Now that the FDA has “re-labeled” Ortho Evra the popular birth control patch, it’s important to recognize the symptoms of impending health issues caused by the patch. Women who use this patch are at a significantly increased risk for blood clots, strokes, and death than those women who use other forms of oral contraceptives. The manufacturer of Ortho Evra, Ortho-McNeil now admits that women using the patch can be exposed up to 60% more estrogen than those using oral contraceptives. Critics of both the patch and the FDA’s approval and monitoring practices, however, see the warning as simply another example of economics being placed above public safety. There has been a constant chorus of warnings about the extremely serious side-effects associated with the patch from a number of experts as well as the consumer watchdog group, Public Citizen (www.worstpills.org) and the Associated Press.
Who watches the watchdogs?
Ortho Evra- The Rest of the Story
It was at Thanksgiving time last year that Kathleen Thoren, a 25-year-old mother of three, died after days of severe headaches that, according to the medical examiner, were provoked by hormones released into her system by Ortho Evra — the once a week birth control patch.
In 2005 alone, about one dozen women died from blood clots believed to be related to Ortho Evra with dozens more surviving strokes and other clot-related problems. These women were largely young and not at risk for clots. Women like Zakiya Kennedy, an 18-year-old Manhattan fashion student who collapsed and died in a New York subway station in April 2004, and Sasha Webber, a 25-year-old mother of two who died of a heart attack after six weeks on the patch.
The Associated Press analyzed federal drug safety reports, finding that women using the patch are at a triple risk of dying or suffering a survivable blood clot compared to women using birth control pills.
The US Food and Drug Administration (FDA) approved Ortho Evra in November 2001 as the first birth control skin patch. But long before the patch reached the marketplace in 2002 both the FDA and Ortho McNeil, the Johnson & Johnson company that manufactures Ortho Evra, saw warning signs of possible problems. The FDA had already noticed that nonfatal blood clots occurred three times more frequently than the pill. Blood clots in the lungs were seen in two women given Ortho Evra in clinical trails conducted before the drug was approved – in addition to many similar cases in women after the drug was marketed. According to Public Citizen, drugs rarely present such strong evidence of a serious problem during randomized pre-approval studies.
Ortho Evra contains two hormones: an estrogen and a progestin. Most pills and the patch contain the same amount of estrogen, but hormones from the patch go straight to the bloodstream while pills are swallowed and digested, losing half the estrogen dose. Women using the patch are exposed to high levels of estrogen 24 hours a day. Associate Professor of Obstetrics and Gynecology at the University of Washington, Dr. Leslie Miller has reported that women using the patch absorb significantly more estrogen than the pill, adding the elevated levels may be high enough to increase some women’s risk of blood clots.
On November 10 the FDA updated labeling for the Ortho Evra birth control path to warn healthcare providers and patients that this product exposes women to higher levels of estrogen (about 60 percent more) than the pill. But not all physicians waited for the new label to take action. In October, Dr. Miguel Cano, an obstetrician and gynecologist in Reedley, California, sent a note to several thousand patients recommending that the stop using the patch and that they come in for appointments to get a new form of contraception. On the website worstpills.com Public Citizen proclaims: “There is no medical reason for women to use the more dangerous Ortho Evra rather than one of the older, better understood, and equally effective oral contraceptives.” Public Citizen’s Health Research Group added Ortho Evra to its ongoing list of dangerous medicines.
Catchy ads featuring Olympic beach volleyball players and supermodel Namoi Campbell — resulted in more than five million US women trying the patch in less than three years. In 2004 Ortho Evra sales topped $411 million for 9.9 million prescriptions, accounting for 15 percent of the US market. In July 2005 J & J CFO Robert J. Daretta reported no sign of increased safety problems with the Ortho Evra birth control patch. Obviously Mr. Daretta did not foresee the increased label warnings.
FDA Issues Warning About Birth Control Patch
On November 10, 2005 the FDA issued an “updated lablelling” concerning possible adverse health effects of using the Ortho Evra birth control patch. Here is the warning issued by the FDA:
The Food and Drug Administration today approved updated labeling for the Ortho Evra contraceptive patch to warn healthcare providers and patients that this product exposes women to higher levels of estrogen than most birth control pills. Ortho Evra was the first skin patch approved for birth control.
It is a weekly prescription patch that releases ethinyl estradiol (an estrogen hormone) and norelgestromin (a progestin hormone) through the skin into the blood stream. FDA advises women to talk to their doctor or healthcare provider about whether the patch is the right method of birth control for them.
Furthermore, women taking or considering using this product should work with their health care providers to balance the potential risks related to increased estrogen exposure against the risk of pregnancy if they do not follow the daily regimen associated with typical birth control pills. Because Ortho Evra is a patch that is changed once a week, it decreases the chance associated with typical birth control pills that a woman might miss one or more daily doses.
The addition of this new warning is a result of FDA’s and the manufacturer’s analysis directly comparing the levels for estrogen and progestin hormones in users of Ortho Evra with those in a typical birth control pill. In general, increased estrogen exposure may increase the risk of blood clots. However, it is not known whether women using Ortho Evra are at a greater risk of experiencing these serious adverse events.
The new bolded warning specifically states that women who use Ortho Evra are exposed to about 60 percent more estrogen than if they were taking a typical birth control pill containing 35 micrograms of estrogen. However, the maximum amount of estrogen to which women are exposed is about 25% lower with Ortho Evra than they are with typical birth control pills.
FDA is continuing to monitor safety reports for the Ortho Evra patch. The manufacturer, Ortho McNeil Pharmaceuticals is conducting additional studies to compare the risk of developing serious blood clots in women using Ortho Evra to the risk in women using typical birth control pills that contain 35 micrograms of estrogen.
The new labeling information is available along with additional information for healthcare providers and consumers online at: www.fda.gov/cder/drug/infopage/orthoevra/default.htm
FDA Issues Warning About Birth Control Patch
On November 10, 2005 the Food and Drug Administration issued an updated labeling concerning Ortho Evra, the birth control patch used by many women. Here is the statement released by the FDA:
The Food and Drug Administration today approved updated labeling for the Ortho Evra contraceptive patch to warn healthcare providers and patients that this product exposes women to higher levels of estrogen than most birth control pills. Ortho Evra was the first skin patch approved for birth control.
It is a weekly prescription patch that releases ethinyl estradiol (an estrogen hormone) and norelgestromin (a progestin hormone) through the skin into the blood stream. FDA advises women to talk to their doctor or healthcare provider about whether the patch is the right method of birth control for them.
Furthermore, women taking or considering using this product should work with their health care providers to balance the potential risks related to increased estrogen exposure against the risk of pregnancy if they do not follow the daily regimen associated with typical birth control pills. Because Ortho Evra is a patch that is changed once a week, it decreases the chance associated with typical birth control pills that a woman might miss one or more daily doses.
The addition of this new warning is a result of FDA’s and the manufacturer’s analysis directly comparing the levels for estrogen and progestin hormones in users of Ortho Evra with those in a typical birth control pill. In general, increased estrogen exposure may increase the risk of blood clots. However, it is not known whether women using Ortho Evra are at a greater risk of experiencing these serious adverse events.
The new bolded warning specifically states that women who use Ortho Evra are exposed to about 60 percent more estrogen than if they were taking a typical birth control pill containing 35 micrograms of estrogen. However, the maximum amount of estrogen to which women are exposed is about 25% lower with Ortho Evra than they are with typical birth control pills.
FDA is continuing to monitor safety reports for the Ortho Evra patch. The manufacturer, Ortho McNeil Pharmaceuticals is conducting additional studies to compare the risk of developing serious blood clots in women using Ortho Evra to the risk in women using typical birth control pills that contain 35 micrograms of estrogen.
The new labeling information is available along with additional information for healthcare providers and consumers online at: www.fda.gov/cder/drug/infopage/orthoevra/default.htm
Bishop Nevins Earned a Reputation
As a former priest and Auxiliary Bishop of Miami, Bishop John Nevins of Venice knows where most of the clerical skeletons are buried in South Florida. Nevins, a NY native, has gained an ignominious reputation for accepting priests accused of child rape and child sexual abuse. After returning from the Dallas bishops’ meeting in 2002, Nevins vowed to lead the way in bringing healing to the church. Yet, in the midst of all the talk of sweetness and light he neglected to mention that some 15 years earlier he had accepted for service in his diocese a priest credibly accused of abusing a 15 year old boy in Louisville Kentucky. Of course, the infamous case of Fr. Ed McLoughlin who was finally removed from ministry after Nevins ignored victims’ cries for help, can’t be left unmentioned. Nevins was part of the same Archdiocese of Miami that allowed the Rev. Rocco D’Angelo to move from Miami to St. Petersburg without a word of warning to the authorities in St. Petersburg. D’Angelo had had a long career of molestation and Miami so when Miami church officials had had enough they sent him packing with high recommendations for priestly service. When he arrived in St. Petersburg, he continued his reign of terror and molested more young boys. As an Auxiliary Bishop in Miami, Nevins was taught the subtle nuances necessary in covering up for abusive priests and transferring them to new dioceses. No wonder the Diocese of Venice is known as a “priestly dumping ground”.
Motorcyclist dies in I-Drive crash
ORANGE COUNTY — A Kissimmee man on a motorcycle died Wednesday afternoon on International Drive in what witnesses told investigators was possibly a street-racing accident.
Gabrail Montanez, 28, was riding a 2005 Kawasaki motorcycle south on International Drive south of Central Florida Parkway about 4:45 p.m. Beside him, Christopher Jones, 27, of Orlando was riding a 2005 Yamaha.
Montanez tried to move left to pass a Ford pickup driven by 41-year-old Matthew Burns of Orlando but clipped the back of the truck, said Trooper Kim Miller, a Florida Highway Patrol spokeswoman.
Montanez was airlifted to Orlando Regional Medical Center, where he was pronounced dead. He was not wearing a helmet.
Jones and Burns were not injured.
National Catholic Reporter Calls for Transparency in Clergy Abuse Scandal
In a strongly worded editorial published October 28, 2005, The National Catholic Reporter, an influential weekly Catholic newspaper, has called on the bishops of the United States to come clean and reveal the true depths of the crippling clergy scandal. The National Catholic Reporter, known for its somewhat liberal but scholarly journalism, has tracked the scandal since 2002. In the editiorial, the paper notes that 3 living American cardinals “have been complicit in what any reasonable observer would term criminal activity.” Of course, the paper is referring to Cardinals Law, Bevilacqua, and Mahony. The three princes of the church still wield great influence in the church in spite of the fact that Bevilacqua is retired and Law is hiding out in a Roman basilica. Mahony remains at the helm of the Archdiocese of Los Angeles and has spent untold millions defending criminal activity by his priests. All three have steadfastly refused to cooperate with civil officials and Mahony continues to fight any change in the civil statute of limitations. While all three men have avoided any criminal prosecution, they have brought shame and embarassment upon the Catholic Church. In its editorial, the National Catholic Reporter has called upon the other bishops to appoint someone like Rev. Theodore Hesburgh, the former President of Notre Dame University, to head a commission to investigate the scandal. Of course, former Governor Thomas Keating thought that he would have access to such documents. He ended up quitting an investigative commission in frustration calling the bishops’ actions something out of La Cosa Nostra.
County sends teams to aid South Florida
A contingent of Osceola County public-safety and electric-utility workers is helping residents in South Florida recover from Hurricane Wilma.
On Thursday, eight Kissimmee police officers left for the Miami area to provide security for Florida Power & Light Co. as the utility restores electricity in the storm-devastated area. They plan to spend a week on the assignment.
Earlier, Kissimmee Utility Authority announced that it was sending repair crews, vehicles and supplies to South Florida to help restore power.
The hurricane left 94 percent of Fort Pierce’s 25,000 residents without electricity, KUA said.
On the night the storm struck, Osceola County and Kissimmee sent 13 paramedics and emergency-medical technicians to the Florida Keys to help with hurricane recovery.
The team was to help transfer hospital and nursing-home patients in hurricane-ravaged areas to other medical facilities.
The team brought its own food, water, cots and supplies and expects to stay in Monroe County as long as 11 days.
A rip in fabric that holds law enforcement together
ike many Americans, I watched with great interest, and with increasing anger, the recent beating of a 64-year-old retired schoolteacher on the streets of New Orleans. The glare of the public eye almost wasn’t there. A New Orleans police horse appeared to be made to walk backward, apparently to block the probing eye of the TV camera.
Unlike many Americans, as a former police chief and current manager of a police academy, I have learned that the facts of alleged police misconduct are many times at odds with the information that comes out publicly. Time after time, I would investigate complaints against officers, only to find the issue to be clouded in misunderstanding or sometimes even blatant lies against an officer making a lawful and professional arrest.
However, even in the eyes of law-enforcement professionals across the nation, who tend to hold back criticism of fellow officers until the very last shred of damning evidence is in, the New Orleans situation was very disturbing. Every officer and police instructor I spoke with in different regions of the country had a similar reaction: disgust.
As the picture speaks a thousand words for itself, so, too, does the obvious crossing of the line with Robert Davis. And while there exists a sliver (and I mean a tiny sliver) that there could be some truth in the position of the arresting officers, an even more unsettling development out of the same situation was the New Orleans police officer who threatened and used profanity with an AP television producer while physically pushing him back against a car.
The blatant and open hostility vented by the officer revealed a brand of law enforcement that could not support a bona fide arrest of that producer and could offer no credible explanation for the verbal barrage of expletives and obvious physical battery. Even if the producer was subject to a legitimate arrest, the officer’s behavior was not acceptable.
When I took the oath of a law enforcer years ago, I told myself that the true measure of what separated me from the bullies and predators in our society was not my badge. Rather it was the inner strength I possessed to curb my impulses and shape my behavior so that “I” did not become “them.” The badge was but the symbol. The true manifestation of policing was within me.
And the true essence of being an honorable law enforcer is in most police officers, deputy sheriffs, and state troopers. New Orleans is a situation that stretches the thread that binds the police fabric together. It pulls at the material and frays the edges, making it easy for an officer to fall victim to his impulses to loot sunglasses or take TVs.
The hidden strength in the blue fabric should be the presence of other interwoven blue threads that lend support for those rare moments of personal weakness. It behooves the rest of us in this noble profession to see the signs of tired and stressed threads and give them support.
When the officer pushed the media producer against the car, I observed several other officers that stood by and watched. Those officers should have been the “cross thread” that gave strength to the situation and intervened. Better yet, maybe they could have foreseen the buildup and moved their colleague down the street to cool off.
The image of New Orleans police as bullies and intimidators on national television does not help the cause of an agency that has strived for some 10 years to break its negative reputation. That impetus to clean up the department’s image began with the arrival of former police Superintendent Richard Pennington (now the police chief in Atlanta) and has come full circle with the recent events.
Nor, for that matter, does it help the image of police professionals elsewhere. While all would acknowledge that the stress on the New Orleans officers during this post-hurricane period has been inordinate, the oath has no clause that makes for allowances of police abuse and brutality.
My 4-year-old son interacts with police officers regularly, pretends that he is one, and wants to be one some day. I am ashamed to say that I had to have him leave the room when the images of those officers breaking their oath came on the television again and again. My little, wide-eyed boy did not yet need to see what happens when the blue fabric that holds the law-enforcement profession together is ripped.
Fla. Physicians, Plaintiffs Lawyers Battle Over Med-Mal Discovery
A West Palm Beach, Fla., attorney has won a ruling declaring that the state Legislature’s implementing law for last year’s Patient Right to Know ballot initiative is unconstitutional because it fails to provide full public access to records on medical errors.
The ruling is at least the second recent Florida circuit court decision in favor of medical malpractice plaintiffs who want to use the new constitutional amendment to obtain previously confidential hospital records on medical errors and physician discipline.
Amendment 7 was passed overwhelmingly by voters last November, and the Legislature passed an implementing law this past spring.
Last month, Theodore Babbitt, a partner at Babbitt Johnson Osborne & LeClainche in West Palm Beach, won a bench ruling from Martin Circuit Judge Robert M. Makemson in a malpractice case that the implementing statute “has the effect of negating significant purposes in portions of the amendment, frustrates the will of the amendment, so I will therefore declare that statute unconstitutional.”
Since the amendment and the implementing law were approved, plaintiff and defense lawyers have battled in circuit courts across Florida over discovery of sensitive hospital records on medical errors. The disclosure of such records could have a major impact on the outcome of malpractice litigation — as well as on the ability of hospitals and their medical staffs to conduct physician peer review and monitor quality of care.
Plaintiff and defense attorneys say that circuit judges in South Florida and other parts of the state have issued disparate rulings on these discovery requests, with some holding that peer review records are discoverable and others saying they’re not. Several cases are in the appellate process.
In July, 3rd Judicial Circuit Judge E. Vernon Douglas in Lake City ruled in a malpractice case that “the Legislature did not attempt to ‘implement’ Amendment 7. … They attempted to abolish it.”
The defendants have appealed Douglas’ order declaring the statute unconstitutional and ordering them to turn over peer review records to the 1st District Court of Appeal. Douglas agreed to stay the order at least until the appellate court decides whether to hear the case.
Both plaintiff and defense camps agree that the issue will have to be resolved by the Florida Supreme Court or the Legislature.
“This is waiting for resolution at the appellate level,” said Lincoln Connolly, of Rossman Baumberger Reboso & Spier in Miami who is representing several malpractice plaintiffs who are seeking hospital peer review records. “There have been a few trial court orders compelling production of records. But to my knowledge, no trial court has forced a hospital to turn over the records before it gets a chance to appeal.”
“You have conflicting decisions not just in different circuits but even within the same circuit,” said Vanessa Reynolds, a partner at Conrad & Scherer in Fort Lauderdale, Fla., whose firm represents hospitals. “Those issues ultimately will have to be resolved by the Supreme Court.”
Bill Bell, general counsel for the Florida Hospital Association, said perhaps two-dozen judges around the state have upheld the implementing legislation, and that he expects the matter to end up in the Supreme Court within the next two years. “There are good public policy reasons” for barring the use of such material in medical malpractice litigation.
State Rep. David Simmons, R-Orlando, a lawyer who heads the House Judiciary Committee, said that if the Supreme Court ultimately strikes down the implementing law, he’ll push to have the Legislature place a measure on the ballot to repeal Amendment 7.
But there may be another complicating factor. State Rep. Dan Gelber, D-Miami Beach, said the Patient Safety and Quality Improvement Act of 2005 passed by Congress may trump both Amendment 7 and the state implementing legislation. The new law says that material generated by “patient safety organizations” is privileged and is not subject to discovery in federal or state court or administrative proceedings.
Congress “protected peer review and very clearly intended to pre-empt state statutes,” Gelber said. “I think they’ll have to look at the federal statute to see if it would force us to make changes.”
EXEMPT FROM DISCOVERY
Amendment 7 landed on the ballot last year as a result of a battle between Florida physicians and plaintiffs lawyers. The Florida Medical Association, dissatisfied with the caps on noneconomic damages it won in 2003, decided to ask voters to place a drastic cap on contingency fees for plaintiff lawyers in malpractice cases.
The Academy of Florida Trial Lawyers launched a counterattack, which its leaders say was intended to force the doctors to drop their initiative. The academy proposed ballot initiatives to require public disclosure of medical errors and to permanently revoke the medical license of any doctor found to have committed malpractice three times.
Hospital, business and insurance groups tried unsuccessfully to convince the doctors to drop their initiative in exchange for getting the plaintiffs lawyers to drop their measures. All three amendments ended up passing overwhelmingly. Since then, there have been pitched fights in the courts and the Legislature over all three measures.
The language of Amendment 7 gives “patients the right to review, upon request, records of health care facilities’ or providers’ adverse medical incidents, including those which could cause injury or death.” It said patients’ identities should not be disclosed.
But the implementing law, SB 938, which was strongly pushed by the Florida Hospital Association, makes records, including hospital peer review records, exempt from public disclosure and, therefore, exempt from discovery in civil court cases.
Unlike the amendment, the statute sets relatively narrow limits on who may obtain hospital records on medical errors. It defines the patient who may obtain such records as “an individual who has sought, is seeking, is undergoing, or has undergone care or treatment in a health care facility or by a health care provider.”
Plaintiffs Karen Beane and Gary Beane challenged that statute in their Martin Circuit Court malpractice suit.
The Beanes seek hospital records in their case against Dr. Robert Pare, Treasure Coast OB/GYN Associates and Martin Memorial Medical Center. They allege that Dr. Pare used an improper medication for the inducement of labor and delivery. As a result, the suit alleges, Karen Beane suffered a uterine rupture, was forced to undergo a complete abdominal hysterectomy and was left unable to bear children.
Judge Makemson said the implementing law for Amendment 7 violates the state constitution because it defies the will of the voters. A written order containing the judge’s ruling has yet to be entered in the case.
Babbitt, who represents the Beanes, said the ruling makes clear that the Legislature caved to pressure from the medical and hospital lobbies when it passed the law this spring to implement Amendment 7.
In the 3rd Judicial Circuit malpractice case, Douglas consolidated three discovery cases against Lake City Medical Center, Pendrak Surgical Group, P.A., and Dr. Robert Pendrak. He ruled that the law implementing Amendment 7 is unconstitutional because the amendment clearly states that patients have the right to access any records made or received during the course of business by a health care facility or provider relating to any adverse medical incident.
The language of Amendment 7 states that “the phrase ‘adverse medical incident’ means medical negligence, intentional misconduct and any other act, neglect or default of a health care facility or health care provider that caused or could have caused injury to or death of a patient, including, but not limited to, those incidents that are required by state or federal law to be reported to … or reviewed by any health care facility peer review, risk management, quality assurance, credentials, or similar committee, or any representative of any such committees.”
SETTLEMENTS AND PEER REVIEW
Amendment 7 opens up a new area of attempted discovery. The disclosure of hospital records on medical errors undoubtedly would have a major impact of the outcome of malpractice litigation, both plaintiff and defense lawyers say.
Plaintiff lawyers are seeking to use the opportunity broadly. Among other things, they hope to pin down hospitals’ corporate negligence in failing to crack down on doctors with chronic quality problems.
“If you find hospital records saying the doctor screwed up and that this is the fourth time he’s done it, that would lead to early resolution of disputes,” Connolly said. It would be hard for the hospital to deny liability when it had previously sanctioned the doctor, he noted.
In his cases, Connolly is filing independent actions under Amendment 7 — outside the malpractice cases — seeking to force hospitals to disclose medical error and peer review records. He said he’s filing these independent actions to sidestep defense claims that the records are privileged.
“There’s no question that the availability of material like this in a suit has a dramatic impact on the settlement dynamic,” said June Hoffman, a shareholder at Fowler White Burnett in Miami, which represents health care providers.
But lawyers who represent hospitals argue that the most significant impact of having to disclose these sensitive hospital records is that it would jeopardize the traditional hospital peer review system.
Hospitals and doctors who participate in peer review long have been granted confidentiality to enable them to investigate possible medical errors and take corrective action against medical staff. Without that protection from disclosure and discovery in malpractice cases, hospital lawyers say, doctors simply won’t participate.
That’s already happening as a result of Amendment 7, Reynolds said. “Peer review protections came about so you gave doctors a chance to speak confidentially about peers who were not performing well,” she said. “Now doctors are reluctant, if not absolutely loath, to participate. They feel they’ve been stripped of incentives and protections to participate.”
She said doctors won’t feel reassured until the Supreme Court rules on the constitutionality of the implementing bill, which exempts peer review records from discovery.
But Sheldon Schlesinger, a prominent malpractice plaintiffs lawyer in Fort Lauderdale, scoffed at that argument, saying hospital peer review has proven to be a failure in protecting the public from bad medicine.
“There was an Iron Curtain hiding vital information that existed until [Amendment 7] passed,” he said. “The hospitals want to maintain the same attitude they’ve always had — see no evil, hear no evil, speak no evil.”
To Rep. Simmons, the battle over Amendment 7 illustrates the need to make it harder to amend the state constitution. “This is a uniquely bitter war between the doctors and the lawyers,” Rep. Simmons said. “And we, the people of Florida, are their stomping grounds.”
Now, both the doctors and the plaintiff lawyers probably feel “a lot of morning-after remorse,” said Gelber, a lawyer and former federal prosecutor who sits on the House Judiciary Committee. “It was a food fight that should not have been fought in Florida’s constitution.”



