Articles Posted in Products Liability

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At Theodoros & Rooth we feel it is our duty to warn you about product recalls that just may be hazardous to your health.

There are dozens of recalls every week; most of them recalled voluntarily by companies to protect their consumers.  Some you hear about; some you do not.

You should be aware of two recalls that have been in the national news lately.   This time it’s Samsung phones and antibacterial soap.


.anti bact soap

sansung phone recall






First, a strong warning that users of the Samsung Galaxy Note 7 phones should stop using them immediately because of the possibility of an exploding battery.

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file000788055222 morguefile claritaIndiana medical device manufacturers are reportedly hopeful that a bill that is currently being considered by the United States Senate will pass without a presidential veto. The proposed Medical Device Access and Innovation Protection Act would repeal a 2.3 percent tax that is currently imposed on surgical tools, bed pans, IVs, orthopedic implants, and many other medical devices. The bill was introduced in January by U.S. Senators Dan Coats and Joe Donnelly. It is apparently enjoying widespread bipartisan support in the Senate, and some believe the proposal is also likely to pass the House of Representatives.

Currently, over 300 medical device manufacturing companies employ approximately 20,000 people in the State of Indiana. In addition, about 28,000 others are employed in positions that support the industry. Rather than being applied to a company’s profits, the tax is imposed on each device manufacturer’s total sales. According to some manufacturers, the tax has strained business, resulted in plant closures and layoffs, and slowed potential growth. Many manufacturers claim they chose not to hire additional workers due to the tax.

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DSC08554-b morguefile username dodgertonskillhauseIn Estate of Hoholek v. AbbVie, Inc., a man apparently used testosterone replacement therapy medication prior to his death. Later, the man’s estate and his spouse filed a lawsuit against the manufacturer of the drug, its parent company, and two unnamed doctors in an Indiana court. Since the corporate defendants were based in Delaware and Illinois, the medical product manufacturers successfully removed the case to the Northern District of Indiana in Hammond based on diversity of citizenship. A federal court may normally exercise diversity jurisdiction where the defendant in a lawsuit hails from a different state than the plaintiff, and the amount in controversy exceeds $75,000.

After the case was removed to federal court, the defendants filed a motion to stay the proceedings and withdraw appearances made by certain counsel. In addition, the drug companies asked the court to provide them with more time to respond to the plaintiffs’ complaint. According to the defendants, the plaintiffs’ case was similar to that of nearly 500 other individuals involved in ongoing multidistrict litigation (“MDL”) over testosterone replacement therapy. In general, MDL is a unique legal proceeding designed to promote judicial economy by combining complex lawsuits with overlapping issues that are pending across federal districts into a single case. A few days after the case was removed to federal court, the ongoing action was conditionally transferred to the MDL.

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In order to make important government health data available to consumers, the U.S. Food and Drug Administration (FDA) launched a new initiative in June of this year.

OpenFDA offers not only information, but programming opportunities to developers who wish to build accessibility to government data into their projects and apps. While initially providing readily usable data to researchers and consumers, the site plans to include large sets of additional data previously difficult for the public to access.

The FDA is phasing in the site with an initial project that includes information on:

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While victims of a meningitis outbreak may never regain full health, a recently filed financial settlement may provide some help.

In September 2012, health agencies and physicians noticed an uptick in incidents of meningitis. Investigation of the illnesses revealed victims suffered from a fungal form of meningitis resulting from contaminated pharmaceutical products produced by the New England Compounding Center (NECC), a Massachusetts company.

For sufferers of back and joint pain, steroid injections are often prescribed to reduce pain and inflammation. Compounding companies, like NECC, make large batches of medication for use in health facilities across the country.

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After a long regulatory battle, the manufacturer of sets of small, high-powered magnets known as Buckyballs agreed to recall the toys.

People of all ages are fascinated by magnets. In recent years, the power of attachment took a giant leap forward with the development of magnets from new materials with exceptionally high magnetic power.

Although not “rare,” these rare earth magnets began to appear in household products and toys more than a decade ago. One manufacturer, Maxfield and Oberton Holdings, LLC, created a set of rare earth spheres called Buckyballs, or Buckycubes, first as a toy for children, then solely as an executive toy for adults. The danger of the toy sets soon became apparent.

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As a medical patient, being informed about potentially dangerous pharmaceutical products or medical devices can prevent you from suffering injury or risking death. Unfortunately, just because the Federal Drug Administration (FDA) initially approves a product for market release does not mean that severe adverse side effects are non-existent for some patients. All too often, adverse side effects do not become apparent until several years after the products’ release. In many cases, the manufacturer is liable.

In some instances, companies reevaluate and recall their dangerous products at a later time. This typically occurs after discovering initial research was inadequate to uncover relevant risks about the drug or medical device. It also occurs after patients suffer injury and send adverse event reports to the FDA.

The following are potentially dangerous medical devices where the companies either recalled the products themselves, were warned by the FDA about violations or continue to face numerous lawsuits based on harm experienced by consumers:

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Manufacturers and retailers are responsible for marketing toys and products free from defects or potential danger. Too often, parents learn too late of the inherent danger in goods sold for use by their children.

In December 2013, IKEA, a Swedish home furnishing retailer, recalled its SMILA line of wall lamps. The lamps, available in bright colors and shapes like a star, seahorse, heart and flower, were marketed for use around children.

The recall was prompted by the death of one child and the near-death of another. The tragic death involved a 17-month-old toddler, who became entangled in the lamp cord of his SMILA wall lamp. Unable to free himself, he suffocated and died. A 15-month-old child became similarly entangled but was rescued before he strangled to death.

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Thanks to research and technology, doctors now have medical devices at their disposal to help patients live better lives. However, because these medical devices often are constructed with man-made materials, they can pose a threat to the patient. One of those devices is transvaginal mesh.

Transvaginal mesh, which is made with polypropylene, is implanted in female patients to repair pelvic organ prolapse and stress urinary incontinence. Pelvic organ prolapse occurs when the issue that holds the pelvic organs in place weakens or stretches. Stress urinary incontinence occurs when urine leaks during physical activities, such as exercise, laughing, sneezing or coughing.

The Food and Drug Administration (FDA) first alerted patients about complications associated with transvaginal mesh in 2008. The FDA updated that alert in 2011, stating that the serious complications associated with the use of transvaginal mesh to repair a pelvic organ prolapse are not rare. This was a significant change from the FDA’s 2008 communication. However, the FDA still is considering any complications associated with the use of transvaginal mesh to repair stress urinary incontinence.

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It’s just about holiday time, which means it’s time to start buying toys for the children in your life. But sometimes toys can present a hazard to children.

The Consumer Product Safety Commission has put together some safety tips to consider when buying toys for children:

  • Use care when selecting a toy. Consider the child’s age, skill level, and interests when deciding what to buy. Also, consider hazards, such as cords and strings and sharp points.
  • Look for toys with quality construction and design. This piece of advice applies to toys for all ages, not just for small children.
  • Make sure the instructions are clear. The directions for the toy should be clear to both you, and in appropriate circumstances, to the child.
  • Discard the plastic wrapping from the toy immediately. The packaging for the toy can be very dangerous for a child to play with.
  • Read the labels on the box. Toy buyers should both read and heed the age recommendations on the box. Also, be aware of safety labels, such as “flame retardant/flame resistant and washable/hygienic materials.”

Toys should not be purchased and forgotten about. The commission recommends periodic inspection of your children’s toys for breakage or other hazards. If a toy is damaged or dangerous, it should be repaired or thrown away. Wood toys should be examined for splinters and rough edges. Outdoor toys should be inspected for rust or weak spots due to exposure to the elements.