After months of withering criticism from industry regulators, Congress, and consumer advocates, FDA’s chief medical device regulator Daniel Schultz is resigning. Much of the criticism leveled at the medical device official has focused on his close relationship with medical device manufacturers. Two years ago during Congressional testimony, Senator Charles Grassley accused Schultz of ignoring science in favor of maintaining his cozy relationship with device companies.
During his tenure at the FDA, Schultz has at times sided with medical device makers over the safety objections of FDA regulators who’ve argued that the medical device in question raises serious health concerns. According to a Wall St. Journal report, “A group of nine device division employees wrote to the House Energy and Commerce Committee last October to complain that the division’s leaders had approved devices despite formal safety and efficacy concerns raised by FDA. They also alleged some scientists who objected to the decisions faced retaliation from leaders of the device division. The FDA at the time declined to comment.”
The resignation comes at a pivotal time for the medical device industry as the Senate is holding hearings on the Medical Device Safety Act of 2009 written to repeal the 2008 Supreme Court Riegel v. Medtronic decision. The medical device industry is also under increased scrutiny with lawsuits pending against manufacturers of defective medical devices such as Stryker and Zimmer hip implants and Medtronic’s Sprint Fidelis defibrillator leads.
Dr. Schultz has been the FDA’s chief medical device regulator for the past five years. FDA officials did not comment on how soon a replacement for Schultz would be made.
Chief Judge Mary M. Lisi, the presiding judge over the Kugel Mesh hernia patch lawsuits, has indicated that the first of four trials is now scheduled for March 2010. The Kugel Mesh hernia patch lawsuits have been consolidated in Multidistrict Litigation in Rhode Island. According to a case management order, three other Kugel Mesh trials are scheduled for April, July and September 2010. Currently, there are more than 1,000 lawsuits in the MDL.
The consolidation of the lawsuits is a result of the number of lawsuits filed as well as similar issues of fact in the cases. The MDL was formed in 2007 in order to handle lawsuits arising from the defective hernia patch that has caused thousands of significant injuries to those who’ve had the hernia repair surgery.
Between 2005 and 2007, three separate Kugel Mesh hernia patch recalls were issued for different types of the hernia mesh patch. The lawsuits also involve Kugel patches that have not been recalled but employ a similar dual-mesh technology which has been associated with problems like intestinal pain, bowel perforation, intestinal fistula and additional surgery to remove the mesh.
I don’t want to jinx it, but the 2009 Medical Device Safety Act looks like it may be approved. The legislation, designed to void Riegel v. Medtronic, was the focus of witness testimony before the US Senate Health, Education, Labor and Pensions Committee. Key witnesses who testified in support of the Act included Dr. William Maisel, director of the Medical Device Safety Institute and a cardiologist at Beth Israel Deaconess Medical Center in Boston. Dr. Maisel also chairs the FDA’s Circulatory Advisory Committee. Maisel, an influential voice in the industry, testified that FDA approval does not guarantee that the medical device is safe.
Essentially, that’s the problem with the Riegel v. Medtronic ruling. This court decision exempted medical device manufacturers from state civil suits if the device had received prior FDA approval.
Another witness testifying before the Senate committee spoke of the suffering he endured after being injured by multiple shocks from a defective Sprint Fidelis defibrillator whose wires malfunctioned causing the medical device to continuously shock the victim. The 2009 Medical Device Safety Act would allow such victims to pursue claims against the manufacturers of such defective medical devices.
Currently, failure to warn and design defect lawsuits are preempted for faulty medical devices but not for drugs. The 2009 Medical Device Safety Act is designed to correct this inequity in the law. Let’s hope it passes and becomes the law of the land.
The Wall St. Journal is reporting that the federal probe into the Chinese drywall debacle should be made available to the public in September. It’s estimated that between 2004 and 2008, 500 million pounds of the tainted Chinese drywall was imported into the United States by construction companies. That’s enough drywall to build 100,000 homes.
While the Chinese drywall issue first surfaced in southwest Florida a number of other states have been affected by the contaminated drywall. The drywall is suspected to cause the corrosion of electrical equipment and metal fixtures in the affected homes. The Environmental Protection Agency has tested some of the affected homes and found elevated levels of strontium sulfide, a compound used in the manufacture of acrylic paint.
The investigation is ongoing and it is still unclear how the Chinese drywall may affect someone’s individual health. There have been complaints concerning respiratory issues and sinus problems.
The FDA is reporting 106 cases of adverse effects linked to the popular drug Reglan and its generic version metoclopramide. The drug has been linked to a serious neurological disorder tardive dyskinesia when it is taken for longer than a 90 day period. Metoclopramide was approved for use by the FDA for short term treatment of certain gastrointestinal disorders such as gastroesophageal reflux disease (GERD) in people who fail to respond to other treatments, and to treat diabetic gastroparesis (slowed emptying of the stomach’s contents into the intestines).
According to the FDA more than two million US patients use metoclopramide. One study has determined that 20% of patients who take metoclopramide for a period longer than 90 days develop tardive dyskinesia, a serious neurological disorder. Patients suffering from tardive dyskinesia present the following symptoms: grimacing, chewing, smacking of lips, rapid eye movements and rapid movements of the fingers, arms, legs, and trunk.
Tardive dyskinesia is permanent and there is no known treatment.
These adverse events led the FDA to order a black box warning in February 2009. The warning informs healthcare professionals that prolonged use of Reglan (metoclopramide) should be avoided except in rare cases.
The US Marshall’s office has seized all skin sanitizers from Clarcon Biological Chemistry Laboratory in Utah after an FDA inspection in June found high levels of bacteria in the skin sanitizing products. The federal seizure requested by the FDA came after company officials refused to destroy the bacteria laden product.
The following Clarcon Products are affected by the recall and should be discarded:
Dermassentials by Clarcon Antimicrobial Hand Sanitizer
Iron Fist Barrier Hand Treatment
Skin Shield Restaurant
Skin Shield Industrial
Skin Shield Beauty Salon Lotion
Total Skin Care Beauty
Total Skin Care Work