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Medtronic Issues Recall for Heparin Coated Equipment

Scott Kappes — Mon, 12 May 2008 11:19:59 GMT

Last week fallout continued resonate from the recall of Baxter International's heart surgery medication heparin, as popular medical device maker, Medtronic, issued a recall for some disposable devices used during heart surgery. The devices are coated with Medtronic's Carmeda BioActive surface that includes heparin. The company has not received any reports of injury from the devices, but said that they issued the recall as a precautionary measure.

The coating is used on blood oxygenators, reservoirs, pumps and other disposable products that are used during the bypass surgery, the company said.

At least 81 deaths have been linked to contaminated batches of heparin. These patients experienced classic signs of allergic reaction including swelling of larynx and plummeting blood pressure among other symptoms.

The FDA suspects that the contamination was a deliberate attempt to pass off a similar but much cheaper product as raw heparin. The contaminant, identified as chondroitin sulfate, is derived from animal cartilage and costs about 100 times less to produce than heparin, which is extracted from pig intestines.

Baxter claims that the contamination occurred somewhere in its Chinese supply line and was not detected sooner because of the close similarity to of the contaminant to heparin. Normal tests to ensure quality could not differentiate between chondroitin sulfate and actual heparin.

Investigation of Endoscopy Clinics Turns Up 77 Cases of Hepatitis

Scott Kappes — Fri, 09 May 2008 12:18:02 GMT

Yesterday Nevada health officials released the findings of a probe investigating the patients treated at Las Vegas clinics that allegedly reused single use medication vials and syringes. This is one of the largest hepatitis outbreaks the nation has ever seen. Seven cases linked to the clinics had previously been identified by authorities, but the 77 new cases discovered by the probe have shocked authorities. "This is a very large outbreak and a very serious illness," said Brian Labus, the senior epidemiologist for the Southern Nevada Health District.

The out break began in February, and since that time gained the attention of the national media, federal health authorities and even the FBI. Over 40,000 individuals were notified of about the outbreak and urged to be tested for hepatitis and HIV. About 50,000 blood test have been preformed on possible victims and those in close contact to them, but officials say that as many as 10,000 patients were unable to be located and therefore most likely have not been tested.

Since the first cases were identified, the Endoscopy Center of Southern Nevada has been closed and fined $500,000. Two doctors, including the center's owner, Depak Desai, have been required to stop practicing.

Health authorities had not inspected the clinics in question since 2001, although state policy requires inspection every three years. The licensing agency cited insufficient funding as the reason for the delay.

This type of blatant disregard for policy and standard hygiene practices is unacceptable. The owners of the these clinics ordered their staff reuse single use products in an effort to maximize profits and in turn placed innocent lives at risk. Hundreds of former patients have joined a class action lawsuit against the clinics and their owners.

Advocacy Group Calls For Ortho Evra to Pulled From the Market

Scott Kappes — Thu, 08 May 2008 16:10:20 GMT

Today the watchdog group Public Citizen petitioned the U.S. government to pull the birth control patch Ortho Evra from the market. Ortho Evra has been linked to higher rates of blood clots and other complications than birth control pills. Some studies have even placed the risk as twice that of the more traditional pill. When the FDA approved the patch in 2001, it became an instant hit among women who wanted an easier alternative to the daily pill; however, by 2004 studies had linked the patch to elevated risks of blood clots. In 2005 the FDA updated the label of Ortho Evra to advise patients of the increased risks associated with the patch.

Just shy of 10 million prescriptions were filled for Ortho Evra in 2004, while by 2007 demand had dropped off considerably to only 2.7 million. Dr. Sydney Wolf, of Public Citizen, argued to day that Ortho Evra offers no increased contraceptive benefit to make up for the increased risks.

Despite the risk, Wolfe said abruptly cutting off users could result in unwanted pregnancies. So he urged the FDA to phase out patch sales with a six-month period during which existing users could only get refills, allowing them time to switch to another contraceptive.

The FDA said that they have not yet had time to review the petition submitted by Public Citizen, but said that that they will respond directly to the advocacy group once the petition has been evaluated.

All Fentanyl Patches Recalled

Robert Binstock — Thu, 08 May 2008 11:06:59 GMT

In February of this year Actavis issued a voluntary recall of 14 lots of their popular fentanyl transdermal painkilling patch. The patches are designed to treat chronic pain by slowly releasing extremely powerful fentanyl gel that is absorbed through the skin; however, some of the patches were found to have a defect that caused the gel to be rapidly released from the patches. This rapid intake of fentanyl can result in respiratory depression and possible fatal overdose.

Actavis has now expanded this recall to include all fentanyl patches. The company says that the recall is precautionary measure because they cannot be sure that all patches are free from defects.

Patients that suspect that they have been exposed to excessive amounts of fentanyl from a defective patch should immediately remove the patch and rinse the affected area with cool water only- NO SOAP, as it may open pores and increase the rate of absorption. Defective patches should be handled carefully and flushed down the toilet to diminish the risk of additional exposure.

Hundreds of injuries and several deaths have been linked to fentanyl overdose from the use of transdermal patches. Dozens of lawsuits have been filed regarding these injuries.

Mouthwash Recalled for Contamination

Scott Kappes — Wed, 07 May 2008 16:08:17 GMT

Today Cardinal Health issued a voluntary recall of affected lots of alcohol-free mouthwash after it was found tests showed the product was contaminated with Burkholderia cepacia (B. cepacia). The bacteria poses only a very small medical risk to healthy individuals, but individuals with weakened immune systems or cystic fibrosis may be susceptible to infections.

The tainted mouthwash was not sold in stores, but rater distributed in hospitals and other heathcare facilities throughout the country. In all the company is recalling some 60,000 bottles of mouthwash from nearly 1,000 medical facilities nationwide. The mouthwash is made by Hydrox Inc and branded with the Cardinal name.

The CDC reports that hospital illness has been associated with the contaminated mouthwash in one state.

Preemption Threatens Public Safety

Robert Binstock — Mon, 05 May 2008 11:24:27 GMT

Preemption has been a big topic in the legal world over the past several months. Basically the issue is whether or not the FDA's approval of a drug should preempt consumers from filing lawsuits for adverse effects experienced from the drugs. Preemption in fact shields pharmaceutical manufacturers from lawsuits brought forth by consumers who were injured from their highly profitable drugs. Since the induction of FDA, over 70 years ago, the drug approval process has been supplemented by the extra layer of protection provided by the right of private litigation. A case coming before the Supreme Court this fall could eliminate this long established president of protection.

As a cascade of recent examples demonstrates, FDA approval does not and cannot warrant a drug's safety over its lifetime. Vioxx, Celebrex, Halcion, Paxil, the weight loss pill ephedra -- the list goes on. In each of these cases, private litigation exposed risks the FDA did not foresee -- and, importantly, likely could not have foreseen -- at the time the drug was approved. Each of these cases also exposed ample evidence that the drug manufacturers did have knowledge of these risks, and did not disclose them.

To think that it is possible for the FDA to ensure accurate safety warnings of every drug they approve is unrealistic. Drugs that are seen to be very beneficial or are thought to have unique treatment aspects are often placed on the fast track for FDA approval. It often takes years on the market before true dangers of a drug are revealed. To take away the right of individual citizens to pursue private legal action gives big pharma free pass. We have seen in the past that even with the threat of multi-billion dollar class-action lawsuits these companies have deliberately concealed data that would be damaging to their products, with no concern for the lives of innocent Americans. What do you think they would be hiding if they knew that they couldn't be sued for the harm caused by their products?

Lawmakers Pledge to Raise More Money For Foreign Inspections

Scott Kappes — Fri, 02 May 2008 17:29:39 GMT

After hearing tearful testimony this week of the family members who recently lost loved ones treated with contaminated batches of the popular blood-thinner Heparin. Heparin was recalled in February when it was discovered that some batches of the product had become contaminated. The contamination was traced back to a Chinese plant that produces the raw ingredients for the American manufacturer Baxter International. The FDA had never inspected the plant. The FDA now believed that the contamination was most likley intentional, in effort to cut costs and improve profits. It is apparent that more inspections are need to ensure the safety of foreign manufacturing plants, but the under funded agency has simply does not have the estimated $250 million it would take to perform the inspections.

One proposal would require drugmakers to pay fees to the U.S. Food and Drug Administration to boost capacity to check overseas manufacturing sites in an effort to keep counterfeit or contaminated drugs from reaching the U.S. market.

While this seems like a good option at face value, some lawmakers were concerned with the intricacies of the proposal, and called for better explanation of exact how the fee would be used.

Over 80 percent of active drug ingredients are produced abroad. With the recent recalls of Chinese toys for lead paint violations and contaminated pet foods, the recall of Heparin should be cause for some concern. The contaminated Heparin has already been linked to 81 deaths, and something must be done to ensure that this does not happen again in the future.

Families of Heparin Victims Tell Their Stories

Scott Kappes — Wed, 30 Apr 2008 14:10:58 GMT

Yesterday the families of some of those who lost lives after being treated with a contaminated blood thinner, Heparin, told their stories to a House committee. The congressional panel listened to the tearful and sometimes angry testimony as family members expressed their discontent for manufacturers and regulators. The panel also heard testimony from manufacturers and industry regulators, but was disappointed with their inability to stop the contaminated Heparin from reaching the US market.

One man, Leroy Hubley of Toledo, Ohio, lost his wife Bonnie and his son Randy, within weeks of each other. They both had an inherited kidney disease and had undergone kidney dialysis at an Ohio clinic and received heparin from a batch made by Baxter International.

Contaminated Heparin has been linked to 81 deaths according to the FDA. Although it is not yet clear exactly how batches of Heparin were contaminated but the current hypothesis is that the contamination was intentional.

The authentic ingredient in raw heparin is made from the lining of pig intestines and costs about 900 dollars a pound, said a congressional investigator, whereas the contaminant, oversulfated chondroitin sulfate, is made from animal cartilage and costs 9 dollars a pound.

Experts suspect that the astronomical difference between the prices of the two similar products enticed someone in the supply chain to substitute one for the other in the interest of profit. This is not really that surprising to me. We have seen pharmaceutical companies engage in deceptive practices and questionable tactics all in the name of profit. I don't know why we would think that the ethics of the industry have changed.

Class I Recall Issued for Digitek Tablets

Scott Kappes — Mon, 28 Apr 2008 18:36:10 GMT

Today the Actavis Totowa LLC in conjunction with the FDA issued a Class I recall of all Digitek tablets. Digitek is used to treat abnormal heart rhythms and heart failure; however, the company has learned that some pills may be twice as thick and contain double the approved level of the active ingredient. Taking these double strength tablets could result in an elevated risk of digitalis toxicity in patients with renal failure. Digitalis toxicity can cause low blood pressure, dizziness, cardiac instability, nausea, vomiting, and bradycardia (a heart rate below 60 bpm).The tablets are distributed by Mylan Pharmaceuticals Inc, under a "Bertek "label, and also by UDL Labratories Inc, under "UDL" a label.

Several reports of illnesses and injuries have been reported. Patients should contact their healthcare professional with questions. Retailers are encouraged to remove all recalled products from their shelves and return to their place of purchase. Additiional information can be found at www.actavis.us.

Claritin-Singulair Combo Pill Rejected by FDA

Scott Kappes — Mon, 28 Apr 2008 13:57:37 GMT

Late Friday the makers of Claritin and Singulair announced that the FDA has rejected an application for a pill combining the two drugs. Singulair, sold by Merck, is a popular medication used to treat asthma and combat allergies. Claritin, produced by Schering-Plough, offers a variety of OTC and prescription medications to treat the symptoms of allergies. The thought was that the combination of the two pills could provide a better solution for some patients by offering a congestion aid that is not demonstrated by the medications when administered separately. The FDA claims that several years of research failed to show an advantage when combining the two medications when treating seasonal allergies.

Combo pills just aren't causing a lot of happiness for Merck and Schering-Plough these days. The companies have been dealing with a firestorm over blockbuster combo pill Vytorin, which they market jointly. So we raised our eyebrow a bit upon reading a quote that Schering-Plough spokeswoman Lisa Ellen gave to Reuters after the Singulair-Claritin news came out: "We're still looking at it, and still evaluating the future of the joint venture as well." The comment inspired a headline on a post at the blog PharmaGossip that read, "Merck and Schering Plough - allergic to each other?"

Who know what the future is for combo pills, but for time being this might be the best thing that could happen for Merck and Schering Plough. With lawsuits mounting over Vytorin and the volatility of the pharmaceutical industry, maybe this denied application is just what the doctor ordered.