St. Jude Medical Receives European Approval to Sell OptiSense Pacemaker Lead

ST. PAUL, Minn. (AP) -- Heart device maker St. Jude Medical Inc. said on Friday it received European approval to sell its OptiSense pacemaker lead.

Pacemaker leads are the thin wires that deliver and sense electrical impulses from the heart.

The OptiSense lead is designed to allow more accurate sensing of the heart's upper chamber, or more specifically, the right atrium, and to block out signals from the heart's lower chambers, according to the company.

The greater sensitivity allows doctors to be more accurate and flexible in programming the pacemaker to suit the patient's needs, the company said.

St. Jude shares fell 62 cents, or 1.4 percent, to $42.80 in afternoon trading.

Questions or comments about this story should be directed to Wallace Witkowski of AP Financial News at 212-621-7190.
by:biz.yahoo.com

Abortion procedure caused death, lawsuit alleges

The mother of a Riverside woman who died of toxic shock syndrome after allegedly undergoing an abortion procedure at Planned Parenthood filed a malpractice suit against the organization and a Riverside County hospital this week.

The lawsuit alleges that Edrica Goode, 21, went to a Planned Parenthood clinic in Riverside for an abortion Jan. 31 and that a nurse inserted cervical dilators, used to gradually expand the cervix in preparation for second-trimester abortions, despite the fact that Goode had a vaginal infection.

The dilators, which are shaped like small sticks and consist primarily of seaweed, became a conduit that spread the infection to the rest of her body, the lawsuit alleges.

Goode, a Riverside Community College student who enjoyed traveling and reading, died Feb. 14.

"My daughter made a choice, but she didn't choose to die," said Aletheia Meloncon, Goode's mother, who said her daughter hadn't told her she was seeking an abortion. "A lost dog gets more attention than my daughter did. This has really torn at my family."

Goode did not return to the clinic to have the dilators removed, even though the devices are supposed to stay in place only one or two days, the lawsuit states.

According to Goode's patient profile at Planned Parenthood, which is in her mother's possession, Planned Parenthood mailed two letters to Goode stating the dilators needed to be taken out.

But Meloncon said the family never received the letters. She also contends that Planned Parenthood should have taken more aggressive steps to contact her daughter.

Vince Hall, director of communications for Planned Parenthood of San Diego and Riverside counties, said his office could not comment on pending litigation. But he said that the "health and safety of our patients is our highest priority."

Planned Parenthood bills itself as the "nation's leading sexual and reproductive healthcare advocate and provider." Its services include abortion procedures; emergency contraception; screening for breast, cervical and testicular cancers; and counseling.

Goode's is the third known death among Planned Parenthood patients in California in the last four years. Holly Patterson, 18, of Livermore, Calif., died of an infection after a nonsurgical abortion in 2003. Diana Lopez, a 25-year-old Huntington Park woman, bled to death a year earlier after her cervix was punctured during the procedure.

Meloncon's lawsuit was filed in Riverside County Superior Court on Tuesday.

After the dilators were inserted, Goode began to experience fevers and started vomiting, Meloncon said. She became mentally unstable, not knowing what the day was and acting aggressively, her mother said.

The dilators are meant to stay in place over one night, and the abortion usually occurs the following day.

With her condition deteriorating, Goode was taken to Riverside County Regional Medical Center in Moreno Valley on Feb. 4.

A hospital blood test confirmed that Goode was pregnant, and Meloncon said she asked that a pelvic examination be performed. The hospital, the lawsuit contends, said it couldn't perform one because Goode would not consent.

"She was confused and disorientated," Meloncon said. "It was totally out of character for what her behavior normally is."

After staying in the medical ward five days, Goode was transferred to a psychiatric unit and then immediately returned to the medical ward, the lawsuit contends. Before the transfer, the lawsuit states, Goode received a gynecological consultation, but no pelvic examination was performed to remove the seaweed sticks.

"If it wasn't for the negligent medical care that Edrica Goode received, she would be alive today," said Jack M. Schuler, Meloncon's attorney.

A Riverside County Regional Medical Center spokesperson said the hospital could not comment on a pending lawsuit.

After Goode returned to the medical ward, her condition continued to deteriorate, Meloncon said. The hospital, she said, performed a pelvic examination Feb. 13 and found the seaweed sticks and gauze. Goode had a miscarriage that day and died the next.

A Riverside County coroner's report listed the causes of death as toxic shock syndrome, prolonged retention of laminaria cervical dilators and intrauterine pregnancy.

"They need to do things different so that patients won't be in risk of great injury or death," Schuler said.
by:www.latimes.com

Mother blames Riverside abortion procedure for daughter's death

The mother of a woman who died after a Planned Parenthood abortion procedure filed a lawsuit blaming malpractice for her daughter's toxic shock syndrome death.

Aletheia Meloncon filed the Superior Court lawsuit this week, claiming her daughter Edrica Goode, 21, died Feb. 14 because cervical dilators used in advance of second-trimester abortions were left in too long.

Goode allegedly went to a Planned Parenthood clinic in Riverside for an abortion on Jan. 31 and a nurse inserted the dilators, which are usually left in overnight before an abortion.

The suit said Goode, who didn't return to the clinic to have the dilators removed, had an infection and the dilators became a conduit, spreading it throughout her body.

"My daughter made a choice, but she didn't choose to die," Meloncon said. "A lost dog gets more attention than my daughter did. This has really torn at my family."

Planned Parenthood mailed two letters to Goode stating the dilators needed to be taken out, but Meloncon said the family never received the letters. The woman said Planned Parenthood should have been more aggressive in contacting her daughter.

Vince Hall, director of communications for Planned Parenthood of San Diego and Riverside counties, said his office could not comment on pending litigation.

With her condition deteriorating, Goode was taken to Riverside County Regional Medical Center in Moreno Valley on Feb. 4. A blood test confirmed Goode was pregnant, and Meloncon said she asked that a pelvic examination be performed.

But the hospital said it couldn't perform one because Goode would not consent, the suit said.

"She was confused and disorientated," Meloncon said. "It was totally out of character for what her behavior normally is."

The hospital performed a pelvic examination Feb. 13 and found the dilators. Goode had a miscarriage that day and died the next, the lawsuit said.

The hospital also declined comment because of the pending lawsuit.

The coroner's office listed the causes of death as toxic shock syndrome, prolonged retention of laminaria cervical dilators and intrauterine pregnancy.
Information from: Los Angeles Times, http://www.latimes.com

Malpractice lawsuits are lawyer's cup of tea

Jeffrey A. Walker, who made partner at Snyder, Walker & Mann in 2004 at the age of 33, has made a name for himself as an up-and-coming trial defense attorney, winning as lead counsel in a number of complex medical malpractice disputes.

Walker has been fascinated with various aspects of the medical profession ever since his college days, although he opted to pursue a legal career rather than attend medical school. Of particular interest, Walker has handled and tried multiple cases involving cardiology and gastroenterology issues.

His experience is broad in the area of medical malpractice, managing a diverse caseload of medical matters also involving related claims of fraud, elder abuse, premises liability, indemnity and medical devices. In addition, he has handled general liability cases that involve disputes over property ownership, premises liability, catastrophic injury, trucking liability, E&O coverage disputes, regulatory defense, breach of contract and legal malpractice.

Walker graduated from Southwestern University School of Law in Los Angeles in 1995 with a juris doctorate. In 1992, Walker completed his undergraduate work at the UC Riverside, where he earned a bachelor's degree in economics and a minor in psychology.

Walker is a member of the Association of Southern California Defense Counsel, the Defense Research Institute, the Southern California Association of Healthcare Risk Management and the Professional Liability Underwriting Society. He is also a member of the Riverside, San Bernardino and Los Angeles Bar Associations.

Walker sat down for Six Questions with Business Editor Michael Rappaport this week.

Question: Doctors are spending huge amounts on malpractice insurance. What effect is this having on certain specialties, such as obstetrics?

Answer: Unfortunately, higher insurance premiums are becoming commonplace even for nonspecialized practices.

For higher-risk practices, such as obstetrics, the impact of higher premiums has placed a heavy burden on specialists, leaving those doctors feeling: (1) like they don't want to specialize any longer; (2) that they need to be more selective about where to practice and what patients to accept (which works against higher-risk and HMO patients); and (3) resentful about paying so much to protect themselves.

Q: People seeking tort reform sometimes overestimate the cost of lawsuits on medical care. What is the significance of litigation in the overall picture?

A: Litigation can be costly, burdensome and an extreme deterrent. Litigation is a necessary evil, as most claims can, and should be, challenged through our legal process.

There are premium increases related to claim frequency, reporting mandates to state boards and federal databanks, and "reputation" damage for those in repeated or drawn out litigation.

In turn, litigation leads to fear, fear leads to premature, excessive or unnecessary settlements, and payouts and litigation costs become a focal point for promoting tort reform.

Q: Your mission statement talks about "cost-effective" defense. What do you mean by that?

A: SWM provides a "cost-effective" defense by having a streamlined litigation team assigned to each matter, a working expertise with the medicine, being heavily invested in technology to accomplish tasks faster and with greater precision, and by ensuring that the firm's successes are measured solely by what is in the client's best interest.

We believe in forming partnerships with our clients for every step in their defense, thus developing effective strategies early on in the process, and determining whether cases need to be settled versus tried.

Q: How have people changed as far as their willingness to sue over bad outcomes?

A: It has been my experience that litigation over "bad" outcomes has, and will always be, heightened where one of three scenarios exist.

First, a sense of not understanding what happened and no one willing to answer the tough "what," "how" and "why" questions; second, the grieving process can be so overwhelming that comprehension of the outcome is virtually impossible to fathom; and third, having a sense that none of the providers cares about or acknowledges the loss or bad outcome.

When one or all three exist, the willingness to sue is far greater.

Q: What's the toughest sort of malpractice case for a jury to understand?

A: In my experience, the tougher cases for a jury are those when the emotions or sentiments of a case are far easier to relate to than a technical medical procedure or treatment.

What sounds "reasonable" to a jury years later in retrospect is not always what was necessary, prudent or even recommended years before at the time the care was rendered.

Today's society is far more skeptical, and is much more willing to accept that which is familiar ("that sounds about right") versus what a doctor or expert will testify to is actually done in the medical trenches.

Q: How do we solve the problem of high malpractice insurance costs while still protecting patients from bad doctors?

A: If I had the answer to this question, I could easily claim my seat in Congress. Simply put, there is no clear answer.

Malpractice costs are costly being balanced with supporting our health-care community, offering quality treatment to patients, and trying to weed out the bad apples.

Insurance companies do reward "good" physicians with reduced premiums and rebated renewals. There are also a growing number of high-risk insurance organizations for high-risk doctors, which require the insured to carry high SIRs (self-insured retentions), thus requiring the riskier doctor to pay for some of any judgment or settlement.

These types of retention groups may be a way to contain malpractice costs by segregating those health-care providers deemed to be higher risks.
by:www.dailybulletin.com

$7.7M settlement in malpractice suit

MORRISTOWN: A 23-year-old Sussex woman who is a paraplegic due to an unde tected spinal tumor won a $7.7 million settlement yesterday in a medical malpractice lawsuit, her attorney said.

Cindy Hotalen's case was about to go to trial before Superior Court Judge Thomas Harper in Morristown when the parties reached the settlement, said Jeff Korek, the Englewood attorney who worked on the case with his associate, Michael Fruhling.
The defendants were: Radiologic Associates of Northern New Jersey and Pennsylvania; Matthew T. Skalla; Neuro Specialists of Morris-Sussex; In fanta A. Stephen; the Orthopedic Center; Mark Rieger, Spine and Orthopedic Center of New Jersey and doctors David Basch, Allan L. Gardner and Eugene Hrabarchuk, according to court papers.

In 2001, Hotalen, then 17, went to a physician complaining of numbness in her right leg. Radiologists misread her MRI, Korek said. The MRI report followed her over the next two years as she sought help for her condition, Korek said.

She finally was diagnosed with the tumor in 2003, after another MRI was performed. Over the years, the condition worsened and she is now ex pected to be in a wheelchair for the rest of her life, Korek said.

"Anyone who doesn't understand why there should not be curbs on malpractice suits should look at this case," Korek said.

The tumor, had it been de tected early, had a 95 percent cure rate, he said.

Public rallies around

abused 'bait' dog DENVILLE: The township's animal control officer has received phone calls from more than 60 people offering to provide a home or foster care or contribute toward the medical bills for a dog found on the side of Route 10 last week.

Authorities believe Benson -- named for a police officer who helped retrieve him -- is a greyhound and Labrador retriever mix and was used as a bait dog to train other dogs to fight. He was covered with more than 50 old and new bites, police said.
by:www.nj.com

Soroka ER doctors found negligent in two medical malpractice cases

Two recent rulings by the Be'er Sheva Magistrates Court reveal medical malpractice at Soroka Medical Center's emergency room.

In one case, an emergency room doctor told a patient with a transplanted kidney to take a medication that severely damaged the kidney, although the patient himself warned the doctor against giving him the drug and begged him to consult a specialist.

In the second case, a Soroka emergency room physician who was treating a woman for facial injuries left pieces of the patient's teeth embedded in her tongue, which were discovered only months later.
Judge Tahar Shahaf handed down the verdicts in a civil suit brought by the patients against the Clalit Health Maintenance Organization, which operates Soroka. The judge criticized the doctors harshly and last week awarded NIS 100,000 in damages to the kidney patient, including damages for pain and suffering, emotional distress and fear of losing the kidney. Two weeks ago, the judge set damages for the woman with the injured face at NIS 80,000.
The 47-year-old transplant patient, from southern Israel, received a kidney from his sister about a decade ago. In September 2001, he went to the Soroka emergency room complaining of back pain. He informed Dr. Yefim Shot, who examined him, that he had a transplanted kidney.

Shot recommended that he take the anti-inflammatory drug Vioxx. The patient told the doctor that he had been instructed not to take medication of this type. According to his lawyer, Dr. Shai Feuerberg, the doctor responded "impatiently and even rudely" and "was angry at the patient," who asked him to consult a kidney specialist. In fact, after taking the medication, the patient suffered muscle and joint pain, fever, weakness and chills, and considerable damage to the kidney was diagnosed.

He was hospitalized in December 2001 and was told that he would have to go back on dialysis and prepare for another kidney transplant. Eventually, however, the transplanted kidney began to function again.

The judge said the doctor had violated "all the proper rules" and standards expected of an emergency room. She rejected Shot's argument that he only suggested that the patient take the medication and advised him to consult his family doctor first.

Soroka responded that "the hospital is studying the verdict and considering its steps," but noted that the court determined that there was no damage to the kidney.
The woman who sustained injuries to her face had fallen down the stairs in her home in Rahat, near Be'er Sheva. She was treated in the emergency room by Dr. Ella Even-Tov, who at the time was in her first year of residency in ear, nose and throat medicine. The patient was diagnosed with a cut to the tongue and was prescribed mouth rinses and painkillers. However, she continued to suffer pain and complained of a strange feeling in her tongue. A few months later, it was discovered that two tooth fragments, which had not been discovered during her initial treatment, were embedded in her tongue. The woman said that she suffered neurological damage to her tongue.

The court determined that the treatment the woman received in the emergency room was "negligent and insufficient." Even-Tov, she noted, "did not see fit to carry out primary, urgent and necessary tests," such as an x-ray, which would have caught the problem in time; nor did she refer the patient to the hospital's mouth and jaw clinic.
Even-Tov told the court that she did not refer the patient to the clinic because if she did so with every patient who suffered cuts to the tongue, the clinic would be overloaded. She also said that if foreign bodies like teeth are not identified by tests in the emergency room, "a lot of energy and public money should not be wasted" in locating them, "because they can't cause many problems"

In her ruling, the judge said that Even-Tov's statements were "unacceptable and insufferable" and that "in retrospect, at the forefront of the doctor's mind was not the good of the patient, but rather that of the system employing her." The judge also said that the Clalit HMO physician in Rahat, Dr. Nasri Yusef, had been negligent in not refering the patient to a specialist earlier.
Soroka said that it intended to appeal the ruling, since according to the information in its possession, the damage to the patient was entirely caused by the fall and not by the medical treatment she received.
by:www.haaretz.com

Delta Opens Medical Malpractice, Professional Liability Division

Delta General Agency announced the formation of a professional liability division with specialized focus on medical malpractice coverage. The company has tapped Marla Timmons, senior health care and professional liability broker, to lead the division.
Timmons will be based in Houston and guided by Dave Van Tiem, senior vice president.

Timmons has many years insurance experience and in the last ten years developed significant expertise in the health care segment of the industry. She has worked for several large insurance brokerage firms including Willis, Sedgwick James and Aon. She was also an account executive in the health care division of a large Houston wholesaler.

Prior to joining Delta, Timmons was a senior health care broker for Aon's Healthcare Practice Group. Her responsibilities included marketing primary and excess medical professional liability for hospitals, physician groups, nursing homes, and miscellaneous / allied healthcare accounts.

Timmons has obtained her Associate in Risk Management (ARM), Certified Insurance counselor (CIC), Associate in Surplus Lines (ASLI) and Associate in Insurance Service (AIS) designations. She has been the instructor of several insurance education courses for insurance professional organizations, insurance brokers and a community college.

Medical malpractice risks served by the new unit include: physicians, surgicenters, home health agencies, medical staffing agencies, specialty and community hospitals, medical clinics, imaging centers, and counseling/social service organizations.

Source: Delta General Agency