News Category Archives — Drug Law Center Published by Chicago, Illinois Drug Law Center

Published on: February 20, 2017

Concern Over Metalosis From Metal Hip Implants Well Justified

Metal on metal hip implant devices have placed an untold number of people at risk, as the grinding of material during movement can lead to the contamination of blood with toxic levels of heavy metals. The buildup of metal in the blood is called metalosis— or metal poisoning— and can have life altering or ending consequences that include severe physical pain, disability, damage to the nervo X-ray hip joint implant us system and death. These risks were never disclosed to patients, and thousands of claims have been filed against the leading manufacturers of metal on metal hip replacement products due to instances of metalosis linked to hip prosthetics.

The Types of Metal Used in Metal on Metal Hip Replacement Systems are Extremely Dangerous

When pieces of metal grind against one another, very small shavings can be produced that may harm surrounding tissue or make their way into the blood. Our blood already has different metallic compounds within it, but certain metals are toxic to our cells. Those metals, which are found in metal on metal devices include cobalt, chromium, titanium, nickel and molybdenum.

Published on: February 20, 2017

Sharp Increases in Number of Drugs Recalled from Market Under FDA Orders

by Drug Law Center

Data released for 2014 revealed a disturbing trend over recent years in the recall of medications and medical devices. The 1,225 recalls issued in 2013 set a record and 2014 was already positioned to break it before the month of August. With so many recalls being initiated, we have to ask why the medicines and treatments are being allowed to make it to market so quickly without solid evidence of efficacy and safety. Production procedures have also come under the microscope, with many recalls initiated due to unsafe manufacturing practices and contamination of products.

Ten Year Trend is Cause for Outrage and Dismay

Recall In 2004, there were 166 drug recalls issued by the FDA. In only the first seven months of 2014, we witnessed 836 recalls. This is staggering and worth a long discussion on the causes of these recalls and why they are becoming so frequent. The public has the right to demand that medications be deemed safe using substantive research and trials in order to ensure their safety and to provide the information we all need to make informed choices about our health.

Published on: February 20, 2017

FDA Drug Approval Process Attempts to Balance Public Safety With Innovative Treatments

by Drug Law Center

There has been much debate over whether the FDA drug approval process is adequate and whether the surge in drug recalls over the last several years is due to a lack of oversight. Arguments on both side of the issue debate whether the process properly protects the rights of consumers or whether it stifles the ability of drug makers to continue developing more effective treatments and a Innovative technologies in medicine lternatives for those who may not respond well to the medications currently on the market. Let’s take a look at the FDA’s approval process for new medications.

Development of a New Medication is a Long and Expensive Process

It can take over a decade and upwards of $350 million for a new medication to make it through the approval process and the FDA attempts to balance innovation with the need to protect patients. Well before a medication is even submitted for approval, a pharmaceutical company will have performed its own internal research to determine whether it is worth moving it into the approval stage. Even though we have seen a rise in the number of drugs making it to market each year, it is worth noting that only one in every one thousand potential medications that make it into a lab are pursued as viable medications.

Published on: February 20, 2017

A Closer Look at Essure Birth Control Complications

by Drug Law Center

The Essure Birth Control System was market as and became a popular permanent birth control option for women who were looking for an alternative to more invasive procedures like tubal litigation. Many of the women who received the system were never warned of very serious risks and complications that could arise and are now filing lawsuits against Bayer on the grounds that the company failed to warn of those risks. A growing number of women have been petitioning the FDA to take more serious action to remove the device from the market and have failed thus far to receive the justice they’ve sought. Birth Control Highlighted In Dictionary

A Close Look at the Complications

Essure is a system that can be installed quickly and without much pain and works by placing coils into the fallopian tube which will eventually cause scar tissue to develop and prevent eggs from reaching the uterus. Where tubal litigation is reversible, the Essure system causes damage to the fallopian tubes that may be far more difficult to reverse, making it nearly impossible for women who later change their minds to have children. The other complications that can result from the procedure include the following.

Published on: February 20, 2017

Making Things Safer: FDA’s Handling of Morcellator’s Demonstrates Role in Improving Public Safety

by Drug Law Center

The use of power morcellators in minimally invasive surgical procedures was extremely popular until the FDA issued a warning due to compelling evidence that they can spread cancer during the removal of fibroids and hysterectomies. One of the benefits of increasingly popular minimally invasive procedures is that patients undergo shorter recovery times, but they are often misled in regards to the level of risk involved. While such surgeries are marketed as low risk, they can actually carry the same risks as traditional procedures, if not more serious ones. Oversight by the FDA is instr Hair Removal Laser Safe wordcloud umental in protecting the public when device manufacturers fail to properly disclose these risks.

Hidden Cancer Risk Compounded Through Morcellator Use

The FDA issued a warning in 2014 that power morcellators could disseminate cancer cells during abdominal and uterine procedures and that this risk was compounded by the fact that a significant portion of the population have undetected cancer. Early detection of cervical and uterine cancer is instrumental in providing a positive prognosis, which is why the spread of cancer cells throughout the pelvic organs is so perilous.

Published on: February 20, 2017

Should IVC Filters Be Removed From Your Body

by Drug Law Center

The very first IVC filters to hit the market were designed to be permanent, but the numerous risks and complications since discovered have prompted the design and approval of similar devices that are meant only to be used until patients are no longer at risk of a pulmonary embolism or stroke. Mounting legal pressure in both the United States and Canada have prompted severe legal action and three manufacturers may soon be forced to pull their defective IVC filters from the market. Two class action lawsuits were filed in Canada when plaintiffs claimed that they were never warned of risks associated with the devices and doctors were unable to remove them.

Pulmonary Embolism a Growing Concern in the United States

Studies have shown that as many as 600,000 people in the United States suffer from blood clots and these clots can travel from the legs to the lungs, heart or brain. A pulmonary embolism occurs when a clot moves to the lungs and contributes to the deaths of 180,000 people in the nation every year. The IVC filter received market approval in 1979 and the permanent filters were in use for over 35 years. It was in 2012 that removable filters were introduced to the market and these produc Infusion bottle IV solution ts are the cause of the current slew of lawsuits being levied against C.R Bard, Cook Medical and Cordis.

Published on: February 20, 2017

How and Why Some Drug Get Categorized as Multi-District Litigation Lawsuits

by Drug Law Center

It is common whenever large pharmaceutical companies are sued by a large number of plai Law Book Gavel ntiffs for the cases to go through what is called Multidistrict Litigation, or an MDL. This process is meant to help with the efficient resolution of such a large number of lawsuits by establishing what evidence and facts can be considered universally relevant. Understanding how this process works will help you determine how your own case may be impacted by the results of the proceedings. There are many misconceptions on how an MDL works and the following will set things straight.

Multidistrict Litigation Does Not Offer Resolution

It is common for many people to mistake MDLs with bellwether trials, which can set precedent for future cases. An MDL is merely meant to determine which pieces of evidence and testimony can be admitted as fact before the cases are al sent back to the courts from where they originated. By having a single judge preside over an MDL, a lot of time is saved in the subsequent trials because testimonies and evidence will not need to be presented to the jury. MDLs also save the courts, plaintiffs and defendants a lot of money in legal fees and court costs.

Published on: February 20, 2017

Most Common Complications Women Experience With Vaginal Mesh

by Drug Law Center

The use of transvaginal mesh quickly became popular as a very simple and uncomplicated alternative in the treatment of conditions such as pelvic organ prolapse and stress urinary incontinence. There are now thousands of lawsuits mounting against the largest manufacturers of these devices, however, due to the concealment of very serious risks and complications to the public. Women who have been injured by these devices have often undergone intense physical pain and devastating emotional trauma after being unable to enjoy normal sexual function or the same quality of living Woman sitting under plaid they were accustomed to.

What are the Most Common Complications Linked to Transvaginal Mesh?

Transvaginal mesh is a product that is used as a sling in order to hold the pelvic organs in place so that women suffering from incontinence and other complications could find relief from their symptoms. While marketed as a safe, effective and easy form of treatment, the FDA ultimately determined that the occurrence of complications was commonplace. By July of 2011, the FDA had received over 4,000 complaints and the total number of lawsuits filed against mesh manufacturers exceeded 70,000 by early 2015.

Published on: February 20, 2017

Study Reveals Concerns About FDA’s Liberal Approval Process

by Drug Law Center

The inability of the FDA to properly screen medications and devices before they make it to the FDA APPROVED market is one of the major contributing factors to the serious problems we are hearing about, according to a study performed by the publication, Obstetrics and Gynecology. Numerous doctors have mounting concerns over just how easy it is for medical devices to make it onto the market through a loophole that allows any device that has similarities with an existing one to pass over the clinical trial, research and approval process that would otherwise be required.

501(k) Process is Irresponsible and a Danger to the Public

Devices such as power morcellators, transvaginal mesh and artificial hip implants have recently been the source of angst and suffering as patients who received defective implants or underwent surgical procedures requiring the use of defective devices suffered extensive physical and psychological harm. The reason this medical equipment has made it to market so quickly is because FDA oversight lacks teeth and the 501(k) process allows the acceptance of new products without any reasonable level of clinical research that would prove the device is safe and effective.

Published on: February 20, 2017

Punitive Damage Award Seen as Excessive in DePuy Pinnacle Hip Lawsuit

by Drug Law Center

Johnson & Johnson scored a victory in the ongoing legal saga the company has been mired in over its defective DePuy Pinnacle hip replacement products, which have injured thousands of patients Fracture shaft femur due to concerns over metal poisoning, early device failure and other defects that have required revisionary surgery to address. After enduring judgements of over $1 billion, a judge recently reduced the rewards to roughly half of what juries had awarded, citing limits to punitive damages. While the recent amendment represents $500 million in relief for Johnson & Johnson, the company is still facing over 9,000 lawsuits from plaintiffs claiming damages.

Damage Caps Have Resulted in Similar Reversals Following Past Judgements

It is not without precedent for judges to reduce the amount of punitive damages awarded when feeling that the jury was excessive in punishing the liable party. The United States Supreme Court has ruled in the past that the amount of punitive damages awarded should reflect the actual damages, or compensatory compensation. Roughly ten times these damages has been established as the limit, meaning that if a plaintiff is awarded $100,000 in compensatory damages, any punitive damages in excess of $1 million would be seen as excessive.