San Antonio Personal Injury Lawyer - FDA

Pharmaceutical company claims controversial laxatives are safe

Beth Janicek — Wed, 01 Jul 2009 10:02:54 GMT

Six months ago, the pharmaceutical company C.B. Fleet pulled two laxative drugs from store shelves. Now, according to the Lynchburg (VA) News and Advance, the company is seeking to reintroduce thousands of cases of the recalled drugs onto the market.

C.B. Fleet, which is based in Lynchburg, is currently facing 38 federal lawsuits concerning the laxatives. The suits were recently consolidated into one federal district court (the Northern District of Ohio) in order to share pre-trial proceedings and discovery. The lawsuits allege that the recalled drugs caused serious kidney damage. Other lawsuits remain in state courts where jurisdiction rules allow.

The drugs are Fleet Phospho-soda and Fleet Phospho-soda E-Z Prep Bowel Cleansing System. Both were over the counter products classified as oral sodium phosphates. C.B. Fleet officials maintain that, when used as directed, the recalled drugs are safe. There have been discussions about making these drugs available by prescription.

The drugs Visicol and OsmoPrep are available by prescription only and the FDA is requesting a Box Warning be added to the label. The Food and Drug Administration issued a warning in December 2008, concerning oral sodium phosphates. The FDA linked them to acute phosphate nephropathy (an acute kidney injury involving a buildup of calcium phosphate crystals). The agency specifically warned that oral sodium phosphates should not be used for bowel cleansing without a prescription due to these serious risks.

The FDA also reported that acute phosphate nephropathy had developed in patients after use of an oral sodium phosphate even when the patients had no identifiable factors putting them at risk for such a kidney injury.

Originally posted at InjuryBoard by Beth Janicek

Nestle Withholds Information from FDA

Beth Janicek — Tue, 30 Jun 2009 12:38:58 GMT

Recently released inspection reports from a Nestle USA cookie dough factory show that the company repeatedly withheld information from Food and Drug Administration inspectors USAToday.com.

The inspection records were made public after Nestle’s Toll House refrigerated, prepackaged cookie dough was pinpointed as the likely source of an E. coli outbreak. There have been 69 people in 29 states have been sickened by the outbreak.

Nestle has voluntarily recalled all refrigerated cookie dough products produced at a Danville, Va. factory and warned consumers not to eat raw Toll House cookie dough.

According to the inspection reports, the FDA was refused access to certain documents in 2004, 2005, 2006, and 2007.

A February 2007 inspection found several health and safety violations at the Danville plant, including improper storage of equipment, leaks, and a hole in a steam line. When the FDA returned in December 2007 to follow up on the violations found in February of that year, the inspectors were denied the right to take photographs, and denied the right to review production records or complaint files.

In 2006 the FDA investigators were also not allowed to take photographs or review a complaint log, pest-control records, or information pertaining to an environmental testing program. The 2006 inspections found insects in the manufacturing area, dirty equipment being stored as clean, and more leaks.

This seems to be similar to the problem consumers were having recently with contaminated peanut butter and pot pies. Texas law allows a consumer to sue the manufacturer and/or seller of a product when the product is harmful. A few of the theories a consumer can pursue against a manufacturer or seller include suing for strict liability, breach of warranty, or deceptive trade practices.

Any person who suffers physical harm as the result of ingesting a food or beverage product that contains a foreign object or is otherwise contaminated may be able to recover money damages. The consumer does not have to prove that the defendants failed to take every precaution available, nor does the consumer have to prove that he had a contractual relationship with the defendants.

Originally posted at InjuryBoard by Beth Janicek

FDA Only Conducted Half of Food Safety Audits

Beth Janicek — Wed, 27 May 2009 18:40:57 GMT

According to new documents sent to Congress, the Food and Drug Administration only conducted about half of the state food safety audits it promised to do in the two years before the recent peanut salmonella outbreak. The documents show that the agency did not do any of the required audits of the state-run food inspections in five states during 2007-2008. In addition the FDA was unable to say whether audits were conducted at all in an additional 11 states. Georgia and Texas, which were linked to the wide-ranging peanut recall earlier this year, were included in that 11. Only 14 states received 100% of the audits promised.

FDA audits are to ensure that food is inspected properly by states that contract with the FDA to perform safety checks. The FDA has admitted that the food safety program is a turnaround project.

Stephen R. Mason, acting assistant commissioner for legislation at the FDA, said the recent salmonella outbreak “has highlighted limitations in our current approach and has prompted internal discussions on potential enhancements to the audit program.”

In 2000 the Health and Human Services Department, which oversees the FDA, said that the agency needed to place a high priority on better evaluating the effectiveness of state inspections of food production facilities. In response to those recommendations, the FDA set a standard that 7% of all state inspections should be audited by the federal agency. The FDA acknowledges that it has fallen far short of that goal.

In 2006-2007 audits were not done at all in Arkansas, Maryland, South Carolina, Tennessee, Texas, Virginia, West Virginia, and Wyoming, and in 2007-2008 audits were not done in California, Iowa, Kansas, Nebraska, and Wyoming. Only 9% of the promised audits were done in California during 2006-2007, in which time an E. coli outbreak in spinach caused three deaths and more than 200 illnesses.

FDA spokeswoman Susan Cruzan said “Although FDA has not been able to fulfill the goal of conducting 100% of the audits expected under FDA’s internal auditing policy, FDA has audited each state at least once, has good knowledge of the state programs and state inspection personnel, and works to improve the programs as needed.”

Congress has since vowed to step up oversight of the FDA. Several members have introduced bills to overhaul the agency, such as proposals to separate its food safety and drug oversight duties, as well as to significantly increase funding.

Originally posted at InjuryBoard by Beth Janicek

Hydroxycut Recall

Beth Janicek — Thu, 07 May 2009 12:36:38 GMT

One death has been linked to Hydroxycut and other cases have involved serious liver injuries, including jaundice and liver failure. Body builders and/or dieters have been warned – the FDA has issued a recall and have urged Americans to stop taking the dietary supplement.

The Hydroxycut products by Iovate Health Sciences Inc., of Oakville, Ontario and distributed by Iovate Health Sciences USA Inc. of Blasdell, N.Y., which have been recalled are as follows:

Hydroxycut Regular Rapid Release Caplets;
Hydroxycut Caffeine-Free Rapid Release Caplets;
Hydroxycut H ardcore Liquid Caplets;
Hydroxycut Max Liquid Caplets;Hydroxycut Regular Drink Packets;
Hydroxycut Caffeine-Free Drink Packets;
Hydroxycut H ardcore Drink Packets (Ignition Stix);
Hydroxycut Max Drink Packets;
Hydroxycut Liquid Shots;
Hydroxycut H ardcore RTDs (Ready-to-Drink);
Hydroxycut Max Aqua Shed;
Hydroxycut 24;
Hydroxycut Carb Control;
Hydroxycut Natural;

"While this is a small number of reports relative to the many millions of people who have used Hydroxycut products over the years, out of an abundance of caution and because consumer safety is our top priority, we are voluntarily recalling these Hydroxycut-branded products," the company said in a statement on its Web site. Consumers can get a refund by returning the pills to the store they purchased them from, the company said.

Regulation on dietary supplements is not as strict as it is for medications. Manufacturers of dietary supplements do not have to prove to the FDA their products are safe, although regulators are closely monitoring aftermarket reports for any signs of trouble. In 2004, ephedra, an ingredient found in dietary supplements, linked to heart attacks and strokes were also banned.

The health risks from dietary supplements can be life threatening. There are other supplements on the market that due not carry such dangerous risks. They are profitable to produce and often marketed to mislead the consumer. We are likely to see litigation result from the serious injuries caused by these dietary supplements.

Originally posted at InjuryBoard by Beth Janicek

Food Safety

Beth Janicek — Sat, 18 Apr 2009 12:42:26 GMT

As President, Barack Obama has a lot of challenging issues to deal with – I am sure he never thought peanut butter would be one of the issues.

"When I heard peanut products were being contaminated earlier this year, I immediately thought of my seven-year-old daughter Sasha, who has peanut butter sandwiches for lunch probably three times a week," he told the nation in one of his weekly addresses from the White House. "No parent should have to worry that their child is going to get sick from their lunch."

In the 1990’s the average number of disease outbreaks due to food contamination were 100. It has risen to 350 yearly. Due to these troubling numbers, Mr. Obama is setting up a working group on food safety comprised of cabinet secretaries and senior officials. He has also promised to address America’s “underfunded and understaffed” Food and Drug Administration.

By last month nine people had died as a result of tainted peanut butter made by Peanut Corporation of America, who has now filed for bankruptcy. Another peanut scare, resulting in a US pistachio recall a few weeks ago, was also due to salmonella being found.

Globalization of the food chain, due to food grown in one part of the world but processed and consumed in others, means a food scare in one country can be felt in other countries as well.

Sourcing ingredients from around the world also makes it "more complex" to manage the food supply chain, says Jean Spence, vice-president for research, development and quality at Kraft Foods. "There are lots of different standards around the world, which makes it challenging when you work with suppliers." Of Kraft's 168 manufacturing plants, 110 are located outside the US - in some 45 countries.”

Ultimately it is the consumer who needs to apply the pressure to the government and companies to improve safety standards, especially since it is the consumer who it effects the most. Without food safety improvements, these salmonella outbreaks will continue and we will see more deaths as a result.

Originally posted at InjuryBoard by Beth Janicek

Recall of Peanut Containing Products

Beth Janicek — Sat, 07 Feb 2009 14:27:26 GMT

The FDA has confirmed that the sources of the outbreak of illnesses caused by Salmonella Typhimurium are peanut butter and peanut butter paste produced by the Peanut Corporation of America (PCA) at its Blakely, Georgia processing plant. During the course of the investigation, the FDA determined the PCA distributed potentially contaminated product to more than 100 consignee firms. The PCA has since recalled all products processed in its facility since January 1, 2007. This recall includes all peanuts, peanut meal, peanut butter, and peanut paste. It does not include peanut butter jars.

The FDA finished its inspection of the PCA’s Blakely plant on January 27, which found deficiencies that indicate that the plant was not compliant with Current Good Manufacturing Practices required by the FDA. During the inspection, FDA’s investigators recorded that the firm had shipped products after having received a positive Salmonella test for the lot, followed by a negative salmonella test. A list of problems observed by the FDA can be found at this link.

Companies nationwide that received PCA’s product have issued voluntary recalls. The FDA has created a searchable database for these products, which can be found at this link. The FDA and CDC have issued some recommendations for consumers:

Consumers are urged to check FDA’s website to determine which products have been recalled and will be recalled in the coming days. Any product that is on the recall list should be disposed of in a safe manner. Consumers are also urged to wash their hands after handling potentially contaminated products.
If consumers are unsure whether a peanut-containing product is potentially contaminated, they should avoid consuming it or feeding it to their pet until they obtain more information regarding the product.
Persons who think they may have become ill from eating peanut products are advised to consult their health care providers.

Originally posted at InjuryBoard by Beth Janicek

Controversy Surrounds Inspection of Peanut Plants

Beth Janicek — Fri, 06 Feb 2009 13:17:27 GMT

Peanut Corporation of America, the company at the center of the recent salmonella outbreak, claimed on Wednesday that its plant in Blakely, GA had been regularly inspected in 2008. The Food and Drug Administration has confirmed that the Georgia plant is the source of the tainted peanut butter which has caused the multi-state spread of salmonella.

The company alleges that federal and state officials visited the Georgia plant in 2008, as well as independent auditors. The independent audits, which were paid for by PCA in order to meet food manufacturers’ requirements, were intended to show the plant’s compliance with federal health and safety standards. The independent audits were conducted by AIB International. AIB gave the Georgia plant “superior” ratings, but the FDA is investigating whether AIB reviewed state inspection reports or the plant’s own internal tests on its products. After the salmonella was linked to peanut butter produced at the Georgia plant another inspection was conducted, revealing roaches, mold, a leaking roof and internal records of more than a dozen positive tests for salmonella.

The Associated Press reported on Monday that another peanut plant operated by PCA in Plainview TX was not inspected or licensed for over 4 years. The Texas plant was registered with the FDA, but it was not able to produce a current food producer’s license.

The salmonella outbreak has caused more than 500 illnesses and 8 deaths, and has resulted in more than a 1,000 food products being recalled. Major national brands of peanut butter are not affected by the recall, but a variety of peanut related products, including pet food, have been included. A complete list of recalled products is available here.

Originally posted at InjuryBoard by Beth Janicek

Lawsuits Consolidated against Manufacturer of Defective Urinary Device

Beth Janicek — Wed, 07 Jan 2009 10:03:56 GMT

I wrote a blog last month about the FDA’s quick review of certain medical devices and I referenced a “fast-track” approved device meant to help women with urinary issues but the device ended up being recalled. Similar urinary devices have made the news again due to recent lawsuits against a device manufacturer. The problematic device is a sling that is surgically implanted to treat stress urinary incontinence, which often is brought on by coughing, sneezing or exercise, and is common in women after childbirth. The product was removed from the market in 2006.

Now there are 32 pending lawsuits against Mentor Corp., a Santa Barbara, Calif.-based cosmetic surgery device manufacturer. The Plaintiffs claim Mentor was negligent in their design of the ObTape device and that they failed to properly warn patients of the risks of injury created by the device. The FDA issued a general warning to doctors about potential risks connected to these slings but the FDA did not specifically name the ObTape device.

A recent California jury verdict came down in favor of Mentor because the jury concluded the doctors knew of the risks involved when they implanted the ObTape. But, the litigation does not end there; a U.S. District Court in Georgia recently consolidated 22 lawsuits against Mentor regarding the ObTape device. Gary Blasingame, a lawyer handling some of the women’s cases said, “What they’re claiming is that because of the defective device, this ObTape, these women have experienced serious medical injuries and problems. We think it's a significant series of cases, and we think this product is one that we have alleged in our complaint and anticipate will be proven is defective."

Originally posted at InjuryBoard by Beth Janicek

Rep. Barton Questions FDA Investigation of Heparin

Beth Janicek — Tue, 06 Jan 2009 12:06:40 GMT

The controversy surrounding the drug Heparin has been unfolding over the past year with reports of drug recalls and deaths and injuries as a result of contaminated Heparin. It appears, however, that some of the reports the public has been receiving contains conflicting information.

The Food and Drug Administration (FDA) began their investigation this year after news of patients having allergic reactions to Heparin. In May, the FDA contributed three deaths to the drug. In December, three officials from the FDA reported in the New England Journal of Medicine that there have been no deaths resulting from Heparin. This is puzzling because in October the FDA sent a letter to Representative Joe Barton of Texas stating that of 16 deaths involving heparin they investigated, the FDA found heparin to be the “possible” cause of death in three cases and the “probable” cause of death in one case.

As a result of this conflicting information, Rep. Barton sent a request to the Government Accountability Office (GAO) asking them to review the FDA’s handling of the heparin issue. In his letter Rep. Barton also points out that the FDA linked one of their “probable” heparin related deaths to drugs made by the American Pharmaceutical Partners APP company, but the APP drugs were never implicated in the heparin recall and the companies own investigation found no links from the heparin they manufactured to the deaths reported. For more details, a copy of Rep. Barton’s letter to the FDA can be found here.

In the end we have medical journals, pharmaceutical companies, and the FDA giving conflicting information about Heparin and the risks it poses to patients. The public deserves clear answers and thorough investigations when it comes to potentially deadly drugs. Maybe Rep. Barton’s letter will initiate some discovery into the truth on Heparin.

Originally posted at InjuryBoard by Beth Janicek

Off-label Drugs Not Researched for Safety

Beth Janicek — Thu, 27 Nov 2008 12:55:00 GMT

There is a recent study which has identified 14 drugs which needed the most pressing research into off-label use. The study says that physicians and patients should be most concerned about the antidepressants and the antipsychotic drugs on the list. The FDA only requires that the drug companies test the drugs for the use that they are seeking approval. For example on the list is Seroquel which has been approved by the FDA to treat schizophrenia and short term episodes of bipolar disease but the drug is more commonly prescribed as maintenance therapy for bipolar disease and yet there has not been ample research by the drug company for the FDA to approve the drug for this purpose. Therefore, it has not been proven to be safe for this treatment or effective.

Once a drug is approved by the FDA then according to PLoS Medicine, industry-paid "nationally known, influential academic physicians" help create "buzz" about off-label uses by writing about them for publication or presentation at scientific meetings.

This is of concern because many of these drugs have serious side effects. For example, Seroquel had added to its label the risk of diabetes and hyperglycemia. There may be other safety risks with these drugs that are unknown because there has not been sufficient testing.

Off-label use is legal and accounts for roughly half of all prescriptions written. I think the most important part is that patients need to be made aware that the drug they are being prescribed is for an off-label use so that they can make an informed decision on whether they want to use the drug. In a recent article in PLoS Medicine, the authors argued that the doctors had an ethical duty and an extension of informed consent to tell the patients about the off-label use. I could not agree more!

Originally posted at InjuryBoard by Beth Janicek