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The U.S. Food and Drug Administration (FDA) today announced that companies marketing unapproved ophthalmic balanced salt solutions (BSS) and unapproved topical drug products containing papain must stop manufacturing these products on or before November 24, 2008, and must stop shipping such unapproved products on or before January 21, 2009, or risk enforcement action. FDA is taking these actions because it has received reports of serious adverse events associated with their uses, including eye inflammation, cloudy vision, permanent loss of visual acuity, a serious drop in blood pressure and increased heart rate. Ophthalmic balanced salt solutions are used to irrigate the eye during surgery on the eye, including cataract and other ocular procedures. The FDA's action does not affect approved ophthalmic BSS products such as approved versions of BSS made by Alcon and Akorn. No topical drug product containing papain has been approved by the FDA. After the above dates, all topi

According to the medical records of the psychiatric emergency room at Kings County Hospital Center in Brooklyn, New York, a patient named Esmin Elizabeth Green, who had been brought to the hospital almost 24 hours earlier but had not yet been seen by a doctor, was sitting quietly in a chair. In fact, she was already dead. The hospital chart also says that she got up to walk to the bathroom when she was actually writhing on the floor. How do we know the truth? Because unlike most instances of medical malpractice, this apparent fiasco is captured on the hospitals own surveillance videotape. The cameras captured Ms. Green, 49, sliding off her chair at 5:32 a.m. on June 19th. About half an hour after she collapsed, the video shows a security guard walking in to look at her, then walking away again as she lies motionless. A security guard can be seen later on the video rolling his chair

Part 2 of this topic discusses new legislation regarding dangerous drugs, defective toys and sexual predators using the internet to prowl and prey. The information herein is set forth in press releases issued by the governor's office. Proposed legislation designed to protect patients from medical malpractice was discussed in Part 1 of this blog. Governor David A. Paterson has proposed legislation to limit the influence of pharmaceutical manufacturers over prescription decisions by banning gifts and payments from drug companies to physicians and other prescribers in excess of $50 per year. The bill would also require practitioners who m

Last week was a busy week for New York's Governor David A. Paterson on issues often written about in this blog - medical malpractice, dangerous drugs, defective toys and sexual predators using the internet. Some bills were signed, others introduced. The most ambitious of these was on the medical malpractice front, Governor Paterson proposed legislation that offers more transparency for patients and tougher discipline for physicians; enhanced infection control requirements will facilitate the prevention of and response to infectious disease transmissions. Part 1 will discuss this legislation, Part 2 the others. The information herein is set forth in press releases issued by the governo

A feature article in the March/April 2007 issue of the Columbia Journalism Review discusses and labels as an epidemic the pervasive role hospitals play in producing "feel good" stories that are essentially advertisements for themselves and feeding the stories to television stations that run the stories as purported health news on their local TV news programs. The stories chosen tend to promote expensive specialties and procedures like bariatric surgery for obesity and gamma knife surgery for brain cancer at the expense of stories about less profitable diagnoses, like AIDS or pneumonia, care for the uninsured, or critical stories such as hospital infection rates, medical mistakes or poor care. Perhaps the most egregious example cited in the feature involves the partnership between the CBS station in Philadelphia with Temple University Hospital, which produces stores called Temple LifeLin

The U.S. Food and Drug Administration's Ophthalmic Devices Panel convened last Friday to discuss post-LASIK (laser-assisted in situ keratomileusis) quality-of-life issues. Of the 7.6 million people who have undergone the procedure in the United States since the mid-1990s, 140 have written letters of complaint to the FDA. Approximately one in four people who seeks Lasik is not a good candidate. Perhaps 1 percent or fewer, suffer serious, life-changing side effects: worse vision, severe dry eye, glare, inability to drive at night. One young man committed suicide because of severe eye pain and fuzzy vision. Some patients have had to have corneal transplants when LASIK went wrong. The FDA says it is concerned that doctors are not adequately informing patients about the potential risks. The FDA advisers recommended that the agency make clearer the warnings it already provides for would-be Lasik patients: Add photographs that illustrate what people suffering certain side

The Centers for Medicare and Medicaid Services (CMS) is proposing to add an additional nine categories to its initial list of 8 conditions that could reasonably have been prevented. that Medicare will no longer pay the extra costs of treating when acquired in the hospital . In a statement dated April 14, 2008, CMS proposed to add the following to its list of conditions that it will not pay for: Surgical site infections following certain elective procedures: Legionnaire's disease; Extreme blood sugar derangement; Iatrogenic pneumothorax or collapsed lungs; Delirium; Ventilator-associated pneumonia; Deep vein thrombosis or pulmonary embolism; Staphylococcus aureus septicemia or bloodstream infection; and Clostridium difficile associated disease. In addition, CMS is proposing to create new codes to better identify two conditions that were previously selected: foreign object retained after surgery; and pressure u

For the first time, the federal Centers for Medicare & Medicaid Services has posted consumer survey information on its Hospital Compare Web site (www.hospitalcompare.hhs.gov) that attempts to capture the experiences of a patients in a hospital. It is a unique attempt by the government to evaluate hospital care from the perspective of the patient. Unfortunately for Long Islanders, on average, Long Island hospitals scored lower in patient satisfaction in eight out of 10 measures compared with other hospitals statewide or nationally. The Island's largest health system, North Shore-Long Island Jewish Health System, did not fare well on the survey. Long Island Jewish Medical Center in New Hyde Park scored below the state and national average in all 10 areas. North Shore University Hospital in Manhasset scored below the state and national average in 8 out of 10 measures. Other North Shore-LIJ hospitals also scored below the state and national average, including Plainview H

After coming under attack from doctors, Aetna has withdrawn its intention, announced late last year, that in New Jersey, effective April 1, 2008, it would drop its coverage of propofol, the anesthesia typically used during colonoscopies, calling the same medically unnecessary. In reality, it is not the propofol that Aetna minds paying for; what Aetna wants to cut-out is the $300 to $1,000 cost that Aetna pays for an anesthesiologist to be present at a colonoscopy. Propofol, also known by the trade name Diprivan, is more powerful than other sedatives traditionally used to help patients endure the discomfort of a colonoscopy. Because of the powerful effects of the drug, good and accepted medical practice usually necessitates the presence of a qualified anesthesiologist during the procedure. Aetnas plan caused much consternation amongst New Jersey doctors, who were so outraged t

The U.S. Food and Drug Administration said the number of deaths possibly associated with the drug heparin, made from pig intestines, had risen to 21 from 4. The reported number of those suffering adverse reactions increased from approximately 350 to 455. Both increases have been reported within just a 2 week time period. But the F.D.A. cautioned that many of those patients were already seriously ill and that the drug might not have caused their deaths. Officials described the linkage of heparin to the additional 17 deaths as more tenuous than the 4 initially reported. Federal drug regulators said yesterday that they had found "potential deficiencies" at a Chinese plant that supplied much of the active ingredient for the drug. The F.D.A. emphasized that it had yet to identify the root cause of the problem, and that it had not concluded that the Chinese plant was responsible. The agency also said it was inve