Defective Medical Products, Medical Devices and Drugs

Medical devices are used by millions of people every day. They introduce such medical devices and products in their daily routine and count on them to maintain healthy and vibrant lives with the belief that such products are safe, present limited risk of adverse effects and outcomes, and the devices will actually perform as indicated.  These assumptions also apply to prescription medications.  After all, drugs that are promoted on the market should have been properly tested for safety and efficacy.

The reality is different, for many reasons. Being safe does not mean that the drug is harmless. The U.S. Food and Drug Administration defines “safe” as the preponderance of the benefits of the drug over the risks for the target population.  Drugs like medical devices may have latent defects unknown or undisclosed upon receiving clearance from the FDA, leaving their users at the risk of causing serious injuries and long-term health problems.

A defective drug encompasses both drugs that present certain risks to the health of a consumer, as well as those that fail to provide adequate information and warnings regarding the risks, indications and counter-indications associated with the use of those drugs.  Medical devices, on the other hand, may be defective due to design, or manufacturing considerations.

Such defective products may still make it to market for a number of reasons which can range sheer greed in the pursuit of profit by device and drug companies, who do not disclose adverse events associated with the drug or device, to public pressure to deliver miracle cures, and finally bureaucratic mismanagement.  At the end of the day, it is the consumer that is at risk.

Liability for defective products and defective drugs and medical devices can be spread across many parties include the manufacturer of the product, as well as physicians and pharmacists.  Liability can also attach to physicians for off-label use of drug and devices, which although legal may nevertheless be construed as negligent since physicians have a legal duty to explain to their patients the risks associated with a particular drug or device with off-label use. The pharmacist’s negligence results from mishandling prescription: incorrect drug, dosage, or instructions to the consumer.

Defective medical products can cause serious injuries and sometimes death.  If you or someone you know has sustained injury or death as a result of these products, the personal injury attorneys of Goldberg Simpson may be able to hold liable those persons or businesses responsible for that injury or death.

Even the most informed consumer can fall victim to a defective drug or medical device.  The personal injury attorneys at Goldberg Simpson have extensive experience in bringing claims against manufacturers, physicians, and pharmacists who negligently perform their duties to provide safe and effective drugs and products to medical patients.

Do not hesitate to call us. Discussing your case with an attorney who is experienced in the field of defective medical products ensures a thorough evaluation of your case, and if warranted, will help you or your loved ones receive appropriate compensation for any injuries or death resulting from the use of such products. In recent years, Goldberg Simpson’s personal injury attorneys have handled cases involving Vioxx®, Zimmer total knee replacements, Accutane®, DePuy hip replacements, and certain defibrillators.  Furthermore, the personal injury attorneys of Goldberg Simpson have contacts nationwide with other law firms that specialize in the area of “mass torts” with whom they can coordinate their efforts to provide effective legal representation to their clients as warranted.



Studies found that many patients who received these DePuy hip implants experience from symptoms including pain, popping swelling, grinding, difficulty walking,  elevated levels of Cobalt and Chromium in their blood streams, fluid-filled cysts under the skin, infection, bone fracture, soft tissue necrosis, bone fractures and have to undergo a revision surgery to correct painful issues with the implants.

These symptoms are caused by design flaws in the hip implant systems. Over time ASR patients may develop symptoms which include pain, when the implant becomes loosened from the bone, and serious effects when the implant becomes dislocated or fractured.

As a result DePuy Orthopaedics, has issued a voluntary recall of two of their hip replacement systems, the ASR™ XL Acetabular System and DePuy ASR Hip Resurfacing System.

Drug Injuries

A defective drug can have long term impact on your health and your wellbeing.

In Kentucky dangerous or defective drugs are frequently distributed. This happens in spite of the Food and Drug Administration (FDA) diligent application of regulations. Drugs may be dangerous for your health even if approved by the FDA for several reasons, including:

  • insufficient testing of drugs
  • premature release into the marketplace
  • “off-label” use where the drugs are used for conditions not originally designed or tested for.

The Goldberg Simpson Personal Injury and Medical Negligence Practice attorneys handle all types of drug injury claims, including:

  • Accutane –(generic name Isotretinoin). Accutane is a prescription drug for severe recalcitrant nodular acne, and troubled skin. Accutane  injuries includes blindness, deafness, Chron’s disease and more.
  • Actos– (generic name Pioglitazone hydrochloride). Actos is a Takeda Chemical Industries drug that was designed to manage type 2 diabetes. Use of Actos has resulted swelling, weight gain as well as the increased risk of bladder cancer.
  • Avandia– (generic name Rosiglitazone). A GlaxoSmithKline fabrication, Avandia purports to deal with type 2 diabetes. Avandia has been associated with severe cardiovascular disorders, namely heart attacks, heart failure, strokes and death.
  • Byetta– (generic name Exenatide). Developed by Amylin Pharmaceuticals, Inc., to help with type 2 diabetes. Byetta has been linked to serious side effects ranging from nausea to GERD, kidney problems and even pancreatitis.
  • Fentanyl Pain Patch. It is a pain management transdermal application that its manufacturer, Fentanyl has recalled after reported occurrences of overdose.
  • Fleet Phospho-Soda. Fleet Phospho-Soda was associated with acute kidney injury and symptoms such as high blood pressure, abnormal heartbeat and even failure of the kidneys altogether.
  • Fluoroquinolones. Fluoroquinolones, originally designed to treat respiratory and urinary tract infections, have been linked to serious side effects such as tendon damage which have resulting in the need for surgery or life-long disabilities.
  • Fosamax– (generic name Alendronate Sodium) A by Merck & Co. product, Fosamax is designed to treat the symptoms of osteoporosis. Unfortunately, Fosamax been linked to several adverse side effects including primarily muscle pain and heart burn. A class action lawsuit was filed in 2006.
  • Gadolinium. Several serious and fatal side effects have resulted from the use of Gadolinium in MRI and MRA procedures such as kidney disease, shortness of breath, hives and blood clots, as well as severe allergic reaction, and nephrogenic systemic fibrosis (NSF).
  • Provigil– (generic name Modafinil). Provigil, a Cephalon Inc. drug concocted to assist in wakefulness with adults struggling with excessive sleepiness. It was associated with serious side effects including erythema multiform (EM), DRESS, Stevens-Johnson Syndrome (SJS) and more.
  • Raptiva. Genentech’s prescription drug Raptiva was recalled in 2009. Increased risk of Progressive Multifocal Leukoencephalopathy (PML) was at issue.  Reported symptoms included headaches, difficulty with memory, blindness, lack of coordination and general weakness in the limbs.
  • Reglan –Reglan (generic name Metoclopramide). Reglan, released by Schwartz Pharma to help treat the symptoms of heartburn. It was linked to depression, confusion, as well as Tardive Dyskinesia and Neuroleptic Malignant Syndrome.
  • Trasylol – (generic name aprotinin). Trasylol, manufactured by Bayer AG, to help prevent blood loss during transfusions. The drug has been shown to cause life-threatening side effects, such as kidney failure, heart attacks and stroke.
  • Yaz –(generic name Ocella). Yaz or Yasmin, one of the most popular forms of birth control, manufactured by Bayer, was linked to serious side effects including pulmonary embolism (PE) and deep vein thrombosis (DVT).



 Actos, developed by Takeda Chemical Industries, and under its generic name Pioglitazone hydrochloride, was originally designed to manage type 2 diabetes. Consumers of Actos experienced a variety of side effects including swelling, weight gain as well as the increased risk of bladder cancer.

Actos (pioglitazone hydrochloride) is a member of a class of drugs known as thiazolidinediones. This drug class has been linked to liver and cardiovascular issues. Actos side effects may include:

  • Gradual weight gain
  • Upper respiratory infections
  • Increased risk of fractures
  • Increased fluid retention
  • Increased risk of congestive heart failure (CHF)
  • Increased risk of bladder cancer
  • Increased risk of liver problems


If you have taken Actos for Type 2 diabetes in the past, please contact David Gray at Goldberg Simpson, LLC.  Studies have shown that Actos is believed to cause bladder cancer. Patients who have bladder cancer are urged not to use Actos.



 The story of Granuflo should be of interest to individuals receiving dialysis treatment. Such patients may have a potential claim if the treatment involves GranuFlo, since has been linked to heart attacks and death.

Do not hesitate. If you are a dialysis patient and have had a heart attack, or if you know someone who is on dialysis and has experienced a cardiac event, you should investigate to see if such an event may have been caused by GranuFlo. GranuFlo contains heightened levels of an ingredient present in many similar dialysis concentrations which, when administered, is converted to bicarbonate.

When patients’ exposure to this ingredient is at too high of levels, it may cause serious health implications, such as:

  • Heart Attack
  • Cardiac Arrhythmia
  • Stroke
  • Sudden Death
  • Metabolic Alkalosis
  • Low Blood Pressure

You may be entitled to compensation for your medical bills, lost income, pain and suffering, and much more.



Several individuals have experienced complications after being fitted with the intrauterine contraceptive device (IUD) called Mirena.

Mirena has been linked to health complications including organ perforation. Even more serious is that it has also been suggested that the IUD can migrate from its original position after insertion, perforating the uterine wall or lodging itself in the uterus. Mirena may also migrate into the pelvic area, leading to adhesions, scarring or intestinal perforation. 

This may trigger the need for nothing less than a full hysterectomy, and more serious complications could result in death.

Other serious side effects that have been linked to Mirena include:

  • Infertility
  • Pelvic Inflammatory Disease
  • Abscesses
  • Birth of a child with a birth defect
  • Erosion of the surrounding areas
  • Perforation of the uterus
  • Peritonitis
  • Intestinal perforations or obstruction

Please contact David Gray and the law firm of Goldberg Simpsons, LLC.  You may have a claim and we would be happy to assist you.