Orthopaedic Alerts - Implant Recall

As we say goodbye to 2013, many people make New Year’s resolutions and wish lists for the coming year – especially when it comes to health. Maybe some would like to be healthier, lose weight or change their diets. Others might want to be less dependent on prescription medications by changing their lifestyles.

At Drugwatch, we also have a New Year’s wish list.

1. Settlements for Those Injured by Hip Implants, Transvaginal Mesh

Thousands of people were injured by faulty hip implants and transvaginal mesh implants, making them two of the largest injury torts in history. These plaintiffs suffered serious injuries, and deserve closure and ease emotional and financial suffering through final settlement of these cases.

People who filed lawsuits against metal-on-metal hip implant manufacturers suffered crippling injuries, including severe pain, bone and tissue death, dislocation and fractures.

By the end of 2013, Johnson & Johnson offered to pay $2.5 billion to settle 8,000 of its DePuy ASR lawsuits, but the pharmaceutical giant still faces thousands more.

Other products involved in multidistrict litigation include Stryker’s Rejuvenate and ABG II neck and stem and Biomet’s M2a-Magnum. Stryker began settling its cases at the end of the year, but many more are pending. In addition, other manufacturers also are being sued by injured patients.

More than 36,000 transvaginal mesh lawsuits have been filed by women suffering injuries such as organ perforation, infections, inability to have sexual intercourse, autoimmune disorders and other life-changing complications. Many of these women required multiple surgeries and were permanently damaged.

Companies have already paid millions to settle some cases, but thousands remain.

2. Settlements for Women Injured by Birth Control Drugs, Devices

Many women are on some form of hormonal birth control, including intrauterine devices (IUDs) like Mirena, Yaz pills or the NuvaRing vaginal ring. Unfortunately, a number of healthy young women using these products suffered serious injuries, including death.

The Mirena is a device that is inserted into the uterus and can release hormones to control pregnancy for up to five years. While convenient and effective, the device may also migrate in the body, puncturing other organs and perforating the uterus leading to lawsuits against Bayer. These cases are still pending.

While Yaz is a pill and NuvaRing is a vaginal ring, they both include third-generation progestins and estrogen. Third-generation progestins are linked to a higher risk of blood clots than older hormones used in pills. More than 10,000 lawsuits are pending in federal courts against Bayer filed by women who suffered blood clots, some fatal.

Cases are also building against Merck & Co. for NuvaRing and about 1,500 complaints have been filed in federal court with a couple thousand more in state courts.

The women injured and families of those who died as a result of these products deserve justice.

3. Safer Type 2 Diabetes Drugs

The number of Americans with Type 2 diabetes is climbing, increasing the need and the market for drugs that can control blood sugar. However, these newer medications are not always safe.

A new class of drugs called incretin therapies have been linked to thyroid cancer, pancreatitis and pancreatic cancer. Some examples of drugs in this class are: Januvia, Byetta, and Victoza.

With so many people who need these drugs to stay healthy, it would be great if these drugs didn’t come with so many dangerous side effects that drive people to file lawsuits.

4. Better Testing, Warranties on Devices

Most people assume all drugs and medical devices on the market are tested for efficacy and safety. Unfortunately, the reality is that not all of them are.

For instance, the majority of medical devices implanted in the body, like hip and knee implants, are allowed on the market under the U.S. Food and Drug Administration’s 510(k) pre-market approval process. Under the 510(K), device manufacturers pay a small fee and only have to show the device is “substantially” equivalent to another device already on the market.

This means people who receive the implants receive untested devices in their bodies. Such important medical equipment should be rigorously tested prior to being surgically implanted.

Consumer Reports’ Safe Patient Project is also campaigning to get medical device companies to warranty their products. Many claim their devices last for several years, but they have no real evidence to justify these claims. A warranty would protect consumers when these devices fail or are defective.

5. More Transparency on Drug Side Effects

In the case of many drugs, information on side effects is not complete or studies may only be available to industry experts and researchers. Some companies may downplay the more dangerous side effects out of concern that it may lower their profits.

For instance, Merck & Co. negotiated using language that downplayed the risk of blood clots that could be fatal on a recent Huffington Post article on the NuvaRing.

Earlier this year, drug companies promised to make more data on their drugs available to researchers, but so far, consumers haven’t seen how this can make them safer.