Product Liability

November 21, 2011

Yaz, Yasmin & Ocella: Benefits Over Touted?

According to company e-mails, Bayer AG, Germany’s largest drugmaker, may have tried to market the Yasmin family of birth- control pills for unapproved uses and misled women about the health risks of the drugs.

Bayer unit officials discussed promoting the contraceptive known as Yaz, a spinoff of Yasmin, for treatment of all types of premenstrual syndrome, according to Bloomberg news. The FDA approved Yaz only for the most severe form of Pre Menstrual Syndrome (PMS), known as Premenstrual Dysphoric Disorder (PMDD).

Bayer faces more than 10,000 lawsuits over injuries allegedly caused by the contraceptives. The FDA reports of at least 50 deaths tied to the pills from 2004 to 2008. Bayer’s contraceptives, which contain the hormone drospirenone, have been the focus of regulators who question their safety.

November 19, 2011

Could Actos suffer the fate of Avandia?

by Dr. Shezad Malik

Effective today, the diabetes drug Avandia will only be available through certified mail-order pharmacies. These new restrictions are designed to limit the number of people exposed to potential heart side effects of Avandia.

The FDA allowed Avandia to remain on the market last year, subject to a new risk evaluation and mitigation strategy (REMS). This special program limits sales of the medication to mail order and requires educational programs before it can be prescribed.

Today, is the last day Avandia will be available on retail pharmacy shelves. To continue receiving the medication after this week, healthcare providers and patients must enroll in the Avandia-Rosiglitazone Medicines Access Program.

November 17, 2011

DePuy Litigation Gaining Momentum Over Recalled ASR Hips

by Dr. Shezad Malik

Not a day goes by, before more bad news regarding the DePuy ASR and Pinnacle Hip Replacement and Recall issue percolates to the surface. As folks who have been following this story, the DePuy saga continues unabated. This week, our firm filed 3 DePuy ASR lawsuits, in the federal court MDL in Ohio. This is the federal court where the federal filed cases have been consolidated, for pretrial workup. And we are evaluating many more cases of DePuy ASR failures and metallosis.

On a more interesting note, this month Johnson & Johnson’s Third Quarter Earnings Report was published. The quarterly earnings report outlines the various legal proceedings the Company is currently defending.

The report states that “[m]ultiple products of the Company’s subsidiaries are subject to product liability claims and lawsuits in which claimants seek substantial compensatory and, where available, punitive damages.” This material appears on page 18 of the 10K Report.

November 15, 2011

DePuy ASR Metal Hips: Tip of the Iceberg?

by Dr. Shezad Malik

Our DePuy ASR Recall and Metallosis team, has been aggressively notifying the general public about the problems and risks associated with the Metal on Metal hips. As explained in the 30 plus articles that I have written, this is a huge problem and that we may be experiencing the tip of the litigation iceberg.

We can report with confidence that the federal ASR hip replacement lawsuits are increasing on a daily basis, as the knowledge of premature failure and the risks of metallosis, are being brought to the attention of the folks who underwent hip relacement with this type of hip model.

We get electronic notification each time a new DePuy ASR lawsuit is filed in the federal court overseeing this litigation. And our email box has been filling up with these notifications. There is an average of 20 new cases filed daily in the federal multidistrict litigation, In re: DePuy Orthopaedics, Inc. ASR Hip Implant Products Liability Litigation (“MDL No. 2197”).

November 13, 2011

FDA & YAZ, Yasmin and Ocella Injuries

by Dr. Shezad Malik

Dr Shezad Malik Law Firm is writing this open letter to the FDA. We are requesting the U.S. Food & Drug Administration (FDA) to complete its ongoing safety review of Yaz, Yasmin and other birth control pills containing the synthetic progestin, drospirenone, as soon as possible.

Watch a tv video interview I did regarding one of my seriously injured Yaz client.

Recently, a FDA-funded study confirmed that women who use such birth control pills have an increased risk of blood clots (known as venous thrombosis) when compared to women using other hormonal contraceptives made with an older progestin called levonorgestrel.

November 11, 2011

Actos Dangerous Drug: Bladder Cancer

by Dr. Shezad Malik

I am writing this Actos update, regarding the Actos dangerous drug cancer side effects.

Actos (pioglitazone) is a medication manufactured and sold by Takeda Pharmaceuticals for treatment of Type 2 diabetes. The drug is part of the same class of medications as Avandia (rosiglitazone), which has been linked to an increased risk of heart attacks.

What is Actos?

November 9, 2011

Dangerous Risks of Yaz Birth Control Side Effects

by Dr. Shezad Malik

The steady drum beat of adverse medical reports and deadly side effects about the popular Yaz birth control pill and its variations continue to surface. Again another medical study has found that side effects of Yaz and Yasmin birth control increase the risk of a pulmonary embolism, deep vein thrombosis or stroke blood clot injury, when compared to older birth control pills.

Israeli researchers, in a report out this week, say they found that drospirenone-based birth control pills increased the risk of venous thromboembolism by as much as 65 percent. This is the latest new study published on-line this week by the Canadian Medical Association Journal. There has been a flood of new studies in recent weeks to confirm the risk of blood clots from Yaz birth control.

The study on more than 300,000 Israeli women, found that women taking Yaz and Yasmin, which contain the fourth-generation progestin drospirenone, were 65% more likely to suffer blood clots than women taking levonorgestrel and other so-called second generation oral contraceptives.

November 5, 2011

Medtronic Infuse Bone Graft Cancer Concerns

by Dr. Shezad Malik

According to the findings of a new medical study, presented at the North American Spine Society, Medtronic’s Infuse bone graft product maybe linked to an increased risk of cancer.

There is growing concerns over a potential risk of cancer from Medtronic Infuse, which contains rhBMP-2, a bioengineered bone growth protein. Research indicates that a higher-dose formulation of Infuse, known as Amplify, has been linked to a significantly higher number of cancers than were found among those who received a traditional bone graft.

The data had been given to the Food and Drug Administration by Medtronic when it sought approval to market a high-strength version of an existing bone growth product Infuse. Based on those study findings, the F.D.A. rejected that higher-dose formulation, known as Amplify, citing concern about cancer risks.

November 3, 2011

NuvaRing Risks Raises Venous Thromboembolic Events 56%

by Dr. Shezad Malik

Medical data from a new FDA funded study indicates that the NuvaRing birth control may cause women to face a 56% higher risk of blood clots than those who take older birth control pills.

NuvaRing is a female birth control device consisting of a medicated flexible ring. NuvaRing releases a combination of etonogestrel and ethinyl estradiol through a ring that is inserted into the vagina once a month. The drugs are a combination of ethinyl estradiol and etonogestrel, which is known as a “third generation” progestin.

NuvaRing is a form of birth control that releases a combination of etonogestrel and ethinyl estradiol through a ring that is inserted into the vagina once a month.

November 1, 2011

Metal-on-Metal Hip Implants Risks Outweigh Benefits

by Dr. Shezad Malik

A group of medical researchers and scientists have determined that the potential risks from metal-on-metal hip implants may outweigh any health benefits provided by these devices.

This is because of higher revision rates are linked to the newer hip replacement designs and the mounting and growing concerns about metal ion blood poisoning, known as metallosis.

The California Technology Assessment Forum (CTAF) has released an assessment of the benefits and effectiveness of using metal on metal hip replacements as an alternative to total hip arthroplasty, and they concluded that the relatively new metal hip implants may not be worth the risk.