The Bitter Pill

The Official Blog of UNITE – uniteforlife.org

J&J Concealed Dangers of Ortho Evra Birth Control Patch

Evelyn Pringle April 16, 2007

Tens of millions of prescriptions have been written for Johnson & Johnson’s Ortho Evra birth control patch since it arrived on the market in 2002, and medical experts say the patch has harmed thousands of young women of childbearing age.

In September 2006, the FDA warned that use of the patch, made by the Ortho-McNeil division of J&J, increases the risk of blood clots, which can lead to heart attack and stroke.

Because the patch releases hormones directly into the blood stream, medical experts say, a much higher concentration of hormones enters the body than with birth control pills. A November 2005, FDA advisory reported that patch users were exposed to about 60% more estrogen than women on the pill.

A recent study in the February 2007, journal, Obstetrics and Gynecology, of 49,000 women who used the Ortho patch, and 202,000 who used oral contraceptives, found that blood clots or “venous thromboembolism” occurred in patch users at a rate of 2.2 times higher than with women on the pill.

Legal experts says proving causation in these cases will be easy because blood clots in young women are almost unheard of. No doubt due to the recognition of this fact, when the first lawsuits were filed, J&J quickly began settling cases out of court for substantial sums of money, trying to keep a lid on the news that women were being injured by the patch.

J&J has already settled lawsuits in state courts in New Jersey, Texas, and California, and federal courts in North Carolina and Pennsylvania, according to Bloomberg on April 2, 2007.

Texas attorney, Ray Chester, told Bloomberg that one settlement involved a 40-year-old woman with 2 children, who had a massive stroke after only 12 days on the patch and is now a quadriplegic with brain damage and requires around the clock medical care.

However, as the number of lawsuits multiplied, that strategy of quietly settling out of court could not continue for obvious reasons. J&J’s Annual Report filed with the SEC in February 2007, states that, as of December 31, 2006, “there were approximately 1,500 claimants who have filed lawsuits or made claims regarding injuries allegedly due to ORTHO EVRA.”

Documents revealed in litigation, prove that J&J knew about the high rate of blood clots because they show the company had been analyzing the FDA’s reports on injuries and deaths in women using the patch, and had even compiled charts showing the higher rates of clots and deaths when compared to women taking birth-control pills.

One memo from 2003, reveals that the company refused to conduct a study to compare the rate of adverse events with the patch to its 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.”

Newly released documents show that, instead of warning consumers and prescribing physicians about the clot problems, Johnson & Johnson has been doing everything in its power to stop the negative information about the patch from becoming public.

Documents unsealed this month by Superior Court Judge, Bryan Garruto, in a New Jersey state court proceeding involving more than 300 lawsuits, reveal that J&J bought up dozens of internet domain names related to the Ortho patch in an attempt to stop negative information from appearing on the internet.

By using the standard trick of claiming the documents contained trade secrets, J&J had previously obtained a court order to keep them sealed so the public would not learn about the extent of the company’s damage control efforts.

But in granting a motion by the plaintiffs’ attorneys to unseal the documents, Judge Garruto said they were not entitled to a protective order because the information did not constitute trade secrets that, if revealed, would benefit J&J’s competitors.

One document released calls for, “Defensive actions to minimize impact of negative presence,” to include buying internet domain names, monitoring blogs and purchasing the top key words related to the patch that would be picked up by Google and Yahoo search engines.

Apparently, drug companies do this on a regular basis. According to Kent Jarrell, a spokesman for J&J, quoted by Bloomberg News on April 2, 2007: “The purchase of the domain names is a standard and accepted business practice for companies that are trying to prevent product disparagement and to safeguard the defendant’s reputation.”

Legal experts view the situation differently. According to Attorney, Derek Braslow, of the Conshohocken, Pennsylvania firm of Pogust & Braslow, “While J&J’s purchase of key internet search terms and domain names does not prove that the Ortho patch causes injuries,” he says, “J&J’s conduct, like the conduct of most drug companies, does show an intentional disregard for the victims of its deadly drug.”

He does not find the drug maker’s conduct surprising. “J&J has only taken the next step in the natural evolution of marketing,” Mr Braslow explains, “promote the drug at all costs during the life of the patent but eliminate all marketing and promotion after the money has been made and the victims start seeking answers and advocacy.”

“Purchasing the domain names has nothing to do with the merits of the litigation,” he says, “it has everything to do with damage control, protecting their drug at all costs and preventing victims from seeking and finding justice.”

After lives have been lost and families devastated as a result of using the patch, he states, the company is attempting to prevent the victims from finding legal counsel. “Instead of coming forward with the truth behind the patch,” he notes, “the company has gone to extraordinary measures to stop victims from finding attorneys to represent them.”

Attorney, Ted Chabasinski, who recently worked on a case involving the release of damaging Zyprexa documents that Eli Lilly had successfully kept hidden with a court order while settling out of court with about 26,000 litigants, agrees that J&J’s conduct is standard procedure when it comes to concealing damaging information about pharmaceutical products.

“What Johnson and Johnson is doing,” he says, “just reflects drug company practices in general.”

“None of them want the public to know that their products are dangerous and often ineffective as well,” Mr Chabasinski notes.

“America must wake up soon,” he warns, “to what these greedy corporations are doing to our health.”

“We need politicians,” he states, “who will stand up to the drug companies, and judges who will recognize that when drug company executives approve hiding the deathly effects of their drugs, thus killing thousands of people, they should be put in prison.”

“It isn’t enough,” he advises, “to make the companies pay damages.”

“Nothing will stop these practices,” he warns, “except holding the people who run these corporations personally responsible for their criminal behavior.”

According to FDA records obtained by the Associated Press with a FOIA request in 2005, in one 18-month period, there were 9,116 adverse events reported by women using the patch, a rate 7 times higher than women taking oral contraceptives.

A factor that must always be considered when assessing the number of people who may have been harmed by a product is that the FDA estimates that only 1% to 10% of adverse events are ever reported, which means the number of women harmed by the patch is definitely much higher. In 2005 alone, doctors wrote more than 9.4 million prescriptions for the patch, according to the pharmaceutical industry-tracking firm, IMS Health.

The review of records by the Associated Press revealed that the FDA knew that blood clots were at least 3 times more common with the patch before the device was approved.

The records show that in 2000, FDA doctors reviewing J&J’s clinical trials warned that clots could be a problem with the patch after finding that 2 women were treated for serious conditions where blood clots had traveled to their lungs.

One reviewer said, “The label should clearly reflect this reviewer’s safety concern about a potential increased risk.” But in the end, the label did not contain the warning, and there was no requirement for follow-up studies other than ordinary reviews of voluntary reports.

Filed under: 2007, birth control patch, Johnson and Johnson, Ortho, settlement, stroke

April 2007 Big Pharma Litigation Update – Drugs – Part I

Evelyn Pringle April 5, 2007

For the last two decades, illegal drug marketing schemes have paid off well for Big Pharma. However, as the old saying goes, all good things must come to an end, and every major drug company is currently involved in massive litigation.

Some companies are facing thousands of lawsuits with a common complaint that the drug maker deliberately concealed the side effects of their products while illegally promoting the drugs for off-label use.

Off-label refers to prescribing drugs to treat conditions other than those approved by the FDA and listed on the label. It can include prescribing drugs to unapproved populations, such as children or the elderly, or in higher doses than specified on the label.

It is illegal for drug companies to promote a drug for off-label uses, but doctors are allowed to prescribe a drug for any use they choose. Almost without exception, the lawsuits currently pending accuse the pharmaceutical companies of influencing doctors to prescribe the product for unapproved uses.

On August 18, 2006, Bloomberg News reported that Wyeth has accumulated more than 175,000 lawsuits since the Fen-Phen diet combination was removed from the market after studies revealed that the drugs caused heart valve damage, and primary pulmonary hypertension, or PPH, a life-threatening lung disorder. All total, Wyeth has set aside more than $21 billion to cover legal costs and settlements since the drugs were withdrawn, according to Reuters on May 24, 2006.

There was a national class-action settlement involving claims for heart valve damage, but it did not include claims for PPH which are proving to be costly. In one 2004 case alone, a Texas jury awarded over $1 billion to the family of a woman who died of PPH after taking Fen-Phen for about two years, including $113.4 million in compensatory damages and $900 million in punitive damages, according to Wyeth’s 2005 Annual Report. The case was later settled for an undisclosed amount.

PPH is a life-threatening condition that can require a heart-lung transplant. According to the FDA, PPH “results in death in about 40% of affected individuals within 4 years.”

The Fen-Phen combination was never FDA approved for any use, which means every prescription was off-label. Patients were able to get Fen-Phen on the internet, and Jenny Craig and Nutri-System set up weight-loss programs where doctors would prescribe the drugs to customers.

And there appears to be no end in sight for Fen-Phen lawsuits. On December 5, 2006, five more women who took the drugs in 1996 and 1997, filed lawsuits against Wyeth after being diagnosed with PPH. When it comes to liability, a plaintiff’s attorney, Paul Rheingold, in “Fen-Phen and Redux: A Tale of Two Drugs,” says, “there is blame enough to go around.”

The doctors who set up store-front Fen-Phen clinics and prescribed the drugs are obvious culprits, he says, and so are drug companies that profited financially from the fad and may have neglected to pass on information about deadly side effects.

On August 18, 2006, Bloomberg reported that Wyeth was facing 5,000 lawsuits over the menopause drug, Prempro, alleging that Wyeth misled the plaintiffs through deceptive marketing about the cancer risks associated with estrogen and progestin. As many as 6 million women took Prempro before it was linked to cancer in a 2002 study.

Financial analysts are predicting that, Merck in the end, will pay out as much as $50 billion for Vioxx litigation. On March 12, 2007, Reuters reported that a New Jersey jury found the drug was responsible for a plaintiff’s heart attack and awarded $20 million in damages.

According to Reuters, the jury also found that Merck committed consumer fraud by making misrepresentations concerning the heart risks, and intentionally concealing safety information from doctors prior to the plaintiff’s heart attack.

A large number of lawsuits have also been filed against Merck, over the osteoporosis drug Fosamax, and against Johnson and Johnson, over the Ortho-Evra birth control patch. The plaintiff’s allege that Fosamax causes jaw-bone death (OJN) and that the patch causes blood clots, which in turn lead to strokes.

Legal experts predict causation in cases involving Fosamax and the Ortho patch will be easy to prove because the plaintiffs have what is referred to as a “signature disease,” meaning a condition easily tied to the drug because it is rare.

The jaw-bone death occurring in people taking Fosamax is extremely uncommon. Kenneth Hargreaves of the University of Texas, noted the increasing cases in the April 3, 2006 LA Times. “We’ve uncovered about 1,000 patients in the past six to nine months alone,” he said, “so the magnitude of the problem is just starting to be recognized.”

FDA approved in 1995, Fosamax is a relatively new drug, and unreported cases may be higher than expected because doctors may attribute the pain caused by ONJ to osteoporosis, according to Diane Wysowski of the FDA’s Office of Drug Safety.

Dr Salvatore Ruggiero, an oral surgeon and one of the first doctors to notice the rise in ONJ in 2001, told the Times, “Even though the chances of getting this are small, considering there are 23 million women taking this drug, we could be talking about a significant number of people.”

The same goes for the Ortho patch. Blood clots seldom develop in young women of childbearing age. And legal experts say, for that reason, many Ortho patch lawsuits have already ended in confidential settlements with hardly a peep in the mainstream press, and J&J has made it clear to other plaintiffs’ attorneys that the company is willing to cut a deal.

Experts predict that many more lawsuits will be filed because there are thousands of young patch victims who are still unaware that the patch caused the health problems. In 2005 alone, more than 9.4 million prescriptions were written for the Ortho patch, according to IMS Health, an industry-tracking firm.

The FDA says it has received about 9,000 reports of adverse events related to the patch, but the agency also acknowledges that only between 1% and 10% of adverse events are ever get reported.

There are over a hundred more lawsuits filed against J&J involving the Duragesic pain patch. The device is supposed to deliver controlled doses of fentanyl, a drug so powerful that high doses can turn off the respiratory center in the brain.

On July 8, 2006, the Associated Press reported that a Houston jury had awarded $772,500 to the daughter of a woman who died after a leak on the patch increased the dose of the painkiller, and the jury found J&J negligent in the way the patch was made.

Another fentanyl product that legal experts say will bring a wave of lawsuits in the next couple of years, is Cephalon’s painkilling lollipop, Actiq. The product was only approved to treat cancer patients in chronic pain who are already on an opioid drug, because life-threatening conditions can occur at any dose in patients without a built-up tolerance for opioids. But a recent study by Prime Therapeutics found Actiq is being prescribed off-label nearly 90% of the time.

Fentanyl is reportedly 80 times stronger than morphine, and is a Schedule II narcotic drug, in the same category as cocaine, opium, methamphetamine and methadone, a class known to have the highest potential for abuse and overdose.

In 2004, there were an estimated 8,000 emergency-room visits for fentanyl overdoses, according the US Substance Abuse and Mental Health Services Administration. Overdose can result in sudden death through respiratory arrest, cardiac arrest, severe respiratory depression, cardiovascular collapse or severe anaphylactic reaction, according to the agency. As of November 16, 2006, there were 653 deaths confirmed in the US since 2005.

In November 2006, the Wall Street Journal, said evidence obtained in litigation showed Cephalon had set high sales quotas for its sales representatives that could not be reached without promoting Actiq off-label.

Internal company documents show sales reps were regularly sent to doctors who treated no cancer patients, with free coupons for doctors to pass out to patients. According to the Journal, Dr Stephen Leighton, a general practitioner with only 3 cancer patients at any given time, said a Cephalon saleswoman stop by once a month and gave him about 60 to 70 coupons to pass out to patients for 6 Actiq lollipops.

He told the Journal that the coupons led him to try the drug for migraines and back pain and said he prescribes Actiq 15 to 20 times a month to patients who do not have cancer.

According to the November 3, 2006, report in the Journal, Actiq sales increased from $15 million in 2000, to more than $400 million today.

The consequences of the off-label prescribing of this product are far reaching. On January 22, 2006, the Free Press reported that the wife of a minister, a former schoolteacher and mother of three, was charged with involuntary manslaughter because she gave Actiq to a friend for a migraine, and the friend died of a drug overdose.

More lawsuits are sure to be filed against Eli Lilly since secret internal documents obtained in litigation by attorney, Jim Gottstein, from Dr David Egilman, an expert in previous Zyprexa litigation, prove that the company concealed Zyprexa’s link to severe weight gain, high blood sugar, and diabetes for a decade, while Lilly promoted the drug for so many off-label uses that more than 20 million people have taken Zyprexa.

To date, Eli Lilly has spent well over $1 billion to settle about 26,000 Zyprexa lawsuits, with still more litigants waiting in line. Zyprexa has been linked to serious side effects, including diabetes, hyperglycemia and pancreatitis.

On January 14, 2005, a class-action lawsuit was filed in Canada with claims that Lilly also withheld information on the safety of Prozac. The plaintiffs allege that the reason Lilly failed to disclose the documents was because they showed a drastic increase in suicide attempts and other violent acts in patients taking Prozac, when compared to patients taking 4 other drugs.

All through the 1990s, Lilly swore that Prozac did not increase the risk of suicide or violence, while the company was quietly settling lawsuits out of court which made it possible to keep the incriminating evidence hidden with court orders, just as it has been doing with Zyprexa until the secret documents showed up in the press in December 2006.

Similar lawsuits are being filed against AstraZeneca over its antipsychotic drug, Seroquel, which reportedly has been used by more than 16 million people since it came on the market in 1997. The plaintiffs in those cases also claim that Astra downplayed the diabetes risks and concealed safety information.

Filed under: 2007, AstraZeneca, Cephalon, Eli Lilly, fen-phen, fentanyl, Fosamax, Johnson and Johnson, Merck, ONJ, Ortho, patch, PPHN, Seroquel, settlement, Vioxx, Wyeth, Zyprexa

Birth Control Patch Lawsuits against J&J Piling Up

Evelyn Pringle October 23, 2006

On October 17, 2006, News Inferno announced that another lawsuit had been filed against Ortho-McNeil, a division of Johnson & Johnson, on behalf of a young Idaho women who was 17 when she was prescribed the Ortho Evra birth control patch, and in less than a month, she developed deep vein thrombosis, a potentially fatal blood clot condition.

The lawsuit alleges that J&J failed to properly test the patch before placing it on the market and knowingly misled consumers about the safety and risks associated with the patch when compared to other types of birth control products.

In the lawsuit, Katy McKellips Braman, describes the onset of the condition as a pronounced swelling in her left leg that gradually increased over the course of a few days. The condition required Ms Braman to be hospitalized and she is now forced to take anti-clotting drugs daily.

She is suing J&J for damages to include all future medical expenses incurred in treating the condition.

Two days later, on October 19, 2006, the Parker & Waichman, LLP law firm announced that it had filed a lawsuit against the company in New Jersey on behalf of a 25-year-old Wisconsin women who was diagnosed with bilateral pulmonary emboli after 6 months of using the patch.

Parker & Waichman has already filed numerous patch related lawsuits and says it plans to file a “significant number” of additional cases by the end of 2006.

The lawsuit states that the injured victim in the case was taken to the emergency room on August 24, 2004, after experiencing lightheadedness, shortness of breath and chest pain, where diagnostic tests revealed bilateral pulmonary emboli.

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. Pulmonary embolism is a sudden blockage in a lung artery, usually due to a blood clot that traveled to the lung from the leg, but clots can also form in the pelvic vein.

After being diagnosed, the Wisconsin woman was hospitalized and received the drugs Heparin and Coumadin, as anticoagulant therapy, and according to the lawsuit, will need anticoagulant medication for a protracted period of time and possibly for the remainder of her life.

These new lawsuits, along with the hundreds of others already filed all over the country, allege that Ortho-McNeil was aware of the increased risks of blood clots, heart attack and stroke associated with the birth control patch even before the device was approved for use in the US, and that once approved, the company failed to adequately warn potential users about the risks.

To substantiate this claim in part, attorneys point to an internal Ortho-McNeil memo that shows that in 2003, the company refused to fund a study comparing the patch to its Ortho-Cyclen pill because of concerns that 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 plaintiff’s attorney also list Ortho-McNeil’s own records obtained and made public by CBS news, that show the company received some 500 reports of serious events associated with the patch between April 2002 and December 2004, during a time when only 61 such reports were received involving all types of birth control pills.

These records also show that there were 4 times as many strokes in women using the patch and that in medically confirmed cases, the risk of blood clots was found to be 14 times higher with the patch.

Users of the Ortho adhesive patch apply it to their body and change it once a week for three weeks and then do not wear it during the fourth week. The patch is intended to release 20 micrograms of estrogen into the bloodstream every 24 hours.

It is widely known that exposure to estrogen increases the risk of blood clots. The first FDA warning about the increased risks of blood clots with the patch was issued on November 10, 2005, and for the first time, Ortho-McNeil admitted that women who used the patch may be exposed to up to 60% more estrogen than women taking a birth control pill.

“FDA is announcing a revision to the label for the drug Ortho Evra,” the agency said. “This change includes a new bolded warning about higher exposure to estrogen.”

“Higher levels of estrogen,” the FDA warned, “may put some women at increased risk for getting blood clots.”

By the time of this warning, the FDA had received more than 9,000 reports of adverse events related to the patch in a 17-month period, while the Ortho Tri-Cyclen birth control pill, only generated a little over 1,200 adverse reports in a 6-year period.

In addition, during a 12-month period, 44 serious injuries or deaths were found to be associated with the patch, while only 17 such reports were found to be linked to the birth control pill during a similar time frame.

Critics say the drastic difference in serious events is further magnified when considering that the number of women using the Ortho Tri-Cyclen pill was 6 times the number of women using the Ortho Evra patch.

According to Jason Mark, an attorney at Parker & Waichman, LLP, who heads the firm’s mass tort department, “The product needs to be withdrawn from the market so that it can no longer cause harm.”

“The notion that periodic warnings of Ortho Evra’s increased risks is sufficient,” Mr Mark said in a press release, “to protect the health of women is misguided.”

“There are many safer alternative forms of hormonal contraception than the patch,” he states. “This is not a last resort, life saving medication.”

On September 21, 2006, the law firm announced that it believes a new study that found women using the Ortho patch were twice as likely to develop blood clots compared with those using birth control pills provides further evidence that the patch is dangerous and should be recalled from the market.

As a result of this study, the firm noted, the FDA updated Ortho Evra’s warning to reflect that women using the patch faced twice the risk of blood clots as women on the pill.

“The FDA also asked Ortho McNeil to conduct a longer study of the contraceptive patch to evaluate the risks of blood clots, heart attack and stroke,” the Parker & Waichman press release stated.

According to its 2005 Annual Report, J&J sold $1.1 billion in contraceptives in 2005, but the report predicted a decline in sales for 2006 because of “labeling changes and negative media coverage concerning product safety.”

Warnings to young women to stay away from the patch are growing in number. On September 29, 2006, the Editorial Board of the Exponent, a Purdue college newspaper, said women should use the birth control pill instead of the Ortho Evra birth control patch and also said the patch should be removed from the market.

The Exponent, published by the Purdue Student Publishing Foundation, is Indiana’s largest collegiate daily newspaper and is primarily a student operation.

According to the Wall Street Journal, in providing health care services to 42,000 students, Pennsylvania State University is no longer writing prescriptions for the patch.

The Journal also reported that similar actions were being taken by health officials at other universities including Stanford, the University of Texas at Austin, the University of California, Berkeley, and the Connecticut College in New London.

Legal experts say the patch maker is scrambling to settle as many of these lawsuits as quickly and silently as possible with substantial monetary awards that come with the signing of confidential settlement agreements because it does not want to risk the public spectacle of a steady stream of young injured women parading before a jury.

“Ortho-McNeil Pharmaceutical,” the April 9, 2006 New York Post reported “has settled a dozen lawsuits for millions of dollars in the last few months.”

On May 2, 2006, a J&J attorney wrote a judge in New Jersey to say that 11 women who filed suit in that state had received settlements, although the amounts were kept confidential.

Also on May 2, 2006, a J&J attorney informed an Ohio judge that the company was prepared to settle all cases where the plaintiffs were hospitalized for pulmonary embolisms, deep vein thrombosis, heart attacks or strokes.

On May 16, 2006, the New Jersey Law Journal quoted a plaintiff’s attorney who estimates that “many of these cases are seven figures, many are probably substantial six-figure cases.”

However, settling these lawsuits as quickly as they are filed may not turn out to be so easy. Critics say there are likely to be tens of thousands more women spread out all over the country who do not yet realize that their health problems are caused by the patch.

Which may very well be true, because even though the FDA says it has received about 9,000 reports of adverse events related to the patch, the agency acknowledges that only between 1% and 10% of adverse events ever get reported and according to Bloomberg News on Mary 13, 2006, Johnson & Johnson has sold patches to 5 million women since the launch of the product in 2002.

Filed under: 2006, birth control patch, Johnson and Johnson, Ortho, stroke

Ortho Evra Birth Control Patch – Statistics do not Lie

Evelyn Pringle October 13, 2006

During one 17-month period between April 2002 and September 2003, the FDA received 9,116 adverse reaction reports on the Ortho Evra birth control patch.

In stark contrast, during a 6 year period between 1997 and September 2003, the Ortho birth control pill only generated 1,237 adverse event reports and 6 time more women were using the pill.

Since the FDA admits that it only receives adverse event reports on between 1% and 10% of the actual adverse events that occur, the death and injury rate for patch users is known to be many times higher than the numbers indicate in the FDA database.

Although patch maker, Ortho-McNeil Pharmaceutical, and its parent company, Johnson and Johnson, have continuously denied any knowledge about problems with the patch, according to CBS News, documents have surfaced in litigation 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.

During the same time frame, CBS notes, there were only 61 adverse event reports received with respect to all types of oral contraceptives. In addition, there were four times as many strokes in women using the patch compared to women using oral contraceptives even though once again, there were three times more women taking the pill.

Finally, CBS said, the evidence indicates that in medically confirmed cases the risk of blood clots was 14 times higher with the patch.

The first lawsuit involving the patch filed in Texas in October 2004, on behalf of a woman who suffered a stoke and became paralyzed after wearing the patch for only 12 days, cited FDA records that revealed that in one year, between May 1, 2002 and April 30, 2003, forty-six women who were using the patch had suffered blood clot related death or injuries.

In the same time period, the lawsuit said, only half as many women on birth control pills had suffered clots even though here too, there were 6 times more women taking the pill. In addition, the lawsuit said, 11 times more fatal or life-threatening clots were developed in women on the patch when compared to those taking the pill.

Notwithstanding all of the above statistics gathered over 3 years, the FDA waited until November 11, 2005, to announce an addition to the patch label warning women who were using the patch that they were being exposed to 60% more estrogen than women on birth control pills. The FDA noted that exposure to higher levels of estrogen increased the risk of serious side effects. Adverse effects of estrogen use include blood clots in the legs or lungs as well as heart attack and stroke.

“In general,” according to the Mayo Clinic, “the higher the amount of estrogen you’re exposed to, the greater your risk of serious side effects.”

Most recently, on September 20, 2006, the FDA announced an update to the Ortho Evra patch label based on the results of two epidemiology studies, both paid for by the patch maker, Johnson and Johnson, supposedly designed to evaluate the risk of serious side effects, specifically due to venous and arterial blood clots in women using patch.

Although both studies were conducted using electronic health care claims data, the two studies produced different results.

According to the FDA, the first study found that the risk of non-fatal venous thromboembolism (VTE) events associated with the use of the patch is similar to the risk associated with the use of oral contraceptive pills.

But the results of the second study, which included a review of patient charts, showed an approximate 2 fold increase in the risk of medically verified VTE events in users of the patch compared to women using of the pill.

The above statistics documenting the much larger number of cases of injury and death in women on the patch compared to the pill do not lie.

To begin with, by its own admission, J&J will not design a head-to-head clinical trial that might show the patch to be more dangerous than the pill. On July 18, 2005, the Associated Press, reported an internal company memo authored in 2003, that showed 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.”

The Associated Press also reported that company documents showed that the drug maker itself had been analyzing the FDA’s death and injury reports.

Critics say the FDA’s latest warning is basically meaningless. “This announcement unfortunately is too little, too late for many women who relied on this dangerous product,” says Attorney John David Hart of the Law Offices of John David Hart in Fort Worth, Texas, who is handling patch related lawsuits.

“While these new warnings are a step in the right direction,” he says, “the simple truth is that a lot of women are hurt today because they were not fairly warned.”

According to a press release by Attorney Hart, from April 2002 to December 2004, Johnson & Johnson in fact logged 27,974 adverse events among Ortho patch users, and during that same time period, the company recorded only 5,571 adverse events for one of its oral contraceptives, even though the pill was used by three times more women than were using the patch.

Other legal experts involved in patch litigation express the same sentiments. “The notion that periodic warnings of Ortho Evra’s increased risks is sufficient to protect the health of women is misguided,” says Jason Mark, an attorney at Parker & Waichman, LLP who heads the firm’s mass tort litigation department.

“There are many safer alternative forms of hormonal contraception than the patch,” he said in a press release. “This is not a last resort, life saving medication.”

“The product needs to be withdrawn from the market,” he says, “so that it can no longer cause harm.”

The legal team for J&J is doing everything in its power to avoid jury trials in patch cases where experts predict the juries would rule for the plaintiffs and the truth about all the suppressed adverse event reports and other damaging information would become public.

Attorneys handling the patch cases say the cause of the injuries and deaths from the patch are more clear than those in other pharma cases. “You’re dealing with primarily women ages 18 to 35 who don’t have a lot of pre-existing conditions to begin with,” a lawyer who is working with a South Carolina law firm on a dozen cases told Knight Ridder on May 12, 2006. “The reason why people are getting the blood clots,” he said, “is a lot cleaner.”

On April 9, 2006, the New York Post 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 wrote, “has settled a dozen lawsuits for millions of dollars in the last few months.”

On May 16, 2006, the New Jersey Law Journal reported that Johnson & Johnson had “adopted a quick-settlement strategy for a spate of suits charging that its Ortho Evra contraceptive patch causes blood clots due to heightened estrogen levels.”

At a May 2, 2006 status conference with US District Judge David Katz in Cleveland, Ohio, where 73 cases from around the country have been consolidated, the Journal said, a J&J attorney announced that the company is prepared to settle all cases with plaintiffs who were hospitalized for stroke, heart attacks, pulmonary embolisms or deep vein thrombosis.

The same day, according to the Law Journal, J&J lawyer, Susan Sharko, wrote a letter to Superior Court Judge, Peter Bariso, in New Jersey informing him that the company had reached confidential settlements with 11 of the 12 plaintiffs who sued there.

On May 13, 2006, Bloomberg News reported that J&J had settled lawsuits with about 30 women quoting a lawyer who negotiated confidential agreements in the cases.

The tactical decision to settle cases as soon as they are filed should not be mistaken for a sign of an honest, kind, repentant drug maker. This tactic serves a much larger purpose. As long as J&J can settle cases with “confidential agreements,” the plaintiffs will be legally bound to not speak about any patch related injuries and the documents from the litigation will be sealed by the court and the public will never learn the truth.

But the company had better start planning to go global to silence all the plaintiffs in the mounting cases because a class action lawsuit was filed in Canada on July 28, 2006, alleging the company failed to adequately warn Canadian patients and physicians that the patch was associated with an increased risk of developing blood clots, pulmonary emboli, strokes, heart attacks and deep vein thrombosis.

And the plaintiffs in this class action may not be so easily silenced. The attorney handling the case, Michael Peerless, a partner in the law firm Siskinds LLP, said by filing the lawsuit the company will be “required to explain to Canadian consumers what it knew about the risks associated with Ortho Evra and when it first became aware of those risks.”

Filed under: 2006, birth control patch, Johnson and Johnson, Ortho, patch, settlement, stroke

Add Triaminic Vapor Patch to List of Dangerous Patches

Evelyn Pringle June 25, 2006

On June 19, 2006, Novartis Consumer Health issued a recall for the cough-suppressing Triaminic Vapor Patches in the US, about three weeks after Health Canada issued a warning after a Canadian child who chewed on a patch suffered a seizure.

There have been eight adverse events with the patch, all involving ingestion, Navartis spokesperson, Julie Masow, told the Philadelphia Inquirer on June 21, 2006.

The patches were sold over the counter at pharmacies and retail stores and Novartis said it has sold more than 50 million vapor patches since they came on the market in 2000.

The Swiss drug maker warned consumers to stop using the patch immediately and said they should either be discarded or returned to the place of purchase for a full refund.

The patches contain camphor, eucalyptus oil and menthol and are meant to be applied to the chest or throat of children as young as 2 years-old. Novartis said the placement of the patch can allow children to remove them and place them in their mouths. It is difficult to believe that the idea never occurred to the drug maker that a 2 year-old would attempt to pick the cherry-scented patch off and eat it.

Ingesting camphor or eucalyptus oils can cause a burning sensation in the mouth, nausea, headache, vomiting and seizure. Other complaints received by the company associated with the patch include reports of blistering, bruising, scarring, hyperactivity and depigmentation.

Whether the patch will remain off the market is not known. According to a June 21, 2006, Press Release by the LecTec Corporation, in January 2004, LecTec entered into a Supply and License Agreement with Novartis under which LecTec licensed certain of its patents to Novartis for the production of vapor patches.

In response to a question from LecTec, a representative of Novartis indicated that no decision had been made whether to reintroduce the product in certain markets, although the patches would definitely not be reintroduced for use by young children, the press release said.

The royalties received by LecTec under this agreement represented substantially all of the firm’s revenues in fiscal 2005, as well as the first quarter of fiscal 2006. The specific patch that caused the seizure was not manufactured by LecTec, according to Novaris quoted in the press release.

Over roughly the past 25 years, patch medications have become a booming business for Big Pharma. More than 30 different types of patches have been used by 12 million people worldwide for conditions ranging from birth control to heart disease to chronic pain to bladder control. The first antidepressant patch was approved by the FDA this month.

In 2004, patch sales totaled about $3.4 billion, according to the medical market research firm Greystone Associates.

All medication releasing patches work the same, according to Bozena Michniak, who studies transdermal patch delivery systems at the Center for Biomaterials at Rutgers University. The medication seeps through the skin into the bloodstream, and the increased blood flow causes the body to absorb the drug.

As more versions of the medication patches are introduced on the market, medical experts say that many of them are unsafe. Multiple studies have shown that heat has a dangerous effect on the patches, whether from a high fever, exercise or a hot tub. Heat increases the absorption rate of the medication and sometimes with fatal results.

As far back as 1986, a study found that just 20 minutes of bicycling with a nitroglycerin patch increased concentration of the drug two to threefold. Similar results were found after 30 minutes in a sauna, according to an article in Philly.com on March 5, 2006.

But yet there was no public warnings added to the Fentanyl pain patch until 36-year-old Kurt Hophan died in Pennsylvania on March 4, 1994.

Fentanyl, a schedule II narcotic analgesic, is roughly 50-80 times more potent than morphine and is used to manage both pain during surgery and for persons with chronic moderate to severe pain who already are physically tolerant to opiates, according to the US Center for Substance Abuse Treatment.

Mr Hophan applied the patch for pain relief associated with a back injury and went to his bedroom in his mother’s home and fell asleep with a heating pad and an electric blanket.

When the heat from the pad and the blanket came into contact with the patch, the amount of Fentanyl released into Mr Hophan’s bloodstream was estimated to be about 100 times greater than the amount prescribed, according to a judge’s opinion in a lawsuit filed by Mr Hophan’s mother, Elaine Hophan, against the drug’s maker.

In 2001, a jury awarded Ms Hophan $5 million in damages but after an appeal, the case was settled under a confidential settlement agreement.

Fentanyl patches are sold under a variety of brand and generic names. Johnson and Johnson’s Duragesic was the first on the market arriving in the early 1990s. It’s the most popular patch with four million prescriptions filled at US pharmacies last year.

Worldwide sales of Duragesic in 2005 were $1.59 billion, according to J& J’s earnings reports. The cost of a 30-day supply ranges from $348 at Target to $408 at Wal-Mart, according to FDA documents.

On April 5, 2004, J&J issued a recall for defective patches that applied to specific lots of patches, which had a faulty seal that permitted Fentanyl to seep from the patch, resulting in patients being given an overdose of Fentanyl.

On July 15, 2005, the FDA issued a public health advisory about the proper way to use the Fentanyl patches to avoid overdose, in response to reports of deaths in patients using the narcotic patch for pain management.

The Los Angeles County Coroners Office reports a growing number of accidental over-doses by patients misusing the patch: 127 deaths over the last six years, according to a CBS News report on December 20, 2005.

“They’re not getting the relief that they want. Therefore they’re slapping more patches on trying to get that instantaneous relief,” says toxicologist Daniel Anderson. “What they don’t realize is that most of these patches are to be applied over a three-day period.”

Utah statistics according to the latest mortality data from the state Health Department show Fentanyl was related to 29 accidental deaths in 2005, up from nine in 2004, and 13 in 2002, according to the March 14, 2006 Salt Lake Tribune.

Lawsuit are being filed as a result of the high accidental overdose rate. Robert Debry & Associates, in Salt Lake City has taken about a dozen cases involving deaths allegedly from Fentanyl. One lawsuit is filed on behalf of the family of Marilyn Titus who died December 14, 2003, at age 72 and alleges Ms Titus, was suffering from severe back pain, and was sold defective and leaking patches.

In December 2005, surviving family members of two more Utah women filed wrongful death lawsuits, alleging the patches leaked and caused the deaths of both women.

Autopsy reports said the women died from drug poisoning after using pain patches. Both lawsuits claim the women were prescribed the patch and were found dead in their homes within one or two days of using the patch.

Both lawsuits claim negligence for failing to research and design the patch and allege the companies misrepresented the safety of the patch for human use.

Overall, US emergency room doctors saw overdoses of Fentanyl grow from 28 in 1994 to 1,506 in 2002, according to the most recent statistics available from the US Substance Abuse and Mental Health Administration.

In March 2006, the FDA announced it would conduct a review of all medication patches beginning with Fentanyl and the Ortho Evra birth control patch, also made by J& J.

The following month, an April 10, 2006, Long Island Newsday report said that “hundreds” of women had filed lawsuits against Ortho-McNeil, the J&J division that manufactures the Ortho Evra patch.

And there will no doubt be many more filed against the company because in 2005, doctors wrote more than 9.4 million prescriptions for the birth control patch, according to IMS Health, an pharmaceutical industry monitoring firm.

On November 10, 2005, Ortho McNeil, in conjunction with the FDA, issued a warning about the increased risks of blood clots associated with Ortho Evra Patch.

In the new warning, Ortho McNeil admits for the first time that women who use the patch are exposed to up to 60% more estrogen than they would be exposed to if they were taking a birth control pill with 35 micrograms of estrogen. It is widely understood that any increase in the exposure to estrogen also increases the risk of blood clots.

A lawsuit filed in Federal Court in New Jersey on September 2, 2005, by a Georgia woman, who suffered a pulmonary embolism, alleges the company promoted the patch despite knowledge of its health risks, for financial gain while failing to warn of the risks of blood clots and other injuries.

Around the time the company introduced the patch to the market, the lawsuit claims, Ortho’s patent for its contraceptive pill, Ortho Tri-Cyclen, was about to expire, creating pressure to make up for lost revenue.

In November 2005, CBS News aired a story about documents that surfaced in a lawsuit involving a young mother who was paralyzed by a stroke and remained a total invalid, that showed the company had received nearly 500 reports of adverse events between April 2002 and December 2004. During the same time frame, only 61 adverse event reports were filed in connection with all type of birth control pills.

The news segment also revealed that during the same time frame, 4 times as many strokes occurred in women using the patch when compared to women using the pill, even though 3 times more women were taking the pill. Overall, in medically confirmed cases, the risk of blood clots was found to be 14 times more likely to occur in women using with the patch.

Since the FDA only receives reports for between 1% and 10% of the serious adverse drug events, the actual death and injury rate for women on the patch is estimated to be much higher that the number of reports registered so far with the FDA

The Ortho Evra Patch was approved by the FDA in November 2001. Over 4 million women have reportedly used the patch since its approval and it remain on the market today.

Filed under: 2006, allergy drugs, birth control patch, fentanyl, Johnson and Johnson, Novartis, Ortho, patch, settlement, Triaminic Vapor Patch

Ortho Evra Patch Maker Johnson & Johnson Waves A White Flag

June 3, 2006

Evelyn Pringle

On May 2, 2006, Johnson & Johnson attorney, Susan Sharko, wrote to New Jersey Superior Court Judge, Peter Bariso, to inform the court that the company had reached confidential settlements with 11 of the 12 plaintiffs involved in litigation in New Jersey.

Less than a month earlier, on April 9, 2006, the New York Post reported that women who suffered life-threatening blood clots and strokes on the Ortho-Evra birth-control patch were already receiving cash settlements from the manufacturer.

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

With J&J waving a white flag this early in the game, the litigation period involving the Ortho Evra birth control patch may go down in history as being the shortest ever against a drug company.

However, many more cases are pending in other federal and state courts. On March 1, the Judicial Panel on Multidistrict Litigation issued a transfer order and appointed a federal judge in Ohio to oversee the consolidated pretrial proceedings of 13 federal products liability suits filed by plaintiffs in different states over the Ortho Evra patch.

The JPML assigned the 13 cases to US District Judge David Katz of the Northern District of Ohio, who was already handling the first federal lawsuit over the Ortho patch.

That case, Bernard v Ortho-McNeil Pharmaceuticals, is “progressing well,” the Panel said, and the Ohio venue would provide a relatively central situs in regard to the geographic dispersal of the constituents and tag-along cases.

As of March 1, 2006, the Panel said it had been notified of 54 potentially related actions pending in the multiple federal districts, and said these actions will be treated as potential tag-along actions.

The Panel noted “that the actions in this litigation involve common questions of fact, and that centralization in the Northern District of Ohio will serve the convenience of the parties and witnesses and promote the just and efficient conduct of this litigation.”

“Among other things,” the Panel wrote, “these actions share allegations that i) the Ortho Evra contraceptive patch was defectively designed, and ii) plaintiffs received inadequate warnings regarding Ortho Evra’s side effects and safety profile.”

“All actions seek damages for personal injury and/or economic damages on behalf of users of Ortho Evra,” the Panel wrote, “asserting various state law claims, such as negligence, products liability, breach of warranties, and negligence and/or fraudulent misrepresentation regarding the risks of using Ortho Evra.”

“Centralization,” the Panel said, “is necessary in order to eliminate duplicate discovery, prevent inconsistent pretrial rulings, and conserve the resources of the parties, their counsel and the judiciary.”

However a white flag has already been waved at many of the plaintiffs in these cases as well. On May 2, 2006, at the very first status conference held by Judge Katz, Johnson & Johnson attorney, Robert Tucker, stated the company was prepared to settle suits in which plaintiffs were hospitalized for heart attacks, stroke, pulmonary embolisms or deep vein thrombosis, according Charles Toutant, in the May 16, 2006 New Jersey Law Journal.

Ellen Relkin, of Weitz & Luxenberg in South Orange, NJ, a member of the plaintiffs’ executive committee for the federal suit, In re Ortho Evra Products Liability Litigation, told the Journal that “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,” explained David Eisenbrouch, of Balkin & Eisenbrouch, who represents plaintiffs. “You’re dealing with primarily very young women, and J&J would rather cut its losses,” he told the Journal.

Less than 2 weeks later, on May 13, 2006, Bloomberg News reported that J&J has settled lawsuits with about 30 women quoting Attorney, Ray Chester, the lawyer who negotiated the confidential agreements.

J&J settled state courts cases in Texas, New Jersey, and California and federal courts in North Carolina and Pennsylvania, Mr. Chester said.

One settlement involved Philomena Ugochukwu, 40, who had a massive stroke after wearing the patch for 12 days, he said.

The mother of two is now a quadriplegic with brain damage and needs round-the-clock care, Mr. Chester told Bloomberg. She was his first Ortho Evra client.

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

The early settlement offers are no doubt due in large part to the damning internal documents that have surfaced that show the company was aware of the lethal dangers of the patch but kept right on selling it in pursuit of the almighty dollar.

For instance, on November 11, 2005, the Associated Press 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 report 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.'”

According to FDA records obtained in July 2005, by the Associated Press with a freedom of information request, over a 71 month period, there were 1,237 adverse event reports by women taking the pill, but over an 18 month period, there were 9,116 adverse event reports by women using the patch, which means there were over seven times more adverse event reports with the patch.

The AP found that before the patch was approved, the FDA had already noticed that blood clots with the patch were 3 times more common than with the pill. In 2000, FDA doctors reviewing the clinical trials submitted by the company warned that blood clots could be a problem if the patch was approved. In those trials, the doctors found that 2 of the 3,300 women using the patch were treated for blood clots that traveled to their lungs.

The reviewer said “the label should clearly reflect this reviewer’s safety concern about a potential increased risk.” But it didn’t and there were no requirements for follow-up studies other than routine reviews of voluntary reports called in by doctors, consumers, and the drug company.

Experts say the dangers with the patch stem from how it works in that rather than digestion and metabolization of the hormones like with the pill, the patch releases the hormones directly into the blood stream, leaving a significantly high concentration of hormones in the body.

In fact, the FDA advisory in November 2005, said users of Ortho Evra are exposed to about 60% more estrogen in their blood than if they were taking a birth control pill.

According to the complaints in many of the lawsuits filed, beginning on May 1, 2002, the FDA received 44 reports of clot-related injuries or deaths caused by the Ortho patch, but only 17 similar reports during the same time period for J&J’s Ortho Tri-Cyclen birth control pill, even though the pill was used by close to six times as many women.

However the statistics are known to be inaccurate because FDA officials acknowledge that as few as 1 to 10% of all serious side effects are ever reported to the agency so the number of clot related adverse events reported would have to be multiplied many times over to get an actual account of the cases.

According to a CBS news report in November 2005, based on documents that had surfaced in litigation, the drug maker’s own records show it received some 500 reports of serious problems with the patch between April 2002 and December 2004, while only 61 reports were received on all types of birth control pills.

In addition, there were four times as many strokes in women on the patch compared to women taking the pill even though 3 times as many women were taking the pill.

Overall, in medically confirmed cases, the risk of clots was estimated to be 14 times higher with the patch.

And yet, according to the complaint filed in the California case of Thoren v Johnson and Johnson, filed on January 20, 2006: “The various sales messages sent to health care providers failed to warn that the patch carried a higher risk of blood clots than oral contraceptives and actually implied that the patch carried the same risk as a pill.”

Injuries listed in many of the complaints are defined in medical terms by the National Institute of Neurological Disorders and Stroke, with thrombosis being the formation of a clot within a blood vessel of the brain or neck, and embolism defined as the movement of a clots to another part of the body such as the heart to the neck or brain and can kill depending on where they lodge in the body.

All hormonal birth control products are known to increase the risk of blood clots because estrogen promotes coagulation. Clots are semisolid masses of blood tissue that form as a result of coagulation. When clots break off into the bloodstream they can block the blood flow to other areas of the body.

Common symptoms for blood clots can include, but are not limited to, pain in the calf, shortness of breath, chest pain, or coughing blood.

If a clot is lodged in the brain, a stroke can occur when the brain does not receive an adequate amount of oxygen. Symptoms of a stroke include sudden: (1) numbness or weakness of face, arm, or leg, especially on one side of the body; (2) confusion, difficulty speaking, or understanding; (3) trouble seeing in one or both eyes; (4) difficulty walking, dizziness, or loss of coordination; and (5) severe headache with no apparent cause.

Milder symptoms may include drowsiness, double vision, nausea, or vomiting.

Attorneys say the plaintiffs in these cases have a “signature disease,” meaning a condition that is closely linked to use of the product but is otherwise rare. In this instance, blood clots are highly unusual in women of childbearing age.

The 7 lawsuits reported in the January 30, 2006 Madison St Clair Record, filed in in US District Court for the Southern District of Illinois on January 23, 2006, allege the drug maker knew about the problems with the patch but failed to warn the plaintiffs about the risk of blood clots and include the following claims and injuries by plaintiffs:

Maral Annayeva suffered from bleeding, heart pain, headaches, nausea and general malaise.

Brandy Houk suffered shortness of breath, fatigue, excessive bleeding, and passed large clots as a result of use of the patch.

Melody Miller suffered multiple blood clots which resulted in the miscarriage of her child in the fifth month of pregnancy.

Tanya Lowe suffered blood clots in her right leg that shattered and spread to her lungs.

Reannon Tutkus suffered blood clots.

Stephanie Curtis discontinued the patch and immediately became pregnant and developed a blood condition which predisposed her to blood clots that required the use of blood thinners while pregnant.

Kristine Bailey suffered blood clots, dizziness and fatigue.

The plaintiffs in the above cases also allege that the drug maker violated the Illinois Consumer Fraud Act by the use of false and misleading misrepresentations in the marketing, promotion and sale of the patch.

The injuries described in women all across the country that have been injured by the patch mirror each other as evidenced by the following cases:

In La Cross Wisconsin, 8th grader, Alycia Brown, died of blood clots in her lower pelvis.

A woman in Maine suffered from a blood clot in her right lung.

An 18-year-old student, Zakiya Kennedy, died in a New York subway station.

In Indiana, a 12-year-old girl was diagnosed with deep-vein thrombosis.

In Missouri, Rachel Cook, 22, experienced chest pains and was hospitalized for blood clots in her lungs.

In California, doctors found a blood clot in the lung of 37-year-old Stephanie Sanchez after she experienced bad cramping in her chest.

In Glen Carbon, Illinois, Jennifer McNichols had to undergo anti-coagulant therapy and vascular surgery because of clots in her right calf and thigh.

Seventeen-year-old Laurie Swanson died after suffering a stroke in August 2004.

In Georgia, Lydia Lilly, 35, experienced pain and difficulty breathing and suffered a pulmonary embolism

In Wyoming, 25-year-old, Kathleen Thoren died when a blood clot caused a fatal amount of pressure on her brain.

In New York, a 25-year-old mother of two, Sasha Webber, died of a heart attack.

And there are bound to be thousands more suits filed because J&J reportedly sold 5 million Ortho patches to women since the product came on the market in 2002. According to its 2005 annual report, all total J&J sold $1.1 billion in contraceptives last year.

Attorneys warn that medical professionals had better think twice before prescribing the patch because any doctor writing a prescription for it after the November 10, 2005, FDA warning, they say, could very well be considered irresponsible in terms of accepted medical practice if an otherwise healthy young patient is paralyzed or dies after using the device.

Filed under: 2006, birth control patch, Johnson and Johnson, medical devices, Ortho, patch, settlement, stroke

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