Eight complaints involving a device used to filter clots out of the bloodstream has lead Boston Scientific to recall 18,000 Greenfield vena cava filters manufactured before March 10, 2004.

Included in the eight complaints were two involving serious injuries and one involving death.
The device is a cone-shaped steel filter that is installed in a large vein to catch dangerous clots before they are able to reach the lungs. The defect in the product occasionally allows the device to detach before it has been implanted. The filter would then tumble through the bloodstream and eventually cause a blockage itself.

No danger exists in patients who already have the device implanted since the defect was in the delivery system and not in the actual filter. The defect was detected and eliminated by a change in the manufacturing process in March 2004. No recall was issued at that time, however.

In November 2004, a patient died when the device became detached. Again, no recall was issued because the company said it did not know enough about the particular incident. It was a year after the death that Boston Scientific claims to have had enough information upon which to base the recall.

Since the Greenfield filter was first marketed in 1972, some 600,000 have been implanted. Only a small fraction of the recalled devices are expected to be returned. The updated version will remain on the market.

Annual sales of the Greenfield filter amount to some $20 million. To put that in perspective, Boston Scientific’s top product, the Taxus coronary stent, brings in about $3 billion in annual sales.

In addition to the U.S. recall, the company is warning healthcare officials in other countries where the device is marketed about the defect.

BPA (bisphenol-A), is and estrogen-like chemical compound that is widely used (3 million tons annually) in the production of plastic food containers, the resins that line food cans, dental sealants, baby bottles, and toys.

The highest levels of the chemical were found in cans of peas. It has also been food in the liquid contained in cans of beans, artichokes, mixed vegetables, corn, and mushrooms.

Research has now repeatedly shown that BPA leaches out of products and may be absorbed into the body at low concentrations.  Those low doses, however, appear to be sufficient to pose numerous (quite serious) health risks as a result of multiple animal studies published this year.

In addition more than 100 studies published in peer-reviewed journals have shown the detrimental effects of BPA. The most recent ones have been as follows:
 
January 2005 – BPA Shown to Increase the Growth of Prostate Cancer Cells:

A study conducted by a research team at University of Cincinnati and published in the January 2005 issue of the journal Cancer Research reported that BPA increased the growth of some prostate cancer cells.

May 2005 - Researchers Find Link between BPA and Breast Cancer:

An animal study suggests that even at extremely low concentrations, BPA exposure in the womb may be harmful. Moreover, the study uncovered evidence that BPA may be a breast cancer risk factor because of its potential effect on the development of vulnerable and sensitive breast tissue.

June 2005 – Japanese Study Links BPA to Recurrent Miscarriages:

BPA (already implicated as a possible cause of breast cancer) was linked to recurrent miscarriages in a study at Nagoya City University Medical School published in Human Reproduction Magazine.

The researchers, led by Dr. Mayumi Sugiura-Ogasawara of the OBGYN department, examined 77 women. Of that group, 45 had suffered three or more consecutive miscarriages and 32 had a history of successful pregnancies.

The women in the miscarriage group were found to have average BPA levels approximately three times higher than those who had not miscarried. Because of the small size of the study, further research is needed into the precise nature of the effect BPA has on human reproduction.

December 2005 BPA Found to Disrupt Brain Development

A University of Cincinnati (UC) research team, now reports in two articles in the December edition of the journal Endocrinology that BPA shows negative effects in brain tissue "at surprisingly low doses." Although best known for its function as a female sex hormone, estrogen also has very important roles in the developing brain of both males and females.

According to team leader, Dr. Scott Belcher: "These new studies are also the first to show that estrogen’s rapid signaling mechanisms are active in the developing and maturing brain in regions not thought to be involved with sexual differences or reproductive functions."

Dr. Belcher is an associate professor in the pharmacology and cell biophysics department at UC College of Medicine. He stated that: "BPA molecules are linked into polymers used to create polycarbonate plastics and epoxy resins that are widely used in many products. While plastics are typically thought of as being stable, scientists have known for many years that the chemical linkage between BPA molecules was unstable, and that BPA leaches into food or beverages in contact with the plastics."

This most recent study utilized rats at a period in their development equivalent to the third trimester of human fetal development through to the first few years of childhood.

In the absence of estrogen, BPA alone was found to mimic the actions of estrogen in developing neurons. Very low doses of BPA completely inhibited the activity of estrogen.

Since estrogen normally increases the growth of neurons and regulates their viability during development, these results support the theory that BPA may harm developing brain cells.

The most startling and disturbing finding, however, was that near-maximal effects of BPA on rat brain neurons occurred "at surprisingly low" doses of only 0.23 parts per trillion and happened in a matter of minutes.
These low-dose results indicate that BPA may be inflicting maximal damage at levels found in developing fetuses and typical human exposure thereby raising the possibility that detection is being missed by standard approaches used in measuring chemical exposure.

According to Dr. Belcher: "Estrogen’s actions on these neurons appear to be a double-edged sword. During certain periods of development estrogen can kill specific subsets of neurons, but at a later developmental stage it actually appears to increase their viability."

Any disruption of either of these actions of estrogen could be considered potentially harmful, Dr. Belcher added. "We have now shown that environmental estrogens like BPA appear to alter, in a very complicated fashion, the normal way estrogen communicates with immature nerve cells. The developmental effects that we studied are known to be important for brain development and also for normal function of the adult brain."

Despite the fact that plastics free of BPA and other toxic chemicals are already available, the chemical industry and every federal agency charged with regulating such compounds have resisted all efforts to have BPA banned.   
 

The courtroom fireworks surrounding Merck’s battle for survival in the ongoing state and federal Vioxx trials in New Jersey and Texas have captured the headlines for the past several weeks.

During that time, however, another major corporation has been in a similar struggle to save itself from the injuries and deaths claimed to be caused by one of its products.

Stun gun manufacturer, Taser International Inc., of Scottsdale, Arizona, has been embroiled in a number of legal problems including: state and federal personal injury and wrongful death cases;  federal class-actions challenging the advertising and marketing claims made by the company; a federal inquiry into claims made by Taser with respect to its safety studies; an SEC probe of an end-of-year sale which appeared to inflate sales in order to meet annual projections; and reports that Taser was deeply involved in a Department of Defense study that company officials touted to police departments and investors as ‘independent’ proof of the stun gun’s safety.

This information is surfacing at a time when the U.S. Securities and Exchange Commission and the Arizona attorney general are pursuing inquiries into safety claims that the Scottsdale firm has made.
Taser International Inc. has also been notified by the NASDAQ Stock Market that its stock could be delisted for failing to file its third-quarter financial report on time.

As a result, the stun gun maker’s shares fell as low as $6.50 a week ago. Despite the company’s spirited defense with respect to the safety of its product, Taser International’s stock has continued to fall from $33.45 in December 2004 to $9.72 on July 30. Last Friday’s closing price now represents a decline of just over 80% in Taser’s value in less than one year.

Over the past two years, safety concerns have continued to mount against the company on three fronts: (1) increased reports of deaths and injuries directly associated with the use (or abuse in many cases) of the stun gun; (2) deaths and injuries indirectly associated with the device; and (3) injuries to law enforcement officers during training exercises involving the Taser.

Another challenge to Taser’s dominance in the stun gun market occurred earlier this week when Maricopa County (Arizona) Sheriff, Joe Arpaio, announced that his deputies will begin testing 30 new stun guns as an alternative to Tasers. This could only have been regarded with concern by Taser International, which is based in Scottsdale, Arizona.  

According to Arpaio: "Stinger tells me their weapons have better target attainment, they cost less and are cheaper to operate. If those claims are true, I may very well move away from Taser weapons."

In October, the American Civil Liberties Union (ALCU) chapters of Nevada and Northern California mounted a two-front assault on Taser International. In Nevada, the ALCU filed a $10 million federal wrongful death and civil rights action arising out of the death of 47-year-old Keith Tucker who died after being shocked multiple times with a Taser during a struggle with the Las Vegas police.    

In a report released by the ALCU (Northern California), the safety of the Taser stun gun has been questioned on several levels. "While the Taser stun gun has the potential to save lives it poses a serious health risk as long as it remains largely unregulated," the report released in San Francisco states.

In early September a Chicago teenager was caused to go into ventricular fibrillation as a result of being shocked with a Taser. That was significant because Taser International has always maintained that its stun guns cannot cause this usually fatal heart disturbance in which the heart loses the ability to pump blood.

Many lawsuits allege Taser has ignored credible research suggesting the device can be extremely dangerous, if not fatal.

For example, using a number of sources, The Arizona Republic has now compiled a list of 153 cases in the United States and Canada since 1999 where a death followed the use of a Taser stun gun. (http://www.azcentral.com/specials/taser/#).  
    
“The Arizona Republic, using computer searches, autopsy reports, police reports, media reports and Taser’s own records, has identified 153 cases in the United States and Canada of death following a police Taser strike since September 1999. In 21 cases, medical examiners said Tasers were a cause, a contributing factor or could not be ruled out in someone’s death. In 31 cases, coroners and other officials reported the stun gun was not a factor. Below is a synopsis of each case. The Republic requested autopsy reports for all of the cases and so far has received 49.”

On January 6, 2005 Taser officials disclosed that federal authorities had launched an inquiry into claims made by the company with respect to its safety studies. The Securities and Exchange Commission was also probing an end-of-year sale which appeared to inflate sales in order to meet annual projections.  

In May, The Arizona Republic also reported that “Taser International was deeply involved in a Department of Defense study that company officials touted to police departments and investors as ‘independent’ proof of the stun gun’s safety…This information is surfacing at a time when the U.S. Securities and Exchange Commission and the Arizona attorney general are pursuing inquiries into safety claims that the Scottsdale firm has made.”

On July 17, the Associated Press reported a Texas man died after being shocked between three and six times with a Taser by an off-duty police officer who was acting as a security guard. The man’s wife said she was suing Taser International because her husband “didn’t deserve the death penalty.” It appears the men had done little more than trespass on private property and confront the officer who had chased him.

Although there had been a surge in Taser use in 2003 and 2004, safety concerns and mounting circumstantial evidence of potentially deadly risks associated with the device have caused sales to plunge in 2005.  

This includes a specific finding by the Coroner of Cook County, Illinois, that a Taser was, in fact, the cause of death of a man arrested in Chicago.

That report came at the same time police officers in five states were filing lawsuits against Taser International claiming they suffered serious injuries after being shocked with the device during training classes.

One officer, a Missouri police chief, alleged that he suffered heart damage and two strokes after he volunteered to be shocked with a Taser in April 2004, while hooked up to a cardiac monitor that was supposed to show the Taser was safe. The officer also claimed he suffered hearing and vision loss as well as neurological damage.

Other injuries claimed by the officers involved include spinal fractures, burns, a dislocated shoulder, and soft-tissue damage. A previous lawsuit file in February 2004 alleged a sheriff’s deputy suffered a fractured back in 2002.

The lawsuits challenge Taser International’s central marketing claim that its device is safe and charge the manufacturer of misleading its customers concerning the potential risks posed by the stun guns. Taser is also accused of minimizing and misrepresenting the 2002 fractured back case even after its own doctor found a one-second shock from a Taser caused the injury and that the company withheld reports of injuries to at least 12 other police officers.

It is the fractured-back-case that became the first product-liability case against Taser to go to trial. The case being tried in Phoenix involves allegations from a former Maricopa County Sheriff’s Deputy, Samuel Powers, who claims a one-second jolt from a stun gun in 2002 fractured his back and ended his career.

According to the Arizona Republic, Mr. Powers’ lawyers charge that “Taser officials misled officers about the safety of the stun gun by misrepresenting medical studies, failing to perform adequate tests and downplaying the potential for injury.” They claimed in “their opening statements…that before being shocked during mandatory training, Powers was given constant reassurances that the stun gun ‘did not, has not, and could not cause any long-term injuries.’”

Taser is defending itself by alleging that “Powers’ medical history, saying evidence showed he had years of back problems and a bone disease that left him vulnerable to the shocks. They denied Taser misled police departments about the safety of its stun guns.”

Taser had originally blamed the Maricopa Sheriff’s Office for Powers’ injury. Immediately after Powers sued Taser, the company claimed the Sheriff’s Office should be held responsible for "unreasonably requiring" officers to be shocked.

In a motion from February 24, 2004 Taser stated: "If there is evidence that the shock from the (Taser) caused any injuries or damages to the plaintiff (the Sheriff’s Office) and/or Sheriff Joe Arpaio are at fault for unreasonably requiring the plaintiff to be shocked by the Taser as part of its non-lethal weapons training."

Of course, that is the same Joe Arpaio who has now announced that his deputies will begin testing 30 new stun guns from one of Taser’s competitors (Stinger) with an eye on moving “away from Taser weapons."

According to the Arizona Republic, pictures “of Powers getting shocked were shown to jurors Wednesday. They showed Powers standing between two deputies, who were supposed to keep him from falling. Electrodes were attached to his left ankle and right shoulder. The shock, which lasted no more than a second, appeared to cause Powers to yell in pain as his body contracted and he fell forward.”

Taser’s attorney told the jury that Powers was given ample warnings about the stun gun’s risks and, despite his previous back injuries, agreed to go forward. "The warnings provided to Samuel Powers, as well as warnings to any other police departments, were adequate."

The attorney “dismissed claims made by Powers’ lawyers that Taser intentionally misreported Powers’ injury as way to avoid admitting the stun gun hurt an officer.”

As to the misrepresentation of Powers’ injury in several filings with the SEC, Taser’s attorney called it a simple mistake. "What the big beef here is they just didn’t amend SEC filings."

The Arizona Republic article, however, pointed out that Powers’ lawyer stated “it wasn’t the first time Taser had misreported critical information. He pointed to a study that Taser cited for years as proof of the stun gun’s safety.

The study, a 1987 report by a California emergency-room doctor, compared gunshot injuries and Taser injuries.”  
Taser, however, used the study to say that Tasers caused "0 percent long-term injuries" without mentioning that was only when compared with gunshot wounds. Taser claims the study’s findings were reported accurately.

”Gary Ordogg, author of the study, who is expected to testify, has previously said that Taser misused his study and that he has believed for two decades that stun guns can cause deaths.”

The outcome of this trial will likely affect the future of Taser International in a significant way regardless of which way the jury decides. Should Taser prevail, it will give the company more of a reason to adhere to its posture of denying anything is wrong with its product. Should Taser lose, however, the verdict may signal the beginning of the end for the once high-flying company that dominated its market.

A federally funded study shows that conventional antipsychotic drugs may be as unsafe or worse for the elderly than the newer drugs that the FDA warned about earlier this year.

In April, the FDA asked drug makers to add warning labels to their newer antipyschotics because studies showed that elderly patients with dementia who took the drugs had an increased risk of death.

In April, the FDA asked drug makers to add warning labels to their newer antipyschotics because studies showed that elderly patients with dementia who took the drugs had an increased risk of death.

In fact, the mortality rate of older patients nearly doubled when they took the newer antipsychotics. These drugs are widely prescribed to the elderly to treat symptoms experienced by those with dementia and Alzheimer’s disease, such as aggressive behavior, hallucinations, and delusions.

To compare the risks of older antipsychotic drugs to the newer ones, researchers at Brigham and Women’s Hospital in Boston looked at prescription and death records for nearly 23,000 older patients who were treated with antipsychotics between 1994 and 2003.

In the first six months, 18% of patients taking conventional antipsychotic drugs died, compared with 15% who were on the newer drugs.

According to the researchers: ‘’If confirmed, our results suggest that conventional antipsychotic medications should be included in the FDA’s public health advisory.'’

The study findings are published in the most recent edition of the New England Journal of Medicine.

‘’All we can do is encourage clinicians to be thoughtful to balance whatever benefits there are with what appears to be risk,'’ Dr. Philip Wang, lead study author said.

Currently, the option for treatments for older patients with dementia and delirium are extremely limited.

The Food and Drug Administration (FDA) has ordered MBI Distributing, Inc. (MBI), also known as Molecular Biologics, to stop production of its over-the-counter (OTC) eye drops and pain relievers.

A consent decree obtained by the FDA shuts down the company which has been found to not be in compliance with FDA manufacturing standards. These deficiencies and other violations have raised concerns as to the safety of the company’s eye drops. Inadequate warnings have also called into question whether consumers can safely use the company’s pain relievers.

The FDA has ordered that BMI stop production until violations found at the Benicia, California, factory are corrected. The agency reports the company has not responded to previous requests to come into compliance with federal standards and that the most current inspection indicated that the firm was not instituting the proper manufacturing controls to maintain sterility in their eye drops.

The FDA also warns that two brand of eye drops, Visitein and Clarity Vision for Life, are unapproved drugs and that the company’s OTC pain relieving drugs, Biogesic, Bio-Ice, and Bio-Heat,  are not labeled with the proper warnings to ensure consumer safety.

Consumers, health care providers, and caregivers are advised to discard the following eye drops: Oxydrops; Bright Eyes; Bright Eyes II; Clarity Vision for Life; Visitein; and Can-C as well as the  pain relievers Biogesic, Bio-Ice, and Bio-Heat.

The FDA’s action prevents the manufacturer from producing eye drops or drugs until its factory and labeling operations are brought into compliance with the Federal Food, Drug, and Cosmetic Act.

Any adverse events related to these products should be reported to MedWatch, the FDA’s voluntary reporting program at 1-800-FDA-1088; by FAX at 1-800-FDA-0178; by mail to MedWatch, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD, 20857-9787; or online at www.fda.gov/medwatch/report.htm.

The consent decree was submitted to the U.S. District Court for the Eastern District of California by the Department of Justice on behalf of FDA and is subject to approval by the court.

This is the second pharmaceutical company to be shut down by way of a consent decree in recent months. Earlier this year, the FDA shut down the leading generic drug manufacturer, Able Labs.

In a scathing 15-page report to Able Laboratories dated July 6, 2005 and posted on the company’s website (http://www.ablelabs.com/FDA/483.pdf), the FDA revealed that its drastic enforcement action was the result of agency inspectors having found massive record falsification and mismanagement by Able in order to elude FDA detection of several defective medications.

After an investigation conducted by New York State Attorney General Eliot Spitzer, the wholesaler, Fast Forward, LLC, has agreed to institute a recall of thousands of children’s lunch boxes because they contain dangerous levels of lead.

These soft plastic and mesh containers were sold by retails throughout New York State from March through September 2005.

Spitzer’s investigation into the vinyl lunch boxes proved that the amount of lead in Fast Forward products exceeds permissible levels as set by environmental protection laws. Laboratory tests showed that several lunch boxes, in particular the ones with Spiderman and Superman, had lead levels that violated New York state laws.

The lead was used in the lunch boxes to help keep the vinyl stable. It is a toxic substance, however, that in elevated levels can lead to both neurological and developmental problems in children.

As a result of the investigation, Wal-Mart and Target promptly removed the product from their shelves. Fast Forward has also consented to recall vinyl lunch boxes featuring Spiderman, Superman, Batman, the Fantastic Four, Precious Moments, and Rocawear products from stores.

Spitzer praised the actions of these retailers. "The recall of these children’s products will protect children and our environment from the damaging effects of lead. I commend the distributor and Wal-Mart and Target for acting promptly to address this important matter."

Despite this major recall the products are still available in some smaller locations and online through eBay.

In addition to the recall Fast Forward will pay $7,000 in civil penalties and costs. The company also promises to ensure that its products comply with hazardous materials laws and to see that the disposal the toxic lunch boxes conforms with New York’s environmental rules.

Consumers who purchased the lunch boxes should return them to the retailer where they were bought by February 28, 2006 for a cash refund with a receipt, or a store credit without a receipt.

Consumers may also obtain a full refund by returning lunch boxes directly to Fast Forward by February 28, 2006 with a Refund Request Form available from the New York Attorney General’s Office.