Drug Injury Lawyers Blog

September 5, 2018

Medical Device Failure – Do We Need Better Pre Market Testing?

Is Negligent Medical Device Testing to Blame for Thousands of Injuries and Deaths?

Seemingly countless injuries involving defective or dangerous medical devices have occurred in recent years, prompting the question—are medical devices being adequately tested for safety? Earlier this month, the Medical Imaging and Technology Alliance (MITA) held a congressional briefing “to discuss how medical device providers are regulated and how standards can be better aligned to ensure patient safety.”

The need for such a briefing may confirm what lawyers, physicians, and the general public have been saying all along—manufacturers’ desire to get medical devices to market supersedes their desire to ensure public safety through proper testing. A Boston personal injury lawyer can help you determine how to proceed if you’ve been injured due to the negligence of a medical device manufacturer.

Medical Device Servicing and Safety Accountability Act

The MITA has proposed new legislation that would make it a requirement for any medical device servicer to “maintain records and make reports as the FDA requires to ensure the safety and effectiveness of serviced devices.” The Medical Device Servicing and Safety Accountability Act would reduce or eliminate the risk of improper servicing and reporting. According to the MITA, “the current regulatory structure for medical device providers could lead to instances of improper servicing.” The quality of servicers varies widely, and improper handling can lead to avoidable injuries, and even death.

In addition to proper servicing, the new bill would prompt any entity performing service on a device to alert the FDA to any issues or “adverse events should they occur.” Further, most medical device servicers agree that “consistent standards for device servicing” would be of benefit to everyone involved. A MA personal injury attorney can help you recover damages if you’ve been injured due to the negligence of a medical device servicer or manufacturer.

Medical Device Testing Facts

The facts below further illustrate the severity of the problem involving improper medical device testing.

The vast majority of medical devices receive no testing before going to market.
Metal hip implants, surgical mesh, and lap-bands are among the most prominent recalls of medical devices in recent years.
According to the Institute of Medicine, medical devices should be tested “at least as rigorously as drugs.”
Currently, no national registry for patient medical devices exists that would allow patients to know if they have a dangerous or defective device.
In 2017, Endo, a major manufacturer of transvaginal mesh agreed to pay $775 million to settle 22,000 lawsuits.
Earlier this year, Mary McGinnis received $68 million after she suffered severe injuries as a result of Bard’s pelvic mesh. The award consisted of $33 million in compensatory damage/$35 million in punitive damages.
All-metal hip implants have been involved in countless lawsuits. In 2014, Stryker settled thousands of lawsuits involving its Rejuvenate and ABG II hip implants for $1.43 billion.
Power morcellators, commonly used during hysterectomies, may spread uterine cancer cells. So far, Johnson & Johnson has settled nearly two-thirds of the morcellator lawsuits it is facing. Individual settlements ranged from $100,000 to $1 million based on various factors.

July 17, 2018

Five of the Most Dangerous Prescription Drugs on the Market Today

by Altman & Altman

Pharmaceutical companies develop, test, market and sell prescription medications that are supposed to treat a litany of medical conditions, from asthma and acne to heart disease and high blood pressure. Pharmaceutical companies are phenomenal at marketing and selling their products, but what about testing? All drugs have unintended side effects, but some can be life-threatening. Without proper testing, medications often enter the market carrying excessive, and unknown (at least to the general public) risks. Below are five such prescription medications, and information about victims’ lawsuits.

Invokamet

More than 28 million Americans have type 2 diabetes. Many are suffering from risks associated with this disease, including blindness, kidney failure, and neurological damage. A medication used to treat type 2 diabetes, Invokamet, helps these patients manage insulin levels by regulating the liver’s glucose production. Unfortunately, Invokamet is linked to multiple health issues, from bone fractures to ketoacidosis, a potentially life-threatening condition characterized by excessive amounts of acid in the blood.

Onglyza

Also for the treatment of type 2 diabetes, Onglyza has its own set of serious health risks. In fact, the FDA recently warned that Onglyza, and other drugs in this class, increase the risk of heart failure and could cause death. A Boston drug injury lawyer can help you determine how to proceed if you’ve been harmed by a dangerous or defective medication.

Xarelto

Marketed aggressively as a low-maintenance alternative to warfarin, the anticoagulant (blood thinner) Xarelto quickly grew in popularity when it hit the market. Although all blood thinners carry an increased risk of excessive bleeding, Xarelto’s predecessor warfarin has an antidote. To date, no antidote exists to stop excessive bleeding caused by Xarelto. As a result, thousands have been seriously injured, some fatally. Xarelto manufacturers, Janssen and Bayer, are facing mounting lawsuits from patients who claim they were never warned of these life-threatening side effects.

Zofran

Originally developed to treat nausea in chemotherapy patients, Zofran soon gained popularity with moms-to-be who were suffering from morning sickness. Unfortunately, the drug was never approved for use in pregnant women, and serious birth defects occurred as a result. Nearly 500 lawsuits are pending in federal court against Zofran’s manufacturer, GlaxoSmithKline. A MA drug injury lawyer can help you recover damages if you’ve been injured by a dangerous or defective prescription drug.

Risperdal

Young men who use Risperdal to treat emotional and cognitive disorders, such as schizophrenia, bipolar disorder, and autism, may develop a painful—and embarrassing—condition known as gynecomastia. In layman’s terms, this antipsychotic drug can cause breast enlargement in young men. Even though Risperdal’s manufacturer, Johnson & Johnson, knew about this risk, it failed to warn patients. Making matters worse, the drug was never approved for adolescent use. In addition to painful procedures to remedy this condition, many young men suffer severe emotional trauma as a result of their breast development. A Philadelphia jury recently awarded $70 million to one such victim. Continue reading

May 23, 2018

Testosterone Replacement Therapy Lawsuit Updates

by Altman & Altman

Thousands of cases are pending against manufacturers of testosterone replacement therapy drugs, including GlaxoSmithKline and Auxilium. Lawsuits allege that manufacturers failed to warn the public and physicians of potentially life-threatening side effects, such as heart attacks and strokes, and that the drugs were marketed aggressively to target younger patients, for whom the drugs have little to no benefit. What are the Risks?

Dangerous side effects associated with testosterone replacement therapies, such as Androgel, Axiron, Testim, and Fortesta, include:

heart attack;

April 10, 2018

Xarelto Lawsuits Update April 2018

by Altman & Altman

Late last year, Pennsylvania’s first Xarelto trial concluded with a Philadelphia jury awarding $28 million to an Indiana woman who was injured by the drug. In January of this year, however, the verdict was dismissed due to insufficient evidence in relation to the substantial award. Three other Pennsylvania plaintiffs are requesting leave to amend their complaints. As stated in their request, they wish to “reorganize the allegations and provide more details about the actions and inactions that form the bases of already-existing causes of action.”

But Xarelto manufacturers, Bayer and Johnson & Johnson aren’t thrilled about this request.

“Plaintiffs should be required to complete this bellwether stage of the litigation under their existing pleadings,” argued the companies in March. “To allow otherwise, on the very eve of trial, would inject significant prejudice into the administration of these cases.” A Boston drug injury lawyer can help you determine how to proceed if you’ve been injured by Xarelto or any other defective or dangerous drug.

The three remaining Pennsylvania plaintiffs are but a drop in the bucket of the many Xarelto victims nationwide. Currently, Bayer and Johnson & Johnson are facing more than 21,000 Xarelto lawsuits, most of which are pending in multi district litigation (MDL) in the U.S. District Court, Eastern District of Louisiana.

What’s the Problem with Xarelto?

As with all anticoagulants (blood thinners), Xarelto carries the risk of excessive bleeding or hemorrhaging, but unlike its predecessor, warfarin, there is no antidote to stop internal bleeding caused by Xarelto. In the past, when someone developed internal bleeding from warfarin, they would be administered a combination of fresh blood plasma and vitamin K and the bleeding would quickly cease. But this does not work with bleeding in Xarelto patients. As a result, many have developed serious health problems, and some have died.

The first lawsuit related to Xarelto was filed in 2014. Shortly thereafter, hundreds of patients began coming forward, claiming that the drug had caused them serious harm, including:

Brain hemorrhage
Gastrointestinal bleeding
Rectal bleeding
Epidural hematoma
Pulmonary embolism
Death

Since then, the cases against Bayer and Johnson & Johnson have piled high. Even so, Xarelto continues to be marketed to patients as a lower-maintenance alternative to warfarin.

Misleading Marketing

Plaintiffs in many of the Xarelto lawsuits allege that the drug’s manufacturers knew about the risks but downplayed them to deceive physicians and patients. Case in point—a 2013 marketing campaign claiming that—due to the drug’s safety—patients didn’t need to be bothered with the pesky blood monitoring required of warfarin. As a result, the drug’s popularity soared…and so did injuries. They even marketed the drug’s dosage as “one size fits all.” A MA drug injury lawyer can help you determine how to proceed if you’ve been injured by Xarelto or any other prescription medication. Continue reading

March 29, 2018

Man Receives $3.2 Million in AndroGel Lawsuit

by Altman & Altman

Just about every pharmaceutical has some kind of negative side effect. The general rule of thumb is; don’t use a medication unless the benefits outweigh the risks. But what if you don’t know what the risks are?

A man who claimed that the manufacturer of a testosterone replacement drug was negligent in not informing him of associated risks, recently received a jury award of more than $3 million. According to the lawsuit, the plaintiff, Jesse Mitchell, used AndroGel for nearly five years until suffering a heart attack in 2012. Mitchell claims that the drug’s manufacturer, Abbvie, failed to provide adequate warnings about the risks linked to AndroGel. The lawsuit alleged strict liability, fraudulent misrepresentation and negligence. Although the jury did not agree with all of Mitchell’s claims, they did agree that Abbvie was negligent.

What is Strict Liability?

To win a case based on negligence, you have to be able to show that the defendant was at fault, whereas strict liability claims do not require proof of fault. Consider a dog bite, for example. In strict liability states, a dog’s owner is responsible for any injuries caused by the dog, whether or not the owner was negligent. If, for instance, the victim was bitten when he reached over a fence to pet the dog, the owner may still be liable because the dog is “unreasonably dangerous.”

Apparently, in the AndroGel case, the jury found that Abbvie acted negligently, but did not regard AndroGel as an unreasonably dangerous pharmaceutical. A Boston personal injury lawyer can help you determine how to proceed if you’ve been injured by a defective medication, dog bite, or in any type of accident.

A Second Chance

This was actually the second round of trials for Jesse Mitchell in his lawsuit against Abbvie. In the first trial, he was awarded $150 million by the jury, but the judge threw out the verdict, calling it “logically incompatible.” In this most recent trial, the jury awarded $200,000 in economic and non-economic damages and $3 million in punitive damages.

Other Harmful Drugs and Devices

It seems that every day there is another new prescription drug or medical device in the news for harming patients. Here are just a few of the dangerous drugs and devices that have made headlines in the past year:

Xarelto: An anticoagulant (blood thinner) linked to excessive bleeding.
Invokana: A medication for type 2 diabetes linked to multiple health problems, including a potentially-deadly condition called ketoacidosis.
All-metal hip implants: Originally touted as more durable than their all-plastic counterparts, all-metal hip implants may rub together, releasing metal debris into the body.
Transvaginal mesh: Intended to remedy pelvic organ prolapse or stress incontinence in women, transvaginal mesh devices have been associated with severe pain, organ perforation and other serious medical complications.

A MA drug injury lawyer can help you recover damages if you’ve been harmed by a defective or dangerous medication. Continue reading

February 27, 2018

Court Upholds $18.5 Million Verdict Against Boston Scientific for its Defective Pelvic Mesh Products

by Altman & Altman

In November 2014, four women were awarded $18.5 million in damages for serious complications they suffered due to dangerous transvaginal mesh devices. A jury found that Boston Scientific Corp.’s Obtryx Transobturator mesh device was defectively designed. Boston Scientific appealed the verdict, claiming that the consolidated nature of the four cases resulted in juror confusion and prejudice.

Earlier this month, a federal appeals court upheld the verdict, citing Boston Scientific’s failure to provide evidence of confusion or prejudice.

“Here, there is little reason to be suspicious of the verdicts given that BSC had a chance to fully develop its defenses and that the judge properly instructed the jury throughout the trial to keep the cases separate,” wrote the Court. “What is more, the four plaintiffs did not receive identical damage awards, but instead received damages that varied by $1 million across plaintiffs. That the total damages awards were of the same order of magnitude appears to reflect the very similarities between the cases that justified consolidation in the first place.” A Boston defective medical products attorney can help you determine how to proceed if you’ve been harmed.

Sadly, Boston Scientific is far from the only company accused of manufacturing and marketing dangerous transvaginal and pelvic mesh. These devices are typically used to treat stress urinary incontinence and pelvic organ prolapse, two painful and embarrassing conditions that affect nearly 50 percent of post-menopausal women. But Boston Scientific is among the worst offenders, admitting that it is facing more than 48,000 liability claims due to the defective implants. In 2015, Boston Scientific agreed to settle nearly 3,000 cases to the tune of about $119 million.

Why is Transvaginal Mesh So Dangerous?

Transvaginal mesh has been linked to serious complications in tens of thousands of women. The complications range from severe pain and vaginal scarring to nerve damage and organ perforation. The most common serious complications include:

Pain
Infection
Pain during intercourse
Organ perforation
Erosion
Urinary problems
Scarring
Nerve damage
Fistulas
Autoimmune problems
The need for revision surgery

In 2008, the FDA began investigating the growing list of adverse event reports. In 2011, the agency issued a warning that complications associated with mesh devices were not rare, as previously thought. And in 2016, transvaginal mesh devices were reclassified as Class III (high risk) by the FDA. A MA injury lawyer can help you recover damages if you’ve been injured by a transvaginal mesh device.

Hope for the Future

Scientists from the University of Sheffield have developed an alternative to the dangerous mesh products on the market today. There is mounting evidence that softer, more elastic materials are better for use in the pelvic area. Further, a device that releases estrogen can help the body to heal more effectively. As such, scientists at the university’s Material Science and Engineering department have developed a polyurethane-based device, which is more elastic than its polypropylene predecessor. Continue reading

February 7, 2018

Attune Knee Replacement Failures

by Altman & Altman

Knee replacements are one of the most commonly-performed surgeries in the United States today. When the pain caused by arthritis, injuries, and years of wear and tear can’t be remedied by less invasive procedures, knee replacement implants are another option. The damaged knee joint is replaced with an implant made of plastic, metal, or a combination of the two.

Manufactured by Johnson & Johnson subsidiary DePuy Orthopaedics, the Attune Knee System was approved by the FDA in 2010. Marketed as having the ability to provide patients with a greater range of motion and better stability, Attune implants quickly rose in popularity. Unfortunately, the reality has been less desirable. Since its approval, multiple patients have reported complications, including the need for painful revision and reconstructive surgeries due to the loosening of tibial components within the device. A Boston defective medical products attorney can help you determine how to proceed if you’ve been injured by a faulty or dangerous medical device.

But J&J and DePuy are no strangers to medical implant failures, massive recalls, or the lawsuits that inevitably follow. DePuy has fought many a legal battle over its metal-on-metal hip implants. The ASR hip implant, which was recalled in 2010, has lead to nearly 9,000 lawsuits from patients who say the failure of their implant caused serious medical complications, such as bone deterioration and blood poisoning, as well as extreme pain. DePuy also recalled its Limb Preservation System knee implant in 2013, following reports of premature failure.

The Journal of Knee Surgery published a study in 2017, in which many of the Attune Knee implants had come loose due to the cement-to-implant interface. According to researchers, the glue does not properly adhere to the smooth surface of the implant. Attune’s “roughness factor” is 60, whereas other devices may have a roughness factor of more than 200. Further, the weakness of the polyethylene plastic used in the Attune implant causes significant load-bearing stress on the other components of the device.

How Do I Know if My Knee Implant is Failing?

In most cases, the first sign that something is wrong will be discomfort or pain. If, however, you experience any of the following symptoms, seek medical attention.

Swelling, inflammation or redness around the joint
Infection
Warmth around the joint
Stiffness
Instability
Mobility problems
Clicking, popping or grinding noises when walking
Nerve damage

The complications above can be the result of the loosening or breaking of various device components, dislocation of the device, misalignment of the device, or damage to the surrounding bone. A MA defective medical products lawyer can help you recover damages if you’ve been injured by a faulty or dangerous medical device.

Successful knee replacement implants are supposed to last for up to 20 years. When premature failure occurs within the first few months or years, revision surgery may be necessary much sooner than the patient anticipated. Unfortunately, revision surgery is typically more painful than the initial surgery because it involves removing the device, which is cemented into the bone. In fact, poorly-implanted knee replacements can cause such severe damage to the bone that the knee must be rebuilt before a new replacement can be implanted. Patients undergoing painful revision surgeries also run the risk of exposure to infection and surgical complications, including deep vein thrombosis, nerve damage, and excessive bleeding. Continue reading

December 11, 2017

Hip Implant Lawsuits – It’s Not Too Late to File a Claim

by Altman & Altman

Hip replacements are one of the most common surgeries in the United States today. For years, hip replacement implants were made of plastic or ceramic, but a “longer-lasting, more durable” alternative gained popularity over the past decade. All-metal hip implants were hailed as having a lower failure rate and a reduced need for replacement surgeries. But these claims soon proved to be false.

When the chromium and cobalt components of all-metal hip implants rub together over time, bits of metal debris can be released into the blood stream and surrounding tissue. This debris can lead to inflammation, bone deterioration, tissue damage, and a type of blood poisoning called metallosis.

What is the Statue of Limitations?

In Massachusetts, as in other states, the Statute of Limitations sets a time limit on bringing lawsuits against an individual or entity who has caused you harm. Once that time limit has expired, the injured party can no longer file a claim in MA. The statute of limitations varies based on the type of incident and the circumstances involved. In certain cases, a person may be unaware of an injury for an extended period. Faulty hip implants are a good example of such a situation.

Johnson & Johnson, for example, has argued that the statute of limitations should have begun when they recalled their defective DePuy ASR hip implant in 2010. Given a two-year statute of limitations, patients would have had to file their claims by 2012 in order to recover damages. However, many patients who received DePuy hip implants in 2010 didn’t discover their injury for several years. A Boston defective medical device attorney can help you determine how to proceed if you’ve been injured by a faulty or defective medical product.

The Discovery Rule

Fortunately, MA imposes the discovery rule in certain situations. The “discovery rule” holds that

the statute of limitations does not begin until the claimant knew or should have known that he was injured and that the injury was caused by another’s negligence. As such, an individual who is only now determining that a) she is injured, and b) the injury was caused by DePuy’s negligence, may still be able to file a lawsuit for injuries caused by a hip implant that was recalled in 2010.

Symptoms of Hip Implant Failure

If you have received an all-metal hip implant, it may be in your best interest to speak to your doctor about the risks. In the meantime, if you develop any of the following symptoms, seek immediate medical attention.

Signs of metal poisoning may include:

Problems with the nervous system

Difficulty hearing

Skin rash

Vision problems

Heart problems

Behavioral or emotional changes

Thyroid problems

Signs of bone deterioration or tissue damage may include:

Swelling around the site
Extreme pain
Difficulty walking
High fever

As many as 93,000 patients may have received DePuy’s ASR hip implant before the device was recalled. Unfortunately, J&J failed to keep adequate records and was unable to notify each person of the recall. As such, the number of lawsuits continues to rise. A MA injury attorney can help you determine how to proceed if you’ve been injured by the negligence of a medical device manufacturer. Continue reading

November 13, 2017

The Dangers Of Transvaginal Mesh

by Altman & Altman

Women may develop medical conditions such as urinary incontinence or pelvic organ prolapse due to age, childbirth, or after having a hysterectomy. These conditions may cause the pelvic organs to slip into the vaginal canal, resulting in discomfort and other medical complications. Many of these women will undergo a surgical procedure using transvaginal mesh to correct the problem. Unfortunately, transvaginal mesh is linked to serious pain and a long list of medical complications.

What is Transvaginal Mesh?

Made from a synthetic substance called polypropylene, transvaginal mesh is a small, net-like device that is surgically implanted into the vagina to hold pelvic organs in place. This type of mesh was first used to treat hernias, beginning in the 1950s. It was approved by the FDA to treat pelvic organ prolapse and urinary incontinence in 1996. However, the FDA did not require that manufacturers conduct safety studies on humans prior to the device’s release. Further, many transvaginal mesh products were modeled after a device called the ProtoGen Sling, which was recalled due to high erosion rates in 1999.

Transvaginal Mesh Complications

In 2011, the FDA reported that it had received 4,000 adverse event reports linked to transvaginal mesh products. Despite the many complications, surgeries to implant transvaginal mesh continue with shocking frequency. The following complications are associated with mesh products:

Erosion of the mesh itself
Erosion of surrounding vaginal tissue
Severe pain in the pelvic area
Pain during intercourse
Bleeding
Infection
Urinary incontinence
Perforation of surrounding organs, including the bladder and bowel
Perforation of blood vessels
Scarring
Fistulas
The need for revision surgery

Transvaginal mesh is intended to remain in the body permanently. As such, revision surgeries can be exceptionally difficult. In layman’s terms, they can be costly and quite painful. In many cases, the mesh has to be removed in pieces, and the revision surgery often has to be performed by a specialized doctor. A Boston defective medical products attorney can help you determine how to proceed if you’ve been injured by transvaginal mesh or a similar device.

Transvaginal Mesh Implants “Cannot be Recommended”

According to a report published in the Journal of Obstetrics and Gynecology, more than 15 percent of patients who have been implanted with transvaginal mesh have suffered from severe pain and infections due to tissue erosion. The article’s authors write that: “Surgeons should be aware of the potential complications of synthetic meshes. Until data on the safety and efficacy of the intravaginal slingplasties are available, these procedures cannot be recommended.”

Talk to Your Doctor

If you are considering getting a transvaginal mesh implant, it is in your best interest to speak with your health care provider about the risks. If you currently have a transvaginal mesh implant and are experiencing side effects, such as bleeding or pain, seek immediate medical attention. A MA defective medical device attorney can help you recover damages if you’ve been injured by any type of mesh device. Continue reading

October 26, 2017

If You Have an All-Metal Hip Implant, Here’s What You Should Know

by Altman & Altman

Every year in the United States, thousands of patients undergo hip replacement surgery to treat severe hip arthritis and other degenerative conditions affecting the hip joint. Hip replacement surgeries are generally a last resort option, after non-surgical treatments have failed to help. These patients are typically in serious pain, and unable to perform basic daily activities. The hip replacement is supposed to help them get their lives back. Unfortunately, that’s not always the outcome.

In addition to relieving pain and improving mobility, hip implants are supposed to last the rest of the patient’s life. Hip replacement surgery is complicated and painful; nobody wants to go through it multiple times. Although hip replacement surgeries have been performed for decades, the hip implants themselves have gone through quite an evolution. In recent years, ceramic and plastic models have been “upgraded” to all-metal devices that were originally hailed for being more durable and providing greater range of motion.

It is common for patients to want the newest model when it comes to surgical implants, and hip implants are no exception. As such, tens of thousands of patients have been implanted with all-metal hip implants in the last decade. But shortly after all-metal hip replacement surgeries skyrocketed, claims of serious complications began flooding in. A MA defective medical products attorney can help you determine how to move forward if you’ve been injured by an all-metal hip implant, or any other medical device.

Complications Linked to All-Metal Hip Implants

All-metal hip implants are designed with a ball and socket, both of which are made of metal. Unfortunately, when the ball and socket rub together, the metal-on-metal contact results in friction that can release metal debris into the patient’s blood stream and surrounding tissue. This metal debris can become toxic in the bloodstream and cause the surrounding tissues to become irritated and inflamed, a condition called Metallosis. If left untreated, Metallosis can be fatal. In addition, these metal particles can cause an immune reaction in the body, leading to soft-tissue damage and bone deterioration around the joint.

If you have an all-metal hip implant, it is in your best interest to visit your doctor regularly for routine evaluations of the implant and your hip joint. If it is determined that your hip implant is causing problems or has failed, you may require a revision surgery to remove and replace the implant. A Boston defective medical products attorney can help you recover damages if you’ve been harmed by any type of medical device.

Symptoms of All-Metal Hip Implant Complications

If you have an all-metal hip implant, seek medical attention if you develop any of the following symptoms:

Severe pain in the hip, groin, or leg
Difficulty walking
Swelling or inflammation around the hip joint
Infection
Feelings of malaise
Nausea
Dizziness
Headaches
Skin rash

The above symptoms may signal a problem with your implant, including loosening of the implant, fracture or deterioration of the surrounding bone, misalignment of the ball and socket, or blood poisoning / tissue inflammation from metal debris. Continue reading