500 Ortho-Evra Birth Control Patch Victims Sue J&J

Evelyn Pringle September 22, 2006

According to Johnson & Johnson’s latest SEC filing for the Second Quarter of 2006, the company is currently facing 500 claimants in lawsuits related to deaths and injuries caused by the Ortho Evra birth control patch.

“These claimants,” the filing notes, “seek substantial compensatory and, where available, punitive damages.

However, the company’s filing does not disclose any of the settlements of cases reported over the past nine months in the press, and does not identify any financial reserves that are set aside to pay the settlements.

Legal analysts say the 500 claims are just the tip of the iceberg, because there are thousands of young women all over the country who have suffered blood clots, heart attacks and strokes who are still unaware of the culprit. And it logically follows, they say, that many families have lost a daughter, sister, wife, or mother who also do not know that the patch is to blame.

In 2005 alone, doctors wrote more than 9.4 million prescriptions for the Ortho Evra patch, according to IMS Health, a pharmaceutical industry-tracking firm.

Attorneys handling these lawsuits say J&J knows these cases are easily winnable because unlike most other cases involving a specific drug, there are no preexisting conditions with women in this age group and the kind of deaths and injuries brought on by the Ortho patch are virtually unheard of in teenagers and young women of childbearing age.

For that reason, J&J has adopted a strategy to settle as many lawsuits as quickly and quietly as possible. The company has obviously taken the position that the deaths, injuries and settlements with these women are just a necessary expense of doing business in the name of profits.

One thing’s for sure, the company is not about to remove the mega-buck patch from the market and lose billions of dollars in future sales.

In fact, many of the lawsuits have already ended in confidential settlements with barely a peep of coverage in the mainstream media. And for others cases, Johnson & Johnson has made it abundantly clear to opposing attorneys that the company is eager to cut a deal.

The New York Post was about the only major newspaper to cover the story about the payoffs. On April 9, 2006, it reported that women “who suffered life-threatening blood clots and strokes on the Ortho-Evra birth-control patch are receiving cash settlements from the manufacturer.”

“Ortho-McNeil Pharmaceutical,” the Post said, “has settled a dozen lawsuits for millions of dollars in the last few months, and more than 100 other suits are pending.”

One lawyer who asked not to be identified told the Post that the company had been “approaching everyone” representing women, and that lawyers had begun submitting cases for settlement.

During its investigation, the Post used the FOIA to obtain FDA records that showed that 17 women between the ages of 17 and 30, who had used the patch, had died from unlikely causes in view of their age group, of heart attacks, blood clots, and possible strokes, since August 2002.

Scores of other women on the patch, the Post reported, had suffered other complications including 21 life-threatening cases of blood clots and other ailments.

Doctors who reviewed the reports voiced alarm over the number of fatalities. “This is a cause for concern,” warned Dr John Quagliarello, a professor of obstetrics and gynecology at NYU Medical Center.

He and other doctors said that the discovery by the Post was the first they had ever heard of multiple deaths linked to the Ortho patch.

Critics also point out that these records do not accurately portray the number of women injured by the patch because according to the FDA, at best, only 10% of all adverse events get reported to the agency.

In attempt to manage the mounting number of lawsuits filed in federal courts, on March 1, 2006, the Judicial Panel on Multidistrict Litigation issued a transfer order to consolidated the pre-trial proceedings of 13 federal lawsuits filed by plaintiffs in different states, along with 54 potentially related actions pending in multiple federal districts.

The Panel assigned the cases to US District Judge, David Katz, of the Northern District of Ohio, in part, because he was already handling the first federal Ortho patch related lawsuit.

That move seemed to push J&J toward settling even more cases out-of-court. On May 2, 2006, at the very first status conference in the Ohio court, Johnson & Johnson attorney, Robert Tucker, informed Judge Katz that the company was prepared to settle cases with plaintiffs who were hospitalized for heart attacks, stroke, pulmonary embolisms or deep vein thrombosis, according Charles Toutant, in the May 16, 2006 New Jersey Law Journal.

Attorney, Ellen Relkin, a member of the plaintiffs’ executive committee for the federal case, told the Journal “many of these cases are seven figures, many are probably substantial six-figure cases.”

“It’s not like a Vioxx, where you have clients in their 50s, 60s, 70s,” said attorney, David Eisenbrouch, who represents plaintiffs. “You’re dealing with primarily very young women, and J&J would rather cut its losses,” he told the Journal.

Also on May 2, 2006, in a coordinated blitz, another Johnson & Johnson attorney, Susan Sharko, sent a letter to New Jersey Judge, Peter Bariso, to inform him that she had reached confidential settlements with 11 of the 12 plaintiffs involved in litigation in New Jersey.

An important point to keep in mind according to legal experts, is that as J&J quietly settles all these cases out-of-court with little or no fanfare, by design, the time limits for filing a lawsuit are slowly but surely ticking away for many persons who may have no idea that the Ortho Evra patch is the cause of an injury or death.

The applicable statute of limitation vary from state to state and in some states a personal injury claim might need to be filed within 3 years from the date an injury is diagnosed, while a wrongful death claim might need to be filed within 2 years from the date of a death. In some states, experts say, the time may be as short as 1 year from the date of diagnosis or death.

On May 13, 2006, the LA Times did get around to reporting that J&J had entered into confidential settlement agreements with about 30 women, quoting a plaintiff’s attorney, Ray Chester, who negotiated the agreements in cases filed in state courts in New Jersey, Texas and California, and federal courts in North Carolina and Pennsylvania.

“Johnson & Johnson is going to lose most of these cases,” Mr Chester said in the Times. “The cost to defend them and the public relations hit they would take if they tried the cases,” he stated, “has tilted them toward settling.”

“It is abundantly clear,” Mr Chester added, “that the patch causes more clots than the pill.”

Its all good and well that the Times published this story but the reporting is old news, because according to Mr Chester, J&J began settling these cases back in January which means the company was somehow able to conceal the fact that it was in essence admitting guilt in 30 cases, for about 5 months.

One case that was settled with a confidentiality agreement involved the first fatality attributed to the patch in the media which occurred on April 2, 2004, when 18-year-old Zakiya Kennedy collapsed in New York City while waiting for the subway.

The people who did catch the story about this 18-year-old dying so suddenly the few times it appeared were not surprisingly shocked. An autopsy revealed the cause of death was a blood clot called a pulmonary embolism that had moved to the lung as a direct result of using the Ortho Evra patch, the coroner ruled.

The New York Post was about the only major newspaper that covered the story in-depth.

But several months after the event, on September 23, 2004, Ms Kennedy’s father and grandmother were interviewed by ABC News and said the young woman had experienced symptoms but did connect them to the patch or take them seriously. “She was complaining about her head was hurting – she felt pain in her leg and she had felt dizzy,” her father recalled.

“She was complaining about pains in her leg or in her shoulder,” he said. “She thought it was from her exercising.”

Roberta Alloway, Ms Kennedy’s grandmother, said the drug company should be warning people about the lethal side effects of the patch. “They need to really let people know that my granddaughter and other people have died from this patch,” she told ABC news.

“I can’t bring her back,” she said. “But I want something to bring attention to these young women.”

Notwithstanding the high statistics of death and serious injuries revealed by the New York Post based on the FDA’s own database, it would take nearly 20 more months for the FDA to force J&J to add a warning to the label of the Ortho patch to alert women about the risk of blood clots, strokes, and heart attacks.

On November 11, 2005, the day after the waning was announced, Dr Sanjay Gupta, CNN’s senior medical correspondent, predicted on CNN that the warnings would probably, at a minimum, “mean a complete redesign of the patch so it doesn’t deliver as much estrogen and doesn’t put women at greater risk for blood clots.”

“Or,” he stated, “it could mean the demise of the patch altogether.”

Unfortunately, neither occurred and as a result, thousands more young women have died or been injured needlessly.

According to J&J at the time, the injuries and deaths with women on the patch were “consistent with the health risks” of the birth control pill, which “kills 0.3 to 1.9 women in every 100,000 users ages 15 to 29.”

However, that assertion was proven to be a bold-faced lie on the part of Johnson & Johnson, by FDA reports obtained by the Associated Press under the FOIA, that showed that in 2004, when 800,000 women were using the patch, the risk of a woman dying or suffering a survivable clot while on the patch was three times higher than women using birth control pills.

In fact, the records show that back in 2000, the FDA scientist in charge of reviewing the pre-approval clinical trials submitted on the patch, warned FDA officials that blood clots could be a problem if the device was approved.

While reviewing the trials, the scientist discovered that two of the 3,300 women using the Ortho Evra patch had been treated for blood clots that had traveled to their lungs. J&J argued that one of the two women should not be counted because she had underwent surgery, but the FDA reviewer, using capital letters to emphasize the point, disputed that argument stating:

“THE REVIEWER DOES NOT AGREE WITH THE SPONSOR’S ABOVE CONCLUSIONS. The two cases of pulmonary embolus, a serious and potentially fatal condition, must be counted as two cases…” “The incidence rates quoted by the sponsor may be misleading.”

The reviewer also said “the label should clearly reflect this reviewer’s safety concern about a potential increased risk.”

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

In addition, he expressed concern about the fact that 211 women out of 3,088 had gained 10 or more pounds during the trials and noted that the effectiveness of Ortho-Evra was reduced in women weighing more than 198 pounds.

The scientist also said that it would be important to study patch users for clot problems after the patch came on the market.

The reviewer might as well have been talking to himself, because when the device was approved, there was no warning on the label about the risks he identified and no requirements for post-surveillance studies other than routine monitoring of the adverse event reports from consumers, doctors and the drug makers.

The Associated Press also reviewed what had happened since the Ortho Evra patch arrived on the market in 2002, and determined that deaths of women on the patch appeared to be at least 3 times higher than women on the pill.

Under the FOIA request, the FDA released approximately 16,000 adverse event reports associated with the patch ranging from a mild rash to death. Within these reports, the AP found 23 different deaths associated with the patch and the doctors who reviewed the 23 deaths, found about 17 to be clot related.

But even after these reports became public, J&J continued to claim that none of the deaths could be directly attributed to the patch.

Nine months after the article in the Post about the 18-year-old women dying in the subway, a glimpse at the truth about the patch occurred in October 2004, when the first lawsuit was filed in Austin, Texas, on behalf of a paralyzed woman who suffered a stoke after only 12 days on the patch.

The lawsuit listed FDA records that showed forty-six women who were on the patch had suffered blood clot related injuries or death in a 1-year period between May 1, 2002 and April 30, 2003.

In the same 12 months, the lawsuit said, only half as many women taking birth control pills had developed clots even though there were six times more women on birth control pills.

Comparatively, the lawsuit alleged, 11 times more fatal or life-threatening clots were suffered by women on the patch when compared to women taking the pill.

On July 25, 2005, CNN reported on a lawsuit filed in New Jersey, on behalf of 10 women, who alleged the Ortho Evra patch had caused them to suffer blood clots and strokes.

The plaintiff’s attorney told CNN that the women listed in the lawsuit were all between 18 and 47-years-old, from Arizona, Arkansas, California, Colorado, Connecticut, Maryland, Mississippi, New Jersey, Ohio and Oklahoma.

The plaintiffs had all suffered debilitating long-term health problems as a result of using the patch. Plaintiff, Amanda Bianchi, 19, developed a 10-inch blood clot in her brain, which doctors said was a direct result of the patch she used for 3 months in 2004, and according to the complaint she had suffered two strokes.

“I don’t want any other woman to have to go through what I’m going through,” Ms Bianchi told CNN. “It’s not fun to have to get up and not be able to go to school and live the life that you were living,” she said.

When contacted by CNN, sticking to its guns, J&J repeated its usual mantra of denial in a written statement saying, “The types of adverse event reports that have been received for Ortho Evra are consistent with the health risks of other hormonal birth control methods and the Ortho Evra product level.”

And a spokeswoman for the industry owned FDA, did the same. She totally ignored the FDA’s own database statistics to the contrary and told CNN:

“The risks of using this product are similar to the risks of using birth control pills, including an increased risk of blood clots, heart attack, and stroke. The data is not precise enough to tell whether there is an increased incidence (with the patch).”

In September 2005, a federal lawsuit filed in New Jersey on behalf of a 37-year-old woman who suffered a pulmonary embolism after using the patch for seven months, laid out the facts as to what J&J knew and when and exactly what the FDA knew and when as well.

The public filing of the information contained in this lawsuit, and more of the same that soon followed, no doubt contributed greatly to J&J’s desire to quickly and quietly settle as many cases possible as soon as they were filed.

Lydia Lilly, a Georgia woman, claimed J&J marketed the Ortho Evra patch for financial gain while failing to warn consumers and doctors about the company’s known risks of blood clots and other injuries.

According to the complaint, before the patch was approved on November 20, 2001, the only studies specifically conducted to examine the effect of the patch on humans were Phase III clinical trials funded and conducted by the drug makers.

As it turns out, the incidence of embolisms and thrombotic injuries in those trials was about six times greater with the patch than the incidence of similar adverse events in women who used a widely prescribed class of oral contraceptives.

Yet the package insert that accompanied the Ortho patch when it was placed on the market stated, “the contraceptive patch is expected to be associated with similar risks” to those of other hormonal contraceptives.

The package insert also stated “there is no epidemiological data available to determine whether safety and efficacy with the transdermal route of administration would be different than the oral route.”

And as far as what the FDA knew first-hand, according to the lawsuit’s complaint, during a 17-month period between April 2002 and September 2003, the FDA logged 9,116 reports of adverse events due to of the patch.

A number significant, the lawsuit states, because over the 6-year time period between November 1997 and September 2003, there were only 1,237 adverse event reports from women taking the leading oral contraceptive. The number is also highly significant because almost six times more women when used the pill.

In addition, according to the complaint, around the time J&J introduced the Ortho Evra patch to the market, the patent for its oral contraceptive, Ortho Tri-Cyclen, was about to expire, creating pressure to make up for lost revenue by getting the patch on the market.

More news of J&J’s intentional suppression of the facts related to the dangers of the patch hit the airwaves on November 2, 2005, when CBS News broke the story that the company’s own records revealed during litigation showed that between April 2002 and December 2004, the company had received some 500 reports of serious problems associated with the patch.

The records also showed that during the same time frame, the company had only received 61 adverse event reports for women on birth control pills.

In addition, CBC reported that there were four times as many strokes in women using the patch even though there were three times as many women taking the pill.

Overall, CBS said, the evidence indicated that in medically confirmed cases the risk of blood clots was 14 times higher with women using the patch.

On November 11, 2005, the Associated Press dropped another bomb by reporting that J&J knew about the higher death and injury rates of women on the patch all the long and had in fact, had refused to conduct additional testing on the patch because it was afraid of the results.

AP reported that 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,” the AP said, “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.'”

From that point on, lawsuits filed included this newly reported information.

In light of all the damaging stories in the press during the fall of 2005, critics say its not that difficult to figure out why Johnson & Johnson was in a rush to start settling cases in January 2006, but at the same time, they say, the stories also made many more women aware of the type of injuries that are associated with the patch.

While J&J may have settled 30 cases in January as reported by the media, any sense of relief was short-lived because on January 30, 2006, the Madison St Clair Record, reported that J&J had been hit with seven brand new federal lawsuits on January 23, 2006, in the Southern District of Illinois, each seeking damages in excess of $75,000.

And since January 2006, the steady filing of lawsuits has continued unabated, with each new case usually accompanied by a press release.

On May 12, 2006, Knight Ridder reported the case of 20-year-old nursing student, Kristin Ribakusky-Templin, who experienced what started as a dull ache in her leg that within two weeks turned into shooting pains leaving her unable to walk and sent her to the emergency room where doctors found multiple blood clots deep in the veins of her lungs and leg.

The culprit, the doctors told her later, was the birth control patch she had been dutifully sticking to her body once a week for less than two months.

“The patch is still on the market,” Knight Ridder noted.

In New Jersey, where 37 cases have been filed, the articles states, “the stories are hauntingly similar: An otherwise healthy Georgia woman develops a pulmonary embolism; a Maine woman suffers from a blood clot in her right lung; a 12-year-old girl in Indiana is diagnosed with deep-vein thrombosis, just like Ribakusky-Templin.”

On May 18, 2006, a lawsuit was filed in New Jersey, on behalf of the family of a 17-year-old who suffered a stroke and died in August 2004 after using the Ortho Evra patch for approximately four months.

In a press release, an attorney from the firm handling the case said, “This is one of the saddest cases I’ve been involved with.”

“This was a sweet 17 year old girl,” he stated, “This shouldn’t have happened and Johnson & Johnson and Ortho McNeil must be held accountable.”

On September 5, 2006, a Drug Newswire press release reported the latest federal lawsuit filed in Texas by a 24-year-old woman who suffered a miscarriage and developed life-threatening blood clots after using the patch.

According to the lawsuit, in 2004, Elizabeth Barroso, began experiencing chest pains and difficulty breathing after using the patch for three weeks and spent eight days in the hospital where doctors treated her for blood clots in her lungs.

Upon release from the hospital, Ms Barroso was placed on blood thinning drugs for 10 months. She became pregnant in October 2004, but later suffered a miscarriage.

In 2005, she became pregnant again and was forced to endure daily injections of blood thinners to prevent another miscarriage. Due to her injuries, all of Ms Barroso’s future pregnancies will carry a risk of miscarriage and will require similar treatment.

“This young lady’s life was put in jeopardy by a company that made a harmful product,” her attorney said in the press release. “And the tragic thing,” he stated, “is the company continues to market and sell this product even today.”

An interesting statistical allegation in this latest lawsuit, says that from April 2002 to December 2004, Johnson & Johnson logged 27,974 adverse events among Ortho Evra patch users when during that same time period, the company noted only 5,571 adverse events for one of its oral contraceptives, even though the pill was used three times more than Ortho patch.

Patch related lawsuits are also being filed in other countries. On July 28, 2006, a class action was filed in Canada alleging that the drug makers failed to adequately warn consumers and doctors that the Ortho Evra patch was associated with an increased risk of developing blood clots, pulmonary emboli, strokes, heart attacks and deep vein thrombosis.

With any luck, now that the media has come out of hibernation, all of the women who have been injured by the birth control patch will hopefully at least know what happened.

Avandia FDA Mole Hawks Lethal Medication Patches

Evelyn Pringle August 12, 2007

Douglas Arbesfeld, the pharmaceutical industry’s mole inside the FDA, recently revealed his existence quite by accident when he attempted to destroy the reputation of cardiologist Dr. Steve Nissen by sending a malicious email to reporters after Dr. Nissen published a study that found the diabetes drug Avandia possibly increases the risk of heart attack and death.

Apparently, a reporter made Dr Nissen aware of the email sent by Mr Arbesfeld from his official FDA email account which subsequently led to his unexpected outing as the industry’s mole.

The email also sought to discredit the Cleveland Clinic by inferring that the Clinic and Dr Nissen published a bogus study on Avandia to punish its maker GlaxoSmithKline because the company does not do research at the clinic.

As a means of emphasizing this point, Mr Arbesfeld included derogatory comments posted on the internet by a supposedly “anonymous” blogger listed as Brian A, who accused Dr Nissen of running the Clinic like the characters in a Mafia TV series stating: “The Cleveland Clinic was one of the most respected names in medicine, now they are positioning themselves as candidates to take over for a new series on HBO to replace the Soprano’s”.

The email also warned other drug companies that they would face a “firing squad” from Nissen and company if they did not hire the Clinic to do research.

For the record, Nissen and the Cleveland Clinic are respected worldwide for the research they conduct and Nissen’s name appears on Time Magazine’s list of the top 100 most influential people. When a drug or medical device is dangerous, he says so.

Most famously, Nissen warned the world about the serious health risks associated with Merck’s Vioxx, and lived to talk about it while the reputations of other esteemed scientists were destroyed by Merck.

Mr Arbesfeld’s attempt to smear Dr Nissen while on the clock at the FDA has led to a Congressional investigation by lawmakers on both sides of the isle. The investigation is focused on Mr Arbesfeld’s alleged ties to the pharmaceutical industry and more importantly, how it came to be that he was hired as a media consultant for the FDA to begin with straight from a company whose products are regulated by the FDA.

It also seems more than a bit odd that the FDA would chose now to hire a media consultant employed by J&J being the company is currently under investigation for the illegal marketing of many of its products while hiding dangerous side effects by several Congressional Committees, the US Department of Justice, the FBI, the US Department of Health and Social Services, and attorneys general in states all over the country.

But then on the other hand, what better time than now for the industry as a whole to have a mole inside the FDA to keep it apprised of the progress or lack of in the numerous investigations underway.

The lawmakers have linked Mr Arbesfeld to drug giant J&J but in fact, a few days of investigating revealed that his employment in the industry has involved just about every drug company at one time or another, including Avandia maker GlaxoSmithKline in 2002.

A few years back, Mr Arbesfeld was hawking medication patches that have since been found to be lethal on behalf of J&I’s Ortho-McNeil division which is currently facing a large number of lawsuits alleging the company and the FDA hid studies that showed the Ortho-Evra birth control patch caused blood clots and promoted the off-label use of its narcotic Duragesic pain patch.

On October 10, 2004, Susan Edelman of the New York Post reported that a “popular and profitable contraceptive patch promoted by sexy TV ads caused 11 times as many fatal or life-threatening blood clots as a leading birth-control pill, a new lawsuit charges.”

She said the patch had been found responsible for 17 deaths in women age 17 to 30 since its release in 2002.

Ms Edelman used the Freedom of Information Act to obtain records from the FDA which also revealed 21 other life-threatening conditions such as blood clots, strokes, and heart attacks.

In the Post article, Mr Arbesfeld maintained that the “adverse event reports for Ortho Evra are consistent with the health risks of other hormonal contraceptives.”

On October 25, 2004, he told the Associated Press that four million women in the US had used the patch since it came on the market in 2002 and about 800,000 women were currently using it.

But when the story got legs due to reports about the large number of adverse events recorded in the FDA database, Mr Arbesfeld said in the New York Post, “We believe that there may have been duplicates in the FDA reports.”

“The way adverse-event reporting works is that reports go in to the FDA as raw data, which has to be analyzed,” he stated. “Several people could report on the same incident, such as a doctor, a relative, a nurse.”

J&J has consistently denied knowledge of any problems with the patch. However, according to a story by CBS News, documents have surfaced in a lawsuit that show the company’s own records reveal that it received some 500 reports of serious problems associated with the patch between April 2002 and December 2004.

In fact, documents that surfaced in litigation showed the company had been analyzing the FDA’s death and injury reports on women using the patch, and had charts that showed a higher rate of blood clots and deaths in women on the patch when compared to women who take birth-control pills.

In July 2005, the Associated Press conducted an investigation that tracked adverse reactions in women using the patch since it was approved for sale in the US. In response to a FOIA request, the FDA provided the AP with a database that contained roughly 16,000 adverse reaction reports.

Since the FDA estimates that it only receives reports on between 1% and 10% of the adverse events that actually occur, the death and injury rate for products is known to be significantly higher that indicated in the database.

Within the group of 16,000 adverse reaction reports, the AP determined that there were 23 deaths. Doctors who reviewed the 23 deaths said about 17 appeared to be clot-related.

According to the AP, about a dozen women, mostly in their late teens and early 20s, died from clots in 2004, and dozens more experienced strokes and other clot-related problems.

In addition, according to the Associated Press on November 11, 2005, an internal company memo shows that in 2003, the company refused to fund a study comparing the Ortho patch to the company’s Ortho-Cyclen pill because there was “too high a chance that study may not produce a positive result for Evra” and a “risk that Ortho Evra may be the same or worse than Ortho-Cyclen.”

According to J&J’s Annual Report, as of December 31, 2006, there were approximately 1,500 claimants who have filed lawsuits or made claims regarding injuries to due to the Ortho Evra patch.

Because J&J knows that blood clots rarely develop in young women of childbearing age, legal experts say not to expect to see public jury trials in cases involving the birth control patch. In fact, many lawsuits have quietly ended in confidential out-of-court settlements but with little fanfare in the mainstream press.

J&J has also been hit with over a hundred lawsuits involving the Duragesic pain patch, a device that is supposed to deliver safe doses of fentanyl, a drug so powerful that high doses can shut down the respiratory center in the brain.

Fentanyl is a Schedule II narcotic, said to be 80 times stronger than morphine, listed in a class of drugs due to the high potential for abuse and overdose.

Here once again, fentanyl was approved for use by cancer patients with unremitting pain who were monitored closely, but before long it was being been prescribed off-label for many uses without any patient monitoring.

In 2004, pharmacists filled more than 4 million prescriptions for J&J’s fenanyl patch according to the November 25, 2005 LA Times. In the six years before the article, the Times reported, the Los Angeles County coroner’s office alone had investigated over 230 deaths involving fentanyl.

In Florida, the Times said, state authorities reported 115 deaths from fentanyl in 2004.

The history of the patch shows that the FDA knew about the risks but ignored the growing use of the narcotic. The US Substance Abuse and Mental Health Services Administration found that emergency-room cases involving fentanyl rose from 28 in 1994 to 1,506 in 2004, according to the federal Substance Abuse and Mental Health Services Administration.

FDA official Dr Robert Meyer, head of the office that oversees painkillers, told the Times that safety officers had just noticed a trend of adverse reactions involving the drug that year.

However, back in 2001, the Times reports, a drug safety group of the Institute for Safe Medication Practices, warned the FDA that patients on the patch were dying of overdoses and doctors were prescribing it for patients who did not tolerate opioid drugs well. And yet it took another four years for the FDA to issue a nationwide alert, on July 15, 2005.

Responding to the reports, Mr Arbesfeld told the Times that the drug met an important need for cancer patients and others with chronic pain and the company was working with the FDA, doctors and patients to make sure it was used safely.

“We take the health and safety of the patients who use this product very seriously,” Mr Arbesfeld said. “We work very closely with the FDA to look into all reports of serious adverse consequences, and we believe that the product is safe and effective when used as directed.”

Yet according to the Times, J&J has promoted the narcotic patch to doctors as superior medication for back pain and other problems. “Game, uninterrupted,” reads the caption on a Duragesic brochure that showed a middle-aged man shooting pool, the Times said.

Another photo showed a pair of hands kneading bread dough. “1,360 loaves … and counting,” with the caption. “Work, uninterrupted.”

Mr Arbesfeld told the Times that the company had stopped using that literature.

It would be impossible for him to not know the narcotic was being massively prescribed off-label for unapproved uses. According to the Times, from 2000 to 2004, sales of the patch more than tripled and the number of prescriptions more than doubled

In 2004, with $1.2 billion in sales the Duragesic patch even surpassed Vioxx, according to Drugtopics.com. However, J&J’s Annual Report says that as of December 31, 2006, there were approximately 100 lawsuits filed against the company related to the patch.

Johnson & Johnson Knee-Deep in Birth Control Patch Litigation

Evelyn Pringle November 5, 2006

Ortho Evra birth control patch lawsuits are becoming increasingly common as very young women are suffering heart attacks, strokes, blood clots and pulmonary embolism while using the patch.

On November 1, 2006, the Associated Press reported that 43 more women have sued the makers of the patch alleging that they suffered from blood clots and other health problems after using the patch.

A second lawsuit contends that 25-year-old Kelly Bracken of Elk Ridge, Maryland, died of severe blood clots in her lungs and legs after she started using the skin patch.

The new lawsuits were filed in San Francisco Superior Court, and the named defendants include patch maker Ortho-McNeil Pharmaceutical, a New Jersey based subsidiary of Johnson & Johnson; and the San Francisco based distributor McKesson Corp.

The case titles for the lawsuits are Bracken-Hodge v Ortho-McNeil, 06-457523; and Abel v Ortho McNeil, 06-457524.

Like nearly all of the cases filed so far, these lawsuits claims that the drug company failed to adequately investigate the safety of the patch and deceived consumers about the potential dangerous side effects, including the risks of strokes and blood clots.

“This product should not be on the market,” said Shawn Khorrami, an attorney for the plaintiffs, in the Associated Press article.

“When you put out a product that gives women more hormones than they need,” he said, “then you’re increasing their risk of developing those ailments.”

New lawsuits are now being filed just about every month. In mid-October a case was filed against Ortho-McNeil in the Superior Court of New Jersey, on behalf of a 25-year-old Wisconsin woman who was diagnosed with bilateral pulmonary emboli after using the patch for six months.

On October 17, 2006, News Inferno reported that a lawsuit had been filed on behalf of a Katy McKellips Braman, an Idaho woman who was 17 when she was prescribed the patch in 2004.

Ms Braman alleges that she had been using the patch for only a little more than a month when she developed deep vein thrombosis, a serious and potentially fatal blood clot condition, in her left leg.

The month before that, on September 5, 2006, a Drug Newswire press release announced that a 24-year-old Texas woman who suffered a miscarriage and developed potentially life-threatening blood clots after using the patch had filed a federal lawsuit in Marshall, Texas.

Going back another month, in August 2006, a 36-year old Kentucky woman filed the first federal lawsuit against the patch makers in that state alleging that she experienced blood clots in her legs, spleen and lung about 5 weeks after she began wearing the patch.

The FDA approved the Ortho Evra patch in November 2001, and it quickly became one of J&J’s most popular products. Once attached to the body, the patch delivers the hormones estrogen and progestin directly into the bloodstream through the skin.

Most experts agree that the dangers of the patch stem from its delivery system. By releasing estrogen directly into the bloodstream, a woman can end up with an estrogen level of up to 60% higher than a woman taking the pill. This is partly due to the fact that the absorption rate of a pill traveling through the digestive system is much lower than the patch, which delivers estrogen 24 hours a day.

Attorneys say the death and injuries attributed to the patch in younger women are what’s known as a “signature disease,” meaning they are practically unheard of in women in this age group. Healthy young women, with no history of any underlying condition, are not known to suffer heart attacks and strokes.

For instance Kelly Bracken’s mother says her daughter never had any health problems when she unexpectedly died from severe blood clots in her legs and lungs at the age of 25. She told ABC News on November 2, 2006, that she blames the drug company for her daughter’s death.

Kelly’s mother also told ABC News that she now dreads her upcoming birthday because it was 2 years ago on her birthday when her daughter collapsed and went into a coma.

She said Kelly complained of problems once she started using the patch and, “Two weeks after complaining about the back ache and head ache she was dead.”

A lawsuit filed in New Jersey Superior Court by ten women who allege they experienced blood clot problems after using the patch alleges the FDA received 9,116 adverse reaction reports from patch users in a 17 month period, which averages out to well over 500 per month, compared to receiving only 1,237 adverse event reports from women using the birth control pill in six years which averages out to less than 20 a month.

Since the FDA estimates that it receives reports on only between 1% and 10% of the serious adverse drug reactions that actually occur, the death and injury rate for Ortho Evra patch users is estimated to be significantly higher than FDA numbers indicate.

In November of 2005, the FDA changed the label on the Ortho Evra patch to include a bolded warning that the patch exposes women to higher levels of estrogen than most birth control pills.

The label explained that hormones from patches applied to the skin get into the blood stream and are removed from the body differently than hormones from birth control pills taken by mouth and warned that increased estrogen exposure may increase the risk of side effects.

On September 20, 2006, the FDA updated the label on the patch again, warning that women who use the patch face a higher risk of blood clots

Through litigation, information has surfaced that shows that the patch makers were aware of the mounting reports of deaths and injuries associated with the patch. On November 11, 2005, the Associated Press 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,” the article reports, “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.'”

CBS News also reported that other documents that surfaced in litigation reveal that the company’s own records show it received some 500 reports of serious problems with the patch between April 2002 and December 2004, while during that same time period the company only received 61 such reports on oral contraceptives.

In addition, there were 4 times as many strokes in women using the patch as in women using the pill even though there were 3 times more women taking the pill and in medically confirmed cases, the risk of blood clots was found to be 14 times higher with the patch.

Because J&J does not want to try cases related to the death and injuries that have occurred uncharacteristically in so many otherwise healthy young women, the company has been offering to settle lawsuits in record numbers in hopes of avoiding public jury trials.

The only hitch is that the check is not issued until after the plaintiff signs a confidentiality agreement and promises to keep everything about the case a secret.

J&J Can’t Settle Ortho-Evra Birth Control Patch Cases Fast Enough

Evelyn Pringle September 26, 2006

More than 500 claimants are seeking “substantial compensatory and, where available, punitive damages,” from Johnson & Johnson for injuries and deaths related to the Ortho Evra birth control patch, according to the company’s Second Quarter Report filed with the SEC.

However, if legal analysts are correct, J&J ain’t seen nothin yet.

Based on the millions of prescriptions written for the Ortho Evra patch since it came on the market in 2002, critics say there are thousands of victims who do not yet realize that an injury or death was caused by the patch.

All total, in 2005, J&J raked in $1.1 billion in sales of contraceptives products but the company says it expects a decline in 2006 because of “labeling changes and negative media coverage concerning product safety,” in the company’s 2005 annual report said.

However, in July 2006, J&J took measures to make up for the lost sales by drastically increasing the price of contraceptive products paid for by Medicaid programs.

Medicaid purchases contraceptives for low income persons covered under the public health care program. For instance, West Virginia provides contraceptives to about 59,000 low income people each year and J&J was the supplier of 75% of those products.

Suddenly and without any warning, J&J created a budget crisis in West Virginia, and many other states, by increasing the price of birth control pills 20-fold, and raising the price on the Ortho Evra patch from $12.15 to $22.46, according to the Associated Press.

When asked about the price hikes, company spokeswoman, Julie Keenan said the pricing for the pills and the patch was in line with federal Medicaid pricing formulas that change every financial quarter.

Considering the fact that Johnson & Johnson has sold patches to about 5 million women since the device came on the market in 2002, according to Bloomberg News on May 13, 2006, a $10 increase times by 5 million women would make for quite a haul.

In response to the dramatic increase in prices, family planning directors across the country began accusing the company of price gouging government funded health centers. “Nobody believes that Ortho-McNeil had any reason to increase these prices by this amount,” said Lon Newman, director of Family Planning Health Services, which operates seven clinics in Wisconsin.

“It’s clearly a market manipulation on Ortho’s part,” he stated.

The increase in costs forced many family planning agencies to stop providing Ortho products to women. In the end, rather than lose all the sales, the company dropped the price of the Ortho patch down to $15, or about $3 more than it was before July 1, 2006, when the company raised the price.

Mainly to suppress negative publicity about the Ortho patch that would have an adverse effect on sales, Johnson & Johnson attorneys have been trying to settle the Ortho Evra lawsuits almost as quickly as they are filed by offering substantial settlements that require the plaintiffs to sign a confidentiality agreement in order to keep the damaging information out of the public eye.

In addition, legal experts say J&J attorneys are fully aware that the cause of the injuries and death alleged in the lawsuits will be easy to prove because the plaintiffs have a “signature disease,” described as a condition closely linked to the use of a drug that is otherwise very rare. In this instance, they point out, blood clots, heart attacks and strokes are extremely unusual in teenagers and women of childbearing years, with the only commonality among the victims being the Ortho Evra birth control patch.

Many litigants have already settled their lawsuits and J&J has made it clear to attorneys for other plaintiffs, and the various judges handling the cases, that the company is ready to negotiate settlements in many more cases.

However, the problem with this legal strategy is that J&J no sooner settles a group of lawsuits before another batch get filed. Seven lawsuits were filed in one day in January to include:

Plaintiff, Maral Annayeva, alleges she was prescribed the Ortho patch between January and May 2005, and used it for 18 days before suffering from bleeding, heart pain, headaches, nausea and general malaise.

Plaintiff, Brandy Houk, used the patch from February to October 2005, and alleges that she suffered shortness of breath, fatigue, excessive bleeding, and large clots as a result.

Plaintiff, Melody Miller, alleges that on December 21, 2003, she suffered multiple blood clots which resulted in the miscarriage of her child in the fifth month of pregnancy.

Plaintiff, Tanya Lowe, alleges that she suffered blood clots in her right leg which shattered and spread into her lungs in January 2004, while using the patch.

Plaintiff, Reannon Tutkus, charges that on December 24, 2004 and January 1, 2005, she suffered blood clots.

Plaintiff, Stephanie Curtis, alleges that in March 2004 she noticed a red spot just above the patch so discontinued the patch and immediately became pregnant. In June or July of 2004, she alleges she developed a blood condition which predisposed her to blood clots that required the use of blood thinners while pregnant.

Plaintiff, Kristine Bailey, claims in late October to early November 2005, she suffered blood clots, dizziness and fatigue.

The plaintiffs also allege that J&J violated consumer fraud statutes with the use of false and misleading misrepresentations in the marketing, promotion and sale of the patch.

Specifically, since January 2006, Johnson & Johnson has been willing to negotiate out-of-court settlements in lawsuits that involve women who have been hospitalized for the following conditions:

* strokes;

* heart attacks;

* pulmonary embolisms; and

* deep vein thrombosis.

In layman’s terms, all of these conditions involve injuries caused by blood clots. According to the National Institute of Neurological Disorders and Stroke: (1) thrombosis is the formation of a clot within a blood vessel of the brain or neck; and (2) embolism is the movement of a clot from another part of the body to the neck or brain.

Hormonal birth control products are known to increase the risk of blood clots because estrogen promotes coagulation. Clots usually form in the legs and cause serious problems when they travel to the heart, lungs, or brain.

A blood clot in the lungs can cause the inability to breathe (lung embolism) and a blood clot in the heart can cause a heart attack or heart failure. A blood clot in the brain can cause stroke by interfering with the free flow of blood to the brain, according to the NINDS:

“A stroke occurs when the blood supply to part of the brain is suddenly interrupted or when a blood vessel in the brain bursts, spilling blood into the spaces surrounding brain cells. Brain cells die when they no longer receive oxygen and nutrients from the blood or there is sudden bleeding into or around the brain.

There are two types of strokes: (1) ischemic – the blockage of a blood vessel supplying the brain; and (2) hemorrhagic – the bleeding into or around the brain. According to the NINDS:

“The symptoms of a stroke include sudden numbness or weakness, especially on one side of the body; sudden confusion or trouble speaking or understanding speech; sudden trouble seeing in one or both eyes; sudden trouble with walking, dizziness, or loss of balance or coordination; or sudden severe headache with no known cause.”

A common disability from a stroke, NINDS says, is complete paralysis on one side of the body. A related disability that is not as debilitating is one-sided weakness. Strokes may also cause problems with thinking, awareness, attention, learning, judgment, and memory.

According to NINDS, stroke survivors also often have difficulty understanding or forming speech and may have problems controlling or expressing their emotions and many people experience depression.

Stroke survivors may also experience numbness, strange sensations, and pain in their hands and feet, made worse by movement and temperature changes, especially cold temperatures. And, about 25% of patients who recover from a first stroke, NINDS says, will have another within 5 years.

The serious health problems caused by the Ortho patch first caught public attention on January 9, 2004, when an article titled, “‘Sex Patch’ Tied To 17 Deaths,” appeared in the New York Post, stating, “A trendy contraceptive patch which has been aggressively marketed using sexy ads, fashion models and Olympic athletes has been linked to the deaths of at least 17 young American women in the past two years.”

Citing FDA reports, the Post said that “scores” of other women using the Ortho Evra patch have suffered complications, including 21 “life-threatening” cases of blood clots and other ailments.

Ten months later, on October 10, 2004, the New York Post published another article titled: “The Patch of ‘Death,'” that stated: “A popular and profitable contraceptive patch promoted by sexy TV ads caused 11 times as many fatal or life-threatening blood clots as a leading birth-control pill,” quoting a complaint filed in a Texas lawsuit by a mother of 2 who had suffered a massive stroke and was left paralyzed after using the Ortho patch for 12 days.

The lawsuit described FDA records obtained with an FOIA request, that showed that in a one-year period, at least 46 women suffered blood clot related injuries or death while using the patch and that only half that number of women taking birth control pills suffered clot related problems, even though 6 times more women used the pill.

Less than a year later, another lawsuit filed in New Jersey in September 2005, on behalf of a woman who suffered a pulmonary embolism after using the patch, disclosed that between April 2002 and September 2003, the FDA’s Adverse Event Reporting System (AERS), had recorded 9,116 adverse events related to the patch, but that with the birth control bill for a period of more than 6 years, there were only 1,237 adverse reports recorded even though the pill was used by almost six times more women.

The AERS is a computerized database, designed to support the FDA’s post-marketing surveillance program for all approved products, that stores and analyzes the adverse event reports that are submitted to the agency.

However, experts say, when considering the number of adverse events reports related to the Ortho patch, its important to know that according to FDA officials, only between 1% and 10% of all adverse events are reported. Which means at best, the number of adverse events reported above must be multiplied by 90%, and at worst by 99%.

Plaintiffs’ attorneys maintain that J&J has long known about the serious risks of using the patch. According to a CBS New report in November 2005, citing documents obtained in a lawsuit, Johnson & Johnson’s own records show the company received 500 reports of serious problems in women wearing the patch between April 2002 and December 2004. And the company records also showed that even though 3 times as many women were taking birth control pills during the same time period, only 61 similar reports were received on women taking the pill.

The records reveal that there were four times as many strokes in women using the patch, and according to the Associated Press, the medically confirmed cases indicate that the risk of blood clots was 14 times higher among women using the patch.

Many experts believe that the increase in health problems is due to the patch delivery system because the medications and dosages in the patch are the same as in the pill and prevent pregnancy by: (1) altering ovulation so that an egg is not released for fertilization; (2) thickening cervical mucus to stop sperm from entering uterus; and (3) changing the endometrium to reduce the likelihood of egg implantation.

However, a European study in 2005, measured the hormone levels among 32 women who took the pill versus those who used the patch, and determined that women who used the Ortho patch had 60% more estrogen in their blood streams than women taking the pill.

Expert say that although estrogen is important in the regulation of the reproductive cycle it provokes clotting and if too much estrogen is released via the patch it can cause excessive clotting, particularly in the arteries and veins of the lower extremities.

Estrogen in birth control pills must travel through the digestive tract before it is absorbed by the body and a great deal of the dosage is lost in the process. With the patch delivery system, full-strength estrogen is absorbed through the skin directly into the blood stream continuously for 3 weeks each month, while the dose of hormones in the once a day pill leaves the body in a matter of hours after the pill is ingested.

Experts say another problem may be that the level of hormones released increase when the patch becomes heated through exercise, or bathing in a hot tub, or a high fever. “Most people don’t realize that heat is going to increase absorption rates, even to toxic levels,” according to Michael Cohen, director of the Institute for Safe Medication Practices.

Studies have shown that heat has a distinct effect on medication patches. As far back as 1986, a study found that 20 minutes of bicycling while wearing a nitroglycerin heart patch increased the drug’s concentration two to threefold. Similar results were found with people sitting in the sauna for 30 minutes.

Despite having first-hand knowledge of the number of women being injured and killed, the FDA did not officially alert the pubic to the high risks associated with the patch until November 10, 2005, when a “Black Box” warning was added to the product label that said the device could expose women to estrogen levels 60% higher than oral contraceptives and that the increased dosage was associated with a greater risk of blood clots.

Unfortunately for the thousands of young women who have already died or been injured, this action by the FDA represents another case where the agency charged with protecting consumers from the profit driven pharmaceutical industry has done too little to late.