Alycia Brown was an eighth-grader in La Crosse, Wisconsin when she died of blood clots in her lower pelvis on May 7, 2004. She had been using the Ortho Evra birth control patch for about eight weeks.

A federal law suit has now been filed in Madison by her parents who claim the patch was the cause of their daughter’s tragic death. The La Crosse County medical examiner has found that Ortho Evra was a likely contributing factor in Alycia’s death.

Although many lawsuits have already been commenced against Ortho-McNeil and its parent company, Johnson & Johnson, for injuries and deaths allegedly caused by the patch, the 14-year-old is now the youngest known victim.

The girl’s mother had feared that her daughter was having sexual relations. The patch was decided upon because the girl was afraid to have a birth control shot because she was afraid of needles.

The mother wanted to avoid the possibility of Alycia ruining her life with an unwanted teenage pregnancy. What happened, however, was far worse.

Only last week did Ortho-McNeil finally acknowledged the fact that women who use its Ortho Evra birth control patch are at a significantly greater risk of blood clots, stroke, and death than woman who use other forms of oral contraceptives.

Ortho-McNeil now admits that women who use the patch can be exposed to up to 60% more estrogen than they would be exposed to if they were taking a birth control pill instead.

Several lawsuits have already been commenced around the U.S. alleging that serious injuries and deaths have been caused by the Patch. Two weeks ago, CBS News presented a story concerning documents produced in the course of a pending lawsuit involving a young mother who was paralyzed by a stroke only 12 days after she began using the patch. She is now a total invalid.

According to that story, Ortho-McNeil’s own records show the company received some 500 reports of serious health problems associated with the patch between April 2002 and December 2004. During that time only 61 such reports were received with respect to all types of existing oral contraceptives.

In addition, there were four times as many strokes in women using the patch as in women using oral contraceptives even though three times as many women were taking those other forms of birth control.
Finally, the evidence indicates, that in medically confirmed cases, the risk of blood clots is 14 times as high with the patch.

An investigative report published by the Associated Press on July 18, 2005 linked the birth control patch, which contains a combination of norelgestromin and ethinyl estradiol, to an increased risk of blood clots and deaths (compared to older contraceptives) in some young healthy women.

Ortho Evra, like the other hormonal contraceptives, has a black box warning about an increased risk of cardiovascular adverse reactions in older women who smoke. This type of warning is the strongest that the FDA can request.

In an Associated Press follow-up story, the AP stated: “Documents released to attorneys as a result of that litigation show Ortho McNeil has been analyzing the FDA’s death and injury reports, creating its own charts that document a higher rate of blood clots and deaths in association with the patch than with the pill.

In addition, an internal Ortho McNeil memo shows that the company refused, in 2003, to fund a study comparing its Ortho Evra patch to its Ortho-Cyclen pill because of concerns there was ‘too high a chance that study may not produce a positive result for Evra’ and there was a ‘risk that Ortho Evra may be the same or worse than Ortho-Cyclen.’”

The patch, like many oral contraceptives, contains two hormones, a progestin and an estrogen. The progestin in Ortho Evra is a new drug (2001) known as norelgestromin, and the estrogen is an existing one known as ethinyl estradiol.

Ortho Evra was approved by the Food and Drug Administration (FDA) in November 2001 and is the first contraceptive product to be approved as a skin patch. It was launched and marketed in a series of “glitzy” television ads featuring “sexy models.” (CBS 11/2/05).

In 2004, the drug accounted for more than 9.9 million prescriptions with sales topping $411 million.

Contraceptives are often referred to as second- or third-generation based on their progestin component. Since some experts classify norelgestromin as a third-generation progestin, Ortho Evra is considered third-generation contraceptive.

Public citizen first listed some third-generation oral contraceptives as “DO NOT USE” drugs in 1998 and 1999 because of an increased risk of blood clots compared to the older, second-generation birth control pills. Thus, elevated blood levels of progestin as well as estrogen are possible with the Patch.

The Associated Press used the Freedom of Information Act (FOIA) to obtain adverse drug reaction reports for Ortho Evra from the FDA and reportedly found that of the 23 cases in which death was the outcome, doctors reviewing the cases found 17 that appeared to be blood-clot-related, including 12 from last year.

Since the FDA estimates that it receives reports of only between 1% and 10% of the serious adverse drug reactions that actually occur, the death rate for Ortho Evra may be significantly higher.

The Associated Press also analyzed the reviews of clinical trial results done by FDA physicians and scientists prior to the drug’s approval. Those results were submitted for review by Ortho-McNeil in support of Ortho-Evra and are available on the FDA’s Web site at:

http://www.fda.gov/cder/foi/nda/2001/021-180_ORTHO.htm.

Significantly, Ortho-McNeil and the FDA medical officer reviewing Ortho Evra strongly disagreed about whether two cases of blood clots in the lungs (pulmonary embolus) in young women participating in the pre-approval clinical trials were caused by the drug. The FDA medical officer wrote:

“THE REVIEWER DOES NOT AGREE WITH THE SPONSOR’S [Ortho-McNeil] ABOVE CONCLUSIONS. The two cases of pulmonary embolus, a serious and potentially fatal condition, must be counted as two cases in the group” [emphasis in the original].

The FDA medical officer also included the following statement in his comments:

The professional product labeling and information written specifically for women using Ortho-Evra “should reflect the possible increased risk of venous thromboembolism (VTE) [blood clots] associated with this new transdermal combination hormonal contraceptive containing the new molecular entity progestin norelgestromin (17d-norgestimate).”

In addition, the medical officer expressed concern that 211 out of 3,088 women (6.8%) in the pre-approval clinical trials gained 10 or more pounds in the trials and noted that the contraceptive effectiveness of Ortho-Evra was reduced in women weighing or than 198 pounds (90 kilograms).

Since contraceptives are usually prescribed to young, healthy women they should be associated with the lowest possible risk of serious adverse drug reactions.

Blood clots in the lungs were seen in two women given Ortho Evra in clinical trials conducted before the drug was even approved (in addition to several similar cases after the drug was marketed).

There is also no evidence that the patch is a superior contraceptive compared to older second-generation birth control pills. As stated in the September 2005 issue of Worst Pills Best Pills (published by Public Citizen); “Rarely do randomized pre-approval studies, the scientific ‘gold standard’ for proving safety or efficacy, present such strong evidence of a serious problem.”

As a result of what it considers strong evidence of the increased risk of blood clots and death, Public Citizen states: “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.”

The Ortho-McNeil’s Press Release is a rather difficult document for the average person to understand. If its implications are considered with respect to the amount of estrogen that can be released in a given period of time, however, the result is shocking since that amount can easily exceed 50 mg which is well beyond the level already determined to be unsafe.

A previous study conducted with respect to another contraceptive product (the “vaginal ring”) documented these excessively high levels of estrogen associated with the Patch over nine months ago in the journal Contraception.
In addition to the risks already discussed, cigarette smoking increases the risk of serious cardiovascular side effects from hormonal contraceptive use. This risk increases with age and with heavy smoking (15 or more cigarettes per day) and is quite marked in women over 35 years of age. As a result, women who use hormonal contraceptives, including ORTHO EVRA, should not smoke.

The mounting litigation focuses on the claim that Ortho-McNeil knew of the blood clot risk and even disagreed with the FDA medical officer who suspected the two incidents that occurred during the clinical trial were related to the drug.

A lawsuit was filed in July 2005 against Ortho-McNeil on behalf of a 30-year-old woman who suffered fatal blood clots thought to be linked to the Ortho Evra risk. The woman was admitted into the intensive care unit shortly before her death suffering from severe headache, visual problems, vomiting, and nausea.

The other deaths reported in connection with Ortho Evra risk factors were the result of heart attacks and strokes. One of the most recent deaths linked to Ortho Evra was suffered by a 25 year old woman who suffered fatal headaches thought to be linked to a surge of hormone release from the birth control patch.

Before the Alycia Brown case was filed, the youngest woman to die had been an 18 year old college student who collapsed in the New York subway. Many other women ranging in age from 18 to 27 have also sued Ortho-McNeil.

In September, Parker & Waichman, a major New York based plaintiffs’ personal injury law firm that is heavily involved in pharmaceutical litigation announced that it had filed suit against Ortho-McNeil Pharmaceutical, Inc., a division of Johnson and Johnson Inc., on behalf of a 37-year-old woman who suffered a pulmonary embolism after using the Ortho Evra contraceptive patch for seven months. The suit was filed U.S. District Court for the District of New Jersey.

According to the complaint in that lawsuit, from April 2002 through September 2003, the U.S. Food and Drug Administration logged 9,116 reports of adverse events because of the patch, according to the suit.

This is significant since there were only 1,237 adverse reports by women taking the leading oral contraceptive, Ortho Tri-Cyclen, over a six-year period even though that drug was used by almost six times as many women as Ortho Evra in 2003.

None of this, however, will bring Alycia back to her grieving parents. Lorie Brown, her mother, told reporters: “I’m out to let people know: get off (Ortho Evra). That’s my biggest goal here. I didn’t save her life, but maybe I can save somebody else’s.”

According to a new study published in the European Heart Journal, diabetes is a serious risk factor for sudden cardiac death with the danger escalating as the diabetes becomes more severe.

Researchers looked at individuals enrolled in the Group Health Cooperative of Puget Sound to determine the link between blood sugar level, diabetes, and the increased risk of sudden cardiac death. 

The study included 2,040 subjects with a range of diabetic conditions such as borderline diabetes, diabetes without disease of the small blood vessels, and diabetes with disease of the small blood vessels. 

These individuals experienced heart attacks between 1980 and 1994.  There was also a control group consisting of 3,800 individuals without diabetes.

The research team found that there was a decidedly higher risk of sudden cardiac death associated with people with diabetes.  Those with borderline diabetes were 24% more likely to experience sudden cardiac death than people without diabetes. 

Individuals with diabetes without disease of the small blood vessels were 73% more likely to experience cardiac death, while people with diabetes with disease of the small blood vessels were a staggering 266% more likely to experience this potentially fatal health risk.

This information indicates that the relationship between diabetes and sudden cardiac death may involve heart disease, atherosclerosis, or a combination of the two.  High blood sugar levels can cause small blood vessel disease without visible symptoms, possibly leading to a greater risk of sudden cardiac death as well.

The antiviral drug Tamiflu has become a hot commodity on the legitimate pharmaceutical market and, now apparently, on the counterfeit drug market as well.

Since November 26, over 50 shipments of phony Tamiflu have been intercepted and seized by U.S. Customs and Border Protection at various locations including San Francisco International Airport. Each package seized contains up to 50 counterfeit capsules labeled as generic Tamiflu.

The seized capsules do not contain any of the active ingredients found in Tamiflu and laboratory tests are still being run to determine just what the capsules actually do contain. The FDA Office of Enforcement has indicated that preliminary tests show the capsules contained some amount of vitamin C.

Although some of the information on the seized packages was written in Chinese, the exact point of origin of the drugs themselves remains unclear. The shipments, however, came from Asian suppliers shipping to Internet purchasers. None of the shipments have been to hospitals or doctors.

Roche, the world’s 9th largest pharmaceutical company manufactures Tamiflu. The Swiss drugmaker’s Web site cautions against Internet purchases of the product.

Customs agents first realized there was a problem with the drugs because there is no generic version of Tamiflu. The agency had already anticipated the possibility of counterfeits once fears of a bird flu pandemic began to spread throughout the U.S.

After three weeks of testimony, a jury found a Catholic priest guilty on six counts of sexually abusing young boys.

The Rev. Paul LeBrun, 49, was the first priest to be convicted on sexual abuse charges in West Valley since the Catholic sex scandal first emerged just over four years ago.

LeBrun was accused of abusing West Valley boys ranging in age from 11 to 16 from 1986 to 1991 at Blessed Sacrament Church in Tolleson and St. John Vianney Church in Avondale.

Four Indiana victims, ranging from 9 to 13, had been abused by LeBrun between 1979 and 1986. The four, now adults in Indiana, offered damning testimony in a Mesa, Arizona courtroom.

LeBrun now faces a maximum sentence of more than 100 years. The Church has stripped him of all priestly duties, although he is yet to be defrocked. He had been in Maricopa County Jail since 2003 awaiting trial on eight counts of sexual conduct with a minor and five counts of child molestation.

The prosecution emphasized that LeBrun used his position to prey on vulnerable young boys who lacked a positive male influence in their lives, and who came from broken homes in Arizona and Indiana. "He was basically a wolf in sheep’s clothing," the prosecutor said. "Everything he did was to get close to these little boys. Everything he did was to abuse these little boys."

The defense claimed that the accusers were motivated by greed since they had not stepped forward for over 20 years. Civil suits for damages, felony conviction, and other bad acts (like attempting to bribe LeBrun’s cellmate to fabricate a jailhouse confession by LeBrun) were cited by the defense as indications that the accusers’ motivations were purely monetary.  

While LeBrun cannot be tried in Indiana for his conduct there due to the expiration of the statute of limitations, Maricopa County Superior Court Judge Crane McClennen did allow their testimony in the Arizona trial as evidence of "a character trait that predisposes him to commit the crimes charged."

Dr. Timothy Brown, an orthopedic surgeon at Boston Medical Center, was disciplined by the Massachusetts Board of Registration in Medicine (Board) after being charged with leaving the operating room at a critical point in an operation to deliver a lecture elsewhere in the hospital.

Brown left the operating room and allowed doctors-in-training to continue the surgery on the severely broken arm of the victim of a car accident. According to the Board, this is a direct violation of state regulations.

The staff in the operating room tried to page Brown numerous times but he did not have his pager with him.  The medical residents were forced to proceed with the surgery on their own, attaching surgical hardware (a plate and screws) to the patient’s fractured arm.  

Brown eventually returned to the operating room in time to complete the surgery and treat the patient for a broken jaw.  There was no indication that Brown’s absence resulted in any complications or injuries to the patient.  

A similar incident occurred in 2002 when another doctor left his patient at Mount Auburn Hospital to run an errand at a bank.  The Board cited two major differences in the cases, however. Brown never left the hospital grounds and was performing a professional obligation while the other doctor had simply left the building to run a personal errand.

Brown, who has no prior history of board discipline, was given five years of probation and a written reprimand from the hospital for failing to supervise doctors-in-training.  He was able t avoid a suspension by voluntarily agreeing to permit another doctor to monitor his operations for at least one year. 

Cigarette companies claim they are not targeting young smokers and they even run ads declaring “there is no such thing as a safe cigarette.” A new study by the Harvard School of Public Health, however, indicates that tobacco companies are enticing children and teenagers by developing flavored cigarettes.

Although the companies claim they are no longer marketing to children, the research, published in the November/December issue of Health Affairs, reveals that attractive packaging and candy flavors are being employed to market to specific racial and ethnic groups.

Harvard researchers compiled the information by consulting a database of more than 7 million internal tobacco industry documents created over the course of more than 30 years. They paid specific attention to the discussion of alternative flavors and flavor technology as a method to attract young smokers.

One internal document from 1993  stated, "Growing interest in new flavor sensations (i.e. soft drinks, snack foods) among younger adult consumers may indicate new opportunities for enhanced-flavor tobacco products that could leverage [a brand's] current strength among younger adult smokers."

The researchers suggest that the companies used new product technology, for example a flavor pellet imbedded in a cigarette filter, to create fruit and liqueur flavors such as Mandarin Mint, Mocha Taboo, Mintrigue, Kauai Kolada, and Margarita Mixer.

Gregory Connolly, senior author of the study and a professor of the practice of public health at HSPH, emphasized that these practices deceptively concealed the harmful effect of cigarettes.

"Tobacco companies are using candy-like flavors and high tech delivery devices to turn a blowtorch into a flavored popsicle, misleading millions of youngsters to try a deadly product. Adding candy flavors to a toxic product (cigarettes) isn’t any different than adding sugar to contaminated meat a century ago. The only difference is that today one is regulated by the FDA and the other is not."

Ford Motor Company, the National Highway Traffic Safety Administration (NHTSA), and the Consumer Product Safety Commission (CPSC) have announced the recall of nearly 226,000 Ford vehicles in the United States and Canada, including the new Ford Five Hundred sedan and Freestyle wagon, because of fire risks.

The recall affects 127,493 Ford Five Hundred and Mercury Montego sedans and Freestyle wagons because the straps that secure the fuel tank to the vehicle body may break, causing the fuel tank and fuel tank heat shield to drop onto the driveshaft or exhaust system, according to the NHTSA.

The problem could cause a fuel leak and result in a fire in the recalled vehicles. So far no injuries or accidents have been reported.

Ford is also recalling 98,444 Crown Victoria, Lincoln Town Car, and Mercury Grand Marquis sedans because on certain vehicles the battery cable may scrape on an attaching bolt and could lead to a fire.

After several years of legal wrangling, Michelle DiLieto has been awarded $5.2 million by a Connecticut jury against Yale School of Medicine and her gynecologist, Dr. Scott Casper.

In 1995, DiLieto was diagnosed with a form of uterine cancer known as endometrial stromal sarcoma, a rare but often fatal cancer. Her gynecologist suggested that she see Dr. Peter Schwartz, a professor at the School of Medicine practicing at Yale-New Haven Hospital.

Although a Yale pathology report confirmed the diagnosis, a 1997 Harvard pathologist report determined that DiLieto never had cancer. Plaintiff’s medical experts, however, testified that tissue samples, released by a court order in November 2004, showed no indication of cancer.

According to DiLieto’s attorney, his client underwent surgery during which Dr. Casper removed her uterus, ovaries and fallopian tubes. Dr, Schwartz was supposed to extract the surrounding lymph nodes, but delegated that operation to Dr. Babak Edraki, a first-year fellow in gynecologic oncology.

DiLieto’s experts also believe Yale knew all along that she didn’t have cancer.  

As a result of the surgery, DiLieto reports she suffered substantial nerve damage and was in terrible pain and unable to walk for months. The doctors attributed the pain not to the surgery but to the fact that she could not take estrogen as hormone replacement therapy for menopause because she was a "cancer survivor," she said. "They were all very arrogant with regard to me," she added.

Although the jury in the recent trial found no negligence on the part of the Yale pathologists, they found in favor of DiLieto for $2.5 million against Yale and $2.7 million against Dr.Casper’s practice at the County Obstetrics and Gynecology Group in Connecticut.

The verdict in plaintiff’s favor follows a long legal battle wherein a jury originally found in favor of Yale in 2000. That verdict was reversed on appeal in 2003 by the Connecticut Supreme Court. According to a hospital spokesman, Yale intends to appeal the verdict.

Baxter Healthcare announced Tuesday that it plans to voluntarily withdraw its 6060 Multi-Therapy Infusion Pump from the market over the next 12 months.

This pump delivers intravenous medications to patients who are primarily in alternate care settings or at home. There are approximately 34,000 pumps currently in use worldwide, including 30,000 in the United States.

In a letter to customers, Baxter stated that it had received reports of one death and two serious injuries due to malfunctions in the pump. The pump may deliver drugs when they are not requested or fail to deliver drugs when they are requested. These product failures can result in an unsafe situation for patients.

Baxter will be working with customers to conduct a controlled removal of all 6060 Infusion pumps from the market. During the transition period, Baxter will continue to provide service and sets for the 6060 pump. Baxter has entered into an agreement with Smiths Medical to provide alternative infusion pumps and products during the transition.

This is not the first time that Baxter has had a problem with its medical pumps. In September, there was a recall of the company’s Colleague Infusion pumps due to battery problems, and in October, the U.S. Food and Drug Administration (FDA) seized 6,000 pumps from Baxter’s manufacturing facilities in Illinois because the firm had continually failed to follow medical device manufacturing requirements.