Articles Posted in Pharmaceutical Litigation

On June 16, the Philadelphia Trial Lawyers Association (PTLA) elected Lawrence Cohan of Anapol Weiss as the new President of the organization.

For more than 50 years, PTLA has sought to protect the rights of all individuals, and it has become a growing force in the community. The organization is made up of more than 1,000 trial lawyers who aim to preserve the legal system and create new laws to protect the rights of the community.

“Because of the Trial Lawyers, the workplace in Pennsylvania is safer,” Cohan said. “Products are safer because manufacturers know we hold them responsible, and perhaps we have also helped make it safer to be a patient in a hospital in Pennsylvania.”

This past spring, the vaginal contraceptive ring NuvaRing followed in the footsteps of Yaz, Depo-Provera and Ortho Evra to become the next big thing in birth control lawsuits. Less than six months later, NuvaRing is losing the spotlight to the popular intrauterine device (IUD) Mirena.

At least 16 lawsuits were filed in the Superior Court of New Jersey by women suffering from perforation and similar Mirena injuries. The alleged Mirena injuries listed in the complaint are different than the side effects of NuvaRing or Yaz. The side effects of Mirena surrounding the litigation involve spontaneous migration of the IUD.

Mirena is a small T-shaped plastic device that measures 32 mm by 32 mm. A reservoir containing synthetic hormone levonorgestrel (LNG) surrounds the vertical stem of the device. The LNG is released at a rate of 20 micrograms per day and declines to a rate of 14 micrograms after 5 years, which is still within the range of clinical effectiveness. The LNG is released directly into the uterus. Most of the hormone stays inside the uterus. Only a small amount gets absorbed into the rest of the body.

Attached to a loop at the end of the device is a monofilament brown polyethylene removal thread. The thread allows physicians and patients to check and make sure the IUD is still in place. This thread also allows easy removal of the IUD.

Mirena was approved by the Food and Drug Administration (FDA) in 2000 for contraceptive use. It was later approved for the treatment of heavy menstrual bleeding in 2009. Mirena was permitted to remain in the body for up to five years.
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What happens when a drug that you have been prescribed by your doctor has been recalled and nobody bothered to tell you?

You’re not alone. It’s a frequent occurrence, one that has a potential quality-of-life altering impact.

Every year dozens of pharmaceutical drugs are recalled because of numerous reasons but adverse side effects and contamination seem to be the most prevalent reasons.

Who’s minding the store? Why aren’t pharmacists and doctors paying attention? It’s quite possible they are not being alerted as the two notification systems – the FDA and MedWatch have a 20 to 40 percent failure rate.

According to a new study published in the Archives of Internal Medicine, the FDA fails to effectively report as many as 40 percent or more of all Class I drug recalls. And is it only the FDA’s responsibility or are the drug manufacturers at fault too?
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If you are pregnant or of childbearing age and plan to get pregnant, talk to your doctors about any over-the-counter, herbal, dietary supplements, and prescription drugs that you are now taking or recommended to take in the future.

Many prescription drugs cause serious birth defects.

Clinical drugs trials on pregnant women are unethical and not practiced. The safety of most medications taken by pregnant women is unknown and dependent on many factors.

However, it’s important to note that if you are now pregnant, you should not stop taking any type of medication without first talking with a doctor. Sometimes women don’t even realize they are pregnant while taking a potentially harmful drug.

What medications can cause birth defects?
Harmful drugs are thalidomide (also known as Thalamid®) and isotretinoin (also known as Accutane®). Such medications should be avoided by all women who are or might become pregnant. While some medications are known to be harmful when taken during pregnancy, the safety of most medications taken by pregnant women has been difficult to determine. Women who are pregnant or trying to get pregnant should not discount dietary and herbal products as they could be harmful to your unborn baby or have other serious side effects when taken during pregnancy.
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Stanford University researchers recently reported a new drug interaction between paroxetine (Paxil, GlaxoSmithKline) and pravastatin (Pravachol, Bristol-Myers Squibb), which may lead to diabetes in prone individuals, or worsen present diabetes cases.

As reported by Drug Topics, citing May data published online by Clinical Pharmacology & Therapeutics, combining the two allegedly elevates average blood glucose levels by 19 mg/dL overall and by 48 mg/dL in patients with diabetes. Because random blood glucose levels usually fall in the low to mid-100s, the interaction may present a distinct risk to individuals suffering from preliminary or full diabetes.

Lead author for the report Nick Tatonetti told Drug Topics that this instance seems to mark the first occasion that data-mining techniques, usually used to monitor and forecast consumer habits, have been used to pinpoint drug interactions. Researchers searched FDA’s Adverse Event Reporting System (AERS) for claims of ill effects involving glucose homeostasis and made a profile for diabetes-related incidents and followed a long trail of research that eventually led to the pairing of paroxetine and pravastatin.

Jim Ronca of Pennsylvania personal injury law firm Anapol Weiss recently won a $19.9 million settlement for patients affected by Bayer AG’s pharmaceutical drug, Trasylol. Mr. Ronca settled 20 cases in the national multi-district litigation and 19 cases in Pennsylvania.

The blood-preserving drug, which was approved for use during high risk heart bypass surgery and coronary bypass redo procedures, and later approved for all coronary bypass procedures, was alleged to cause kidney failure in some patients and increase the risk of death. Trasylol was available in the U.S. from 1993 until 2007 when the FDA requested that the drug be pulled off the market. In April 2008, the pharmaceutical giant recalled all stocks of Trasylol.

2006 saw the first Trasylol lawsuit filed by Anapol Weiss and the firm was one of the first to earn settlements in litigation. The firm believes that its case played a key role in settlement discussions for both its cases and 34 other cases pertaining to Trasylol.

Prescription drugs are supposed to be designed and manufactured to help people with medical conditions, not make those conditions worse or cause an individual to develop new ailments. While every pharmaceutical drug, both over the counter and prescription, runs the risk of side effects, some drugs carry much more serious side effects that outweigh their benefits.

One medication that has the potential to cause serious injury in some patients is Zocor, a popular prescription drug that is taken to lower cholesterol. Zocor is manufactured by Merck & Co. and is included in a family of pharmaceutical drugs called statins. These drugs are used to treat patients with high cholesterol as well as some people with cardiovascular disease. According to reports from the FDA, the serious risks associated with Zocor include:

  • kidney damage or failure

The Pennsylvania personal injury law firm of Anapol Weiss is pleased to announce the debut of its new Arava website: The new website provides valuable information and resources regarding the following:

  • Arava Side Effects
  • Liver Failure Risks

The Pennsylvania personal injury law firm of Anapol Weiss is proud to announce the debut of its new Mylan Generic Keppra website,

To help consumers and patients become more familiar with the potential risks of Keppra and Mylan generic Keppra, Anapol Weiss’s new website addresses epilepsy, types of seizures, seizure statistics, generic Keppra side effects, generic Keppra, Levetiracetam (LVT), Topamax, Anti Epilepsy Drugs (AEDs), as well as the differences between generic and name brand drugs. The website also serves as a helpful resource for patients who have experienced serious side effects after their pharmacy switched them from the brand name to a generic without the patient’s or neurologist’s approval, or even notification.

As one of the leading manufacturers of generic drugs in the world, Mylan received final approval by the Food and Drug Administration (FDA) in 2009 to manufacture a generic substitute for the anti-seizure medication, Keppra, developed by UCB Pharmaceuticals Inc. and marketed to epilepsy patients. However, some generic Keppra users have experienced breakthrough seizures and also several other serious side effects despite being seizure free for years and not experiencing any side effects on brand name Keppra.

Three pharmaceutical companies have issued a voluntary nationwide drug recall of liquid preparations of Ondansetron, an anti-nausea medication. The recall covers batches of Ondansetron manufactured between August 2009 and May 2010. The only affected batches are those in flexible plastic containers designed to be administered by IV, which are typically sold to hospitals.

West-Ward Pharmaceuticals, Pfizer, and Sagent Pharmaceuticals all recalled batches of Ondansetron prepared by Claris LifeSciences, Inc. after it was discovered that the batches were not sterile because they had not been prepared properly. Although none of the three companies have received any complaints or reports of patients suffering adverse effects from the non-sterile preparations, all three issued a recall due to the danger a non-sterile medication poses, especially to patients with damaged immune systems.

Ondansetron is frequently given to cancer patients and patients recovering from surgery to help control nausea and vomiting. It is also known by its original brand name, Zofran.

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