Articles Posted in Johnson & Johnson

Johnson & Johnson tort lawsuits around the country.

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The U.S. Supreme Court yesterday shot down a petition by a Johnson & Johnson to hear a case in which J&J sought a ruling that preemption should be extended to failure to warn claims involving over-the-counter drugs.

Drug and medical device defendants continue to think preemption is some magic elixir around their negligence.

Hey, you Republicans out there. Does it bother you that state tort rights are being tossed in the ground by the overly intrusive federal government? If you answered yes, you are a real Republican. I have a Barry Goldwater sticker for you. The rest of you are just Republicans when it is convenient for you.

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In January, Johnson & Johnson got a defense verdict in a Levaquin case involving Achilles tendon injuries to a 78-year-old man who alleged that Levaquin did not carry an appropriate warning of the risks of such an injury.

This was the third bellwether trial in the MDL. This win upped J&J’s record in the Levaquin cases to 2-1. J&J lost the first Levaquin lawsuit in December 2010 when a jury awarded $1.8 million in compensation to a Minnesota man. A year ago, it won a defense verdict in state court in New Jersey.

There are always lots of potential appellate issues for both sides in these complex cases. Plaintiff moved for a new trial, contending that the jury’s verdict was against the weight of evidence. Okay, that one pretty much always fails. But the plaintiff also alleged that the trial judge mistakenly failed to exclude a juror who found out in the middle of the trial that their company did some work for J&J.

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Johnson & Johnson has agreed to pay about $600,000 to settle three, the first three, of approximately 8,000 lawsuits over hip implants that were recalled in 2010. The suits were scheduled to go to trial later this year.

J&J’s DePuy unit recalled approximately 93,000 ASR hips worldwide in 2010, saying that more than 12% of the devices failed within five year. The defective implants caused patients pain and immobilization by joint dislocations, as well as infections and bone fractures.

According to a university professor who follows the pharmaceutical industry, J&J should have expected to pay between 200k and 500k, so they were able to settle at the low end of what they should have expected to pay. What does he know? Probably not much. What I can tell you is that it is always easy to pick off a few plaintiffs and underpay on the claim as a way of getting plaintiffs’ lawyers thinking that the cases are worth less than they think. Good strategy on their part but let’s not fall for it. Some of these DePuy ASR cases are going to settle north of $1 million.

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This is the interesting story of a woman who scheduled to speak today to an FDA advisory panel hearing looking into the problems of metal-on-metal hip-replacement systems. The woman’s husband has a hip implant and is one of the thousands of plaintiffs who have filed a lawsuit against Johnson & Johnson’s DePuy Orthopedics division claiming its metal-on-metal ASR hip system was defective.

You can read the article here.

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As expected, the South Carolina trial judge denied post-trial motions to overturn a $327 million civil penalty against Johnson & Johnson, which was found to have overstated the claims about its antipsychotic drug, Risperdal. The award was $4,000 for each of more than 43,000 letters pushing Risperdal that J&J sendt to doctors, plus $300 each for 509,000 free samples given to doctors that contained detailed package inserts.
Still, J&J made a fortune off of Risperdal, pulling in as much as $3.4 billion a year in sales. Think about that. It is more than a third the size of the NFL and chances are you have never heard of Risperdal. It had ten good years of sales.
The problem, ultimately, is that from an economic standpoint and assuming J&J has no moral compass at all (I don’t assume this, by the way), was it still a good play to put Risperdal on the market and push it as they did? Arguably, even after all of the pain (more might come in a lawsuit brought by the country state of Texas), it still probably makes economic sense. That’s the problem.

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Johnson & Johnson, eager to pad its record recall year before 2011 closes out, is recalling certain lots of MOTRIN IB, because testing of product samples showed that some caplets may not dissolve as quickly as intended when nearing their expiration date. This is not a consumer level recall, meaning consumers do not need to dispose of or return the product.

There is no safety concern if consumers continue taking the product in accordance with its label; there may just be a delay in experiencing relief. The recall is NOT being made on the basis of any adverse events.

The lot numbers for the recalled product can be found on the side of the carton label. The recalled lots are as follows:

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DePuy issued a U.S. recall of its metal-on-metal ASR hip implants in August of 2010 (after 93,000 implant procedures) because of an extremely high failure rate requiring patients to have revision surgeries. Evidence so far indicates that the device is exceedingly difficult for orthopaedic surgeons to implant properly. For background on the DePuy saga, see prior DePuy Drug Recall Lawyer Blog entries.

The hip implant was withdrawn from the Australian market in late 2009. DePuy (a subsidiary of Johnson & Johnson) told the public in the U.S. shortly thereafter that it was phasing out the implant because they were “focusing on newer technologies.”

The Australian Senate likened these hip implants to “ticking time bombs.” They want a system put in place to monitor adverse outcomes for hip implant patients, and they want to make sure doctors and patients are aware of the problems they may be facing. Most importantly, they want to make sure implant patients are continually monitored for future problems.

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When I was in elementary school, my best friend has asthma. I know this because he told me he had it. I never saw any symptoms, he was a great athlete with good endurance.
Today, it seems like everyone and their brother has asthma. The street wisdom on why we have more asthma in 2011 than 1981: kids are not as tough as they used to be. Eventually, I think science will show that there are other factors that have actually increased asthma, nut allergies, and the like.
 
Cue the suspects. Today’s suspect is Tylenol. It is one of those “everyone uses this at some point” products. Tylenol, known by its generic name acetaminophen, is a popular pain reliever and fever reducer. It is estimated that in any given week 23% of Americans use acetaminophen. Recent concerns regarding liver injury have been raised; however, other side effects such as asthma and eczema have also recently been gaining notice. The potential risk for asthma when administered to children and use during pregnancy is a concern that was first raised over 10 years ago.
 
Several studies have suggested that acetaminophen use in pregnancy, infancy, later childhood and adulthood may be associated with an increased prevalence of asthma. Two large observational studies have demonstrated that increased use of acetaminophen in children has occurred due to concerns of Reye’s Syndrome and allergy/asthma to aspirin or other NSAIDs (non-steroidal anti-inflammatory drugs).

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Tylenol is one of the most commonly used drugs in the United States. The active ingredient in Tylenol is a drug called acetaminophen. Acetaminophen-containing products such as Tylenol are used by more than 50 million Americans weekly to treat conditions such as pain, fever and the aches and pains associated with the common cold and flu. If taken at recommended doses, Tylenol (acetaminophen) causes very few side effects; however, taking more than the recommended dose can result in serious liver damage, acute liver failure and even death. Overdoses can result when patients accidentally take more than the recommended dose of Tylenol (or another acetaminophen product), or by taking more than one acetaminophen-containing product at the same time.

Liver Failure

Numerous studies have demonstrated that acetaminophen overdose is a leading cause of liver damage and liver failure in the United States, and the FDA notes that “the extent of liver failure cases reported in the medical literature provides an important signal of concern.” The Agency also concedes that ingesting even a small amount of Tylenol (acetaminophen) over the recommended total daily dose may lead to liver injury and even acknowledges that “currently recommended doses and tablet strengths of acetaminophen leave little room for error…”.

Widespread Use

In addition to Tylenol, acetaminophen is an active ingredient in over 600 over-the-counter and prescription medications. As such, individuals may inadvertently use more than one acetaminophen-containing product at the same time. For example, acetaminophen is a common ingredient in many multiple-ingredient medications, such as Sudafed Triple Action™ and NyQuil. Someone who takes Tylenol for a headache and who subsequently takes one of these combination medications to treat the aches and pains associated with the flu may unknowingly consume more than the recommended daily dose of acetaminophen.

Unclear Labeling

Further complicating the picture for consumers is the fact that acetaminophen may be difficult to identify as an ingredient. Some prescription medications that contain acetaminophen label the ingredient simply as “APAP.” The lack of clear labeling may also lead consumers to accidentally ingest more than one product that contains acetaminophen.

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Bloomberg ran an interesting article yesterday that raises the issue of whether or not there should be a vaginal mesh recall. There is a lot of data coming out now that supports the idea of a recall. At some point, these pharmaceutical companies need to cut their losses and not only stop making these vaginal mesh products but also recall the ones that are already on the market.

New information continues to underscore what is becoming increasingly obvious: these surgical implants are unsafe. The FDA is starting to get wind of this fact, and last month expressed more concerns about the risks of transvaginal surgical mesh used to treat pelvic organ prolapse.

This article also talks about the issue moving forward: how these defective mesh implants came on the market in the first place. As it should, it takes a long time to get the approval to put new drugs and medical devices on the market. But the FDA has a loophole called the 510(k). This process is a backdoor through the approval process companies usually have to go through to get a medical device on the market. It allowed vaginal mesh manufacturers a free pass on proving their product was safe and effective since it is “substantially equivalent” to others already for sale. One problem with this loophole: the definition of “substantially equivalent” is ever expanding. The FDA is finally catching on to this. Later this week, the FDA will gather more opinions from doctors and researchers as to whether we need to rewrite 510(k) to make it harder to get untested products on the market.

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