Sources: NPR (National Public Radio); US Centers for Disease Control and Prevention (CDC)
WE’VE blogged about MRSA (methicillin-resistant Staphylococcus aureus), VRE (cancomycin Resistant Enterococcus) and C-Diff (Clostridium difficile). Get ready to add another nasty super bug to the list -CRE (carbapenem-resistant Enterobacteriaceae).
Federal officials warn that the newest kid on the block has become a significant health problem in hospitals throughout the United States. These germs, known as carbapenem-resistant Enterobacteriaceae, or CRE, have become much more common in the last decade, according to the Centers for Disease Control and Prevention. And the risk they pose to health is becoming evident. “What’s called CRE are nightmare bacteria,” says Dr. Thomas Frieden, director of the CDC, “They’re basically a triple threat.” First of all, they are resistant to virtually all antibiotics, including the ones doctors use as a last-ditch option. Second, these bugs can transfer their invincibility to other bacteria. “The mechanism of resistance to antibiotics not only works for one bacteria, but can be spread to others,” Frieden says. Third, the bacteria can be deadly. Infection with the bacteria “have a fatality rate as high as 50 percent,” Frieden says.
While resistant bacteria potentially pose a risk to anyone, people whose immune systems are weaker, such as elderly people, children and people who have other health problems, tend to be most susceptible to infection.
CDC data show the proportion of bacteria that have this resistance to many drugs has quadrupled in the last decade or so. CRE cases were reported by 4 percent of hospitals in 2012, up from about 1 percent from about a decade earlier, according to the report. In long-term care hospitals the situation is even worse — about 18 percent have reported cases, the CDC says. In addition, the proportion of Enterobacteriaceae bacteria that were resistant increased from 1.2 percent in 2001 to 4.2 percent in 2011, the CDC reported.
The big fear is that they’ll start to move out of hospitals and into the communities around them. “If CRE spreads out of hospitals and into communities, that’s when the ship is totally underwater and we all drown,” Infectious disease specialist Dr. Brad Spellberg, of the Los Angeles Biomedical Research Institute at the Harbor-UCLA Medical Center, says. To prevent that from happening, the CDC and others are calling on hospitals to contain CRE. The first thing hospitals need to do is test patients to see if they have these bugs. That includes common-sense things like keeping them away from other patients and sterilizing everything they come into contact with. And doctors have to use antibiotics more carefully to prevent more germs from developing into more dangerous superbugs.
The Lewis Law Firm represents patients and their families who are victims of hospital and physician malpractice in Philadelphia and New Jersey resulting in serious injury and death. If you or a loved one were the victim of hospital or physician malpractice, contact the Lewis Law Firm for a FREE consultation and case review today.
Sources: Bloomberg News, US Food & Drug Administration
THEY have been hailed as the latest state of the art technology and their manufacturer has given them a name worthy of a medical rennaissance -the Da Vinci. But are robotic surgeries actually safer than those performed directly by the hand of a surgeon?
Robot systems (da vinci) made by Intuitive Surgical Inc. (ISRG) have been linked with incident reports of 70 deaths sent to U.S. regulators since 2009, according to a review by Bloomberg News. Intuitive, based in Sunnyvale, California, dominates the robot-surgery field. It’s the only company whose system is cleared in the U.S. for soft tissue procedures that include general surgery, prostate operations and gynecological surgery, according to a company spokeswoman.
The da vinci robotic systems consist of a video-game style console with foot pedals and hand controls attached to a HD display and mechanical arms equipped with tools -all guided by a 3-D camera. They are priced at $1.5 million each and have helped make Intuitive one of the hottest stocks in health care, growing 61 percent since the end of February 2010 to a market value of $21.7 billion. The number of U.S. procedures done with the robots has grown to about 367,000 in 2012, according to a company filing.
More than half of last year’s total involved gynecological treatments including delicate ureteral repairs. The reported benefits include better visualization, robot arms that can precisely manipulate small areas inside the body, and improved ergonomics to reduce surgeon fatigue.
According to a Bloomberg review of adverse incident reports sent to the US Food and Drug Administration since 2009 reportedly shows an increase in adverse incidents during robotic surgery. Injury reports involving the procedures jumped to at least 115 in 2012 from 24 in 2009, while deaths rose to 30 from 11. Intuitive Surgical remains confident the robots are “extremely safe,” according to Myriam Curet, the company’s chief medical adviser. An “extraordinarily small” percentage of deaths and injuries “hasn’t grown” over time, Curet reportedly stated.
The Lewis Law Firm handles cases of physician malpractice and hospital malpractice causing injury and death in Philadelphia and New Jersey . If you or a loved one were the vitim of wrong-site or wrong surgery, contact the Lewis Law Firm for a FREE consultation today.
Source: US Food & Drug Administration (FDA)
The FDA has recently updated its March 29, 2012 Class I recall of the dialysis products, Naturalyte Liquid and Granuflo Acid Concentrate. On March 29, 2012, the firm sent an Urgent Product Notification to their clinics and customers. This notification provided clinicians with prescribing information regarding the Naturalyte Liquid and Granuflo Acid Concentrate. Naturalyte Liquid and Granuflo Dry Acid Concentrate are used in the treatment of acute and chronic renal failure during hemodialysis. The concentrate is formulated to be used with a three-stream hemodialysis machine, which is calibrated for acid and bicarbonate concentrates.
Class I recalls are the most serious type of recall by the FDA and they involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
The relevant Serial numbers for Naturalyte Liquid Acid Concentrate range from:
08-0231-4, 08-1001-0, 08-1201-8, 08-1231-3, 08-1251-1, 08-1301-4, 08-2201-5, 08-2231-2, 08-2251-0, 08-2301-3,08-2351-8, 08-3201-4, 08-3231-1, 08-3251-9, 08-3301-2, 08-4123-1, 08-4223-7, 08-4225-1, 08-4230- 2, 08-4231-0, 08-4323-5, 08-4325-1, 13-1251-1, 13-2201-5, 13-2231-2, 13-2251-0, 13-3231-1, 13-3251-9, 13-4123-1, 13-4220-1, 13-4225-1, 13-4325-1
Serial numbers for Naturalyte GranuFlo (powder) Acid Concentrate range from:
OFD1201-3B, OFD1251-3B, OFD2123-3B, OFD2201-38, OFD2220-3B, OFD2223-3B, OFD2225-3B, OFD2231-3 B, OFD2251-3B, OFD2301-3B, OFD2323-3 B, OFD2325-3B, OFD3201-3B, OFD3231-3B, OFD3251-3B, OFD3301-3B
This concentrate was manufactured and distributed from January 2008 through June 2012 by Fresenius Medical Center, the largest operator of dialysis centers in the US. The manufacturer is cautioning clinicians to be aware of the concentration of acetate or sodium diacetate (acetic acid plus acetate) contained in Fresenius’ Naturalyte Liquid and Granuflo Dry Acid Concentrate. Inappropriate prescription of these products can lead to a high serum bicarbonate level in patients undergoing hemodialysis. This may contribute to metabolic alkalosis, which is a significant risk factor associated with low blood pressure, hypokalemia (low calcium), hypoxemia (low oxygen), hypercapnia (too much carbon) and cardiac arrhythmia, which, if not appropriately treated, may culminate in cardiopulmonary arrest. This product may cause serious adverse health consequences, including death.
Consumers may contact the firm at 1-800-662-1237.
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to MedWatch: The FDA Safety Information and Adverse Event Reporting Program1 either online, by regular mail or by FAX.
The Lewis Law Firm handles cases of defective drugs and medical devices. If you or a loved one were injured by a defective durg or defective medicaldvices, including dialysis solutions, contact the Lews Law Firm for a FREE Consultation and Case Review, today.
Posted by Gayle R. Lewis, Esquire
Sources: US Food & Drug Administration; Journal of Oral & Maxillofacial Surgeons
A recent report of Oral & Maxillofacial Surgeons focuses upon the link between bisphosphonates (Fosomax, Boniva, Actonel, Reclast) and osteonecrosis of the jaw. Osteonecrosis of the jaw is a disease in which bone tissue in the jaw does not heal after minor traumas, such as tooth extractions by a dentist. The delayed healing causes the bone of the jaw to become exposed leading to infections often requiring long-term antibiotic therapy and surgery to remove the dead and dying bone tissue. Other patients experience actual breaking of the jaw on tooth remocal. Patients using Fosamax and other bisphosphonates should try to avoid tooth extractions and other major dental work while taking these medications.
The FDA announced as early as October of 2010 that bisphosphonates, medications to treat osteoporosis (a condition which makes bones brittle) may actually cause fractures of the femur (thigh bone).
Bisophosphonates are drugs which are currently prescribed to more than half a million people diagnosed with osteoporosis. Their prolonged use may be responsible for making bones more brittle. These drugs operate by slowing down the process of osteoclast cells which break down bone and replace it -a natural process. The longer this natural process is delayed, the older the cells which make up the bone actually become. Accordingly, the replacement bone is made up of old bone cells which are more brittle and more subject to fracture with limited or no trauma. Those taking Fosomax for more than 3 years appear to be at most risk for low-energy femur fractures.
Merck, the manufacturer of Fosamax (Alendronate), has largely denied the claims currently the subject of several class action lawsuits, although their labeling has been revised consistent with this information.
If you or a loved one are taking Fosomax, Boniva, Actonel, Reclast or any other osteoporosis drug and you have experienced a low-energy femur fracture or osteonecrosis of the jaw, contact the Lewis Law Firm to determine if you have a case. Our consultation and initial opinion are free.
Posted by: David M. Schwadron, Esquire
Source: US Food and Drug Administration (FDA)
The FDA has issued an update warning doctors and patients of the dangers of transvaginal mesh placement. This follows years of dramatic increases in reports of adverse events over the use of surgical mesh for the transvaginal repair of POP (pelvic organ prolapse). POP occurs when the internal structures that support the pelvic organs -the bladder, uterus, and bowel, become so weak or stretched that the organs drop from their normal position and bulge or prolapse into the vagina. Women with POP often experience pelvic discomfort; disruption of their sexual, urinary, and bowel functions; and an overall reduction in their quality of life.
The FDA previously suggested (in a 2008 report) that serious complications associated with surgical mesh for POP procedures and stress urinary incontinence were “rare.” In July of 2011, the FDA reversed their position on this issue stating that there was no clear evidence that transvaginal POP repair with mesh is more effective than traditional non-mesh repair in all patients with POP and actually may expose patients to “greater risk.” It appears the FDA is maintaining their latest position.
“There are clear risks associated with the transvaginal placement of mesh to treat POP,” according to William Maisel, MD, MPH, deputy director and chief scientist of the FDA’s Center for Devices and Radiological Health. “The FDA is asking surgeons to carefully consider all other treatment options and to make sure that their patients are fully informed of potential complications from surgical mesh. Mesh is a permanent implant — complete removal may not be possible and may not result in complete resolution of complications.”
An FDA review of adverse events of all urogynecologic surgical mesh products from January 2005 to December 2010 identified 3979 reports of injury, death, and malfunction. There were 5x as many reports of adverse events associated with transvaginal mesh from January 1, 2008, to December 31, 2010 than in the previous 3 years, according to the FDA.
Erosion of mesh through the vagina and mesh contraction may lead to severe pelvic pain, painful sexual intercourse, or an inability to engage in sexual intercourse. infection and urinary and fecal incontinence. The FDA cleared the first surgical mesh product specifically for use in POP in 2002. Mesh manufacturers include: American Medical Systems; Bard; Boston Scientific; Johnson & Johnson and Caldera.
If you or a loved one underwent vaginal mesh implantation and are experiencing complications, contact the Lewis Law Firm to determine if you have a case against the manufacturer or the doctor who performed the procedure. Our free consultation and initial opinion may assist you.
Posted by: Gayle R. Lewis, Esquire
Source: Chicago’s Northwestern University News Center; www.northwestern.edu
In what has been termed the “first study in which women are actually asked questions,” a staggering 36% of postmenopausal women who are treated for estrogen-sensitive breast cancer quit using drugs that help prevent the disease from recurring. Universally the reason is because of side effects of the medication, which are more severe and widespread than previously known. Researchers noted that women do not tell their doctors about all of the side effects they experience or their degree.
“Clinicians consistently underestimate the side effects associated with treatment,” said lead investigator Lynne Wagner, Associate Professor at Northwestern University Feinberg School of Medicine and a clinical psychologist at Robert H. Lurie Comprehensive Cancer Center of Northwestern University. “They give patients a drug they hope will help them, so they have a motivation to underrate the negative effects. Patients don’t want to be complainers and don’t want their doctor to discontinue treatment. So no one knew how bad it really was for patients.”
Among reported side effects, the most common one causing cessation of treatment was joint pain. Other side effects women reported as compromising their quality of life were hot flashes, decreased libido, weight gain, feeling bloated, breast sensitivity, mood swings, irritability and nausea. 2/3 of all breast cancers are stimulated by estrogen and the drugs given to women halt the production of estrogen in the body. This causes symptoms commonly associated with menopause.
The women at highest risk for quitting the medications before the recommended five years are those who still are experiencing residual side effects from recent chemotherapy or radiation therapy when they start the aromatase therapy. “The more miserable they were before they started, the more likely they were to quit,” according to Wagner.
The Northwestern study surveyed 686 women with a detailed questionnaire about their symptoms before treatment and at 3, 6, 12 and 24 months after starting treatment. The researchers found after three months of treatment that 33-35% of women had severe joint pain, 28-29% percent had hot flashes, 24% had decreased libido, 15-24% experienced fatigue, 16-17% reported night sweats and 14-17 % felt anxiety. 36% of women ended treatment before an average of 4.1 years. After two years, 10% had quit; the remainder quit between 25 months and the 4.1 years. When one considers that the risk of recurrence of breast cancer in this group of women is high, it is concerning that they would voluntarily stop their medical therapy because of side effects. Perhaps more research into better drugs with less side effects is needed. The research was funded by the National Cancer Institute.
Posted by: Gayle R. Lewis, Esquire
Source: NY Daily News; Eli Lilly & Co.
According to Audits conducted on Nursing Home Facilities in the United States, elderly patients with dementia are too often prescribed anti-psychotic drugs to calm disruptive behavior. The Senate Committe on Aging is apparently having hearings on this issue. Health and Human Services Inspector General, Daniel Levinson has stated that recent government audits raise concerns about the use of antipsychotics by elderly people with dementia in nursing homes, raising their risk of death and wasting money for the US healthcare system.
More than half of such prescriptions were wrongly paid for in 2007 by government Medicare because the patients did not exhibit symptoms of schizophrenia or bipolar disorder, amounting to about 230 million dollars in waste. One audit showed 14 percent of nursing home residents had Medicare claims for antipsychotic drugs, Levinson said.
Toby Edelman, Senior policy attorney in the office of the Center for Medicare Advocacy, Tobt Edelman, said that the estimate was low because it only included some kinds of anti-psychotics. “Nursing facilities’ self-reported data indicate that in the third quarter of 2010, 26.2 percent of residents had received antipsychotic drugs in the previous seven days. That is approximately 350,000 individuals,” she said. “Facilities reported they gave antipsychotic drugs to many residents who did not have a psychosis, including 40 percent of patients at high risk because of behavior issues.”
Sadly, this issue is not new -the same Senate committee issued a report on the misuse of drugs in nursing homes back in 1975. Although it is against federal law the practice of medication control continues, because of serious understaffing in nursing facilities, high turnover of staff, and “aggressive off-label marketing of anti-psychotic drugs.” In particular, in 2009, Eli Lilly Company accepted a Misdemeanor Charge related to Zyprexa(R) (olanzapine).Promotion Between 1999 and 2001. Lilly promoted Zyprexa in elderly populations as treatment for dementia, including Alzheimer’s dementia, although Zyprexa is not approved for such uses. As part of this agreement regarding the criminal investigation, Lilly agreed to pay $615 million. Under terms for the resolution of the civil investigations, Lilly agreed to make payments totaling nearly $800 million.
Posted by: Gayle R. Lewis, Esquire
Source: US Food and Drug Administration (FDA)
The US FDA has revoked it’s prior approval of Avastin for the treatment of metastatic breast cancer. Avastin came onto the market as being a meidication with great promise for the treatment of metastatic breast cancer. FDA Commissioner Margaret Hamburg stated plainly in her Decision of the Commissioner, that, “[T]there is no benefit to breast cancer patients that would justify its risks.” Among Avastin’s more significant side effects are: heart attack; heart failure; and, severe bleeding.
Avastin was orginally granted “Accelerated Approval” by the FDA in 2008. Accelerated approval is an FDA process which “fast-tracks” drugs which might treat life-threatening conditions where evidence suggests that following more testing the drug’s effectiveness will be proven. However, in this case, a different approval measure was used, Progression Free Survival (PFS) or demonstrating that patients survive longer while taking the drug. Avastin’s sponsor, Genetech, Inc. had produced one study which suggested that the PFS was a median of 5.5 months. However when the date for this single study was later produced, the 5.5 month survival was not supported and the dangers of the drug were found to outweigh the benefits. Genetech was unable to provide any additional studies which suggested that Avastin had a clear clinical benefit for women with breast cancer.
Obviously disappointed with the decision, Genentech put out the following statement, ”We are disappointed with this outcome.” Yes there was more. But don’t feel too badly for Big Pharma, Avastin will remain on the market despite the known risks of the drug. The FDA has approved Avastin for the treatment of certain types of brain, colon, kidney and lung cancers and doctors are still free to prescribe Avastin for any use they see fit, including breast cancer (so-called “off label” usage).
Posted by: David M. Schwadron, Esquire
WHITEHOUSE STATION, N.J., Nov. 22, 2011 – Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced it has reached a resolution with federal and state authorities regarding a previously disclosed investigation concerning Vioxx. Merck voluntarily withdrew Vioxx from the market in September 2004. The company previously recorded a charge of $950 million in October 2010 in anticipation of today’s agreements.
The company pleaded guilty to the criminal charge of violation of the US Food Drug and Cosmetic Act for promoting rofecoxib for the treatment of rheumatoid arthritis for approximately three years before that use was approved by the FDA. For this, the firm will pay a $321.6 million criminal fine, the US Department of Justice said yesterday.
Merck will also pay $628.3 million as part of a civil settlement, which covers, amongst other things, allegations that company representatives made “inaccurate, unsupported, or misleading statements” about rofecoxib’s cardiovascular safety to increase sales. Approximately a third of that civil settlement will be distributed to Medicaid agencies from 43 states and the District of Columbia. In November 2007, Merck entered into an agreement to resolve myocardial infarction and stroke claims filed as of that date in the US, paying out $4.85 billion to resolve more than 99.9% of eligible claims. (Our Note -LLF)
Previously disclosed litigation with seven states remains outstanding. The civil settlement does not constitute any admission by Merck of any liability or wrongdoing.
“We believe that Merck acted responsibly and in good faith in connection with the conduct at issue in these civil settlement agreements, including activities concerning the safety profile of Vioxx,” said Bruce N. Kuhlik, executive vice president and general counsel of Merck. Separately, the company agreed to plead guilty to a misdemeanor under the Federal Food, Drug, and Cosmetic Act arising out of the marketing of Vioxx by company representatives to physicians in the United States for the treatment of rheumatoid arthritis before the FDA’s approval of that indication in April 2002. The company will pay a fine of approximately one-third of the reserved amount to the federal government as part of the plea agreement. As part of the plea agreement, the United States acknowledged that there was no basis for a finding of high-level management participation in the violation. The government also recognized Merck’s full cooperation with its investigation.
Merck also has entered into a new corporate integrity agreement (CIA) with the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services. This agreement replaces Merck’s current CIA and builds upon the company’s existing comprehensive compliance program. Merck’s compliance program includes specific policies and procedures governing the company’s interactions with healthcare professionals and is designed to help prevent, detect and resolve potential violations of company policy or law. “Merck recognizes the importance of robust compliance programs and is committed to adhering to the law and to our fundamental values and standards. We believe that the settlement of this lengthy investigation is in the best interests of our stakeholders, and we look forward to focusing on our mission to save and improve lives around the world,” said Kuhlik.
Today’s Merck is a global healthcare leader working to help the world be well. Merck is known as MSD outside the United States and Canada. Through our prescription medicines, vaccines, biologic therapies, and consumer care and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to healthcare through far-reaching policies, programs and partnerships. For more information, visit www.merck.com and connect with us on Twitter, Facebook and YouTube.
Go on, tell them how you feel.
Posted by: David M. Schwadron, Esquire
Source: FDA final report Combined Hormonal Contraceptives (CHCs) and the Risk of Cardiovascular Disease Endpoints (10/2011); Associated Press; NPR Health News
The FDA has now released their report on Combined Homonal Contraceptives (CHCs), such as Yaz, and the increased risk of blood clots in women. The study followed more than 800,000 U.S. women taking different forms of birth control between 2001 and 2007. On average, women taking Yaz had a 75 percent greater chance of experiencing a blood clot than women taking older birth control drugs.
From the report directly, “There has long been concern about the risk of both arterial and venous cardiovascular complications imparted by the use of combined hormonal contraceptives (CHCs) in large part because of the prothrombotic effects of estrogen (ethinyl estradiol [EE]). An increased risk of venous thromboembolism [VTE] (deep venous thrombosis [DVT] and pulmonary embolism [PE]) is well established and has been consistently reported”
The FDA concludes that, “[T]he study results add to the small body of literature which shows that the NGMN (norelgestromin/ethinyl estradiol) transdermal patch is associated with higher risk of VTEs relative to standard CHC pills and provides another positive finding to the increasing body of evidence linking DRSP to increased risk of VTE relative to standard low-dose CHC (combined hormonal contraceptive) pills. DRSP was associated with higher risk of ATE in new users overall with this finding restricted to women in the 35-55 years age group only. The finding of increased risk of VTE with the ETON (etonogestrel/ethinyl estradiol ) vaginal ring relative to standard CHCs is new and raises concern but needs to be replicated in other studies.”
The main findings of this study are that all use of the DRSP pill and each of the continuous exposure preparations, the NGMN patch and the ETON vaginal ring, are associated with an increased risk of VTE relative to the standard low-dose OCPs.
Combined hormonal contraceptives are marketed under the following brands and doses:
|Drospirenone and ethinyl estradiol||Drospirenone 3 mg and ethinyl estradiol 0.03 mg|
|Ocella||Drospirenone 3 mg and ethinyl estradiol 0.03 mg|
|Safyral||Drospirenone 3 mg, ethinyl estradiol 0.03 mg, and levomefolate calcium 0.451 mg|
|Syeda||Drospirenone 3 mg and ethinyl estradiol 0.03 mg|
|Yasmin||Drospirenone 3 mg and ethinyl estradiol 0.03 mg|
|Zarah||Drospirenone 3 mg and ethinyl estradiol 0.03 mg|
|Beyaz||Drospirenone 3 mg, ethinyl estradiol 0.02 mg and levomefolate calcium 0.451 mg|
|Drospirenone and ethinyl estradiol||Drospirenone 3 mg and ethinyl estradiol 0.02 mg|
|Gianvi||Drospirenone 3 mg and ethinyl estradiol 0.02 mg|
|Loryna||Drospirenone 3 mg and ethinyl estradiol 0.02 mg|
|Yaz||Drospirenone 3 mg and ethinyl estradiol 0.02 mg|
Yaz contains estrogen along with a next-generation synthetic hormone called drospirenone, which is known to increase potassium levels in the blood. FDA compared medical records of women taking the drug with those taking the older drug levonorgestrel. Yaz, Yasmin and related drospirenone-containing pills were Bayer’s second-best-selling franchise last year at $1.6 billion in global sales. The FDA reports also highlight complications in women using the Ortho Evra patch from Johnson & Johnson and the Nuvaring vaginal ring from Merck & Co. Inc. Those drugs combine estrogen, which is present in all birth control pills, with two other synthetic hormones launched in the last decade
The FDA has recommended that: “Patients should talk to their healthcare professional about their risk for blood clots before deciding which birth control pill to use. Known risk factors that increase the risk of a blood clot include smoking, being overweight (obesity), and family history of blood clots, in addition to other factors that contraindicate use of birth control pills” and that “Women currently taking a drospirenone-containing birth control pill should be informed of the potential risk for blood clots.”
“At a certain point we have to ask why the FDA continues to approve drugs that are less safe and have no benefit compared to drugs already on the market,” said Dr. Diana Zuckerman, president of the National Center for Women and Families, a consumer group for women’s health issues. “With all these different birth control options, why take the most expensive one that can also kill you?” Good question, Dr. Zuckerman. Let’s hope that we finally get anwers.
Posted by: Gayle R. Lewis, Esquire