The recent news that Guidant defibrillators may malfunction during life critical moments has given heart patients pause. The highest rate of malfunction among Guidant machines is the Ventak Prizm 2 DR (Model 1861)with 28 reports of short-circuiting including one resulting in death. According to a story in today’s Wall St. Journal, physician reaction is mixed. The WSJ reported that prominent Indiana cardiologist Douglas Zipes believes it’s a matter of conscience. “I put the implanted defibrillator in the patient because the patient is at risk of sudden death. How can I in good conscience then not replace the device?” At this point, it’s important to check with your cardiologist if you have one of these implanted devices. Also, keep monitoring my blog for the latest updates.
Monthly Archives: June 2005
Consumer Safety Alert: Heart Device Manufacturers Decide for Themselves When and If to Tell Public About Faulty Devices
According to a June 14th article in the NY Times, heart device manufacturers make their own decision when and if to inform the general public and doctors if a potentially life saving heart device like a defribrillator is faulty. There are no set guidelines and there is no close monitoring of these devise manufacturers even though they make outrageous profits. The article points out the recent death of a 21 year old student with an implanted defibrillator made by the Guidant Corporation. Unfortunately, patient safety is not the only concern of these companies. The potential loss of profits as well as the legal liability play huge roles in the company’s evaluation of the benefits of disclosing a product flaw. Until there is closer monitoring, consumers are not safe.
At FDA’s Urging, Guidant Recalls 29,000 Heart Devices
Guidant Corporation is recalling 29,000 heart devices because of flaws that may cause them to malfunction when they are supposed to deliver a potentially life saving electrical shock to the heart. The three defibrillator devices manufactured by Guidant came under FDA scrutiny during their review of Guidant’s handling of issues surrounding the three products particularly the Prizm 2 DR. The other two models are the Contak Renewal and the Contak Renewal 2. Guidant did not tell doctors for more than three years that the product (Prizm 2 DR) was prone to electrical failure due to a design flaw. Guidant also disclosed yesterday that the other two products were prone to the same failure. The company said it was aware of two recent deaths involving the units at issue.
Johnson & Johnson’s Drug Risperdal Raises Tumor Questions
A June 17th article in the Wall St. Journal raised questions about Johnson & Johnson’s antipsychotic drug Risperdal. According to the story, government researchers found a higher incidence of benign tumors in the pituitary gland among patients taking the drug. The Journal article noted that the finding is preliminary and their is no definitive link proving the drug caused the tumors. Researchers analyzed 2.5 million adverse events reported by doctors and found that of the 307 reports of pituitary tumors 64 or 21% occurred in patients taking antipsychotics. Risperdal is a widely prescribed drug used to treat schizophrenia and bipolar disorder. Last year, it was J&J’s second biggest selling drug with world wide sales of $3.1 billion
Catholic Church Paid $1B for Sex Abuse Claims So Far
Recently, the Associated Press reported that the Catholic Church’s payment for sexual abuse claims has reached the $1billion mark. It’s sad to note that the Church hierarchy was warned of such a financial cataclysm back in 1985 when Fr. Thomas Doyle and others warned the US bishops that priests preying on minors was a major problem. Doyle, a Dominican priest, has been vilified for his outspoken and prophetic position on such matters.
As the US Catholic bishops meet in Chicago this week to discuss revisions to their sex abuse policy, it appears that they will vote to weaken it. Some of the proposed changes include: moving to a system by which the Bishops are in charge of their own audits and leaving it up to the individual bishop to determine if past cases of sexual abuse are to be sent to the authorities. Present policy mandates that all abuse allegations are to be sent to the civil authorities for investigation. This seems like a clear bacwards step.
It’s truly a sad commentary when it takes major financial consequences for a large institution to begin to mend its ways. The jury is still out on whether true reform has begun. The US bishops are wavering and equivocating. Real change is difficult and takes courage and integrity. We’ll have to wait and see if these bishops have those qualities of character.
Sarasota Doctor Still Practicing After 25 Counts of Health Care Fraud
According to a story published in the St. Petersburg Times, Dr. Michael Rosin continues to practice medicine in Sarasota in spite of 25 counts of health care fraud and 25 counts of making false statements. In one case, Dr. Rosin operated on one elderly patient 122 times! In a recent federal indictment, Dr. Rosin is accused of falsely diagnosing skin cancer and performing unnecessary surgery. In one case, according to the indictment, Rosin based his diagnosis on a slide that contained chewing gum, not human tissue. In another case, a lab tech decided to test Rosin by substituting a sliver of Styrofoam for a tissue sample. Rosin examined the slide and told the unwitting patient that her cancer was very aggressive and that she needed surgery the next day.
Who’s watching these doctors? Who’s protecting you and your loved ones from bad doctors?
Profits Outweighed Safety Concerns with Propulsid
According to a recent article in the NY Times, in 1998 the makers of the heartburn medicine Propulsid negotiated a new warning label rather than remove it from the market in spite of overwhelming evidence of its dangerous, sometimes fatal, effects. Johnson & Johnson continued to promote the drug to children in spite of evidence showing the drug caused serious heart problems. Two years later, as such reports mounted, Johnson & Johnson continued to aggressively market the drug but then abruptly pulled it from the market before a governmental hearing threatened to draw attention to the drug’s long, hidden, record of trouble. Documents from lawsuits against the drug’s manufacturer show that the company did not conduct safety studies urged by federal regulators and the company’s own consultants that could have revealed the drug’s dangers early on and saving countless lives. According to the NY Times, Propulsid’s history has “striking parallels with the painkillers now at the center of the controversy. Dozens of studies sponsored by Johnson & Johnson that might have warned doctors away were never published, just as the pharmaceutical manufacturer Pfizer failed to publish an early study of Celebrex that indicated a heart risk. And Johnson & Johnson was able to delay and soften some proposed label changes, just as Merck later did with Vioxx.” Drug companies are more concerned with profits than protecting and helping consumers.
Info for Victims of Auto Accidents in Florida
Auto accidents remain the leading cause of death for Americans under the age of 34. Each year, 40,000 people lose their lives in auto crashes. The resulting psychological, economic, and physical toll places tremendous strain on families and individuals alike. If the accident is not stressful enough, the aftermath can be a nightmare dealing with issues such as medical treatment, car repairs, mounting hospital bills, lost time from work, and lost wages. Yet, the decisions you make during this stressful period can have lasting impact upon you and your family.
If you’re involved in an accident what should you do?
Call the Police immediately
Fill out an accident report thoroughly
Obtain names and phone numbers of witnesses
Seek medical treatment even if you feel ok at the scene (your adrenaline may mask a serious injury)
What is PIP and how does it work?
As a no fault state, Florida requires that each insured driver pay for their own auto accident related medical expenses. This is done through what is commonly known as PIP or Personal Injury Protection and MP or Medical Payments coverage. PIP provides for the following:
80% of all reasonable expenses related to treatment for the auto accident. This includes medical, surgical, x-ray, dental, and rehab services.
Accident victims may also recover for replacement services which are whatever ordinary services they could perform on their own but can no longer due as a result of the accident.
What is Medical Payments Coverage and what does it do?
MP coverage pays the remaining 20% of expenses not paid by PIP. It also will cover expenses related to the accident if PIP is exhausted.
As you can see, this gets complicated, especially if you are injured or disabled as a result of the accident. I’m a Board Certified Civil Trial Lawyer who’s been handling auto accident cases for my clients for more than 20 years now. My office staff and I will help you with questions about getting your car fixed or replaced and answer any questions you may have regarding lost wages. I have the experience and the understanding to help you in your time of need.
Fox Guarding the Hen House: FDA’s New Drug Safety Board
A news story published in the Washington Post today cites problems with the FDA’s new drug oversight board. According to FDA Safety Officer David Graham, the new board is “severely biased in favor of industry” rather than consumer protection. The oversight committee was initially set up after sudden market withdrawals of painkiller drugs such as Vioxx and Bextra.
According to Iowa Senator Charles Grassley the problem with the board is its composition. 11 of the 15 members already serve on the same FDA committee approving drugs for Americans. Obviously, a truly independent review board is necessary if the American consumer is to be served and protected.
Consumers are no better off with the new board since the fox is guarding the hen house once again.
Embattled Bishop Spurned by High School Seniors
Fifty seniors at Trinity High School in Manchester NH have asked NH Bishop John McCormack not to come to their graduation. McCormack, a top lieutenant of disgraced Cardinal Law of Boston during the 1980’s has been in the forefront of the clergy abuse scandal in Boston and Manchester NH. According to the Boston Herald, a tense meeting between the Bishop and students was held last Friday. During the meeting, the Bishop was asked questions about the abuse scandal and responded by yelling, “Prove it! Show me the evidence!”
In spite of the students’ protests, a spokesman for the Diocese of Manchester said McCormack will celebrate a Mass at the graduation anyway. So much for listening to the voice of the faithful.
During McCormack’s tenure in Boston, he was in charge of supervising and transferring such pedophile priests as John Geoghan and Paul Shanley.