Two National Recalls Prompt Food and Drug Administration (FDA) to Update Metal-on-Metal Hip Implant Safety Concerns

GFI Blog LabelBy George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law and Carole C. Schriefer, R.N., J.D., The Health Law Firm

On January 17, 2013, the Food and Drug Administration (FDA) issued an updated public health communication about hip replacement components that have both a metal ball and a metal socket, or metal-on-metal hip devices. This comes after two recent hip replacement recalls that are sparking thousands of lawsuits. Click here to read the FDA communication.

In August 2010, Johnson and Johnson’s DePuy Orthopaedics implemented a DePuy ASR hip recall, withdrawing more than 93,000 hip implants from the market. (Click here to read the press release on the recall from DePuy.) In July 2012, Stryker Orthopaedics implemented a similar recall on the Rejuvenate and ABG II modular neck components. (Click here to read the Stryker recall press release.)

Updated Information on Metal-on-Metal Hip Implants From the FDA. 

According to the FDA, in metal-on-metal hip implants, metal can be released into the body when two connecting components slide against each other. This can happen during daily activities. Metal release will cause some tiny metal particles to wear off of the device and into the space around the implant. Wear and corrosion at the connections may also occur. Some of the metal ions from the implant can enter the bloodstream. If this happens, patients can suffer from muscle, nerve and bone damage.

Click here to read more on metal-on-metal hip implants from the FDA.

Second Trial Over DePuy Hip Implant in Progress.

The president of DePuy testified during the second DePuy ASR hip trial. According to an article in Bloomberg News, the DePuy president said that the metal-on-metal hip implants were recalled because of a high rate of corrective surgeries required in patients, not because the device’s design was defective. Click here to read the Bloomberg article.

You may remember on March 8, 2013, in the first ASR hip recall trial, a California jury awarded the plaintiff $8.3 million in compensation damages after finding the ARS’s design defective. This result will have significant impact in the 10,750 other lawsuits against DePuy. Click here to read a previous blog on the first trial over the DePuy hip implants.

Stryker Orthopaedics Facing Similar Lawsuits.

As of February 2013, more than 80 lawsuits against Stryker have been consolidated into multicounty litigation (MCL) in the Superior Court in New Jersey. Stryker is currently in the process of sending out letters to surgeons urging them to perform clinical exams, such as blood work and cross sectional imaging, on any patient who had implants installed. Click here to read a previous blog on the Stryker lawsuits.

We’ve also learned some Stryker patients are being contacted by Broadspire. This company is trying to discuss settling with these patients. We want to encourage any metal-on-metal hip implant recipients to contact and experience attorney first, because there is still time to file a claim for injuries.

Contact an Attorney Experienced in Products Liability Litigation.

Although The Health Law Firm represents predominantly physicians and other health care providers, we are involved in products liability litigation. The Health Law Firm has recently undertaken plaintiffs’ products liability cases against the manufacturers of defective hip implants. We are now representing plaintiffs in a number of products liability cases involving both the DePuy hip and the Stryker hip implants. We are able to combine our knowledge of the health law industry with our litigation experience for the benefit of patients.

If you received a DePuy or Stryker hip replacement and have experienced pain, swelling, high levels of metal in your blood, a corrective revision surgery, or other complications, we may be able to help you.

To learn more about your legal rights, contact The Health Law Firm for a consultation by calling (407) 331-6620 or (850) 439-1001 or visit our website at www.TheHealthLawFirm.com.

Comments?

What are your thoughts on these recalls? Are you a Stryker or DePuy hip implant recipient? Please leave thoughtful comments below.

Sources:

Harris, Andrew and Voreacos, David. “J&J’s Ekdahl Says Hip Recalled for Clinical Reaons.” Bloomberg. (March 13, 2013). From: http://www.bloomberg.com/news/print/2013-03-13/depuy-chief-questioned-over-records-calling-asr-defective.html

Hooks, Beau. “Stryker Hip Replacement Lawsuits.” Drug Watch. (February 2013). From: http://www.drugwatch.com/stryker/lawsuit-hip-replacement/

Guilfoyle, Jeanine. “Stryker Initiates Voluntary Product Recall of Modular-Neck Stems.” Stryker. (July 6, 2012). From: http://www.stryker.com/stellent/groups/corporate/documents/web_prod/147504.pdf

About the Authors: George F. Indest III, J.D., M.P.A., LL.M., is Board Certified by The Florida Bar in Health Law.  He is the President and Managing Partner of The Health Law Firm, which has a national practice.  Its main office is in the Orlando, Florida, area.  www.TheHealthLawFirm.com  The Health Law Firm, 1101 Douglas Ave., Altamonte Springs, FL 32714, Phone:  (407) 331-6620.

Carole C. Schriefer is an attorney with The Health Law Firm, which has a national practice. Its main office is in the Orlando, Florida, area. www.TheHealthLawFirm.com  The Health Law Firm, 1101 Douglas Avenue, Altamonte Springs, Florida 32714, Phone:  (407) 331-6620.

 

The Health Law Firm” is a registered fictitious business name of George F. Indest III, P.A. – The Health Law Firm, a Florida professional service corporation, since 1999.

Copyright © 1996-2012 The Health Law Firm. All rights reserved.

Stryker Orthopaedics Facing Dozens of Hip Implant Lawsuits

4 Indest-2009-3By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

As of February 2013, more than 80 lawsuits have been consolidated into multicounty litigation (MCL) in the Superior Court in New Jersey against Stryker Orthopaedics. Patients are claiming the company’s Rejuvenate and ABG II modular-neck femoral hip systems are defective, according to a number of news sources. The case is on track to becoming one of the largest mass-tort litigations in the country.

In July 2012, Stryker issued a voluntary recall of the Rejuvenate and ABG II modular-neck femoral hip systems. (Click here to see the press release from Stryker.) The company is currently in the process of sending out letters to surgeons urging them to perform clinical exams, such as blood work and cross sectional imaging, on patients who had implants installed. The letters state that Stryker will compensate patients for any tests or work that has to be done.

Click here to read a letter from Stryker to a surgeon.

Unfortunately, for some, this notice is too late. Hundreds of patients are already experiencing pain from the Stryker hip implants, which has forced them to have the implants removed. Even after surgery some patients alleged they have permanent damage and are demanding compensation.

Early Lawsuit Filed from Florida Patient.

According to the Palm Beach Post, one of the first lawsuits against Stryker came from a Boca Raton retiree. Her replacement came with a promise to last for decades. The device allegedly failed within months. Click here to read the patient’s entire story.

According to Drug Watch, most patients who received Stryker’s devices allegedly suffered from muscle, nerve and bone damage as the metallic components of the device rub against each other, causing metallic elements to be released into the body and be absorbed into the blood stream and body tissue. To read the entire article from Drug Watch, click here.

More Lawsuits to Come – Contact an Experienced Health Lawyer.

Since the implants were recently recalled, it’s expected that there are many more cases out there.

Many of the people who have already filed lawsuits claim Stryker marketed and sold a defective device and failed to warn the public, among other issues.

If you or a family member received a Stryker Rejuvenate or ABG II hip implant and suffered complications, you don’t have to face the medical issues alone. Contact an experienced attorney that is board certified in health law. Before you talk about settling, call an attorney.

Stryker Lawsuits Similar to DePuy.

According to an article in The Records, similar mass-tort cases in New Jersey include hundreds of lawsuits filed against DePuy Orthopaedics. More than 2,500 plaintiffs in that case alleged similar complaints due to a metallic hip part. DePuy’s product, ASR, was recalled by the company in August 2010. The cases being heard involve potentially hundreds of millions of dollars in settlements or verdicts. Click here to read the entire article from The Records.

Contact Experienced Health Law Attorneys.
If you or a family member received a Stryker Rejuvenate or ABG hip implant and suffered complications you don’t have to face the medical issues alone. Our attorneys are available seven days a week to answer your questions. We can help you decide whether filing a lawsuit is the right option for you. Our attorneys include those who are board certified by The Florida Bar in Health Law, as well as licensed health professionals who are also attorneys.

To contact The Health Law Firm, please call (407) 331-6620 or (850) 439-1001 and visit our website at www.TheHealthLawFirm.com.

Comments?

Did you or someone you know have a Stryker Rejuvenate or ABG II modular-neck femoral hip implant? What has been your experience? Did you know about the recall? Are you in need of legal assistance? Please leave comments below.

Sources:

Markos, Kibret. “Mahwah-based Stryker Orthopaedics Faces Hip Implant Lawsuits.” The Records. (February 28, 2013). From: http://www.northjersey.com/mahwah/Over_80_lawsuits_on_hip_implants_filed_against_Mahwah-based_Stryker_Orthopaedics_.html?c=y&page=3

Singer, Stacey. “Artificial Hips Corrode, Poisoning Some Patients, Local Lawsuits Say.” The Palm Beach Post. (January 27, 2013) From: http://www.palmbeachpost.com/news/lifestyles/health/artificial-hips-corrode-poisoning-some-patients-lo/nT7jf/

Hooks, Beau. “Stryker Hip Replacement Lawsuits.” Drug Watch. (February 2013). From: http://www.drugwatch.com/stryker/lawsuit-hip-replacement/

Guilfoyle, Jeanine. “Stryker Initiates Voluntary Product Recall of Modular-Neck Stems.” Stryker. (July 6, 2012). From: http://www.stryker.com/stellent/groups/corporate/documents/web_prod/147504.pdf

About the Author: George F. Indest III, J.D., M.P.A., LL.M., is Board Certified by The Florida Bar in Health Law. He is the President and Managing Partner of The Health Law Firm, which has a national practice. Its main office is in the Orlando, Florida, area. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Ave., Altamonte Springs, FL 32714, Phone: (407) 331-6620.

The Health Law Firm” is a registered fictitious business name of George F. Indest III, P.A. – The Health Law Firm, a Florida professional service corporation, since 1999.
Copyright © 1996-2012 The Health Law Firm. All rights reserved.

First Trial Over DePuy Hip Implants Finished – Plaintiff Receives $8.3 Million

GFI Blog LabelBy George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law and Carole C. Schriefer, R.N., J.D., The Health Law Firm

On March 8, 2013, a California jury ruled that Johnson and Johnson’s DePuy unit designed a defective metal-on-metal ASR XL hip implant and was negligent, according to Bloomberg News. The plaintiff in this case was awarded $8.3 million in compensation damages, after the jury found that the design of the hip implant was the reason behind the plaintiff’s injuries. This is the first trial, out of 10,750 lawsuits filed against DePuy’s ASR XL hip implant. Click here to read more on the first trial against DePuy from Bloomberg News.

In August 2010, DePuy recalled 93,000 ASR XL hip implants after 12 percent (12%) failed within five years. Last year, 44 percent (44%) allegedly failed in Australia within seven years. (Click here to see the press release on the recall from DePuy.) We recently blogged on similar problems with Stryker brand hip implants and similar litigation. Click here to read that blog.

Hip Implants Allegedly Sold with Design Flaws.

During the trial, attorneys for the plaintiff argued DePuy knew that the design flaws in the defective device could cause it to shed particles into patients.

Almost all the patients who filed lawsuits complain that DePuy’s ASR XL hip implants have caused them constant pain and follow-up surgeries, according to Bloomberg News.

DePuy Believes Product is Solid.

During the trial a DePuy spokeswoman said the company believes the ASR XL was properly designed and that the actions they took concerning the product were appropriate.

According to Bloomberg News, an attorney for DePuy said three things have to work well for a successful surgery: a doctor who does his/her job; a device that works properly; and a patient whose body responds to the implant. The attorney went on to say that the bodies of some patients with existing medical conditions did not react well to the implants, and they do not know why.

Second Lawsuit in Court in Illinois.

On March 12, 2013, a second trial began in Illinois. This time a nurse claims her DePuy hip failed after three years and she needed a replacement surgery. Click here to read more on the second trial.

DePuy has a long road ahead. The company faces about 500 lawsuits in state court in Illinois, about three-quarters of the total lawsuits were consolidated in the federal court in Ohio and more than 2,000 are in the state court in California. The next trial is scheduled for May in Ohio federal court.

DePuy Cases Very Similar to Those Against Stryker Orthopaedics.

As of February 2013, more than 80 lawsuits have been consolidated into multicounty litigation (MCL) in the Superior Court in New Jersey against Stryker Orthopaedics. Patients claim the company’s Rejuvenate and ABG II modular-neck femoral hip systems are defective, according to a number of news sources. The case is on track to becoming one of the largest mass-tort litigations in the country.

In July 2012, Stryker issued a voluntary recall of the Rejuvenate and ABG II modular-neck femoral hip systems. (Click here to see the press release from Stryker.) The company is currently in the process of sending out letters to surgeons urging them to perform clinical exams, such as blood work and cross sectional imaging, on patients who had implants installed. Click here to read a letter from Stryker to a surgeon.

Contact a Health Law Attorney Experienced in Products Liability Cases.

Since the implants were recently recalled, it’s expected that there are many more cases out there.  Many of the people who have already filed lawsuits claim Stryker marketed and sold a defective device and failed to warn the public, among other issues.

If you or a family member received a Stryker Rejuvenate or ABG II hip implant and suffered complications, you don’t have to face the medical issues alone. Contact an experienced attorney that is board certified in health law. Before you talk about settling, please call an attorney. Our attorneys include those who are board certified by The Florida Bar in Health Law, as well as licensed health professionals who are also attorneys.

To contact The Health Law Firm, please call (407) 331-6620 or (850) 439-1001 and visit our website at www.TheHealthLawFirm.com.

What Do You Think?

What do you think of the DePuy and Stryker lawsuits? Have you experienced complications for a hip implant? Please leave thoughtful comments below.

Sources:

Possley, Maurice, Voreacos, David and Pettersson, Edvard. “J&J Must Pay $8.3 Million Over Defective Hip, Jury Says.” Bloomberg. (March 8, 2013). From: http://www.bloomberg.com/news/2013-03-08/j-j-must-pay-8-3-million-in-suit-over-defective-hip-jury-says.html

Harris, Andrew and Voreacos, David. “J&J Faces Second Trial Over Recalled Hip After Loss.” Bloomberg. (March 12, 2013). From: http://www.bloomberg.com/news/2013-03-11/j-j-faces-second-trial-over-recalled-hip-after-losing-first-case.html

About the Authors: George F. Indest III, J.D., M.P.A., LL.M., is Board Certified by The Florida Bar in Health Law.  He is the President and Managing Partner of The Health Law Firm, which has a national practice.  Its main office is in the Orlando, Florida, area.  www.TheHealthLawFirm.com  The Health Law Firm, 1101 Douglas Ave., Altamonte Springs, FL 32714, Phone:  (407) 331-6620.

Carole C. Schriefer is an attorney with The Health Law Firm, which has a national practice. Its main office is in the Orlando, Florida, area. www.TheHealthLawFirm.com  The Health Law Firm, 1101 Douglas Avenue, Altamonte Springs, Florida 32714, Phone:  (407) 331-6620.

The Health Law Firm” is a registered fictitious business name of George F. Indest III, P.A. – The Health Law Firm, a Florida professional service corporation, since 1999.Copyright © 1996-2012 The Health Law Firm. All rights reserved.

FDA Issues New Warning for Popular Type 2 Diabetes Drug

2 Indest-2009-1By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law
The Food and Drug Administration (FDA) recently warned that a new class of type 2 diabetes drugs may cause a serious condition and can lead to hospitalization. Included in that warning is Invokana, the first in a new class of frontline treatment for type 2 diabetes. It was approved in 2013 and quickly gained popularity among health care providers and patients. Other drugs in the class include Invokament, Jardiance, Xigduo XR, Farxinga and Glyxambi. These drugs, known as SGLT2 inhibitors, are intended to improve glycemic control in patients with type 2 diabetes by blocking the absorption of glucose in the kidneys.

The Problem.

According to the FDA’s warning, SGLT2 inhibitors can lead to the development of diabetic ketoacidosis, a serious condition that can result in cerebral edema, pulmonary edema, heart attacks, strokes, cardiac dysrhythmia, nonspecific myocardial injury, diabetic retinopathy, severe dehydration, coma and death. The FDA recently took notice of these significant health risks and issued a safety announcement that warned of the serious side effects potentially resulting from treatment with SGLT2 inhibitors. To read the FDA’s warning, click here. To read one of our blogs on a similar case, click here. Click here to find out how The Health Law Firm can help you with a situation such as this.

Comments?

Did you develop ketoacidosis after taking a SGLT2 drug such as Inkovana? If you or a loved one took Invokana or another type 2 diabetes drug that resulted in ketoacidosis, you may have legal options. Please leave any thoughtful comments below.

About the Author: George F. Indest III, J.D., M.P.A., LL.M., is Board Certified by The Florida Bar in Health Law. He is the President and Managing Partner of The Health Law Firm, which has a national practice. Its main office is in the Orlando, Florida area. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Ave., Altamonte Springs, FL 32714, Phone: (407) 331-6620.

KeyWords: Food and Drug Administration, FDA, defense attoryney, defense lawyer, defense counsil, Inkovana, Type 2 Diabetes Drug, SGLT2 inhibitors, products liability attorney, products liability lawyer, ketoacidosis, safety announcement, recall, safety warning, drug side effects, plaintiff products liability attorney, health care attorney, health care lawyer, health law, The Health Law Firm

The Health Law Firm” is a registered fictitious business name of George F. Indest III, P.A. – The Health Law Firm, a Florida professional service corporation, since 1999.
Copyright © 1996-2015 The Health Law Firm. All rights reserved.

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