Zimmer Recalls Persona Knee Replacement Components

On March 12, 2015, Zimmer issued a voluntary recall of the Persona Trabecular Metal Tibial Plate following an increase in complaints of loosening and radiolucent lines (x-ray evidence of separation of the metal plate from the bone). The loosening of the device can result in severe pain and the need for revision surgery.

According to the FDA, this recall affects 11,658 of these knee components worldwide. Zimmer distributed the recalled Persona Trabecular Metal Tibial plates in at least 25 states and at 13 major Veterans' Administration medical centers throughout the U.S. from Nov. 29, 2012 until Jan. 23, 2015. This recall does not involve the femoral component or cemented tibial plates.

Zimmer marketed the Persona Knee as the “most clinically successful knee replacement more personalized than ever.” Yet, patients who were implanted with the Persona Knee have experienced serious problems or needed revision surgery.

Complications can include:

•       Loosening of the implant

•       Pain

•       Limited mobility

•       Numbness or stiffness in the leg

•       Appearance of radiolucent lines on x-ray

•       Early implant failure of the knee implant

•       Need for revision surgery

If you or someone you know received the Zimmer Persona Trabecular Metal Tibial Plate and have experienced complications, please call Booth Samuels at (866) 515-8880 or by email at booths@pittmandutton.com

Johnson & Johnson Exec To Resign

Johnson & Johnson Chief Executive William Weldon will step down from his post in April after a series of recalls called into question the quality of the health care conglomerate's products, from artificial hips to infant Tylenol.  Vice Chairman Alex Gorsky, 51, will become CEO effective April 26, the date of J&J's next board meeting, the company said. Gorsky was also nominated to the board, it added. Weldon, 63, remains the chairman.  The conglomerate, which had more than 250 companies under the J&J umbrella, has been plagued by a series of massive recalls across a wide range of product and medicine lines over the past two years.  The quality control problems at J&J's consumer healthcare unit were deemed so pervasive that last March, U.S. health regulators took over supervision of three J&J manufacturing plants.

The Cost of Metal-on-Metal Hip Implants

Some are calling metal-on-metal hip implants the most widespread medical implant failure in decades. Medical and legal experts estimate the hip failures may cost taxpayers, insurers, employers and others billions of dollars in coming years, contributing to the soaring cost of health care. The financial fallout is expected to be unusually large and complex because the episode involves a class of products, not a single device or just one company. There are many companies that manufacture and market metal-on-metal hip prosthetics, but the company most in the spotlight is DePuy Orthopaedics, a division of Johnson & Johnson.

The device’s ball and joint are made of metal and are failing at high rates within a few years instead of lasting 10 to 15 years or more, as artificial joints normally do. The wear of metal parts against each other is generating debris that is damaging tissue and, in some cases, crippling patients. Often times, this leads to metallosis, which can cause pseudo-tumors.

The incidents have set off a financial scramble. The New York Times recently reported that lawsuits and complaints against makers of all-metal replacement hips passed the 5,000 mark. Insurers are alerting patients that they plan to recover their expenses from any settlement money that patients receive. Medicare is also expected to try to recover its costs. However, this occurs in almost any lawsuit where a plaintiff is injured and a third-party has paid medical expenses related to that injury. The problem here is the grand scale of that recovery.

The New York Times reported that until a recent sharp decline, all-metal implants accounted for nearly one-third of the estimated 250,000 hip replacements performed each year in the United States. Most of that decline can be attributed to the recall of the ASR hip, which some estimate to have been implanted in 40,000 patients in the United States. As of October, some 3,500 patients had filed a lawsuit involving that device.

Some 500,000 patients have received an all-metal replacement hip, according to one estimate. A new study found that no new artificial hip or knee introduced during a recent five-year period — implants that included some of the all-metal hips — were more durable than older devices, and 30 percent were worse. The numbers on this are stifling. Does this mean that metal-on-metal technology, whether it involves hips or knees, is a complete failure?

Unfortunately, there is no data on the number of all-metal hips, or any prosthetic hip for that matter, that have failed prematurely in the United States because the outcomes of orthopedic procedures are not formally tracked by our government or private companies. However, by analyzing data from overseas and comparing that data to the estimated numbers in the United States, tens of thousands of patients in our country may have to undergo operations over the next decade to replace the implants. This is the conclusion of Dr. Art Sedrakyan, a researcher at Weill Cornell Medical College of Cornell University, who is studying the hip problem.

DePuy would not comment on how much it had paid in recall-related costs. But a spokeswoman, Mindy Tinsley, said in a statement that DePuy was working with patients and insurers.

Along with the ASR-related cases, DePuy also faces over 560 lawsuits in connection with the all-metal version of another hip model, called the Pinnacle. DePuy has not issued a recall of the Pinnacle because the company says that the model is performing well. Nevertheless, Pinnacles are being replaced and the costs for their replacement are being borne by Medicare, insurers or patients themselves.

If you or a loved one have had hip replacement surgery and have been implanted with a defective DePuy hip, you may be entitled to compensation for medical bills, pain and suffering, lost wages and other injuries. Our firm is currently investigating claims for those people who have been implanted with DePuy hip replacement devices, both ASR and Pinnacle. If you would like a free case evaluation, please contact Booth Samuels toll free at 1-866-515-8880 or at booths@pittmandutton.com.

Another Headache for Zimmer

More than 200,000 potentially defective Zimmer NexGen knee components may have been implanted throughout the United States, which could have caused thousands of people to experience problems or require additional knee revision surgery due to early failure of their Zimmer knee replacement.

The majority, 85%-90%, of total knee replacements last for up to 10 years or even longer. However, some recipients of the Zimmer NexGen CR-Flex implant are experiencing loosening and other failures, sometimes within the first two years of surgery. In September 2010, the tibial portion of the Zimmer CR-Flex implant was recalled.

One reason for knee implant failure is the implant loosens from the femur bone where it is affixed. Loosening, for reasons other than infection or rejection, can occur because the cement holding it in place crumbles or the bone reabsorbs the cement used. In a standard knee implant, loosening is thought to occur in 1% of patients per year. Loosening will occur with knee implants 25% of the time after 10 years and require a second, revision surgery.

Loosening can be very serious to your health because movement between the implant and femur can impede blood supply to the bone tissue. When this occurs, only soft tissue can grow between the implant and the bone, which results in an unstable implant. The symptoms of loosening are often unusual stiffness, persistent pain, difficulty performing any weight bearing activity and diminished range of motion in the knee.

If you suspect that your implant may have loosened, it is important to see your physician. Your doctor will likely perform bone scans and X-rays to determine the viability of your implant. Our firm is currently investigating claims for those people who have Zimmer knee implants and have been injured. If you would like a free case evaluation, please contact Booth Samuels toll free at 1-866-515-8880 or at booths@pittmandutton.com.

Johnson & Johnson CEO Answers to Recalls

Johnson & Johnson's CEO says he hopes most of the company's product recalls are behind it, but he can't use the word never. William Weldon has run the health care giant since 2002. He says J&J has learned some lessons, invested heavily in improving quality and will work to regain consumer confidence.

Since September 2009, the company has had about two dozen recalls of prescription and nonprescription medicines, replacement hips, contact lenses and diabetes test strips. These recalls include recalls from J&J’s subsidiary companies, such as DePuy. One of its consumer health products factories is still being upgraded a year after it was closed, and two others are under close scrutiny by federal regulators. Even Congress has been investigating J&J's handling of recalls. Weldon will face shareholders at J&J's annual meeting April 28.

Among the many products recalled by the corporate giant is the DePuy ASR XL hip device. This hip prosthesis is a metal-on-metal device which causes, among other things, pain, inflammation and swelling. The constant friction between the metal parts releases cobalt and chromium into the blood stream and body. This in turn results in metallosis, a dangerous form of poisoning which can lead to rashes, soft-tissue damage, pseudo-tumors and neurological disorders.

DePuy also manufactures a Pinnacle Hip System. Some of the Pinnacle hips are metal-on-metal, which are extremely similar to the ASR hip device. Lawsuits have been filed by patients who were implanted with the Pinnacle device alleging the Pinnacle has caused similar damages to those patients who were implanted with the ASR hip devices. Our firm is currently investigating claims for those people who have been implanted with DePuy hip replacement devices, both ASR and Pinnacle. If you would like a free case evaluation, please contact Booth Samuels at toll free 1-866-515-8880 or at booths@pittmandutton.com.

DePuy Pinnacle MDL News

Since DePuy was forced to recall the defective ASR hip implants in August, an MDL was formed to handle those lawsuits. Attorneys who have filed lawsuits on behalf of clients who have been injured by DePuy’s Pinnacle Hip System have petitioned the U.S. Judicial Panel on Multidistrict Litigation that all of the federal DePuy Pinnacle lawsuits be consolidated and centralized before a single District Judge.  If the panel agrees to form a DePuy Pinnacle MDL, a new MDL will be formed that will solely focus on DePuy Pinnacle lawsuits. The likelihood that an MDL for Pinnacles would be attached to or included with the ASR MDL is highly unlikely.  

This MDL will function in a similar manner as the MDL for ASR’s. All discovery and pretrial motions will be consolidated under one District Judge and the lawsuits will revert back to their original districts for trial, if necessary. Injuries from the Pinnacle Hip System are similar to ASR injuries: pain, swelling, inflammation and metal poisoning. High levels of cobalt and chromium found in blood and urine samples are causing the most alarm as metallosis can cause rashes, soft-tissue damage and pseudo-tumors.

If you or a loved one have had hip replacement surgery and have been implanted with a defective DePuy hip, you may be entitled to compensation for medical bills, pain and suffering, lost wages and other injuries. Our firm is currently investigating claims for those people who have been implanted with DePuy hip replacement devices, both ASR and Pinnacle. If you would like a free case evaluation, please contact Booth Samuels at toll free 1-866-515-8880 or at booths@pittmandutton.com.

Yaz and Yazmin Recall Urged

A number of women who have suffered an injury caused by side effects of Yaz and Yasmin birth control are expected to call for Bayer to issue a Yaz recall  at an upcoming shareholder’s meeting, as the popular birth control pills may be responsible for the death of more than 190 women in the United States. However, that number is likely only a fraction of the actual number of deaths from Yasmin and Yaz, as it is widely acknowledged that only about 1% to 10% of all adverse events associated with the use of medications are ever reported.

Bayer holds its annual shareholder meeting on April 29 in Cologne, Germany. About 4,000 shareholders are expected to participate in the meeting and vote on the future of the company. According to the group Coalition against Bayer Dangers (CBG), based in Germany, several women will speak out at the meeting about the dangers posed by health problems from Yaz and Yasmin, which will include countermotions by CBG to rein in what it considers to be irresponsible corporate activity by Bayer. The group points out that Bayer’s line of drosperinone-based oral contraceptives, including Yaz and Yasmin, have been found to carry an 80% increased risk of thrombosis events than older birth control pills by some studies. They are calling for a recall of Yaz, Yasmin and all other birth control products made by Bayer that contain drosperinone.

Thousands of women throughout the United States have filed a Yaz lawsuit or Yasmin lawsuit against Bayer, alleging that the drug maker failed to adequately research the risks associated with the medication or warn women that they may be exposed to an increased risk of serious and potentially fatal side effects when using the birth control pills. Lawsuits also allege that Bayer engaged in deceptive and misleading advertisements that were directed to consumers and the medical community.

Our firm is currently investigating claims for those women who have been injured by Yaz or Yasmin. If you would like a free case evaluation, please contact Booth Samuels at toll free 1-866-515-8880 or at booths@pittmandutton.com.

Johnson & Johnson News

U.S.-Swiss medical device maker Synthes Inc. confirmed Monday it is in talks to be bought out by health giant Johnson & Johnson, in a deal that could make its chairman Switzerland's richest man. Synthes makes surgical instruments, implants and materials for repairing bone and soft tissue. Johnson & Johnson, which is under close Food and Drug Administration scrutiny over repeated product recalls, hopes to boost its medical equipment business. J&J owns DePuy, manufacturers of the ASR XL prosthetic hip device that was recalled in the fall of 2010. Johnson & Johnson's repeated product recalls have resulted in the year-long closure of a nonprescription medicine factory in Fort Washington, Pennsylvania, a Philadelphia suburb.

Shares of Synthes jumped Friday after the Wall Street Journal reported that J&J is in talks to buy the company, possibly for about $20 billion, which is far bigger than a typical J&J acquisition, but well below the price of recent pharmaceutical megamergers. Shares of Johnson & Johnson, the world's largest health-care company, were trading slightly higher in early trading in New York.

Synthes is based in West Chester, Pennsylvania, but has its global headquarters in Solothurn, Switzerland.
Like Johnson & Johnson, Synthes has had recent trouble with regulators. In 2010, Synthes pleaded guilty to a felony and dozens of misdemeanor crimes over unauthorized testing of its bone cement on spinal surgery patients, even though the cement was approved only for use in the arm. Three patients died on the operating table. Synthes and subsidiary Norian Corp. performed the tests from 2002 to 2004. The companies agreed to pay $23 million in fines.

DEPUY PINNACLE RECALL ON THE HORIZON???

In the fall of 2010, a recall was implemented for the DePuy ASR hip replacement system, causing the public to question DePuy’s reliability as the leading medical device manufacturer in the world. DePuy is a subsidiary of Johnson & Johnson. When the recall was initiated, the failure rate of the ASR system was estimated to be 12-13% among patients. DePuy has another hip replacement system called the Pinnacle which is similar to the recalled ASR model.

The U.S. Food and Drug Administration (FDA) allowed the marketing of the DePuy ASR system to the public through the 510(k) approval process on the basis that the device was substantially equivalent to the DePuy Pinnacle hip replacement system already approved for distribution. The 510(k) approval process allows a medical device to be placed on the market without being subjected to necessary clinical trials. The ASR system is a metal-on-metal hip replacement device that utilizes a metal ball and metal lined cup to replicate the natural movement of a hip joint. Some Pinnacle hips are also metal-on-metal because the device can include a metal liner. DePuy claimed that metal-on-metal hip replacements have increased durability.

The most prevalent and serious problem associated with metal-on-metal hips is metallosis, which can lead to soft-tissue damage, rashes and pseudo-tumors. Another common complaint of the DePuy Pinnacle hip replacement system is loosening of the device. One of the more serious complications is bacterial infection, occurring more often in elderly or obese patients. In addition, blood clot formation is another life-threatening condition, especially if the clot travels through the bloodstream and causes a stroke.

Although a DePuy Pinnacle hip recall has not been issued, patients who have been implanted with the DePuy Pinnacle Acetabular Cup System may have legal recourse. Several DePuy Pinnacle lawsuits have already been filed, and patients experiencing DePuy Pinnacle problems with the metal-on-metal systems may be able to participate in a similar legal action. Our firm is currently investigating claims for those people who have been implanted with DePuy hip replacement devices, both ASR and Pinnacle. If you would like a free case evaluation, please contact Booth Samuels at toll free 1-866-515-8880 or at booths@pittmandutton.com.

Birmingham IV Infections Update

The Alabama Department of Public Health and the Centers for Disease Control and Prevention have been investigating the outbreak of Serratia marcescens in five hospitals around Birmingham and one in Prattville. It is linked to bags of TPN, total parenteral nutrition -- a supplement given intravenously to patients too sick to eat -- mixed by Meds IV and sent to those hospitals in January, February and March.

A failure in the sterilization process at a Birmingham pharmacy appears to have caused the infection that sickened 19 people in Alabama hospitals, nine of whom died, the Alabama state health department said Thursday. Investigators found exact matches of the bacteria on a water faucet, a container and a device used to mix intravenous nutritious supplements at Meds IV. But there are still questions about how the contamination occurred.  "We've identified the weak point in the chain where infection occurred," State Health Officer Don Williamson said. "We're now trying to figure out exactly what happened."

Samples of the bacteria were taken from Meds IV's compounding room, grown out and run through a genetic fingerprinting process. The same strain found in the TPN and in 12 patients turned up on the water tap and mixing equipment. Samples weren't available from six patients and one is still in process, the health department said.

S. marcescens also grew from samples taken from a bag of amino acids used to make the TPN, but that culture hasn't been fingerprinted yet. Investigators suspect it will match and was tainted at the pharmacy.
Williamson said Meds IV staff used tap water to wash the mixing vessel before rinsing it with sterile water. Then the amino acid solution, which was mixed from a powder and sterile water, was also contaminated by touching the equipment. That amino acid mixture is supposed to be run through a filter small enough to catch the bacteria, but for some reason, that didn't work. At this point, he said, it's not clear what went wrong, and whether the problem lies in the process itself, a flaw in the filtering equipment or in human error.

Investigators are working with the Alabama Board of Pharmacy and federal Food and Drug Administration to find out more about what went wrong. Williamson said investigators plan to look at patients who received TPN in those six hospitals but did not show signs of infection and is working with the FDA to get samples of other recalled products made by Meds IV. Fortunately, it does not appear that there is any additional contamination.

We are currently investigating this recall and are available for a  free consultation regarding a Meds IV lawsuit. Call 1-866-515-8880 (toll free) or email booths@pittmandutton.com

Birmingham Area IV Bag Contamination Update

Nine people died and 10 more were sickened in six Alabama hospitals after receiving IV packs filled with liquid nutritional supplements that were contaminated. Inspectors have identified the contaminate as the bacteria Serratia marcescens, organisms that can cause infection in several sites on the body including the urinary tract, respiratory tract, eyes, and in wounds.

In this case the bacteria entered the bloodstream due to the contaminated IV fluids. The bacteria can cause pneumonia and meningitis, and the infections are often fatal.

The Centers for Disease Control and Prevention (CDC) has identified six Alabama hospitals where infections were confirmed - Princeton Baptist Medical Center, Shelby Baptist Medical Center, Cooper Green Mercy Hospital, Medical West, Prattville Baptist Hospital and Select Specialty Hospital, a long-term acute care hospital that operates within Trinity Medical Center.

In addition to the deaths, a total of 19 people were confirmed to be infected. A Birmingham pharmacy, Meds IV, was reported as being the supplier. According to officials, the contaminated bags have been removed off the shelves and the threat of injury or more wrongful deaths to more Alabama hospital patients has been contained.