Articles Posted in Wrongful Death

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General Motors (GM) Co., is exposed to a barrage of lawsuits in the U.S. and Canada over faulty ignition switches. According to sources, GM was served with the first wrongful-death suit involving two fatalities in a 2006 car crash. GM recalled 1.6 million vehicles in February.

Dallas Personal Injury AttorneyPlaintiff Cobalt Death Claims

Megan Phillips, aged 17, was driving a 2005 Chevrolet Cobalt with two friends in Wisconsin when the ignition switch moved to the “accessory” position and cut power to the car. The Cobalt hit a telephone junction box and two trees and the air bags didn’t deploy. Phillips was seriously injured and her two passengers were killed.

Twelve Deaths

GM admits to 12 deaths in connection with the recall of 1.6 million models made in the mid-2000s, including some Chevrolet Cobalts and HHRs as well as Opel, Pontiac and Saturn models. Investigators have documented the 2006 Wisconsin accident and identified a failure similar to one cited by GM in its February recalls, according to a report commissioned by the National Highway Traffic Safety Administration.

Huge Recall

Facing serious legal concerns surrounding the failure to disclosure ignition problems with certain General Motors (GM) vehicles, the auto maker has recalled another 1.5 million cars. The company has admitted that they may pose a risk of engine fires, air bag problems and fail to meet crash standards. CEO Mary Barra admitted that the company’s quality control process have failed, resulting in “terrible things.”

Recent ignition problems were acknowledged that resulted in the recall of 1.6 million cars. The ignition problems, result in suddenly turning off the engine when heavy keys are used or if the keys are jolted. The company announcing three new recalls, bringing the total number of impacted vehicles to over 3 million.

The largest recall affects 1.18 million crossovers, including 2008-2013 Buick Enclave and GMC Arcadia vehicles, 2010-2013 Chevrolet Traverse vehicles, and 2008-2010 Saturn Outlooks. Those vehicles have a wiring issues that could lead to nondeployment of side airbags.

Another recall affects about 303,000 Chevrolet Express and GMC Savana vans, which was issued due to the need to replace the instrument panels, which were made with plastic materials that do not meet federal crash safety standards.

The third recall, affects 63,900 Cadillac XTS sedans from the 2013-2014 model year, following at least two reports of engine compartment fires that may have been caused by a brake booster pump wiring problem.

Diminished Value Class Action Claim

GM was hit with a class action lawsuit filed on behalf of customers who say their vehicles lost value due to the ignition problem. The lawsuit was filed in district court in Texas, and accuses the company of creating an “unreasonably dangerous” condition for drivers. The lawsuit also accuses the company of sitting on the problem since 2004 and not acting.

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According to newly unsealed legal documents, Boehringer Ingelheim, the manufacturer of the blood-thinning drug Pradaxa were anxious that an internal research paper would damage drug sales and they suggested it should be suppressed.

Pradaxa Wrongful Death AttorneyKey Documents Unsealed

The key documents were recently made public by Chief Judge David Herndon in Illinois who is overseeing thousands of lawsuits filed by patients, who claim that the German company Boehringer Ingelheim, failed to properly warn them about the risks of taking the drug.

Since its approval in 2010, the drug, which can cause fatal bleeding, has brought in more than $2 billion in sales in the United States, according to the research firm IMS Health. It has been prescribed to 850,000 patients, and has been linked to more than 1,000

Internal Research Paper Torpedoes Pradaxa Benefits

Many of the documents released included emails, memos and internal presentations, and a research paper which would torpedo Pradaxa’s main claim, that it does not require regular blood tests to ensure it is working.

Testing is at the heart of the controversy, because Pradaxa and two other recently approved drugs, Xarelto and Eliquis, are in a race to gain market share from warfarin, a generic drug that has been the standard treatment for preventing blood clots and strokes. Many patients regard warfarin as a nuisance because it requires frequent blood tests and careful attention to diet and other drugs.

The new drugs claim not require such monitoring, and claim to be better, at preventing strokes and blood clots in patients with a heart-rhythm disorder known as atrial fibrillation.

Internal Fight to Suppress Research Paper

The documents and the results of the research paper, written by Paul A. Reilly, an employee at the company, indicated that some patients could benefit from monitoring of their blood. A certain segment of patients, the paper found, absorb too little of the drug to effectively prevent strokes, while another group absorbs so much that they are at a higher risk for bleeding.

One company supervisor, Dr. Jutta Heinrich-Nols, wrote in an email to other employees that she could not believe the company was planning to publish research that would negate a decade’s worth of work proving that patients taking Pradaxa would not need regular tests.

Publishing the research results, she warned, could make it “extremely difficult” for the company to defend its long-held position to regulators that Pradaxa did not require testing.

Need for Blood Testing Suppressed

According to pharmaceutical experts, the documents demonstrates how much information about drug safety is in the hands of people with a financial interest in the outcome.

Dr. Reilly’s paper was published recently in the Journal of the American College of Cardiology, and although many of the conclusions in the draft version remained, references to a patient’s optimal blood-level range no longer appear in the article.

Pradaxa Side Effects

Medical experts aid the newly released documents show that drug makers and regulators had been too eager to approve such powerful drugs without more careful monitoring.

“The one-size-fits-all was a mistake for a drug with this kind of risk,” said Thomas J. Moore, a senior scientist at the Institute for Safe Medication Practices, which keeps track of safety reports submitted to the F.D.A. He rated anticoagulants — including warfarin and Pradaxa — as the most serious safety problem in 2011 and 2012. He said Pradaxa has been cited in more than 1,000 deaths reported to the agency through the end of 2012.

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A federal judge has opened the way for St. Jude Riata defibrillator lead lawsuits to move ahead, after rejecting the manufacturer’s claim of federal preemption protection.

U.S. District Judge Selna, in the Central District of California, denied a motion to dismiss filed in five product liability lawsuits from folks who experienced injuries from St. Jude Riata leads. St. Jude Riata leads were recalled after reports that the wire insulation may fail after implantation.

st judes reata recall attorneySt. Jude Tried to use the Federal Preemption Defense

St. Jude argued that they should not be held responsible because such claims are preempted by federal law since the medical device was approved by the FDA. Judge Selna found that the injury claims either paralleled federal requirements or were based on alleged violations of FDA regulations. The judge also rejected arguments that plaintiffs had failed to show a plausible link between their injuries and the leads.What is the St. Jude Riata Lead?The St. Jude Riata and Riata ST ICD leads are electric wires used to connect a programmable implantable cardiac defibrillator (ICD) medical device unit to the heart. These heart leads were recalled in late 2010 after medical reports that revealed that the insulation surrounding the leads was subject to failure, from exposed wires inside the body. Exposed wires can result in unnecessary painful electric shocks or cause the defibrillator to fail to deliver a life-saving jolt when needed.St. Jude issued a warning to doctors in late 2011 about reports of insulation problems, and the FDA later determined that the action qualified as a St. Jude Riata recall.Scope of the St. Jude Problem

227,000 St. Jude Riata wires were sold worldwide before it was removed from the market, and 79,000 of the leads remain active in patients in the United States.

In August 2012, the FDA issued a safety communication in response to concerns among individuals who still have one of the recalled St. Jude Riata or Riata ST leads, recommending that individuals undergo x-ray or other imaging exams to monitor the condition of the leads.

St. Jude faces many product liability lawsuits throughout the country, which allege that the manufacturer designed and sold an unreasonably dangerous and defective product. Also that they knew or should have know that these wires were defective yet they continued to sell the wires.

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Fresenius Medical Care’s Granuflo and NaturaLyte dialysis lawsuits in the federal multidistrict litigation (MDL), are beginning to make progress. Recently in April, the U.S. Judicial Panel on Multidistrict Litigation ordered that all Fresenius dialysis lawsuits will be consolidated for coordinated management, as part of an MDL.
Approximately 188 complaints filed in the federal court system have been transferred to U.S. District Judge Woodlock in the District of Massachusetts.

Dallas Defective Medical Device attorneyPlaintiff Fresenius Allegations

The injured plaintiffs claim that Fresenius Medical Care failed to adequately warn about the potential side effects of Granuflo and Naturalyte dialysate solutions, which have been  during hemodialysis.

The plaintiffs have filed a lawsuit involving cardiac arrest, heart attack or sudden death was allegedly caused by Granuflo or NaturaLyte. Complaints allege that Fresenius failed to adequately warn doctors about the importance of monitoring bicarbonate levels while these products were used.

Fresenius GranuFlo and NaturaLyte Dialysis Side Effects

Fresenius Medical Care is one of the largest providers of dialysis treatment in the United States. The company also manufactures and sells many of the products used during dialysis treatments at other clinics, including solutions known as Granuflo and NaturaLyte.

NaturaLyte is a liquid acid concentrate and GranuFlo is a dry acid concentrate. Both products contain sodium acetate,  converts to bicarbonate at a higher-than-expected levels.

“Smoking Gun” Internal Memo

Fresenius sent an internal memo to doctors at their own clinics in November 2011, that identified at least 941 events where individuals suffered sudden cardiac arrest during dialysis treatments. The company failed to provide this warning to federal safety regulators or to other dialysis clinics that were using Granuflo or NaturaLyte.

The internal memo was leaked to the FDA in March 2012, and only then did Fresenius provide a warning letter to all healthcare providers, which the FDA has classified as a NaturaLyte and Granuflo recall.

Granuflo and NaturaLyte Litigation

According to experts, the number of lawsuits against Fresenius is expected to continue to grow, and some estimates indicate that thousands of complaints will be filed throughout the country.

What is Fresenius MDL?

The centralized proceedings in the federal court system are set up to reduce discovery, avoid conflicting pretrial rulings and to serve the convenience of the parties.
Following the coordinated pretrial proceedings and early “bellwether” trials, if a Fresenius dialysis injury settlement is not reached to resolve the cases, individual lawsuits will be remanded back to the U.S. District Courts where they were originally filed for separate trial dates.

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Medical data from a new FDA funded study indicates that the NuvaRing birth control may cause women to face a 56% higher risk of blood clots than those who take older birth control pills.

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NuvaRing is a female birth control device consisting of a medicated flexible ring. NuvaRing releases a combination of etonogestrel and ethinyl estradiol through a ring that is inserted into the vagina once a month. The drugs are a combination of ethinyl estradiol and etonogestrel, which is known as a “third generation” progestin.

NuvaRing is a form of birth control that releases a combination of etonogestrel and ethinyl estradiol through a ring that is inserted into the vagina once a month.

Recently, the FDA released data from a birth control study that reviewed a range of female birth control products and compared them to older drugs to determine the risk of blood clots. Newer progestin-based birth control were found to carry a much higher risk of blood clots, or venous thromboembolic events (VTE), than older drugs like levonorgestrel.

Medical researchers looked at medical data on about 800,000 women from 2001 to 2007, and found that women who used NuvaRing were 56% more likely to suffer a VTE than their levonorgestrel-using counterparts. VTE includes deep vein thrombosis (blood clots in the legs) and pulmonary embolisms (blood clots in the lungs). Women were also at higher risk of arterial thrombotic events (ATE), which can include heart attacks and strokes.

FDA researchers suggested that use of the NuvaRing led to higher sustained exposure to estrogen, which could be the reason the VTE risk is higher. The same study found that drospirenone-based drugs like Yaz and Yasmin increased blood clot risk by 75%.

This data provides further scientific support for claims brought by hundreds of women throughout the United States, who have filed a NuvaRing lawsuit against the manufacturer, Organon and Merck, after suffering serious and fatal injuries from a blood clot. The complaints allege that the manufacturers failed to properly research the birth control ring or warn about the risk of health problems from NuvaRing.

Organon, a subsidiary of Merck, failed to conduct adequate studies that would have revealed the risk of blood clots from Nuvaring before it was introduced into the U.S. market, according to allegations by the plaintiffs. They claim that physicians would have never prescribed the Nuvaring had the true risks of blood clots and pulmonary embolism been properly communicated by the manufacturers.

MANUFACTURERS: Organon Pharmaceuticals USA Inc., Organon USA Inc., Organon International Inc., Schering Plough Corp., and Akzo Nobel NV.

All NuvaRing federal lawsuits have been consolidated for pretrial proceedings as part of an MDL, or multidistrict litigation, before Judge Rodney Sippel in the U.S. District Court for the Eastern District of Missouri. The first NuvaRing bellwether trials are expected to begin in 2012. The complaints all involve similar allegations that women suffered blood clots as a result of NuvaRing side effects, leading to injuries like a stroke, heart attack, pulmonary embolism, deep vein thrombosis (DVT) or sudden death. The claims argue that the drug makers failed to adequately research the birth control ring or warn about the potential increased risk of these serious problems.

The bellwether process is common in complex litigation involving a number of claims that raise similar allegations. By selecting a small group of cases for an early trial, the parties are able to get an idea how a jury is likely to respond to evidence and testimony that may be similar to what would be presented in other cases. The outcome of these trials often shapes the litigation and may ultimately lead to an agreement to settle NuvaRing birth control lawsuits by the drug maker.

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A group of medical researchers and scientists have determined that the potential risks from metal-on-metal hip implants may outweigh any health benefits provided by these devices.

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This is because of higher revision rates are linked to the newer hip replacement designs and the mounting and growing concerns about metal ion blood poisoning, known as metallosis.

The California Technology Assessment Forum (CTAF) has released an assessment of the benefits and effectiveness of using metal on metal hip replacements as an alternative to total hip arthroplasty, and they concluded that the relatively new metal hip implants may not be worth the risk.

The assessment (PDF) is the third time the group has reviewed metal-on-metal hip implants, and the group says that questions and concerns about the technology that were present years ago are still important today.

Because of high revision rates and the risk of metallosis, caused by cobalt and chromium particles shed by metal-on-metal implants, the group concluded that “there is clearly no evidence that the potential benefits outweigh the potential risks.”
After they were introduced, metal-on-metal hip implants accounted for about 1/3 of the 250,000 hip replacements performed each year in the United States. Over the past two years, concerns have increased about metal hip replacement complications, resulting in use of the implants dropping to just 5% of the artificial hip market.

Research suggests that as the metal hip replacement ball and socket grind against each other, microscopic particles of cobalt and chromium are shed into the body, which results in metal poisoning. This metallosis may result in soft tissue damage, inflammatory reactions, bone loss, aseptic and local necrosis that may lead to the need for a hip revision surgery.

In May 2011, the FDA requested artificial hip manufacturers to provide more data on problems with metal poisoning and metal implants.

Attention on the metal-on-metal hip implant risks increased after the DePuy ASR hip recall in August 2010. The DePuy metal-on-metal artificial hip system is no longer available after more than 90,000 components were sold throughout the world.

More than 1,000 people have already filed a DePuy ASR hip replacement lawsuit due to complications caused by the recalled system. These lawsuits have been centralized in the Northern District of Ohio for pre-trial consolidation. To make matters worse, DePuy Orthopaedics additionally faces a growing number of DePuy Pinnacle hip lawsuits filed as a result of problems associated with their other metal-on-metal artificial hip implant. These lawsuits have been centralized in the Northern District of Texas, for pre-trial consolidation. To date a DePuy Pinnacle hip recall has not been issued, and these lawsuits also allege that these older system features similar design defects that increase the risk of early loosening or failure.

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As a Yaz, Yasmin and Ocella Pulmonary Embolism attorney and Texas Medical doctor, I am providing this blood clot side effect update.

Women taking pills containing the hormone drospirenone were 74 percent more likely to experience clots than those on low- estrogen pills, according to the latest Food and Drug Administration report.

There is an FDA conference in December that is going to examine and address the health risks associated with birth control pills Yaz and Yasmin. Thousands of patients have already filed a Yaz or Yasmin lawsuits against pharmaceutical manufacturer Bayer Corporation. The injured plaintiffs claim that the drugmaker aggressively highlighted the birth control pills benefits while minimizing the serious side effects such as Yaz deep vein thrombosis, pulmonary embolism, stroke and death.

FDA Investigates Yaz, Yasmin and Ocella Increased Blood Clots Side Effects
The FDA has been investigating the health risks associated with Yaz, Yasmin and Ocella. In 2011, the FDA has issue two warnings about the birth control pills, indicating that the national health agency “remains concerned” about the increased risk of blood clots and other potentially life-threatening side effects associated with the birth control pills.

Yaz and its predecessor, Yasmin and the generic version, Ocella, all contain a synthetic female sex hormone known as drospirenone. Medical studies show that all birth control pills have an increased risk of blood clots, but the risk is even greater with drospirenone-containing pills such as Yaz, Yasmin and Ocella.

The FDA is set to hold a meeting with the Reproductive Health Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee on December 8 to comb through the mass of “conflicting” data concerning Yasmin, Yaz and Ocella blood clots.

The recommendations of that FDA meeting could have profound implications and affect the outcome of the Yaz lawsuits. The FDA may revise the drug labels again (revised in 2010 and 2011), or issue stricter warnings regarding the birth control bills or may even ban the pills from the market altogether due to the dangers of Yaz blood clots. The last scenario is highly unlikely.

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As a Yaz, Yasmin and Ocella Deep Vein Thrombosis, Pulmonary Embolism and Stroke Attorney, we are providing this timely update. Watch the old Yasmin advertisement here.

According to a recent population-based study, newer forms of progesterone in contraceptives result in higher venous thromboembolic (VTE) risk than older drugs.

According to Ojvind Lidegaard, MD, of Rigshospitalet at the University of Copenhagen, Denmark, an international expert, women on the pill with the older, levonorgestrel version were at three times the risk of VTE as those not on any hormonal contraception.

But oral contraceptives containing desogestrel, gestodene, drospirenone, or cyproterone boosted the risk six to seven times over that of non-users, the group reported in BMJ.

The researchers explain that newer forms of progesterone in combination hormonal contraceptives carry higher venous thromboembolic (VTE) risk than older forms.

Furthermore, they point out that this study found that women on the pill with the older, levonorgestrel version were still at threefold elevated risk of VTE compared with those not on any hormonal contraception, whereas those on the newer versions were at six and sevenfold risk.

The Food and Drug Administration is already studying the possible increased risk of blood clots with pills containing the drospirenone. The F.D.A. says its preliminary results suggest a 1.5-fold increased risk compared with other hormonal contraceptives, to about 10 women in 10,000 from 6 women in 10,000.

These findings were based on the national registry data in Denmark from 2001 through 2009, after the launch of the newest synthetic progesterone, drospirenone.

Other studies over the decades also have found almost universally elevated VTE risk with hormonal contraception, with the estrogen and progestogen (synthetic progesterone) components both appearing to play a role.

The risks appear real and may lead many clinicians to prescribe a combined oral contraceptive with levonorgestrel whenever possible.

The updated analysis included more than 1.2 million non-pregnant 15- to 49-year-old women in Denmark without a history of thrombotic disease. Data came from national vital status, inpatient, cause of death, and pharmacy registries.

From 2001 to 2009, 4,307 first-ever VTEs occurred in this cohort. Most were deep vein thrombosis only (63.6%) or pulmonary embolism with or without deep vein thrombosis (26.2%).

Compared with women not taking hormonal contraception, confirmed venous thromboembolism was elevated for users of oral contraceptives containing 30 to 40 μg ethinylestradiol plus the following:

Levonorgestrel, with a relative risk of 2.9
Desogestrel, with a relative risk of 6.6
Gestodene, with a relative risk of 6.2
Drospirenone, with a relative risk of 6.4
With levonorgestrel-containing pills as the comparator, rate ratios of confirmed venous thromboembolism adjusted for length of use were:

2.2 with desogestrel
2.1 with gestodene
2.1 with drospirenone
Lower estrogen doses were associated with modestly lower VTE risk for oral contraceptives with norethisterone, levonorgestrel, desogestrel, or gestodene but not with drospirenone, the investigators reported.

More information
The American College of Obstetricians and Gynecologists has more about birth control pills.

Primary source: BMJ
Source reference:

Lidegaard Ø, et al “Risk of venous thromboembolism from use of oral contraceptives containing different progestogens and oestrogen doses: Danish cohort study, 2001-9″ BMJ 2011; 343: d6423.

Additional source: BMJ
Source reference:

Hannaford PC “The progestogen content of combined oral contraceptives and venous thromboembolic risk” BMJ 2011; 343: d6423.

Jick S, Hernandez R “Risk of non-fatal venous thromboembolism in women using oral contraceptives containing drospirenone compared with women using oral contraceptives containing levonorgestrel: case-control study using United States claims data” BMJ 2011; DOI: 10.1136/bmj.d2151.

[Get full-text PDF from Pubget]

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As an Actos Blader Cancer attorney and Texas medical doctor, I am providing this latest update regarding the diabetic drug, Actos.

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The European Medicines Agency (EMA) issued an update on the safety concerns for Actos on October 21, indicating that the drug is still a valid diabetes treatment. But, due to the Actos bladder cancer risk, it should only be used when other treatments have failed. This update is similar to the latest one issued by United States regulators.

Watch the ABC News report here.

European drug regulators indicate that they are not recommending an Actos recall, even though the diabetes drug has been linked to an increased risk of bladder cancer. Instead, doctors have been recommended to only use Actos as a second or third line treatment options for diabetics.

The statement is meant to add information to the July opinion by the EMA’s Committee for Medicinal Products for Human Use (CHMP), which confirmed that the side effects of Actos include a risk of bladder cancer.

CHMP determined that while there was a risk of bladder cancer, there are still some diabetes patients for whom the risk was manageable because other drugs fail to bring their diabetes under control. The committee recommended careful screening of patients being prescribed the drug and close monitoring while they are on Actos to watch for signs of bladder cancer. The European Commission still has to agree to adopt the opinion as a decision.

Actos (pioglitazone) was introduced as a treatment option for type 2 diabetes in July, 1999. Until recently, it was Takeda Pharmaceuticals’ best-selling drug, with sales of $3.4 billion last year.

In June, France required a recall of Actos after a review of public insurance data identified an increased incidence of bladder cancer with Actos use.

FDA officials began reviewing the potential risk of Actos bladder cancer problems in September 2010, after interim data from an on-going 10 year study found that users may face an increased risk the longer they take the drug.

In the United States, new Actos cancer warnings were approved by the FDA in August 2011, indicating that patients who use the drug for more than a year may face an increased risk of bladder cancer.

A growing number of individuals throughout the U.S. are filing an Actos bladder cancer lawsuit against Takeda, alleging that the drug maker failed to provide adequate warnings for consumers or the medical community. Many of the complaints indicate that Takeda should have removed Actos from the market, arguing that the risk of bladder cancer outweighs the minimal benefits.

Some expert estimates suggest that more than 1,000 cases may ultimately be included as part of the Actos litigation. A panel of judges is scheduled to meet on December 1 to decide whether all federal Actos lawsuits should be consolidated as part of an MDL, or multidistrict litigation.

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As a Johnson & Johnson Gynecare TVT Trans Vaginal Mesh injury attorney and Texas medical doctor, I am providing this timely update.

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Johnson & Johnson (JNJ), the world’s second-biggest health-care products maker, is facing many lawsuits over its Gynecare TVT vaginal implant. The Gynecare TVT implant is based on a similar device pulled from the medical device market more than a decade ago for safety reasons.

The lawsuits are the latest to implicate the shoddy and perfunctory approval process for medical devices at the U.S. Food and Drug Administration, which has cleared faulty hip implants and malfunctioning defibrillators.

In the case of vaginal mesh implants, the FDA continued approving the mesh devices made by J&J and other companies based on their similarity to Boston Scientific Corp’s ProteGen even after it was pulled amid safety complaints. Today, the makers of the entire category of implants face more than 600 lawsuits from women who claim the devices caused serious injury.

The devices treat urinary incontinence and pelvic organ prolapse, in which internal organs slump into the vagina. They were allowed on the market as result of the agency’s approval process, known as 510(k), which relies on the premise that if one device has been cleared by the FDA then similar devices need little if any testing in patients.

In July, the FDA issued a statement saying it is unclear whether prolapse implants provide any benefit over traditional surgery. The statement came three years after the agency first acknowledged a problem in a 2008 report that said mesh complications were serious. An advisory panel of physicians said last month that the FDA should demand more clinical testing of the devices.

According to J&J, its vaginal mesh products are safe and the J&J’s Gynecare TVT was based on the Boston Scientific product.

But according to 510(k) critics, the chain of approvals that began with Boston Scientific’s device highlight a major flaw in the 510(k) process. The system lets manufacturers get clearance for a product by citing its similarity to an already approved device, known as a “predicate.” That second device can be cited as the basis for a third, the third to clear a fourth and so on. And if a first device is recalled, they don’t necessarily look at the second, third or fourth device that are based on that.

The unfortunate Vaginal Mesh story began in 1996, when Boston Scientific gained clearance for ProteGen, the first vaginally implanted mesh designed specifically to treat incontinence. Two years later, J&J won approval for a similar device, called Gynecare TVT. Under the 510(k) system, J&J was not required to conduct human testing because the company claimed its device was “substantially equivalent” to the Boston Scientific device.

A year later, Boston Scientific voluntarily pulled about 20,000 ProteGen meshes, saying it had received 123 reports of problems, including discomfort, pain during sex, and erosion of vaginal tissue. But J&J and at least two other manufacturers, American Medical Systems and Covidien Plc (COV), soon came out with products that traced their design back to ProteGen.

The FDA has said it does not know the number of women who have received the implants since 1998, though it estimates almost 300,000 were used in 2010. All of the devices were approved through the 35-year-old 510(k) system, used by the FDA to review some 90 percent of device applications each year. The same process was used to clear the 93,000 artificial hips pulled by J&J last year due to high failure rates, as well as hundreds of external heart defibrillators recalled since 2005 by Minneapolis-based Medtronic Inc. (MDT)
J&J named ProteGen as a basis for the Gynecare TVT, noting in its application that “technologically, both the new device and predicate device are the same.” By that time, complaints about Boston Scientific’s device were already reaching the FDA. A year after J&J’s TVT won clearance, Boston Scientific voluntarily recalled about 20,000 of its meshes.

J&J’s Gynecare TVT later became a predicate for the IVS Tunneller I, made by Dublin-based Covidien, and the Sparc Sling, made by the American Medical Systems unit of Endo Pharmaceuticals Holdings Inc. (ENDP), based in Chadds Ford, Pennsylvania. Those, in turn, were cited to clear future versions, each said to be “substantially equivalent” to its predecessors, according to FDA records. In 2003, Boston Scientific settled 738 suits over its mesh for an undisclosed sum.

The safety debate has presented a dilemma for manufacturers, who have avoided clinical tests for the devices by calling them similar to one another and now say the products have advanced far beyond the earlier versions.

The FDA advisory panel disagreed. The 17-member group, comprised mostly of pelvic surgeons, recommended at last month’s hearing that some vaginal meshes be reclassified as high-risk devices requiring new studies to stay on the market.

The FDA appears to be inching toward a decision. At the September hearing, Colin Pollard, director of the FDA’s obstetrics and gynecology devices branch, said it may take as long as three years to issue new rules. Until then, current models can stay on the market, he said.