Articles Posted in Products Liability

Finally, Stryker Recalls Defective Hip Implants

In a somewhat tight-lipped press release and website page, Stryker Orthopaedics notes that it is voluntarily recalling two components of its metal-on-metal hip implant devices. The hip implant recall, according to Stryker, is based on post-market surveillance, which means that there have been a lot of complaints and problems with the devices.

hipInterestingly, Stryker’s recall is qualified by its statement that “The incidence of complications associated with modular-neck stems is extremely low.” Stryker makes a neat little bit of history here by admitting its hip implants are a train wreck while at the same time defending the product to the hilt. Kids, don’t try this at home.

Anyway, the recalled hip implants include Stryker’s Rejuvenate and ABG II modular-neck stems. These are devices used to help the surgeons correct for anatomical abnormalities, by customizing the implant to the patient. Problems with the devices include corrosion, which can cause inflammation in the body with symptoms of pain and swelling. The original press release for the Rejuvenate hip implant stated that “Laboratory testing demonstrates the compatibility of these materials without concern for fretting and corrosion.”
Regardless of whether patients are experiencing pain or other symptoms, they should contact their orthopedic surgeons to determine whether a revision surgery is necessary, or whether the surgeon recommends monitoring of the implant. It’s not a bad idea to contact a lawyer, either. Medical device lawsuits have strict deadlines, and the failure to file a lawsuit within a short amount of time means that a lawsuit might not be allowed. For many patients, the clock may start ticking with this notice of recall.

Stryker set up a website for patients affected by the recall. Not much information there. Shocker. Continue reading

Patients with DePuy ASR hip implants, recalled in 2010, are making their way to trial. DePuy is a subsidiary of Johnson & Johnson, and they are defendants in a type of class action known as multidistrict litigation (MDL). There are over 6,000 lawsuits, about 4,000 in a federal Ohio court, and another 2,000 spread out in various state courts. There were over 93,000 hip implants recalled. August, 2013 update: we have won one and lost of one of these cases.

The hip implants were recalled because they are metal-on-metal implants, and doctors are finding out that the grinding of the metal joints causes metal debris to get loose, harm tissue, and enter the bloodstream. Additionally, the hip implants are failing at a higher rate than other types of implants.hip

Not all of the cases will go to trial—in the federal case, Judge Katz and the parties are selecting a few model cases to go to trial early. Those model cases are known as bellwether cases, and they are intended to be a springboard for settlement of the rest of the cases. The theory is, by having a few representative trials, the parties get a better idea of what a jury will do with these cases, and they can make informed decisions about whether to settle, and for how much. The federal trial will probably be set for early next year.

In the meantime, there are some earlier trial dates set in state courts. The first trial is set for Las Vegas in December, and another trial is set here in Prince George’s County, Maryland in January, 2013. Continue reading

The Pennsylvania Supreme Court stuck down a $5 million verdict in an Ethicon endocutter design defect case last week, finding that the trial court was not restricted to considering only one use of the device and that it correctly applied a risk-utility analysis. The case talks about product liability risk-utility analysis in the Restatement (Third) of Torts. You can read the court’s opinion here.

Plaintiff, a 40-year-old mother, underwent gastric bypass surgery (Technically, she is the plaintiff’s decedent. I use “plaintiff” because of my refusal to use plaintiff’s names on this blog, a stance that sometimes makes recitation of the facts awkward in wrongful death cases.). To cut and resection plaintiff’s stomach, her doctors
endocutter2utilized an ETS-Flex45 Articulating Endoscopic Linear Cutter – called an an “endocutter” – made by Johnson & Johnson, subsidiary Ethicon Endo-Surgery (Let’s say charitably that both of these companies are frequent flyer product liability defendants.). The device was designed for use in less-invasive endoscopic surgery. It also was marketed for use in traditional “open” surgery in which a large incision is used to view internal organs.

After complications, Plaintiff’s doctors conducted a second surgery and discovered that staples were absent in two small sections and attributed the problem to “mechanical staple failure.” Sadly, Plaintiff’s stomach contents had leaked into her abdominal cavity, causing sepsis, and her eventual death.

Plaintiff’s Estate filed a wrongful death suit contending that the endocutter was unreasonably dangerous because it was not equipped with a means to either measure the thickness of the tissue being stapled or lock the device if the tissue thickness was incorrect. Plaintiff’s Estate contended that had the endocutter been designed with this capability, it would have prevented the staple line failure that caused Plaintiff’s death.

An Allegheny County, Pennsylvania jury agreed, finding the endocutter’s defective design caused the woman’s wrongful death and awarded $ 5 million, finding that the endocutter was defectively designed.

The big issue in the case was the application of the risk/utility analysis required in a products liability action to determine whether a product is unreasonably dangerous. In this case, the endocutter at issue was marketed for multiple recognized uses, but the injury to the plaintiff was caused by only one of those uses. So the question is whether the trial court’s risk-utility analysis should be limited to the use that caused the plaintiff injury or should it consider all of the uses of the product. Continue reading

Pat Malone writes a guest blog on Don Keenan’s Trial Blog arguing that confidential settlements undermine public safety and justice. 2013 Update: the link is now broken but this post is still really worth reading.

His point is that confidential settlements make it harder for future plaintiffs to get evidence and information they need to bring out all of the facts about the defendant’s conduct.

Specifically, Malone suggests:

Here’s one tip for avoiding last-minute pressure from the defense to cave into a secrecy agreement: Be proactive. Tell the defense counsel at some appropriate point – such as with any settlement demand letter or in a pre-mediation communication – that you will not agree to secrecy because of the ethical issues. This can be one item on a list of settlement conditions.

Pat Malone is an extremely well respected lawyer who not only gets great results for his client, but also graciously spends a lot of time helping other persobusinesshandshakenal injury lawyers. I also agree with his premise: there is doubt doubt that confidential settlements make it harder for the next plaintiff. This also make the company less accountable, too, in the big picture.

But here’s the problem: people who have been badly injured, even the best of people, have a hard time focusing on the global interests of plaintiffs everywhere when they are fighting and scrapping to be compensated for their injuries. And I have a hard time telling them that they should.

Let me give you a case in point. We recently settled a case with a Fortune 500 company. No discussion of confidentiality in the settlement discussions. You know what comes next. They send a release with a confidentiality clause. We balk. They say, “Okay, let’s try the case.”

Boy, I hate being bullied by big companies. I try hard not to take these things personally. But they were so arrogant in the way they delivered their ultimatum. They never would had the guts to play it through and I knew it. So we plotted a “file a motion to enforce the settlement and, in the off chance we lose, we try it” strategy. In angry detail. With our feathers up and blood boiling, we forgot, ah, that we have a client. So we call the client. She could not care less about confidentiality. She wants to execute the settlement and get her money.

So what do you do? I know what we did: we put our hurt pride on a shelf and sent the client the release. Continue reading

In the United States alone, approximately 581,000 knee replacement surgeries are performed each year. Getting a knee replacement is clearly a big deal: if you need a replacement, you have really run out of options with the knee problems that you are having. So knee replacement surgery is the last line of defense for patients suffering from extensive fractures, arthritis and/or osteoarthritis.

Continue reading

The history of “bad cholesterol” has had a checkered past. Bayer’s cholesterol-reducing blockbuster Baycol allegedly caused more than 100 deaths. Bayer paid over $1 billion to settle the Baycol cases.

Now come Crestor and Zocor, two more widely prescribed prescription strength drugs designed to lower “bad cholesterol”. Both drugs allegedly cause serious muscle and kidney problems, including the potentially fatal, muscle-destroying condition rhabdomyolysis. This blog post focuses on Zocor.

Zocor (simvastatin) is a statin drug used to treat a condition known as hypercholesterolemia (better known as high cholesterol) in people at risk of developing coronary artery disease.Zocor
Statins block the ability of the liver to produce cholesterol, so that the body takes any cholesterol it needs from food. It all sounds good in theory.

Zocor’s big competitive advantage in the cholesterol drug wars? It was cheaper. A lot cheaper. The old, “you get what you pay for” cliché does not usually apply to drugs. The price is usually arrived at through an amalgamation of factors that don’t involve comparative efficacy. But in this case, it might hold up: at least one study has found that 80mg of Zocor was not as effective at reducing heart risks compared to the same dose of Lipitor.

But let’s get back to the point. In 2010, 2.1 million people in the United States were prescribed Zocor at a dose of 80mg. This dosage is particularly effective, in that it lowers LDL cholesterol by an additional 6% versus a 40mg dose. More drug, more cholesterol reduction. This makes sense. Continue reading

The FDA is currently investigating a possible association between the diabetes drug Actos (pioglitazone) and an increased risk of bladder cancer.

Actos is commonly prescribed to treat type 2 diabetes and works by increasing the body’s sensitivity to insulin. It is usually taken once a day by mouth. By all accounts, Actos helps treat type 2 diabetes, which is undoubtedly an awful disease. But there are other diabetes options where there is no suggestion of a link to cancer. The questions that doctors are going to have to answer are whether Actos is worth the risk of cancer and whether there are other less risky options Actos2available. Ultimately, juries are also going to be asked these questions, too. They will also have to dig into the other question: what did the manufacturer of Actos know or should it have known about the association between cancer and Actos and should they have issued a recall for Actos or at least provided a warning of the risk?

The bubbling concerns about Actos culminated in a safety announcement dated June 15, 2011, wherein the FDA warned the public that “use of the diabetes medication Actos (pioglitazone) for more than one year may be associated with an increased risk of bladder cancer.” Information about the potential risk will be added to the Warnings and Precautions label for medicines that contain Actos, and the corresponding patient Medication Guides will also be updated to reflect information on bladder cancer. In response to the FDA’s actions, the drug’s manufacturer (Takeda) has undertaken a 10-year observational study to assess the long-term risk of bladder cancer associated with the use of Actos. Continue reading

Almost two years ago now, Medicaid/Medicare liens became even more difficult to deal with as the law pushed to the lawyers and insurance companies the obligation of confirmation and resolution of Medicare/Medicaid liens. I’m sure betting an insurance company has yet to receive a fine for not verifying a lien before paying a personal injury settlement. But nobody wants to be the first.courtroom7

Medicare, Medicaid and State Children’s Health Insurance Program Extension Act of 2007 created so many headaches people starting fighting back. In Haro v. Sebelius, an Arizona case in U.S. District Court, Medicare beneficiaries (and, interestingly, a personal injury lawyer in his own capacity) challenged – as a class – two things: (1) Can Medicare/Medicaid (hereinafter “Medicare because I’m sick of the slash) “require prepayment of a reimbursement claim before the correct amount is administratively determined where the beneficiary either appeals or seeks a waiver of the MSP reimbursement claim?, and (2) Are personal injury lawyers financially responsible for reimbursement if they do not hold or immediately turn over to Medicare their clients’ personal injury settlement awards.

Personal injury lawyers are completely in a pickle on these liens. Our clients want their money; we want to get them the money they are entitled to get. The question is whether personal injury attorneys are precluded from giving the clients their settlement money until after Medicare’s claim has been satisfied, and, let’s be honest, whether Medicare can recover the reimbursement claim directly from the attorney if the client fails to pay the reimbursement claim after the settlement money has been turned over to the client.

Continue reading

Our lawyers are reviewing Topamax birth defect lawsuits in Maryland.

Topamax causes an increased risk of oral birth defects – most prolifically cleft lips and cleft palates – in children’s mothers took Topamax while pregnant. That’s not plaintiffs’ lawyers spinning: the FDA is saying this.topamax

These lawsuits argue that the manufacturer either knew or turned a blind eye to the fact that the durg caused these birth defects.

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