Dallas Fort Worth Injury Lawyer Blog

The Medtronic Infuse saga, is a case of the fox guarding the hen house. And guess who are the chickens?

Prior to its entry into the market in 2002, orthopedic doctors were excited about how the back surgery product known as bone morphogenetic protein-2 would revolutionize orthopedic medicine.

But instead of success in fusing degenerated spines with no complications, BMP-2 became a tainted biotech breakthrough associated with sordid corporate scandal involving many bit players.

The full saga of bone morphogenetic protein-2 (BMP-2) is yet to be told. At the heart of the scandal has been a circle of prominent surgeons whose research papers failed to report adverse events including cancer, infections, the painful growth of unwanted bone, and sterility in men among patients treated with BMP-2.

An investigation found that as a group those doctors received tens of millions of dollars in royalties from Medtronic, the company that markets BMP-2. Rarely were those payments disclosed in the published papers.

According to Bradley Weiner, MD, chief of spine surgery at Methodist Hospital in Houston and a deputy editor with the Spine Journal, over the years spine surgeons have become increasingly aggressive in their treatment of common back problems, often without adequate evidence these treatments actually benefit patients. And financial profits may also have a role in promoting aggressive strategies.

Vernon Tolo, MD, editor-in-chief of the Journal of Bone and Joint Surgery, said in an editorial that concern among doctors and the public about conflicts of interest "continues unabated." Some of the questionable BMP-2 research appeared in that journal, including a 2009 paper that failed to link the product to an increased cancer risk.

In June, editors at the Spine Journal published a scathing rebuke of BMP-2 research. An entire edition of the journal was devoted to a scientific and financial expose of the product and the financially conflicted doctors who tested and promoted it.

Amid the cries for reform are calls for the U.S. Food and Drug Administration to do more.

According to Spengler, a Vanderbilt surgeon, someone at the FDA must have been aware that BMP-2 data it held didn't always match up with what was being put in the medical journal articles.

But the agency, "didn't throw a flag," he said. "They have to be more aggressive."

According to FDA spokeswoman Karen Riley, many of complications associated with BMP-2 occur mainly in off-label uses, those for which it was not initially approved. And some of those complications are listed on the product label.

"The FDA does not regulate the practice of medicine," she said.

Monitoring what is being said in the medical literature would mean the FDA would have to play "journal cop," she said. "That's the job of the peer-review process, not the FDA," said Riley. "Shouldn't the journals be checking the label and asking the hard questions?"

Investigations by two U.S. Senate committees and the Department of Justice also are under way.

In August, Medtronic said it would spend $2.5 million for Yale University researchers to oversee an independent review of the controversial spine product.

Under the arrangement, Medtronic will provide the Yale reviewers with patient data from all BMP-2 clinical trials as well as all adverse events reported to the U.S. Food and Drug Administration since Infuse came on the market in 2002.

Last month, Yale selected two independent academic groups to perform the Infuse review. Medtronic will have no control over the process and will have to turn over all data, said Harlan Krumholz, MD, a professor of internal medicine at Yale.

The human tragedy of the most widespread medical implant failure in decades continues to unfold. These involve thousands of all-metal artificial hips that need to be replaced. And now as the litigation slowly grinds on, it has entered its most important phase of cost, both in financial terms and the cost of human suffering.

Medical and legal experts estimate the hip failures may ultimately cost billions of dollars in coming years. The metal-on-metal hip device’s ball and joint are made of metal, are failing at high rates within a few years instead of lasting 15 years or more. The grinding of metal parts against each other is generating metal ions that is damaging tissue and crippling patients. This medical condition known as metallosis.

All-metal hip implants accounted for nearly one-third of the estimated 250,000 hip replacements performed each year in the United States. According to experts, 500,000 patients have received an all-metal replacement hip. According to a new study, no new artificial hip or knee introduced in the last five years were more durable than older devices, and 30 percent were worse.

One all-metal model, the DePuy ASR, implanted in 40,000 patients in the United States, was recalled last year by the DePuy division of Johnson & Johnson.

10 years ago, Sulzer Orthopedics paid a record $1 billion to settle claims by 6,800 patients who received artificial hips and knees that were contaminated with industrial oil during the manufacturing process.

Along with ASR related cases, DePuy also faces over 560 lawsuits in connection with the all-metal version of another hip model, called the Pinnacle.

Now the insurance companies and Medicare are notifying patients that they expect to be reimbursed for the cost of the re-do hip surgery, a process called subrogation.

Any potential settlement is unclear at this time and DePuy has not announced any global settlement like Sulzer did 10 years ago.

Read more on DePuy ASR Recall and Pinnacle litigation and visit my website for further information.

Three Fosamax jaw decay lawsuits are scheduled to go to trial in 2012, including a new trial on damages in one case that resulted in an $8 million jury award in 2010.

U.S. District Judge John Keenan issued an order calling for additional Fosamax bellwether trials to take place in May, September and November of 2012.

Experts and legal commentators are most interested in the re-trial of the Boles case. In that case, the jury will only evaluate the damages that should be awarded for Boles developing osteonecrosis of the jaw (ONJ) from Fosamax.

Earlier in October 2010, another jury determined that Boles’s damages were caused by Merck’s failure to adequately warn about the risk of the devastating jaw damage. Judge Keenan determined that the jury’s award of $8 million in damages was excessive, and Boles elected to have a new trial instead of accepting a reduced award of $1.5 million. The Boles damages trial is scheduled for September 10.

All of the plaintiffs claim that side effects of Fosamax caused them to suffer ONJ, where the jaw bone begins to decay. Occasionally, full or partial jaw removal is required as a result of the condition. Fosamax (alendronate sodium), is a member of a class of drugs known as bisphosphonates, which are prescribed for treatment of osteoporosis.

Merck faces about 1,000 ONJ product liability suits over Fosamax that involve similar allegations. All federal cases are consolidated before Judge Keenan in the U.S. District Court for the Southern District of New York as part of an MDL, or multidistrict litigation.

Fosamax bellwether cases are selected for an early trial to help give the parties an idea of how juries will respond to evidence that may be similar to what will be presented in other cases. Such trials are often useful in gauging the strengths and weaknesses of common claims in complex litigation, and could help lead to an eventual Fosamax settlement.

Merck has successfully defended itself in all cases except for the Boles trial, and Keenan has assigned a settlement master in hopes of reaching an out-of-court settlement on most of the pending claims.

Furthermore, Merck also faces a growing number of lawsuits over femur fractures from Fosamax. Those complaints allege that long-term use of Fosamax can lead to atypical femur fractures, which typically occur with little or no trauma at all. Those cases are consolidated as part of a different MDL, which is centralized in the U.S. District Court for the District of New Jersey.

The FDA is concerned over new liquid acetaminophen products for infants because of the possibility of accidental Tylenol overdoses and dosing confusion by parents.

The FDA issued a consumer update on December 22, warning parents that several new liquid acetaminophen products for infants have different potency than older liquid acetaminophen medications.

According to the FDA, caregivers of infants and children may give a child too much of the drug because they are used to the dosing sizes of older brands of liquid acetaminophen drops.

Acetaminophen is used as a pain killer and anti-inflammatory medication. It is found in many over-the-counter and prescription drugs. It is also aggressively marketed for the treatment of fever, aches and pain.

According to the FDA, medication errors with acetaminophen led to 14 deaths and 74 injuries from 2000 to 2010 in children under the age of 13.

In response to concerns raised by the FDA over the high potency of many infant liquid acetaminophen products, a number of drug makers have reformulated their medications to be more diluted.

The change was voluntary and not all drug manufacturers have adopted it. This means that several different concentrations are now on store shelves, this could lead to confusion.

The FDA is recommending parents to carefully read the dosing instructions and medication guides of this and all other drugs, and to use the dosing device included in the packaging.

Furthermore, to add to the confusion, the packaging often changed very little, and if the person bought older version of the drug and then bought the newer version, they may not realize that there was a difference.

The FDA cited as an example; Little Fevers by Little Remedies. Both boxes say “New!” on the front and are very similar in design, but are of different concentrations.

According to the FDA, acetaminophen overdose has been a leading cause of liver failure in the United States, resulting in more than 50,000 emergency room visits, 25,000 hospitalizations and over 450 deaths annually.

Due to the risks associated with receiving too much acetaminophen, an FDA advisory panel was convened in May to make recommendations about new warnings or other regulatory actions. The panel recommended that dosing instructions be based on a child’s weight instead of their age.

Stronger warnings about the potential risk of liver failure from acetaminophen have also been added to all products over the past year, including clearer indications about what products contain acetaminophen as the active ingredient to avoid the risk of overdose.

A recent Australian study indicates that the newer technology for artificial hips and knees did not perform any better than older, well tested and less expensive designs.

This week, data was published from Australia’s orthopedic registry, which covered implants introduced from 2003 to 2007. The study's findings are significant for patients in the United States because many of the new designs, like the metal-on-metal hips, are widely used here and have come under increasing scrutiny.

These metal on metal implants, consist of a ball and cup made of metal, and according to experts are expected to fail prematurely in tens of thousands of patients. The artificial joints were marketed to last 15 years or more and provide better mobility and be more durable for the elderly population.

The Australian study showed that not a single new artificial hip or knee introduced over a recent five-year period was any more durable than older ones. In fact, 30 percent of them fared worse.

The Australian study concluded that both patients and government health care programs were being short changed because orthopedic surgeons were rushing to use the newly designed metal implants. These implants were introduced with little testing, over existing designs that had track records.

The review concluded, “not only has the introduction of this technology been potentially detrimental to patient care, but the current approach may be an important driver of increased health care costs.”

Dr. Stephen E. Graves, the director of the Australian registry and a co-author of the study, said he believed that surgeons, hospitals and regulators should closely look at the review’s results. In the case of the all-metal hips, some experts say they believe that replacing them may cost companies, insurers and taxpayers billions of dollars.

The United States does not have an orthopedic registry, and the Food and Drug Administration is researching to see whether data from sources like overseas databases and registries run by hospitals here can be used to better monitor device performance.

Many experts argue that such efforts are essential because 700,000 Americans undergo hip or knee replacement every year, and that number is expected to increase sharply as the population ages.

In a medical device registry, information about a patient is entered into a database when he or she receives an implant. Then, when that patient undergoes surgery again to replace that device, more data is added. By looking at large numbers of patients followed in a registry, researchers can tell whether certain device models are failing prematurely at significantly higher rates.

Some experts believe that when an implant problem is detected in a registry, it may be too late. Therefore some experts suggest that there must be greater scrutiny of implants either before or after they go on the market to detect problems earlier.

An Austrian review found that the results of published studies that accompany the introduction of new implants could bear little resemblance to registry findings about a device’s success once it went into broader use.

That review, found that surgeons involved in the original published reports are often involved in its development and may have a financial stake in them. These often created an ethical and moral dilemma for the doctors, which the companies are only too eager to exploit.

This month, bipartisan legislation was introduced in the Senate that could force manufacturers to track the performance of implants like artificial hips after they have been approved for sale.

Both device producers and their allies in Congress have maintained that any additional F.D.A. regulations would slow the development and marketing of innovative products that benefit patients. For his part, Dr. Graves, the Australian official, said he believed that such arguments were misleading.

“The purpose of regulation is not to impede innovation but to ensure safety and effectiveness of medical devices,” he stated. “This protects patients, but it also protects companies.”

The safety of Bayer’s two blockbuster oral contraceptives, Yaz and Yasmin, have been called into question. These drugs which were the first to contain a progestin known as drospirenone, which is now used in a number of generic versions of the pills.

Yaz and Yasmin have been implicated in the formation of blood clots, a condition known as venous thrombo-embolism (VTE). The FDA recently found that Yaz and Yasmin side effects increased the risk of blood clots 74% when compared to older birth control pills that use levonorgestrel as a progestin instead of drospirenone. A number of other independent studies have shown an increased risk of blood clots from Yaz and Yasmin as well.

Newly unsealed documents, revealed during discovery in thousands of Yaz and Yasmin lawsuits being pursued against Bayer, indicate that experts believe that the company kept important safety data from federal regulators. Ex FDA Chief, Kessler gave expert opinion testimony that Bayer purposefully mislead the FDA about Yaz and Yasmin’s safety by selectively presenting data on blood clots and other thromboembolic events to make the drugs appear to be safer than they really were.

An Israeli study has found that side effects of Yaz and Yasmin birth control increase the risk of a pulmonary embolism, deep vein thrombosis or another blood clot injury, when compared to older birth control pills. Researchers say they found that drospirenone-based birth control pills increased the risk of venous thromboembolism by as much as 65 percent, in a new study published by the Canadian Medical Association Journal. This is at least the third study in recent weeks to confirm the risk of blood clots from Yaz birth control.

Drospirenone was originally introduced by Berlex Laboratories in Yasmin. Once Berlex was acquired by Bayer Healthcare an updated version of Yasmin was introduced called Yaz. More recently, Bayer introduced a third version, marketed as Beyaz, which includes a folate supplement. Generic versions of Yaz and Yasmin are also now available from other manufacturers. Generic versions of Yaz and Yasmin include Ocella, Gianvi, Loryna, Safyral, Syeda and Zarah.

As a result of Bayer’s failure to adequately warn about the risk of blood clots from the birth control pills, thousands of women throughout the United States have filed a lawsuits against Bayer after suffering serious and potentially life-threatening injuries who on the birth control pills, such as stroke, pulmonary embolism, deep vein thrombosis, gallbladder disease and sudden death.

There are currently more than 10,538 lawsuits filed in federal district courts throughout the United States that have been centralized before Judge David R. Herndon in the U.S. District Court for the Southern District of Illinois. Our law firm is expecting to file 10 Yaz, Yasmin lawsuits this week in time for Christmas.

Currently the Yasmin and Yaz injury suits have been centralized for pretrial proceedings in the federal court system as well as several states. In federal court, all cases filed throughout the country are being handled out of the U.S. District Court for the Southern District of Illinois for coordinated management during discovery, the early bellwether trials and any preliminary attempts to negotiate settlement offers.

Similar centralized management for the cases has been put in place for state court cases filed in New Jersey, California and Pennsylvania.

All of the cases involve similar allegations that Bayer failed to adequately warn about the risk of serious and potentially life-threatening side effects of Yaz and Yasmin birth control.

In October 2010, Judge Herndon implemented a process that calls for a handful of cases to be prepared for a series of three early trials, known as bellwether cases. The first trial, which is expected to begin January 9, 2012, will involve a pulmonary embolism from Yaz. The second trial will involve a gallbladder injury from Yaz and the third trial will involve a venous thromboembolism (VTE), such as a deep vein thrombosis (DVT).

You have been impacted by Yaz, Yasmin side effects and injuries, including deep vein thrombosis, pulmonary embolism, stroke or gallbladder disease, January 9, 2012 is around the corner and finally the jury can decide whether or nor Bayer is liable for your injuries.

Read more on YAZ, Yasmin and Ocella side effects here and visit my website for further information.

Accutane side effects and injuries have prompted 6,634 people to file an Accutane lawsuit in New Jersey against the manufacturer of the controversial acne drug, Hoffman-LaRoche.

A master complaint was filed as more plaintiffs joined the Accutane mass tort lawsuit. The purpose of the master complaint is to centralize the plaintiffs’ common allegations, which include Accutane Crohns disease and Ulcerative Colitis. The master complaint alleges that Hoffman-LaRoche created a defective product and negligently marketed that product to consumers.

Furthermore, the complaint alleges that the company failed to warn consumers about the serious side effects associated with Accutane use; inflammatory bowel disease, (IBD). The complaint also alleges that Hoffman-LaRoche failed to take the product off the market once the bowel side effects, birth defects and suicide were known.

A master complaint is intended to streamline the legal process generally, and potentially lead to more timely settlements.

Crohns disease and Ulcerative Colitis are two forms of IBD. Both diseases involve the patient’s digestive tract. Crohns disease can lead to ulcers, incontinence, intestinal blockages, bowel cancer, and removal of the colon and rectum.

The New Jersey court agreed to the Accutane lawsuit mass tort, placing it under the direction of Judge Carol E. Higbee.

Judge Higbee has chosen several lawsuits as bellwether cases. Each Accutane lawsuit identified as a bellwether case will address some of the issues outlined in the master complaint, including whether or not patients were adequately warned about the risks of dangerous side effects like Crohns disease. The bellwether cases will likely set a precedent for future Accutane lawsuit outcomes and settlements.

Click here to visit my website and learn more about Accutane Lawsuits

St. Jude Medical Inc.’s Riata defibrillator leads, which the company stopped selling last year, were recalled by the U.S. Food and Drug Administration because of their potential to injure or kill patients.

The devices remain implanted in an estimated 79,000 U.S. patients. The company voluntarily sent a letter to doctors on November 28 informing them that the wires used to connect the devices to the heart have a higher failure rate than was previously known.

According to the company, the FDA issued the Class 1 recall, its most serious designation, because of its potential risk of serious injury or patient death.

The company acknowledged that the wires inside some leads can penetrate the insulation, compromising the device’s integrity. The devices may inappropriately shock some patients and fail to deliver necessary therapy to others.

This potential for device failure, particular for defibrillators or for folks dependent on pacemakers, is worrisome.

Patients who need frequent shocks from their defibrillator to restore a normal heart rhythm and those who are dependent on pacemakers may be at greater risk, the company said. Doctors may design individual treatment plans for those with the damaged wires based on their risk level and options should be discussed with patients, the company said.

FDA notified healthcare professionals of a Class I Recall of the St. Jude Medical Riata and Riata ST Silicone Endocardial Defibrillation Leads. The silicone insulation covering these defibrillation leads is at risk of premature abrasion. When abrasion occurs, the conductors inside the leads can come out (externalized) of the insulation. Leads with externalized conductors may develop electrical dysfunction and not work as intended. In the event the device does not work as intended, should a life-threatening heart rhythm occur, pacing or defibrillation therapy may not be delivered as intended. This may result in serious adverse events, including death.

The recall includes the following model numbers:

Riata (8F) Silicone Endocardial Defibrillation Leads
Models: 1560, 1561, 1562, 1570, 1571, 1572, 1580, 1581, 1582, 1590, 1591, 1592
Riata ST (7Fr) Silicone Endocardial Defibrillation Leads
Models: 7000, 7001, 7002, 7010, 7011, 7040, 7041, 7042

BACKGROUND: The leads connect an implantable cardioverter defibrillator (lCD) or cardiac resynchronization therapy defibrillator (CRT-D) to cardiac tissue in order to monitor and regulate a patient’s heart rate by providing pacing and delivery of high voltage therapy for ventricular arrhythmias.

The FDA have added new safety warnings to the heart rhythm drug Multaq, (dronedarone) after Sanofi company study linked the medication to higher rates of heart attack, stroke and death in a subset of patients. The FDA completed a safety review of dronedarone, which showed that the heart drug increased the risk for serious CV events, including death, when used by patients with permanent atrial fibrillation.

The review was based on data from the PALLAS and ATHENA trials. As a result of the review, the FDA has provided new information and recommendations for use of dronedarone to manage the potential serious CV events associated with the drug, according to a statement from the agency.

The boxed warning highlights the results of a study in which Multaq doubled the risk of heart-related complications in patients with permanent atrial fibrillation. The revised label indicates that Multaq is only approved for the short-term form of atrial fibrillation and atrial flutter. Doctors routinely prescribe drugs for conditions not listed on the labeling approved by the FDA, a process called "off label prescribing."

The label, instructs doctors to check patients' heart rhythm at least once every three months. If patients appear to have the permanent form of atrial fibrillation, Multaq should be discontinued.

When first approved in 2009, Multaq was the first new drug in 10 years for atrial flutter and atrial fibrillation. Both conditions can cause stroke and death. Multaq has been subject to a series of safety concerns, both before and after its approval in the U.S.

European Union health officials have already restricted Multaq's use based on the same safety information. In September the European Medicines Agency said that the drug should only be used after other treatments for atrial fibrillation have been tried.

In the study that triggered the warning, Sanofi recorded 25 deaths in the Multaq group compared with 13 in the placebo group. All 3,200 the patients in the study were older than 65 and had permanent atrial fibrillation.

Atrial fibrillation is the most common heart rhythm disorder and a frequent contributor to stroke. About 278,000 people in the U.S. have received prescriptions for Multaq as of October, according to the FDA.

The FDA originally rejected the French drugmaker's request to approve Multaq in 2006. That was after a widely publicized study showed patients in the group taking Multaq were twice as likely to die as patients in the comparison group.

But Sanofi said the study involved patients with severe heart failure and many of them did not even have the irregular heart rhythm Multaq was designed to treat.

Multaq already carries another black box warning, the most serious type of warning. It says that the drug can cause severe complications, including death, in people with recent severe heart failure and should not be used by them.

The new label changes for the drug include the following:

Dronedarone should not be prescribed to patients with permanent atrial fibrillation (those who cannot or will not be converted into normal sinus rhythm) because of the twofold risk of cardiovascular death, stroke, and heart failure in such patients.

Patients on the drug should be monitored via ECG every three months and patients in atrial fibrillation should discontinue the drug or be cardioverted if that is clinically indicated.

Patients prescribed dronedarone should receive appropriate antithrombotic therapy.

In January, the FDA alerted healthcare professionals to the potential for liver damage from dronedarone based on two reported post-marketing case reports of acute liver failure that required transplantation. The agency recommended periodic liver enzyme tests, especially in the first six months of treatment.

The U.S. Judicial Panel on Multidistrict Litigation (JPML) has rejected calls for all federal Plavix lawsuits to be consolidated in one court for coordinated handling during pre-trial litigation. This means that the litigation will proceed as individual cases in various district courts throughout the United States.

Last week, the JPML denied a motion by Bristol-Myers Squibb and Sanofi-Aventis to centralize the federal Plavix litigation in the U.S. District Court for the District of New Jersey. According to the panel, the centralization would not help move the cases through the system faster and would provide no benefit to the parties involved.

There are currently only 12 lawsuits filed against Plavix pending in the federal court system, with 10 of them pending in the U.S. District Court for the District of New Jersey.

All of the Plavix suits allege that the drug makers failed to adequately research their medication or warn about the risk of Plavix side effects, which could increase the risk of serious and potentially life-threatening bleeding, as well as a rare blood disorder known as thrombotic thrombocytopenic purpura (TTP). Lawsuits had been filed against the makers of Plavix over internal bleeding, ulcers, heart attacks, strokes and other health problems allegedly caused by the popular blood thinner.

There are 40 Plavix cases filed in New Jersey state court. Plavix (clopidogrel) is prescribed as an anti-platelet agent, to prevent blood platelets from sticking together to form clots. It is prescribed to reduce the risk of heart attacks, strokes and blood clotting when drug coated stents are used in patients with arteriosclerosis and in other at-risk patients.

In November 2009, the FDA issued a public health advisory warning that side effects of Prilosec may interfere with Plavix effectiveness, increasing the risk of heart attack, death or other injuries for patients.

In March 2010, a Plavix “black box” warning was added to alert patients and healthcare professionals that the anti-clotting drug may not work in some patients due to genetics. The FDA indicated that a genetic test is available to determine whether patients are able to metabolize Plavix efficiently and suggested that doctors should consider another medication for at-risk patients who are confirmed to have the gene variant.

According to plaintiffs’ lawyers, Knauf Plasterboard Tianjin Co., (KPT) a Chinese drywall maker, agreed to pay at least $800 million to settle homeowner claims that defective building materials contaminated their homes with corrosive sulfur fumes.

Knauf agreed to settle claims involving about 4,500 properties that contain the defective drywall. Homeowners said the faulty wallboard emits noxious sulphur gases that corrodes copper coils and electrical and plumbing equipment.

The accord was announced before U.S. District Judge Eldon Fallon in New Orleans, who is overseeing about 12,000 suits filed over the contaminated drywall that have been consolidated for pretrial evidence gathering.

According to the plaintiff attorneys, “homeowners who can show they have KPT product in their homes will be covered and the costs of those repairs are covered by the agreement no matter how much the total cost may be to the company."

According to state Attorney General James Caldwell, More than 1.1 million sheets of harmful Chinese drywall were used in Louisiana rebuilding projects after hurricanes Katrina and Rita struck in 2005.

About 55 percent of the property owners who may benefit from the settlement live in Florida while 35 percent are Louisiana residents, according to experts.

The remaining cases involve drywall made in China by units of Taishan Gypsum Co. and Beijing New Building Materials Public Limited Co., the judge said. Fallon said he will travel to Hong Kong to supervise depositions in the suits.

Other drywall suppliers, such as Miami-based Banner Supply Co., agreed in June to pay about $55 million to settle claims over the contaminated building materials made in China.

The consolidated case is In re Chinese-Manufactured Drywall Products Liability Litigation, 2:09-md-02047, U.S. District Court, Eastern District of Louisiana (New Orleans).

As public awareness of problems with artificial hips and other medical implants increase, legislation was introduced in the Senate that would force manufacturers to track the performance of such products after they were approved for sale.
The bill would allow the Food and Drug Administration (FDA) to compel companies to track medical implants.

The bill is to address the controversial 510(k) process that the FDA uses to clear the sale of certain implants like artificial joints. To sell a new product under 510(k) process, a producer need only show that it is “substantially similar” to a product already on the market.

Thousands of the all-metal hips that are now failing prematurely in patients were approved through the 510(k) system. The new proposal would not require added premarket testing of such implants but would broaden the F.D.A’s postapproval oversight by giving it the authority to mandate that companies collect data on device performance.

Along with introducing the bill, the bill originators sent letters to five major producers of medical devices seeking documents about how they track product safety and recall devices.

The companies were Johnson & Johnson, an artificial joint maker; Zimmer Holdings, another producer of artificial joints; Medtronic, a heart and spinal implant producer; Boston Scientific, a heart device maker, and C. R. Bard, a surgical implant maker. All of these companies have had problems with defective medical products, leading to recalling them.

Specifically, in the case of Johnson & Johnson, Congressional investigators want to know when the company was warned that one of its all-metal hips — the ASR, or Articular Surface Replacement — was failing and how it tracked those problems. Last year the DePuy division of Johnson & Johnson recalled the device after it had been implanted in some 93,000 patients worldwide, including 40,000 in this country.

As of early October, about 3,500 lawsuits have been filed against Johnson & Johnson in connection with the ASR, and medical studies suggest that the ASR may have already failed a few years after implant. Artificial hips are supposed to last 15 years or more before requiring replacement.

Last month, a legislative panel in Australia issued a report that concluded that Johnson & Johnson was probably aware of serious problems with the ASR well before recalling it. The panel also characterized the company’s responses to its questions as “decidedly opaque.”

“Many people could have avoided considerable pain, suffering and diminished quality of life if the company had acted in a responsible manner to known problems with these devices,” the Australian report stated.

Dillon Yeaman was awarded nearly $1 million in damages by a federal jury, which found baseball bat makers Hillerich & Bradsby liable for the design of the Exogrid Model CB71X, and for failing to warn of the bat's dangers.

More than five years after a Norman High School pitcher was struck in the face by a line drive, he won a product liability claim against the maker of the aluminum bat used in the incident.

Dillon Yeaman was pitching against Westmoore High in 2006, when he was struck in the face by a batted ball. The impact fractured his nose and his orbital bones.

The Yeamans sued the 100-year-old bat company, whose signature model is the Louisville Slugger, claiming in court documents that the bat's design was “defective and unreasonably dangerous … posing a “known risk of grave harm” to those using it.

Hillerich & Bradsby, the plaintiffs maintained, marketed the bat based upon “profit-driven motivations, and was consciously indifferent to the dangers which the bat posed.”

The bat maker, according to court documents, argued that the Exogrid was in compliance with “rules, requirements and specifications which had been created by the NCAA and adopted by the National Federation of High Schools, the Oklahoma Secondary Schools Activities Association and Pure Prairie League."

According to a recent study, more than a dozen players have been killed by batted balls nationwide. The bat in question in the Yeaman case is banned by Major League Baseball and recently was prohibited for use by the NCAA, which has adopted a new testing standard that requires metal bats to perform more like wood in order to protect pitchers and other players.

A 2002 Brown University study found balls hit by metal bats have a higher velocity, an average of 93.3 miles per hour compared to 86.1 mph by wood bats.

A motion has been filed with the U.S. Judicial Panel on Multidistrict Litigation (JPML) to consolidate and centralize all federal Wright Conserve hip replacement lawsuits. These lawsuits have been brought in courts throughout the United States by individuals who experienced injury problems after receiving the metal-on-metal artificial hip system.

Several lawsuits have been filed against Wright Medical in different federal district courts through the nation by individuals who complain that their metal-on-metal Wright Conserve Plus hip system failed within a few years of implant, often resulting in the need for revision surgery.

Since the FDA approved the Wright metal-on-metal hip replacement system under their controversial 510(k) approval system, more than 200 adverse event reports have been submitted by patients or physicians, which likely only represents a small percentage of the total number of problems with Wright Conserve hip replacements.

All of the lawsuits involve similar allegations of design defects involving the Conserve acetabular cup, which plaintiffs claim has a tendency to loosen and fail as metal particles are shed into the body from the metal parts rubbing against each other.

The Wright Conserve hip system is a metal-on-metal design, which consists of cast cobalt chromium molybdenum that provides the cup (socket) for the cobalt chromium molybdenum femoral head (ball). The metal femoral head turns within the metal monoblock Conserve Cup, which does not have a protective liner. This may result in the release of metal particles, through the metal on metal grinding. The metal ions can cause metal toxicity in the blood, soft tissue and bone. This condition can result in metallosis, tissue necrosis and pseudotumors, according to the complaints.

In May 2011, the FDA asked Wright Medical and other metal-on-metal hip makers such as DePuy, Smith and Nephew, Stryker and Zimmer, to obtain more information about the level at which the metal particles released by hip replacements becomes dangerous, how much metal they actually release and to quantify the potential side effects of metallosis.

The Wright Conserve Cup features a similar design to the DePuy ASR Cup, which was recalled in August 2010 after medical data suggested that a higher-than-expected number of people had their artificial hip fail within a few years.

Due to the similarities between the designs, the MDL motion suggests that a Wright Conserve hip recall is likely to be issued as well.

The plaintiffs argue that centralizing the Wright Conserve metal-on-metal hip lawsuits as part of an MDL will serve the convenience of the parties, prevent duplicative discovery and avoid conflicting pretrial rulings from different judges.

Transvaginal mesh plaintiffs are petitioning for the vaginal mesh litigation pending against 4 different companies to be centralized before one judge in the U.S. District Court for the Southern District of West Virginia.

As described in previous blogs, thousands women throughout the United States are bringing product liability lawsuits against the 4 main medical device manufacturers as a result of injuries with transvaginal bladder mesh systems, which have been associated with reports of infection, vaginal erosion and pelvic pain.

The U.S. Judicial Panel on Multidistrict Litigation (JPML) in November received motions for many Boston Scientific pelvic mesh lawsuits, American Medical Systems (AMS) mesh lawsuits and Ethicon/Gynecare mesh lawsuits to be centralized before Chief Judge Joseph R. Goodwin, who is already presiding over all federal Bard Avaulta mesh lawsuits that were consolidated for pretrial proceedings.

The plaintiffs are calling for the Panel to establish three new MDLs, or multidistrict litigations, in the Southern District of West Virginia, where Judge Goodwin can coordinate the litigation together with the Bard Avaulta cases.

The vaginal mesh lawsuits contain allegations involving defects with pelvic repair products used during transvaginal surgery to repair pelvic organ prolapse (POP) or stress urinary incontinence (SUI), which caused women to experience painful and debilitating complications.

Commonly, women are implanted with more than one product, which are often manufactured and sold by different companies. Thus, plaintiffs have requested that currently unconsolidated litigation for vaginal mesh products sold by Boston Scientific, AMS and Ethicon/Gynecare be transferred to the Southern District of West Virginia, for coordinated handling.

The plaintiffs argue that “the centralization of these actions in a single judicial district for coordinated and/or consolidated pretrial proceedings will promote the interests of justice.”

“The transfer of these cases will conserve judicial resources, reduce litigation costs, avoid potentially inconsistent pretrial scheduling orders and substantive rulings, and will eliminate unnecessary duplicative discovery.”

Plaintiffs further argue that the claims against all of these manufacturers are similar, and Judge Goodwin has already become familiar with the factual and legal issues presented throughout the cases and is uniquely positioned to handle the conflicts that may arise from cases involving individual women who received multiple devices from different manufacturers.

The general public has become increasingly about the risk of vaginal mesh problems, after the FDA issued warnings about an increasing number of adverse event reports associated with the products.

In July, the FDA issued transvaginal mesh warning, indicating that they have been unable to find any scientific evidence that transvaginal mesh kits provide any benefit over other available means of treatment.

In September, an FDA advisory panel was held to review the potential health risks with vaginal mesh products. At the hearing, a majority of surgical mesh manufacturers joined together to create a “Transvaginal Mesh Working Group”, making a joint presentation to the committee and presenting a unified voice and position at the hearing.

A panel of federal drug experts has recommended that the FDA require newer warnings for side effects of the Ortho Evra birth control patch. These patches may increase the risk of venous thrombosis embolism (VTE) when compared to using some older oral contraceptives. The panel did not recommend that the FDA issue an Ortho Evra recall due to the potential dangers.

The FDA recently held the advisory committee to review the risk of VTE with the Ortho Evra patch, as well other newer forms of contraceptives, such as Yaz and Yasmin birth control pills and the NuvaRing birth control ring.

The panel voted 19-5 that the benefits of the Ortho Evra outweighed its health risks, and they voted 20 to 3, to recommend that the birth control patch’s blood clot warnings be rewritten.

Ortho Evra is a form of birth control that is delivered through a patch. Ortho Evra patch is promoted as an alternative to daily birth control pills, some studies have shown that the Ortho Evra patch delivers substantially more estrogen and significantly increases the risk of blood clots and VTEs in women.

The FDA committee’s recommendations would call for the language to be simplified and made clearly understandable by consumers. While the committee’s decisions are not binding for the FDA, they generally factor significantly into the agency’s final regulatory action.

A recent FDA study of all of the newer forms of birth control indicated that women who use the Ortho Evra patch or the NuvaRing are 55% more likely to suffer a VTE, which can lead to a pulmonary embolism, heart attack or stroke, than women who take levonorgestrel-based birth control pills.

Women who took Yaz, Yasmin or other generic pills that also use the drospirenone progestin, faced a 75% increased risk of VTE and twice the risk of heart attack or stroke.

The committee voted against recommending a recall for Yaz and Yasmin, but also found that the label warnings should be made more clear on those products as well.

Another example of a corporation being caught with its hand in the cookie jar. Medtronic has agreed to pay the U.S. Justice Department $23.5 million to settle allegations that the company paid doctors to implant its pacemakers and defibrillators.

The Justice Department investigation alleged that Medtronic paid doctors between $1,000 and $2,000 per patient implanted with a Medtronic pacemaker or defibrillator as part of four post-marking studies.

According to a press release from the Justice Department, the payments were to promote doctors to use a Medtronic device over other competing devices, and to persuade them to be loyal to Medtronic for future cardiac procedures.

The settlement ends a federal qui tam suit filed in Minnesota, as well as a similar qui tam suit filed in California. Both suits alleged Medtronic violated the U.S. False Claims Act by using post-market studies and device registries as vehicles to pay participating physicians kickbacks for implanting its pacemakers and ICDs in Medicare or Medicaid beneficiaries.

According to the attorneys bringing the whistle blower action, "Our society owes an enormous debt to individuals with the courage to blow the whistle when medical device makers try to influence physicians." "When the use of procedures or devices is driven by corporate greed rather than medical need, it creates a potentially dangerous situation for patients and contributes to escalating medical costs."

The qui tam or whistle blower provisions of the False Claims Act permit private citizens, called "relators," to bring lawsuits on behalf of the United States and receive a portion of proceeds of any settlement or judgment.

According to Tony West, assistant attorney general for the department's civil division, "patients who rely on their healthcare providers to implant vital medical devices expect that those decisions will be made with the patients' best interests in mind." "Kickbacks, like those alleged here, distort sound medical judgments with financial incentives paid for by the taxpayers."

Medtronic said the payment is not an admission that any of the company's studies were "improper or unlawful."

"Medtronic is happy to have this investigation behind us, so we can continue designing and executing clinical trials that generate evidence to improve patient care, outcomes, and cost effectiveness," Marshall Stanton, MD, vice president of clinical research and reimbursement for the Medtronic's Cardiac and Vascular Group, said in a statement.

Medtronic also is being investigated by the Justice Department over allegations that doctors paid by the company failed to report serious side effects associated with Medtronic's spine surgery device, Infuse.

So did the company learn anything? Or were they surprised to be caught with their hand in the cookie jar. The hits keep on coming..., are there any depths to which these corporations will not stoop to? Where will the companies draw the line, where is the lesson learnt?

Unfortunately we will have to wait until the corporate executives start being accountable for their actions and end up in jail. So far only civil fines and no admissions of guilt or liability. Just the cost of doing business in the US of A.

This week the FDA held a 2 day meeting evaluating the newer oral, patch and ring contraceptives. This was a long overdue and highly anticipated hearing.

The FDA advisory panel voted 19-5 that the benefits of the Ortho Evra norelgestromin/ethinyl estradiol transdermal patch outweigh the blood clot risks, but panel members think those risks should be more clearly stated on the label.

The FDA's Advisory Committee for Reproductive Health Drugs and a drug safety committee voted Friday to recommend that the FDA should allow the patch to remain a contraceptive option.

The same panel had voted 15-11 that the benefits of drospirenone-containing oral contraceptives such as Yaz and Yasmin outweigh the risk of venous thromboembolism (VTE).

Reproductive and drug safety experts advised the FDA to add stronger label warnings of Yaz and Yasmin blood clot risks, but decided not to recommend a Yasmin and Yaz recall.

The panel voted 21-5 to add new blood clot label warnings to drospirenone-based birth control pills, saying that the current warnings are vague, too confusing, and need to be updated with the most recent drug safety information.

One of the most recent reports examined by the committee was from the FDA itself, which found that Yaz and Yasmin side effects increased the risk of blood clots 74% when compared to older birth control pills that use levonorgestrel as a progestin instead of drospirenone. The panel noted that the FDA study did not account for smoking, obesity and some other health factors which could have played a part in its findings.

Newly unsealed documents, revealed during discovery in thousands of Yaz and Yasmin lawsuits, indicate that Former FDA Commissioner David Kessler believes that the company kept important safety data from federal regulators. Kessler gave expert opinion testimony that Bayer purposefully mislead the FDA about Yaz and Yasmin’s safety by selectively presenting data on thromboembolic events to make the drugs appear to be safer than they really were. The testimony was barred from the committee hearing because it was not submitted in time.

The Ortho Evra patch, from Johnson & Johnson's Janssen, does not contain drospirenone, but it contains higher levels of estrogen than found in many common second-generation birth control pills (which contain lower doses of estrogen than the first-generation pills introduced in the 1960s).

An FDA postmarking report in October stated that the patch, the norelgestromin/estradiol vaginal ring, and birth control pills containing drospirenone, were all associated with increased risk for VTE, compared with hormonal contraceptives with relatively low doses of estrogen.

The panel addressed labeling on the patch, voting 20-3, that it should more clearly state the patch's risks and calling the current labeling confusing.

Janssen has changed its label three times since 2005 to update the risk of the patch, and earlier this year the FDA added a boxed warning saying that one study found the VTE risk was significantly greater with Ortho Evra than with lower-estrogen birth control pills.

The black box warning was meant to draw more attention to the risk of blood clots, according to Scott Monroe, MD, director of the FDA's Division of Reproductive and Urologic Products.

So what does all add up to? It means we have to slog through the bellwether trials that are scheduled for next year for both the Nuvaring and Yaz and Yasmin contraceptives. After they are played out, perhaps then these companies will come to the settlement table and compensate the thousands of women who have been horribly injured by these drugs.

Unfortunately the general public does not understand the risk associated with these drugs. They are not benign and they have a significant side effect profile and risk. These women need to understand that and the risk needs to be emphasized by their doctors. But sadly it is not. And in fact most doctors do not have that discussion with their patients. A lot of refills are filled automatically and the game of Russian Roulette continues.

The FDA could have done the right thing but sadly it abrogated its regulatory role to the powerful business interests and lobbyists at the hearing. Business as usual at the FDA, with its revolving door and life goes on Washington, except it does not for the women who have died as a side effect of these drugs. I will light a candle for you and your families, and you are in my prayers this Holiday Season.

After a much publicized hearing, federal health experts said that drug labeling for Yaz and other drospirenone containing birth control pills should be updated to highlight recent data suggesting a higher risk of blood clots with these drugs than older contraceptive pills.

Expectations were heightened and many experts felt that the FDA may put a restriction on the sale of these drugs, but according to many, the FDA's findings was very disappointing.

The FDA's panel of experts voted 21-5 Thursday that labeling on the popular drugs made by Bayer is inadequate and needs more information about the potential risk of blood clots in the legs and lungs, known as deep vein thrombosis and pulmonary embolism.

Yaz, its predecessor Yasmin and others use a synthetic progestin hormone called drospirenone. Yaz was approved in 2006, and quickly became the best-selling birth control pill in the U.S. by 2008. But prescriptions have fallen more than 80 percent in the last two years over safety concerns and mounting lawsuits.

Medical experts debated more than nine hours discussing the blood clot risk of drospirenone-containing drugs. The overwhelming majority said it should be clearly stated in the medication label the potentially fatal nature of blood clots.

"Clearly the wording is inadequate and incomplete," said Dr. Richard Bockman of New York's Hospital for Special Surgery. "Adverse events have to be made graphic so physicians and patients are aware of the consequences."

The panelists voted 15-11 that the pills remain a beneficial option for preventing pregnancy. This ruling amounts to a vote of confidence for keeping the drugs on the market, over a third of panelists voted against the drug's overall benefit, citing numerous alternatives available.

"I can see no real group of patients that this drug benefited over existing alternatives," said Mark Woods of New York University School of Medicine. "Without any clear benefit, and given the potentially catastrophic risk, I voted no."

The most recent study by the FDA found women taking Yasmin had a 75 percent higher chance of suffering a blood clot than patients taking a combination of older drugs.

Panelists heard more than a half-dozen patients or their family members who blame Yaz or Yasmin for sometimes deadly blood clots.

Cindy Rippee spoke about her last conversation with her 20-year-old daughter Elizabeth Rippee, who died Christmas Eve 2008 when a blood clot traveled to her lung. Rippee said her daughter had been taking Yasmin for about two months, after taking another birth control pill, Tri-Sprintec, for a year previously.

"My daughter was a very smart young woman. If Elizabeth had been clearly told that Yasmin had more risk, maybe twice as much risk, as other pills she never would have switched to Yasmin and would be here today," said Rippee, of Escondido, Calif.

Rippee is among 10,000 plaintiffs suing Bayer in personal injury lawsuits pending throughout the U.S. federal court system.

The FDA has not set a timetable for any changes in Yaz's labeling. For now, many doctors say they don't expect to stop prescribing the drugs anytime soon.

The FDA convened the panel to consider additional safety measures for newer contraceptives based on recent studies that show a higher risk of blood clots with the drugs.

The panel is now scheduled to discuss adding new warning information to the drugs' labeling about the potential risks of blood clots.

Dr Malik Law Firm is currently evaluating and filing Yaz, Yasmin and Ocella Injury lawsuits, please click here for further information.

Medical research has demonstrated that newer birth control formulations containing a synthetic new progestin, Drospirenone, are more likely to cause venous thromboembolism (VTE) blood clots than older drugs. This data has lead the Food and Drug Administration (FDA) to consider new safety measures in meetings later this week. The increased risk is significant because VTE can cause heart attacks, strokes and blockages in lungs, (pulmonary embolism PE) or blood vessels, (deep vein thrombosis DVT) which can be deadly.

Yaz, Yasmin (manufactured by Bayer) and generic versions of the drugs use drospirenone which appears to reduce side effects found in older drugs, including bloating and mood swings. Evaluating the VTE risk of birth control drugs is difficult because all hormone-based contraceptive drugs increase the risk of VTE. Furthermore VTE risk can be increased by smoking, obesity or family history (genetic blood clotting defects).

Yaz, Yasmin and other generic pills containing drospirenone are the focus of a FDA discussion this week. Bayer says its studies have shown no difference in VTE risk between its drospirenone drugs and the older birth control drugs. But several large, independent studies suggest the risk with Yaz and similar medications is slightly higher. The latest analysis by the FDA estimates the risk of VTE with drospirenone-containing pills is 1.5-fold higher than other hormone-based contraceptives.

Introduced in 2001, Yasmin was the first birth control pill to use drospirenone, which appeared to have fewer side effects. The reformulated version of the drug, Yaz, was approved in 2006 with approval to claim on the label that it decreased acne and a severe type of mood disorder, Pre Menstrual Dysphoric Disorder, PMDD.

A Bayer AG unit withheld from U.S. regulators findings by company researchers of increased reports of VTE in users of its Yasmin birth-control pills, according to the FDA. David Kessler, the former FDA commissioner, in a document unsealed in federal court in Illinois, said Bayer didn’t include an analysis “that demonstrated an increase in the U.S. reporting rate” for venous thromboembolism, in a 2004 review of Yasmin’s safety provided to the agency.

Bayer faces 10458 lawsuits filed in the federal court, over injuries allegedly caused by the drospirenone contraceptives. Lawyers suing the drugmaker cited FDA reports of at least 50 deaths tied to the pills from 2004 to 2008. The first trials for pulmonary embolism are scheduled for January 9, 2012 in federal court in Illinois and January 23 in state court in Philadelphia.

Bayer’s contraceptives generated $1.58 billion in sales last year, making them the company’s biggest-selling drugs after Betaseron, a multiple sclerosis medication.

In October, the FDA warned that women taking the drospirenone pills were 74 percent more likely to suffer VTE blood clots than women on other low-estrogen contraceptives. The FDA examined data on 835,826 women who took pills containing the hormone, including Bayer’s Yasmin line of birth-control pills, according to the FDA report. The agency set the Dec. 8 hearing to discuss the findings.

The FDA told Bayer in June 2003 that it was “very concerned” about the number of adverse events, particularly deaths, reported in Yasmin users, Kessler said, citing an agency letter to the company. This included six deaths in the U.S., five of which were first reported to the FDA after April 2, 2003, the agency said.

Bayer responded that its data didn’t show a higher risk for Yasmin. Internally, the company decided to produce a “White Paper,” to the FDA, which would be “a scientific write-up that lays out the issues,” according to a Bayer document quoted by Kessler.

The white paper would compare Yasmin to other oral contraceptives, covering multiple adverse events including venous thromboembolism (VTE) and pulmonary embolism (PT).

According to Kessler, an early draft reported, “Compared to the three other oral contraceptives, Yasmin has a several fold increase in the reporting rates for DVT, PE and confirmed VTEs.”

The case is In re Yasmin and Yaz (Drospirenone) Marketing, Sales Practices and Product Liability Litigation, 09-md-02100, U.S. District Court, U.S. District Court, Southern District of Illinois (East St. Louis).

The Trans Vaginal Mesh (TVM) saga continues and another Multidistrict litigation is pending. American Medical Systems (AMS), a pelvic mesh manufacturer, is filing motions for the centralization and consolidation of all transvaginal mesh lawsuits filed in federal district courts throughout the United States.

There are currently at least 85 AMS mesh lawsuits filed on behalf of 133 different people, which are pending in 20 different federal district courts. The complaints all involve allegations of design defects associated with various AMS surgical mesh products, including the AMS Apogee, AMS BioArc, AMS Elvate, In-Fast Unltra, MiniArc, Monarc, AMS Perigee, SPARC and Straight-In mesh. The medical devices are implanted in women to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI).

On November 23, AMS filed a motion with the U.S. Judicial Panel on Multidistrict Litigation to consolidate all of the cases for pretrial proceedings in the U.S. District Court for the Eastern District of Minnesota. In the alternative, the medical device manufacturer has proposed that the cases be centralized in the Southern District of West Virginia.

AMS claims that centralizing the cases as part of an MDL, or multidistrict litigation, would serve the convenience of the parties, prevent duplicative discovery and avoid conflicting pretrial rulungs from different judges.

All of the lawsuits allege that problems with the design, manufacturing, testing, marketing or labeling of the AMS vaginal mesh products caused plaintiffs to experience severe complications and permanent injuries.

In July, the FDA issued a warning about the risk of transvaginal mesh problems, especially when used for repair of pelvic organ prolapse. A number of women have filed adverse event reports with the FDA after experiencing infection and erosion of the mesh through the vagina.

From January 1, 2008 through December 31, 2010, the FDA reports that it received 2,874 reports of complications linked to the use of surgical mesh devices meant to treat pelvic organ prolapse (POP) or female stress urinary incontinence (SUI). A review of available data has led the FDA to conclude that there is no evidence that vaginal mesh implants provide any additional benefits when compared to more traditional surgeries to fix POP and SUI.

AMS argues that the cases should be centralized in Minnesota, where they maintain their headquarters and where most of the documents and witnesses are located.The first federal lawsuit involving AMS mesh was filed in September 2008 in the U.S. District Court for the Northern District of California, where 23 of the AMS cases are currently pending.

Only 4 lawsuits are pending in Minnesota, where AMS has proposed the litigation be centralized, and there are only 2 pending in the Southern District of West Virginia, which was identified as the alternative location.

Over the past year, a growing number of Bard Avaulta vaginal mesh lawsuits have also been filed by women who have experienced gynecological problems. All of the complaints involve similar allegations that C.R. Bard’s Avaulta Anterior and Posterior BioSynthetic Support System, which was introduced in 2007, was negligently designed and that the company failed to warn patients of possible complications that can result in severe pain and disfigurement.

In October 2010, the federal Bard Avaulta litigation was consolidated as part of an MDL for pretrial proceedings in the U.S. District Court for the Southern District of West Virginia.

Another generic birth control pill based on Yaz has been approved by the FDA, despite concerns that the pill may increase the risk of blood clots including deep vein thrombosis, pulmonary embolism, strokes and heart attacks when compared with older birth control pills.

Vestura, is manufactured by Watson Pharmaceuticals, containing ethinyl estradiol and drospirenone, a newer “fourth” generation progestin that is only found in the Yaz-family of contraceptives.

Yaz, and an older version known as Yasmin, are two of the most popular birth control pills on the market. Gianvi is a generic Yaz version and Ocella is a generic Yasmin version. Bayer also introduced Beyaz, a newer version, which is not available as a generic, which includes a folate supplement.

Drospirenone is a newer type of progestin that is usually used in combination oral contraceptives that also include estrogen. It was originally introduced by Berlex Laboratories in Yasmin. Once Berlex was acquired by Bayer Healthcare an updated version of Yasmin was introduced called Yaz.

In addition to Yaz, Yasmin and Beyaz, drospirenone is also used in the brand name birth control pill Safyral, as well as generic Yasmin equivalents sold as Ocella, Syeda and Zarah, and generic Yaz equivalents sold as Gianvi and Loryna.

An FDA advisory panel meeting is scheduled for December 8, to evaluate the safety of drospirenone and determine if regulatory actions may be necessary to protect women from a possible risk of blood clot-related injuries.

In October, the FDA released a report that determined drospirenone-based birth control pills may increase the risk of blood clots by 75% over some older birth control pills. And they also doubled the risk of heart attacks and strokes in users who were new to birth control, with some health problems appearing less than three months after women started to take the pills.

Thousands of women throughout the United States are currently filing Yaz, Yasmin, Beyaz and Ocella lawsuits against Bayer after experiencing health problems and side effects.

The use of Actos, a popular diabetic drug, is associated with an increased risk of bladder cancer. If you have developed bladder cancer as a result of using the drug Actos, then you need to consider the time you have to file a lawsuit for the injuries you have suffered. The right to file a lawsuit is not indefinite and is time limited, this is known as the statute of limitations. You have a certain amount of time to file a personal injury lawsuit, or the claim will expire irrespective of how strong your case is.

In the United States, personal injury statute of limitations vary from the state to state. Most states have a statute of limitations that runs for two years after the date of the injury. But, it is hard to pin down the starting date of the injury. For example, did the injury occur when the patient first began taking Actos, or was it when the bladder cancer was first diagnosed, or when the victim first realised the link between the bladder cancer and Actos or when the patient had surgery for his bladder cancer?

Typically, the court rules that the statute of limitations starts when the victim should have known about the dangerous side effects of the drug. Sometimes the drug manufacturer makes a public announcement that their drug is causing side effects; then the plaintiff should know about the danger, starting the statute of limitations. Sometimes, the court rules that the statute of limitations begins after the Food and Drug Administration issues a warning about the danger of the drug or makes a "black box warning." At this point, the drug manufacturer’s dangerous drug is public knowledge. In the case of Actos, the FDA went public in June of 2011, and issued a warning.

In most drug injury cases, the victims may have been taking the dangerous drug for many years before the risk became known, for example Accutane and Inflammatory Bowel Disease. Here, the court must extend the statute of limitations to the point at which the danger became public, or most of the people who are harmed will be excluded from claiming compensation.

Multi-District Litigation and Statutes of Limitations
The Court presiding over the representative cases (bellwether trials) will establish damages for all other cases. The jurisdiction for the representative cases was likely chosen for some specific reason, for example because it is the home jurisdiction of the defendant. While the damage caps, procedures, and rules of evidence will be those of jurisdiction handling the representative cases, the statute of limitations will be that of the jurisdiction in which the victim was injured; you retain the statute of limitations of your state, which is two years in Texas, three years in Arkansas etc. Click here to find out the Statute of Limitations in your jurisdiction.

Disclaimer: This blog was created to provide timely information about Actos®. The information on this site is intended for educational purposes only and is not intended for the purpose of providing legal advice, nor the formation of an attorney-client relationship. The information presented is general and may not apply to your specific circumstances.

Actos is a member of a class of drugs known as thiazolidinediones, which have been linked to bladder cancer. Actos side effects include increased risk of congestive heart failure, and an increased risk for bladder cancer. In August 2011, the first lawsuits were filed against Actos manufacturer Takeda Pharmaceuticals blaming the diabetes drug for instances of bladder cancer. Victims are suing for financial compensation for the cost of hospital bills and loss of income, as well as physical and emotional suffering.

Federal judge, Judge Keenan has appointed a law professor to oversee settlement talks in hundreds of Fosamax jaw decay lawsuits filed throughout the United States.

John Feerick, of the Fordham University School of law was appointed Special Settlement Master on November 22, in the federal multidistrict ligitation (MDL) for all federal lawsuits involving jaw problems from Fosamax.

Feerick will attempt to facilitate a Fosamax settlement agreement between Merck and plaintiffs who claim that the osteoporosis drug caused them to suffer decay of the jaw bone, known as osteonecrosis of the jaw (ONJ).

If the resolution of the Fosamax jaw litigation is not successful, then Judge Keenan may remand individual lawsuits back to the federal district courts where they were originally filed for individual trials throughout the country.

There are currently close to a thousand product liability lawsuits over Fosamax jaw necrosis filed in federal court against Merck, with another two hundred cases pending in New Jersey and other state courts. All of the complaints involve similar claims that Merck failed to adequately warn consumers and doctors about the risk of Fosamax side effects.

Fosamax (alendronate sodium) is an oral bisphosphonate medication, which has been associated with decay of the jawbone when taken long-term or at high doses. With a very long half-life of 10 years, most of the Fosamax claims argue that dose accumulation over time increases the risk of ONJ; where the jaw bone begins to decay and can result in bone showing through the skin. In some cases full or partial jaw removal is required, with resulting facial deformities.

Merck has successfully defended its medication in all but one of the Fosamax jaw cases that have gone to trial so far. In the one trial where the plaintiff was successful in establishing that the medication caused her jaw problems, the jury awarded $8 million in damages from Fosamax. Judge Keenan subsequently ruled that the verdict was excessive and the plaintiff elected to have another trial rather than accepting Keenan’s reduced award of $1.5 million. Merck is currently appealing that verdict on other grounds.

In addition to the jaw litigation, Merck also faces a growing number of Fosamax lawsuits over sudden femur fractures, which have been consolidated before U.S. District Judge Garrett E. Brown, in the U.S. District Court for the District of New Jersey as part of a separate multidistrict litigation (MDL).

According to a new medical study and analysis, irrespective of the implant material, all types of hip replacement devices appear to work the same. The researchers said, the newer, metal-on-metal implants seem to be no more effective than older implants and may sometimes even be more problematic.

"Metal-on-metal and ceramic-on-ceramic hip implants might not be associated with any advantage, compared with traditional bearings such as metal-on-polyethylene or ceramic-on-polyethylene," said lead researcher Dr. Art Sedrakyan, director of the Patient-Centered Comparative Effectiveness Program at Weill Cornell Medical College in New York City.

Sedrakyan said there is some medical evidence from three large national registries that higher rates of replacement surgery are associated with metal-on-metal implants, compared with metal-on-polyethylene implants. Even for newer implants such as metal-on-metal or ceramic-on-ceramic bearings, their advantage over traditional implants is not clear, Sedrakyan added.

The report was published in the Nov. 29 online edition of the BMJ.

Older hip implants made with metal-on-polyethylene or ceramic-on-polyethylene surfaces are associated with low failure rates. Newer metal-on-metal hip implants have been linked with severe cases of accumulation of metal ions in patients' tissues, a condition called metallosis.

Working with the FDA, Sedrakyan's team looked at the safety and effectiveness of various types of hip implants in 18 studies including more than 3,000 patients and 800,000 operations.

The investigators found no difference between the various types of implants in terms of the patients' quality of life or ability to function normally. "A large and high-quality randomized controlled trial of bearing surfaces in total hip replacement needs to be conducted before any claims of benefit are made," they wrote online in BMJ.

The analysis included 3,139 patients (and 3,404 hips) enrolled in 18 randomized trials or comparative observational studies, and more than 830,000 operations in national registries. The mean age of the patients ranged from 42 to 71. Follow-up ranged from three months to 8.1 years.

In the three largest registries -- from Australia, New Zealand, and England and Wales -- revision rates were higher with metal-on-metal implants compared with metal-on-polyethylene.

Compared with metal-on-polyethylene bearings, ceramic-on-ceramic implants were associated with more revisions in New Zealand, fewer in England and Wales, and a similar number in three other registries. "Only large, longitudinal, multinational registries can provide denominator data for adverse events related to specific implants and allow proper conduct of comparative safety and effectiveness studies, particularly for rare endpoints," they wrote.

To that end, the FDA has started the International Consortium of Orthopedic Registries to lay the groundwork for a worldwide collection of registries.