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:
Citrushield Lotion
Dermasentials DermaBarrier
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

The FDA has issued a warning to all consumers to not purchase or use any body building supplements or dietary supplements that may contain steroids due to their association with kidney and liver issues.
While the warning was general in nature, the FDA noted that consumers should be aware of any products that are labeled or advertised as “anabolic” and “tren,” or phrases like “blocks estrogen,” and “minimizes gyno”. According to the FDA, these are code words indicating the possibility that the products contain steroids or other harmful substances.
In the warning letter, the FDA pointed out 8 specific products from American Cellular Labs. The NY Times quoted an official as saying, “We think that there may be a number of firms that are marketing similar products, if not products that are exactly the same,” Michael Levy, director of the Division of New Drugs and Labeling at the agency’s Center for Drug Evaluation and Research, said in a conference call with reporters on Tuesday.
Supplements are a multi-million dollar industry that is not regulated by the FDA in the same fashion as prescription drugs. The FDA has authority to intervene only after there are reports of problems with supplements and can prove the particular product is a health hazard.

Recently, I’ve heard rumors that Zimmer Inc. is attempting to contact patients injured by the defective Zimmer Durom Cup hip implant in order to settle potential legal claims. While some of those injured may be anxious to speak with Zimmer officials about such a settlement, it’s not always in the best interest of those injured to resolve their claims without first speaking to an attorney who’s experienced in handling medical device defect claims. Let me explain why. First, experts are not sure the extent of the Zimmer hip problem. The exact nature and cause of the defect has yet to be determined. Second, a patient is rarely in a position to negotiate a fair resolution for the injuries suffered due to the Zimmer hip. Third, even the injured party may not be aware of future problems the Zimmer hip implant may cause. These are just some of the reasons to consult an attorney who has handled medical device cases.
It’s also important to mention that if you have retained an attorney, Zimmer officials are not allowed to speak with you about your potential case without the consent and advice of your attorney.
Just as I wouldn’t represent myself in a criminal matter, it’s never a good idea to represent yourself in any civil matter. You owe it to yourself and your loved ones to find and retain an attorney so that your rights are protected and your potential claim is investigated thoroughly.

While we’re still not 100% certain the exact cause for the failure of the Zimmer Durom Cup hip implants, one this is for certain, many patients who’ve had the artificial Zimmer hip implanted, have experienced extreme pain and suffering as a result of the hip replacement surgery. It appears that the components of the Zimmer Durom hip don’t experience bone growth so that the implanted medical device loosens and separates at some point after hip surgery.
It’s interesting and ironic to note that the first medical professional to complain about the potential problems with the Zimmer Durom hip was Dr. Lawrence Dorr, a former paid consultant for Zimmer. Upon Dorr’s complaints about the artificial hip, Zimmer officials countered that Dorr was not using the correct procedure in performing the artificial hip implant surgery. Zimmer made this claim in spite of Dr. Dorr’s 30 years of experience in hip implant surgery and his reputation as one of the foremost artificial hip experts in the country. Instead of taking Dorr’s concerns seriously, Zimmer officials waited until 1,300 more patients had Zimmer hip implants before recalling the defective hip implant.
The defective medical device has been recalled in the US but not before approximately 13,000 patients in the US have had Zimmer Durom Cup hips implanted. At this stage, it’s estimated that the failure rate is 5% however it may grow to around a 20% failure rate.

The effort is receiving scant attention from the media but it’s a part of the healthcare reform discussion in Washington DC. Proponents of stopping pharmaceutical ads on television note that the marketing campaigns often exaggerate the benefits of the particular drug while downplaying the adverse effects. Other critics point to the ads encourage consumers to self-diagnose ailments and go to their doctors asking to receive certain drugs for previously undiagnosed ailments such as restless leg syndrome, arthritis, and sexual dysfunction.
Pharmaceutical companies spent $4.8 billion last year on direct to consumer advertisements. The companies receive tax deductions for such marketing efforts meaning the consumer is partially paying the bill for these large pharmaceutical companies.
The United States and New Zealand are the only two countries in the world that allow direct to consumer marketing campaigns. We’ve already seen the adverse consequences of some of these efforts. In 2004, Merck removed Vioxx from the market after revelation of safety concerns. However, this happened after Merck had already garnered handsome profits from its aggressive and extensive direct to consumer marketing efforts. In 2008, Pfizer discontinued television commercials for its cholesterol drug after it was discovered that the ad misrepresented the credentials of the doctor pitching the drug. Also last year, Bayer’s popular birth control drug came under FDA scrutiny for downplaying the drug’s side effects. Yasmin and Yaz are both the subject of lawsuits.
In spite of the lawsuits, pharmaceutical companies remain undeterred in their efforts to market their drugs. They stand to make more profits from misleading marketing campaigns than they’ll lose from lawsuits after a drug is found to cause serious injury.
It’s time for direct to consumer drug ads become a central part of the healthcare reform agenda. Consumers will be safer and the doctors who prescribe the drugs will have better, more independent information based on science and not on marketing.