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21 Reasons the American Trial Lawyers are on Your Side

On November 24, 2008, In Product Safety, By admin

As President Bush gets ready to leave office, the American Association for Justice (AAJ) will be montering 21 possible regulations that could prove devastating to consumers’ safety and their right to hold corporations accountable for producing dangerous products. Regulations to have 60 days to go into effect before President Bush leaves office and that deadline is quickly approaching.

“In their final days, we hope the Bush administration will keep in mind the safety of consumers over the corporate profits they have sought to protect time and time again,” said AAJ President Les Weisbrod.

The list which includes safety standards for over-the-counter drugs, sunscreens, automobile safety standards, and crashworthiness of railroad cars transporting hazardous materials mostly contains the “preemption” language that could prohibit using the civil justice system as a means to hold manufacturers responsible for unsafe products.

The pending regulations AAJ has been following include six from the Food and Drug Administration, nine from the National Highway Traffic Safety Administration (NHTSA), three from the Federal Railroad Administration (FRA), a regulation from the Department of Homeland Security (DHS), and a regulation from the Transportation Security Administration (TSA).
To read the complete list

Pain Pump Catheters Linked to Shoulder Deterioration

On November 16, 2008, In Product Safety, Uncategorized, By admin

Intra-articular pain pump catheters devices that are temporarily implanted in the shoulder during surgery and have been linked to a serious injury know as Postarthroscopic Glenohumeral Chondrolysis (PAGCL). This is an extremely painful condition involving the deterioration of cartilage in the shoulder joint. Symptoms of PAGCL include very limited mobility, weakness in the affected shoulder and arm and pain in the shoulder. Popping, clicking and grinding in the shoulder are also symptoms of PAGCL.

For years, surgeons have used the intra-articular pain pump for managing pain. Because these flexible plastic catheters deliver pain medication directly to the joint, and they can extend the effectiveness of other shoulder numbing agents for up to 48 hours.

However,a study published in the American Journal of Sports Medicine concluded that these pumps were associated with PAGCL. This association was greatest when the intra-articular pain pumps were used to deliver a combination of the painkillers bupivacaine and epinephrine directly into the shoulder joint space.

In spite of this knowledge, the manufacturers of these pumps have persisted in recommending that physicians deploy the pumps to inject medicine directly into the joint space.

Tagged with: pain pump • Pharmaceutical News • Product Safety

Diabetes syringes mislabeled and may cause death

On November 6, 2008, In Product Safety, By admin

Covidien Ltd is recalling nearly half a million single-use syringes that could pose a serious risk to diabetics.

During the packaging process, some syringes labeled for use with U-40 insulin were mixed with syringes labeled for use with U-100 insulin.

The ReliOn syringes were mislabeled during the packaging process and could lead to patients receiving an insulin overdose of as much as 2.5 times the intended dose which could in turn lead to low blood sugar levels and serious health consequences, including death.

The syringes were sold at Wal-Mart stores and Sam’s Clubs from August 1 until October 8, the FDA said.

The FDA said the manufacturer has received one adverse report related to a syringe from the lot numbered 813900.

Consumers and health care professionals who suspect they have the recalled product may contact Covidien at 866-780-5436 or www.relion.com/recall for more information.

Tagged with: FDA • Pharmaceutical News • recalls • Relion • syringes

Raptiva Receives New Warnings on Infections

On November 4, 2008, In Product Safety, By admin

RAPTIVA,a medicine given by injectionused to treat adult patients (18 years or older) with moderate to severe plaque psoriasis, may cause life-threatening infections, including bacterial sepsis, viral meningitis, invasive fungal disease, progressive multifocal leukoencephalopathy and other opportunistic infections.

The FDA notified healthcare professionals of extensive labeling changes, including a Boxed Warning, to highlight these risks.

In addition, the prescribing information will be updated to describe a potential risk for the permanent suppression of the immune system with repeat administration of Raptiva in children. Raptiva is not approved for children under 18 years of age.

Doctors and other prescribers should carefully evaluate and weigh the risk/benefit profile of Raptiva for patients who would be more susceptible to these risks. Health care professionals should monitor patients treated with Raptiva for the signs and symptoms of these adverse events and also instruct patients to report any such signs and symptoms to them without delay.

Patients with pre-existing infections or who have a compromised immune system should notify their health care professional before beginning treatment with Raptiva.

This release comes at a time when we await the Supreme Courts decision on Wyeth v. Levine that could determine whether federal regulation can block patients from suing drug makers in state courts. The question before the court is whether the Food and Drug Administration’s approval of drug labels should knock out state lawsuits that contend the labels did not contain adequate warnings.

Tagged with: FDA • Pharmaceutical News • Raptiva

The Supreme Court Hears Levine v. Wyeth

On November 3, 2008, In Uncategorized, By admin

The Supreme Court seemed divided today while hearing oral arguments in Levine v. Wyeth.

Levine, a musician, had her arm amputated after gangrene set in. The Gangrene was caused when an IV push, designed to speed delivery of the drug into her bloodstream to counteract nausea caused by a migraine, hit an artery instead of a vein.

Levine’s Attoreny, David Frederick, argued that Wyeth and FDA were aware of the danger, which was indicated in the labeling, but that the warning was insufficiently strong and that Wyeth should have strengthened cautions.

Wyeth argues that the FDA did not allow such a label change.

Chief Justice John Roberts and Justice Antonin Scalia appeared to be siding with Wyeth. Wyeth lawyer Seth Waxman said: “We cannot have a world in which the very day after an intensive process – the FDA says you may distribute this drug, but you must use this specific language – either A, manufacturers can just run in and change the label and ask for permission down the road, or …. a state legislature or 50 state legislatures can decide because you could have gone back and asked, we can impose an obligation on you that you must have done so or must have changed the labeling.”

Edwin Kneedler, representing the government, agreed. “It’s been the FDA’s long-standing interpretation that only new information would justify a change [in labeling],” said Kneedler.

Justices David Souter, Ruth Bader Ginsburg, Samuel Alito and Anthony Kennedy seemed inclined towards the plaintiff.

Justice Samuel Alito wondered: “how could the FDA [have] concluded that IV push was safe and effective when on the benefit side of this you don’t have a life-saving drug, you have a drug that relieves nausea, and on the risk side, you have the risk of gangrene?”

Justice Ginsburg asked: “No matter what benefit there was, how could the benefit outweigh that substantial risk?”

Justice Souter said: “as I understand it, the company, Wyeth, could have gone back to the FDA at any time and said …. We think the label ought to be changed to say ‘Don’t use IV push.’ Wyeth could have done that at any time, and it simply didn’t do it.”

David Frederick, representing the plaintiff, argued that “the label itself is not set in stone …. Manufacturers change their labels all the time as new drug risks come in, and the regulations provide that the manufacturer is responsible not only for the label but for monitoring post-market information.”

The full transcript of the hearing is available at http://www.supremecourtus.gov/oral_arguments/argument_transcripts/06-1249.pdf

Tagged with: levine v wyeth • Pharmaceutical News • preemption

Bush Administration’s Preemption Plot Confirmed by House Report

On November 1, 2008, In Product Safety, By admin

As Levine V. Wyeth gets ready to be argued in front of the Supreme Court on Monday, a report released from the House Oversight and Government Reform Committee: says that top scientists and career employees at the Food and Drug Administration had opposed the agency regulations that weaken consumers’ ability to sue drug makers.

The issue is language in a drug-labeling rule from 2006 that effectively limits when people can sue in state court over injury claims involving medications. The FDA contends pre-emption, which is when federal regulations prevail when there is a conflict with state law. The concept of pre-emption is being used as a way to prevent a person from suing a drug company if they are injured by a drug, as long as the drug had recieved approval from the FDA.

The recently released report highlights internal FDA documents which show high-ranking career officials repeatedly warning about the dangers of not allowing drug companies to add additional warnings to their labels without FDA approval.

The report cites Dr. John Jenkins, the highest official in FDA’s new drug review process, writing:
[M]uch of the argument for why we are proposing to invoke preemption seems to be based on the false assumption that the FDA approved labeling is fully accurate and up-to-date in a real time basis. We know that such an assumption is false.”

A copy of the report.

For Further Reading: Associated Press story on the issue:

LA Times story:

Tagged with: FDA • levine v wyeth • Pharmaceutical News • Pharmaceutical News • preemption

Bisphosphonates linked to heart problems

On October 27, 2008, In Product Safety, By admin

Bisphosphonates are a class of medications that increase bone mineral density. They are commonly prescribed to treat people with osteoporosis and also for people who have suffered hip fractures. Bisphosphonates may also be used to treat Paget’s disease of bone.

This class of medications includes alendronate (Fosamax), zoledronic acid (Reclast), ibandronate (Boniva), risedronate (Actonel), and more.
Although effective, these medications can cause serious side effects in some people. Gastrointestinal side effects, such as nausea, stomach pain, constipation and diarrhea can occur. Of more concern are rare side effects, such as osteonecrosis of the jaw, unusual bone fractures, and severe muscle, bone or joint pain.
Now, there is some evidence that they may also be linked to an increased risk of atrial fibrillation– an erratic heart rhythm that can lead to blood clots that may cause heart attacks or strokes.

“In addition to possible gastrointestinal side effects, bisphosphonates can have possible cardiac side effects. For serious cases of atrial fibrillation, there was a significant increase in risk — about 68 percent,” said review lead author Dr. Jennifer Miranda, an internal medicine resident at Jackson Memorial Hospital in Miami, who is expected to present the findings Monday at the American College of Chest Physicians annual meeting, in Philadelphia.
Here’s the latest from the U.S. Food and Drug Administration on bisphosphonates and atrial fibrillation

Tagged with: aredia • bisphosphonates • fosamax • Pharmaceutical News • zometa

Seniors and bone death or osteonecrosis of the jaw

On October 20, 2008, In Product Safety, By admin

Recently, the channel 4 covered a story about seniors facing “bone death” of the jaw, otherwise known as osteonecrosis or ONJ or more lately BONJ.

More than half of people in the U.S. over the age of 50 are being treated for low bone mass or osteoporosis — more than 44 million people. Many take medicines called bisphosphonates, which are prescribed to prevent further bone loss but can help cause the condition.

ONJ causes pain, swelling, infections of the gums or jaw, gums that will not heal, loose teeth, numbness, drainage and exposed bone.

Tagged with: aredia • BONJ • onj • OSTEONECROSIS • Pharmaceutical News • zometa

Fosamax cases remanded to State Court

On August 29, 2008, In Uncategorized, By admin

The United States District Court for the Southern District of New York, the presiding Court in the Fosamax MDL No. 1789, has remanded several cases to state courts in the States of California, Florida, and Illinois. In a lengthy order, the District Court also taxed costs and fees against Merck for the improvident removal of the cases to federal court.

Michael Seelie, PA is representing Fosamax patients who have been diagnosed with osteonecrosis of the jaw or who have had low-energy subtrochanteric femur fractures after long-term use of Fosamax as well as zometa and aredia manufactured by Novartis. For information regarding these claims, please feel free to contact our office.

Tagged with: fosamax • Pharmaceutical News

Merck used “Seeding” to Accelerate Vioxx’ Market Entrance

On August 24, 2008, In Uncategorized, By admin

Doctors while reviewing roughly a million Merck documents for plaintiffs’ lawyers preparing for trials in Vioxx lawsuits who werre involved in providing expert testimony in some of the Vioxx cases discovered that some of the “research” that Merck had done in 1999, was actually disguised as research but was in fact intended as marketing.

The Technique, known as “Seeding Trials”. The objectives of the clinical trial which Merck called “ADVANTAGE” were to provide product trial among a key physician group to accelerate uptake of Vioxx as the second entrant in a highly competitive new class,” the memo states.

Investigators involved in the study are unaware that the purpose of their participation is to sway sales of the new drug.

Tagged with: Clinical Trials • Pharmaceutical News • Seeding

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Michael E. Seelie, PA