Personal Injury

September 1, 2011

FDA Transvaginal Mesh Safety Alert

As a Texas medical doctor and Transvaginal Mesh Recall and Replacement Attorney, I am fielding many calls from concerned plaintiffs regarding their implanted Transvaginal Mesh medical device. We are providing the following update and commentary. The FDA recommends surgical mesh be reclassified as “High Risk.”

FDA Transvaginal Mesh Safety Alert – Transvaginal Mesh Lawsuit and Class Actions being filed across the Nation. Johnson & Johnson, Boston Scientific Corp. (BSX) and other makers of surgical mesh may have to submit added safety data to regulators to keep their products on the market under a Food and Drug Administration staff recommendation.

The transvaginally implanted products fail to lead to better outcomes than non-mesh repair and should be reclassified as posing a high risk to patients, according to a FDA report. Patient advocates are demanding a recall of the devices, now classified as moderate risk.

August 28, 2011

Surgical Mesh in Pelvic Repair Procedures Should Be Recalled

by Dr. Shezad Malik

As a Texas medical doctor and Transvaginal Mesh Recall and Replacement Attorney, I am fielding many calls from concerned plaintiffs regarding their implanted Transvaginal Mesh medical device.

According to the Public Citizen watchdog group, the surgical mesh products made by Johnson & Johnson (JNJ) and Boston Scientific Corp. (BSX) to correct falling pelvic organs in women should be immediately recalled because of painful side effects.

Public Citizen, said that mesh products made of non-absorbable synthetic material can erode and cause pain, bleeding and urinary incontinence. The mesh is implanted through incisions made in the wall of the vagina to reinforce the tissues around the pelvic organs.

August 27, 2011

Yaz MDL Court Pushing for Yasmin Lawsuit Settlements

by Dr. Shezad Malik

As a Texas medical doctor and YAZ, Yasmin and Ocella Personal Injury attorney, I am providing this litigation update, information and commentary.

Judge Herndon overseeing the federal Yaz and Yasmin MDL, has rejected the consolidation of multiple cases during the early bellwether trials. The Court plans for “meaningful” settlement negotiations after the initial trials are held. These mini trials will help decide how juries will to respond to similar evidence and testimony like other cases in the litigation.

There are more than 6,350 lawsuits that have been centralized in the U.S. District Court for the Southern District of Illinois. All of the cases allege that Bayer failed to adequately warn about the risk of serious and potentially life-threatening side effects of Yaz and Yasmin birth control, such as a stroke, pulmonary embolism, deep vein thrombosis or gallbladder disease.

August 26, 2011

Risks of DePuy Metallosis Following a Metal On Metal Hip

by Dr. Shezad Malik

As a Texas medical doctor and DePuy Hip Recall and Replacement Attorney, I am fielding many calls from concerned plaintiffs regarding their implanted DePuy ASR and DePuy Pinnacle Metal on Metal Hip prosthesis.

The Food and Drug Administration has received many complaints recently about failed hip replacements. The FDA has received more than 5,000 reports since January concerning metal-on-metal hips. The majority of complaints involve patients who have had an all-metal hip removed, or will soon undergo such a procedure because a device failed after only a few years. Metal-on-metal hip replacement systems are a widely used type of artificial hip, which are designed to last about 15 years. However, complaints suggest that thousands of people are experiencing early failure of the hip implants within a few years of surgery, often leading to additional surgery to replace the hip.

The complaints confirm that all-metal replacement hips are becoming the biggest and most costly medical implant problem since Medtronic recalled a widely used heart device component in 2007.

Some patients have suffered crippling injuries caused by tiny particles of cobalt and chromium that the metal devices shed as they wear. This is known as metallosis. This may result in soft tissue damage, inflammatory reactions, bone loss, genetic damage, asceptic fibrosis, local necrosis or other problems that may lead to the need for a risky hip revision surgery.

Hip replacement is one of the most common procedures in the United States and all-metal implants accounted for nearly one-third of the estimated 250,000 replacements performed each year. According to one estimate, some 500,000 patients have received an all-metal replacement hip.

One of the artificial hip devices, the A.S.R., or Articular Surface Replacement, was recalled last year by Johnson & Johnson and accounted for 75 percent of the complaints. Under F.D.A. rules, many all-metal devices were sold without testing in patients or without a requirement that producers track their performance. The F.D.A. in May ordered producers to study how frequently the devices were failing and to examine the threat to patients.

In August 2010, a DePuy ASR hip recall was issued for more than 90,000 of the metal hip implants, after it was discovered that a higher-than-expected number were failing within a few years of surgery. Similar problems have been reported in connection with other metal-on-metal hip implants sold by other companies.

In February 2011, the FDA launched a new website in February 2011, which was designed to provide information about the risks associated with metal-on-metal hip replacements.

The FDA has now asked device manufacturers to obtain more information about the level at which the metal particles shed by hip replacements becomes dangerous, how much metal they actually shed and what the potential side effects of metallosis are.

As problems and questions grow, some surgeons are abandoning the all-metal hips, saying they are unwilling to expose new patients to potential dangers when safer alternatives — mainly replacements that combine metal and plastic components — are available.

For many patients, it is too late. The number of complaints filed with the F.D.A. about a product understates a problem because while companies must file reports, doctors and patients do not have to. The filing volume for the DePuy A.S.R. and the Zimmer Durom cup probably reflects a surge of lawsuits filed against their makers.

According the recent New York Times review, there were 7,500 complaints about the A.S.R., nearly 5,000 of them coming since January. In the case of the Durom cup, about 1,600 complaints were filed with the regulator from 2007 to this June.

It is impossible to say how many adverse reports about all-metal hips have been submitted. The Times analysis found some 200 complaints about an all-metal version of another DePuy device called the Pinnacle as well as 400 additional complaints that noted metal-related problems in Pinnacle patients. But the Pinnacle is sold in several versions, so it was not clear how many of the metal-related complaints were linked to the all-metal device.

Many individuals throughout the United States have already filed metal-on-metal hip replacement lawsuits over problems allegedly caused by metallosis or metal poisoning. All DePuy ASR hip lawsuits have been consolidated in federal court as part of an MDL, or multidistrict litigation, in Northern District of Ohio. Lawsuits over DePuy Pinnacle hip metal-on-metal implant replacements, which is another has been consolidated in the Northern District of Texas in Dallas.

August 15, 2011

Dog Mauling and Dangerous Dogs

by Dr. Shezad Malik

As a Texas Medical Doctor and Dallas dangerous dog attorney, I am writing this update to inform the public about recent dog attacks.

A Washington jury found Pierce County partly responsible for injuries suffered by a woman mauled by a pit bull. The jury awarded $2.2 million to the woman who was attacked by a neighbor’s dog who entered her house through an open door.

The jury determined the owners of the dog were 52 percent responsible. Pierce County received 42 percent of the liability because animal control officials took no action after getting a dozen complaints from the neighborhood. The injured woman, was assigned 1 percent of the blame. She suffered injuries while trying to pull the pit bull off her two Jack Russell terriers.

August 9, 2011

DePuy Pinnacle Hip MDL Hearing

by Dr. Shezad Malik

As a DePuy Pinnacle Hip Replacement attorney and Texas Medical doctor I am providing this important update, regarding the first MDL hearing held in my home town of Dallas, Texas.

Attorneys from throughout the United States who represent DePuy Pinnacle hip replacement plaintiffs, met today in the U.S. District Court for the Northern District of Texas. This hearing was held in Dallas, and was the first status conference with the judge presiding over the recently formed multi-district litigation (MDL). The meeting between the plaintiff and defense attorneys was quite cordial and the hearing with Judge Kinkeade, lasted over 2 hours. This was an informal, esssentially a meet and greet type of hearing, much different from other types of contentious hearings.

It was interesting to stand at the back of the courtroom and observe the proceedings, the court room was jam packed, standing room only.

August 8, 2011

Actos Bladder Cancer Side Effect Update

by Dr. Shezad Malik

As a Texas medical doctor and Actos Bladder Cancer Attorney I am providing this information and commentary.

The maker of the world’s best-selling diabetes drug is facing many lawsuits as adverse medical research shows that taking the pill for more than a year raises the risk of bladder cancer.

In June, Takeda Pharmaceuticals Co. Ltd. halted sales of Actos, in Germany and France after pressure from government health regulators. Actos (pioglitazone) is a medication manufactured and sold by Takeda Pharmaceuticals for treatment of Type 2 diabetes. The drug is part of the same class of medications as Avandia (rosiglitazone), which has been linked to an increased risk of heart problems. As a result of concerns about Avandia side effects, sales of Actos have grown substantially in recent years.

August 6, 2011

Transvaginal Mesh Lawsuits Moving Ahead

by Dr. Shezad Malik

As a Texas medical doctor and Transvaginal Mesh Attorney I am providing this information and commentary.

Read previous Transvaginal Mesh side effect blog here.

A number of lawsuits over Bard Avaulta mesh and other transvaginal products manufactured by C.R. Bard have been filed throughout the United States. The general allegations in these claims are that women experienced painful complications after receiving the vaginal mesh products for repair of pelvic organ prolapse (POP) and other gynecological and urological medical conditions.

August 4, 2011

Fracking Water Contamination

by Dr. Shezad Malik

As a Texas medical doctor and Fracking water contamination attorney, I want to pose this rhetorical question; What happens when the foxes are guarding the hen house? Consider that as you savor your morning coffee, which may be contaminated with benzene, from a contaminated water aquifer.

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Oil and gas industry as well as government regulators have maintained for many decades that a drilling technique known as hydraulic fracturing, or fracking, that is used for natural gas wells has never contaminated underground drinking water. The fracking process, involves water and toxic chemicals being injected at high pressure into the ground to break up rocks and release the gas trapped there. This process according to industry officials, occurs thousands of feet below drinking-water aquifers and because of that distance, the drilling chemicals allegedly pose no risk.

According to ExxonMobil at a Congressional hearing on drilling…“There have been over a million wells hydraulically fractured …and there is not one, not one, reported case of a freshwater aquifer having ever been contaminated from hydraulic fracturing…”
But there is in fact a documented case, and the E.P.A. report suggests there may be more. Researchers, were unable to investigate many suspected cases because their details were sealed from the public when energy companies settled lawsuits with landowners. E.P.A. says this practice continues to prevent them from fully assessing the risks of certain types of gas drilling.

The American Petroleum Institute, dismissed the assertion that sealed settlements have hidden problems with gas drilling, and according to their data, they have found that drinking water contamination from fracking is highly improbable.

The documented E.P.A. case, and the report was published in 1987, and the contamination was discovered in 1984. The report concluded that hydraulic fracturing fluids or gel used by the Kaiser Exploration and Mining Company contaminated a well roughly 600 feet away on the property of James Parsons in Jackson County, W.Va., referring to it as “Mr. Parson’s water well.”
“When fracturing the Kaiser gas well on Mr. James Parson’s property, fractures were created allowing migration of fracture fluid from the gas well to Mr. Parson’s water well,” according to the agency’s summary of the case. “This fracture fluid, along with natural gas was present in Mr. Parson’s water, rendering it unusable.”
In their report, E.P.A. officials also wrote that Mr. Parsons’ case was highlighted as an “illustrative” example of the hazards created by this type of drilling, and that legal settlements and nondisclosure agreements prevented access to scientific documentation of other incidents. “This is typical practice, for instance, in Texas,” the report stated. “In some cases, the records of well-publicized damage incidents are almost entirely unavailable for review.”
Industry officials emphasize that all forms of drilling involve some degree of risk. The question, they say, is what represents an acceptable level. Once chemicals contaminate underground drinking-water sources, they are very difficult to remove, according to federal and industry studies.

A 2004 study by the E.P.A. agency concluded that hydraulic fracturing of one kind of natural gas well — coal-bed methane wells — posed “little or no threat” to underground drinking water supplies. The study was later criticized by some within the agency as being unscientific and unduly influenced by industry.

Instances of gas bubbling from fracked sites into nearby water wells have been extensively documented. The industry has also acknowledged that fracking liquids can end up in aquifers because of failures in the casing of wells, spills that occur above ground or through other factors.

Both types of contamination can render the water unusable. However, contamination from fracking fluids is widely considered more worrisome because the fluids can contain carcinogens like benzene.

The risk of abandoned wells serving as conduits for contamination is one that the E.P.A. is currently researching as part of its national study on fracking. Many states lack complete records with the number or location of these abandoned wells and they lack the resources to ensure that abandoned and active wells are inspected regularly.

A 1999 report by the Department of Energy said there were about 2.5 million abandoned oil and natural gas wells in the United States at the time.

Short answer, carbon based energy is not the answer, in this current heat wave that most of the country is withering under, think of the amount of solar energy that can be harvested?
Studies have shown that a solar array set up, in Nevada can supply all of the energy needs of the USA, for the next century.

August 2, 2011

Ethicon Gynecare Prolift Mesh Linked to 11.6% Reoperation Rate

by Dr. Shezad Malik

As a Texas medical doctor and Transvaginal Mesh Attorney I am providing this information and commentary.

11.6% of women who undergo surgery with transvaginal placement of Ethicon Gynecare Prolift Mesh for repair of pelvic organ prolapse (POP) have to undergo additional operations due to post operative complications.

This complication rate was found as a result of a new study, published by the American Journal of Obstetrics and Gynecology. Most of the re-operations were due to urinary incontinence that occurred after the mesh was implanted, with other problems including transvaginal mesh complications and prolapse recurrence.

Researchers reviewed the outcomes for 524 patients who received the Ethicon Gynecare Prolift vaginal mesh over a 4 year period. At a follow up of 38 months, 11.6% had to undergo reoperation after receiving the Prolift Mesh for pelvic organ prolapse. Over 50% of those reoperations were due to urinary incontinence, More than 25% due to mesh-related complications and more than 25% due to recurring prolapse. The researchers found that the number of mesh-related complications and POP decreased when experienced medical teams implanted the mesh.

The Gyncare Prolift Total, Anterior and Posterior Pelvic Floor Repair Systems was first introduced in September 2005, and Gynecare Prolift+M variations were introduced in May 2008. The vaginal mesh or bladder sling is designed reinforce weakened or damaged tissue on the pelvic floor that hold organs in place, such as the bladder, the uterus and the rectum.

Recently, the FDA issued a warning about the risk of problems with Ethicon Gynecare vaginal mesh and other similar products used for pelvic organ prolapse. The agency declared that transvaginal surgical mesh for pelvic organ prolapse does not provide any benefit over other means of treatment, and has been associated with hundreds of reports of serious problems.

Between 2008 and 2010, the FDA received more than 1,500 reports of transvaginal mesh problems after pelvic organ prolapse repair surgery, including erosion of the mesh into the vagina, contraction or shrinkage of the mesh, infection, pelvic pain, urinary problems, vaginal scarring among other complications.

A number of Gynecare Prolift mesh lawsuits have been filed against Ethicon, Inc., which is a subsidiary of Johnson & Johnson. At least 400 complaints have been filed in New Jersey state court over the Prolift mesh and other similar vaginal bladder sling products made by Ethicon, such as Gynemesh, Prolene Mesh and TVT slings.

In addition to Ethicon vaginal mesh products, problems have also been associated with slings sold by American Medical Systems (AMS), Boston Scientific, C.R. Bard and other companies. Transvaginal mesh lawyers are also reviewing potential claims against manufacturers of these products for women who experienced problems with surgical mesh for pelvic organ prolapse repair.