Monthly Archives: April 2009

FDA Clamps Down on Medical Device Makers

The Food and Drug Administration is asking several medical device makers, including Zimmer Holdings, Inc. and Medtronic to justify their devices’ safety and effectiveness. This comes in spite of the fact that many of the medical devices are already on the market. Zimmer’s Durom Cup hip implant has faced major scrutiny for defective design.
Of course, the medical device companies are trying to avoid further clinical trials of their products by persuading the federal agency to re-classify them as less risky medical devices.
The controversy stems from a 1990 Congressional order that demanded the FDA to collect sound scientific evidence that the medical devices classified as Class III (most risky) were indeed safe. The problem is that the law was never fully implemented by the FDA. Instead, many medical devices that should have been bound by the Congressional order, received what is known as a 510(k) classification. This “exemption” allowed hundreds of Class III medical devices to be sold in spite of the lack of clinical testing required by law.
In the meantime, consumers remain at risk from these medical devices that have been allowed to slip through the bureaucratic cracks of the FDA. Medical device manufacturers win since they’re can continue to sell products that may in fact be dangerous to consumers and have not been bound to the rigorous and extensive clinical testing required by a Class III categorization.

GM Recalls 1.5 Million Vehicles Due to Fire Danger

This is not what any of the Big 3 US automakers need right now, another auto recall due to the potential for fires. In the midst of a declining US auto industry that has caught the attention and scrutiny of the federal government, bad press is not what the industry needs.
Yet, General Motors has issued a large recall of some vehicles that aren’t even in production. The recall includes the 1998-1999 Oldsmobile Intrigue, the 1997-2003 Pontiac Grand Prix, 1997-2003 Buick Regal, and the 1998-2003 Chevrolet Lumina, Monte Carlo and Impala.
All of the vehicles in question have a 3.8 liter V-6 engine and the danger concerns oil that can spill into the exhaust potentially igniting sparks or a fire. In spite of the recall, GM says there have been no reported injuries or fires with any of the vehicles.

Genentech Recalls Raptiva

With reports of its psoriasis drug linked to progressive multifocal leukoencephalopathy (PML), a serious, progressive neurologic disease caused by a virus that attacks the central nervous system, Genentech has ordered the recall of Raptiva. The drug became available to treat psoriasis in 2003. Since that time, reports of brain infection caused by the suppression of the immune system have dogged the psoriasis drug. In October 2008, the FDA issued a black box warning for Raptiva because it had been linked to serious, life-threatening brain infections.
Raptiva is designed to suppress the immune system in order to treat the psoriasis. However, the suppression of T-cells increases susceptibility to brain infections such as PML.
Since the Raptiva recall just occurred, there remain many questions as to why the drug was approved for use. Did Genentech know about these life-threatening effects and when did they know them? Once again, it’s tragic that psoriasis patients didn’t know about the severity of the Raptiva side effects. As is often the case, healthcare professionals were also unaware and were not able to protect their patients from these brain infections caused by Raptiva.

Tallahassee Update

Betty, age 56, was coming home from a trip to the mall when she was rear ended while stopped at a traffic signal. The police came to the scene of the accident and issued a ticket to the other driver. Even though Betty was very sore, and the Police offered to call an ambulance for Betty to take her to the hospital to be checked for injuries, she declined and went home to rest.
A few hours later, there was a knock on the door of her home. At her door was Mike Cheatem, an adjuster for Auto Wreck Insurance, the insurance company for the driver who rear ended her earlier that day. Mr. Cheatem asked Betty how she was feeling, and acknowledged that his insured was at fault for the accident. Mr. Cheatem then told Betty that Auto Wreck Insurance wanted to make sure that all of her medical bills were taken care of if she went to the doctor, so he offered to give her a check for $500.00 – which he proceeded to fill out and hand to her on the spot. He told Betty that she would have to sign a form acknowledging that he had given her money for her bills.
Betty, who had not yet been to see a doctor even though she was feeling kind of sore, thought this sounded great, so she took the money and signed the form.
The next morning when Betty woke up, her neck and back were hurting her very badly, and the fingers on her right hand felt like they were asleep. She called her son, who lived in another state, and told him about the accident and how she was feeling. Her son suggested she go to her doctor, just to be safe.
Five days later, Betty was able to get in to see her doctor. After examining Betty and listening to her complaints, her doctor ordered an MRI of her neck. When the results came in, Betty was informed that she was suffering from a herniated disc in her cervical spine. Her doctor told her that’s why her right hand still felt like it was asleep.
When Betty told a friend about the accident and her injuries, her friend suggested she contact an attorney to learn about her rights. So, seven (7) days after the accident occurred, Betty contacted an attorney to discuss her situation. Unfortunately for Betty, after the attorney learned about her accepting the check from Auto Wreck Insurance, and after obtaining a copy of the form Betty signed, the attorney had to advise Betty that under the facts of her case, he could not help her. Because Betty had signed the release, she could not pursue a claim against the other driver or his insurance company. Despite the severity of Betty’s injuries, Betty had unwittingly settled her claim for $500.00.
Betty’s story is not unusual. In the State of Florida, it happens every day. While an attorney is not permitted to contact a person involved in an accident for 30 days, there is no similar restrictions on insurance companies.
Many insurance companies routinely go to the scene of an accident or to the accident victim’s home shortly thereafter in an attempt to limit their liability and exposure by making a minimal offer to the accident victim and then obtaining full and final release from those persons.
In an effort to prevent this story from continually repeating, I filled HB 1281. This bill would prevent an insurance company which provides bodily injury coverage, uninsured motorist coverage, personal injury protection coverage, medical payments coverage or general liability coverage, from fully and finally settling a claim for at least 30 days after the date the injury occurred. Any settlement or release entered in violation of this section would be unenforceable.
The bill would not prevent an insurance company settling a claim in full IF it was tendering its policy limits nor would the bill prevent an insurance company from advancing funds to an injured person. Additionally, if the person injured has consulted with an attorney and WANTS to settle his/her claim before the 30 days have passed, he/she may do so under the provisions of this bill.
When I filed this bill, my goal was to make sure that Betty, and Floridians like Betty all around this state had the time necessary to make an informed decision about their case. Within a few weeks of the bill being filed, I was visited in my office by a lobbyist representing several liability insurance companies. Not surprisingly, he informed me that his clients would not be able to support my bill, stating that it could cost his clients money because they might have to pay more to settle a claim if the person had a chance to think about their claim, and that many of the cases his clients were able to settle quickly could go into litigation down the road. Too Bad.
Aside from the fact that this bill would provide needed protection to persons injured through no fault of their own, the bill also saves money for you and me, the taxpayers of this state, because once a case is settled, if the injured person goes to a hospital for treatment and has no settlement money to pay the medical bills, who do you think pays them? You and me.
I wish I could report that this bill has moved through all committees and is ready for a vote on the floor of the house. But I can’t. This bill, which was assigned to four committees/councils, has not been scheduled for a hearing in even ONE committee. Guess the insurance lobby is stronger than the consumer lobby.

Medtronic’s Sprint Fidelis Leads Causing Problems for Doctors and Patients

Since 2007, at least five people have died as a result of defective Sprint Fidelis defibrillator leads implanted in order to correct irregular heart rhythms. Since that time, thousands of patients and doctors have agonized over how to correct the problem. With certain medical devices, the simple solution of removing the offending device is the best option. However, with the Sprint Fidelis defibrillator leads, it’s not that simple, according to cardiology experts. The removal of such leads can cause death if not done properly and some health experts are complaining that the procedures are being performed by those who are not qualified to perform the extraction.
The anxiety for the patient who relies on the cardiac defibrillator is overwhelming. Imagine for a moment you or a loved one had one of these defibrillator leads implanted in order for your heart to function properly. Now you find out the leads are defective and may not work when your heart needs it most. This is a terrible situation for poor patients and a difficult dilemna for healthcare professionals.

Tallahassee Update

Rep. Rick Kriseman (D-53) is an attorney with Saunders & Walker PA
Mikey, age 14, and his friend decided they wanted to go buy a Slurpee at the local convenience store. After telling his mom where he’s going, Mikey and his friend grabbed their bikes and headed off down the street to the local convenience store. When they got back home, Mikey’s mom was waiting at the front door for him. She was not happy. Mikey looked confused, unsure of why his mother was mad at him.
Then, Mikey’s mom reminded him of the law in the State of Florida, specifically Florida Statute 316.2065 3(d), which states that
“A bicycle rider or passenger who is under 16 years of age must wear a bicycle helmet that is properly fitted and is fastened securely upon the passenger’s head by a strap, and that meets the standards of the American National Standards Institute (ANSI Z 90.4 Bicycle Helmet Standards), the standards of the Snell Memorial Foundation (1984 Standard for Protective Headgear for Use in Bicycling), or any other nationally recognized standards for bicycle helmets adopted by the department. As used in this subsection, the term “passenger” includes a child who is riding in a trailer or semitrailer attached to a bicycle.”
Mikey’s mom was mad at him because neither he nor his friend wore their helmets when they rode their bikes to the store.
If HB169/SB68 passes the legislature this year, Mikey will also have to wear a helmet if he goes horseback riding. Under HB 169, any person under the age of 16 must wear a helmet when riding a horse on public lands unless they are competing or performing during a show or an event, or they are riding the horse on private property or engaged in an agricultural related activity. This bill further states that anyone renting a horse to be ridden by a person under the age of 16 must either provide the underage person with a helmet or verify that the underage person has their own helmet.
Therefore, if this bill passes and Mikey and his mom ever go horseback riding, he will have to wear a helmet before he is allowed out of the stables on the horse.
It is the hope of the sponsor that passage of this bill will prevent future head injuries from occurring.
Unfortunately, in the State of Florida, the concern over head injuries seems to cease when a person turns 21, as Florida law DOES NOT require a person over the age of 21 to wear a helmet which complies with Federal Motorcycle Vehicle Safety Standard 218 promulgated by the United States Department of Transportation, provided they carry an insurance policy providing for at least $10,000 in medical benefits for injuries which might be incurred as a result of a crash while operating or riding on a motorcycle. So when Mikey turns 21, the state no longer seems to care about him.
Not a very good example for Mikey, is it? Sure hope he learns of the importance of wearing it now.

FDA Warns Drug Companies About Their Internet Ads

In what the Wall St. Journal has reported as a first for the FDA, the federal agency has warned 14 big pharma companies about their misleading advertisements on the Internet. The ads were typically found as a result of Google searches and the ads were usually sponsored links meaning the drug companies paid for the ads as part of their “pay per click” marketing campaigns. Sponsored links are one way of attracting Google search engine traffic by targeting certain key words that a person surfing the web may be trying to find.
The ads typically overpromoted their benefits while completely ignoring their risks and side effects. The Wall St. Journal article cites one ad by Biogen Idec Inc. for its drug Tysabri which boldly but inaccurately state, “”A Multiple Sclerosis Treatment That’s Different from the Others” or “Satisfied with your MS Medication or Looking for Something Different?”
This is a good sign that the FDA is not only reviewing big pharma’s traditional marketing practices to mainstream media but is branching out and investigating drug companies’ behavior on the Internet.
According to the Wall St. Journal, the companies that received the warning include: Pfizer, Biogen Idec Inc., Sanofi Aventis, Johnson & Johnson, GlaxoSmithKline PLC, Forest Laboratories Inc., Cephalon Inc., Bayer AG, Novartis AG, Merck & Co., Eli Lilly & Co., Roche Holding AG, Genentech Inc., and Boehringer Ingelheim Pharmaceuticals Inc. Genentech was recently acquired by Roche.

Rocket Fuel Chemical Found in Baby Formula

Scientists have discovered trace amounts of perchlorate in various brands of powdered baby formula. The chemical is mixed with water that also contains perchlorate can exceed what the CDC considers safe for adults. The chemical is usually associated with defense and aerospace facilities. The scientists didn’t disclose which baby formulas were tested. Perchlorate has been tied to problems with thyroid function. However, the health effects to babies and adults is still undetermined at this point. Various municipalities’ drinking water supplies have been tested and shown to have amounts of the chemical in the drinking water.
While some states have already set acceptable limits of perchlorate in drinking water, the EPA is reviewing the issue. It did state earlier this year that the chemical’s presence in drinking water may pose a serious health risk and a top priority for the EPA.
The tests that found the chemical in the baby formula were not health related so no determination as to the risks associated with the chemical can be made at this time.

Pope Speaks Out on Behalf of Economcially Poor

In light of the recent G-20 meeting in London, Pope Benedict XVI has called upon the world leaders to remember the poor when devising plans to aid the world economic situation. This is a laudable act considering a great many peoples still live below the poverty line.
However, poverty transcends the mere economic. Many live in poverty due to a lack of education, healthcare, and justice. In terms of the latter, many in this country are poor because they lack access to justice. I’m thinking in particular those who are poor because they lack access justice after they’ve experienced sexual abuse. This is a paralyzing poverty that often spills over into the educational, health, and economic spheres of life. Those who’ve been sexually abused and lack the proper recourse in a system of justice continue to suffer. The pope should’ve included those in his remarks as well. Very often, sexual abuse victims who’ve been abused by clergy are robbed of their relationship with God, a faith community, and their own human family. This is a justice issue and a life issue just as important as any other justice or life issues. When will we hear the church speak about that?

Priest Abuse Scandal: Bishops Knew Back in the 1950’s

Rev. Gerald Fitzgerald, founder of the Catholic order Servants of the Paraclete, dedicated his life and his priestly ministry to stopping the sexual abuse of children at the hands of Catholic priests. He did so by writing numerous letters to at least 12 Catholic bishops and one pope warning them of the dangers of sexually abusive priests. Fitzgerald even attempted to buy a Caribbean island where he would send the problem priests. The letters, unsealed a few years ago but now becoming public, show Fitzgerald as a priest who consistently warned bishops about the danger of transferring sexually abusive priests. In some letters, he called for their removal from the priesthood.
These revelations contradict the Catholic bishops consistent defense over the years that they didn’t know the nature or the extent of the problem. Fitzgerald had been working with priest abusers since the 1940’s and had spoken with Pope Paul VI in 1962 about the issue. Some of the most notorious priests were sent to Fitzgerald’s retreat in Jemez Springs New Mexico for treatment and counseling. The strongly worded letters mince no words in depicting the priests as “vipers” and “devils”. In a 1957 letter to a bishop in New Mexico, Fitzgerald wrote, “These men, Your Excellency, are devils, and the wrath of God is upon them, and if I were a bishop I would tremble when I failed to report them to Rome for involuntary layization (sic).”
Fr. Fitzgerald’s prescient warnings went unheeded until the scandal broke wide open in 2002 after the Boston Globe uncovered years of conspiracy and coverup by the Archdiocese of Boston. Fitzgerald died in 1969 and his successors changed the tone and manner in which priests with sexual abuse problems were treated. Often, the change resulted in the priests being returned to ministry in different dioceses. Fitzgerald himself was the object of scorn from some bishops who considered his methods and warnings bizarre and alarmist.
The Catholic bishops of the United States can no longer pretend they didn’t know about the issue. Nor can they feign ignorance of the magnitude of the abuse. As early as the 1940’s they received warnings from Fr. Fitzgerald. In the 1980’s Fr. Tom Doyle took up the mantle and warned the entire group of bishops assembled for their annual meeting. Just like Fitzgerald, Doyle was dismissed and ostracized by the bishops.