Articles Posted in Recalls

On March 13, The Lancet, a top-notch British medical journal, published Failure rates of stemmed metal-on-metal hip replacements: analysis of data from the National Joint Registry of England and Wales.

The article is nothing less than a wholesale condemnation of metal-on-metal hip implants manufactured by orthopedic (orthopaedic, if you’re British) device companies:
Metal-on-metal stemmed articulations give poor implant survival compared with other options and should not be implanted. All patients with these bearings should be carefully monitored, particularly young women implanted with large diameter heads. Since large-diameter ceramic-on-ceramic bearings seem to do well we support their continued use (emphasis added).
In 2009, one-third of all total hip replacements in the United States were metal-on-metal. There are over 500,000 patients in the U.S. now living with a metal-on-metal implant.

The article concluded that metal-on-metal total hip replacements failed and required subsequent replacement surgeries at an alarmingly high rate, particularly for larger metal “head” sizes. Overall, the failure rate was 6.2% after five years. Women seem to be more seriously affected, perhaps because they usually require larger implants. Ceramic implants – old school implants – had a much lower rate of revision.

The articles authors also pointed out that these conclusions likely could have been made with adequate pre-market studies and regulation. But medical device manufacturers have a very large financial incentive to push these devices out as soon as possible. First, so their investment in research and development is not wasted. Second, because the amount they will later pay in lawsuit claims is nothing compared to the massive profits they will get.

Though the article’s authors seem to support a worldwide recall on metal-on-metal total hip replacement devices, the Medicines and Healthcare products Regulatory Agency (MHRA—the British answer to the FDA) seems to believe that clinical data on the subject is “mixed.”

A total hip replacement basically involves a rod inserted into the leg bone (femur), which connects to a stem that has a ball at the end of it. The other component is a socket that is implanted into the hip. Implants may be metal, plastic or ceramic, or some combination. The implants discussed by the authors of The Lancet article have both a metal ball and a metal socket.

Some problems associated with metal-on-metal total hip replacements are the wearing of the device that releases metal particles into the body, sometimes into the bloodstream with catastrophic or fatal results.

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The number of vaginal mesh lawsuits (also called transvaginal sling lawsuits) has skyrocketed. This is in part due to the fact that there are at least six companies involved, including Johnson & Johnson. Mostly though, this is because these products are just horrible, were not properly tested, and cause unspeakable and sometimes embarrassing injuries to people.

Background
Vaginal mesh is a medical device that is surgically implanted to treat pelvic organ prolapse. An extremely high number of patients suffer from infection, erosion of the mesh into the vagina, pelvic pain, organ perforation, and urinary problems. Women who have these devices implanted frequently need surgery to remove them, and sometimes follow-up surgeries to repair the damage to their bodies.

Manufacturers
Our lawyers are looking at cases including these vaginal mesh products:

• C.R. Bard Avaulta
• AMS Elevate Prolapse Repair System
• AMS Apogee Valut Suspension Systm
• AMS Perigee System
• AMS Monarc Sling System
• AMS Sparc Sling System
• Johnson & Johnson (Ethicon) Gynecare Gynemesh
• Johnson & Johnson (Ethicon) Gynecare Prolene Soft Mesh
• Johnson & Johnson (Ethicon)Gynecare Prolift Pelvic Floor Repair System
• Johnson & Johnson (Ethicon) Gynecare TVT Transvaginal Sling
• Boston Scientific Pinnacle Pelvic Floor Repair Kit
• Boston Scientific Uphold Vaginal Support System
• UGYTEX Dual Knit Mesh
• Covidien IVS Tunneler Sling
Even Congress is Concerned
In most medical device lawsuit cases, the scientific community first gets a sense that something is wrong. It sometimes starts as a medical journal article by one doctor who is particularly involved in the medical device. Other scientists or doctors see that report, and review their own case files, searching for patterns. Meanwhile, the FDA is receiving reports from victims of the device, and they start to see patterns, as well. Medical device lawyers then get involved, and do their own research. It is only when the lawyers begin filing cases that the actual documents from the defective medical device manufacturers see the light of day. Those internal company documents, more often than not, tell a story of greed and Wall Street profit-seeking that tramples public safety concerns.

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There have been a significant number of Avandia settlements and many clients are now starting to receive settlement checks.

Incredibly, there are still a lot of potential cases that would be ripe for an Avandia settlement that is still sitting out there. These cases fall into two fundamental categories: (1) people who have not considered the potential connection between their heart or liver injuries and Avandia; and (2) people that, for whatever reason, are just hesitant to bring a claim.

The latter group – people who think they have drug injury claims and just don’t bring them – make up a much larger group than I think most people realize. You can break these people down into two categories too: (1) people with good reasons not to bring a claim; and (2) people with bad reasons not to bring a claim.

A good reason not to bring a claim is that you have a view of life that says essentially:

I don’t believe claims against drug companies are a good idea even if the drug company was negligent and/or reckless. Too many people think lawsuits are the answer to every problem in life and I just don’t want to be one of those people. You could tell me a settlement check is waiting for me at your office and I wouldn’t come and pick it up. Lawyers and lawsuits are the problem in this country.

In some wrongful death cases, people do not bring claims because their husband/wife/father/mother hated lawsuits and they think that cashing a settlement check would dishonor their memory.

I don’t agree with this worldview, obviously, for reasons that are not worth going into here. But people smarter than I do feel exactly this way. If you think you have an Avandia claim and you feel this way, you should not be bringing a claim.

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There have been a lot of lawsuits involving hip replacements: Zimmer, Stryker, and DePuy have all been in the scopes of plaintiffs’ lawyers. But a bigger problem might be looming: metal on metal hip implants. In the last few years, metal on metal hip implants have been used in approximately one-third of the replacements performed annually in this country. What is the problem with metal on metal hip implants?

Doctors clearly don’t fully understand the problem yet. But studies are leading some doctors to conclude that the problem manufacturers may have underestimated is the degree to which metal on metal causes the release of microscopic ions of chromium and cobalt.

The body fights back against these metals causing a reaction called metallosis that compromises the immune system. Inflammatory reactions to the metal can cause groin pain, fatigue, death of tissue in the hip joint, loss of surrounding bone and muscle, and…. who knows what else? There is also speculation it may cause heart and kidney problems as well. Metal on metal hip implants are still relatively new so we don’t really know what the long term consequences may be.

Depakote birth defect lawsuits are gaining the increased interest of lawyers around the country.

Like Topamax, Depakote is an anticonvulsant used to prevent epileptic seizures. In 1978, the FDA approved Abbott Laboratories’ New Drug Application (NDA) for Depakene. In 1982, the FDA approved Abbott’s NDA for Depakote, which was also marketed to doctors as a medication for limiting or eliminating seizures.

The Problem with Depakote

Depakote is a known human teratogen.  Plaintiffs’ lawyers allege that it is associated with a number of congenital malformations and cognitive deficits.  Possible harmful effects include heart defects,  hydrocephalus, craniofacial defects, spinal Bifida, microcephaly, heart defects, limb, and digital defects, urogenital defects, cleft lip and palate,  decreased IQ, mental retardation, and developmental delay.

When do these injuries happen?  Early in the pregnancy.  These malformations generally occur in the first nine weeks of gestation.  Depakote specifically affects cells and neurons, including those which develop the brain, face, and limbs. The thumbs are completely formed by sixteen weeks, but the absolute dysmorphia occurs in the first nine weeks.

After years on the market, the FDA required Abbott to include a “Boxed Warning” alerting doctors and patients – most notably, mothers and women of childbearing age who might become pregnant – of the risk of birth defects as a result of Depakote use. There are also risks on the box now about hepatotoxicity and pancreatitis. These are serious and potentially fatal conditions.

Depakote lawsuits that involve birth defects such as spina bifida, craniofacial defects, cardiovascular malformations, and similar malformations in young children whose moms were taking Depakote when they were pregnant.

2018 Update: In 2018, there were 255 lawsuits in federal court alleging birth defects related to Depakote. Settlement negotiations are ongoing.

More Depakote Information

Specifically, there is data suggesting that:

• Infants whose mothers took Depakote during the first trimester were more than 12 times more likely to have spina bifida than mothers who were not on Depakote; (Note: all of this data is for valproic acid. Valproic acid is the active and key ingredient in Depakote.)
• Babies whose mothers took Depakote were also 2.5 times more likely to have a heart defect;
• Depakote users who became pregnant were five times as likely to have a baby with a cleft palate or a penis abnormality;
• Children of moms on Depakote were more than two times as likely to have an extra digit on their hand; and
• Mothers on Depakote are seven times – seven times – more likely to have a premature fusion of the skull during fetal development which limits brain growth.
• They found women who took Depakote early in their pregnancy had two to 12 times the risk of having a baby with one of six specific birth defects compared to women who took no epilepsy drugs.

Can you see why plaintiffs’ lawyers are predicting a lot of Depakote lawsuits? You would think there would have been a recall. But instead of a recall – which still has not happened – this problem has festered on for years. How on earth is this possible? I have no idea. Ultimately, this may prove to be the tip of the iceberg in terms of birth defects from Depakote.

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Our lawyers are investigating potential Topamax lawsuits. The plaintiffs’ Topamax lawsuits allege that Ortho-McNeil failed to identify the risks associated with Topamax causing injuries to unborn children.

Topamax

Topamax, also known by its generic name topiramate, is an antiepileptic medication developed by Ortho-McNeil Pharmaceutical, a subsidiary of Johnson & Johnson. It was first approved by the U.S. Food and Drug Administration (FDA) in 1996. Initially, Topamax was primarily used for the treatment of epilepsy and seizures, as it demonstrated efficacy in reducing the frequency and severity of seizures in patients.

There are problems being reported with the Wright Profemur hip replacement. The Wright Profemur Total Hip System includes the Conserve Plus Cup, the Conserve Total Femoral Head, the Wright Modular Femoral Neck and the Profemur E Cementless Stem. Specifically, Australian data shows that the Profemur Z hip implant, manufactured by Wright Medical Technologies, has an 11.2% failure rate after three years.

This Profemur Z hip implant is sold as new hip replacement surgery that does not require the hip to be dislocated. Wright’s Profemur Xm hip stem is as modular neck hip implant with cemented fixation which, ostensibly, allows for a better connection between the implant of the stem and the cup and purportedly bends easier than traditional hip implants. In theory, this causes less soft tissue injury during and after the hip surgery.

I think Wright Medical would disagree with the 11.2% figure. But I think even Wright would agree that if this number is accurate, there should be a recall of this hip implant. The DePuy hip implant caused a “no-brainer, let’s set aside a billion dollars for settlement” recall.