Drug Recall Lawyer Blog

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.

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:

• MOTRIN IB 24 COATED TABLETS - Lot Numbers: ADA069, ALA168, ALA244 AMA286, APA001, ASA001 - UPC Code: 300450463029
• MOTRIN IB 24 COATED CAPLETS - Lot Numbers: ACA310, ACA460, ADA407 AEA262, AFA226, AJA170, ALA037, ALA163, AMA012, AMA331, AMA342, APA035, ASA082, ASA123, ASA285, BDA238, BDA260, BDA383, BEA065, BEA148, BEA269 BEA277, BFA064, BFA144, BFA244, BHA078, BHA147, BHA167, BHA198, BJA164, BJA221, BMA144, BMA215, BMA271, BSA022, BSA056, CBA063, CBA107, CCA028, CDA003, CFA065, CFA100, CHA012, CHA044, CHA066, CHA080, CMA028, CMA035, CMA057, CMA102, CMA108 - UPC Code: 300450481030
• MOTRIN IB 24+6 COATED CAPLETS - Lot Numbers: ACA761, ALA265 - UPC Code: 300450481641

The products were distributed in the United States, Puerto Rico, Bahamas, Fiji, Belize, St. Lucia and Jamaica.

Is this a serious safety hazard for Motrin users? No. But it continues to underscore that Johnson & Johnson needs to get its act together. Drug companies are going to have recalls. Even the best companies are going to have to recall product from time to time. J&J just has way too many.

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 our DePuy Recall website and 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.

The medical monitoring program would help people to be regularly evaluated for metallosis, blood poisoning caused by metal fragments from the implants. So far, 430 out of 5,500 Australian patients have undergone a second surgery because of the faulty implant—that’s almost a ten percent failure rate. The real number is probably higher—many patients may be in line for that surgery, and experts believe that many more installed devices will fail within about six years of implant.

If you have had a DePuy ASR hip implant, and you are experiencing problems or have had to replace the implant, contact us at 800-553-8082 or get a free online consultation.
Sources: Sydney Morning Herald

• All Metal Hip Replacement: No Advantage Over Older Implants
• Metal On Metal Hip Replacents - A Colossal Failure?
• New Repor Highlights Metal Hip Problems
• Hip Replacement Profits

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).

Continue reading "Tylenol Linked to Asthma?" »

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.

Continue reading "Tylenol Liver Damage Symptoms and Information" »

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.

Continue reading "Vaginal Mesh Recall?" »

The vast majority of DePuy hip replacement lawsuits will - if they go to trial - be tried in the states where the surgeries occurred (excluding bellwether trials and state court cases). But the discovery of these DePuy cases is consolidated in Ohio. That means for now, every federal court case sits in what is called an MDL in Ohio.

Some DePuy plaintiffs' lawyers, for various reasons, do not want to wait on the slow pace of the MDL in Ohio. A number of cases that were transferred from Alabama have named a sales representative from DePuy/Johnson & Johnson as a defendant. Plaintiffs' lawyers claim because there is diversity of citizenship - an Alabama resident on both sides of the "v" - that the cases should be remanded to Alabama.

Let's be honest. Plaintiffs' lawyers would not have named this sales rep if he was not an Alabama resident. The DePuy lawsuits are clearly not about a sales rep. Still, that is not the litmus test as to whether the joinder is fraudulent. In fact, the burden for the defendants is quite high. To keep these Alabama cases in the MDL, DePuy was required to meet the difficult burden of showing either “(1) there is no possibility the plaintiff can establish a cause of action against the resident defendant; or (2) the plaintiff has fraudulently pled jurisdictional facts to bring the resident defendant into state court; or (3) there is no real connection between the claims against a diverse defendant and those against a non-diverse defendant.

Continue reading "Where Are DePuy Hip Implant Cases? New Opinions from MDL Judge in Ohio" »

USA Today writes an article that I thought was going to have the false premise of "Does the Tylenol recall pose a risk for consumers?" There is no evidence this latest and greatest Tylenol recall puts consumers in harm's way. But then it asks the larger question: are Johnson & Johnson's products safe? Here's the argument:

"Clearly if a company has one recall, I could say 'Well, that's sort of an accident, just something that was very unfortunate.' But I think Johnson & Johnson has had it happen over and over and over again. They don't have their act together," says Curt Furberg, a professor of public health sciences at Wake Forest Baptist Medical Center in Winston-Salem, N.C. "I would be worried and try to go with other drugs, other pain relievers." Furberg has served on the Food and Drug Administration's Committee on Drug Safety and Risk Management.

That's the key point, well phrased. Does Johnson & Johnson have its act together and, if it doesn't, does that make all of its products - or a least products where there appears to be the theoretical possibility that a defect could cause injury - a riskier bet for consumers?

Johnson & Johnson, recall and odor. These words just flow together. J&J will recall of 16,000 bottles of the antipsychotic drug Risperdal because of - wait for it - an unnatural odor.

The culprit? You guess it. Wooden pallets. Unbelievable.

On Monday, a U.S. Judicial Panel on Multidistrict Litigation assigned all DePuy Pinnacle hip implant recall lawsuits pending in federal courts nationwide to Judge James E. Kinkeadein in the U.S. District Court for the Northern District of Texas.

The whole idea of the MDL process confuses victims? Are the DePuy claims a class action lawsuit?

The answer is the DePuy hip claims are "sort of" a class action lawsuit. The federal cases will be consolidated in Texas for what is called core discovery - interrogatories (written questions) to DePuy, depositions of key DePuy witnesses and experts on both sides, and other discovery procedures to determine the facts of these lawsuits. Typically, the MDL judge may preside over a few trials to help both sides better understand the value of the cases. If there is not a global "class action settlement" at that point, the cases are sent back to their home state for specific discovery and trial.

What is the settlement value of these DePuy hip implant cases? Anyone who answers this question definitively is not being entirely honest - at this point, no one really knows. But DePuy/Johnson & Johnson have set aside almost $1 billion to pay these claims and, ultimately, I don't think is going to cover it. Many of these cases have trial values that are worth millions of dollars. So are high six figure and seven figure DePuy settlements likely? I think so. But only time will tell.

Do you have a DePuy Pinnacle hip implant? Get more information at 800-553-8082 or get a free online consultation here.

Alas, the good news for Johnson & Johnson on this blog ends here. A Pennsylvania jury found J&J responsible for not properly warning of Motrin's risks and ordered Johnson & Johnson to pay $10 million to a young girl and her family.

The girl took Motrin 11 years ago as an infant and was blinded in one eye and suffered burns over 84 percent of her body.

Nobody is saying the Motrin should be recalled or even that it is anything other than a quality drug. But the jury specifically found J&J negligent in failing to provide a proper warning about Children’s Motrin’s risks. J&J did not warn that ibuprofen, can trigger a severe allergic reaction. J&J's failed defense: it was a 1 in 25 million shot.

Johnson & Johnson. Drug Recall Lawyer Blog. It rarely ends well.

But there is some good news for J&J. Johnson & Johnson plans to introduce four promising new drugs this year to treat: (1) AIDS, (2) prostate cancer, (3) hepatitis C and (4) strokes. The sale of these drugs should be worth billions of dollars in annual revenue.

Johnson & Johnson has been a train wreck lately. They really have. Maybe I'm just nostalgic but I really think J&J can be a great company again. Here's hoping these drugs have been well tested and can really make a difference for patients and Johnson & Johnson.

Johnson & Johnson is back on the recall wagon again, issuing a recall for the HIV drug Prezista in Austria, Germany, Ireland and the United Kingdom. Why the recall? Usual drill - an odd musty odor in the drugs from the shipping pallets. Maybe there would be some wisdom in buying new shipping pallets at this point.

I have taken more than my fair share of swipes on this blog at Johnson & Johnson. I'm sure my objectivity is discounted given the name of the blog: Drug Recall Lawyer Blog. Fair enough. But when the Wall Street Journal is mocking a pharmaceutical company, it is like Charlie Sheen telling you that you are out of control.

Johnson & Johnson is purchasing medical device maker Synthes Inc. for $21.3 billion in the largest deal ever by J&J. This move will further - to say the least - J&J's effort to capture more market share in the surgical trauma equipment and orthopedic implant markets.

A few months ago (I couldn't find the post I did), I wrote that you should buy J&J stock because the number of recalls/screw-ups just could not continue at the frenetic pace it was maintaining. Well I was wrong about the frenetic pace part of it but, the stock is continuing to rise which furthers my Pet Theory #853,034: product liability lawyers overestimate how much litigation matters to these huge pharma companies. J&J sets aside nearly a billion dollars for the Depuy hip replacements and we think that must be a big deal. But it is simply an accounting error to J&J in a deal of this size.

Everybody wants in. You can't do a search on Google without finding 20 lawyers looking for recalled DePuy hip replacement cases. It is pathetic. (Oh, now that you mention it, you can find some pandering from us here.)

Anyway, the fund that manages health benefits for a number of towns in New Jersey has filed a class action lawsuit against DePuy Orthopaedics over its ASR hip implant recall. The fund accuses DePuy (Johnson & Johnson) of fraud and unjust enrichment, alleging DePuy knew its hip implants had problems and left them on the market, ostensibly hoping no one would notice (no one did for a while, actually).

In other words, their lawsuit mimics the language of virtually every DePuy hip replacement lawsuit.

I wish Vegas had a line on things like: Johnson & Johnson will have another recall that almost makes them caricatures of themselves. With that intro, I give you another Tylenol recall.

I'm repeating myself but Johnson & Johnson was a great company. You shouldn't lose that status virtually overnight. (I'm using dog years to define "overnight".) If I were a stock analyst, I would rate J&J a long term buy because I'm convinced in the long run, someone is going to turn this company around. Hopefully, this is the bottom. I've been saying this about the housing market for a year. But, really, there has to be a bottom, right?

Johnson & Johnson Ethicon will recall of 360,000 surgical wound draining devices after concerns that the sterilized packaging could be compromised.

It is late on a Friday. You will have to fill in your own snarky comment about another J&J recall.

Johnson & Johnson owned Ortho-McNeil misled doctors about the safety and effectiveness of Risperdal, according to a South Carolina jury who may give South Carolina $360 million in penalties. Last year, a Louisiana jury awarded that state $257.7 million in damages. Shouldn't every state jump on board this train? Ten states already have.

You can find the details here. Honestly, I'm thinking of a spin off Johnson & Johnson Drug Recall Lawyer Blog. It could be "The Jeffersons" to "All in the Family".

The CEO of recall-plagued Johnson & Johnson took a 7% pay cut last year. Ouch! He had to feed his family on $28.7 million? Mercifully, he got a 3% pay raise in February.

Big picture, it is hard to know how much of J&J's problems rest with its CEO just like it is hard to tell how many of our economic problems were caused by President Obama or President Bush. But the game is scored by what happens on your watch. Since J&J's CEO took the helm 9 years ago, the wheels have fallen off the cart. J&J's drugs and medical devices have gained the interest of not just plaintiffs' drug injury lawyers. There have been investigations by various government bodies, including a House committee, the FDA and even a criminal probe by the feds. Arguably, you and I could run the company for half of his salary - I might even go down to $10 million - and create a similarly situated mess.

Topamax lawsuits may be "what's next?" in terms of significant mass tort cases. The gist of the allegations in the Topamax lawsuits are that Ortho-McNeil, which - surprise - is owned by Johnson & Johnson should have (1) never put Topamax on the market because of the risk of birth injuries in children whose moms were on Topamax, and (2) issued a recall for Topamax as the evidence accumulated that Topamax was causing cleft lip/cleft palate birth injuries. Even if you don't think there should have been a recall, it is hard to argue that the risks of these injuries were adequately laid out for potential mothers and their doctors.

We put up a page on Topamax lawsuits on our website which will provide more information about the Topamax claims.