembled by the FDA has slammed the federal agency for ignoring what it views as crucial evidence in the ongoing debate over bisphenol-A, also known as BPA. The chemical is used in the manufacturing of hard, clear plastics and is found in nearly every clear plastic bottles including baby bottles.
The safety concerns regarding BPA are wide-ranging and vary from producing estrogen-like effects to causing cancer. In some studies, BPA has been linked to a higher risk of heart disease and diabetes as well as interfering with chemotherapy.
The scientific panel, composed of seven scientists from three major universities, the Environmental Protection Agency and the Centers for Disease Control and Prevention.
According to a story published in the New York Times, their concerns include the following:
The F.D.A. assessment does not have an adequate number of infant-formula samples and relies too heavily on averages, rather than accounting for variability in the samples.
¶The agency excluded several important animal studies that raised questions about the safety of BPA.
¶New research on BPA in adult humans and animals was published after the F.D.A.’s draft report and should be included.
¶The margins of safety for BPA exposure used by the agency are “inadequate.”

The NY Times Sunday magazine has published an interested if somewhat disconcerting article on China’s burgeoning role in the pharmaceutical industry. China’s booming economy has provided an opportunity for the country to become one of the world’s leading suppliers of pharmaceutical ingredients to make the drugs we consume here in the United States.
According to the article, China presently produces 2/3 of the world’s supply of aspirin and is poised to become the sole supplier in the not too distant future. Just last year, the FDA listed 1,154 plants providing the pharmaceutical ingredients to manufacture generic drugs. 43% of the plants are Chinese while 39% are in India. The US has a paltry 13% of the plants supplying these ingredients.
With profit margins squeezed, once skittish US pharmaceutical companies are turning to China to manufacture these ingredients. They can be made cheaper but we still don’t know if they’re safe since the FDA rarely inspects these foreign plants.
The other problem facing consumers and the FDA is the counterfeit drug trade. According to the Times Magazine article, it was estimated that in 2002 8% of the drugs in China are counterfeit. That number is presumably higher now given increased competition, the global economic crisis, and the demand for more drugs.
The US has already been affected by the consequences of this safety gap. The heparin scare earlier this year was the direct result of Chinese manufacturers substituting a cheaper counterfeit ingredient in order to manufacture heparin. The resulting deaths and sicknesses forced the FDA to ban the drug.
It’s not just contaminated or counterfeit drugs which cause concern. Recently, Chinese baby formula was linked to the tragic deaths of 4 Chinese babies and 53,000 others sickened by melamine, a toxic chemical that had been added to the baby formula to increase the protein count and trick quality control inspectors. The baby formula debacle never reached our shores but it did affect other countries. This is a problem that can’t be dismissed with facile explanations that it was contained to foreign countries. The prudent thinking has to assume that eventually a drug or consummable product will reach our shores and have disastrous consequences.
We need to do something about this Chinese safety gap. It’s not enough for the FDA to send over a few inspectors and set up a few FDA outposts in foreign countries. It’s a matter of national consumer safety that we know what’s being imported into our country. We can’t afford to take the risk in assuming these products are safe and effective. The pharmaceutical industry and the federal government must work together to regulate these manufacturing processes in order to keep us safe

The chorus of anti-Avandia advocacy and medical groups continues to increase. In spite of the growing concern about the diabetes drug Avandia, its maker GlaxoSmithKline PLC continues to defend the safety of its drug. “We do not believe there is a connection between liver toxicity and this medicine.”
This in spite of two respected medical groups advising against the use of Avandia. American Diabetes Association and the European Association for the Study of Diabetes said members of a joint medical panel “unanimously advised against using” Avandia.
On Thursday, the consumer watchdog group Public Citizen called on the FDA to ban the drug. The FDA originally approved Avandia in 1999. Public Citizen noted that Avandia carries with it more risks than heart attacks. It cited 14 cases of Avandia-induced liver toxicity and failure. In spite of the fact that GlaxoSmithKline had not read Public Citizen’s report, it denied its veracity anyway. The company said, “We do not believe there is a connection between liver toxicity and this medicine.”
The FDA said it will carefully review the new findings. However, it did acknowledge that the federal agency is split on how to deal with the Avandia issue. Avandia was originally approved to fight Type 2 diabetes and the accompanying high blood glucose levels.
Avandia has an interesting history. It was brought to market after the Rezulin recall. In approving Avandia, the FDA never said it was safe. Rather, it stated that Avandia posed a lesser risk than Rezulin. (That’s not a ringing endorsement of any drug.) Early on in its marketing of Avandia, GlaxoSmithKline ran into difficulties with the FDA over its misleading marketing practices. The FDA warned Glaxo that it was promoting Avandia without giving proper attention to its potential dangers and side effects.

In an unprecedented move, the Vatican has decreed that priest candidates (seminarians) who show signs or tendencies of homosexuality will have to undergo a battery of psychological tests prior to ordination to the priesthood. While psychological testing is not new to the priesthood-most seminaries require some sort of psychological report prior to accepting a candidate for a course of priestly study. However, the public manner in which the Vatican is making this move is somewhat new.
Of course, while many will question the Vatican’s attempt to link homosexuality with the sexual abuse of minors. The Vatican is clearly linking the two and is taking a public step to do something about the abuse scandal.
It’s quite interesting to note the words the Vatican officials are using to describe what they’d be looking for in a dubious candidate. Here are sampling of the terms: “strong affective dependencies; notable lack of freedom in relations; excessive rigidity of character; lack of loyalty; uncertain sexual identity; deep-seated homosexual tendencies, etc.” These are words we’ve seen on numerous occasions when investigating the background of a sexually abusive priests. They often come up in the church’s internal documents and are terms to describe sexually abusive behavior of minors.
It seems to me that if the Church were truly serious about eradicating this sex abuse problem it would develop a program for wayward bishops who transfer and cover up for these sick priests. Therein lies the real problem and the real scandal.

Wyeth Lawsuit Supreme Court Ruling March 2009
Wyeth Lawsuit Supreme Ruling March 2009
Officially, the FDA supports federal drug-approval and warning-label standards trumping stricter state laws in the Supreme Court case, Wyeth v. Levine that will be heard this coming Monday. However, internal memoranda support the opposite. In internal FDA memos, two FDA officials state that it’s wrong to assume FDA drug labels are completely reliable or that they contain full disclosure of the drug’s risks.
According to a story in today’s Wall St. Journal, “‘[M]uch of the argument for why we are proposing to invoke pre-emption seems to be based on a false assumption that the FDA approved labeling is fully accurate and up-to-date in a real time basis,’ wrote John Jenkins, the top official in the drug approval section, in 2003.”
When the FDA was confronted with the apparent contradiction, an FDA spokesperson noted that any large orgnization is bound to have differing views. However, the contradictory notions coming from the FDA are bound to give anti-preemption legislators fodder for overturning the Bush preemption policies.
The injustice of the Levine case is the unwarranted extension of the preemption doctrine. The basic law is this: Congress can preempt state laws in areas of national concern by expressly providing in the language of a bill that state regulations are preempted or superseded by the federal law. That is called express preemption. Until the Bush administration the FDA had always taken the position that state consumer tort suits were a consumer protection that complemented the federal FDA regulation. The Levine case is a prescription drug labeling case. The FDA approves labeling including warnings for prescription drugs. In most drug lawsuits the consumer claims that the manufacturer did not warn of a danger of which it knew. Most of the time these dangers are not disclosed or are concealed from the FDA like with Fen Phen or Vioxx. The drug company argument in Levine is that consumer tort suits for failure to warn on the labeling should be preempted under implied preemption because the FDA reviewed and approved the label.
This preemption question is one that can be solved by legislation that has already been proposed that expressly states that the the FDA regulatory process is not intended by Congress to preempt state consumer lawsuits.

The FDA has sent two warning letters to Bayer regarding two aspirins, Bayer Women’s Low Dose Aspirin + Calcium and Bayer Aspirin with Health Advantage. According to the FDA, Bayer’s marketing campaigns make health claims that have not been proven by the federal agency. The Bayer aspirins are marketed as successfully battling osteoporosis and heart disease. The claims have been made with out substantiation or at the very least such substantiation has not been submitted to the FDA.