Surgical Ablation Devices Draws Deparment of Justice Inquiry

Surgical ablation devices have been approved by the FDA to cauterize tissue in order to stop bleeding in wounds. However, a front-page Wall St. Journal article notes that 25,000 patients last year were treated with the ablation device in order to treat atrial fibrillation. The medical device used in these procedures has not been approved by the FDA. Doctors have been treating “A-fib” with these ablation devices in order to re-route the electrical impulses of the heart. While doctors may use medical devices and pharmaceutical drugs for off-label treatments, medical device and pharmaceutical companies may not market their products for off-label uses.
This is where the issue becomes complicated. The Journal cites doctors and industry executives to note that the surgical ablation devices are almost exclusively being used to treat atrial fibrillation and the market is a lucrative one for medical device companies-$100 million a year.
A former medical device sales executive, Elaine George, has filed lawsuits in which she contends that medical device companies are indeed marketing the ablation devices for purposes not approved by the FDA. She’s won two lawsuits against medical device makers AtriCure and Estech. The settlement with AtriCure cost the company $3.8 million while the lawsuit against Estech was resolved for $1.5 million. As a whistle blower, Ms. George has received $688,000 and $226,000. By law, she is entitled to 15% to 30% of any recovery as a whistle blower. George has three other lawsuits pending against Boston Scientific, Medtronic, and St. Jude Medical. All the lawsuits allege that these medical device companies marketed their products to doctors for uses which aren’t approved by the FDA.
FDA approval for medical devices is a costly process that requires medical trials and lengthy submissions to the FDA. Medical device companies argue that they want to get their devices to market to provide the maximum benefit to the patient.
The surgical ablation devices were approved by the FDA under a provision that allows their approval if they are similar to devices already approved by the federal agency. However, surgical ablation devices have not been approved to treat atrial fibrillation and there is no study available to determine is such use is safe or more beneficial than approved forms of treatment for “A-fib”.
“The misuse of medical devices has the potential of exposing patients to dangerous procedures,” said Tim Johnson, U.S. Attorney for the Southern District of Texas, after settling with AtriCure Inc. in January. As a result of the lawsuits, the FDA is considering revising the provision that allows similar medical devices to be approved for use.
The Journal article notes that 80% of atrial fibrillation patients are treated effectively with drugs. However, the medical device industry sees the growth of surgical ablation devices as a profitable new opportunity. The article provides excerpts of industry executive comments at two trade conferences last year, “Medtronic, at an investor conference last year, called it a “fast growing, underpenetrated market.” St. Jude, also at a 2009 investor conference, said atrial fibrillation “may be the best growth market in the medical device space for the next 5-7 years.”
Elaine George was an industry insider and participated in these conferences as well as medical device marketing seminars for 17 years before being fired by her last employer Boston Scientific after calling into question the marketing presentations she witnessed. During one training session, a presenter showed participants how to sell the surgical ablation devices to doctors for use in atrial fibrillation cases. Later during the conference, regulatory officials cautioned salespeople to be cautious not to market devices for unapproved uses. Understandably, she was confused by the contradictory messages. So she asked the trainer if there were legal uses for which she could promote the product. The response, according to the Wall St. Journal was, “Don’t worry about that. This is how you sell it.”
Soon after the training seminar, she received a letter from her supervisor critical of her job performance. Two months later she was fired by Boston Scientific. That’s when she decided to sue the company for wrongful termination and retaliation. The lawsuits sparked interest in the Department of Justice which is now investigating the medical device companies for illegally marketing medical devices to doctors for uses which haven’t been approved by the FDA.
The DOJ investigation is ongoing and will be interesting in terms of what they discover. It will be more interesting to see how the medical device companies respond to these allegations. This is a $100 million a year market. Will $3 million dollar settlements deter companies who stand to make $100 million?

Johnson & Johnson Withdraws Hip Device

DePuy, a unit of Johnson & Johnson, has announced that it has warned doctors that its artificial hip device known as ASR has a higher early failure rate in some patients. Months before this latest announcement, DePuy had said it planned to phase out the ASR hip device due to poor sales.
ASR is a metal on metal artificial hip device that has shown an early failure rate that has led to painful and complicated revision surgery in some hip replacement patients. DePuy officials have disputed the safety issues although an Australian doctor, Dr. Stephen Graves, found that data has shown for some time that the ASR has a higher early failure rate than those of ASR’s competitors. Dr. Graves is the director of an implant database in Australia. ASR was removed from the Australian marketplace in December 2009. Graves and other physicians have criticized DePuy for its failure to remove the hip device sooner.
According to the NY Times, DePuy officials cited poor sales figures for the phase out of ASR in spite of Dr. Graves’ contention that there are safety issues with the artificial hip.
“With declining sales of this particular product in its market segment, we are focusing on newer technologies,” Sally Hunter, DePuy’s worldwide vice president for regulatory affairs, said last month.
The Times reports that the FDA has received 300 complaints from ASR patients since the beginning of 2008. The majority of those patients have undergone a revision surgery to replace the failed ASR hip with a new hip device.
Some orthopedic surgeons, including the ASR’s co-developer, Dr. Thomas P. Schmalzreid, have admitted to issues with the ASR device. “The window for component position that is consistent for good, long-term clinical function is smaller for the ASR,” stated Schmalzreid. When notified of Dr. Schmalzreid’s comments concerning ASR, DePuy officials expressed surprise.
The problems to which Dr. Schmalzreid was referring concerning the positioning and placement of the cup.
DePuy is not the only artificial hip device manufacturer to experience safety problems in the past few years. Stryker Corp. and Zimmer Holdings Inc. have had design defect issues that have led to hip recalls or the suspension of sales of these products.

FDA Won’t Rescind Zicam Warning Letter

In spite of their best efforts, Matrixx Initiatives, Inc. has failed to persuade the FDA to withdraw its warning letter concerning the homeopathic cold remedy Zicam. Last June, the FDA issued a warning letter to Zicam’s manufacturer’s after certain Zicam products were linked to a loss of the sense of smell (anosmia). As a result of the warning letter, Matrixx Initiatives pulled the Zicam products in question off the market.
The FDA has refused to rescind the warning letter because no new evidence has demonstrated that the Zicam nasal swabs and gels are not associated with the loss of the sense of smell. According to the FDA, the federal agency has received 130 reports of issues with the nasal products. These Zicam products contain zinc gluconate a compound that has been linked to nasal cavity damage.
“Loss of sense of smell is a serious risk for people who use these products,” the FDA said in its letter.

Super Poligrip Recalled in Japan

GlaxoSmithKline’s Super Poligrip with Zinc has been recalled in Japan. The American Dental Association has issued a warning about denture creams that contain zinc. The ADA has acknowledged that use of denture creams that rely on excessive use of zinc have been linked to neurological and hematological issues. Zinc reacts with copper by lowering copper levels and thus a higher instance of neurological and hematological problems.
As a precautionary measure, GlaxoSmithKline has decided to stop using zinc in the following products: Super Poligrip Original, Super Poligrip Ultra Fresh and Super Poligrip Extra Care.
In spite of the Japanese recall, no FDA action regarding denture creams has been taken in the United States.

Avandia Tops List for Safety Concerns

Avandia, GlaxoSmithKline’s diabetes drug, has topped the list of most reported adverse events for the third quarter of 2009. The report was published by The Institute for Safe Medication Practices. Avandia has been plagued by adverse events such as an increased risk of heart attacks since 2007 when Dr. Nissen of the Cleveland Clinic first linked the drug to cardiac problems.
GlaxoSmithKline received more bad news today about Avandia. UBS, one of the world’s largest financial firms forecast a potential $6 billion loss as a result of Avandia lawsuits in the United States. The financial firm noted that there are already more than 13,000 Avandia lawsuits with more expected as public awareness of Avandia’s safety concerns grow.
The first Avandia federal bellwether trial is scheduled to begin in Pennsylvania June 1. Last week a US Senate report was highly critical of GlaxoSmithKline for understating Avandia’s safety risks as well as its failure to report drug data to the FDA. There are also allegations that company officials coerced experts to downplay the Avandia risks.

Metal on Metal Artificial Hips Scrutinized

Once thought to be more durable and effective, metal on metal hip replacements are being questioned by orthopedic surgeons who are finding that these artificial hips are not lasting as long. The metal on metal devices are wearing out and causing metallic debris, bone loss, and the destruction of soft tissue. Such devices are also used in so-called hip resurfacing procedures. The problem has become significant enough that a recent editorial in The Journal of Arthroplasty has suggested that doctors use the metal on metal devices with “great caution, if at all.”
These devices are relatively new since they’ve only been used in the last decade and some studies suggest that 1 to 3% of the hip replacement population may be affected by the problem. Still, that may account for thousands of hip patients in the US.
According to the NY Times, surgeons at Rush University Medical Center have performed two dozen revision surgeries in the past year. The Mayo Clinic reports similar numbers of patients with problems resulting from metal debris. The metal debris, primarily cobalt and chromium, can be absorbed in surrounding tissue or enter the blood stream. Symptoms of metal on metal problems include inflammation of the joint, bone loss, and pain in the groin area.
According to the Times article, all major hip device makers sell these metal and metal devices and some have responded to the concern over them. Zimmer Holdings, one of the country’s largest hip device manufacturers, has sought to downplay to significance of the issue as well as the potential risk to patients.

Avandia Faces Lawsuit from a California County

Santa Clara County in California has filed a civil lawsuit against the manufacturer of diabetes drug Avandia. GlaxoSmithKline is the defendant in the lawsuit which seeks damages from all Santa Clara County Avandia users who were mislead by GlaxoSmithKline. The suit alleges GSK failed to warn potential consumers of the associated risks of heart attacks that studies have shown are attributable to Avandia.
Avandia has been dogged by controversy and studies linking it to an increased risk of heart attacks in those Type 2 diabetes patients who are prescribed the drug. During the third quarter of 2009, Avandia was linked to 304 deaths. Two FDA doctors, Dr. David Graham and Dr. Kate Gelperin, have called for an Avandia recall after the doctors reviewed scientific research linking the drug to higher heart attack risk. GlaxoSmithKline officials have fought recall efforts and continue to insist the cardiac risk link is bogus. The problem with Avandia began in 2007 after a Cleveland Clinic cardiologist link Avandia with heart attacks. Since that time, Avandia’s manufacturer has tried to prop its $3.2 billion diabetes drug.
According to county offiicals, the lawsuit seeks treble damages since GlaxoSmithKline’s marketing campaign targeted diabetics who are recognized as disabled by the State of California.

Court Allows Paxil Suicide Lawsuit to Move Forward

It’s been a little less than a year since the Supreme Court’s ruling in Wyeth v. Levine, yet that decision led the 7th Circuit to rule in favor of 23 year old Patricia Mason’s family who sued GlaxoSmithKline, the manufacturer of Paxil after she committed suicide.
In its unanimous ruling, the appellate court ruled that the drug company had not met the standard of “clear evidence” set in the Levine case whereby the FDA would have rejected the change in the drug’s labeling to warn about the potential side effects of Paxil which included suicide.
This is the second pro-consumer court decision that deals with the controversial notion of preemption which preempts lawsuits against pharmaceutical companies and medical device manufacturers if the drug or device had received pre-market approval from the FDA.

Raytheon Says It Will Take 78 Years to Clean Up Toxic Plume in St. Petersburg

That’s not a typo. Raytheon’s consultant Arcadis estimates that it will take 78 years for the defense contractor to clean up the toxic mess it caused in St. Petersburg’s Azalea neighborhood. 78 years is generational damage. This is simply not acceptable. If Raytheon expects to be regarded as a good corporate citizen it can’t expect the good people of St. Petersburg’s Azalea neighborhood to sit idly by and accept their consultant’s conclusion that it will take 78 years to clean up this mess.
Of course, as Mark Douglas, the Channel 8 reporter who first broke the story points out, the Raytheon mess would still be a secret if the news channel hadn’t uncovered the problem in the first place. This is an outrageous situation in which a large corporation is allowed to operation with impunity while innocent citizens suffer the consequences of their behavior.

Delaware Pediatrician Abuse Case Eerily Familiar

The circumstances surrounding the arrest and subsequent revelations of sexual abuse concerning Delaware pediatrician Dr. Earl Bradley is all too familiar to this writer. What I’ve seen and experienced helping survivors of priest sexual abuse over the years is sadly similar to what I’m reading about the pediatrician. Dr. Bradley was in a position of special trust among parents, colleagues, and law enforcement. That special trust allowed Bradley to continue sexually abusing kids for decades in spite of the fact that there were suspicions about him for years. Bradley, like the Catholic priest abusers, groomed his victims. He was very popular and appeared to be generally good with children. He had a thriving practice. The possibility that he could be a monster abusing the community’s children was unthinkable. Essentially, he was an iconic figure in the town.
And that’s part of the problem. Institutional figures-whether they be teachers, police officers, clergy, doctors, or lawyers-are not above the law. They are human beings who’ve been given a special trust in society. However, that does not mean they should be treated with a blind faith or the sense that they are infallible. Because of their special role in our community, these people should be held to a higher standard of accountability. If this were the case, perhaps Dr. Bradley would have been arrested years ago when the first child complained that the doctor had touched him/her or kissed him/her.