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The Food and Drug Administration conducted an investigation of a OsteoSymbionics plant located in Cleveland, Ohio to learn that the company was manufacturing cranial implants which was not in accordance with Current Good Manufacturing Practice (CGMP) requirements of the Quality System regulation found in Title 21, Code of Federal Regulations (C.F.R.), Part 820.

The Food and Drug Administration determined that these cranial implants are devices which fall under the Federal Food, Drug and Cosmetic Act because the product is intended for the use of disease diagnosis, mitigation, treatment, disease prevention or may affect the structure or function of the body.

Furthermore, the Food and Drug Administration found that the company had inadequate design controls for the development of the cranial implants, did not establish or maintain procedures for ensuring that specific design requirements are met consistently, and did not establish procedures for validation which limited follow up inspections and testing; including an inadequate sterilization process. The company also failed to maintain a device master record for the cranial plate implants and did not adhere to other regulations.

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Advanced Bionics took swift action to recall the company’s HiRes 90K cochlear implant device and all un-implantable devices that have been distributed. This hearing aid recall was initiated following two reports from users who experienced excessively loud sounds, shocking sensations and a high level of discomfort. These side effects occurred within eight to ten days of initial use of the hearing aid.

At present, Advanced Bionics does not know why the HiRes 90K cochlear implant device and the company’s unimplantable devices are producing such side effects. The company is working with the Food and Drug Administration to determine the root cause that prompted the hearing aid recall. Typically, flaws in the design of the product or in safeguards of the product are the reasons for malfunction in products.

Hearing aids have come a long way from the first ear trumpet style versions of the 1700’s. By the mid 1850’s, a thin metal device was designed to meet specific needs for the hearing impaired. Nearing the 1900’s, ear tubes with speaker connections gained popularity. By the 1940’s, more modern hearing aids were developed and were offered in a variety of sizes to meet the specific needs of individual users. By the end of the 50’s, hearing aid styles were smaller due to advancements in microphone and battery technology.  In the 1990’s, digital processing hearing aids took over the marketplace, which provided greater clarity, a full range of tones and a more discreet appearance.  With the advent of digital technology, designs specifications have changed and hearing aid manufacturers are dedicated to creating advanced design specifications that do not pose risks for consumers.

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The dietary supplement known as Duro Extend Capsules, manufactured by Intelli Health Products, has been recalled throughout the nation.  Intelli Health Products took this step after the Food and Drug Administration produced results from an analysis of the product showing that it contains Sulfoaidenafil.  Sulfoaidenafil is an ingredient that is FDA approved for the treatment of erectile dysfunction.  The reason why Sulfoaidenafil must be FDA approved is because the drug can negatively interact with other prescription drugs when taken together, such as with nitroglycerin. In addition, Duro Extend Capsules may lower your blood pressure to a high risk level. These two noted risks place people with high blood pressure, diabetes, high cholesterol and heart disease in danger for serious adverse reactions that may be life threatening when taking Duro Extend Capsules with their prescriptions for their medical condition.

Duro Extend Capsules are sold across the U.S. in a blister pack containing one capsule per unit, 12-pack, 24-pack display boxes, or 3 count and 10 count bottles. All lot numbers have been recalled by Intelli Health Products.

People who have experienced an adverse reaction when using the dietary supplement should contact their physician immediately. All consumers using the product should stop using it immediately and return the unused portion to the place of purchase.

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Last year alone, roughly 10 million people in the U.S. used propoxyphene, known under the brand names Darvocet and Darvon, to relieve post operative pain.  It is unknown how many people have died or been seriously injured since the drug was approved in 1957. Recently, Public Citizen, a consumer advocacy group, petitioned the Food and Drug Administration to ban the drugs from the U.S. market, stating that the drugs caused over 2000 deaths, are highly addictive, and are not more effective than other safer pain relievers.

In June 2010, Public Citizen alleged that the Food and Drug Administration violated the law by failing to act on a petition that was originally filed in 2006. The FDA discovered over 3000 serious side effect cases involving Darvocet or Darvon. In December of this year, Darvocet and Darvon have been banned from the U.S. market.

The list of life threatening side effects associated with Darvocet and Darvon include: serious or fatal heart arrhythmia, heart attack, cardiac arrest, heart valve issues, myocardial infarction, pacemaker implantation, overdose, and suicide. The Public Citizen group determined that the risks associated with Darvocet and Darvon outweighs the benefit of pain relief, which can be accomplished by other less harmful drugs.

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In October 2010, JP Morgan Chase announced that the company would be temporarily suspending certain foreclosure processes following the discovery that court documents were not being properly reviewed by third party personnel. JP Morgan Chase had allocated some of its foreclosure verification processes to third party foreclosure companies. However, JP Morgan determined that the personnel at the third party companies were not reviewing or properly notarizing foreclosure affidavits before signing off on them.

Consequently, two lawsuits have been filed against JP Morgan Chase regarding their methods for managing foreclosures. The lawsuits were specifically filed against Washington Mutual Bank and JPMorgan Chase & Co in the United States District Court for the Northern District of Illinois, and against Chase Home Finance in California state court.

The allegations in the lawsuit are common law fraud and misrepresentation, as well as violations of state consumer fraud statutes. It is not known who filed the lawsuits at this time. JP Morgan also indicated that the company is being sued for mortgage backed securities by other companies, such as Charles Schwab and Cambridge Place Investment Management. For this reason, class action status seems appropriate to some.

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Hostility, irritability and aggressive behavior are the serious side effects that are still being reported by parents whose children take Singular.   This comes as no surprise to the U.S Food and Drug Administration because in March of 2008 the agency reexamined the safety of Singular and required new labeling to disclose the risks associated with the drug for adults and children, including:

  • Anxiousness
  • Depression
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A year ago, it was difficult to know who to sue for the health issues and property damage caused by defective Chinese Dry Wall located in homes across the U.S. Recently, a $2.6 million verdict came back in favor of seven Virginia homeowners who were adversely affected by Chinese Dry Wall. This verdict lays the foundation for thousands of others to receive financial compensation for the injuries they have sustained because of the dry wall. The Chinese Dry Wall lawsuit claims are being overseen by a federal judge in New Orleans. This is considered multidistrict litigation (MDL), but you can contact a local attorney if you feel you have been injured by Chinese Dry Wall.

If you have experienced serious respiratory infections, sinus infections, rashes, hair loss, hospitalization or irreparable damage to your home’s air conditioning unit, heating unit, electricity or plumbing, your damages may be linked to Chinese Dry Wall. It is not uncommon for all household members to become ill from Chinese Dry Wall.

People who live in homes with Chinese Dry Wall should evacuate because of the risk of toxicity and unknown long term side effects. There is also no viable means to remedy Chinese Dry Wall toxicity and damage, making the financial loss for property very high.  It is also unknown how Chinese Dry Wall will affect the groundwater supply in areas that have homes built with this type of dry wall.

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On November 18, 2010, the U.S. Judicial Panel on Multidistrict Litigation will meet in Durham North Carolina to decide if all states’, including Indiana, DePuy ASR Hip Implant lawsuits should be heard in one court.  This outcome is the result of the high number of lawsuits that are being brought against the company, estimated at 4000 to date and thousands more expected because consumers who have this hip implant are still learning about the risks.

The DePuy ASR Hip Implant was recalled by the FDA following a report by the National Joint Registry of England and Wales which demonstrated that 1 out of every 8 patients who received the DePuy ASR Hip Implant had undergone revision surgery within a five year time period after the initial placement of the implant. Typically, a hip implant should be long lasting, at least 15 years.  Revision hip surgery is real surgery that is very invasive, requires a significant recover time period and is associated with risks. There has also been an additional warning about metal on metal hip implants, such as the DePuy ASR Hip Implant, which can cast metal particles into the body, causing soft tissue damage and inflammatory responses that may lead to bone loss.

People who have filed lawsuits are those who have undergone revision hip surgery or are concerned about the increased risks associated with the hip implant. Approximately, 93,000 DePuy ASR Hip Implants were distributed throughout the U.S.

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In order to safeguard against misunderstandings and medical malpractice lawsuits, physicians and surgeons must have discussions and secure agreements about treatment with people that they are interested in receiving treatment.  These discussions and agreements are part of the informed consent process that every physician and surgeon must provide to a patient when undergoing care. Physicians and surgeons use several tools to enforce informed consent communication. These tools include visual props to help people understand information about the proposed treatment, risks associated with the treatment, skill required to compensate for complications, and alternatives to the procedure. These tools may also include: video tapes, DVD’s and informational websites.

Legal Consent

Legal consent to treatment is evident in the document entitled Informed Consent that you sign at your physician’s office before undergoing treatment. Physicians also document in your chart that you understand and have agreed to the procedure. In the case of medication distribution, you will be advised to read the product label which outlines risks associated with the drug. You will also have a discussion with your pharmacist about the medication when it is dispensed to you.

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The crux of the Duke Energy Corp scandal surrounds the company’s $2.8 billion power plant located in Southern Indiana.  Michael Reed, president of Indiana operations, and Scott Storms, regulatory affairs lawyer, both based out of the Plainfield Indiana office were fired, according to a newsletter announcement that went out to employees.

Duke Energy Corp had been hit hard when it came to the attention of the public that Reed and Storms created a conflict of interest by proposing to raise fees for consumers while discussing a job opportunity for Storms with Duke. Specifically, Reeds was speaking to Storms about a job opportunity with the company while Storms was an administrative law judge for the Indiana Utility Regulatory Commission. During Storms’ term as an administrative law judge, he ruled on Duke Initiatives that help to pass cost overruns for its coal gasification plant in Edwardsport onto customers.

Duke hired the law firm Gibson, Dunn & Crutcher Duke to investigative the matter internally. Based on the attorney’s findings, Storms and Reed were fired. Duke has revealed some of internal information with the Securities and Exchange Commission.

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