Monthly Archives: November 2005

Former Vicar General of Phoenix Diocese Arrested on Sex Charges

As the bishops of the Catholic Church try to put the scandals behind them new horrors appear. On November 21st, the former Vicar General of the Diocese of Phoenix and founder of Life Teen, Monsignor Dale Fushek was arrested on charges of abusing young boys in the 1980’s. The Monsignor was charged with three counts of assault, five of contributing to the delinquency of a minor and two of indecent exposure. All are misdemeanors, punishable by no more than three years and nine months in all. We’ve heard it all before. There are more shocking stories coming out of Brazil as reported by the courageous National Catholic Reporter. Their reporter writes about priest who actually keep journals of their predatory habits and tips for luring young, unsuspecting children into their lair of pain and suffering.
If this is to be stopped, the laity have to rise up and demand and end to this scandal. It’s clear that the church officials are incapable of policing themselves. Jason Berry’s article in today’s LA Times gives further evidence that the “fish rots from the head”. If true reform is to found it must come from lay or secular sources.

Autistic Man Killed by Taser

A man with autism is dead after a scuffle with northwest suburban police, who used a Taser gun in a struggle to subdue him.
The man had just bitten his caregiver at a group home in Des Plaines. CBS 2’s Mike Parker reports the Taser was just one way the officers tried to get the victim under control.
Police around the country are now using Taser guns to subdue suspects with electric shocks.
The weapons are supposed to be non-lethal. On Sunday, in the back yard of a Des Plaines home, 30-year-old Hansel Cunningham died moments after police used a Taser and pepper spray to take him down.
“He was extremely combative, completely enraged, wouldn’t listen to reason,” said Des Plaines Police Chief Jim Prandini.
The victim was a resident of a group home for autistic adults. Police came to the house after Cunningham allegedly severely bit his caregiver then, according to officers, went out of control.
The Des Plaines police chief says the fatal incident was “unfortunate.”
“I will certainly review the use of our Taser in this incident. We’ve used it successfully on several other occasions where we haven’t had a problem with it,” Prandini said.
The company that runs the group home said, “we are deeply saddened by this tragedy. Our condolences go out to the family of the victim.”
The medical examiner says it may take weeks to determine precisely what killed the man. One theory is that he may have died from the Taser shock combined with prescription drugs he may have been taking.
Illinois State Police are investigating.

Autistic Man Dies After Being Hit By Taser

A man with autism is dead after a scuffle with northwest suburban police, who used a Taser gun in a struggle to subdue him.
The man had just bitten his caregiver at a group home in Des Plaines. CBS 2’s Mike Parker reports the Taser was just one way the officers tried to get the victim under control.
Police around the country are now using Taser guns to subdue suspects with electric shocks.
The weapons are supposed to be non-lethal. On Sunday, in the back yard of a Des Plaines home, 30-year-old Hansel Cunningham died moments after police used a Taser and pepper spray to take him down.
“He was extremely combative, completely enraged, wouldn’t listen to reason,” said Des Plaines Police Chief Jim Prandini.
The victim was a resident of a group home for autistic adults. Police came to the house after Cunningham allegedly severely bit his caregiver then, according to officers, went out of control.
The Des Plaines police chief says the fatal incident was “unfortunate.”
“I will certainly review the use of our Taser in this incident. We’ve used it successfully on several other occasions where we haven’t had a problem with it,” Prandini said.
The company that runs the group home said, “we are deeply saddened by this tragedy. Our condolences go out to the family of the victim.”
The medical examiner says it may take weeks to determine precisely what killed the man. One theory is that he may have died from the Taser shock combined with prescription drugs he may have been taking.
Illinois State Police are investigating.

An Alternative to the Defective and Deadly Taser

Arizona Sheriff Announces Test of Alternative to Taser Stun Gun
Date Published: November 21, 2005
By Steven DiJoseph
Maricopa County Sheriff, Joe Arpaio, has announced that his deputies will begin testing 30 new stun guns as an alternative to Tasers. The new electric stun guns are being donated by Stinger Systems Inc., and will be evaluated for safety, price, and risk factors.
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.”
Taser International, which is based in Scottsdale, Arizona, is the largest manufacturer of stun guns currently arming over 8,000 U.S. law enforcement agencies with some 171,000 units. Notwithstanding the widespread use of Tasers, serious safety issues including numerous deaths have plagued the company for some time now driving its stock price down nearly 80% this year.
The stun gun produced by Florida-based Stinger Systems is designed to shut off automatically after only four seconds. Taser has been criticized by experts because numerous situations have occurred where officers armed with Tasers have shocked suspects for excessively long periods of time by holding down the trigger for 30 seconds or longer.
Taser has recently announced that it plans to introduce a ‘TaserCam’ that will begin recording video and audio whenever the stun gun is activated. The system will turn off when the Taser itself is turned off.
According to the Arizona Republic, Taser claims that the addition to its product would “help better examine how Tasers are used…illuminate why Tasers are needed – and add another layer of accountability for any officer who would abuse the weapon.”
The cameras will cost about $400 in addition to the $800-$1,000 cost of the stun gun itself. Taser hopes to have the camera ready for sale by March 2006.
Stringer Systems already markets a $200 video-audio recorder for use on its $600 stun gun.
Taser believes the recording equipment would explain the circumstances surrounding controversial cases such as when Miami, Florida, police used a Taser to shock a 6-year-old special needs student last year in an elementary school office.
The boy had cut himself twice with a shard of glass and was threatening again to slash himself or any approaching police officer when the decision was made to employ the stun gun. The police defended its use; the public was outraged. The Taser-Cam would have permitted the episode to be reviewed.
Taser International’s position has never changed with respect to the safety of its stun gun. According to the company’s latest statement, their product is “a more humane and safer alternative” than firearms, batons, or chemical sprays. “Or do citizens want to go back to the cave man days of using batons as clubs?” Taser maintains that it is up to individual police agencies to train officers to use the device properly.
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.
“What happened to Keith Tucker was unfortunately not an isolated incident,” ACLU of Nevada executive Gary Peck said. “We hope this lawsuit and others like it will be a catalyst for change.”
Tucker was one of three people who died in custody after being shocked with a Taser since Las Vegas police began using the devices in April 2003.
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.
The ACLU surveyed 79 California law enforcement agencies. Of the 56 that use Tasers, 54 provided the ACLU with copies of their training materials and policies regarding stun gun use.
Among the ALCU’s major concerns was that only four departments actually regulate the number of times an officer may shoot a person with a Taser gun. A common factor in several of the death cases is that the victim was shocked more than once.
The ALCU report also included findings that:
Only four departments created their own training guides for the Tasers. The rest relied exclusively on materials produced by Taser International.
Some training manuals provided by Taser were misleading and outdated.
There has been a lack of independent studies on safety issues.
While the ALCU is not advocating a ban on the device, it is recommending that policies be adopted that are specifically aimed at minimizing the possibility that a suspect might die. For example, a 21-year-old man died after Vallejo police shot him with a Taser 17 times in only three minutes.
Indeed, Taser International and its supporters continue to be used by many law enforcement agencies under the premise they are safe, non-lethal weapons that save lives. That position is becoming more and more difficult to maintain, however, given the mounting number of cases in which people have died or suffered serious or life-threatening injuries after being shocked.
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.
Apparently, the only reason the teenager survived was that he received immediate medical attention. Dr. Wayne H. Franklin, a pediatric electrophysiologist at Children’s Memorial Hospital in Chicago (and a second doctor), claimed that an electrocardiogram confirmed that the boy did, in fact, suffer fibrillation.
Dr. Franklin stated that this case demonstrated the danger posed by Tasers and why portable defibrillators should be available whenever the stun guns may be used.
Taser International immediately countered the medical opinion of the two doctors with an email from a doctor of their own who stated the conclusion was purely speculative and not backed by scientific evidence.
Regardless of the circumstances, Taser has challenged any suggestion, opinion, or finding in every case where the stun gun has been implicated in a death or serious injury.
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.
Recently, Canadian Police Research Institute stated that Tasers and other “conducted energy devices” are acceptable because the advantages they provide outweigh the risks they pose.
In reaching this conclusion in its report to Canadian police chiefs, however, the Institute was apparently not overly troubled by the enormous number of deaths that have occurred in cases where a Taser has been used.
The 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 also appears to have been ignored in the report as the type of definitive evidence it was seeking to support the claim that the devices can cause death.
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.
The lawsuits also allege Taser International withheld reports of injuries to at least 12 other police officers and that the company has ignored credible research suggesting the device can be extremely dangerous, if not fatal.
As with all previous allegations against it, Taser International has stated that it intends to vigorously defend the claims. The company has denied any of the 159 deaths which have occurred following the use of a Taser was caused by its product.
Clearly, both sides cannot be right in this matter. As we reported on August 7, Taser International has now issued a training bulletin warning that repeated blasts of the Taser can “impair breathing and respiration.”
According to a posting on Taser’s website, for subjects in a state known as excited delirium, repeated or prolonged stuns with the Taser can contribute to “significant and potentially fatal health risks.”
The three-page bulletin appears to counter instructions in a training manual Taser International issued only last year. It also departs from Taser’s previous dismissals of safety concerns raised by groups such as Amnesty International, which has documented well over 100 U.S. and Canadian deaths of people stunned by Tasers.
The Houston Police Department (HPD), Taser’s biggest U.S. customer, has formed a review committee of police officials and community leaders, including representatives from the NAACP and League of United Latin American Citizens, to study the use of Tasers in the city of Houston.
The committee started by reviewing the HPD use-of-force policy, training sessions that officers receive, and the first 200 incidents in which Tasers were used in Houston.
Houston will also be involved in a study of Taser use conducted by a national police-research organization according to a report in the Houston Chronicle.
The viability of a non-lethal weapon must be questioned when it is implicated in a number of questionable deaths and charges of abuse. Many critics of the Taser believe that time has already come.
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. (
“ 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. ”
From the very beginning, many experts questioned the safety of the 50,000 volt “non-lethal” weapon.
A lack of adequate testing and independent medical evidence supporting the company’s bold marketing claims have been cited by such diverse critics as Amnesty International, the American Civil Liberties Union, and a consulting electrical engineer as reasons for removing the stun guns from the market until more extensive testing is done especially with respect to how the device affects pregnant women, people on drugs, or those with heart conditions.
Even the International Association of Chiefs of Police has suggested that further testing is needed. The organization advocates using the device only to subdue violent suspects; not to use it on handcuffed persons unless they are “overly assaultive;” to use it the least number of times; and to seek medical attention for anyone who has been shocked.
In addition, all types of Taser-related lawsuits abound. Personal injury and death claims have been commenced in a number of states. In March of this year, Mesa, Arizona, settled a claim by a 43-year-old man who fell out of a tree after being shocked twice with a Taser by a city police officer. The City paid $2.2 million to the man who became a quadriplegic and another $200,000 to the hospital where he was treated.
A class-action lawsuit was brought in U.S. District Court in Chicago by the city of Dolton, Illinois, on behalf of police departments across the country for being misled about the safety of the Taser and for leaving the police with weapons that are too dangerous to use on the street.
The law firm representing the city of Dolton claimed to have already been retained by other police departments in four states. Paul Geller, an attorney from that firm, states that the law suit would be dropped if Taser would agree to take back the stun guns.
The potential for huge personal injury and death claims have left many municipalities rethinking their purchase of Tasers. Some police forces like those in Birmingham and Lucas County ( Ohio) have either stopped issuing the weapons or have pulled them of the street altogether. Other cities like Chicago have backed off making additional purchases.
The mayor of Birmingham ordered police to stop using Tasers after the death of an inmate who had been shocked with a Taser several hours before he died.
The mayor of Dolton, which suspended their use, calls his city’s purchase of Tasers “a mistake” because “they need far more testing.” He went on to say that losing the money his city paid for the Tasers was far less than the financial risk posed by even one wrongful-death lawsuit.
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.
The report went on to state: “In the past nine months, at least six people in Texas – including three in Fort Worth – have died after authorities shocked them with a Taser gun.”
On July 27, a prisoner being held in a Queens, New York, police station died after being shocked with a Taser.
Finally, on July 30, for the first time, the Cook County ( Chicago, Illinois) Medical Examiner ruled the February 10 death of an agitated 54-year-old man was caused by being shocked excessively with a Taser.
The finding indicated that the 57-second shock was sufficient, in and of itself, to have killed the man. Why such a long shock (ten times the usual amount) was administered was not immediately explained.
Although the Chicago police force will continue to use the Tasers they already have, an order for additional units was suspended. The report involving the Chicago teenager who suffered ventricular fibrillation following his encounter with a Taser may alter that city’s position regardless of Taser International’s denial of blame.
Taser has vigorously defended its stun guns in every situation where it has been linked to an injury or death. The company continues to maintain that Tasers are non-lethal and that all of the reports regarding deaths and injuries associated with the device are baseless and can be explained away on the basis of other causes.
A recent training bulletin issued by Taser, however, advised police that “repeated, prolonged, and/or continuous exposures to the Taser may cause strong muscle contractions that may impair breathing and respiration, particularly when the probes are placed across the chest or diaphragm.”
The advent of the Taser-Cam, healthy competition from Stringer Systems, better training practices, and more judicious use of the stun guns will have the effect of making the devices less controversial and more likely to be regarded as the non-lethal alternative they were originally designed to be.

LA Times Article by Jason Berry

The moral hypocrite in the Vatican
By Jason Berry, Jason Berry’s books include “Lead Us Not Into Temptation” and, with Gerald Renner, “Vows of Silence: The Abuse of Power in the Papacy of John Paul II.”
CONSERVATIVE Catholics rejoiced at the election of Pope Benedict XVI because, as a cardinal, he had famously decried “moral relativism.”
Now, however, the pope appears to be backtracking and, worse yet, he is tolerating a scandalous moral relativism by the Vatican secretary of state.
In 1986, then-Cardinal Joseph Ratzinger sent a global letter to bishops denouncing homosexuality as a “moral disorder.” The language was harsh, much to the delight of conservatives.
But now that Ratzinger is pope, the church says that homosexual seminarians are to be treated with “respect and delicacy” if they are chaste, according to the newspaper Il Giornale, quoting from a leaked copy of a recently completed Vatican document on homosexuals in the seminary. That’s a reasonable position, albeit a retreat from Ratzinger’s denouncement of gays in 1986.
Perhaps more troubling for conservatives should be the pope’s tolerance of the behavior of the Vatican secretary of state, Cardinal Angelo Sodano. Six years ago, Sodano persuaded Ratzinger to halt a canon law case seeking the excommunication of a friend of his, an alleged pedophile, Father Marcial Maciel, founder of the Legion of Christ order in Mexico.
After Ratzinger became pope last spring, Sodano injected himself into a Vatican investigation of Maciel. Sodano also invited his old friend to a prestigious religious conference in Lucca, Italy. No president or elected prime minster would tolerate his chief diplomat championing a priest with 20 accusations of pedophilia.
Sodano and Maciel became friends in the 1970s, while Sodano served as papal nuncio in Chile and Maciel was cultivating supporters of corrupt Chilean dictator Augusto Pinochet. The allegations against Maciel date from 1976, when two former Legion priests sent the Vatican formal accusations, with names of other young victims from seminaries in Rome and Spain.
The Vatican ignored the charges, even as the number of alleged victims grew. The Legion’s response has always been to attack the accusers, portraying Maciel as the victim of a conspiracy by men jealous of his success.
In late 2004, with Pope John Paul II dying, Ratzinger realized that he might become pope and launched an investigation of Maciel. At the time, Ratzinger’s office had a backlog of 700 cases of priests whose bishops wanted them defrocked. He knew that the media would seize on the Maciel case as a coverup. As the investigation began, Maciel stepped down from the helm of the Legion, citing his age, 85.
Ratzinger sent Msgr. Charles Scicluna, a canon lawyer on his staff, to question witnesses in the United States and Mexico. In April, Scicluna heard testimony from 30 people, 20 of whom directly accused Maciel of abusing them. Scicluna has taken a papal vow not to comment on investigations. But witnesses spoke to journalists, praising Scicluna’s moral probity.
In mid-May, as the investigation continued, Sodano’s office inexplicably notified the Legion that there would be no canonical process against Maciel. Reporters responded to the statement by contacting the Vatican press office, which denied that the church was investigating Maciel. The Legion then crowed that Maciel was exonerated, a claim the press office never made.
After the announcement, however, two more witnesses gave testimony to Scicluna in Rome.
So who is in charge of the case, Sodano or the pope? Did Benedict abort the investigation with Scicluna still gathering information? Did Sodano force deception on the papal spokesman, who under church rules is not allowed to confirm a “secret” probe?
The Maciel case makes a mockery of canon law, and it is symptomatic of something deeper. As a 2004 Dallas Morning News investigation found, Catholic religious orders for years have sent allegedly abusive priests to other countries to avoid prosecution.
The Holy See is a signatory to a U.N. covenant on the rights of children. The Vatican cannot presume to remain above the law if it persists in shielding child molesters.
On Nov. 12, Pope Benedict spoke about “universal moral law,” saying that “the rich patrimony of values and principles embodied in that law is essential to the building of a world which acknowledges and promotes the dignity, life and freedom of each human person.” Sodano’s highhanded tactics betray Benedict’s remarks. The Maciel investigation is now a year old. Did Benedict cave in to Sodano’s pressure, as he did in 1999, and abort the cause of justice?
With Cardinal Roger Mahony trying to seal away clergy files in California cases, the pattern from Rome to Dublin to Los Angeles is glaring.
Benedict XVI cannot credibly lecture us on moral law when his secretary of state reeks of hypocrisy. The pope should stand for justice by firing Sodano and putting Maciel where he belongs — out of the priesthood.

Catholic Church Sex Abuse Scandal a Thing of the Past? Think Again!

A high ranking official in the Diocese of Phoenix Monsignor Dale Fushek, the founder of Life Teen, was arrested today on sex abuse charges. The following are excerpts of the Associated Press report:
The former vicar general of the Roman Catholic Diocese of Phoenix was arrested Monday on charges he fondled boys and young men and asked them prying questions about their sex lives that he pretended were part of confession.
Monsignor Dale Fushek, 53, becomes one of the highest-ranking priests to be charged in the sex scandal that has engulfed the church. The vicar general is the highest-ranking administrator of a diocese next to the bishop.
Fushek was charged with three counts of assault, five of contributing to the delinquency of a minor and two of indecent exposure. All are misdemeanors, punishable by no more than three years and nine months in all.
Fushek “used a relationship of trust to perform criminal acts, including but not limited to sexual activities, improper sexual discussions and physical contact, upon vulnerable minor and adult victims,” prosecutors said in court papers.
Prosecutors said Fushek committed the acts between 1984 and 1994 at St. Timothy’s Catholic Church in Mesa or on property belonging to the church. The alleged victims were seven young men and boys.
Fushek resigned as pastor of St. Timothy’s in April after someone claimed to have recovered a repressed memory involving sexual improprieties by Fushek in 1985. He has denied the allegations and remains on administrative leave.

Bishops Still Don’t Get It

Bishop William Skylstad, President of the US Conference of Catholic Bishops and head of the bankrupt Catholic diocese of Spokane Washington, continues to downplay the severity of the clergy abuse crisis. During a session of the bishops’ annual fall meeting in Washington DC this week, Skylstad remarked that a “handful” of abusive priests had caused the rest of the Catholic clergy “to endure an avalanche of negative public attention.” Who does he think he’s kidding? Estimates place the financial cost of this crisis to top $1billion in acknowledging more than 11,500 victims. Yet, in spite of the evidence Skylstad and the bishops continue to downplay and ignore the pain and trauma caused by the heinous acts of a “few” clergy members. The bishops’ failure to acknowledge the pain and alienation is not about one priest or one bishop. It’s about an institution that has been corrupted by years of secrecy, coverup and denial.

Sexual Abuse and the Catholic Church

For those of us old enough to remember Watergate, we learned that very often the “coverup is worse than the crime.” The same can be said about the crisis in the Catholic Church. Since 2002, when the Boston Globe broke the story about institutional cover up of the clergy sex scandal, we’ve been inundated with stories of heinous acts committed against our children. Yet, worse than the acts themselves is the lack of action on the part of bishops and cardinals who have sought first to protect the reputation of the church rather than protect innocent children. In the past two months, two “Princes of the Church” Cardinals Bevilacqua of Philadelphia and Mahony of Los Angeles have been implicated in decades of coverups of abusive and predatory priests. The Church must change or perish. The faithful will forgive “seventy times seven” but they can’t tolerate those who would prey on innocent children.

Birth Control Patch Warning Signs

Now that the FDA has “re-labeled” Ortho Evra the popular birth control patch, it’s important to recognize the symptoms of impending health issues caused by the patch. Women who use this patch are at a significantly increased risk for blood clots, strokes, and death than those women who use other forms of oral contraceptives. The manufacturer of Ortho Evra, Ortho-McNeil now admits that women using the patch can be exposed up to 60% more estrogen than those using oral contraceptives. Critics of both the patch and the FDA’s approval and monitoring practices, however, see the warning as simply another example of economics being placed above public safety. There has been a constant chorus of warnings about the extremely serious side-effects associated with the patch from a number of experts as well as the consumer watchdog group, Public Citizen ( and the Associated Press.
Who watches the watchdogs?

Ortho Evra- The Rest of the Story

It was at Thanksgiving time last year that Kathleen Thoren, a 25-year-old mother of three, died after days of severe headaches that, according to the medical examiner, were provoked by hormones released into her system by Ortho Evra — the once a week birth control patch.
In 2005 alone, about one dozen women died from blood clots believed to be related to Ortho Evra with dozens more surviving strokes and other clot-related problems. These women were largely young and not at risk for clots. Women like Zakiya Kennedy, an 18-year-old Manhattan fashion student who collapsed and died in a New York subway station in April 2004, and Sasha Webber, a 25-year-old mother of two who died of a heart attack after six weeks on the patch.
The Associated Press analyzed federal drug safety reports, finding that women using the patch are at a triple risk of dying or suffering a survivable blood clot compared to women using birth control pills.
The US Food and Drug Administration (FDA) approved Ortho Evra in November 2001 as the first birth control skin patch. But long before the patch reached the marketplace in 2002 both the FDA and Ortho McNeil, the Johnson & Johnson company that manufactures Ortho Evra, saw warning signs of possible problems. The FDA had already noticed that nonfatal blood clots occurred three times more frequently than the pill. Blood clots in the lungs were seen in two women given Ortho Evra in clinical trails conducted before the drug was approved – in addition to many similar cases in women after the drug was marketed. According to Public Citizen, drugs rarely present such strong evidence of a serious problem during randomized pre-approval studies.
Ortho Evra contains two hormones: an estrogen and a progestin. Most pills and the patch contain the same amount of estrogen, but hormones from the patch go straight to the bloodstream while pills are swallowed and digested, losing half the estrogen dose. Women using the patch are exposed to high levels of estrogen 24 hours a day. Associate Professor of Obstetrics and Gynecology at the University of Washington, Dr. Leslie Miller has reported that women using the patch absorb significantly more estrogen than the pill, adding the elevated levels may be high enough to increase some women’s risk of blood clots.
On November 10 the FDA updated labeling for the Ortho Evra birth control path to warn healthcare providers and patients that this product exposes women to higher levels of estrogen (about 60 percent more) than the pill. But not all physicians waited for the new label to take action. In October, Dr. Miguel Cano, an obstetrician and gynecologist in Reedley, California, sent a note to several thousand patients recommending that the stop using the patch and that they come in for appointments to get a new form of contraception. On the website Public Citizen proclaims: “There is no medical reason for women to use the more dangerous Ortho Evra rather than one of the older, better understood, and equally effective oral contraceptives.” Public Citizen’s Health Research Group added Ortho Evra to its ongoing list of dangerous medicines.
Catchy ads featuring Olympic beach volleyball players and supermodel Namoi Campbell — resulted in more than five million US women trying the patch in less than three years. In 2004 Ortho Evra sales topped $411 million for 9.9 million prescriptions, accounting for 15 percent of the US market. In July 2005 J & J CFO Robert J. Daretta reported no sign of increased safety problems with the Ortho Evra birth control patch. Obviously Mr. Daretta did not foresee the increased label warnings.