New York Accident Lawyer Blog

Spinal fusion surgery is a procedure to correct problems with vertebrae by basically welding them together and allowing them to heal into one solid bone. This procedure may relieve symptoms of back problems such as fracture, scoliosis, spinal stenosis, spondylolisthesis, and degenerative disk disease. The idea is to prevent pain by preventing movement. Some form of bone material must be utilized in order to promote the fusion and healing. This procedure is called a bone graft and involves placing pieces of bone into the area between the vertebrae and sometimes additional pieces elsewhere for support. Previously, the only way to do this was by making an additional incision to harvest a bone graft from the hip (called an autograft). This meant a longer procedure time and possibly a more complicated healing process. Now, there are alternatives to bone grafts such as use of a cadaver bone (called an allograft) or the use of an artificial bone graft material.

Nine years ago the FDA approved Medtronic's Infuse Bone Graft for one particular type of spinal fusion surgery. It was one of the alternatives to harvesting a bone graft from the hip. Eventually it was also used, albeit off-label, with other types of spinal surgeries, such as cervical spine surgeries. Doctors are free to prescribe drugs beyond their official uses (though insurance companies, such as Medicare and Medicaid, may choose to reimburse only if there is a representation that the product will be used for its intended use). Some researchers estimate off-label uses at 85% of total Infuse use. What followed the extraneous uses were numerous reports of side effects and complications such as death, cancer, sterility, infections, bone dissolution, worsened back and leg pain, ectopic bone (bone outside of the target area), and swelling of the neck and throat area (leading to suffocation).

As a result, in the Fall of 2008, the Justice Department began to investigate. It turns out that some of the adverse side effects reported above had been found in 10-50% of patients who were given Infuse or its sister product during clinical trials funded by Medtronic over a decade long study. But not all of the findings (namely the risk of sterility) were reported in the research papers by Medtronic's surgeons or written on the product label. In a number of their papers regarding Infuse, they also failed to disclose their financial ties to Medtronic. Coincidentally, 15 of Medtronic's surgeons had been paid upwards of $62 million over the last 10 years for "unrelated" work.

The probe also revealed that the physicians who reviewed a sister product of Infuse, Amplify, completely omitted the 90-95% probability of a link between the product and cancer, which had been discussed in 15 of the 68 pages of the FDA's summary of the product. Furthermore, 3 of the surgeons who were involved in the trial of that product were paid at least $10 million by Medtronic since 2001.

Medtronic was directed not to destroy its reports. Presently, the Senate Finance Committee is investigating whether doctors with financial ties to Medtronic were aware of potentially serious complications with products yet failed to reveal those problems in published journal articles.

Resources:
Wall Street Journal, Medtronic Experts Held Back, Study Says, John Carreyrou and Tom McGinty, 06.29.2011.

Similar Blog Posts:
Forbes, Medical Journal Slams Medtronic Over Payments To Doctors, Matthew Herper, 06.28.2011.

By Kathleen Beatty

New York State received a $3 million federal grant to implement a test program designed to encourage early (or earlier) settlement of medical malpractice cases. The program requires that a judge with training in medical issues be assigned at the beginning of a case and frequent settlement conferences be held. A nurse with legal training assists the judge and lawyers must arrive with authority to settle the case. The injured party is not present and there is no jury.

The program intially began in the Bronx in cases against city hospitals and is presently being expanded to courts in Brooklyn and Manhattan, as well as to cases against private hospitals. The program is slated to begin in Buffalo courts in the fall.

Advocates of the program say it cuts down on time and costs of litigation for injured patients and defendants. Opponents of the program say it pressures attorneys to take a settlement amount that is less than fair. The important question is whether the system can save money and still accomplish the right results.

Resources: New York Times, William Glaberson, To Curb Malpractice, Judges Jump in Early, 06.12.2011.

By Kathleen E. Beatty

The proposed $250,000 cap on medical malpratice cases was eliminated before the latest New York budget was adopted. But the neurologically impaired infant fund was not. The new statute, Public Health Law § 2999-5[1], qualifies "birth-related neurological injuries" as "an injury to the brain or spinal cord of a live infant caused by the deprivation of oxygen or mechanical injury occuring in the course of labor, delivery or resuscitation or by other medical services provided or not provided during delivery admission that rendered the infant with a permanent and substantial motor impairment or with a developmental disability".

Under the law, infants may not obtain premium treatment but are relegated to services that are covered at the prevailing Medicaid rate. Judges and juries are divested of their discretion to award neurologically impaired infants a lump sum of damages that they determine to be suitable. Rather, parents of neurologically impaired infants can expect to fill out a flurry of paperwork and prove their case over and over again to recover medical costs that the system will provide compensation for on an annual basis. The size of the fund will vary each year according to state actuaries. Ironically, the fund will be administered by a combination of the state insurance and banking departments. Only once the fund is reduced to twenty percent or less of its annual size can lawsuits be brought to recover the medical expenses that the infants need.

Participation in the fund is mandatory to those filing medical malpractice suits for injuries covered by the statute after October 1, 2011 as well as those who previously filed cases which have not reached verdict or settlement. Will Cuomo ever pressure the health care industry to provide better care or will he continue to deprive victims of malpractice of their ability to receive the care and compensation they deserve?

Resources:

New York Law Journal, Lawyers Await Specific Regulations on Infant Medical Malpractice Fund, Joel Stashenko, April 20, 2011.

By Kathleen Beatty

Governor Cuomo has submitted as part of the proposed budget for New York State a cap on compensation for victims of medical malpractice for their pain and suffering of $250,000. This mandatory cap will kick-in only after a doctor or hospital has been found guilty of malpractice that caused an injury to the patient. Therefore, it will punish only those patients who have meritorious cases. Those who are most seriously injured will be forever barred from seeking reasonable compensation from the wrong-doer and their insurance company..

Cuomo also is attempting to force the State Legislature to pass the budget, on an up or down vote, which also includes a fund, paid for by taxpayers but administered by the insurance-industry, that will decide the amount and extent that brain-injured children can receive medical treatment. Essentially he is gutting New York's civil justice system and forcing brain-injured children and their families to become perpetual litigants against a fund that will control all aspects of their financial lives. This is being done in the name of "budget cutting" and "Medicare reform." In reality, the cap will have the result of forcing more brain-injured victims of malpractice into the Medicare system. Meanwhile private insurance carriers, who insure hospitals and doctors, will no longer bear any real burden in compensating victims of their clients' malpractice.

The following is an excerpt that appeared on March 7th, 2011, in CounterPunch and articulates why Cuomo's cap must not become the law of New York:

"Many in the health care and insurance industry seem to regard the civil justice system as a nuisance that threatens to destroy our economy and way of life. In reality, America's civil justice system plays an indispensable role. When the rights of injured consumers are vindicated in court, our society benefits in countless ways: compensating victims and their families for shattering losses (with the cost borne by the wrongdoers rather than taxpayers); preventing future injuries by deterring dangerous health care and other practices, spurring safety innovation; and educating the public to risks associated with certain products and services. These legal rights provide society with its moral and ethical fiber by defining appropriate norms of conduct.

Continue reading "Cuomo's Proposed Budget Will Punish Injured Children and Their Families" »

As of late there has been a colossal debate over medical malpractice law. Gov. Andrew M. Cumo and his Medicaid Redesign Team came up with Proposal Number 131 to impose a cap of $250,000 on noneconomic damages for victims of medical malpractice and create an indemnity fund for neurologically damaged infants, among other things. But are injured people the ones who should be penalized?

What about fixing the medical system so the possibility of injury from malpractice is decreased in the first place? Seemingly, this would make all sides better off. One Columbia-Presbyterian study by three medical doctors was done with the goal of finding a comprehensive obstetric patient safety program to reduce compensation payments and sentinel adverse events. Data was gathered from 2003 through 2009 and the results are simply astounding. "Average yearly compensation payments decreased from $27,591,610 between 2003-2006 to $2,550,135 between 2007-2009, sentinel events decreased from 5 in 2000 to none in 2008 and 2009. Instituting a comprehensive obstetric patient safety program decreased compensation payments and sentinel events resulting in immediate and significant savings." Yes, that is about $25 million. Here is the report:

Columbia-Presbyterian Patient Safety Study

The issues that this study covers are very real. Bronx-Lebanon Obstetricians in the South Bronx recently received a warning from their insurance company that their practice may be cut off from insurance coverage, due to their subpar "method of practice" and "practice environment".

Continue reading "Medical Malpractice Debate in New York: Limit Injured Parties' Ability to Recover or Fix the System?" »

The House Judiciary Committee voted 18-15 along party lines in the past week to send a Republican sponsored medical malpractice tort reform bill to the full house for approval. This bill is the latest in a long continuing assault by the minions of corporate america, i.e the Republican party, to limit or eliminate the individual's right to seek redress in the courts for injuries sustained as a result of medical negligence and eventually destroy the right of the average citizen to seek compensation for negligent medical treatment. The law, if passed, would limit without condition all monetary recoveries for acts of medical malpractice for pain and suffering to $250,000 or twice the amount of economic damages, whichever is greater, that juries could award patients who bring suit for injuries suffered during the course of medical treatment. The bill is sponsored by Rep. Phil Gingrey, M.D. (R-Ga) an obgyn who himself has been a defendant in medical malpractice cases (does he have an ulterior motive here?).

The truth about the motivations behind these constant attempts to eviscerate medical malpractice litigation is not to help reduce health care costs. Everyone admits that malpractice law suits add very little to the costs of healthcare, and help redress the terrible toll of pain and suffering by victims of malpractice. The real motivation behind these bills is to help protect the profits of insurance companies who have to pay out on any settlements or verdicts.

If you want to maintain your right to sue, immediately write or e-mail your congressman and senator to vote against this draconian bill that will do nothing to help bring down the costs of healthcare and will eliminate yet another tool in the arsenal of the individual in his fight against corporate america.

By Philip R. Papa

As one of the first legislative agendas the U. S. Congress will attempt to repeal the recently enacted National Health Care Reform Act. Despite all of the negative hype this legislation has generated and whether or not you are for or against the present Health Care Bill the need for a major overhaul of the health care industry to enable the average middle class individual to have access to safe and effective health care should be a priority for our legislators.

In the New York Metropolitan area access to safe and effective medical care is getting more and more tenuous. We all know how frustrating it is to sit for hours in a walk in clinic or emergency room only to be quickly processed out with no real quality care or follow up. Hospitals, Clinics and emergency rooms are overcrowded and understaffed and closing at alarming rates. This healthcare crisis has led to suboptimum medical care and misdiagnosis of serious medical conditions that otherwise should have been diagnosed sooner and treated more effectively. In some cases these overcrowded understaffed clinics completely miss serious conditions such as undiagnosed life threatening infections, cancers, etc. that result in injuries and even premature deaths of hundreds of people every year who with timely diagnosis and treatment would have avoided serious complications and even death.

At Leav & Steinberg LLP we have successfully represented hundreds of victims of medical malpractice due to failure to timely diagnose serious medical conditions, including a recent 1.4 million dollar settlement before trial for a woman who lost her eye as a result of a post cataract eye infection which went undiagnosed and treated for several weeks due to an inadequate and incompetently staffed medical clinic.

Resources:
KETK NBC.com New Congress to vote on repeal of Health Care Law, By Ashley Aldrich 1/4/11.

The Wall Street Journal April 8th 2010 St Vincent's Hospital in New York to Close By Suzann Sataline

By Philip R. Papa