Hip implants aren’t the only defective medical devices giving patients problems.

An Illinois man has filed a product liability lawsuit alleging that he experienced problems with the Zimmer NexGen CR-Flex Porous knee replacement system as a result of a defective design. According to the lawsuit, the design caused the artificial knee to loosen inside the patient’s body and led to the need for additional surgery.

The complaint revolves around the same Zimmer NexGen knee replacement that was the focus of concern at the annual conference of the American Academy of Orthopaedic Surgeons last year. In March 2010, data was presented by several prominent surgeons, including Dr. Richard A. Berger, a former Zimmer knee implant consultant, that suggested Zimmer NexGen CR-Flex knee replacement problems resulted in revision surgery in nearly 9 percent of cases examined and resulted in knee replacement loosening in more than a third of the cases.

Although Zimmer previously paid Dr. Berger millions of dollars to work as an orthopaedic consultant, they reportedly dismissed the surgeon’s concerns and canceled their relationship with him. The medical device manufacturer suggested that the problems identified by Dr. Berger were caused by his surgical skills or technique, not the design of the device.

In August 2010, Senator Charles E. Grassley wrote a letter to the Zimmer CEO and President requesting additional information on what the company was doing to respond to complaints about failures with some Zimmer products and whether there were more consultants who had raised concerns about the company’s implants.

In September 2010, a Zimmer NexGen knee recall was issued for other components, including the NexGen TM Tibial Trays, NexGen MIS Tibial Components and MIS Modular Tibial Plates and Keels. The recall was issued after the company received at least 114 reports of Zimmer NexGen knee loosenings and other complications involving those products.

A growing number of Zimmer NexGen lawsuits are being pursued by individuals throughout the United States who have experienced loosening or failure of their knee replacement.

If you have had hip or knee replacement surgery and suffer from defective implants, please call us for professional insight.

After more than 50 product recalls in 15 months, including for artificial hips and Tylenol, the $60 billion company is fighting to clear its once-trusted name.

The recalls — voluntary and otherwise — reads like your family medicine cabinet: Tylenol and St. Joseph Aspirin were recalled for foul odors people said made them sick; Benadryl and Zyrtec were recalled for botched amounts of ingredients; Rolaids were recalled for containing bits of wood and metal.

Over the last 15 months, the company has recalled contact lenses, syringes filled with prescription medications, hernia devices, and other products made by subsidiaries around the world.

In the year ended Mar. 8, 2011, J&J was involved in at least 11 major recalls, as defined by the FDA, almost twice as many as Pfizer (PFE), the world’s largest health-care-products company by revenue, or Procter & Gamble (PG), the world’s largest consumer-products company.

J&J’s woes aren’t confined to the last couple of years. During the last decade, the company has been repeatedly confronted with claims that it sold a product that was defective, or that carried risks J&J downplayed in its marketing. It has been accused of paying kickbacks and using other financial incentives to promote off-label use of drugs and devices. It has been cited by federal authorities for trying to avoid the publicity of a recall by quietly buying up tainted products. And it frustrated FDA regulators who were urging the company to strengthen quality control at the factories that produced many of the recalled over-the-counter products.

J&J has steadfastly denied these claims, but its own annual report for 2010 contains eight pages detailing government criminal and civil investigations and thousands of private lawsuits covering a wide range of drugs, devices, and business practices.

If you’ve haven’t been keeping up, here is a recap of the recalls in just the last couple of years.

Johnson & Johnson’s recall rap sheet:

• AUG 2008: Consultants to J&J buy defective Motrin from stores. The FDA says it wasn’t notified of this “phantom recall.”
• NOV 2009: McNeil pulls about 6.3 million bottles of tainted Tylenol Arthritis Pain caplets made in Puerto Rico.
• JAN 2010: McNeil expands withdrawal to include Benadryl Allergy, Tylenol, Children’s Tylenol Meltaway, and Rolaids.
• APR 2010: J&J recalls 135 million bottles of meds made in Fort Washington, Pa., and closes the plant.
• MAY 2010: The FDA says the U.S. may pursue criminal charges against J&J.
• JUNE 2010: McNeil expands the recall from its Puerto Rico plant to include five more lots of Benadryl and Tylenol.
• JULY 2010: Yet more recalls; company submits remediation plan for McNeil plants to FDA.
• AUG 2010: Company appoints quality-control czar, announces corporation-wide standards.
• AUG 2010: J&J pulls 100,000 boxes of 1-Day Acuvue TruEye contact lenses; days later, DePuy recalls ASR hips.
• DEC 2010: 13 million packages of Rolaids softchews are recalled after customers find wood and metal particles in them.
• JAN 2011: J&J withdraws 43 million bottles of Rolaids, Tylenol, Benadryl, and Sinutab.
• JAN 2011: J&J announces 2010 earnings, puts lost sales from recalls and plant slowdowns at $900 million.
• FEB 2011: J&J units announce recalls of 70,000 potentially cracked syringes preloaded with the antipsychotic Invega.
• MAR 2011: J&J withdraws 585,000 surgical sutures due to concerns about compromised sterile packaging.
• MAR 2011: J&J’s Animas unit announces recall of 384,000 insulin-pump cartridges that may leak.
• MAR 2011: FDA and McNeil announce consent decree that will give agency expanded oversight of three plants.

Each year hundreds of thousands of Americans undergo elective hip replacement surgery. For the most part, few patients regret undergoing this surgery which reduces pain and increases their mobility.

Most of the prosthetic devices used are safe, however, through the years various orthopedic medical devices, such as prosthetic knees and prosthetic hips have been associated with complications.

DePuy Orthopaedics, a subsidiary of Johnson & Johnson is the latest manufacturer to recall a defective medical device.

On August 24, 2010 DePuy voluntarily recalled ASR XL Acetabular Hip System and DePuy ASR Hip Resurfacing System Implant products sold after 2006. It is estimated that 1 in 8 patients will suffer from complications. As a result medical monitoring including blood tests and X-rays may be necessary especially if a patient is experiencing pain or difficulty walking.

DePuy customers should avoid any discussions with company representatives since it may compromise their legal rights. There are many complex issues pertaining to the valuation of past, present and future pain and suffering; issues regarding the cost of ongoing medical monitoring and future revision surgery; as well as the potential reimbursement of medical claims by Medicare and other insurance company interests.

Before speaking with any representative it is advised to contact a lawyer skilled in medical device litigation.

All DePuy implant customers should speak to a lawyer to gain a full understanding of their rights concerning a problem which may last decades and should be leery of signing any documents or authorizations before consulting with lawyers.

An earlier Class I recall of saline flush syringes has now prompted a secondary FDA recall of venous catheter trays that included the defective syringes.

Cook Inc., of Bloomington, Ind., has issued an urgent recall for a series of defective central venous catheter trays, including single, double, triple, and five-lumen trays as well as single and double lumen PICC peripheral inserted central venous catheter trays.

The original Class I recall, announced in October 2010, involved certain lots of 6-mL prefilled saline flush syringes (0.9 percent sodium chloride) manufactured by Excelsior Medical Inc.

Leaks in the plunger luer were detected during a routine syringe leak test. The potential exists for leakage and possible loss of sterility.

After learning of the problem with this defective medical device, Cook initiated its own Class I recall. This class of recall means the affected products pose a risk of serious injury or death.

The recalled defective medical devices include 123 individual catheter products, which come packaged in trays containing different sizes. The catheters are used to monitor a patient’s pressure in a vein, for blood sampling, and administration of drugs and fluids.

Source: John Gever, Senior Editor, MedPage Today

The U.S. Food and Drug Administration (FDA) has been allowing tens of millions of relatively untested, unsafe medical devices to be marketed and sold in the U.S. and used in patients, according to an analysis published online by the Archives of Internal Medicine.

“We think patients will be shocked to learn how often new medical products using different materials, made by a different manufacturers, are not scientifically tested in humans to see how well they work,” said study authors in a statement released with the report.

Researchers examined the FDA’s list of high-risk device recalls issued between January 2005 and December 2009 to determine whether the devices had been approved using the rigorous premarket approval (PMA) process or the less-rigorous, less-expensive 510(k) process that does not require clinical testing or inspections of the manufacturing process.

Of the 113 high-risk device recalls issued in the four-year period, 71 percent of the devices had been cleared by the FDA using only the 510(k) process, a process typically intended for low-risk devices to speed along the approval process.

Only 19 percent of the recalled devices had been approved through the PMA process, which requires testing in actual patients as well as post-marketing safety studies. The remaining 7 percent of the recalled devices were exempt from regulation by the FDA.

“Our findings reveal critical flaws in the current FDA device review system and its implementation that will require either congressional action or major changes in regulatory policy,” wrote study authors Diana M. Zuckerman of the National Research Center for Women & Families in Washington, D.C., and Steven E. Nissen of the Cleveland Clinic in Cleveland.

About half of the studied device recalls involved cardiovascular devices such as automatic external defibrillators (AEDs) and implantable defibrillators.

The issue of untested, unapproved medical devices is an ongoing concern in connection with last year’s recall of two popular DePuy hip replacement systems in the U.S. The hip device has since been connected to numerous health complications, as the manufacturer was allowed to sell and market the defective hip replacements without having received FDA approval due to a loophole in the device approval process.

A judge accepted a guilty plea by a division of Boston Scientific on charges that it hid defects in heart defibrillators. In addition, the judge  placed the company on three years’ probation.

In August, Johnson & Johnson issued a voluntary recall for up to 93,000 artificial hips that had been surgically implanted since 2005.

The popular hip implant, the DePuy ASR XL Acetabular hip socket implant system, has an unacceptably high rate of failure. In fact, according to one study, one in eight of the implants have failed.

“That’s really a terrible track record,” said Richard Dodd, a senior partner with the Cappolino Dodd Krebs law firm in Cameron. The firm has extensive experience helping patients recover from the fallout of defective medical devices. “Most hip implants are given to older people for whom second surgeries can be life-threatening.

According to Dodd, symptoms of an implant failure include infection, bone fracture, dislocation and pain. In some cases, the implant can became loose in the socket which creates even more problems. Other complications of a failure of the DePuy Hip Implant include bone staining, necrosis, swelling, nerve damage, tissue damage and/or muscle damage. Increased metal toxicity from chromium and cobalt debris entering the blood stream of an unsuspecting patient can also lead to problems, even patients who have experienced no other symptoms.

Dodd said that many patients have received a recall notice, typically from the patient’s treating orthopedic surgeon, and urges patients to discuss any problems or symptoms with a doctor.  Of note, the letter indicates that DePuy will pay for the medical examination and any medical follow up listed in an “Information for Patients” sheet which should accompany the letter.

The letter also includes a medical release form. Dodd cautioned patients against signing the release form without consulting an attorney about it.

“We’re finding that DePuy is using this private medical information to twist the claim back on the patient,” he said. “I know it sounds strange but DePuy’s attorneys can and will use this information to build the case that the patient abused the implant.”

Even if DePuy does cover the costs of a revision surgery, Dodd warned that a second hip surgeries are technically more difficult, take longer to perform, place the patient at risk of higher complications and take longer to recover from.

“That’s in addition to the pain and suffering, invasive surgery, risk for infection, general complications and even risk of death,” he said.

Dodd urged patients who have had implant surgery since 2005 and know that it was a DePuy implant, to call your doctor right away. “Don’t sign anything that would let anyone other than your doctor have access to your medical records without first talking to an attorney.”

Is the Food and Drug Administration properly overseeing the approval and manufacturing of medical devices? This is the question brought by a House Energy and Commerce subcommittee who is seeking legislation to increase oversight of the FDA.

The Congressional subcommittee claims that the FDA has serious deficiencies in their reviewing processes, substandard postmarket surveillance, and that they irregularly inspected manufacturing facilities.

Their basic solution is this—allow consumers to file lawsuits against manufacturers of defective medical devices directly instead of just filing incidences with the FDA. This would prevent companies from being able to hide behind inadequate FDA standards for the products, thus ensuring safer devices.

Approximately 21,000 Kappa and Sigma pacemakers have been recalled by the FDA due to a wiring defect that could cause a severe heart injury or death.

Medtronic first notified physicians and patients of the pacemaker defects in May, reporting that there had been at least two fatalities potentially connected with the wiring. The FDA has now classified the action as a “Class I” recall, which indicates that the product carries a reasonable probability of adverse health consequences of death.

While the recall only applies to about 21,000 of the more than 1.7 million Kappa or Sigma pacemakers implanted throughout the world, approximately 15,200 patients with Medtronic Kappa pacemakers installed for five years or longer and another 6,100 patients with Medronic Sigma pacemakers installed for more than five years are included in the recall. Medtronic Kappa Series 600/700/900 pacemakers and Sigma Series 100/200/300 pacemakers could be affected by this latest recall. These devices were manufactured primarily between November 2000 and November 2002.

According to a letter sent to healthcare professionals on May 18, 2009, Medtronic did not recommend that physicians consider replacing the device unless a patient is pacemaker dependent or a device is already at the elective replacment time.

Patients experiencing problems with a defective pacemaker may show signs of lightheadedness and fainting, and should contact their doctor if these signs occur.

Hundreds of deaths and thousands of injuries can be traced to defective medical devices each year.

The Heart Rhythm Society has said that defibrillator lead wires need better surveillance to detect defects, and has called on hospitals to train doctors in the delicate procedure of removing such wires from patients.

The lead is a wire that connects an implantable defibrillator to the heart. If a lead breaks, the defibrillator can emit a massive and painful shock, and in the worst case scenario, preventing a defibrillator from sending a necessary shock to the heart.

In 2007, Medtronic Inc.’s Sprint Fidelis lead was removed from the market following reports of 5 deaths due to lead fractures with another 13 deaths caused by “possible or likely contributing factor” of defective leads.

Before the recall, Sprint Fidelis leads had been implanted with 90% of Medtronic’s defibrillators, and around 150,000 people are still implanted with a Sprint Fidelis lead.

The Heart Rhythm Society used the Sprint Fidelis recall in its request for a surveillance system to track lead performance in order to spot defective devices earlier. The group also said hospitals need to train more doctors to remove faulty defibrillator leads.

During the Sprint Fidelis recall, four deaths occurred when doctors tried to remove defect leads from patients. The group said physicians should perform at least 40 extractions under expert supervision before operating on their own. Supervising physicians should have performed at least 75 extractions with a high rate of success, the group states. They also recommended that such training take place only medical centers that perform a large number of lead extractions each year should train physicians to perform the surgery.

Finally, the group called on the FDA to require that new defibrillator leads be tested in humans before they are approved. Currently, most leads are approved through the agency’s fast track process, which is reserved for devices that are considered modifications of existing products. The fast track process does not require human studies.

If you or someone you love has been injured by a defective medical device, it’s important to seek out expert advice of an experienced defective drug attorney for valuable insight.