Product Liability

August 26, 2011

Risks of DePuy Metallosis Following a Metal On Metal Hip

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 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.

July 29, 2011

DePuy ASR and Pinnacle Metal on Metal Hips

by Dr. Shezad Malik

As a Texas medical doctor and Dallas DePuy Pinnacle hip replacement Attorney I am providing this information and commentary.

Johnson and Johnson Pinnacle hip trials. DePuy is under fire over its Pinnacle/Ultamet line of metal hip devices causing metal poisoning and premature failure according to lawsuits.

DePuy Orthopaedics ASR hip replacement devices have resulted in a tsunami of lawsuits against DePuy’s parent company, Johnson & Johnson. Could the DePuy Pinnacle hip replacement result in a similar wave of litigation against the device maker?
According to sources, Johnson & Johnson faces approximately 1,000 lawsuits related to its metal-on-metal hip replacement devices. Both the ASR and the Pinnacle are metal-on-metal devices. The ASR devices were recalled following reports of high failure rates in the devices. The Pinnacle has not been recalled.

DePuy claims that a report from Britain that showed a high failure rate was the first sign that there was a problem with the metal-on-metal hip device. When DePuy knew about the high failure rate of its ASR devices will be a key issue in litigation concerning the ASR. Some lawsuits allege DePuy knew in 2007, approximately two years before the device was recalled, about the high failure rate associated with the ASR.

In addition to failure of the hip device—which can result in revision surgery to replace the faulty hip device—some patients say they have developed toxic levels of cobalt and chromium in their bloodstream, a side effect of metal debris coming loose from the hip replacement device. This medical condition is called metallosis.

Some lawsuits have been filed against DePuy concerning the Pinnacle, although those lawsuits reportedly number in the dozens, not in the thousands. According to reports, similar defects have been reported in the Pinnacle as in the ASR devices. DePuy defends the Pinnacle as a safe and effective device.

According to experts, Johnson & Johnson could face up to $1 billion in liability and costs linked to the DePuy ASR lawsuits. Many lawsuits filed against Johnson & Johnson have been consolidated in federal court. Whether or not Johnson & Johnson and DePuy Orthopaedics will face a wave of litigation related to the Pinnacle remains to be seen.

July 26, 2011

Case Specific Discovery in Yasmin and Yaz Litigation

by Dr. Shezad Malik

As a Texas medical doctor and Yaz Side Effect Product Liability attorney, I am providing this litigation update regarding the increased discovery that has been allowed in the federal MDL.

NON-BELLWETHER CASE-SPECIFIC DISCOVERY.

The judge presiding over all federal Yaz lawsuits and Yasmin lawsuits has expanded the scope of discovery in the litigation beyond the selected bellwether cases. According to Judge Herndon’s most recent order, “… This matter is before the Court for case management. The Court is in the process of compiling a list of the the “oldest 100 non-bellwether” cases. Thus, a list identifying the 100 member actions that will be subject to core, case-specific discovery pursuant to Doc. [1866] will be forthcoming…”

In essence the Court is allowing case-specific discovery to move forward in up to 100 other cases filed on behalf of women who allege that side effects of the Bayer birth control pills caused them to suffer injuries. The Court has expanded the scope of discovery beyond the 24 cases selected last year to serve as a pool of bellwether lawsuits. Case-specific discovery, including depositions of individual plaintiffs, will also now be permitted in the oldest 100 non-bellwether cases that have been filed.

About 6,350 lawsuits are now consolidated as part of the Yasmin and Yaz litigation in the U.S. District Court for the Southern District of Illinois and the number of cases is expected to only increase as Yaz, Yasmin and Ocella lawyers file additional cases.

All of the suits involve claims that Bayer failed to properly research their birth control pills or adequately warn about the increased risk of serious and potentially life-threatening injuries from the birth control pills containing drospirenone, such as a stroke, heart attack, pulmonary embolism, and deep vein thrombosis. Yaz and Yasmin were the first birth control pills to contain drospirenone, a new type of progestin.

The outcome of the bellwether trials and information obtained from the additional plaintiff depositions could help facilitate an eventual Yaz settlement agreement between the parties.

July 25, 2011

Ethicon Gynecare Transvaginal Mesh Lawsuits

by Dr. Shezad Malik

As a Texas medical doctor and Ethicon Gynecare Transvaginal Mesh Lawsuit attorney, I am providing this important update regarding the New Jersey litigation involving these products.

Several hundred patients have filed a transvaginal mesh defective product lawsuit in New Jersey state court against Ethicon, Inc. and Johnson & Johnson over side effects from their Gynecare mesh products. Gynecare mesh products are used for treatment of pelvic organ prolapse and stress urinary incontinence.

Women filed these lawsuits, received Gynecare Prolift mesh, Gynecare Gynemesh, Gynecare Prolene mesh, Gynecare TVT sling or another pelvic mesh product manufactured by Ethicon, a subsidiary of Johnson & Johnson.

These transvaginal mesh products are used strengthen damaged tissue, to repair pelvic organ prolapse (POP) and female stress urinary incontinence (SUI). These products were marketed as a safe and effective alternative to traditional surgical procedures, and women allege that Ethicon Gyncare mesh problems caused them to experience pelvic pain, infections, urinary problems, erosion of the mesh and other complications.

All of the Ethicon Gynecare mesh lawsuits filed in New Jersey state court are centralized for pretrial proceedings before Judge Higbee in Atlantic County. According to court information, there are now about 500 cases that have been filed.

The lawsuits claim that Johnson & Johnson knew the products were unreasonably dangerous, but continued to manufacture and sell them. Other a;;egations iclude manufacturing a defective product, negligence, failure to warn, strict liability and fraud.

According to a study in the Journal of the American College of Obstetricians and Gynecologists, researchers concluded that there was a high rate of vaginal mesh failure with Gynecare Prolift mesh, while providing no difference in cure rates.

Earlier, the FDA issued a warning about the risk of problems from transvaginal mesh when used for pelvic organ prolapse, indicating that the agency was unable to find any significant benefit for the products over other available means of treatment.

In addition to Johnson & Johnson’s Ethicon mesh products, problems have also been associated with transvaginal mesh sold by American Medical Systems (AMS), Boston Scientific, C.R. Bard and other companies.

July 18, 2011

Chronic NSAID Usage Linked to Heart Attack, Stroke and Death

by Dr. Shezad Malik

As a Dallas Dangerous Drug attorney, I am writing about this interesting medical study in the recent American Journal of Medicine.

According to the findings of a new medical study, patients with hypertension and heart problems who regularly take common over-the-counter painkillers could be at a greater risk of heart attack, stroke and death.

Non-steroidal anti-inflammatory drugs (NSAIDs) have been used in pain management in patients with osteoarthritis and other painful conditions. In the United States an estimated 5% of all visits to a doctor are related to prescriptions of non-steroidal anti-inflammatory drugs and they are among the most commonly used drugs. In 2004, rofecoxib, VIOXX, marketed as a cyclo-oxygenase-2 (COX 2) selective inhibitor, was withdrawn from the market after the results of a randomized placebo controlled trial showed an increased risk of cardiovascular events associated with the drug.

In this recent study, patients with heart disease and high blood pressure were at 47% increased risk of the cardiovascular events if they were chronic users of non-steroidal anti-inflammatory drugs (NSAIDs), examples include Advil, Aleve, Celebrex, Motrin and the recalled drug Vioxx.

The findings were published in the latest issue of The American Journal of Medicine. The study looked at data on 882 long-term NSAID users and 21,694 nonchronic NSAID users. All had hypertension and heart disease and had an average age of 65. Researchers found that 4.4 out of every 100 chronic NSAID users suffered a nonfatal heart attack, nonfatal stroke, or died. The rate was only 3.7 out of 100 for nonchronic NSAID users.

After five years of chronic NSAID use, high blood pressure patients with heart disease were at 126% increased risk of death and 66% increased risk of heart attack.

In June, Danish researchers published a study that found that NSAIDs could cause abnormal heart rhythms. That study, published in the British Medical Journal, found a 40% to 70% increase in the risk of atrial fibrillation among NDAID users. Use of non-aspirin NSAIDs was associated with an increased risk of atrial fibrillation or flutter. Compared with non-users, the association was strongest for new users, with a 40-70% increase in relative risk (lowest for non-selective NSAIDs and highest for COX 2 inhibitors). Atrial fibrillation or flutter needs to be added to the cardiovascular risks to be considered when prescribing NSAIDs.

In January, researchers found that all NSAIDs appeared to increase the risk of heart problems, and all except Aleve carried an increased risk of cardiovascular death. The study was published in the British Medical Journal, focusing on nonsteroidal anti-inflammatory drugs (NSAIDs). The researchers looked at the cardiovascular risk of seven different generic NSAIDs, including generic Aleve (naproxen), Advil and Motrin (ibuprofen), Voltaren and Cataflam (diclofenac), Celebrex (celecoxib), Arcoxia (etoricoxib), Vioxx (rofecoxib) and Prexige (lumiracoxib).

In June 2010, Danish researchers published a study that found evidence of NSAID heart problems, with the recalled drug Vioxx, as well as Voltaren and Cataflam being linked to the highest risk of death due to cardiovascular problems. Voltaren and Cataflam were also associated with double the risk of heart attack, while Vioxx was linked to triple the increased risk. The study was published in Circulation: Cardiovascular Quality and Outcomes, that indicated the class of drugs, which include Motrin and Advil, increase the risk of cardiovascular problems in healthy users. The study indicates that the risk appears to vary widely from brand to brand, with Vioxx, Voltaren and Cataflam as the worst offenders, and the pain reliever Aleve actually appearing to lessen the risk of death.

Lawsuits over Vioxx were filed by thousands of people following a September 2004 recall of the drug amid reports that it increases the risk of heart attacks and strokes. The prescription medication, which was approved for treatment of chronic pain from arthritis and other conditions that cause acute pain, was used by more than 80 million people worldwide.

Keywords: Coronary artery disease, Hypertension, Myocardial infarction, Nonsteroidal anti-inflammatory drugs, NSAIDs, Advil, Aleve, Cataflam, Celevrex, Heart Attack, Heart Disease, Motrin, Stroke, Vioxx