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.

Topamax: Another Headache For J&J

Topamax was first approved in 1998 by the FDA for the treatment of seizures due to epilepsy. The drug is also referred to by the generic name Topiramate.  In 2004, it was also approved for treating migraine headaches.  It has been increasingly reported that Topamax has been linked to serious birth defects such as cleft palate/cleft lip.  On March 4 of this year, the FDA required the manufacturers of Topamax to significantly strengthen warnings for the drug because of increasing data linking the product to certain types of birth defects including cleft lip/cleft palate and genital malformations including Hypospadias.

It appears that the greatest risk to the unborn baby comes from exposure to the drug during the first trimester of the pregnancy. During this extremely important developmental period, the mother may or may not know that she is pregnant. Therefore, it is not just women that know they are pregnant that are risk, but any woman of childbearing age taking Topamax could get unexpectedly pregnant and have a child with a cleft lip/cleft palate. One study shows that expecting mothers on Topamax are 21.3 times more likely to give birth to infants with oral birth defects (most notably, cleft lips or cleft palates) compared to the risk in a background population of untreated women.

Topamax is manufactured by Ortho-McNeil Pharmaceutical LLC, a subsidiary of Johnson & Johnson. From January 2007 through December 2010, approximately 32.3 million Topamax prescriptions were filled for over 4 million people in the United States.  Ortho-McNeil has made a fortune off of Topamax. 

J&J has had a large amount of recalled products in the last year and a half, notably the DePuy ASR Hip device recalled in the fall of 2010. In fact in April of 2011, J&J recalled close to 57,000 bottles of Topamax because of complaints of an odor. This odor is believed to be caused by trace amounts of a chemical used to preserve the wooden pallets the medicine sits on in storage -- that's the same cause that prompted gigantic recalls of Tylenol and other over-the-counter medications at McNeil Consumer Healthcare. The two companies are both part of Johnson & Johnson. Generic versions of the drug have been available since 2006.

In March of 2010, Ortho-McNeil pled guilty and paid $6.14 million in criminal fines for the misbranding of Topamax. Ortho-McNeil also paid an additional $75.37 million to resolve civil allegations (mostly reimbursement for fraudulent Medicare claims).   The U.S. government said that Ortho-McNeil promoted Topamax by hiring doctors to join sales representatives in promoting Topamax for unapproved uses in unapproved doses for medical indications not covered by those programs. Reports indicate they promoted the drug as a way to help with weight loss and pain. The federal share of the civil settlement is $50,688,483.52, and the state Medicaid share of the civil settlement is $24,681,516.48.

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

Zimmer Durom Hip Problems

Zimmer hip replacement has been making the news ever since Dr. Lawrence Dorr, renowned orthopedic surgeon and director of the Dorr Institute for Arthritis Research and Education, alerted doctors and the medical community in 2008 with regard to a high failure rate of the Durom Acetabular Component, otherwise known as the Zimmer Durom Cup.

In his warning to doctors, Dorr referenced 10 revisions out of 165 hip surgeries involving the Durom Cup, with four additional surgeries then in the pipeline to replace failed Zimmer defective hip replacements.

"This failure rate has occurred within the first two years," Dorr writes. "In the first year the x-rays looked perfect. We have revised four that did not have any radiolucent lines or migration. These early cups fooled us, but the symptoms were so classic for a loose implant that we operated on the patients. When we hit on the edge of the cup it would just pop free. As time goes by the cups begin developing radiolucent lines.

"We now have one cup at two years that has actually migrated a short distance. It has tilted into varus. We do not believe the fixation surface is good on these cups. Also there is a circular cutting surface on the periphery of the cup that we believe prevents the cup from fully seating. We stopped using the cup after the first revisions."

Zimmer has refused to admit that there is a product defect with the Durom components and, instead, has argued that surgeons lack the required skill or finesse to be able to implant the Durom components. However, Zimmer stopped selling their hip replacement device in July 2008. The corporation went ahead and funded a study and found that 8 percent of the people that received the initial hip replacement required a revision surgery within a two year period. This has led many in the medical and legal communities to believe that the issue is with the replacement device and not with the surgeons.

Our firm is currently investigating claims for those people who have been implanted with Zimmer Durom hip replacement devices. If you would like a free case evaluation, please contact Booth Samuels at toll free 1-866-515-8880 or at booths@pittmandutton.com.