A company spokesman said on Monday the NobelDirect dental implant was safe and that Nobel Biocare (NOBN.VX) would fight the lawsuit, which was filed on June 30 in the U.S. District court in Los Angeles.

The suit by Jason M Yamada seeks compensation for dentists who have had to perform surgery on their patients, or pay for restorative surgery, after complications from the implants, which it said were defectively designed.

“Because of Nobel’s practices, plaintiff and the class members now face a flood of complaints from injured dental patients who have needed, and will need, immediate intervention to remove the defective implants,” the lawyers Lopez McHugh and Audet & Partners wrote in the 26-page complaint.

The suit proposed a class action to cover thousands of dentists in the U.S. who have used the NobelDirect implant, adding that Nobel Biocare had knowledge of the defect, but marketed the implant as safe and effective.

The Swedish Medical Products Agency investigated the same implants in 2005 to 2006 after complaints about bone loss. The company got approval to continue sales, but the agency told it to revise instructions and marketing material.

Nobel Biocare spokesman Nicolas Weidmann said NobelDirect was probably the most well documented product in the entire industry as a result of the Swedish investigation, and that it was safe if correctly used.

“We have very, very comprehensive material and data, including the clearance from the SMPA in Sweden, that the product is absolutely safe,” he told Reuters.

“We have the information to prove that NobelDirect is a good product, is a safe product, and in that respect we will fight against the lawsuit, definitely.” (Reporting by Sven Nordenstam, additional reporting by Steve Gorman in Los Angeles, editing by Will Waterman)

Simplicity Crib Recall

The CPSC has announced a major crib recall of all Simplicity full size cribs with tubular metal mattress support frames.  This crib recall covers both fixed side and drop side cribs.  These Simplicity Cribs have been pulled off the shelves because they present a serious risk of injury and even death caused by collapsing of the mattress support, leading to entrapment, strangulation, suffocation and the risk of falling.

This crib recall involves ALL Simplicity cribs with tubular metal mattress-support frames regardless of model number.

Graco® Drop Side Crib Recall

LaJobi, the New Jersey manufacturer of Graco Drop Side Cribs, is issuing a major recall of their products due to serious risks of entrapment and suffocation.  This voluntary crib recall, issued in cooperation with the US CPSC, involved approximately 217,000 Graco cribs sold in the United States.

Graco Crib Defect: The drop side hardware on these cribs can break or fail, allowing the drop side to separate from the crib. When the drop side separates it creates a dangerous gap between the drop side and the mattress through which an infant can become trapped or fall.

Incidents/Injuries: Nearly 100 reports of drop side incidents, including hardware breakage and drop side detachment, have been reported.  Fortunately, no child has been killed by these defective cribs, but at least six children have fallen through the cribs, with one suffering a concussion.

What to Do

Parents and caregivers are asked to stop using these defective cribs immediately and to find another safe sleeping environment for their child.  No attempts should be made to fix this product.  If you know of anyone using these cribs that is unaware of this recall, let them know so they can stop using this dangerous product.  Consumers are advised to contact the store where the crib was purchased—such as Walmart, Target, and Babies R Us—to receive a refund, store credit, or crib replacement.

If your child has suffered injury due to this crib defect, you may also wish to contact an attorney who can evaluate your case.

Note to Reader: The FDA classified the recall as a Class I recall, meaning that Stryker’s Custom Cranial Implant Kit could predictably cause serious harm or death.

If you or someone you know has been implanted with a Stryker cranial implant and is suffering side effects or injuries, an individual’s legal rights incur time limits, contact our law firm at once.

Stryker’s Custom Cranial Implant Kit is used during surgical procedures, such as cranioplasties, to repair deformities or defects in the skull. The FDA approved Stryker’s Custom Cranial Implant Kit in March 2005 as a non-sterile device. This meant that hospitals and doctors sterilized the devices themselves prior to using it. However, In October 2007, Stryker began illegally marketing and labeling its Custom Cranial Implant devices as sterile. This meant that Stryker was now solely responsible for sterilizing these products. Despite this requirement and the potential health risks to patients, Stryker negligently failed to follow at least nine (9) safety requirements established by the FDA to ensure that only safe and sterile device are implanted in patients.

Stryker’s illegal marketing and negligent manufacturing practices have resulted in serious injuries in what is believed to be hundreds of patients.

Serious injuries include but are not limited to:

• Intracranial abscesses
• Sepsis
• Severe infections
• Meningitis
• Death
• Other types of long term care were often required such as intravenous antibiotic treatment, re-operation, and additional hospitalization.

In September 2009, the FDA investigated the manufacturing facility in which these product were made and discovered that Stryker’s manufacturing practices violated numerous federal safety regulations. As a result, Stryker recalled all Stryker Custom Implant Kits labeled as sterile. Stryker stated that it was recalling these devices because it could not assure sterility of the product and because implantation could result in serious health problems including infection intracranial abscess, wound infection, sepsis, re-operation with revision of cranioplasty, long-term neurological deterioration, additional hospitalizations, long-term intravenous antibiotic treatment and death.

Legal rights for victims

Lopez McHugh is a consumer advocate law firm working on behalf of all U.S. citizens in 50 states that have received defective medical devices, such as the Stryker cranial implant. Legal rights vary by state, and the time for filing a claim is limited. Call our law firm today to have your questions answered by our attorneys who are familiar with the Stryker Corporation and the defective cranial implant.

If you or someone you know was overdosed with radiation, contact our law firm by calling 877-737-8525, or email using the form to the right to learn your legal rights.  Your consultation is free, and there is no obligation.

Injuries caused by medical error

Of the 206 patients exposed to this dangerous dose of radiation, at least 40 percent reported patchy loss of hair as a result of exposure during brain scan. Others reported a reddening of their skin in response to this overdose. What’s worse: according to medical experts, radiation at such a high dose poses an increased risk of cancer.

A spokesperson from Cedars-Sinai pointed out, the risk of cancer from high radiation exposure is lower in older patients who are more likely to die of other causes first. Of those exposed to high radiation due to medical error at the Cedar-Sinai Medical Center, the median age was 70. Nonetheless, this careless medical error subjected hundreds of patients to dangerous levels of radiation, which poses potentially deadly risks.

Details on the medical error

According to the hospital, this medical error occurred in February 2008, when the Medical Center initiated a new protocol on a special type of CT scan that is used to diagnose stroke. This new protocol was implemented because doctors believed it would provide better information about blood flow disruptions in the brain following stroke.

To use this new protocol, the CT scan machine’s standard pre-programmed settings required an override. Unfortunately, there was a misunderstanding about the default settings and the new protocol resulted in the administration of radiation at eight times the intended amount.

According to hospital officials, once these new settings were established, they locked in this higher dose, administering it to every patient who came to the hospital for a CT brain perfusion scan. While the scanner was used for other tests as well, those receiving this specific CT brain perfusion scan were the only patients who received this extremely high dose of radiation.

Astonishingly, this error went unnoticed by hospital staff for 18 months—between February 2008 and August 2009—until a stroke patient reported loss of hair following a CT brain scan.

At that point, the hospital began investigating the problem, discovering that 206 patients had been exposed to eight times the intended amount of radiation during this time. Each of these patients were informed of this serious medical error.

According to medical experts, it would have been difficult to detect this excess radiation exposure simply by looking at the result of a CT scan. However, increased radiation does produce a clearer image.

After learning of the incident, the Food and Drug Administration issued an alert to warn other hospitals and urge them to check their CT protocols. Other “advanced hospitals” around the country are currently reviewing their own safety procedures to detect and/or prevent such errors from occurring at their facilities.

While medical radiation experts claim it is not uncommon for radiologists to re-program CT equipment, doctors often do so in order to administer less, not more, radiation to their patients. Some experts note that overrides are more common in large “state-of-the-art” hospitals.

If you or someone you know was overdosed with radiation, contact our law firm by calling 877-737-8525, or email using the form on the top right-hand side of your screen to learn your legal rights.  Your consultation is free, and there is no obligation.

The FDA has reported that Raptiva can cause the development of a condition called progressive multifocal leukoencephalopathy.  This is a neurologic disease that can be fatal.  Anyone currently using Raptiva should communicate with their physicians so they can begin tapering off the drug, as it will no longer be available after June 8, 2009.  Physicians are not supposed to issue any new prescriptions.

Read More Details on Raptiva and progressive multifocal leukoencephalopathy

In addition to the messages sent that day there were also messages sent less than a week prior with the implications of Sanchez allowing a friend to operate the train:

[Sanchez to friend]: “I’m REALLY looking forward to getting you in the cab and showing you how to run a locomotive.”

[Friend to Sanchez]: “OMG dude me too.  Running a locomotive. Having all of that in the palms of my hands.”

[Sanchez to friend]: “I’m gonna do all the radio talkin’…ur gonna run the locomotive & I’m gonna tell u how to do it. ”

Sanchez had been caught with a cell phone twice before; once an employee turned him in, and another time a manager called his phone, which rang inside the cab.

Sanchez missed several signals that instructed the Metrolink train to stop, in order to give the oncoming freight train time to exit a tunnel and move onto a side rail in order to let the Metrolink train by.  As these signals were not radioed in, Sanchez closed the gap between the two trains, both coming into sight of eachother for what is believed to be less than 5 seconds.  The freight train applied its brakes for 2 seconds while records show the Metrolink did not apply an.

The Union Pacific conductor’s blood and urine tested positive for marijuana, but no other crew member’s from either train showed traces of drugs or alcohol.

A month after the crash, former President Bush signed into law a bill requiring railroads to be equipped with a rail-traffic control system, similiar to ones used by air-traffic controllers.  Unfortunately the rail lines must implement by as late as 2016, leaving nearly 7 years of what could more deadly train collisions.

In October of 2008, the drug’s manufacturer, Genentech, revised the drug’s label to warn about the risk of risks of life-threatening infections.  The FDA is looking into whether Raptiva should remain on the market. In Europe, supervisory agencies are recommending that physicians stop prescribing Raptiva and that patients using the drug be switched to something else.

August 20, 2005

The Philadelphia Inquirer

It was just the first of more than 4,200 lawsuits against Merck & Co. Inc. over its Vioxx painkiller, but news of yesterday’s $253.4 million verdict in Texas against the drugmaker surged through the legal profession and Wall Street.

In New York City, where Alise Reicin, Merck’s vice president of clinical research, was being deposed by lawyers representing plaintiffs in other Vioxx cases, the verdict caused a stir.

Shortly after learning the damage amount, Philadelphia lawyer Thomas R. Kline says he asked Reicin for her reaction to it and got no response from the Merck executive. She has defended the company’s handling of Vioxx, including testifying in the Texas trial over the death of Robert Ernst.

“She stormed out of the room and never returned,” Kline said. “Her lawyer told us that she was too upset to continue.”

Kent Jarrell, a spokesman for Merck’s defense attorneys, disputed that Reicin stormed out of the deposition but acknowledged that she was upset.

“Everybody at Merck is upset about this,” Jarrell said. “They believe in the drug and believe that Merck’s decisions are based on science and in the interest of the patient.”

Merck is a big employer in the Philadelphia area, with more than 12,000 people in Montgomery County, most at its West Point corporate campus. Much of Vioxx’s global marketing, sales and legal work were done in West Point. Hundreds of people worked on the development of Vioxx, which was voluntarily recalled by Merck Sept. 30.

Kline, one of the lead attorneys in the consolidated federal litigation in New Orleans, said that while each Vioxx suit would be tried individually, much of the same evidence would be presented as in the Texas case.

“I would expect to see that finding replicated repeatedly in future jury verdicts,” Kline said.

Defense attorneys cautioned against reading too much into a single verdict, particularly one from Texas, which is viewed as a “plaintiff-friendly” venue.

“You can’t draw conclusions about what is going to happen in litigation overall from any one individual case,” said John Lavelle, head of the product-liability practice of Ballard Spahr Andrews & Ingersoll in Philadelphia. He said Merck had strong grounds for an appeal and that the punitive damages would be automatically reduced under Texas law.

Merck said it was examining four aspects of the trial that its lawyers believed were grounds for an appeal.

“We believe that we have strong points to raise on appeal and are hopeful that the appeals process will correct the verdict,” said Kenneth C. Frazier, Merck’s general counsel, in a statement. “There are other Vioxx cases coming to trial, and we will vigorously defend them one by one over the coming years.”

Merck has set aside $675 million to pay for its defense costs in the Vioxx suits. Defending each case could mean years of litigation. In New Jersey alone there are nearly 2,400 pending Vioxx suits.

“If we had 20 trials a year, it would take over 100 years to try those cases,” said Michael A. Ferrara, a Cherry Hill lawyer representing plaintiffs in more than 200 Vioxx lawsuits. “It is time for Merck to accept responsibility for what they did… and sit down with the victims to work out a resolution.”

William M. Janssen, chairman of the life-sciences practice at Saul Ewing L.L.P. in Philadelphia, said the verdict suggested the passions engendered by injured plaintiffs might overwhelm the evidence and hurt Merck’s case.

Several plaintiffs’ attorneys said the decision to impose $229 million in punitive damages was significant because it meant the jury found that Merck was not only responsible for Ernst’s death, but that it also had acted recklessly.

“If Merck continues to take the position that they are going to litigate each and every case to conclusion, they would similarly be reckless toward their shareholders,” said James J. McHugh Jr., a lawyer at the Beasley Firm in Philadelphia.

Wall Street analysts expressed concerns about Merck’s potential Vioxx liability, which could exceed the record $21 billion Wyeth expects to pay out from litigation over the diet-drug combination commonly known as fen-phen.

“The company may face upward of 100,000 cases, which implies damages in the tens of billions of dollars,” David Moskowitz of the investment firm Friedman Billings Ramsey in Arlington, Va., wrote in a report to clients yesterday.

Shares of Merck, a component of the Dow Jones industrial average, plunged $2.35 a share, or 7.7 percent, to close at $28.06.

New Jersey Law Journal

February 13, 2008

Plaintiffs in New Jersey and six other states who claim the antibiotic Ketek caused liver disease are getting a booster shot from a congressional inquiry into the clinical trials that led to FDA approval.

On Tuesday, witnesses at a hearing before the House Committee on Energy and Commerce’s Subcommittee on Oversight and Investigations testified that Ketek’s trials were flawed and that the company had knowledge of flawed data even before FDA approval.

More than pending 100 suits raise product liability and consumer fraud claims against the manufacturer, Sanofi-Aventis Pharmaceuticals of Bridgewater. Ten suits are in Middlesex County and the rest in Illinois, Wisconsin, North Carolina, Alabama, Tennessee and California.

The Food and Drug Administration approved Ketek, or telithromycin, in 2004 for treatment of respiratory ailments but later limited its use because of reported health problems, such as liver failure.

The first death due to liver disease linked to Ketek was reported in February 2005, seven months after the drug was introduced, according to the FDA.

Three cases of severe liver problems from use of Ketek at a medical center led the FDA to issue an advisory on Jan. 20, 2006, instructing health care providers to watch for symptoms of liver problems. By the end of 2006, an FDA committee had received reports of 53 cases of liver failure among Ketek users.

On Feb. 12, 2007, the FDA required “black box warnings” on the drug’s packaging to alert users of serious adverse effects, such as liver damage.

As of last September, the most recent data available, the FDA had received 93 reports of adverse reactions, including 12 deaths.

Scrutiny of Ketek’s clinical-trial process began even before FDA approval. In 2003, Anne Kirkman-Campbell, of Gadsden, Ala., one of 1,800 private physicians running the tests, came under investigation. She later pleaded guilty to mail fraud and was sentenced to four years in prison.

Kirkman-Campbell’s clinical trial had been monitored by Ann Marie Cisneros, then a senior clinical research assistant with Pharmaceutical Product Development Inc. in Wilmington, N.C.

Cisneros testified Tuesday that she noticed some medical consent forms were initialed by Kirkman-Campbell rather than the patients, the doctor’s staff and family were enrolled in the 407-patient study, and medical records had been altered.

Cisneros said that she relayed those concerns to the Copernicus Group IRB in Cary, N.C., which sets the protocols for trials, but that no action was taken. Sharon Hill Price, Copernicus’s CEO, testified in response that she never got the message.

Robert West, special agent with the FDA’s Office of Criminal Investigation, testified that in July 2003, after the Kirkman-Campbell allegations, he recommended to his superiors that the FDA launch an investigation of Sanofi-Aventis’ role in the clinical study, but his request was ignored.

Paul Herbert Chew, president of the U.S. Research and Development Division of Sanofi-Aventis Pharmaceuticals, testified that his company was not able to confirm fraud in the clinical trials. He added that the company has since changed training and procedures.

Sen. Charles Grassley, R-Iowa, who chaired the House committee before he was elected to the Senate, testified Tuesday that the investigation into Ketek has been marked by foot-dragging. He said it took a year for the FDA to respond to his questions about Ketek.

Plaintiffs’ lawyer Ramon Lopez, of Lopez McHugh in Moorestown, who represents 30 Ketek users or their survivors, said the hearing testimony bolsters claims that the manufacturer had to have known of the flawed clinical trials.

He represents Charles Gregg of Ashland, Ohio, who took Ketek for bronchitis for four days and then was hospitalized on Feb. 7, 2006, for blurred vision, nausea, vomiting, fever, jaundice, hepatitis and liver failure.

Sanofi-Aventis’ attorney, David Sheehan, of Troutman Sanders in Newark and New York City, declined to comment.

Lisa Kennedy, a Sanofi-Aventis spokeswoman, did not return a call.