Product Liability Lawyer Blog

September 25, 2014

Federal Jury in West Virginia Awards Plaintiff $3.27 Million in TVM Lawsuit

According to a recent article from the West Virginia Record, a federal jury has just awarded a plaintiff $3.27 million in a multidistrict litigation (MDL) case involving transvaginal mesh (TVM) products manufactured by Johnson & Johnson.

This case involved the Gynecare TVT Obturator. This device, manufactured by Ethicon, a Johnson & Johnson subsidiary, is a surgically implanted medical device used in the treatment of stress urinary incontinence. The TVM device consists of what is essentially a layer of mesh being held within a support device. The fact that it is supported in this manner is the reason it is called a tension-free vaginal tape (TVT) design, which was marketed as being superior and safer than previous TVM devices that are linked to serious injuries to patients, including erosion of tissue and vaginal dehiscence.

As our TVM plaintiff attorneys in New England understand, these products pose several other risks to women, including erosion of the mesh itself. There is also a risk that, when the device is surgically implanted through incisions made in the vagina and then anchored to the pelvic bone, the patient’s bowel and other internal organs may be perforated (punctured), resulting in internal bleeding, urinary incontinence, and potentially deadly infections.

In this case, the jury found that the drug company had defectively designed the product and failed to adequately warn doctors and patients of known risks. The verdict was in the amount of $100,000 to compensate for medical expenses, $470,000 in pain and suffering and emotional distress that had already been experienced, and $2.5 million for pain and suffering, disability, and loss of enjoyment of life that will likely be experienced by plaintiff in the future. Plaintiff’s husband was also awarded $200,000 in damages associated with loss of consortium.
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September 20, 2014

Chapman, et al. v. The Procter & Gamble Dist., et al.: On Scientific Evidence in Products Liability Cases

by Jeffrey S. Glassman

As our Boston products liability attorneys can explain, the use of a qualified and knowledgeable expert can significantly increase a plaintiff’s chance of obtaining complete financial recovery.

Chapman, et al. v. The Procter & Gamble Dist., et al., an appeal heard by the United States Court of Appeals for the Eleventh Circuit, involved a plaintiff who alleged that she developed myelopathy as a result of using a particular brand of denture adhesive two times a week over an eight-year period.

Myelopathy is a spinal court disorder that affects a patient’s extremities. Plaintiff claimed that she developed a variety of neurological symptoms from 2006 to 2009. Plaintiff asserted that her condition was, specifically, a zinc-induced copper deficiency that was a result of using the denture adhesive.

Evidence was presented to show that defendant introduced zinc into its denture adhesive in the 1990s to improve the functionality of the product by increasing adhesion.

One case report from 2008 presented the hypothesis that zinc in denture adhesives could cause the user to become copper deficient, and this could cause a neurological condition. After this study came out, lawsuits were filed across the country against the manufacturers of dental adhesives.
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September 17, 2014

Johnson & Johnson and Bayer Aim to Increase Market for Xarelto

by Jeffrey S. Glassman

As our Xarelto attorneys have discussed on other blog entries, Johnson and Johnson, Bayer, U.S., and German drugmakers involved with the production and marketing of the drug are performing new studies to increase the profit potential for their flagship anticoagulant.

According to a recent article from The Wall Street Journal, the drugmakers have developed two studies to show that Xarelto is effective in treating patients with Acute Coronary Syndrome (ACS). This is significant because the U.S. Food and Drug Administration (FDA) has rejected previous efforts to seek approval to market Xarelto to ACS patients.

The reason for the rejections was that the FDA was concerned flawed study data did not establish that the benefit of Xarelto for ACS patients outweighed the known risk of serious and potentially fatal side effects.

The drug companies have also included two other blood disorders in the study, including strokes caused by clots of unknown origins and peripheral artery disease.The danger related to Xerelto is that it has been shown to cause an increased risk of internal bleeding, including intracranial bleeding.

In any dangerous drugs lawsuit, there can be a variety of claims presented under a theory of negligence. As with any negligence action, the plaintiff must prove by a preponderance of the evidence that the defendant owed a duty of care to protect foreseeable persons from foreseeable harm. There is generally no question that a drug company owes a duty of care to protect users of their pharmaceuticals from foreseeable injury.
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September 16, 2014

Boston Scientific Ordered to Pay $73 Million to Transvaginal Mesh Plaintiffs

by Jeffrey S. Glassman

According to a recent Bloomberg article, Boston Scientific was found liable and ordered pay $73 million in connection with its Transvaginal Mesh (TVM) medical device.

As our experienced vaginal mesh attorneys in Massachusetts can explain, the product involved in the lawsuit was the Obtryx sling. The Obtryx sling is a device designed to treat women who suffer from stress urinary incontinence and pelvic organ prolapse (POP). The device was fast tracked to the market based upon an FDA policy that allows a product to be sold without additional testing if it similar to a product on the market. Many other manufacturers of TVM products have taken advantage of this loophole in the approval process.

In this case, plaintiffs alleged that, once implanted into the body, the TVM device broke down and cause painful organ damage. Lawyers for the plaintiffs told the jury that women who went to their doctors for minor bladder leaking issues ended up with a life-altering catastrophic result caused by the defective TVM product.
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September 15, 2014

Freeman v. Wyeth – Eighth Circuit Upholds Dismissal of Prempro Lawsuit

by Jeffrey S. Glassman

A plaintiff attorney’s failure to register for the multi-district litigation’s case management/electronic case file system resulted in the dismissal of the plaintiff’s case against the makers of menopause drug Prempro. The decision was recently upheld by the U.S. Court of Appeals for the Eighth Circuit in Freeman v. Wyeth, et al..

The disappointing conclusion is why our product liability attorneys in Massachusetts always stress these types of cases require a legal team with experience and proven success. We are experienced with multi-district litigation involving pharmaceutical firms, and remain committed to excellent representation of our clients’ interests from beginning to end.

In the Freeman case, the plaintiff filed her lawsuit in early 2009 against Wyeth Pharmaceuticals Inc. She alleged she developed breast cancer after using a drug called Prempro, which is used to treat certain symptoms of menopause.
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September 11, 2014

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

by Jeffrey S. Glassman

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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