Lawsuit Update Center

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 over 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 cause severe 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 take over one acetaminophen-containing product simultaneously.

• The Tylenol class action lawsuit for autism is taking off in 2023

Liver Failure

Numerous studies have demonstrated that acetaminophen overdose is a leading cause of liver damage and liver failure in the United States. 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. It 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 over 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 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 that acetaminophen may be challenging 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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In September, Topamax lawsuits pending in federal courts throughout the country were consolidated in Pennsylvania. The lawsuits allege birth defects in children whose mothers took Topamax. This blog post discusses these suits. If you have an interest in discussing a potential Topamax lawsuit, call 888-322-3010 or get a free online consultation.

Topamax is an antiepileptic medication. It is often prescribed, off label, as a mood stabilizer for patients with bipolar disorder. Topamax lawsuits claim that birth defects such as cleft lip, cleft palate, genital malformations, and other birth defects in children were caused by their mothers taking Topamax (topiramate).

Topamax and topiramate (generic) are manufactured by several companies. The lawsuits allege that manufacturers failed to warn both the public and regulatory agencies about the potential for birth defects if used during pregnancy. To give you some idea of who the bad guys are in this story, consider this: Ortho-McNeil Pharmaceutical and Ortho-McNeil-Janssen Pharmaceuticals agreed to pay more than $81 million dollars in fines in 2010 for illegal promotion of Topamax related to off-label psychiatric use. History is replete with the choice of profits over patients.

Earlier this year, the FDA issued a warning and required label changes to list oral clefts as a possible side effect of its use during pregnancy. Risk is the highest if used during the first trimester of pregnancy. Data from the North American Antiepileptic Drug (AED) Pregnancy Registry show that infants exposed to antiepileptic drugs have a 0.38 to 0.55% prevalence of oral clefts, however, those exposed to topiramate have a 1.4% prevalence of oral clefts, nearly 3-4 times higher than other anticonvulsants.

Cleft palate is a condition in which the infant has a gap on the roof of the mouth which interferes with the normal functioning of the mouth including chewing and talking. To correct the birth defect, surgery is required. Surgery is generally required between 6 and 12 months of age and can take several surgeries, and years, to correct.

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After eight hours of deliberations, a Montana jury found that a Breg infusion shoulder pump was defective and caused injury to an orthopedic surgeon.
Plaintiff’s verdict? Not so fast. The jury found the product was defective but that the infusion pump conformed to the state-of-the-art design at the time it was sold. This can be fatal to a failure to warn claim.

The state-of-the-art defense under Maryland law in strict liability, failure to warn cases was explained in the landmark claim of Owens-Illinois Inc. v. Zenobia (which is best known for requiring actual malice for punitive damages in Maryland). Zenobia found that the manufacturer of a product, which is defective only because of the lack of an adequate warning, is not liable when the failure to warn resulted from an absence of knowledge of how dangerous the product was. Still, required knowledge is “knew or should have known” – it can be established by evidence that the risk should have been known because it was known in the scientific or expert community. This knowledge is called the ‘state of the art’ evidence.

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The C.R. Bard Avaulta vaginal mesh lawsuits allege that mesh surgically implanted to treat pelvic organ prolapse may be defective. As a result, an unbelievable number of women are at risk for internal injuries and urinary problems.

The FDA recently expressed an even graver concern that the placement of surgical mesh through the vagina to repair pelvic organ prolapse may expose women to greater risks than other available options.

Bard Avaulta mesh lawsuits allege that the defective design of the mesh implant may increase the risk of infection, erosion, and other painful complications. Plaintiffs’ lawyers are bringing lawsuits against C. R. Bard, Inc., which makes and sells Avaulta Plus and Avaulta Solo synthetic surgical mesh tissue supports, and a host of other manufacturers.

These lawsuits are multiplying quickly. But there are a lot of women who are not going to bring a vaginal mesh lawsuit because they perceive a privacy invasion. This is understandable, but it underscores a general misconception about what a claim will entail.

These are national mass tort cases. Frankly, mass torts are rather impersonal and are handled by national lawyers – attorneys you likely will ever meet. Many vaginal mesh lawsuits have already settled for pretty decent sums of money – life-changing for many people. In many ways, it is about filling out some paperwork and waiting and you always have the option of just dropping your case if you don’t like where it is going in terms of your privacy or your need to be involved in the case.

Ultimately, some women will read the preceding paragraph and say “I don’t care, I’m not putting myself out there in any way.” I can’t really argue with this. I’m just trying to provide the full context to potential clients.

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A Chantix murder/suicide lawsuit has been filed in Pennsylvania alleging that Chantix caused a man to kill his wife and then himself. The victims’ families claim there was not an adequate warning that Chantix could cause this extreme level of aggressive behavior. Obviously, the claim is that Chantix was a causal factor in the murder-suicide.

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Last month, I took exception to a Drug and Device Law Blog post and wrote a semi snarly retort on the topic of the confidentiality of discovery documents.

Bad move. The Drug and Device Law Blog fired back a response pretty much took my post and beat me over the head with it. Adding insult to injury, they did it with good writing and good humor. I hate it when the bad guys are good and funny. It makes them seem almost human, an idea that fits in poorly with my worldview.

I thought they got some substance just dead wrong and there was lots of room for a good counterattack. But to find the time to write a cogent, witty response to rival theirs? They spit that response out in an hour; I bet. It would take me all day to come up with something and it still would not have been as well written.

Thankfully, my brother jumped in to stand up for me. My brother? Yes, for our purposes here, my brother. Justinian Lane stepped up and wrote the response I wanted to write (link since deleted, unfortunately). Even better, actually.

So instead of beating this topic any further, I’ll comment off-topic to the core issues in this debate and address another fascinating point Justinian makes about the economic disparity between plaintiffs’ lawyers and defense lawyers:

In DDL’s first post, they made a quip about plaintiffs’ lawyers buying Maybachs, and now they’re complaining that “plenty” of plaintiffs’ lawyers have private jets. While I don’t think that the authors of DDL are green with envy over the financial success of a few plaintiffs’ lawyers, plenty of their readership is. By and large, defense lawyers go to better schools than plaintiffs’ lawyers, earn better grades, write better briefs, and I’ll say it – are better lawyers. And they know it. It therefore irritates them to no end that lawyers who they perceive as being inferior to them are more financially successful than they are.

I don’t know that defense lawyers are better trial lawyers than plaintiffs’ lawyers in mass tort cases. Plaintiffs’ lawyers get more reps because, typically, plaintiffs’ lawyers have more trial experience. A lot of great mass tort defense lawyers can go a career without trying a case. I’m not saying they can’t do it effectively when called upon but, like with most things, experience counts. Pharmaceutical companies hire great trial lawyers but if cases are remanded all over the country, they don’t have as deep of a bench as plaintiffs’ lawyers.

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The Drug and Device Law Blog has an articulate rant about plaintiffs’ lawyers jerking around defendants on whether certain documents produced should be deemed confidential. The core of their argument is that plaintiffs’ interests in the battle over confidential documents are either for (1) sport or (2) to shop documents obtained in discovery to the press.

There is some measure of truth to almost the entire post. But it is as if Tiger Woods told the following story: “I was looking forward to a nice Thanksgiving weekend with my family but on Sunday my wife just left. Didn’t say goodbye or anything.” That’s a true story.

Similarly, the Drug and Device Law Blog leaves out a little fact of the story: mass tort defense lawyers are the undisputed kings of making plaintiffs’ lawyers work for pure sport. Plaintiffs’ lawyers in drug and device cases largely just want to get from Point A to Point B as quickly as possible. I think this is a function both of the personality types attracted to these very different jobs (and I’ve done both) and fundamental economics: plaintiffs’ lawyers get paid for success while defense lawyers get paid for working, even if they are just creating work.

Lots going on in GlaxoSmithKline’s Avandia world. They’ve been wounded but avoided summary execution yesterday when twelve of 33 members voted to allow it to stay on the market, albeit with significant restrictions and black box warnings. See CNN’s article.

One expert cited in the article noted that:

“I don’t have any patients currently taking Avandia,” said Nathan. He stopped prescribing the drug because “it just didn’t make sense,” considering there are alternatives that didn’t carry the potential risk, he said.

The medical journal The Lancet is chiming in on the Avandia debacle. Back in 2009, The Lancet published a paper about the RECORD study (funded by Avandia manufacturer GlaxoSmithKline) which was widely criticized. The major complaint is that the article did not include the drop-out rate—without knowing which patients went off the drug, it is impossible to calculate the risk of Avandia-caused heart attacks. Now, The Lancet issued an editorial titled “Strengthening the credibility of clinical research.” It describes briefly the Avandia situation, likening the recent Senate Committee on Finance report to a John Grisham novel: “GlaxoSmithKline (GSK), intimidated researchers and manipulated the scientific process for commercial advantage.”

Here are some “talking points” from the editorial:

• At a time when some pharmaceutical firms have received record fines for misconduct, the saga of rosiglitazone [Avandia] tests the limits of tolerance

Two prominent Chicago orthopedic surgeons are calling for the recall of Zimmer’s NexGen CR-Flex Knee replacement devices. There has already been a recall of related devices to a part of the knee.

The porous femoral component (that is, the part of the replacement that covers the head of the femur, the bone that goes from the pelvis to the knee) is associated with a high rate of failure. The two Chicago surgeons calling for the Zimmer recall, Richard Berger and Craig Della Valle from Rush University Medical Center, have observed after two years’ of use that 36% of the implants were loose, and 9.3% were revised or set to be revised because of looseness and associated pain.

The doctors stated that “This component is still commercially available but should not be used for any patient.” They also questioned the fact that the product was released for sale to the public without clinical testing. Dr. Berger described the failure rate as “horrific.”