Archive for the ‘Product Liability’ Category

Heparin Safety Recommendations – Four Years Later

Monday, May 14th, 2012

Last month, to the satisfaction of personal injury attorneys nationwide, the U.S. Environmental Protection Agency (the EPA) at last issued its long-awaited final health assessment of the chemichal perchloroethylene, publishing the assessment to the EPA’s Integrated Risk Information System database. The database, known as IRIS, is used by the agency and others to assess human health issues and evaluate risk information when environmental contamination and exposures occur.

Perchloroethylene is a chemical solvent. It is commonly used across the nation in dry cleaners. For some time, scientists have known that perchloroethylene is a likely human carcinogen. Now, the EPA has provided estimates for human exposure to perchloroethylene over the course of a lifetime, including the risk of cancer and non-cancer health effects.

Not included in the EPA’s assessment is any indication that wearing clothing treated with perchloroethylene in the dry cleaning process creates an exposure level which can cause health problems.

The EPA has already taken steps to address the perchloroethylene problem. For example, dry cleaners are already subject to EPA air standards, and dry cleaners located in residential buildings are required to phase out perchloroethylene use entirely by the end of 2020. Importantly, the EPA has already established permitted levels of perchloroethylene in drinking water, as well as levels for Superfund cleanup across the county – both of which will now be updated to reflect the new IRIS assessment.

Before posting the IRIS, the agency’s assessment underwent a rigorous scientific review, by the agency itself, other federal agencies, a public comment period, and an independent scientific review by the National Research Council. And in a surprising show of governmental efficiency and responsiveness, all the major comments made during the comment period have now been addressed by the agency.

Last week’s new IRIS assessment replaces the existing IRIS health risk assessment for perchloroethylene, issued in 1988. The most important update is a change in perchloroethylene’s reference dose. The IRIS reference does is meant to estimate the maximum level of daily oral exposure which a human can encounter without an “appreciable risk” of health problems over the course of his lifetime. The 1988 IRIS reference dose for perchloroethylene was set at 0.01 mg/kg-day.

The new IRIS reference dose is 0.006 mg/kg-day – a significant downward departure which will result in highly tightened standards and cleanup. This will affect Superfund sites – at hundreds of which perchloroethylene is present, drinking water standards, atmospheric emissions standards, and all areas of future agency rulemaking.

Our Chicago personal injury lawyers applaud the EPA for taking this important step. We also join with others in urging the Occupation Safety and Health Administration (OSHA) to act on this new data and revise the current allowed perchloroethylene exposure levels in the workplace.
In the meantime, if you or a loved one has developed cancer or another serious medical condition after working at or near a dry cleaner, talk to a personal injury attorney about whether your condition may have been caused by prolonged perchloroethylene exposure. An experience attorney can help you to sort through the possible causes in your case, and to determine whether legal action is warranted.

For a free consultation with an experienced Chicago personal injury lawyer at Passen Law Group, call us at (312) 527-4500.

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Another Dangerous Breast Implant Leads to Criminal Charges in Europe

Thursday, February 23rd, 2012

In yet another blow to the breast implant market, the burgeoning scandal of the implants from Ploy Implant Prothese (known as “PIP”) has rapidly become a medical products liability nightmare.

The implants were used in over 400,000 women across 65 countries in Europe and South America. The implants have not been sold in the United States since 2000, but may effect women who have had their implants in place since then.

The implants were made with industrial-grade, rather than proper medical grade. Industrial-grade silicone has more contaminants. The silicone the company used had been manufactured for use in mattresses – not medical procedures. As many experts have noted, this means that no one can be sure just how dangerous the implants – or any particular set of PIP implants, actually are.

In fact, the company made two versions of the implants: one, using American medical-grade silicone, was used for wealthy patients. The other, containing the industrial silicone, was used for everyone else. Moreover, the shell used to contain the silicone is also shoddy, and weaker than the industry standard.

The implants thus run the risk of ruptures and leaks, which can lead to inflammation, scarring, and infection.

Unfortunately, the company went bankrupt in 2010, after the French government banned further use of the implants. The company’s assets have already been fully liquidated. Thus, victims of these substandard medical products are left with little-to-no financial recourse.

Fortunately, many to most of the implants were sold in countries with a national medical system. Some nations have decided to pay for removal and replacement of the implants, but all such nations will pay if medical problems emerge as a result of the implants. But women in other nations, such as any U.S. residents who may have obtained the implants abroad, are left with very little in the way of options.

But this is not the end of this legal story. In fact, the head of the French Company, 72-year-old Jean-Claude Mas, has now been arrested. He was charged at the national police station in Marseilles with involuntary injury, and is being held under house arrest in Six-Fours-les-Plages, a community in the South of France.

Mr. Mas has other legal problems, as well, including an admission to French police that he directed employees to hide the industrial-grade silicone from inspectors, and his admission that the company had been fooling EU inspectors for around 13 years.

Mr. Mas, however, remained completely unrepentant. In an interview, he stated that he did not wish to address the victims, and accused the victims of acting for financial, rather than medical, reasons.

Mr. Mas’ attitude is, sadly, typical of the attitude of those who manufacture consumer products, even medical products. It is because of this utter lack of concern for the health and safety of the public that the products liability laws are necessary. Consumers and patients cannot rely upon companies to ensure that their products are safe, but must attempt to scare manufacturers into caring for the safety of their patients via the threat of a lawsuit.

That is why, if you or a loved one have suffered injury due to a faulty medical devise, our top products liability attorneys urge you to talk to a lawyer about the possibility of legal action. Not only can you obtain compensation and justice for yourself, but your courage, and the legal judgment you obtain, may make the next Mr. Mas think twice before gambling with the health of the public.

For a free consultation with an experienced Chicago products liability lawyer at Passen Law Group, call us at (312) 527-4500.

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Heparin Safety Recommendations – Four Years Later

Wednesday, February 15th, 2012

In yet another example of the inadequacy of federal regulators to protect patient health, the FDA this month issued recommendations for measures to ensure that Heparin, the popular blood-clot prevention drug, was produced safely. While our products liability attorneys applaud the issuance of such recommendations, it is important to note that the agency has finally taken this step four years after the contamination scare which rocked drug users worldwide.

Heparin, a blood thinner derived from pig intestines. The drug was previously produced by Baxter International, Inc., a major U.S. pharmaceutical supplier, but the company sold this portion of its business last year to Hikma Pharmaceuticals Plc.

In the early months of 2008, the FDA first began receiving reports of problems with Heparin, with users reporting serious reactions to the drug. Many users were hospitalized, left on dialysis, and even killed. These problems were traced to the Heparin – and led to a large products liability problem that rocked the international pharmaceutical industry.

The FDA then conducted a probe, and determined that a contaminant was present in some Heparin batches. The contaminant was then traced to certain of Heparin’s active ingredients, which were themselves manufactured in China. Subsequent investigations determined that the contamination with oversulfated chondroitin sulfate (OSCS) “appeared” to be intentional – a move by the Chinese manufacturers to use OSCS as a filler to reduce the costs of production. Hikma asserts that it now uses only materials from the U.S. and Canada in the production of Heparin.

The Heparin problems triggered massive public outcry, and eventually led to congressional hearings about drug products and components manufactured in foreign plants – and the lack of oversight and inspections at those plants.

The FDA posted the draft guidance on its website, stating that it was designed to assist the manufacturers of Heparin’s active ingredients (and the finished product) to avoid contamination. Said FDA Commissioner Margaret Hamburg, “We’re making sure we have systems in place to prevent that particular problem.” In addition to the original contamination, the FDA has also expressed concern about the substitution of cow-based heparin, which could lead to contamination with mad-cow disease.

The draft guidance calls for testing of each shipment of crude heparin, including testing to determine the species origin (to ensure that it is pork-based), and to look for the OSCS. Testing would be done before the manufacture of the drug Heparin from the crude ingredients. The draft guidance also calls for manufacturers to audit their suppliers.

While encouraging, the FDA’s draft guidance is a classic case of “too little, too late.” First, it is phenomenal that the FDA has taken four years to take action on this very serious problem. The draft will now be open for comment for 60 days, at which point the FDA will decide whether to make changes, resulting in additional delays, or issue the guidance in non-draft form.

In addition, the proposed guidance is just that – guidance. Even if adopted, it would simply be a list of recommendations for manufacturers, and would not create any legally-binding, or enforceable, rules or responsibilities.

Our top products liability attorneys are disappointed that FDA action has taken this long, and dismayed that, in the end, the FDA has chosen to issue only “guidance,” without taking any real action to protect consumers. We urge the agency to reconsider, and to make this guidance binding, requiring manufacturers to take these very basic steps to protect U.S. patients and the public.

For a free consultation with an experienced Chicago products liability lawyer at Passen Law Group, call us at (312) 527-4500.

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