Product Liability Lawyer Blog

September 11, 2014

Germain v. Teva Pharm, USA, Inc. – Single Darvocet Lawsuit to Proceed

A pain medication known as Darvocet has been on the market since 1972, when it first received approval from the U.S. Food & Drug Administration. Less than six years later, the medical community acknowledged a link between the drug (a combination of propoxyphene and acetaminophen) and heart trouble. The concerns were serious enough that the United Kingdom pulled it from shelves.

Here in the U.S., however, the FDA simply required the new drug application holder change the labels to include a “Black Box Warning.” It also required the drug manufacturer to undertake a clinical trial to assess the connection between the medication and certain heart complications. Generic drug manufacturers continued to produce the drug, too. It wasn’t until 2010 the agency finally determined the risks of the drug outweighed the benefits and pulled it from shelves.

Since then, there have been a number of lawsuits filed against the makers of Darvocet. Our Boston defective product attorneys know some of these cases have floundered because they have been brought against generic drug manufacturers.
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September 8, 2014

Court Rules Victims of Generic Drugs Can Sue Original Manufacturers

by Jeffrey S. Glassman

When a patent expires on a medication, drug companies can produce generic versions of the drug to sell to the public. Unfortunately, this can create significant legal complications. In 2011, a court decision established that generic drugmakers cannot make changes to product labels even if the drugmaker is alerted to side effects. The label can be changed only if the brand-name drug manufacturer alters it to warn the public of the risks. As a result, generic drug manufacturers shouldn’t be held legally responsible for failure to warn patients about the risks of a medication.

An experienced Boston dangerous drugs lawyer knows failure to warn is normally legal grounds for a defective product lawsuit when a drug turns out to be dangerous. However, since the generic drugmaker cannot be sued, the question becomes: who can the patient hold liable? The answer, it turns out, may be the manufacturer of the original brand name drug.
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September 2, 2014

The “Hip Generation” Faces Difficult Recall Process on Artificial Joints

by Jeffrey S. Glassman

A recent story from wfmynews2.com takes a closer at the problems many total hip replacement patients are facing do to dangerous and defective artificial hips. As millions of Americans are undergoing total hip replacements members of the “hip generation” are having more problems than they did before surgery.

DePuy manufactures one hip at issue. The DePuy artificial hip was made with a metal on metal joint. When the DePuy hip fails, several dangerous things can happen. As your Boston DePuy hip lawyer know, the metal-on-metal joint was marketed to lead people to believe that the smooth surface would better emulate a natural hip and allow people to live more active lives.

In reality, the metal on metal joint can break down and cause metal shards to build up in the tissue surrounding the artificial hip. This condition is known as metallosis and can cause pain, suffering, and the development of tumors. As a result of this and other issues, some models of the hip have been recalled. The obvious problem is that, unlike an automotive recall, where you just drop the car off at the dealership for a couple of hours, the patient must face another painful and risky surgery to have a new hip implanted. This means more time away from work and family, and more painful recovery and rehabilitation. The three hip replacement patients interviewed for the article had eight hip replacements between them.
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August 31, 2014

Is Pradaxa Worth the Risk?

by Jeffrey S. Glassman

A recent article in The New York Times examines the risks of Pradaxa. Pradaxa, like Xarelto, is among a relatively new class of blood-thinning drugs turning huge profits for the manufacturer.

Patients who had been taking Warfarin, the traditionally prescribed medication to aid in the prevention of strokes, needed to get their blood levels checked every few weeks. Depending on results,, the dose of Warfarin would be adjusted.

Pradaxa has been marketed in a way that users are led to believe regular blood testing is not necessary with this new drug. They were told there is no need to adjust the dose, like you do with Warfarin. However, as your Boston medical malpractice lawyers can explain, this advice by the marketing arm of the pharmaceutical company can lead to internal bleeding and bruising, including intracranial hemorrhaging.

As noted in the article, the more convenient nature of Pradaxa was a key reason the U.S. Food and Drug Administration (FDA) fast-tracked its approval and allowed it to hit the market after only a single large clinical trial.
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August 28, 2014

Payne v. Novartis: On Aredia and Zometa Lawsuits

by Jeffrey S. Glassman

Payne v. Novartis, an appeal argued before the United States Court of Appeals for the Sixth Circuit, involved a woman and her husband who sued Novartis, a drug manufacturer, for failing to warn her that its drugs could cause serious damage to her jaw. Those two drugs were Aredia and Zometa.

As your Boston pharmaceutical negligence lawyer can explain, Aredia and Zometa are in a class of biophosphate drugs given to patients with cancer to prevent pathological fractures and bone pain. The drugs are administered intravenously. During the early 2000s, members of the medical community discovered a connection between taking biophosphates and developing a serious medical condition known as osteonecrosis of the jaw (ONJ).

ONJ is a condition that causes the gums to be eaten away until the bone is exposed. The gums and the bone then die. This is an extremely painful condition that resulted in doctors having to remove part of the patient’s jaw.
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August 25, 2014

Artificial Knee Manufacturer Invents Robotic Arm to Aid in Surgery

by Jeffrey S. Glassman

According to recent article in the Boston Business Journal, a technological innovation will allow partial and total knee replacement surgeries to be performed by a robotic arm. The company claims that this robotic arm sets them apart form companies such as Stryker, DePuy, and Zimmer. As your Boston knee replacement lawyer can explain, there have been many products liability lawsuits filed against the makers of these knees for issues involving defective design and a failure to adequately warn patients of known dangers.

The robotic arm is intended to be used by surgeons to allow for a more precise alignment of the artificial knee components. This company is claiming that proper alignment is the difference between success and failure in a knee replacement procedure.

The new device uses a 3D image of the knee and uses the image to saw off the knee joint at the proper place and at the proper angle. Without the use of the new robotic arm, surgeons use a metal guide and attempt to come within a few degrees of perfect alignment. The company also claims that if alignment is not proper, it can lead to a total failure in the replacement knee, and the patient will require another operation and another artificial knee to replace the failed one. Surgeons typically get the alignment right 75 percent of the time, and this robotic arm is supposedly able to get an exact alignment over 90 percent of the time.
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August 22, 2014

Risk for Internal Bleeding after Taking Pradaxa

by Jeffrey S. Glassman

According to a recent article from Australia, at least 30,000 people in the country have been put at serious risks for internal bleeding after taking Pradaxa. Claims are being made that Boehringer Ingelheim, the drugmaker, was more concerned with marketing and making money than patient safety and failed to warn users of this known danger or methods to minimize the risk of internal bleeding.

As your Boston Pradaxa attorneys understand, the drug is intended to be a blood thinner to minimize the risk of strokes, heart disease, and blood clot related illness. Pradaxa and another new blood thinner, Xarelto, were hailed as major advances in blood thinning medications and were marketed as a better alternative to the traditional blood thinner, warfarin.

The company’s marketing claimed that the advantage of Pradaxa over warfarin was that patients did not need regular blood monitoring. The problem is that the drug companies were apparently aware of the fact that regular blood monitoring would reduce the risk that Pradaxa patients would suffer internal bleeding and brain hemorrhaging. The drug company did not want to hurt windfall profits they were reaping from Pradaxa sales and worried that fewer people would choose the drug over warfarin if they knew this information.
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August 19, 2014

New Article Looks at the Risks and Effectiveness of Testosterone Replacement Therapy

by Jeffrey S. Glassman

Our testosterone replacement therapy attorneys understand that the Low -T craze sweeping the nation may have some serious health consequences in the near future.

A recent article from Fox News examines whether testosterone replacement therapy (TRT) is appropriate for the many new patients taking the medication. According to the article, prospective patients are being told that depression, fatigue, reduced muscle mass, sexual dysfunction and loss of sex drive and increased belly fat are all symptoms of “Low T” or low testosterone levels.

These are basically all of the signs or “symptoms” of male aging, so doctors and testosterone clinics (T Clinics) are presenting TRT as an age management therapy for a wide range of male patients.
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August 17, 2014

New Theory on How Testosterone Levels Can Be Responsible for Male Aggression

by Jeffrey S. Glassman

While it has been well established that testosterone levels can lead to aggressive behaviors in males, according to a recent article in Medical News Today, there is a specific neural receptor that is affected by the hormone in a way that causes male aggression.

Researchers in Canada performed a study on a group of 16 male volunteer patients. The patients were given a test to perform, and their results were tracked. The participants were then given either a placebo or testosterone. All participants were given a drug to lower their testosterone levels, so that there would be a common baseline for researchers to analyze without having to take into account the varying natural testosterone levels of the subjects.

Over the two days of testing, the subjects were monitored with MRI machines. The males who had higher testosterone levels were noted as making more angry and frustrated facial expressions as compared to participants on the placebo. The specific brain areas identified on the MRI were the amygdala, hypothalamus and periaqueductal grey.

Researchers noted that the research involved a small group of subjects and all participants were of a similar age. They need additional research and funding to solidify their results.

As your Boston Testosterone Replacement Therapy (TRT) attorney can explain, this is another example of how scientists only really seem to know the negative effects of raising a man’s testosterone level. We know that TRT has been associated with increased risk for heart attacks, strokes, and other serous illness, and doctors know that if you have a “Low T” count, as drug companies would say, administering TRT drugs can artificially raise levels.
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August 17, 2014

More Younger Americans Undergo Total Hip Replacement Surgery Than Ever Before

by Jeffrey S. Glassman

A recent article in the Washington Post chronicles the columnist’s experiences as he researches and then undergoes total hip replacement surgery at the age of 45.

The point is that hip replacement surgery isn’t just for older people anymore. The article details that the number of total and partial hip replacements performed each year has risen nearly 60 percent between 1998 and 2011. Within that group of people having the operation, the number of patients between the ages 45 and 65 has increased by nearly 20 percent, to account for just less than half of all hip replacement operations.

By the numbers, nearly 500,000 patients are having a total or partial hip replacement each year. The reason given in the article for the increase in hip replacements is that younger, more active people are no longer willing to live with the pain and suffering of joint disease anymore and would rather have this relatively common operation and get back to their active lifestyle.

While that is the good news, as your Boston hip replacement lawyer can explain, there is a corresponding number of patients that have experienced significant pain and suffering as a result of defectively dangerous artificial hips. Some patients were the victims of deceptive marketing and not given adequate warnings to allow them give an informed consent to the life-changing operation.
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