medical devices

Tell Congress to Protect Your Case and Your Rights!

Congres

From the American Association for Justice:

Congress is pushing legislation that will make lawsuits brought by injured patients, nursing home residents, and their families nearly impossible to pursue. The so-called "Protecting Access to Care Act of 2017" [H.R. 1215] will rig the system against individuals like you and tip the scales in favor of the health care and insurance industries. We need to send a strong message to Congress that they must protect patients and reject this bill. 

What to Know about H.R. 1215

• Affects medical malpractice, nursing homes and assisted living facilities, and drug and device issues.

• Eliminates joint and several liability, caps attorneys' fees, limits periodic payment of future damages, and gives immunity to health care providers who prescribe or dispense prescription drugs by prohibiting them from even being named in product liability lawsuits.

• Directly preempts state law by capping noneconomic damages in lawsuits against health care providers to $250,000 in the aggregate, even in wrongful death cases involving multiple defendants. The cap purports to be flexible and not preempt states that have higher damage caps, but the cap would apply to states that have struck down damage caps, and states with an overall damage cap could also now have the $250,000 cap.

If you agree that it is unacceptable for Congress to eliminate your rights to hold the parties that harmed you or your loved ones accountable, we urge you to contact your Congressperson and Senators today. Tell your representatives to stand up for you and your family and vote NO on this offensive bill.

We urge you to call your representatives’ offices and send them a letter. Please visit www.takejusticeback.com/ProtectPatients to find contact information for your elected officials in Washington.  You will also find a sample letter you can send to your Representative and Senators.

Please take action today! Your elected officials need to hear from you that you want to preserve your rights to access the civil justice system.

Linda A. Lipsen
CEO
American Association for Justice

You Should Know: Top Safety and Justice Stories of 2016

Are you making all those lists and checking them twice? Gifts? Holiday cards? Party invitations? New Year’s resolutions? Well, here’s one more for you courtesy of the American civil justice system: safer products and services.

This past year we’ve been following several stories of dangerous products or unfair practices that threaten the health, safety and legal rights of all Americans. Think exploding batteries, lead-laced drinking water, forced arbitration or faulty medical devices, for example. 

But thanks to the courage of citizens like you and the power of the civil justice system, we are holding accountable many of those who put profit over public well-being. And that’s a list we can all be proud of, as these stories so richly illustrate.

1. Faulty Medical Devices: Recalls Double

According the the FDA, medical device recalls doubled from 2003 to 2012, and new data shows that the numbers keep climbing. While the FDA approves medical devices before release, they do not do any testing and instead rely on the manufacturers to provide accurate and comprehensive testing data.

Two St. Jude Medical defibrillators recalled due to battery defects.

Two St. Jude Medical defibrillators recalled due to battery defects.

Two examples of faulty medical devices now on the market include the Essure birth control coil and the St. Jude defibrillator. The FDA has received over 10,000 complaints from women suffering painful side effects due to the Essure birth control device. Countless lawsuits against Essure’s manufacturer, Bayer, have sprung up across the country. Rep. Mike Fitzpatrick (R-PA) has since introduced a bill to pull Essure off the market. Meanwhile, more than 400,000 defibrillation devices made by St. Jude Medical were the subject of a recent recall due to a faulty battery. To learn more about medical device recalls, click here.

2. Forced Arbitration: Sign a Contract, Lose Your Rights

There’s always a holiday gift year that’s a dud. Maybe you’ve received an ugly sweater three times too big or a candle that smells so terrible it gives you a headache. Unfortunately, many corporations are now giving you those ugly sweaters (and forcing you to wear them), hiding “forced arbitration” clauses in consumer and employment contracts.

This loophole prohibits Americans from taking companies to court and instead forces them into secretive arbitrations, which are typically stacked in favor of the company. An investigation by The New York Times has focused renewed scrutiny on the harm caused by forced arbitrations in claims of medical malpractice, sexual harassment, hate crimes, discrimination, theft, fraud, elder abuse and wrongful death. You can join others in petitioning Congress to ban forced arbitration right here.

3. Flint, Michigan: Lead in Water Sickens Thousands

Lead found in the Flint water supply has poisoned thousands, including 27,000 children.

Lead found in the Flint water supply has poisoned thousands, including 27,000 children.

Residents of Flint, Michigan, were exposed to dangerous levels of lead in their drinking water ever since a decision was made to switch the source of the city water supply from Lake Huron to the Flint River.

Dr. Mona Hanna-Attisha, a young pediatrician known affectionately in Flint as Dr. Mona, discovered the problem when she noted an increase in the symptoms of lead poisoning in her young patients. Knowing that it was her moral and ethical duty to share her discovery with the public as soon as possible, Dr. Mona held a press conference. Michigan officials and lawmakers denounced her findings at first, only to relent when Dr. Mona wouldn’t back down. Dr. Mona continues to lead the recovery efforts.

4. Concussions and Brain Disease: NFL Settles Lawsuit

If you’re a movie fan, you probably saw the film Concussion, starring Will Smith. This movie is based on the true story of Dr. Bennet Omalu and his discovery of chronic traumatic encephalopathy in NFL players. CTE is a disease of the brain tissue and is caused by repetitive brain trauma. CTE is associated with dementia, aggression, memory loss and depression.

Subsequent research has prompted athletic organizations to make concussion prevention and recovery a priority. This includes many “When in Doubt, Sit Them Out” laws, which mandate that any youth athlete suspected of suffering a concussion be cleared by a medical professional before returning to practice or competition. Earlier this year an appeals court upheld a settlement by the NFL with former players, setting aside almost $1 billion for medical care due to repeated head trauma. Since this lawsuit, head injuries have decreased for NFL athletes.

5. Asbestos: Still a Widespread Hazard

Asbestos may seem like a thing of the past, but any building built in the United States before 1981 is presumed to contain asbestos. And in fact, asbestos-related diseases still kill about 15,000 Americans a year. Even though asbestos is known to be extremely dangerous, the substance has not been banned in the United States. President Obama recently signed the Frank R. Lautenberg Chemical Safety for the 21st Century Act, a bipartisan bill that strengthens ways to regulate and restrict chemical substances. Because of this bill, the EPA can officially work to ban asbestos in the U.S. 

6. Exploding Devices: Faulty Lithium-Ion Batteries

Over 1 million Samsung Galaxy Note 7 phones have been recalled due to defective and explosive batteries.

Over 1 million Samsung Galaxy Note 7 phones have been recalled due to defective and explosive batteries.

From e-cigarettes to hoverboards to smartphones, reports continue of everyday devices posing an unsafe explosion hazard. The culprit is lithium-ion batteries, which include unstable and flammable liquids. When improperly made devices include these batteries, the liquid can overheat and burst through the battery, igniting the device itself. These explosions have caused burns as well as property damage from subsequent fires. The Consumer Product Safety Commission (CPSC) recently issued a recall of all 1 million Samsung Galaxy Note 7 phones, including replacement models thought to fix the problem. 

7. Prescription Drug Addiction: A National Epidemic

Prescription opiate deaths have quadrupled since 1999, killing an estimated 165,000 Americans. During the same time period, profits recorded by the drug companies that manufacture prescription painkillers have also skyrocketed. Meanwhile, a coalition of opioid manufacturers and their lobbyists have fought legislative measures introduced to stem the tide of overdose deaths.

8. Dangerous Toys: Still on Store Shelves

Nearly 260,000 kids visit emergency rooms each year for toy-related injuries, according to the CPSC. And sadly, 11 children under the age of 15 died while playing with toys in 2015. [Download report] The most common injuries include poisoning, choking, ingesting magnets or falling from riding toys. While regulators, safety advocates and the parents of injured children have succeeded in ridding store shelves of many unsafe toys, too many still get through. Learn more.

This article appeared in our December 2016 "You Should Know" e-newsletter.

You Should Know: Fast-Track Approval of Medical Devices Called into Question

Arthroplasty, the reconstruction or replacement of a joint, as shown here in this hip x-ray, is big business for aging baby boomers.

Arthroplasty, the reconstruction or replacement of a joint, as shown here in this hip x-ray, is big business for aging baby boomers.

The United States is the largest medical device market in the world with sales expected to reach $133 billion by 2016. In most cases, medical devices save and improve lives. Unfortunately, not all devices undergo the same rigorous review process before hitting the market.

A number of new medical devices can and do bypass scrutiny by the U.S. Food and Drug Administration (FDA) through a fast-track approval process called the 510(k) program. If a manufacturer can prove that its product is “substantially equivalent” to an existing product, it can avoid stringent premarket testing. While the 510(k) clearing process provides patients with quick access to new products, there is an unsettling consequence: Medical devices can be implanted in patients without requiring manufacturers to prove safety and effectiveness. And in fact, a recent study published in JAMA Internal Medicine found that only eight of the 50 new devices cleared through the program from 2008 to 2012 included required scientific data.

Defective Medical Devices Raise Concerns

Here are just a few examples of more notable defective medical devices that have caused injury to patients:

Knee and Hip Replacements – Clinical evidence continues to show that the design of some knee and hip replacement implants is seriously flawed. Adverse results include failing to properly bond to the thigh bone, improper placement or loosening after surgery. Bone fractures can occur as well as dislocation of the joint. Symptoms patients may feel range from general pain to swelling to an inability to walk. In 2013, The New York Timesreported that Johnson & Johnson knew an all-metal hip implant would fail within five years in nearly 40 percent of patients who had the surgery. 

Transvaginal Mesh Complications – Surgical mesh, composed of synthetic materials, is permanently implanted in patients to repair weak or damaged tissue. But in certain procedures it can cause life-changing health complications, including mesh erosion when the device migrates from its point of placement and cuts through the soft tissues of the vagina or pelvic organs. In addition, patients have experienced pain, bleeding and urinary complications, which the product was designed to fix in the first place.

Defibrillator Leads – Defibrillator leads are implantable wires that connect the defibrillator to the heart. In the event of a heart attack, defibrillators automatically administer corrective shocks. Over the past decade, there have been several high-profile examples of defibrillators malfunctioning, causing the device to fire unexpectedly or fail to fire at all when a patient’s life is at risk.

Protect Yourself with These Tips

These tips from Consumer Reports can help protect you or loved ones from the risk of defective medical devices:

  1. Consider the alternatives: If your doctor suggests an implant, simply ask what will happen if you don’t get it. Sometimes patients aren’t adequately informed about the alternatives. For example, women who received transvaginal mesh for prolapse repair may not have needed surgery. But people ill enough to require an implantable defibrillator for their heart may not have a choice.
     
  2. Research the device: The Food and Drug Administration’s website, FDA.gov, contains information on device safety warnings, complaints and recalls, which are all accessible by searching the name of the device. Also look for patient forums and other information about the device by searching online.
     
  3. Write down the details: Ask for the brand name, model and serial number (if applicable) of your device so that if you learn of a warning or safety recall, you’ll know whether yours is one of the problem models.
     
  4. Don’t panic: If you learn there are problems with your device, don’t assume that it has to be removed. Contact your doctor and learn to recognize possible negative side effects in your case.

This article appeared in our April 2015 "You Should Know" e-newsletter.