Medical Risk Law Weekly News

Week of: August 20, 2012


FDA Approves Lucentis To Treat Diabetic Macular Edema

The FDA approved Lucentis (ranibizumab injection) for the treatment of diabetic macular edema (DME), a sight-threatening eye disease that occurs in people with diabetes. Lucentis is an injection administered once a month by a health care professional. It is intended to be used along with good diabetic blood sugar control.


To Preserve Last Effective Treatment Option, CDC No Longer Recommends Oral Drug for Gonorrhea Treatment

The Centers for Disease Control and Prevention no longer recommends the oral antibiotic cefixime as a first-line treatment option for gonorrhea in the United States because of the possibility that the bacteria which causes gonorrhea is becoming resistant to the drug. The change was prompted by recent trends in laboratory data showing that cefixime, marketed under the brand name Suprax, is becoming less effective in treating the sexually transmitted disease.

FDA Approves First Generic Versions of Singulair To Treat Asthma, Allergies

The FDA approved the first generic versions of Singulair (montelukast sodium) for use in adults and children to control asthma symptoms and to help relieve symptoms of indoor and outdoor allergies. Montelukast is in a class of medications called leukotriene receptor antagonists. It works by blocking the action of leukotrienes, substances in the body that cause the symptoms of asthma and hayfever (allergic rhinitis).

Prepared Foods Sold at Target Recalled Due to Possible Listeria Contamination

The Rhode Island Department of Health advised consumers that they should not eat certain foods from the Market Pantry and Archer Farms Deli Salad lines sold at Target stores. These products are being voluntarily recalled because they may be contaminated with Listeria monocytogenes.


Certain State Law Medical Device Claims Partially Preempted

A man received a drug-eluting arterial stent to treat coronary artery disease. Five months later, a blood clot formed near the site of the stent and he suffered a subacute stent thrombosis. Eleven days later, he died. Three years and nine months later, his widow filed suit in New Jersey seeking damages for the injuries suffered by her husband and his estate. The defendant filed a motion to dismiss all the claims which the trial court granted. The court of appeals affirmed in part, reversed in part and remanded. The Supreme Court of New Jersey affirmed the court of appeals.

Promotion of Off-Label Use May Make Medical Device Manufacturer Liable

A seventeen-year-old girl underwent arthroscopic surgery on her shoulder. The surgeon installed a pain pump device, manufactured by the defendant, to administer a local anesthetic to the patient’s shoulder for four days following her surgery. The device’s catheter was installed directly into the patient’s shoulder joint. Subsequently, the girl experienced extreme pain, and worsening stiffness, clicking, and popping in her shoulder joint. She was diagnosed with glenohumeral chondrolysis, a painful condition involving the permanent destruction of articular cartilage in the shoulder joint. Her prognosis is poor, and she will likely require several complete shoulder replacements during her lifetime. The patient sued the manufacturer of the pain pump device raising a number of common law claims as well as statutory claims that hold manufacturers strictly liable for defective design and inadequate warning or instruction.

Hospital Liable in Negligence Not Malpractice for Discharge of Dementia Patient Resulting in Financial Exploitation

A woman was admitted to the defendant acute care facility that specialized in the evaluation, treatment, and placement of elderly patients. While at the facility, the woman was diagnosed with mild to moderate dementia as a result of Alzheimer's disease. Her doctor at the defendant facility concluded that, due to her dementia, she needed a guardian to make medical and financial decisions for her.


A week after the patient was admitted, a social worker employed by the defendant met with another woman who claimed she would take care of the patient upon discharge from the defendant facility. The social worker printed out a power of attorney form for the patient to sign in order to give the other woman power over her personal and financial affairs in order to facilitate discharge and obtain services following discharge. Later, the patient was discharged. The other woman allegedly exploited the former patient financially using the power of attorney.


The county legal guardian sued the defendant hospital on the former patient’s behalf arguing that the social worker employed by the defendant failed to exercise due care when he helped her arrange her financial affairs in furtherance of her discharge.