J & J Mesh Product Based on Recalled Product.

Source: Bloomberg

Pelvic Mesh treats incontinence and a condition called pelvic organ prolapse, in which internal organs slump into the vagina. They were allowed on the market as result of the agency’s approval process, known as 510(k), which relies on the notion that if one device has been cleared by the FDA then similar devices need little if any testing in patients.

The chain of approvals that began with Boston Scientific’s device highlight a key flaw in the 510(k) process, said Amy Allina, a policy director at the National Women’s Health Network, a Washington-based advocacy group.  The system lets manufacturers win clearance for a product by citing its similarity to an already approved device, known in FDA jargon as a “predicate.” That second device can be cited as the basis for a third, the third to clear a fourth and so on.

“If a first iteration is recalled, they don’t necessarily look at the second, third or fourth things that are based on that,” Allina said in an interview. The system, she said, “is a mess.”

The story began in 1996, when Boston Scientific won clearance for ProteGen, the first vaginally implanted mesh designed specifically to treat incontinence. Two years later, J&J won approval for a similar device, called Gynecare TVT. Under the 510(k) system, J&J wasn’t required to conduct human testing because the company claimed its device was “substantially equivalent” to the Boston Scientific device.

A year later, Boston Scientific voluntarily pulled about 20,000 ProteGen meshes, saying it had received 123 reports of problems, including discomfort, painful sex, and erosion of vaginal tissue. Nonetheless, J&J and at least two other manufacturers, American Medical Systems and Covidien Plc (COV), soon came out with products that traced their design back to ProteGen.

The FDA has said it doesn’t know the number of women who have received the implants since 1998, though it estimates almost 300,000 were used in 2010.

In the case of vaginal mesh implants, the FDA continued approving the hammock-like devices made by J&J and other companies based on their similarity to Boston Scientific Corp. (BSX)’s ProteGen even after it was pulled amid safety complaints. Today, the makers of the entire category of implants face more than 600 lawsuits from women who claim the devices caused serious injury.

The complaints are the latest to implicate the approval process for medical devices at the U.S. Food and Drug Administration, which has cleared faulty hip implants and numerous other products.

In the case of Johnson and Johnson, this is nothing new.  How may recalls have we seen from this company in the last 36 months.  Where was the FDA when other countries with databases were recalling J&J's faulty hips that now may have affected 34,000 Americans and subjected them to toxic levels of heavy metals.  I guess those guys just don't want to mess up those cushy jobs waiting for them when they leave government service to cash in.

In July, the FDA issued a statement saying it is unclear whether prolapse implants provide any benefit over traditional surgery. The statement came three years after the agency first acknowledged a problem in a 2008 report that said mesh complications were serious, if rare. An advisory panel of physicians said last month that the FDA should demand more clinical testing of the devices.

To learn more about Pelvic Mesh Implants, visit: http://www.pelvicmeshlawyer.com/about_mesh_implants.html

Huntsville Neurosurgeons Identified in WSJ article: Taking a Double Cut, Surgeons Implanting Their Own Devices

Source:  WSJ

In the weekend edition of The Wall Street Journal, John Carreyrou and Tom McGinty investigate the ownership of medical device companies whose products the surgeons implant in their patients.

A federal antikickback law prohibits medical device makers from paying surgeons to use their products.  Mindful of the law, big device makers entered into partnerships with spinal surgeons, paying them consulting fees and royalties for help designing their products. In some cases, surgeons receiving payments would use that company's devices exclusively and would author research favorable to those products, company documents obtained by congressional investigators show. 

Critics of such arrangements say they give surgeons an incentive to do
more operations, and that the conflict of interest has led to unnecessary back surgeries that waste health-care dollars and often do patients more harm than good. "Patients are having huge operations that are un-indicated because of this," says Scott Lederhaus, a neurosurgeon in Pomona, Calif., and member of the Association for Medical Ethics, an organization of doctors that focuses on conflicts of interest. 

The inherent conflict of interest is fueling concern. In June, five U.S. senators asked the Inspector General of the Department of Health and Human Services to open an investigation into physician-owned device companies, citing concerns that the surgeons involved have a financial incentive to "perform more procedures than are medically necessary." 

Many of the products at issue are approved by the FDA pursuant to the 501(k) process. Under this process, surgeons only have to submit mechanical-testing data attesting that their implants are "substantially equivalent" to existing ones. The FDA
usually gives its green light within 90 days. This process has been under increasing criticism as abuses continue to mount and virtually everything has become substantially equivalent.

The article highlights Spinal USA. 

In the spring of 2007, FDA inspectors paid a surprise visit to Spinal  USA's offices. They assessed the company with 14 violations, ranging from failing to maintain master records for its devices to having no system in place to track and label them, according to a warning letter the agency issued to the company. The violations were "symptomatic of serious problems," the warning letter stated.

A spokesman for Spinal USA said its rapid growth caused it to run afoul of FDA procedures. He said the company hired an experienced manager to oversee quality control in February 2008, and a second FDA inspection that September cleared the company of the violations.  During a third visit in December 2010, FDA inspectors found problems with the way Spinal USA was storing bone products, which the company also addressed.

So why would surgeons use Spinal USA product and why is it that so many neurosurgeons in Huntsville, Alabama would jump on the product bandwagon?
According to the article, in 2007, four spine surgeons in Huntsville, Ala. to invested in the company. Those surgeons, Gilbert Aust, Cyrus Ghavam, Morris Seymour and Larry Parker, switched to using Spinal USA implants in most of their surgeries, according to a local representative for a big medical-device maker.

Four more Huntsville spine surgeons subsequently joined Spinal USA, giving the company a relationship with eight of Huntsville's current 15 spine surgeons. Spinal USA also expanded to Mobile, Ala., where it recruited two surgeons.

Dr. Aust, who is chairman of Spinal USA, confirmed that he and Drs. Ghavam, Seymour and Parker are investors. The company declined to comment on its other surgeon investors.

At Huntsville Hospital, one of the city's two hospitals, 351 spinal-fusion surgeries were performed on Medicare patients in 2009, up from 333 in 2006, before Spinal USA came to town, a Wall Street Journal analysis of Medicare claims data shows. At Crestwood Medical Center, the city's other hospital, there were 187 such operations on Medicare patients in 2009, up from 107 in 2006, the analysis shows. Huntsville Hospital says it spent $5.6 million on Spinal USA products in its most recent fiscal year. 

Dr. Aust is quoted as saying that he performs such hardware replacements for medical reasons, not financial ones. He says he doesn't see anything wrong with the fact that they benefit him financially by contributing to Spinal USA's sales. "I know some people in the profession don't think it's ethical,but I just don't see it," he says. 

The federal antikickback law doesn't specifically address the issue of surgeons using medical devices made by companies they co-own, but HHS's Office of the Inspector General has issued regulatory guidance for complying with the statute: Among other things, it advises that no more than 40% of a company be owned "by investors who are in a position" to "generate business" for it. 

Dr. Aust says he and Spinal USA's other surgeon investors own "the majority of the company," but are working on lining up outside investors. The Spinal USA spokesman says its surgeon owners are in compliance with federal laws because their shares of profits are proportional to their ownership stakes, not to how much business they generate through their surgeries. He adds that more than 60% of the company's business is generated by surgeons who aren't owners. 

Spinal USA declines to say how much its surgeon owners earn from the company. But a filing in the personal bankruptcy case of spine surgeon Michael Molleston, one of its investors, says Dr. Molleston received $26,000 a month from Spinal USA as of Nov. 19, 2008, when the filing was made. Dr. Molleston couldn't be reached for comment. 

Medicare data showed that a doctor in Jackson, Mississippi  with a similar agreement performed spinal fusions more frequently than many of his peers. In 2008 and 2009, he performed 278 spinal fusions on Medicare patients, tenth most in the nation, according to the Journal's analysis of Medicare claims data. In 150 of those cases, or 54%, the patients' diagnosis was degenerative disks. 

Considering the catastrophes we are seeing in medical devices and the murky relationships between physicians and pharmaceutical and medical device companies, everyone should consider asking their surgeon to disclose these type of arrangements and Congress should mandate it. 

Related articles

• Surgeons Implant Devices They Make (online.wsj.com)
• You: Taking Double Cut, Surgeons Implant Their Own Devices - Wall Street Journal (news.google.com)
• Medtronic pays 5 surgeons $7m kickbacks in just 9 months: The rape of Medicare (ktwop.wordpress.com)

Former U.S. Senator Fred Thompson and other Lawyers: State Farm covered up support of candidate in most expensive judicial race in U.S. history.

Former Tennessee Republican Senator and others have filed suit accusing  insurance giant State Farm of defrauding the Illinois Supreme Court by covering up its support of the Republican candidate in the most expensive state judicial race in U.S. history.

A petition was filed last week, asking the court to reconsider its decision to void a $1 billion verdict against State Farm. The petition is based on an investigation by a former FBI agent Michael Reece.

"The bottom line of my investigation is that State Farm used the Illinois Civil Justice League to elect Judge Karmeier and Judge Karmeier knew it," Reece stated in his affidavit that accompanied the petition.

The petition alleges Karmeier received at least $2.5 million and up to $4 million in contributions from State Farm during the 2004 campaign against his opponent, Democrat Gordon Maag. Karmeier declined to recuse himself from the class-action case against State Farm because of a conflict of interest and eventually cast his vote to void a $1 billion judgment.

In a 2009 ruling, the court stated a West Virginia appellate judge should have recused himself from a case where the judge received $3 million in campaign contributions, then overturned a verdict against a contributor.

The U.S. Supreme Court decided the judge should have recused himself because of the "serious risk of actual bias."

The Illinois case dates back to 1997 when it was filed in Williamson County. The suit alleged State Farm breached its contract with policyholders when it directed the use of non-original parts in vehicles damaged in crashes. A jury awarded $465 million to some State Farm customers. Williamson County Associate Judge John Speroni awarded $730 million to other policy holders.

In 2001, the Appellate Court let stand a $1.05 billion judgment.

The Supreme Court heard oral arguments in May 2003.

Karmeier, then a circuit judge in Washington County, announced six months later that he would run as a Republican for Illinois Supreme Court.

Karmeier was elected to the Supreme Court in November 2004.

State Farm later represented to the Supreme Court that it provided $350,000 to the Karmeier campaign when plaintiffs' attorneys requested Karmeier recuse himself from the class-action decision.

Nine months after Karmeier was elected, he sided with a 4-2 majority to void the judgment against State Farm. To overturn an appellate decision, there must be a four-justice majority. If that does not occur, the appellate court ruling stands.

Reece discovered evidence that State Farm lobbyist Bill Shepherd vetted Karmeier for the job, helped direct Karmeier's campaign, along with Illinois Civil Justice League head Ed Murnane, used the league's political action committee, JUSTPAC, to raise $2.5 million and "funneled" it to Karmeier's campaign, according to his affidavit filed with the recent petition.