Boston Personal Injury Attorney Blog

March 30, 2013

J&J Admits DePuy Defect in Trial Awarding Plaintiff $8.3M

A Montana man, the first to take on medical device manufacturing giant Johnson & Johnson and subsidiary DePuy over defective hip implants, has prevailed, with a jury awarding him $8.3 million in damages.

Our Boston personal injury lawyers reported the verdict last week. One of the most interesting developments of the trial is that a high-level executive at J&J testified that the rate of corrective surgeries as a result of the product was “not acceptable.”

Yet in the same breath, he called the assertion that a recall was an admission of a defect “absurd.” Of course, why would a product need to be recalled if there was nothing wrong with it?

The Los Angeles jury sided with the Montana plaintiff, awarding him $8.3 million in damages.

A second trial is underway in Chicago, where a 54-year-old nurse is claiming that her ASR XL hip replacement device was defective. She had the all-metal device implanted back in 2008. It had to be replaced just three years later in 2011.

Her case, Strum v. DePuy, is the second of some 10,750 pending lawsuits involving ASR implants.

Altogether, the company recalled some 93,000 hip implants back in 2010. The J&J executive said that the devices weren’t meeting the clinical expectations of the company. In other words, they were failing.

Still, the executive backpedaled on his statement, saying that, “We absolutely didn’t say the product is a defective product. We said, ‘We don’t know. We need to figure this out.’ ”

It’s unfortunate, though unsurprising, that a corporate giant such as this simply won’t admit to the damage it has caused these individual consumers, many of whom were ailing to begin with, and simply compensate them for the suffering they have endured.

The silver lining about the $8.3 million verdict is that it sets a strong precedent. It’s basically an incentive for J&J to settle legitimate claims, rather than drag each one into court, considering the time and expense of a trial.

The problem with the DePuy devices is that they are solid metal, and normal erosion on the parts has resulted in metal poisoning, as well as a breakdown of the product years before intended. That means patients often must undergo new surgical procedures to correct the problems.

In other hip replacement news, the U.S. Food & Drug Administration has proposed stricter regulations for two different hip replacement models manufactured by Stryker Corp. that were allowed to remain on the market. Those included improved practices for pre-market clinical studies. Unfortunately, these proposed changes have come too late for tens of thousands of patients who have already been implanted with these faulty devices.

Stryker issued a voluntary recall last July of its ABG II and Rejuvenate hip implant systems. These devices had the same metal-on-metal debris issues as the DePuy models.
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March 25, 2013

Spring Gives Rise to Boston Child Bicycle Injuries

by Jeffrey S. Glassman

March 20 marks the first day of spring this year. While here in Boston, we’ll still be thawing out from a rough winter, it’s not too early to think about you’re child’s bicycle safety, as kids will no doubt be begging to get out and ride within a few short weeks.

Our Boston child injury lawyers know that city officials have been keeping closer tabs on bicycle trends and related crashes in recent years, as bicycle ridership increased 122 percent between 2007 and 2009.

In part, this is due to certain bicycle-friendly improvements throughout the city, including many miles of bicycle lanes in various locations.

We don’t know exactly how many of those riders are children, but we do know that while about 72 percent of Boston cyclists report wearing helmets, just 45 percent of those requiring EMS attention were wearing head protection. Wearing a helmet, according to the National Highway Traffic Safety Association, reduces the risk of brain and head injuries by nearly 90 percent.

Yet, the NHTSA noted, just 25 percent of kids between the ages of 5 to 14 actually wear a helmet when biking. Teens report numbers close to zero.

In the last 10 years, an average of 130 children aged 14 and under die in this country each year in bicycling accidents.

Here in Boston area, there are approximately 1,500 bicycle crashes reported annually, with injuries ranging from scrapes and bruises to permanent disabilities and death. Late last year, the death of a 23-year-old Boston University graduate student, who died while bicycling his way to school, followed a fatality a month earlier when a 21-year-old student was on his bicycle when he was struck and killed by a metro bus.

As a result of these two incidents, the city announced this month that it will be installing more caution signs, enhanced bicycle lane markings and reflectors in the pavement in certain areas.

Children, however, should not be biking in traffic alone, unsupervised.

While the sad fact is, you can’t force motorists to abide by traffic safety laws, you can do everything in your power to keep your children safe.

To do this, keep the following tips from the NHTSA in mind:

Wear a helmet, and make sure it is properly-fitted. You can learn more about how to ensure a proper fit by clicking here.
Adjust the fit of your child’s bicycle. Have him or her stand over the bike and make sure there are 1 to 2 inches between you child and the top tube and that the seat is level front to back and adjusted to allow a slight bend at the knee when the leg is fully extended.
Teach your child to check the inflation of the tires and the breaks – every time – before heading out.
Instruct your child on how to best make him or herself visible. Whether it’s day or night, wear bright or even fluorescent colors, as well as something that will reflect light, such as reflective tape or flashing lights. Understand that just because you see a car doesn’t mean the driver sees you. For this reason, it’s better to avoid driving at night.
Your child should know how to watch for road hazards, like potholes, gravel, leaves, broken glass, puddles and dogs.
Children under the age of 10 should not be riding in the street. They should be on the sidewalk.
Teach your child to watch for parked vehicles, as there is a risk of them backing out or a door suddenly opening.

March 23, 2013

Transvaginal Mesh Defect Results in Multi-Million Dollar Verdict

by Jeffrey S. Glassman

In the first out of some 2,000 pending lawsuits against Johnson & Johnson and its division Ethicon, a woman was awarded approximately $11 million for the pain she had suffered due to the now-recalled Prolift vaginal mesh.

Our Boston personal injury lawyers were encouraged at the precedent this case sets, though not surprised at all that the companies are vowing to vigorously appeal. They don’t want a verdict like this to stand because that might force their hand in terms of providing a greater incentive to settle future claims, so they won’t incur the enormous cost of a trial on each.

This verdict could have a significant impact not only these manufacturers but others who produced similar defective medical products.

The plaintiff in this case, a 47-year-old nurse from South Dakota, filed suit back in November of 2008 in Atlantic City, NJ.

As you are likely familiar, the mesh was used to treat pelvic organ prolapse. It’s characterized by a portion of the vaginal canal protruding (or prolapsing) from the opening of the vagina. Most often, this conditions happens when the pelvic floor collapses due to childbirth.

It’s a condition suffered by about 316 million women worldwide as of 2010, or more than 9 percent of all women. In the U.S., it’s estimated to be about 34 million women.

In severe cases, surgery, with the implantation of the mesh, was supposed to fix the problem. But the real problem is that these devices in fact weren’t safe. These manufacturers had a duty to know they weren’t safe, and they failed to warn patients and doctors about the issues that were being reported.

In this woman’s case, she suffered almost immediate and near constant levels of pain after having the transvaginal mesh implanted. As a result, she had to undergo another 18 operations in order to repair the abdominal injuries she suffered as a result.

The product was taken off the market completely last year, but it was too late for tens of thousands of woman who had already had the procedures. By that time, the FDA had received some 1,000 reports of adverse events, including pain, infections, erosion, incontinence and even a recurrence of the prolapse.

Ultimately, this woman was awarded $3.3 million in economic damages and $7.8 million in punitive damages.

This sounds like a lot, but consider that J&J has assets totaling $122 billion and a net worth of $65 billion, as of Dec. 31, 2012. This is a drop in the bucket for the company. That’s why they are seeking to aggressively fight this verdict.

No doubt, other manufacturers will as well. (It’s estimated that Endo Health Solutions, another top manufacturer of the mesh, is currently preparing to face some 3,000 lawsuits making similar claims.)
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March 21, 2013

First DePuy Hip Trial Results in $8.3M Verdict For Plaintiff

by Jeffrey S. Glassman

There are more than 10,000 lawsuits that have been filed regarding the premature failure and other complications of the DePuy ASR hip replacement system.

Our Boston DePuy ASR hip replacement plaintiff lawyers understand the first of those has set a promising precedent: An $8.3 million verdict in favor of the plaintiff. This verdict is likely to open the door to future settlements in the case with parent manufacturer Johnson & Johnson.

With so many cases pending, the company is likely to want to speed up and resolve the pending litigation. Seeing that plaintiffs are having success in court means it’s less costly for them in terms of time and lawyers fees to simply settle a claim before it ever gets to court.

Court documents in this case revealed that Johnson & Johnson, as well as DePuy, were aware of critical design flaws in the product that would result in early failure – years before they initiated a recall on the ASR model. In fact, DePuy knew that the product had failed internal testing as far back as 2007. And yet, according to The New York Times, the company continued to sell the product without disclosing to doctors the results of those tests.

Those internal tests showed that the ASR model was probably going to fail within five years on about 40 percent of the patients who received it. Compared to the failure rates of most other orthopedic implants, the DePuy ASR was eight times higher.

These devices are metal-on-metal, with a metal ball inside a metal pocket. The inherent problem is that the cup had only a small surface area in which the ball could move. In turn, that increased the risk for the ball to grind against the cup, which generates metallic debris and further erosion. The production of debris, additionally, resulted in shards of chromium and cobalt being released into the nearby tissue, which resulted in swelling, inflammation and even poisoning.

In this case, the plaintiff’s hip implant was installed sometime in 2007. Immediately after the surgery, he knew something wasn’t right. He suffered severe complications, which included extreme pain, difficulty with walking and metallic poisoning. In order to have the device removed and replaced, he had to undergo a risky revision surgery.

It wasn’t until August of 2010 – some three years after DePuy and Johnson & Johnson knew about the defects that would lead to situations like this, that the devices were actually recalled, some 93,000 units.

The trial stretched several days, after which the Los Angeles jury awarded the plaintiff nearly $400,000 in economic damages and $8 million in non-economic, or punitive, damages.

Of course, DePuy has announced its intention to appeal. It would, since it’s never accepted responsibility. Our Boston hip replacement plaintiff attorneys believe they have little chance at success.

A second trial is underway involving a 54-year-old nurse from Illinois who had the device implanted back in 2008.

Andrew Ekdahl, president of DePuy’s orthopedic products unit, testified before a Chicago jury in that case that the reason for the recall was that the revision rate, or the number of patients who had to return for corrective surgery, was “not acceptable.”
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March 18, 2013

Food Poisoning: Undeclared Nuts Can Prove Deadly

by Jeffrey S. Glassman

Most people with a severe nut allergy know from a very young age that they must be extremely cautious about any and all foods they consume and products they use, as even miniscule contact could be fatal.

However, our Boston personal injury lawyers know that all too often, problems arise when companies fail to properly note every ingredient in their products. Alternatively, sometimes food manufacturers or restaurants aren’t careful in their food preparation, causing cross-contamination to occur.

Even in cases where an individual may not have died from the incident, taking the company to court may help prevent such a situation from ever occurring there again.

Sadly, these kinds of errors happen all the time.

For evidence of this, just peruse the U.S. Food & Drug Administration’s recent list of recalled food products. On March 1, the agency recalled some 20 lots of cereal produced by the California-based Food for Life because there were almonds in the cereal that weren’t listed as an ingredient on the box. Specifically, the Original, Golden Flax and Cinnamon Raisin varieties were all affected. There haven’t been any illnesses reported to date, but affected individuals may not have realized what made them sick – as they wouldn’t have suspected cereal that didn’t have nuts listed as an ingredient. The boxes were distributed between late last November and early February.

And then just last month, the FDA recalled numerous lots of snack mixes produced in Florida for undeclared peanuts.

Other products the agency has recently recalled for undeclared nuts include:

Brownie mix;
Coffee;
Fruit cereal;
Cookies;
Candy;
Granola bars;
Fruit bars;
Ice cream bars;
Pasta;
Pies;
Spreads;
Chocolate protein drinks;
Popcorn.

Severe nut allergies are basically the body’s overactive immune response triggered by the allergen. People suffering an episode may have trouble breathing, plummeting blood pressure or an increased pulse rate due to shock.

It’s estimated that approximately 200 people in the U.S. die every year due to nut allergies, with about 60 percent of those caused by peanuts. Tree nuts, meanwhile, are another common allergy, meaning those individuals must steer clear of things like almonds, cashews, chestnuts, hazelnuts, macadamia nuts, pecans, pine nuts, walnuts and pistachios.

The problem is that these foods, and their derivatives, are found in so many different products. Those with allergies know they have to carefully screen labels and grill their restaurant servers. But these entities have a responsibility to know what is in the product and to inform consumers.

Undeclared nuts are a top concern to the FDA, due to the fact that they can potentially be life-threatening. Other kinds of undeclared ingredients that are on the agency’s top list of inspection priorities for the same reason are: milk and milk by products, eggs, fish and shell fish, soy and wheat.

The most common offenders, according to the FDA, are bakeries, candy manufacturers and ice cream manufacturers.

Other food items in which you might not readily expect to find nuts include: chilis and soups, breads, honey, vegetarian burgers, pasta sauces, marinades and salad dressings.
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March 16, 2013

Boston Malpractice Cases Could Stem from Painkiller Overdoses

by Jeffrey S. Glassman

When it comes to drug addiction, there is little room for doubt in our modern understanding that it is a disease.

As such, those who perpetuate the disease – i.e., the illicit dealers – are sanctioned by society, typically in the criminal justice system. To often, the exception to this are those who are causing the most harm: The doctors.

Our Boston medical malpractice attorneys know that in 2009, some 15,500 people died in this country as a result of narcotic painkiller overdoses. That is a 300 percent increase in a period of two decades. For every death attributable to this cause, there are another 10 treatment admissions, more than 30 trips to the emergency rooms and roughly 830 non-medical users of these substances.

Prescription narcotics cause more deaths today than cocaine and heroin – combined.

The U.S. Food and Drug Administration this month released an open letter to doctors, calling the abuse and inappropriate use of opiod painkillers “epidemic” and a “major public health challenge.”

Some 320,000 doctors across this country wrote prescriptions for at least one opiod last year – most wrote many more. These physicians may not be able to control whether the drug is stolen from the patient or whether the patient turns around and sells it on the street. However, doctors do have a responsibility to be informed about illicit uses. They need to use their best judgment in terms of figuring out who is actually a legitimate patient and who may be an addict or a street dealer. They also have a responsibility to educate their patients about the appropriate use of the drugs, as well as the potential risks and the right way to dispose of them.

We want to believe that most doctors are being cautious and doing the best they can. Unfortunately, there is a lot of anecedotal evidence out there to suggest that is simply not the case. And sadly, many doctors are putting profits ahead of the welfare of both their patients and society at-large.

A recent extensive investigation by The Los Angeles Times found in a review of coroners’ reports that a small number of physicians were responsible for writing a disproportionate number of the prescriptions of people who were ending up dead of an overdose.

In reviewing some 3,735 prescription-related deaths, nearly 50 percent were directly and solely attributable to prescription painkillers. Of those, 0.01 percent of doctors in the area were responsible for 17 percent of the deaths. Four of those doctors had 10 or more patients who had overdosed, with the most being 16 in a four-year time frame.

Some are calling for a review of a doctor every single time a doctor’s patient dies of an overdose. Our Boston personal injury lawyers would certainly support such a move.

What the FDA is asking for is:

Assurance that doctors have adequate training in opiod therapy;
Proof that doctors have knowledge of the content of most of the current opiod drug labels;
That doctors take the time to inform patients about the appropriate use of these drugs and the risks.

All this, in our view, would be just a start.
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March 13, 2013

Boston Injury Lawyers: Z-Pak Heart Risk Warning From FDA

by Jeffrey S. Glassman

Given that it’s cold and flu season, patients will no doubt be headed in droves to doctors’ offices and pharmacies in search of antibiotics – particularly a powerful one called Zithromax, also sometimes called a Z-Pak.

These prescriptions are most commonly used for bronchitis, sinus infections, pneumonia and other respiratory infections. It tends to be more popular than other similar drugs because its potency allows it to be taken for a shorter period of time.

However, our Boston personal injury lawyers have learned that the drugs are also now tied to a sudden deadly heart problem. That’s according to a recently-concluded 14-year study conducted by Vanderbilt University researchers in Tennessee.

The risk was reportedly relatively rare, but surprising, and not one that has been advertised by distributors or warned about by doctors or pharmacists.

Researchers looked at outcomes for nearly 550,000 patients who were given Zithromax between 1992 and 2006. Of those who took the five-day treatment, there were approximately 30 heart-related deaths. That was more than double the rate of what patients who had taken other antibiotics – or no antibiotics – had suffered.

So per 1 million Z-Pak patients, researchers estimated about 85 would be at risk for a sudden heart death, compared to 32 among patients who took amoxicillin and 30 among those who took no antibiotics at all. To put it another way, there would be 47 more heart-related deaths among those patients given Z-Paks versus those given amoxicillin.

Researchers said they controlled for heart risks, meaning that those in each category were no more at risk for a heart complication or problem than those in any of the other groups.

Although the risk at first glance may appear to be relatively low, consider that some 40 million people in this country are prescribed the drug annually. That means that on average, we’re talking about 3,400 deaths a year from sudden heart problems caused by this drug. That is a significant number.

Those with existing heart complications undoubtedly should be steered away from the drug, as should those with lower-than-normal levels of magnesium or potassium in their blood.

Doctors worry what the longer-term effects might be of this news, and whether there are other potential risks involving the drug that we don’t yet know about. Z-Paks, which are marketed by Pfizer Inc., have only been around for about 20 years, which means we may yet have a lot to learn. Sales last year alone for the drug topped nearly $465 million.

There has been past research that has shown that Z-Pak’s might benefit people who have severe lung disease, but in light of this new information, it’s not clear whether those individuals should continue to take it.

In response to the study, which was recently published in the New England Journal of Medicine, federal authorities with the U.S. Food and Drug Administration have issued a formal notice to doctors. Additionally, the agency announced that new labels warning of the risk would be added to the prescription bottles, so they could be easily read by patients.
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March 11, 2013

Dorchester Pedestrian Accident Injures Two Children

by Jeffrey S. Glassman

An unfortunate accident in Dorchester left two children seriously injured. According to the Boston Globe, the man is being charged for driving under the influence.

The at-fault driver reportedly struck the children as they attempted to use the crosswalk at the intersection of Dorchester and Talbot avenues at about 6:00 p.m. Accident reports indicate that the 28-year-old drive appeared to be intoxicated and he failed a number of sobriety tests. He has been charged with negligent operation of a motor vehicle, operating under the influence of drugs and operation after license suspension. The child pedestrians were transported to Boston Medical Center.

Our Boston personal injury attorneys understand that our child pedestrians are most at risk. Whether drivers are intoxicated or not, many of them overlook children. To make it even worse, these young pedestrians don’t always understand the workings of traffic and unknowingly put themselves at risk. Sit down and talk with the child in your family and make sure they know how to act near vehicular traffic — their safety relies on it.

According to SafeKidsUSA, there were close to 400 children under the age of 14 who were killed each year since 2000 in pedestrian accidents. In 2009, there were about 244 child pedestrian fatalities recorded in the U.S. In addition, there were close to 15,000 child pedestrians injured in these same scenarios. Although this number is on the decline, we’re still losing way too many of our youngsters.

With spring break approaching, our children are going to be spending more time outside and spending more time in dangerous situations. The maturity level of children under the age of 10 makes them less able to correctly gauge road dangers and renders them at greater risk for injury and death.

Talk to your child about always using a crosswalk or a street corner to cross the road. Make sure they know to look in all directions before stepping out. They need to know to never assume that a driver sees them. Always make sure that children make eye contact with drivers before attempting to cross.

When you’re walking with your child, make sure to hold their hand. This goes for sidewalks, when crossing the street and even when walking in parking lots.

You should always beware when sending children to the bus stop. Make sure they know to wait at the bus at least 5 giant steps from the roadway. Make sure they’re in bright clothing so that motorists can see them more easily. If they’ve got to walk along a road that has no available sidewalks, make sure that they know to walk facing oncoming traffic as far from cars as possible. You also want to teach them that this is no time for horseplay. Always stay aware of your surroundings.
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March 9, 2013

Boston Child Injury: CPSC Releases Tougher Play Yard Standards

by Jeffrey S. Glassman

If there’s a young child in your household — Listen up! Officials with the Consumer Product Safety Commission (CPSC) recently released new standards to help to keep children safe in play yards.

Play yards are those framed enclosures that have a solid floor and fabric or mesh for side panels. They can be folded for storage or for travel. They can also be dangerous for your child.

Last month, CPSC officials announced new standards as a part of the Danny Keysar Child Product Safety Notification Act. It’s also called “Danny’s Law” and it was named after a young child who was killed back in 1998 in Chicago while he was napping. He was napping in one of these play yards when it collapsed and he was suffocated. The Act is working to make sure that this doesn’t happen to another family.

Our Boston child injury lawyers understand that these devices are designed to offer our children a safe place to play and nap. Unfortunately, many of the designs are faulty and can serve up some serious dangers to children. With the new standards, the design should be safer and should provide parents with more peace of mind.

New Standards for Play Yards from the CPSC:

-Play yards must have safe rails. They can’t have rails that have sharp edges that can cut children.

-They’re required to have stronger brackets. These brackets are to help to prevent any kind of sharp edges or cracks to prevent a collapse.

-The mattresses are to be sturdier. The attachments that keep the mattresses to the floor are also required to be sturdier. This is to help children from getting trapped, suffocated or sustaining other injuries.

There are other things that parents can do to help to ensure their child’s safety while in play yards and in cribs. These safety precautions start with the items you place in with the children. You want to be careful of the pillow and blankets you offer your child. We want them to be comfortable, but we want them to be safe.

Officials with the CPSC estimate that there were about 700 children under 12-months who were killed from 1998 to 2010 because of the pillow and blankets that were in their cribs and sleep environment. The safest way to allow your child in a crib is with no pillows, no heavy quilts, no thick blankets, no pillow-like stuffed toys or other large stuffed toys and no child carrying devices, recliners or sleep positioners.

Be cautious of what you offer your child in their crib or play yard. Sometimes, the soft and comforting items can quickly turn deadly.
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March 7, 2013

Boston Injury Lawyers Note FDA Injunction Against Ohio Cancer Drug Maker

by Jeffrey S. Glassman

The federal government has issued a permanent injunction against an Ohio drugmaker for numerous violations related to cleanliness, appropriate practices and investigations.

Our Boston personal injury lawyers know that the U.S. Food and Drug Administration has really given Ben Venue Laboratories Inc. more chances than it ever deserved to get its act together. That the FDA has taken such a strong stance in actually shutting down operations speaks volumes not only of the severity of violations here, but also of a repeated and blatant unwillingness or inability to address these problems.

The FDA has a list of minimum requirements that drugmakers have to meet in order for operations to be considered abiding by good manufacturing practices. The end goal is that the companies will ensure both the purity and quality that the company advertises is actually what patients are getting.

These minimum requirements include things like sterile work environments, efforts to minimize contamination and proper training and protocol for staffers. Drugmakers really should be going above and beyond these standards, as they are a minimum.

But Ben Venue, a primary manufacturer of certain cancer drugs, including Doxil, apparently couldn’t even do that, according to the government, and this move was a long time in coming.

Since February 2002, the firm has had no fewer than 40 recalls of its products and drugs. Ten of those have occurred just in the last handful of years, and France and Germany have actually forbidden Ben Venue’s drugs to be sold. About a quarter of those recalls were prompted by reports of serious negative health effects and the risk of death.

Back in 2010, the FDA conducted an inspection of the company and found that a leaking roof caused metal contamination in two different medications. That inspection also reportedly found mold in areas where the drugs were made, equipment that was rusted, glass contamination and a huge bucket in the manufacturing area that contained urine. A number of the medications were found to have been contaminated with bacteria.

This was followed by another inspection in the spring of 2011. Following that, FDA inspectors reported some 48 violations that included untimely and insufficient investigations, failure to prevent contamination of products, inadequate quality control and employee practices that were sorely lacking.

Another month-long inspection at the end of 2011 prompted company officials to voluntarily shut down operations, where some 1,300 people were employed. A number of drugs were also recalled, including those used to treat patients with ovarian cancer, AIDS, viral eye infections and those with myelodysplastic syndromes (bone marrow diseases).

But the halting of operations at the lab created a huge problem: exacerbation of the serious shortage of Doxil, which already had a waiting list of cancer patients hoping to gain access to the drug.

So as part of the injunction, FDA is allowing the firm to continue making Doxil and a few other in-demand drugs, but under an extremely intense microscope and only after adopting a number of corrective actions. Before the firm can fully resume operations, it must:

Hire an outside expert to regularly inspect the facility and to conduct batch-by-batch quality control tests;
Develop and implement a remediation plan;
Undergo an in-depth FDA inspection to make sure that operations are in full compliance with the law.

Unless and until these criteria are met, Ben Venue will not be able to resume full operations.

That it took such severe and repeated violations for the firm to be ordered into compliance is beyond disappointing. Those who have been harmed by Ben Venue’s products should contact an attorney to discuss the potential for compensation.
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