Defective Drugs and Medical Devices

Patients who look to medical professionals for receipt of proper care and to pharmaceutical companies for safe medications do not expect to be prescribed a medication or given a medical device that causes harm.

During the past several years the Food and Drug Administration (FDA) has at times restricted the sale of certain medications and medical devices. In some cases it has ordered these products to be removed from the marketplace. Concern is growing that manufacturers of these devices and pharmaceutical companies who manufacture defective medications do not act responsibly and in a timely manner to ensure the quality and safety of their products. When companies are more concerned about profit and rapid product development and production over patient safety, patients are in danger.

Across the U.S. thousands of patients have been harmed by the DePuy hip implants.  The ASR XL Acetabular hip system and the ASR hip resurfacing system have been recalled by Depuy Orthopedics Inc., due to a high rate of failure of this medical device.  DePuy Orthopedics Inc. is a division of the Johnson & Johnson Company.  The recall did not occur until after the medical device had been surgically placed into many patients’ bodies.

Beginning in 2003, sales of the DePuy hip replacement system were in amounts of 37,000 here in the U.S., and 93,000 hip replacement systems were sold worldwide.  Although Depuy was forced to take its hip implant off the market in Australia in 2009, the company continued selling the Depuy hip implant for profit in the U.S. until late August, 2010, when the company issued a recall for the defective medical device in America.

Recall of the DePuy hip implant is not just a matter of removing the implant from medical device catalogues.  The defective medical device must be surgically removed from patients’ bodies and replaced with better hip implants.

The surgery required is painful and dangerous especially to older patients, the very patients who were likely candidates for hip replacement to begin with.  The company calls this second surgery for the purpose of removing its defective medical device revision surgery.

DePuy has agreed to pay in full for this revision surgery, but the real truth is that the company is recalling and reclaiming their hip implants in order to mitigate its liability in possible court actions.

DePuy has set up its own help line.  Patients who have received their defective hip implants are directed on the company website to call for assistance, but DePuy is making use of an insurance adjuster in order to lessen the dollar amount of claims.  The adjuster conducts and records conversations from the help line for possible use in court against patients who have been harmed should the case be taken to court.

The company’s aim is to reduce recovery amounts.  Damage amounts should far exceed the payment DePuy is offering patients for a new surgery. 

Amounts should include all medical costs associated with the defective medical product and in addition, lost wages due to time away from work as well as pain and suffering endured by patients who have become victims of a company whose medical device was defective.

In January, 2010, Johnson & Johnson expanded its recall of over-the-counter medications, the second time it had done so in less than a month. Some containers of medications had the smell of mold which made those who took the medications sick. Johnson & Johnson’s McNeil Healthcare Products unit had recalled several months prior Tylenol Arthritis Caplets because of the same moldy smell which caused vomiting, diarrhea, stomach pain and nausea in those who took the defective medication.

The wider recall includes regular and extra-strength Tylenol, children’s Tylenol, Tylenol PM, eight-hour Tylenol, children’s Motrin, Motrin IB, Benadryl, Rolaids, Simply Sleep and St. Joseph’s aspirin. Both gel tab and caplet forms of these medications were sold in North and South America, as well as in other parts of the world.

The Food and Drug Administration reported that the company was aware of the problem early in 2008, but at that time conducted only a limited investigation. The company did not aggressively investigate in order to take all action needed to address the medication manufacturing problem. The F.D.A. has sent McNeil a warning for violation of manufacturing standards and for failing to report the problem and investigate the issue in a timely manner.

The Food and Drug Administration stated that they wanted to know the reasons why the problem was not made public sooner.

Johnson & Johnson, in its reply, said that the odor was caused by the presence of a chemical linked to the treatment of wooden pallets. The chemical could volatilize into the air. The use of this particular chemical was linked to a plant in Las Piedras, Puerto Rico.

The following is a partial list of defective medications:

• Avandia: Glaxo Smith Kline—Avandia is used to treat patients who have type-two diabetes. People who have taken Avandia have developed severe cardiovascular problems and strokes.
• Accutane: Hoffman La Roche—This widely used acne treatment has been linked to health problems such as Crohn’s Disease and Inflammatory Bowel Disease.
• Fosamax: Merck & Company—This medication is prescribed to treat osteoporosis. Its benefits claimed include an increase in bone mass. In many cases the opposite effect occurs in patients who have taken the medication. The drug has also led to complications such as fractures of the femur.
• Hydroxycut: Iovate Health Services Inc.—This dietary supplement has caused cardiovascular problems and seizures.
• Reglan: Baxter Pharmaceutical—This medication is prescribed to diabetics and is used in order to fight symptoms of nausea associated with chemotherapy treatment and to treat nausea which often occurs after surgery. Extended periods of taking Reglan have been linked to a disorder which causes involuntary twitching of muscles and other uncontrolled facial movements.
• Seroquel: Astra Zeneca—Seroquel is used to treat mental disorders such as bipolar disease and schizophrenia. Use of Seroquel has been linked to the development of pancreatitis and liver disease.
• Yaz, Yasmin, Ocella: Bayer—These oral contraceptives have all been linked to the formation of blood clots and to gallbladder disease leading to the need for removal of the gallbladder.
• Zicam: Matrixx—This medication is meant to decrease the duration of cold symptoms as well as their severity. Zicam products in various delivery forms have all been associated with loss of smell—sometimes the permanent loss of smell.

You need the New York medical injury lawyers of the Schwartzapfel Partners, P.C. at your side.

We will fight for you!

Call us at (877) 625-4473 or fill out our online contact form for a free case evaluation.

These Hubs are provided for informational purposes only and should not be considered legal advice. Professional legal counsel should be sought for specific advice relevant to your circumstances.