Pfizer has been ordered to pay $142.1 million for off-label marketing of its epilepsy drug Neurontin. Federal judge Patti B. Saris upheld a jury’s verdict in favor of Kaiser Foundation Health Plan and Kaiser Foundation Hospitals that Pfizer had been marketing Neurontin for uses that had not been approved by the FDA.
The judge’s ruling is significant in that she awarded treble damages under the Racketeer Influenced and Corrupt Organizations Act of 1970. The original award was $47.3 million. In the lawsuit, Kaiser claimed it had been forced to pay Pfizer $90 million more than it should have for the drug Neurontin.
According to the NY Times, “Pfizer currently faces more than 300 suits accusing it of illegally promoting Neurontin or hiding its health risks. Lawyers for former users of Neurontin contend the drug maker knew the medicine posed a suicide risk and failed to disclose it to patients and doctors.
The Warner-Lambert Company developed and marketed Neurontin for several years before Pfizer acquired the drug maker in 2000. Four years later, Warner-Lambert pleaded guilty and agreed to pay $430 million to resolve off-label marketing allegations by the Justice Department.”
Six state hospital doctors will face felony charges for allegedly accepting secret payments from DePuy Inc. in exchange for using DePuy products. Last year, a former DePuy executive was found guilty of making illegal payments to doctors in the Greek public healthcare system. That case involved DePuy making payments to doctors in exchange for the doctors’ use of DePuy orthopedic products from 2002-2005.
The pending criminal charges couldn’t come at a worse time for DePuy Inc., a subsidiary of Johnson & Johnson. DePuy faces mounting defective hip lawsuits regarding its recalled DePuy ASR XL hip implant products. The ASR XL was recalled last year due to a higher than acceptable failure rate as well as the potential for DePuy patients suffering from metallosis or metal poisoning as a result of having a DePuy ASR XL hip implant.
Last week, I attended the first court hearing for the newly formed DePuy ASR XL MDL hip implant litigation. If you’ve had a recent hip implant in the last few years and are experiencing difficulty or don’t know the type of hip product you received, consult your physician to ensure that the hip implant you received is not the DePuy ASR XL or a similarly defective hip the Zimmer Durom Cup. We represent both DePux hip clients as well as those affected by Zimmer Durom Cup hip products.
I saw many friends from past hip implant litigations at the first court hearing on the DePuy ASR Hip Implant Litigation in West Palm Beach, Florida on Thursday, January 20, 2011. The DePuy Hip Implant Litigation has been consolidated in a federal multidistrict litigation before Judge David Katz in Toledo, Ohio. However, Judge Katz was hearing cases in West Palm Beach, Florida under a longstanding program in which senior federal judges can serve temporarily in Florida to help the judges down here with their caseloads.
So many lawyers appeared for the hearing that Judge Katz had to move the hearing to a larger courtroom. There were close to one hundred lawyers present for the hearing. Judge Katz described how he intended to handle the litigation and asked lawyers to speak about the composition of the steering committees and about the management of the cases. I suggested to Judge Katz that a geographically diverse steering committee would help with communication between the court and the lawyers and clients throughout the country. The hearing went on for most of the day. Judge Katz spent most of the time listening to lawyers suggestions and opinions about the most effective ways to manage the litigation. I could see that Judge Katz was genuinely interested in the lawyers opinions and comments and took notes throughout the lawyers presentations.
Judge Katz discussed his interest in the importance of settlement discussions as well as the management of the litigation process.
Many of the lawyers that were present that I knew had been active in the prior Sulzer Hip Implant Litigation, the Stryker hip implant litigation, and the Zimmer Durom Cup hip cases. It was encouraging to to me to see so much interest among so many good lawyers in representing consumers who suffered injury from the ASR hips. I think this is a good sign that injured hip implant patients will get a fair hearing in these court cases.
Two unrelated incidents this past week reveal much about where the Catholic Church stands regarding the sex abuse scandal that has plagued the institution for the last decade. Catholic officials, including bishops, archbishops, even the Pope, have often said they always cooperate with civil authorities in investigating allegations of sexual abuse. In fact, the US bishops continue to tout their “zero tolerance” policy when it comes to clergy that have been “credibly” accused of the abuse of minors. We’ve heard seemingly heartfelt statements from the Pope, bishops and archbishops about their anguish in learning of the survivors’ struggles. The words have always been well crafted. Yet, actions always speak louder and more eloquently than words.
This past week, we discovered that the senior Vatican representative to Ireland sent a letter to the Irish bishops in 1997 forbidding them from cooperating with civil authorities in their investigation of priest sex abuse cases. The papal representative even went so far as to mention “moral and canonical” difficulties with his brother bishops cooperating with the police. If you’re reading this and shaking your head, you should be? What “moral” difficulty could there possibly be with helping police catch those who abuse kids? The after spin by the Vatican has been interesting. Some church officials said that the letter was issued by the Congregation for the Clergy and they no longer handle priest abuse cases (now it’s the Congregation for the Doctrine of the Faith). The intimation is that somehow the Congregation for the Clergy made an error.
The second action that speaks louder than words concerns the Archbishop of Boston’s promise that he would post all those archdiocesan clergy who’ve been accused of sex abuse. The archbishop made the promise two years ago and there’s been no action. That’s when Mitch Garabedian, a friend of mine and a courageous defender of survivors, took matters into his own hands. He posted the 117 names on his website! Good for him.
Actions do speak louder than words. If your words aren’t consistent with your actions, you risk the possibility of being labeled a hypocrite.
Multaq, a Sanofi-Avenitis drug approved to treat atrial flutter and atrial fibrillation in July 2009, has now received a warning about potentially fatal liver disease associated with the drug. Mutaq already carries with it a black box warning, the most severe warning, for a number of potential adverse health consequences.
In announcing the additional warning for liver toxicity, the FDA informed Multaq patients to contact their physicians if they experience any symptoms of liver problems such as nausea or vomiting.
The FDA warning comes in the wake of several reports of liver damage in Multaq users. Two of the reports included patients who had to have their livers removed after they used the drug-one for 4.5 months and the other for 6 months.
Johnson & Johnson was once considered the epitome of quality products. Over the counter pharmaceutical products such as Motrin, Tylenol, Rolaids, and Zyrtec have all been recalled in the past year due to manufacturing defects.
According to a featured article in this Sunday’s edition of the NY Times Business Section, “Some of its products are in short supply at drugstores and supermarkets because the McNeil Consumer Healthcare unit of J.& J. last year recalled about 288 million items, including about 136 million bottles of liquid Tylenol, Motrin, Zyrtec and Benadryl for infants and children.”
The manufacturing problems have become so acute and the recalls so frequent, Johnson & Johnson now faces a huge public relations problem. Its products are now considered suspect and many consumers are switching to generic brands rather than buying the more expensive J&J brand products. The problems don’t only reside in the pharmaceutical division either.
DePuy, a division of Johnson & Johnson, has been forced to recall one of its popular medical devices, the DePuy ASR XL hip replacement after unacceptable failure rates became public last summer. The resulting negative publicity coupled with the DePuy hip lawsuits now consolidated into an MDL in Ohio, has the company reeling.
DePuy, a division of Johnson & Johnson, aggressively marketed their DePuy ASR XL hip implants as the newest and best artificial hips in 2005 when they were allowed on the market. Unlike pharmaceutical drugs which must undergo a rigorous testing process, the DePuy ASR XL hips were similar enough to already approved hip devices that they didn’t receive the scrutiny that other types of medical devices do.
Soon after the DePuy hips were put on the market and surgeons began implanting them in patients, the problems began. Patients began complaining of joint pain and difficulty walking. Surgeons noticed that the surrounding area of the hip implant had also been affected by the metal on metal hip device. These same surgeons complained to DePuy and notified them that the hips were failing at an unacceptable rate. DePuy officials scoffed at the suggestion and told the surgeons that the failures were due to mistakes made by the physicians themselves. They said that the doctors weren’t following proper procedure. Once the DePuy hip recall occurred last year, more bad news about the hips surfaced. The metal on metal design of the DePuy hips could cause to metallosis or metal poisoning where particles of cobalt and chromium fall into the bloodstream as a result of the metal on metal grinding.
So, besides the obvious symptoms of joint pain and difficulty walking, patients were faced with a potentially more dangerous, more sinister type of problem. Their hips may be defective and the patient would have no visible warning signs! That’s why we’ve asked anyone who suspects they have a DePuy hip to consult their surgeon immediately.
About a month ago, civil lawsuits involving defective DePuy ASR XL hip replacements were consolidated into a multidistrict litigation in US District Court for the Eastern District of Ohio. Although the DePuy hips were recalled in August 2010, many DePuy hip patients remain unaware of the recall. Some hip patients aren’t certain they received a DePuy hip when they underwent hip replacement surgery. Others, because they are experiencing no symptoms such as difficulty walking or joint pain assume the hip recall doesn’t apply to them.
In this instance, any person who may have had a DePuy ASR XL hip implant should consult their surgeon because the problems with the DePuy hip may not reveal any symptoms. One of the issues with the DePuy hip concerns metallosis or metal poisoning that may occur because the DePuy model is a metal-on-metal device. The grinding metal may cause metal particle such as cobalt and chromium to be released into the bloodstream. This may lead to blood poisoning.
So far, approximately 150 DePuy hip lawsuits have been filed with more expected in the future. If you or a loved one suspect you may have a DePuy ASR XL hip replacement, consult your physician.
A Puerto Rico jury has ordered Pfizer to pay $1.5 million in damages to a woman who developed breast cancer after taking the menopause drug Prempro. The jury found that Pfizer failed to warn Helen Rivera-Adams about the possible dangers of the drug. After the verdict, Pfizer officials expressed disappointment as well as insistence that the drug is not dangerous.
It’s estimated that 6 million women took the Pfizer drugs before a 2002 study by the National Institute of Health linked the drug to cancer. Prempro is a combination of Premarin, a Wyeth product, and Provera made by Pfizer.
Since 2006, Pfizer has lost 8 of 15 Prempro lawsuits in jury verdicts. In this particular case, jurors found that the drug Prempro caused Ms. Rivera-Adams cancer. She had been taking the drug for 19 months before being diagnosed with breast cancer in 2002.
Senators Max Baucus and Charles Grassley are asking the commanding general of Walter Reed Army Hospital probing questions about its doctors’ use of an experimental medical device. The medical device, Hydrosorb Mesh, has not received FDA approval for use in spinal surgeries. While surgeons may use drugs and/or medical devices in ways not approved by the FDA, the two Senators believe the Army should have received permission before conducting a study that included spinal surgery.
According to a NY Times article, The Army doctors had implanted Hydrosorb Mesh in spinal fusion procedures for 35 patients in an 18-month period, according to a study published in the journal Neurosurgical Focus in 2004. The study covered 22 patients, including 15 active duty soldiers, to determine whether the bio-absorbable Hydrosorb was possibly preferable to similar titanium mesh. The study concluded, in glowing terms, that Hydrosorb might be “ideally suited” to spinal use. Medtronic has also made payments for consultancy or other services to the three doctors — Timothy R. Kuklo, Michael K. Rosner and David W. Polly Jr., all then with Walter Reed.”
The fact that the three doctors have been remunerated by Medtronic and that after six years Hydrosorb has yet to receive FDA approval has caused concern about safety issues and conflict of interest questions.