The Food and Drug Administration doesn’t try to find out whether or not medical-device recalls are successful.

Referring to a report by the Government Accountability Office,  The Hill reports that the FDA doesn’t have clear policies in place to determine whether a recall worked and doesn’t analyze individual recalls in search of more fundamental problems, the GAO said.

According to the GAO report, the FDA doesn’t have criteria for measuring whether manufacturers actually pull every defective device during recalls. Agency officials sometimes disagree about whether similar recalls have worked, the report says.

The agency also does not document its reasons for determining that recalls are complete.

By Lucia Graves, The Huffington Post

According to a new report, industry regulators have known for years that Roundup causes birth defects.

Roundup, produced by U.S. company Monsanto, is the world’s best-selling herbicide.

The report, “Roundup and birth defects: Is the public being kept in the dark?” found regulators knew as long ago as 1980 that glyphosate, the chemical on which Roundup is based, can cause birth defects in laboratory animals.

But despite such warnings, and although the European Commission has known that glyphosate causes malformations since at least 2002, the information was not made public.

Instead European regulators misled the public about glyphosate’s safety, according to the report, and as recently as last year, the German Federal Office for Consumer Protection and Food Safety, the German government body dealing with the glyphosate review, told the European Commission that there was no evidence glyphosate causes birth defects.

The report comes months after researchers found that genetically-modified crops used in conjunction Roundup contain a pathogen that may cause animal miscarriages. After observing the newly discovered organism back in February, Don Huber, a emeritus professor at Purdue University, wrote an open letter to Secretary of Agriculture Tom Vilsack requesting a moratorium on deregulating crops genetically altered to be immune to Roundup, which are commonly called Roundup Ready crops.

Although glyphosate was originally due to be reviewed in 2012, the Commission decided late last year not to bring the review forward, instead delaying it until 2015. The chemical will not be reviewed under more stringent, up-to-date standards until 2030.

Johnson & Johnson’s troubles just get more and more stinky.

According to CNN, the pharmaceutical giant announced on Thursday a recall of 57,000 bottles of the prescription anti-seizure medication Topamax following consumer complaints of an “uncharacteristic odor.”
Johnson & Johnson said the recall represents two lots of the Topamax 100 mg tablets made by its Ortho-McNeil Neurologics division.

The affected drugs were shipped and distributed between Oct. 19, 2010 and Dec. 28, 2010 in the United States and Puerto Rico.

The company said it believes fewer than 6,000 bottles of the medicine remain in the marketplace to be recalled. However, Ortho-McNeil Neurologics said it does not anticipate a product shortage resulting from the recall.

J&J said it initiated the recall after receiving four consumer reports of an uncharacteristic odor thought to be caused by trace amounts of TBA (2,4,6 tribromoanisole).

The drug is already under fire because it has been linked to oral birth defects in infants who were exposed when their mothers took it.

Last month, the government announced it was taking over three Tylenol plants operated by McNeil following a wave of drug recalls and a Food and Drug Administration criminal investigation into safety issues at the factories.

While not considered to be toxic, J&J said TBA can generate an offensive odor, and a very small number of patients have reported temporary gastrointestinal symptoms.

Source: CNN Money

Hip implants aren’t the only defective medical devices giving patients problems.

An Illinois man has filed a product liability lawsuit alleging that he experienced problems with the Zimmer NexGen CR-Flex Porous knee replacement system as a result of a defective design. According to the lawsuit, the design caused the artificial knee to loosen inside the patient’s body and led to the need for additional surgery.

The complaint revolves around the same Zimmer NexGen knee replacement that was the focus of concern at the annual conference of the American Academy of Orthopaedic Surgeons last year. In March 2010, data was presented by several prominent surgeons, including Dr. Richard A. Berger, a former Zimmer knee implant consultant, that suggested Zimmer NexGen CR-Flex knee replacement problems resulted in revision surgery in nearly 9 percent of cases examined and resulted in knee replacement loosening in more than a third of the cases.

Although Zimmer previously paid Dr. Berger millions of dollars to work as an orthopaedic consultant, they reportedly dismissed the surgeon’s concerns and canceled their relationship with him. The medical device manufacturer suggested that the problems identified by Dr. Berger were caused by his surgical skills or technique, not the design of the device.

In August 2010, Senator Charles E. Grassley wrote a letter to the Zimmer CEO and President requesting additional information on what the company was doing to respond to complaints about failures with some Zimmer products and whether there were more consultants who had raised concerns about the company’s implants.

In September 2010, a Zimmer NexGen knee recall was issued for other components, including the NexGen TM Tibial Trays, NexGen MIS Tibial Components and MIS Modular Tibial Plates and Keels. The recall was issued after the company received at least 114 reports of Zimmer NexGen knee loosenings and other complications involving those products.

A growing number of Zimmer NexGen lawsuits are being pursued by individuals throughout the United States who have experienced loosening or failure of their knee replacement.

If you have had hip or knee replacement surgery and suffer from defective implants, please call us for professional insight.

2004 Tests Found Chemical Nationwide

Some water utility representatives have protested Environmental Working Group’s report of laboratory tests that found worrisome levels of chromium-6, a suspected carcinogen, in the drinking water of 31 cities across the country.

Yet the tap water industry was worried enough about the contaminant to conduct its own extensive survey in 2004 that found clear evidence of widespread chromium-6 pollution in untreated source water. The survey, conducted by the Awwa Research Foundation (since renamed the Water Research Foundation), an offshoot of the American Water Works Association, obtained data on 341 source water samples from 189 utilities in 41 states. The conclusion: chromium-6 is common in American groundwater.

Tap water industry representatives made no mention of their study when they testified alongside EWG at a Feb. 2 Senate environment committee hearing on chromium-6 pollution. There is no indication that customers of the 189 participating utilities were advised of the chemical’s presence in source waters in their communities.

Chromium-6, also known as “hexavalent chromium,” is often called the “Erin Brockovich” chemical, after the crusading legal assistant who helped residents of tiny Hinkley, Calif, win a $333 million settlement from Pacific Gas & Electric Co, accused of dumping the chemical in local ground water. Actress Julia Roberts won an Oscar for her portrayal of Erin Brockovich in the 2000 film of the same name.

The 2004 industry study, which EWG obtained from a source and cited in its December 2010 report, “Cancer-causing Chromium-6 Pollution in U.S. Tapwater,” demonstrates that chromium-6 pollution was not confined to California.

“The tap water industry’s 2004 study is unmistakable proof that it has known about extensive chromium-6 contamination for at least seven years,” said Jane Houlihan, EWG senior vice president for research. “Water utilities should tell their customers any time they know that a suspected carcinogen has polluted local waters. People have a right to know what they and their families may be drinking.”

Pollution levels in untreated and treated water are not directly comparable. Even so, the two studies, read together, paint a picture of coast-to-coast chromium-6 pollution.

The industry research group provides its report Occurrence Survey of Boron and Hexavalent Chromium to water utilities and their consultants, who pay four or five-figure subscription fees and a document fee of about $300. (The report can now be bought online for $200 or more.)

EWG is a nonprofit research organization based in Washington, DC that uses the power of information to protect human health and the environment.

After more than 50 product recalls in 15 months, including for artificial hips and Tylenol, the $60 billion company is fighting to clear its once-trusted name.

The recalls — voluntary and otherwise — reads like your family medicine cabinet: Tylenol and St. Joseph Aspirin were recalled for foul odors people said made them sick; Benadryl and Zyrtec were recalled for botched amounts of ingredients; Rolaids were recalled for containing bits of wood and metal.

Over the last 15 months, the company has recalled contact lenses, syringes filled with prescription medications, hernia devices, and other products made by subsidiaries around the world.

In the year ended Mar. 8, 2011, J&J was involved in at least 11 major recalls, as defined by the FDA, almost twice as many as Pfizer (PFE), the world’s largest health-care-products company by revenue, or Procter & Gamble (PG), the world’s largest consumer-products company.

J&J’s woes aren’t confined to the last couple of years. During the last decade, the company has been repeatedly confronted with claims that it sold a product that was defective, or that carried risks J&J downplayed in its marketing. It has been accused of paying kickbacks and using other financial incentives to promote off-label use of drugs and devices. It has been cited by federal authorities for trying to avoid the publicity of a recall by quietly buying up tainted products. And it frustrated FDA regulators who were urging the company to strengthen quality control at the factories that produced many of the recalled over-the-counter products.

J&J has steadfastly denied these claims, but its own annual report for 2010 contains eight pages detailing government criminal and civil investigations and thousands of private lawsuits covering a wide range of drugs, devices, and business practices.

If you’ve haven’t been keeping up, here is a recap of the recalls in just the last couple of years.

Johnson & Johnson’s recall rap sheet:

• AUG 2008: Consultants to J&J buy defective Motrin from stores. The FDA says it wasn’t notified of this “phantom recall.”
• NOV 2009: McNeil pulls about 6.3 million bottles of tainted Tylenol Arthritis Pain caplets made in Puerto Rico.
• JAN 2010: McNeil expands withdrawal to include Benadryl Allergy, Tylenol, Children’s Tylenol Meltaway, and Rolaids.
• APR 2010: J&J recalls 135 million bottles of meds made in Fort Washington, Pa., and closes the plant.
• MAY 2010: The FDA says the U.S. may pursue criminal charges against J&J.
• JUNE 2010: McNeil expands the recall from its Puerto Rico plant to include five more lots of Benadryl and Tylenol.
• JULY 2010: Yet more recalls; company submits remediation plan for McNeil plants to FDA.
• AUG 2010: Company appoints quality-control czar, announces corporation-wide standards.
• AUG 2010: J&J pulls 100,000 boxes of 1-Day Acuvue TruEye contact lenses; days later, DePuy recalls ASR hips.
• DEC 2010: 13 million packages of Rolaids softchews are recalled after customers find wood and metal particles in them.
• JAN 2011: J&J withdraws 43 million bottles of Rolaids, Tylenol, Benadryl, and Sinutab.
• JAN 2011: J&J announces 2010 earnings, puts lost sales from recalls and plant slowdowns at $900 million.
• FEB 2011: J&J units announce recalls of 70,000 potentially cracked syringes preloaded with the antipsychotic Invega.
• MAR 2011: J&J withdraws 585,000 surgical sutures due to concerns about compromised sterile packaging.
• MAR 2011: J&J’s Animas unit announces recall of 384,000 insulin-pump cartridges that may leak.
• MAR 2011: FDA and McNeil announce consent decree that will give agency expanded oversight of three plants.

Topiramate (brand name: Topamax) is used to treat epileptic seizures and prevent migraines. However, the drug presents a risk of  birth defects in children born to mothers taking the drug.

As a result, the FDA has required that Topamax carry a stronger warning to alert pregnant women of the risks regarding taking the drug while pregnant.

According to the research, infants who were exposed to Topamax during pregnancy, specifically the first trimester, had an increased risk of developing cleft lips or cleft palates. If you took topiramate during pregnancy and delivered a child with an oral birth defect, you may be entitled to monetary damages.

Topamax Pregnancy Guidelines
Topiramate (brand name: Topamax) presents a risk of birth defects in children born to mothers taking the drug. As a result of this risk, the FDA released new Topamax pregnancy guidelines:

• Women of childbearing age should speak with their doctors about alternate treatment options, to limit the use of Topiramate during pregnancy
• Women of childbearing age who continue treatment with Topamax should use an effective birth control method
• Before beginning Topamax, women should speak with their doctor if they are pregnant or plan to become pregnant
• Women who become pregnant while taking Topamax should speak with their doctor immediately
• Women, even those who are pregnant, should not stop treatment with the drug before speaking with their health care professional

Due to the recent information regarding Topamax and pregnancy, women who took Topiramate during pregnancy and delivered a child with a cleft palate or cleft lip may have legal recourse. A Topamax lawsuit would allow women the opportunity to recover the cost of medical bills and other damages resulting from their child’s Topamax birth defects. To find out if you can participate in a Topamax lawsuit, complete our no cost case review form with details of your Topamax pregnancy side effects.

Each year hundreds of thousands of Americans undergo elective hip replacement surgery. For the most part, few patients regret undergoing this surgery which reduces pain and increases their mobility.

Most of the prosthetic devices used are safe, however, through the years various orthopedic medical devices, such as prosthetic knees and prosthetic hips have been associated with complications.

DePuy Orthopaedics, a subsidiary of Johnson & Johnson is the latest manufacturer to recall a defective medical device.

On August 24, 2010 DePuy voluntarily recalled ASR XL Acetabular Hip System and DePuy ASR Hip Resurfacing System Implant products sold after 2006. It is estimated that 1 in 8 patients will suffer from complications. As a result medical monitoring including blood tests and X-rays may be necessary especially if a patient is experiencing pain or difficulty walking.

DePuy customers should avoid any discussions with company representatives since it may compromise their legal rights. There are many complex issues pertaining to the valuation of past, present and future pain and suffering; issues regarding the cost of ongoing medical monitoring and future revision surgery; as well as the potential reimbursement of medical claims by Medicare and other insurance company interests.

Before speaking with any representative it is advised to contact a lawyer skilled in medical device litigation.

All DePuy implant customers should speak to a lawyer to gain a full understanding of their rights concerning a problem which may last decades and should be leery of signing any documents or authorizations before consulting with lawyers.

An earlier Class I recall of saline flush syringes has now prompted a secondary FDA recall of venous catheter trays that included the defective syringes.

Cook Inc., of Bloomington, Ind., has issued an urgent recall for a series of defective central venous catheter trays, including single, double, triple, and five-lumen trays as well as single and double lumen PICC peripheral inserted central venous catheter trays.

The original Class I recall, announced in October 2010, involved certain lots of 6-mL prefilled saline flush syringes (0.9 percent sodium chloride) manufactured by Excelsior Medical Inc.

Leaks in the plunger luer were detected during a routine syringe leak test. The potential exists for leakage and possible loss of sterility.

After learning of the problem with this defective medical device, Cook initiated its own Class I recall. This class of recall means the affected products pose a risk of serious injury or death.

The recalled defective medical devices include 123 individual catheter products, which come packaged in trays containing different sizes. The catheters are used to monitor a patient’s pressure in a vein, for blood sampling, and administration of drugs and fluids.

Source: John Gever, Senior Editor, MedPage Today

The U.S. Food and Drug Administration (FDA) has been allowing tens of millions of relatively untested, unsafe medical devices to be marketed and sold in the U.S. and used in patients, according to an analysis published online by the Archives of Internal Medicine.

“We think patients will be shocked to learn how often new medical products using different materials, made by a different manufacturers, are not scientifically tested in humans to see how well they work,” said study authors in a statement released with the report.

Researchers examined the FDA’s list of high-risk device recalls issued between January 2005 and December 2009 to determine whether the devices had been approved using the rigorous premarket approval (PMA) process or the less-rigorous, less-expensive 510(k) process that does not require clinical testing or inspections of the manufacturing process.

Of the 113 high-risk device recalls issued in the four-year period, 71 percent of the devices had been cleared by the FDA using only the 510(k) process, a process typically intended for low-risk devices to speed along the approval process.

Only 19 percent of the recalled devices had been approved through the PMA process, which requires testing in actual patients as well as post-marketing safety studies. The remaining 7 percent of the recalled devices were exempt from regulation by the FDA.

“Our findings reveal critical flaws in the current FDA device review system and its implementation that will require either congressional action or major changes in regulatory policy,” wrote study authors Diana M. Zuckerman of the National Research Center for Women & Families in Washington, D.C., and Steven E. Nissen of the Cleveland Clinic in Cleveland.

About half of the studied device recalls involved cardiovascular devices such as automatic external defibrillators (AEDs) and implantable defibrillators.

The issue of untested, unapproved medical devices is an ongoing concern in connection with last year’s recall of two popular DePuy hip replacement systems in the U.S. The hip device has since been connected to numerous health complications, as the manufacturer was allowed to sell and market the defective hip replacements without having received FDA approval due to a loophole in the device approval process.