As of today, there has not been a single gadolinium trial.  Nevertheless, millions of dollars hasas traded hands during scores of gadolinium settlements reached between plaintiffs and the four manufacturers of gadolinium-based contrast agents (GBCAs).

On January 23, 2011, the eve of what would have been the first  lawsuit to stand trial, GE Healthcare settled out of court with Loralei Knase, a 68-year-old Minnesota native who developed nesphrogenic systemic fibrosis (NSF) after being injected with Omniscan several times between 2003 and 2005. Today, she is wheelchair-bound and may one day die from her NSF injuries.

Gadolinium settlement amounts remain confidential

The details of her gadolinium settlement amount and those of dozens of other gadolinium settlements that are reported to have secretly occurred with Knase’s settlement remain undisclosed. In fact, none of the hundreds of gadolinium settlement amounts reached with drugmakers GE Healthcare, Bracco, Bayer or Mallinckrodt have been made public. Secrecy, for the defendants, is the purpose of the settlement. By settling, the companies preclude a tide of sensitive information – from trade secrets to grotesque NSF details to gadolinium settlement amounts – from reaching the public sphere.

Still, some experts have pegged gadolinium settlement amounts in the range of $50,000 to $200,000. Some gadolinium settlement amounts are much more. In the GE cases alone, which numbered just less than 400 before the Knase et al. settlement, lawyers said they expected a total windfall in excess of $1 billion. Lawyers for GE Healthcare said that estimate was unreasonable.

Gadolinium settlements offered by several defendants

It’s unclear exactly how many gadolinium lawsuits still stand in US courts. Many plaintiffs remain hidden in claims structured so that they can back out if unsatisfied with a gadolinium settlement amount. At least 150 plaintiffs didn’t settle when German pharmaceutical giant Bayer reached settlements with 140 of nearly 300 Magnevist plaintiffs in 2009. At least that many plaintiffs remain involved in suits against GE Health, whose Omniscan has a GBCA market share of only 30 percent, but accounts for nearly 75 percent of all NSF litigation.

The future of gadolinium lawsuits remains up in the air. Knase’s gadolinium lawsuit was scheduled to be one of three bellwether gadolinium trials, meant to give lawyers on both sides an idea of how litigation might play out in hundreds of other gadolinium lawsuits filed in courts. The other two bellwether trails were also settled out of court. If the pattern holds, those with outstanding gadolinium lawsuits may soon reach settlements for themselves.

If you’re thinking about filing a gadolinium claim, it is important you become familiar with the history of gadolinium–based contrast agent (GBCA) litigation.

Nephrogenic Systemic Fibrosis (NSF) prompts Gadolinium black box warning

GBCAs have been prescribed to patients undergoing magnetic resonance imaging (MRI) since 1988. It wasn’t until more than a decade later that physicians first described Nephrogenic Systemic Fibrosis (NSF), a debilitating, sometimes deadly, gadolinium side effect that develops in people with reduced kidney function. It took 7 more years before the FDA required GBCAs to contain a “black box” warning for NSF.

Gadolinium warning too slow in coming

That warning came too late for many. Hundreds, if not thousands, of people have developed NSF since undergoing what they thought were harmless MRIs. Many have died. Hundreds of those living with the painful and progressive condition today have hired a gadolinium lawyer and filed gadolinium litigation. Many have already reached gadolinium settlements.

Bayer settles Gadolinium litigation

In 2009, Bayer settled out of court with 140 people who had filed litigation after developing NSF from Magnevist, one of five GBCAs on the market. The details of the deal were never disclosed. More than 150 Magnevist lawsuits remain unsettled today.

GE Healthcare settles Gadolinium litigation

Just a week ago, GE Healthcare settled with one of several plaintiffs who had sued over the company’s GBCA Omniscan. The settlement occurred on Sunday, January 23, 2011, a day before the case was scheduled to go to trial in the US District Court for the Northern District of Ohio. The plaintiff, Loralei Knase of Minnesota, had received Omniscan several times between 2003 and 2005. Knase alleged that she and her doctors were never made aware of her increased risk of NSF, an incurable disorder that has caused her to be disabled. She is afraid NSF will one day take her life.

A gadolinium lawyer connected to the Knase case tells ProPublica that GE also settled out of court with several other gadolinium lawsuit plaintiffs. Again, the details of the deal are secret. Secrecy, after all, is what GE is aiming for. By settling with plaintiffs out of court, GE can keep under wraps any evidence that the company knew its gadolinium product posed a danger to the public. The settlements do not equate to an admission of guilt.

When did manufacturers know of Gadolinium NSF risk

But there is evidence GE and other GBCA manufacturers are guilty. In 2006, a Danish radiologist published a report suggesting GE knew of gadolinium’s NSF risk long before it issued a “black box” warning. GE sued him for libel in response. Last February, the company and scientist reached an out of court settlement, preventing details of the case from coming to light.

Today, each of four GBCA producers has settled out of court with some of those who have filed a lawsuit. If you think you have a case, hire a gadolinium lawyer today and fight for the compensation you deserve.

When the Judicial Panel on Multidistrict Litigation approved consolidation in 2008 of hundreds of gadolinium lawsuits filed in federal courts, Ohio Judge Dan Polster became the most important man in gadolinium litigation.

At the time, nearly 300 lawsuits were funneled into his court, the US District Court for the Northern District of Ohio, where they would undergo consolidated pretrial litigation before being sent back to the districts where the gadolinium lawsuits were initially filed.

The number of gadolinium side effects lawsuits filed against the likes of drug giants GE Healthcare, Bayer and Mallinckrodt soon swelled to more than 500, and very soon, the defendants began negotiating settlements with Gadolinium lawyers.

Bayer reached Gadolinium settlements with over 140 plaintiffs

Gadolinium Judge Dan Polster, while fair, hasn’t been very easy on defendants during the MDL proceedings. Perhaps as a result of his actions, defendants in gadolinium lawsuits have consistently sought to settle with plaintiffs.

In March 2010, Bayer announced in its 2009 annual report that it reached settlements with approximately 140 plaintiffs who had filed gadolinium lawsuits involving its gadolinium-based contrast agent (GBA) Magnevist.

In May 2010, Judge Polster issued what may turn out to be his most important decree yet. In a 58-page opinion, he ruled that a crucial but speculative scientific theory could be presented by experts called to the stand by plaintiff attorneys – testimony that the defendant, GE Healthcare, maker of the GBCA Omniscan fought hard to rule inadmissible.

According to the decree, experts would be allowed to present the theory that Omniscan can break down in the body, releasing gadolinium into the bloodstream and tissue where it can cause nephrogenic systemic fibrosis (NSF), the rare but severe side effect at the center of all consolidated gadolinium lawsuits.

Soon after Judge Polster made the ruling, GE Healthcare began negotiating settlements with plaintiffs. By 2011, GE Healthcare had settled scores of gadolinium lawsuits. On January 23, 2011, the day before the first gadolinium lawsuits was set to go to trial, GE Healthcare reached a settlement with plaintiff Loralei Knase, who developed NSF after being injected with Omniscan several times prior to MRIs between 2003 and 2005. According to reports, GE Healthcare reached a Gadolinium settlement with a number of other plaintiffs at that time, as well. Terms of the deal remain undisclosed.

So far, not a single gadolinium lawsuit has gone to trial. That might not be the case if gadolinium judge Dan Polster wasn’t presiding.

In 2008, hundreds of gadolinium lawsuits were funneled into a single Ohio court, where they were scheduled to undergo pretrial proceedings such as evidence discovery and witness testimony before the lawsuits were sent back for trial to the districts where they were originally filed.

Some of the lawsuits involved claims of gadolinium death. In rare cases the drug could cause fatal nephrogenic systemic fibrosis (NSF).

Gadolinium lawsuits settle before trial

Three years later, not one of the consolidated gadolinium lawsuits has reached trial. It is possible that no gadolinium lawsuit will ever reach trial.

Gadolinium makers such as GE Healthcare and Bayer have repeatedly settled with plaintiffs who developed debilitating side effects such as NSF from gadolinium use.

Several intravenous gadolinium compounds have been used on millions of Americans to enhance the results of MRIs. All have been implicated in NSF, which thickens skin and internal tissue, reducing mobility and making it difficult to breathe. NSF sometimes results in gadolinium death.

In January, GE Healthcare reached a settlement with Loralei Knase, who developed NSF after receiving several gadolinium injections prior to MRIs between March 2003 and October 2005. The details of the settlement remain undisclosed.

Knase et al v. General Electric Company et al would have been the first of 3 gadolinium bellwether cases to reach trial. The prior 2 were also settled for undisclosed sums.

Gadolinium lawsuits in Ohio with an uncertain future

It’s unclear what is next for hundreds of gadolinium lawsuits that may remain unsettled at the Ohio court. Judge Dan Aaron Polster, who is overseeing the consolidated litigation, known as MDL 1909, would hope that remaining legitimate claims also reach settlement.

A judge often prefers swift conflict resolution undertaken by opposing sides to drawn out litigation mediated by the court.

The history of the litigation shows gadolinium manufacturers also prefer settlement. While costly, settlement is often less expensive than damages ordered by jury. More so, settlements are secret, preventing the release of embarrassing, sometimes damning evidence that could surface during a public trial.

Still, this might not be the last the public hears about gadolinium lawsuits and gadolinium death. On March 15, the FDA approved Gadavist (gadobutrol) the sixth gadolinium-based contrast agent to be made available in the United States. According to the FDA, Gadavist puts users at a lower risk of NSF than other gadolinium products. Gadavist could hit the US market within months.

As millions of dollars in gadolinium settlements exchanges hands, the fate of hundreds of other gadolinium lawsuits remain unknown.

When Loralei Knase of Minnesota settled in January with GE Healthcare, maker of the gadolinium-based contrast agent (GBCA) Omniscan, more than 300 Omniscan lawsuits had been filed in US courts.

Gadolinium settlements reached before trial

According to some reports, GE Healthcare reached a gadolinium lawsuit settlement with many, but not all plaintiffs involved in Omniscan gadolinium litigation. The details of the settlements with Knase and others, who developed the gadolinium side effect nephrogenic systemic fibrosis (NSF), remain undisclosed.

Confidentiality is one of the main reasons GE Healthcare and other GBCA manufacturers like Bayer Healthcare and Mallinckrodt, Inc have sought to reach settlements with those who have filed gadolinium lawsuits.

With a settlement, a defendant can keep secret sensitive information such as trade secrets and disturbing side effect details that would otherwise be disclosed during trial. Settlement agreements regularly include language that bars plaintiffs from speaking about the settlement in public.

Such may be the case in the settlement with Knase, who was previously open about her struggle with NSF, which has affected her entire body and severely impaired her mobility. Legal experts estimate her settlement could be worth more than $200,000 and possibly much more.

Gadolinium trials awaited in court for some

Previously, Bayer reached settlements with more than 100 plaintiffs who developed NSF after using the GBCA Magnevist. Not all Magnevist plaintiffs were offered or agreed to the settlements, and it is believed their claims still await trial in court.

Gadolinium lawsuits involving the GBCAs MultiHance, OptiMARK and Prohance also still await trial. Some of the lawsuits are consolidated in multidistrict litigation (MDL), a legal process similar to class action.

Loralei Knase’s gadolinium lawsuit would have been the first case to reach trial in the ongoing multidistrict litigation, which is centralized in Ohio. It was the third bellwether trial scheduled, and the third to be settled.

Throughout the United States legal system, not a single gadolinium lawsuit has yet gone to trial.

On February 27, 2008 the Judicial Panel on Multidistrict Litigation created MDL 1909 to consolidate pretrial proceedings and issued a transfer order for all gadolinium lawsuits based on gadolinium side effects currently in federal courts throughout the United States. The current gadolinium lawsuits and any new ones to be filed in, or remanded to, federal court are to be transferred to the Northern District of Ohio and managed by the Honorable Judge Dan A. Polster. At the time of the original order there were only 24 actions to be consolidated. According to the JPML’s website there are now 525 current cases that are part of this MDL with the historical total being 667 cases.

Gadolinium lawsuits target five brands

The defendants are a group of manufacturers that produce gadolinium-based contrast agents (GBCA) for use with MRI imagining scans. Gadolinium is a metal that is known to be highly toxic to human tissue but when it is bound to molecules through chelation it is more stable and less toxic. In healthy individuals it is excreted by the kidneys. It is used in MRI imaging because of its paramagnetic properties. In an MRI scan large magnetic fields are used to produce images and gadolinium only moves or becomes magnetic when an external field is applied. The gadolinium lawsuits claims are against five different GBCA brands, Ominscan manufactured by General Electric Healthcare, Magnevist by Bayer Healthcare Pharmaceuticals, Optimark by Mallinckrodt Inc., as well as Prohance and Multihance by Bracco Diagnostics.

Gadolinium Nephrogenic Systemic Fibrosis in patients with impaired kidney function

The majority of gadolinium lawsuits filed as part of this MDL are related to injuries sustained by individuals with impaired kidney function who received GBCAs and developed nephrogenic systemic fibrosis (NSF) as a result. This condition causes fibrosis, a thickening or scarring of the skin and connective tissue, everywhere in the body, including the joints which causes mobility issues, and vital organs which can lead to death. The patients who are at the greatest risk of developing this disorder are those with low glomerular filtration rates. The theory behind the cause, called the “free gadolinium theory”, is that because GBCA’s are not excreted by the kidneys quickly enough in patients with low glomerular filtration rates this allows de-chelation of the GBCA to occur, and the toxic gadolinium is released causing the systemic fibrosis.

Correlation between gadolinium use and NSF may have led to gadolinium settlements

During pretrial proceedings the court determined, because of the rapid emergence and then decline of NSF and its correlation with the increase and decrease of GBCA use in patients with renal impairment, along with the presence of GBCA in their tissues, the known toxicity of gadolinium, and the majority view in published and peer reviewed studies that de-chelated GBCA’s cause NSF, that the exact mechanism by which the GBCAs de-chelated was not needed in order to present the “free gadolinium theory” to a jury. This ruling which was in the plaintiffs favor allowed for proof of causation and maybe the reason for so many out of court gadolinium settlements.

Three of four gadolinium bellwether cases settled before trial

There were four bellwether cases selected for trial in this MDL and in all of them GE Healthcare was the defendant. In the first the plaintiff was Kimberly Bullock and the case was scheduled for trial on May 24, 2010 but was settled out of court on May 3, 2010 when the manufacturer reached an agreement with her gadolinium lawyer. In the second, the plaintiff was Doyle Kona, with the trial date scheduled for September 9, 2010, but there is no record of this trial taking place. In the third, the plaintiff was Loralei Knase, a Minnesota woman who received Omniscan and developed NSF, the trial was scheduled for January 24, 2011 but was settled secretly out of court early in January. The last bellwether trial is scheduled for October 31, 2011 and the plaintiff is Linda Marino according to case management order #24 filed on April 24, 2011. Even though these settlements have been kept under-wraps there have been reports that other gadolinium lawsuits are also being settled discretely out of court.

With a major Gadolinium lawsuit trial just a few months away and millions of dollars already awarded to plaintiffs, there exists that the question of whether a new Gadolinium settlement will be reached with plaintiffs whose cases remain unsettled.

Gadolinium settlement historically reached as trial date approaches

Defendants in federal Gadolinium litigation have consistently reached settlements as trial dates approach, paying out what has been presumed to be hundreds of millions of dollars to plaintiffs who develop Gadolinium side effects following use of a gadolinium-based contrast agent (GBCA) – an intravenous solution often administered in preparation for a magnetic resonance imaging (MRI) test.

Gadolinium settlement can avert trial and publicity

By reaching a gadolinium settlement, defendants such as Bayer (manufacturer of the GBCA Magnevist) and GE Healthcare (maker of Omniscan) can avert a trial, during which trade secrets or unwanted publicity may emerge.

The latest gadolinium settlement occurred in January, the night before a Minnesota woman’s bellwether case was set to begin trial in the Northern District of Ohio.

The gadolinium settlement, which was made between plaintiff Loralei Knase and GE Healthcare, is believed to have distributed millions of dollars to scores of plaintiffs who had filed a gadolinium lawsuit over Omniscan, one of about half a dozen GBCAs on the market.

Several Omniscan users were not involved in that gadolinium settlement, including a number of plaintiffs who have retained a gadolinium lawyer and joined the litigation since the settlement was announced.

Gadolinium settlement reached by Bayer with 100 plaintiffs

Previously, Bayer reached a gadolinium settlement with more than 100 plaintiffs who developed gadolinium side effects following use of the GBCA Magnevist. During that round of settlements, a number of Magnevist claims went unsettled.

Perhaps 500 gadolinium lawsuits remain unsettled

It is believed that more than 500 gadolinium lawsuits remain unsettled in consolidated federal gadolinium litigation, which is known collectively as MDL No. 1909.

Most gadolinium lawsuits involve side effect of Nephrogenic Systemic Fibrosis

Virtually every gadolinium lawsuit involves complaints about the side effect nephrogenic systemic fibrosis (NSF), which causes excess tissue to grow in the skin and joints, severely impairing mobility and sometimes causing death. NSF primarily affects people with renal insufficiency.

Fourth bellwether gadolinium trial scheduled for October

The next Gadolinium lawsuit – the fourth bellwether trial – is scheduled to commence in an Ohio court on October 31, 2011. None of the three previous bellwether trials went to trial, with defendants reaching last-minute settlements with all 3 named plaintiffs and hundreds of others. Another large gadolinium settlement may be placed on the table as the trial date arrives.

If history is any indication, the likelihood of a gadolinium settlement being reached will increase as the trial date approaches.

With the date of the fourth bellwether trial approaching, there is no word that the final bellwether Gadolinium lawsuit has been settled. The three previous times that Gadolinium lawsuits have approached trial, the defendants have settled, so those who suffered as a result of Gadolinium nephrogenic systemic fibrosis and other side effects will undoubtedly be watching with interest.

Fourth bellwether Gadolinium Lawsuit

The Marino trial, as the fourth Gadolinium lawsuit is known, is set to begin on October 31st, 2011. The defense was given thirty days to respond to the complaint made by a Gadolinium lawyer on April 28th, now well past. Once all pretrial matters are concluded, the trial itself has been allotted two weeks by the judge.

Gadolinium Side Effects

Gadolinium nephrogenic systemic fibrosis, or Gadolinium NSF, is a side effect that many people who have been administered the MRI enhancer or Gadolinium Based Contrasting Agent (GBCA) have reported. Gadolinium NSF occurs when those injected with the substance have experience trouble in their body breaking down and eliminating the Gadolinium. The metal then accumulates in the body causing Gadolinium NSF which initially causes symptoms such as pain, a burning sensation, dark patches and hardened skin, and stiffness in the joints. If Gadolinium NSF is left untreated, it can spread to internal organs and be potentially lethal, .

Gadolinium Lawsuit

The multidistrict litigation or MDL of the Gadolinium lawsuit has had four bellwether trials scheduled so far. In the first three cases, the defendants have elected to settle with the people participating in the lawsuit rather than going to trial. Settlements may well have paid out millions, without the expense of having to go to trial. But these previous settlements came just days before the trial date.

MDL allows the defendants to attach additional cases to already proceeding lawsuits that have similar facts in the case. That means that while many who suffered from Gadolinium side effects have received a settlement already, others who have suffered but did not know their options can still contact a Gadolinium lawyer to find out if they are eligible to pursue legal action.

Plaintiffs generally seek Gadolinium settlements on the grounds that they experienced a common Gadolinium effect such as nephrogenic systemic fibrosis (NSF). However, the plaintiff in a new Gadolinium lawsuit is seeking a settlement related to heart-based Gadolinium side effects.

Nov. 19, 2010, Charles A. Bernardo, Sr. filed a lawsuit in the U.S. District Court, Middle District of Florida alleging that Gadolinium manufacturer, Covidien, Inc., defectively manufactured and sold Gadolinium, causing the plaintiff to suffer from cardiac arrest, heart attack and other injuries.

Gadolinium lawsuits based on potentially deadly side effects

Gadolinium is used in contrasts given to patients before MRI screenings. Contrasts allow physicians to more clearly see imaged body parts. Gadolinium lawsuits have been on the rise since the Federal Drug Administration (FDA) issued a warning in 2006 about dangerous Gadolinium side effects. Plaintiffs in Gadolinium lawsuits generally claim Covidien failed to warn them of common Gadolinium side effects, which include NSF, allergic reactions and death. Heart-related lawsuits are very uncommon.

NSF is the most serious Gadolinium side effect. It generally impacts those that have kidney issues before Gadolinium exposure. Weak kidneys prevent patients from expunging Gadolinium from their systems. As a result, NSF sets in causing joint problems and hardening of the skin.

A new angle on Gadolinium lawsuits?

NSF has impacted millions of Gadolinium patients and is a primary reason for Gadolinium lawsuits however, Bernardo vs. Covidien, Inc. could have a major impact on Gadolinium settlements because the plaintiff’s allegations are fairly uncommon for Gadolinium lawsuits. If a settlement is reached in favor of Bernardo, others who experienced similar side effects could file suit.

Most Gadolinium lawsuits reflect a Gadolinium fda warning users about the risk of kidney disease patients developing NSF after Gadolinium exposure. The FDA has not focused its warnings on heart-related Gadolinium side effects.

The recently filed Bernardo vs. Covidien, Inc. case will be heard by Judge James D. Whittemore. The pretrial conference is set for Nov. 9, 2012. The jury trial is set for Dec. 4, 2012.

Gadolinium lawyers will be watching closely as the fourth and final Gadolinium bellwether trial is scheduled for next week. With a court date of October 31, no word has yet been heard on whether there will be a pre-trial settlement like there was in the three previous bellwether trials. According to the most recent Gadolinium lawsuit news, this bellwether trial is still slated for action, and it is anyone’s guess on the final outcome of this Gadolinium NSF trial.

Gadolinium Lawsuit News Mostly Revolves around Settlements to Date

There have been three previous Gadolinium bellwether trials to date; all of them overseen by Judge Dan Aaron Polster from the United States District Court, Northern District of Ohio. The first three trials all ended in last-minute settlements, sparing the manufacturers of Gadolinium-based contrasting agents like Bayer and GE Healthcare from the time, expense and potential embarrassment of a publicized trial. While the terms of the settlement remain private, it is suspected that companies have shelled out millions of dollars already to compensate those who claim they were injured by Gadolinium dyes during MRIs and MRAs.

The fourth Gadolinium bellwether trial scheduled for this month is referred to as the Marino case. The dates for the defense to respond to the complaint, as well as deadlines for most of the preliminary trial requirements have now passed. The trial was scheduled for a two-week time frame by Judge Polster, and is slated to begin the first of the week. Either Marino’s Gadolinium lawyers will be arguing his case in court next week, or a last-minute settlement will be reached. According to the latest Gadolinium lawsuit news available, no such settlement has been announced at this time.

Gadolinium NSF: A Common Denominator for Gadolinium Lawyers

At the core of the large majority of Gadolinium lawsuit news is a serious medical condition known as nephrogenic systemic fibrosis, or Gadolinium NSF. The condition results in tissue growth around the joints and skin, impairing mobility in a relatively short period of time. Those who are diagnosed with gadolinium NSF may be in a wheelchair within a few weeks’ time. There is no cure for Gadolinium NSF at this time, and severe cases can result in death. The condition has been linked by clinical studies and the FDA to exposure to Gadolinium – a substance used in some contrast dyes that are administered prior to MRIs and MRAs.

With more than 500 Gadolinium lawsuits waiting in the wings of the MDL overseen by Judge Polster, many Gadolinium lawyers will be waiting to see what this latest bellwether trial will bring. Most assume that a fourth settlement will result in settlements for many of the other plaintiffs and Gadolinium lawyers waiting for their turn in court as well. With the impending date fast approaching, it won’t be long before those involved in these lawsuits will discover which turn Gadolinium lawsuit news will take next.