In an unprecedented move, the FDA has admitted that it should have never approved a medical device but succumbed to outside influence in approving the Menaflex knee patch manufactured by ReGen Biologics. The pressure came from NJ elected officials including Senators Frank R. Lautenberg, Robert Menendez, Reps. Frank Pallone, Jr. and Rep. Stephen R. Rothman.
Controversy began to swirl around the medical device last year when FDA officials complained that politics had unduly influenced the approval of Menaflex. FDA scientists released a detailed report showing that FDA scientists had found the device not worthy of FDA approval but were overruled by FDA managers who had come under the sway of the New Jersey politicians in whose state the device is manufactured.
According to an article in the NY Times, “Dr. Robert Smith, a former F.D.A. device reviewer who was among those who complained to Senator Grassley, said in an interview that the agency had yet to discipline the managers responsible for the ReGen decision. Some of those managers have since left the agency.
“There was serious managerial wrongdoing during the clearance of the device, and that needs to be investigated, and the managers involved need to be held accountable,” Dr. Smith said.
The controversy and potential improper conduct includes the FDA commissioner who is cited in the report for inappropriate involvement in the approval process.
The four NJ elected officials who pressured the FDA had received significant campaign contributions from ReGen headquartered in Hackensack New Jersey.

Metronic, Inc. has announced that it has agreed to settle lawsuits regarding its Sprint Fidelis defibrillator leads (Models: 6930,6931, 6948, and 6949) for $268 million. Many of the Sprint Fidelis lawsuits had arisen from the October 2007 Sprint lead recall that had been prompted by reports that the defibrillator leads were fracturing. The fractures caused the leads to malfunction. Many of those who had implanted Sprint Fidelis defibrillator leads had to undergo explantation of the leads as a result of the fractured leads. The fractured leads caused the defibrillators to short and not transmit proper electric impulses to the heart.
According to a Medtronic press release, the parties will file joint requests to terminate the Multi-District Litigation which had been set up to handle all of the Sprint Fidelis lawsuits.

The DePuy artificial hips that were recalled in August are facing mounting lawsuits as news about the hips’ defects and the device maker’s failure to notify the FDA and the public about what they knew about the problems continues to surface. There are widespread reports that DePuy officials knew the metal-on-metal artificial hip implants were failing at an alarming rate but those same officials didn’t disclose the problems until this past August.
According to DePuy, the company sold approximately 93,000 of the SR Hip Resurfacing Systems and ASR XL Acetabular Systems and that these devices have suffered a 12% failure rate requiring revision surgery within the first five years of implantation.
Any revision surgery is painful, subject to further failure and may lead to other complications. The metal-on-metal devices can cause metal debris which can lead to inflammation, loss of bone and tissue, and groin pain.

Depuy Orthopedics has filed a brief in opposition to consolidating all DePuy ASR hip lawsuits in an MDL. The MDL petition was filed on September 3rd in order for all DePuy hip cases to be heard by one judge. An MDL allows for all discovery to be consolidated and centralized.
According to the opposition brief, DePuy doesn’t object to the consolidation of the lawsuits for purposes of DePuy settlement discussions. However, the hip manufacturer objects to the cases being transferred to Judge Susan D. Wigenton in New Jersey.
DePuy’s objection to Judge Wigenton concerns her involvement in the ongoing Zimmer Durom Cup hip implant lawsuits. DePuy believes that if Judge Wigenton had both the Zimmer and DePuy defective hip cases, it would be unfair to the different hip manufacturers and may cause confusion and prejudice to the defense.
However, consolidation of both hip cases before a single judge may provide the parties with the knowledge and experience necessary to make difficult decisions in the MDLs.

Gardasil, Merck & Co.’s vaccine designed to prevent certain forms of the human papillomavirus, has been linked to 16 deaths. The new information about the dangers of Gardasil has been reported by Judicial Watch, a consumer watchdog group that obtained the information from the FDA. The deaths occurred between May 2009 and September 2010. The report includes nearly 4,000 adverse reactions to Gardasil including 213 involving permanent disability. Additionally, the report includes 25 cases of young girls contracting Guillian Barre Syndrome, an autoimmune disorder affecting the peripheral nervous system. The Syndrome is one of the leading causes of non-trauma-induced paralysis in the world.
“To say Gardasil has a suspect safety record is a big understatement. These reports are troubling and show that the FDA and other public health authorities may be asleep at the switch,” said Judicial Watch President Tom Fitton. “In the meantime, the public relations push for Gardasil by Merck and politicians on Capitol Hill continues. No one should require this vaccine for young children.”

Avandia, GlaxoSmithKline’s controversial diabetes drug, will have its sales restricted in the US and altogether removed from the European marketplace. The moves come after a long series of reports and studies that Avandia increases the risk of heart attacks and strokes in diabetes patients. Some reports have also expressed concerns about Avandia’s effectiveness especially in comparison with other diabetes drugs such as rival Actos.
According to the Wall St. Journal, “The FDA will require GlaxoSmithKline to develop a restricted access program for Avandia that would make it available only if other types of drugs fail to properly treat diabetes. Patients currently taking Avandia can continue on the medication.”

“It is a complete untruth that DePuy did not have reason to withdraw the ASR before now; we have been telling them since 2007, but they allowed it to be used on thousands of people,” that’s according to Professor Stephen Graves, head of the Australian National Joint Replacement Registry. Graves was speaking on the record with the Independent, a United Kingdom media outlet about the recent recall of DePuy’s ASR hip replacement medical devices.
According to Professor Graves, the Australian Registry had sent DePuy, a subsidiary of Johnson & Johnson, had sent DePuy seven reports concerning defects with their ASR hip product back in 2007. The DePuy hips were taken off the Australian market in December 2009.
Graves believes the medical device company is liable for the needless suffering of thousands of patients who’ve since received DePuy hips. According to him, the fact that DePuy neglected to publicly announce the problems with the defective hips until recently is irresponsible.

The House on Oversight and Government Reform is investigating whether Johnson & Johnson avoided a recall of its product Motrin by having a private contractor buy the product off store shelves. The pharmaceutical company and medical device manufacturing company has been rocked by drug recalls as well as medical device product defects the last few years including the DePuy ASR hip replacements that were recently recalled due to defects.
The issue involving Motrin has the FDA and J&J in a “he said she said” standoff. J&J officials maintain that they kept the FDA informed of the Motrin purchases while the FDA claims they were never informed of such a decision.
A hearing is scheduled for September 30 and the committee chair, Rep. Edolphus Towns plans to call J&J CEO William Weldon to testify as to what actions were taken and if the company was trying to evade a recall of its popular drug Motrin.
The Motrin problem began in November 2008 when J&J discovered that certain Motrin pills were not dissolving properly due to a manufacturing problem in the company’s San Juan Puerto Rico plant.
Besides the DePuy hip recall and this latest problem with Motrin, the company has also faced scrutiny and criticism for manufacturing defects that forced the recall of its popular Tylenol products.

DePuy Hip lawsuits against the manufacturer Johnson & Johnson may be consolidated into a multidistrict litigation. A motion for such consolidation was filed on September 3rd with the US Judicial Panel on Multidistrict Litigation.
Lawsuits that are consolidated into an MDL are normally approved if they have similar fact patterns, the same defendant, and demonstrate that such consolidation will expedite the lawsuits through the court system.
The hip manufacturer, Johnson & Johnson recently announced a DePuy hip recall of the device after data from the National Joint Registry of England showed that 12-13% of DePuy hips have had to be replaced within 5 years of implantation. Approximately 93,000 DePuy hips have been implanted worldwide.
Because Johnson & Johnson does not maintain a database of DePuy hip transplant patients, those who’ve undergone a hip transplant since July 2003 have been advised to check with their surgeon about their hip implant. Even those patients who are not experiencing any symptoms of hip implant failure have been encouraged to check with their surgeon for further testing in order to determine if their hip is defective.

Certain drugs used as contrast agents in MRIs will get new, tougher warnings from the FDA due to their association with a dangerous skin condition known as nephrogenic systemic fibrosis. The drugs are gadolinium-based contrast agents which pose a higher risk when used in patients with kidney disease.
In announcing the new warnings for the MRI contrast agents, the FDA also noted that three gadolinium-based contrast agents should not be used at all in patients with kidney disease. They are Covidien PLC’s Optimark, Bayer AG’s Magnevist, and General Electric Co.’s Omniscan.
NSF is a rare but potentially fatal skin disease characterized by excessive fibrous connective tissue in the skin, eyes, joints, and internal organs. The FDA also stated that there have been no known cases of NSF in patients who have no kidney problems.