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.

Partial Settlement in Chinese Drywall MDL

A partial “settlement” has been reached with Interior/Exterior Building Supply LP, the New Orleans company that distributed the Knauf-brand imported Chinese drywall from Texas to Alabama, and its insurers. It appears that the settlement is broken down into two groups-“Louisiana homeowners” and “Non-Louisiana homeowners”. No details are available yet on how and when money could be distributed to eligible homeowners.

Under the deal, which is still subject to court approval, Interior/Exterior's two primary insurers will put up the $8 million limit of their insurance policies to compensate homeowners. Sadly, this amount is but a drop in the bucket to cover remediation and health care costs related to the toxic drywall. That is why later this year, the plaintiffs will proceed to trial against Interior/Exterior's excess insurers, who have another $72 million in coverage.

Drywall was imported from China from 2004 to 2008 because the domestic drywall industry couldn't keep up with the demands of the housing boom and massive rebuilding efforts in the Gulf South after the 2004 and 2005 hurricane season. The drywall releases sulfuric gases that corrode metal appliances and components in homes, and residents of homes with problem drywall complain that it gives them headaches and respiratory ailments. They have been stuck living in houses they can't afford to fix and are unable to sell because insurers won't cover Chinese drywall related damages.

Today's settlement builds upon a deal that was reached in October with Knauf Plasterboard Tianjin, a Chinese manufacturing unit of the German company Knauf Gips. Knauf and other entities that dealt with the problem drywall, including Interior/Exterior, agreed to pay for a pilot program to remediate 300 homes with Knauf-brand drywall in Louisiana, Mississippi, Alabama and Florida. The program launched in February with homes in Florida, and in March with homes in Louisiana. Moss & Associates, the Florida contractor hired to run the program, has said that all 300 homes should be enrolled in the program by the end of June, and all work should be completed by the end of the year. The pilot program has been slow and there were some delays to begin the program.

The goal of the program was to get a more realistic sense of what it costs to repair a home with bad drywall, and use it to confect a larger settlement. But it only touches 300 homes in four states, while the U.S. Consumer Product Safety Commission has received complaints from about 6,300 homeowners in 38 states, and some estimates say tens of thousands of homes are affected. Louisiana has the second highest number of complaints on file at the CPSC, behind Florida. It also appears that more and more Knauf homes are being discovered in Alabama, and particularly in the mid-to-northern counties of the State.

Knauf is believed to be the largest company that manufactured bad drywall, and it is the only manufacturer that has voluntarily stepped up to try to resolve problems. Interior/Exterior, based out of New Orleans, is Knauf's primary distributor in the South.

Our firm is currently investigating Chinese drywall claims. If you or a loved one have been injured by toxic Chinese drywall, 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.

Florida Judge Rules in Plaintiffs' Favor Against Builders in Chinese Drywall Suit

Judge Glenn Kelley of the 15th Judicial Circuit in Palm Beach County, Fla., said that builders and installers can only be held liable for “negligence” in faulty drywall cases if they had actual or implied notice of a defect in the Chinese manufactured drywall at the time of construction. Plaintiffs must prove that the builders and others should have known the drywall was defective.

While the ruling affects only Palm Beach County, Plaintiffs hope it will sway court decisions being made across Florida and the country, particularly in the MDL out of New Orleans, which consolidated federal drywall cases brought by thousands of aggrieved homeowners.

During the devastating hurricane seasons of 2004-2005 combined with the large home construction boom, drywall, which is gypsum pressed between paper and used in walls and ceilings, was imported from China to fill a domestic shortage. A growing number of homeowners complain of egg-like odors and corrosion that tarnishes metals and causes appliances such as air conditioners to fail. The government recommends consumers remove any possibly faulty drywall.

While several court settlements and decisions have been reached, the role and liability of home-building companies and the distributors of the drywall  remain unclear. Last year, Knauf Plasterboard Tianjin, one of the biggest suppliers of the problematic wallboard, along with suppliers and commercial liability insurers, agreed to remove and replace drywall they made and sold, as well as all electrical wiring, gas tubing and appliances, at 300 homes in four states. That pilot program is still being implemented, but not quick enough for the homeowners.