Monthly Archives: December 2009

Dietary Supplement Recall

Another dietary supplement has been recalled after an FDA analysis of the product found it had Sulfoaildenafil, an FDA-approved substance to treat male erectile dysfunction. Atlas Operations Inc. has announced it is recalling the following lot numbers of its product: 494, 520C, 520B, 520A, 520, 521, 705, 706, 779, and 807. The product is sold under the following names: Rock Hard T12-705-09, R52-705-09, 72 hrs B54-708-09, Stamin It R2-705-08, Finally On Demand R26-706-09, R27-706-09, Sexual Surge H49-705-09, Staminil T25,705-09, Virect T29-705-09.
As with other recalled dietary supplements, the active ingredient which prompted the recall was not listed on the product label. Dietary supplements have come under increased federal scrutiny due to misinformation or lack of information on the product label. Such dietary supplements are not regulated by the FDA prior to market approval. The FDA will investigate these products if there are complaints or other issues raised after the supplements have reached the marketplace.

Avandia Maker Ordered to Produce Documents

Avandia, manufactured by Glaxo, is the subject of multidistrict lititgation for its dangerous side effects which include serious cardiovascular problems. The judge in the MDL, the Honorable Cynthia M. Rufe of the United States District Court for the Eastern District of Pennsylvania, has ordered Glaxo to release dozens of documents that Glaxo had argued were subject to attorney-client privilege. In Judge Rufe’s opinion, she noted ““attorney-client privilege does not shield documents merely because they were transferred or routed through an attorney,” and that “documents prepared by a corporation as part of efforts to ensure compliance with federal regulatory agencies or maintain a positive public image for its products, and not because of possible litigation, are not protected by [the] work-product doctrine.”
In November 2007, Avandia received a black box warning from the FDA concerning Avandia’s connection with myocardial ischemia. A Cleveland Clinic study that same year found Avandia users to be 43% more susceptible to heart attacks. Since that time, thousands of Avandia patients have filed Avandia lawsuits.

Medtronic Receives Subpoenas from HHS

Medtronic has received subpoenas from the Department of Health and Human Services concerning its heart rhythm devices. The subpoenas requested information about the company’s revenue, marketing, reimbursement programs, and scientific studies. Medical device companies including Medtronic and Boston Scientific have come under more scrutiny after investigations into the company’s relationships with doctors as well as their marketing programs.
In the last few years, the federal government has been investigating medical device company’s transparency as well as the manner in which their medical device products are approved for market use.

Chinese Drywall Class Action Lawsuit

Our law firm is participating in a massive Chinese Drywall class action lawsuit against Knauf and other Chinese Drywall manufacturers. The class action lawsuit was filed yesterday in New Orleans in U.S. District Court for the Eastern District of Louisiana, where all pending federal cases have been consolidated in a multidistrict litigation.
The class action lawsuit names Knauf Plasterboard (Tianjin) Co., Ltd. as one of 600 other defendants in the case. An interesting side note to the filing-New Orleans Saints head coach Sean Payton was named a lead plaintiff in the case. The first trial should begin in January 2010.
Thus far, the Consumer Products Safety Commission has received over 2,000 complaints from 32 states. The culprit in the Chinese Drywall is hydrogen sulfide which is emitted from the putrid drywall. That’s the element that’s causing the corrosion and damage to the majority of the homes.

Drug Safety Not Improved Post Vioxx

Congressional investigators are looking into why the FDA has not implemented the new guidelines for drug safety after the Vioxx debacle of 2004. After Vioxx was removed from the market drug industry safety experts called for changes in the manner in which drugs are evaluated and monitored. The guidelines called for a more active role for those who monitor the side effects of the drug. Instead, the scientists who initially approved a drug for market are still in charge of the monitoring of the drug post market.
Some Congressional leaders like Senator Charles Grassley have been openly critical of the slow progress. “No more time should be wasted at the FDA in establishing independence for its post-market surveillance,” Sen. Charles Grassley, R-Iowa, said in a statement.
In spite of clear recommendations from drug safety experts, the FDA has failed to make the change.

Zicam Maker Says FDA Should Reverse Warning

Matrixx Initiatives, the manufacturer of the homeopathic Zicam Cold Remedy nasal spray, has asked the FDA to reverse its ruling in June of this year concerning the adverse affects of the product. Matrixx claims that the Zicam nasal spray gels are effective and safe in spite of at least 130 FDA reports of users suffering from anosmia (loss of the sense of smell). The FDA has so far rejected the request noting that the company had received an additional 800 reports of a loss of smell after using the product. These adverse events were never reported to the FDA, as required by law.
Zicam lawsuits are mounting. In October, U.S. Judicial Panel on Multidistrict Litigation consolidated the Zicam lawsuits for pretrial proceedings in the District of Arizona. The consolidated lawsuits have similar fact patterns including that zinc gluconate, the active ingredient in the Zicam nasal sprays, is toxic to the nasal tissues and can lead to a permanent loss of the sense of smell.

Zicam Lawsuits

A University of Washington study published by PLoS ONE in October has noted that Zicam users may suffer a loss of the sense of smell.
“Our results demonstrate that Zicam use could irreversibly damage mouse and human nasal tissue and may lead to significant smell dysfunction,” the research group concluded.
Since the homeopathic cold remedy was introduced to the marketplace in 1999, the FDA has received 130 reports of anosmia (loss of smell). The loss of the sense of smell could lead to other health risks associated with a loss of the sense of smell.

Antidepressant Norpramin Receives Warnings for Heart Problems

French drug make Sanofi Avenis is warning healthcare professionals and patients about risks associated with its antidepressant Norpramin and heart problems. Patients who have a history of cardiac problems including cardio dysrhythmias and cardiac conduction disturbances should be cautious about prescribing or taking the antidepressant drug Norpramin.
The warning letter issued by Sanofi Aventis cautions healthcare providers about the risks associated with their antidepression drug. Excerpts of the letter include:
Under WARNINGS General, the addition of patients who have a family history of sudden death, cardiac dysrhythmias, or cardiac conduction disturbances; also the addition of a note that seizures precede cardiac dysrhythmias and death in some patients.
 Under OVERDOSAGE:
o This section was revised to read, “Overdose of desipramine has resulted in a higher death rate compared to overdoses of other tricyclic antidepressants.”
o Under Manifestations of Overdosage, addition of: “Early changes in the QRS complex include a widening of the terminal 40 msec with a rightward axis in the frontal plane, recognized by the presence of a terminal S wave in Lead 1 and AVL and an R wave in AVR.”
o Under Management, Gastrointestinal Decontamination, revised to read: “Activated charcoal should be administered to patients who present early after an overdose.”
o Under Management, Cardiovascular, revised to read: “A maximal limb-lead QRS duration widening to greater than 100 msec is a significant indicator of toxicity, specifically for the risk of seizures and, eventually, cardiac dysrhythmias. Serum alkalinization with intravenous sodium bicarbonate and hyperventilation (as needed) should be instituted in patients manifesting significant toxicity such as QRS widening. Dysrhythmias despite adequate alkalemia may respond to overdrive pacing, beta-agonist infusions, and magnesium therapy.”
o Under Management, CNS, “phenytoin” was replaced with “propofol” and the following was deleted: “Physostigmine is not recommended except to treat life-threatening symptoms that have been unresponsive to other therapies, and then only in consultation with a poison control center.”
 Under DOSAGE AND ADMINISTRATION, Usual Adult Dose, deletion of: “Plasma
desipramine measurement would constitute the optimal guide to dosage monitoring.”
Any adverse effects connected to the use of Norpramin should be reported to the Food and Drug Administration.

Diocese of Bridgeport Releases Abuse Documents

The Diocese of Bridgeport has complied with a court order demanding the release of church documents detailing the sexual abuse by priests. The court order came after years of legal wrangling between the Diocese and survivors of sexual abuse who fought to make the secret documents public.
The church documents reveal years of church officials transferring abusive priests from one parish to another as well as the mindset of Bridgeport bishops, particularly retired Cardinal Edward Egan. Egan, bishop of Bridgeport from 1988 to 2000, was deposed as part of 23 lawsuits against the Diocese of Bridgeport. As the Bishop of Bridgeport, Egan has been criticized for failing to act when confronted with allegations of priest abuse. At times, he has staunchly defended the innocence of the priests accused.
As the documents were released earlier this week, the Diocese of Bridgeport officials claimed that it was “old news” and that past mistakes have been corrected.